Frequency Of Anginal Attacks Research Articles

Efficacy and safety of Danlou tablets in the treatment of stable angina pectoris with intermingled phlegm and blood stasis syndrome in coronary heart disease: a multicenter randomized controlled study.

In this study, we assessed the clinical efficacy and safety of Danlou tablets in the treatment of stable angina pectoris (SAP) with intermingled phlegm and blood stasis (IPBS), to provide high-quality evidence-based medical evidence for the prevention and treatment of coronary heart disease. In this multicenter randomized controlled study, 304 patients diagnosed with stable angina pectoris with IPBS enrolled from 12 national traditional Chinese medicine (TCM) clinical research centers in China were randomly assigned to the treatment group and the control group at a ratio of 1:1. Each group was divided into four subgroups based on the results of TCM syndrome differentiation: IPBS, IPBS combined with qi deficiency, IPBS combined with qi stagnation, and IPBS combined with toxin accumulation. The control group was treated with routine Western medicine. In addition to routine Western medicine treatment, the treatment group (the IPBS group) was treated with Danlou tablets or Danlou tablets supplemented by interventional therapies based on the results of traditional Chinese medicine differentiation. The frequency of angina attacks per week was the main efficacy evaluation indicator and the secondary efficacy evaluation indicators included angina symptom score, Seattle Angina Questionnaire, an electrocardiogram (ECG) efficacy evaluation, a cardiac Doppler two-dimensional ultrasound, an electrocardiogram treadmill exercise test, blood lipids, blood glucose, a coagulation function test, hemorheology indicators, homocysteine, C-reactive protein (CRP) or high sensitivity-CRP, TCM syndromes (syndrome score, tongue, pulse), and long-term prognosis (endpoint outcome, cardiovascular events). There were 300 cases in the full analysis set (FAS), 266 in the per-protocol set (PPS), and 300 in the safety set. Regarding the main efficacy indicator, after treatment, the reduction in the frequency of weekly angina attacks in the treatment group was significantly greater than that in the control group (P < 0.05). The results of the FAS and PPS were consistent. Regarding the secondary efficacy evaluation indicators, the angina symptom, TCM syndrome, ECG evaluation, Seattle Angina Pectoris Questionnaire, and 36-item Health Status Survey Summary Form scores of the treatment group were significantly higher than the control group (P < 0.05) and the homocysteine levels of the treatment group were significantly reduced (P < 0.05). The results of the FAS and PPS were consistent. In the PPS, the triglyceride levels in the treatment group were significantly lower than those in the control group after treatment (P < 0.05). The activated partial thromboplastin time in the treatment group decreased significantly (P < 0.05). There was no statistically significant difference in the safety indicators and incidence of adverse reactions between the two groups. Treatment with Danlou tablets and the modified combination therapy based on Western medicine treatment could improve angina pectoris symptoms of patients with SAP and IPBS syndrome and its concurrent syndromes, and improve patients' quality of life. Furthermore, the treatment is safe, has a long-term prognosis, and is worth further promotion and application in clinical practice. https://www.chictr.org.cn/showproj.html?proj=39724, ChiCTR registry, ChiCTR1900023708.

Are there any benefits from prescribing a cardiac cytoprotector to enhance the quality of life in patients with coronary heart disease and chronic heart failure?

Introduction. Type 2 diabetes (T2D) increases the risk of developing cardiovascular diseases, which leads to a high mortality in this category of patients. Issues regarding the prevention of the onset and progression of coronary heart disease (CHD) and chronic heart failure (CHF) in patients with T2D and/or metabolic syndrome (MS) are still not fully understood. The use of metabolic drugs with cardioprotective effects, in particular Mildronate®, is one of the possibilities to improve the effectiveness of combination treatment of CHD and CHF.Aim. To study the effect of Mildronate® on the quality of life (QoL) of patients with CHD and CHF, suffering from T2D and/or MS.Materials and methods. A total of 2.084 patients with co-occurring two (or more) disorders: obesity, type 2 diabetes, angina pectoris, CHT, and CHF were included in the INDICOR observational study conducted in real-life clinical practice settings. Group 1 received therapy with disease-modifying agents prescribed due to CHD and T2D; Group 2 received Mildronate® at a dose of 1000 mg per day in addition to the same therapy. The studied lab test results were assessed at baseline and 42 days of therapy.Results. A 42-day course of therapy in patients receiving Mildronate® at a dose of 1000 mg per day in addition to disease-modifying therapy (DMT) contributed to a percentage increase in the number of patients with CHD, FC (functional class) I angina pectoris (Δ,% + 63%, p &lt; 0.001 ) as compared to the control group with no significant changes (Δ,% + 7%, p &gt; 0.5). A significant increase in the number of patients with FC I CHF was recorded in Group 2 (from 23.5 to 42.1%, Δ,% + 79%) as compared to Group 1, where no significant changes were detected (22.7 to 23.7%, Δ,% + 4%). The QoL in patients with CHF based on data collected using the Minnesota Questionnaire and QoL in patients with CHD based on data collected using the Seattle Questionnaire significantly improved in the groups that received Mildronate® in addition to DMT, as compared with the group of patients who were only on DMT.Conclusion. Results from the Seattle and Minnesota questionnaires showed that the use of Mildronate® as part of combination therapy in patients with CHD and CHF, suffering from T2D and/or MS, contributed to a significant reduction in the frequency of angina attacks and lowering angina FC, CHF FC, and also enhanced the quality of life in this category of patients.

Характеристика пацієнтів з ішемічною хворобою серця та стабільною стенокардією в Україні, оцінка підходів до їх лікування за даними багатоцентрового дослідження GO-OD

Treatment of coronary artery disease (CAD) and stable angina, includes lifestyle modification, pharmacological therapy and invasive interventions to achieve stabilization or regression of the disease. Knowledge of the current situation regarding the use of pharmacological therapy and evaluation of its effectiveness is necessary for further management optimization. Trimetazidine (TMZ) has previously been shown to reduce angina symptoms and increase exercise tolerance in patients with CAD and stable angina and may be among an option for optimizing antianginal treatment. However, the effectiveness of long-term treatment depends on patient adherence, so the use of TMZ once daily (OD) at a dose of 80 mg may improve satisfaction and adherence in patients with CAD and stable angina.Methods. The GO-OD study is a 3-month, non-interventional, observational, multicenter prospective study conducted in Ukraine in a real-world outpatient cardiology practice during February – August 2021. Physicians were instructed to continue monitoring and treating patients in accordance with usual practice and international guidelines. No additional diagnostic or monitoring procedures were performed. Clinical, instrumental and laboratory data, frequency of angina attacks, consumption of short-acting nitrates (SAN), adherence to antianginal drugs, as well as the overall efficacy, tolerability of TMZ OD 80 mg in real-world clinical practice were analyzed. The observation includes regular assessment of patients` clinical status, treatment optimization and its effectiveness at follow up visits.Results. The study included 1529 patients (mean age 62.5 years, 56 % men). In the absence of adequate control of risk factors, pharmacological control of symptoms, and limited use of interventional and surgical treatments, the frequency of angina episodes was high, most patients had a pronounced angina functional class according to the Canadian Society of Cardiology classification (10.5 % – CCS I, 60.1 % – CCS II, 29.5 % – CCS III). Thus, the average number of angina attacks per week in CCS I was 3.7, in CCS II – 5.2, and in CCS III – 7, 97 attacks. In addition to the severity of symptoms, the following pattern was observed: the higher the angina class, the more risk factors and comorbidities patients had. After 3 months of follow-up due to optimization of therapy, there was a significant (p&lt;0.001) decrease in the frequency of angina attacks – from (5.8±4.7 to 1.6±2.0)/week, and the use of SAN – from (4.2±4.3 to 0.8±1.6)/week). At the same time, in 3 month the % of patients with CCS II and III significantly decreased, while the % of patients with CCS I increased (48.4 % – CCS I, 45.7 % – CCS II, 6 % – CCS III). Adherence to medication was improved: 49 % of patients reported high adherence (vs. 18 % at baseline) and 12 % – low adherence (vs. 52 % at baseline). After 3 months of follow-up most of doctors rated the overall tolerability and effectiveness of the therapy as «very satisfied». Patients’ satisfaction with TMZ OD 80 mg therapy after 3 months of follow-up was 9.5 points [on a scale of 1 to 10 (very satisfied)]. Patients’ assessment of daily physical activity increased significantly: 2.42 versus 5.89 points at baseline (on a scale of 1 to 10 (severe limitation)).Conclusions. In general, the management of outpatients with CAD and stable angina in the current cardiologists’ practice, which was complicated by the COVID-19 pandemic, was not effective enough, resulting in a high frequency of angina attacks – almost 6 per week, and a significant limitation of daily activity due to angina symptoms.Significant deficiency in the management of studied population was insufficient correction of such important risk factors as hypertension, heart rate, dyslipidemia, and lifestyle-related risk factors (overweight and obesity, low level of physical activity). The baseline therapy of patients in the study was in line with current guidelines, but with an insufficient frequency of statin prescription (78 %) and ACE inhibitors (54.5 %); antianginal treatment with an average of 2 or more antianginal drugs was not optimal for controlling angina symptoms, and the frequency of coronary revascularization procedures was also insufficient, mostly during acute MI (58.0 %).Optimization of drug therapy as the first step in correcting the condition of patients with CAD and stable angina in accordance with all current recommendations with the inclusion of the original trimetazidine OD 80 mg once daily among antianginal drugs, as well as active monitoring of patients for 3 months allowed to reduce the frequency of angina attacks regardless of its initial FC, increase patient adherence to treatment and their functional activity.

Real-World Data from the Use of Ranolazine in Patients with Stable Angina Pectoris: The RANGER Study.

Background: Although ranolazine has been available for years as a second-line treatment to reduce angina attacks in patients with stable angina pectoris, real-world data on the effectiveness, tolerability, and safety of ranolazine are limited. Methods: A non-interventional, prospective study was conducted to assess the effectiveness and safety of ranolazine. Patients eligible for enrolment had a baseline assessment between one and fourteen days after initiating ranolazine for the first time and a follow-up visit three months later. The primary endpoints comprised the weekly frequency of angina attacks, total adverse events, and ranolazine discontinuation rate. The secondary endpoints included the use of short-acting nitrates, changes on the Canadian Cardiovascular Society (CCS) angina classification score and quality of life scale score (QoL). Results: In total, 1101 patients were enrolled at 214 sites. Mean weekly angina attacks were reduced from 3.6 ± 2.9 to 0.4 ± 0.9 (p < 0.0001) and the mean weekly consumption of short-acting nitrates decreased by 1.7 ± 2.2 (p < 0.0001). CCS class and QoL were also improved (p < 0.0001). Adverse events were reported by 11 (1%) patients in total, while 2 of them (0.2%) were characterised as serious. Treatment was discontinued for various reasons in 23 patients (2.1%) after the follow-up period. Ranolazine treatment was equally effective in all subgroups tested, with larger benefits observed in patients with more frequent angina and CCS angina class III and IV. Up-titration of ranolazine during the study improved the outcomes. Conclusions: Ranolazine was well tolerated and effectively reduced angina attacks, with simultaneous improvement of the CCS class and QoL score in patients with stable angina.

Compound Danshen Dripping Pills combined with isosorbide mononitrate for angina pectoris: A systematic review and a Meta-analysis

ObjectiveTo evaluate the efficacy of Compound Danshen Dripping Pills (CDDP) combined with isosorbide mononitrate (ISMN) versus ISMN alone for treating angina pectoris in patients. MethodsThe PubMed, Web of Science, Cochrane Library, Embase China National Knowledge Infrastructure, China Biomedical Literature Service System, Chinese Medical Journal Database, and Wan Fang MED databases were searched from inception to November 2022. Randomized controlled trials (RCTs) and cohort studies were included. The primary outcomes were angina symptom and electrocardiography (ECG) efficacy, angina symptom efficacy, and ECG efficacy. The protocol was registered with PROSPERO No. CRD42022314774. ResultsOur study included 7 245 patients with angina (59 RCTs, 11 cohort studies). When ISMN was combined with CDDP, the efficacy of angina symptom and ECG [odds ratio (OR) = 4.824, 95% confidence interval (CI) = 3.636–6.401, P = 0.000], the efficacy of angina symptom (OR = 4.347, 95% CI = 3.635–5.198, P = 0.000), the efficacy of ECG (OR = 3.364, 95% CI = 2.767–4.089, P = 0.000) were better than that of patients treated with ISMN alone. CDDP combined with ISMN was superior to ISMN alone in reducing triglyceride (TG) [mean difference (MD) = −35.176, 95% CI = −37.439 to −32.912, P = 0.000], total cholesterol (TC) (MD = −24.296, 95% CI = −26.429 to −22.163, P = 0.000), the duration of angina attack (MD = −1.991, 95% CI = −2.349 to −1.633, P = 0.000), and the frequency of angina attack [standardized MD (SMD) = −2.840, 95% CI = −3.416 to −2.265, P = 0.000]. There was no increase in adverse events between CDDP combined with ISMN and ISMN alone (OR = 0.513, 95% CI = 0.421–0.626, P = 0.000). ConclusionCDDP combined with ISMN improved treatment efficacy and was well tolerated. Therefore, this combination could be used as an alternative treatment. However, clinical and patient conditions should be considered.

Efficacy and safety of tongxinluo capsule for angina pectoris of coronary heart disease: an overview of systematic reviews and meta-analysis.

Tongxinluo capsule (TXLC) is a common drug for treating angina pectoris of coronary heart disease (CHD). In recent years, many systematic reviews (SRs) and meta-analyses (MAs) have reported the efficacy and safety of TXLC for improving angina symptoms in patients with CHD. We aimed to comprehensively evaluate the existing SRs and MAs of TXLC in treating angina pectoris of CHD, summarize the evidence quality, and provide scientific evidence and recommendations. We searched seven databases for relevant SRs/MAs published up to 1 June 2023. Two reviewers independently completed the literature retrieval, screening, and data extraction. We used A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) to evaluate the methodological quality, the Risk of Bias in Systematic Reviews (ROBIS) to assess the risk of bias, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to determine the strength of the evidence. RevMan 5.3 was used to synthesize data. We identified 15 SRs/MAs, including 329 RCTs and 33,417 patients. According to the evaluation results of AMSTAR-2, only one SR was of high methodological quality, the others were very low. ROBIS assessment showed that one SR (6.67%) had a low risk, 3 SRs (20%) had an unclear risk, and 11 SRs (73.33%) had a high risk. We assessed 42 outcomes by the GRADE, 10 (23.81%) for moderate-quality evidence, 17 (40.48%) for low-quality evidence, and 15 (35.71%) for very-low-quality evidence. Mate-analysis showed that TXLC combined with conventional western medications improved electrocardiogram efficacy (RR = 1.38, 95% CI: 1.23-1.43, P < 0.001) and angina efficacy (OR = 3.58, 95% CI: 3.02-4.24, P < 0.001), reduced angina attack frequency (SMD = -0.54, 95% CI: -0.64 to -0.44, P < 0.001) and angina duration (SMD = -0.42, 95% CI: -0.57 to -0.28, P < 0.001), with general heterogeneity. The pooled results showed that TXLC appears to have some efficacy in improving cardiac function and relieving angina symptoms, but there is limited evidence that it improves cardiovascular event rates, hemorheology, lipids, or hs-CRP. In the assessment of drug safety, TXLC was associated with different degrees of adverse drug reactions. Based on the evidence, TXLC may be effective as an adjuvant treatment for angina pectoris of CHD. However, the quality of the evidence is low, and the drug's safety must be carefully interpreted. In future studies, high-quality randomized controlled trials are needed to confirm the effectiveness and safety of TXLC. http://www.crd.york.ac.uk/PROSPERO/, identifier (CRD42022365372).

Clinical comprehensive evaluation of Shexiang Tongxin Dropping Pills

Based on literature and questionnaire research, related evidence and related data on Shexiang Tongxin Dropping Pills were collected in terms of safety, effectiveness, economy, innovation, suitability, and accessibility. In addition, multi-criteria decision analysis(MCDA) model was used to comprehensively evaluate the clinical value of Shexiang Tongxin Dropping Pills. Quality control was carried out strictly based on evidence-based medicine evaluation. Shexiang Tongxin Dropping Pills were recommended for stable fatigue angina of coronary heart disease with Qi deficiency and blood stasis by guidelines and experts. The conventional treatment of western medicine adds Shexiang Tongxin Dropping Pills to reduce the frequency of angina attacks, shorten the duration, improve exercise tolerance, and improve the quality of life and Chinese symptoms, and the effectiveness is rated as grade A. Adverse reactions are mostly general adverse reactions, and no serious adverse reactions have been reported, consistent with the known risks listed in the instruction for adverse events, contraindications, and precautions. The safety is rated as grade A, and the daily cost is 7.74 yuan. The cost-effectiveness shows that it is a treatment regimen with pharmacoeconomic advantages, and the economic performance is rated as grade A. According to specialist research, Shexiang Tongxin Dropping Pills have good clinical innovation and service innovation, and innovation is rated as grade A. There are no special storage conditions, medicinal material ingredients, or other restrictions, and the clinical use meets the specifications of the medication guidelines. The suitability is rated as grade A. The price level, availability, and affordability of drugs are generally good, and the accessibility is rated as grade A. The clinical value of Shexiang Tongxin Dropping Pills is great.

PECULIARITIES OF CARBOHYDRATE METABOLISM INDICATORS, THE FUNCTIONAL STATE OF THE THYROID GLAND IN THE COURSE TREATMENT WITH TELMISARTAN AS PART OF THE COMPLEX THERAPY OF PATIENTS WITH CORONARY ARTERY DISEASE, TYPE 2 DIABETES MELLITUS ON THE BASIS OF METAB

Aim. Is to study the characteristics of carbohydrate metabolism indicators, the functional state of the thyroid gland in the course treatment with Telmisartan as a part of the complex therapy of patients with Coronary Artery Disease, type 2 Diabetes Mellitus on the basis of Metabolic Syndrome.&#x0D; Materials and Methods. Research design. The first stage - formation of groups (the experimental group and the comparison group). The experimental group consisting of 27 patients (13 men and 14 women), taking Telmisartan 80 mg/day as a part of complex therapy (Metformin, Amlodipine, Rosuvastatin, Acetylsalicylic acid, and Nitroglycerin as needed). The comparison group consisting of 24 patients (12 men and 12 women) taking Ramipril, 5 mg/day in addition to the standard therapy, mentioned above. At the second stage, the patients were examined for carbohydrate metabolism and Thyroid-stimulating hormone and free Thyroxine. At the third stage, patients were prescribed the treatment for 1 month. The dose of metformin did not change during the study. Re-examination of hormones and carbohydrate metabolism parameters one month after the start of therapy was carried out at the fourth stage. The control group consisted of 40 practically healthy people (17 men and 23 women). The work involved researching the carbohydrate spectrum parameters as well as the followings hormones: free Thyroxine and Thyroid-stimulating hormone, control of blood pressure parameters. The Patients were examined twice, on the day of admission to inpatient treatment and after 1 month. According to the results of the obtained data, the studied groups were compared with each other, as well as with a group of healthy individuals.&#x0D; Results and Discussion. The study compared the dynamics of blood pressure parameters, indicators of carbohydrate metabolism, Thyroid-stimulating hormone and Free thyroxine in patients with Coronary Artery Disease and compensated type 2 Diabetes Mellitus on the basis of Metabolic Syndrome, depending on their intake of Telmisartan or Ramipril against the background of standard therapy, which included: Metformin, Amlodipine, Acetylsalicylic acid. In the group taking Telmisartan as part of complex treatment, a decrease in clinical manifestations of syntropic pathology was found, and the presence of positive dynamics of diastolic blood pressure indicators was noted even after 1 month of treatment. Patients experienced a decrease in the frequency of angina attacks, reduced shortness of breath, palpitations during exercise, headaches, dizziness, anxiety, improved attention and memory. The results of our study show taking Telmisartan as a part of complex therapy contributed to changes in the parameters of carbohydrate metabolism such as fasting blood glucose, insulin level, HOMA-IR index decreased significantly, which can be explained by a decrease in insulin resistance at addition Telmisartan to the complex treatment. In contrast to the mentioned above parameters, indicators of glycosylated hemoglobin after 1 month treatment did not change significantly, which can be explained by the insufficient duration of treatment. In the patients of the experimental group, it was found that the level of Thyroid-stimulating hormone significantly decreased during treatment with Telmisartan as part of complex therapy, in contrast to the comparison group, taking Ramipril at the same time. The level of free Thyroxine in patients with experimental group increased a month after start of therapy, while it remained unchanged in patients with comparison group.&#x0D; Conclusions. The effectiveness of correction of diastolic blood pressure parameters, the presence of peculiarities of changes in carbohydrate metabolism and thyroid functional state when Telmisartan is used as part of the complex therapy of patients with Coronary Artery Disease and compensated type 2 Diabetes Mellitus on the basis of Metabolic Syndrome. The use of Telmisartan as part of complex treatment reduces insulin resistance; helps to reduce the level of fasting blood glucose, values of the HOMA-IR index, as well as the amount of insulin in the blood. The use of Telmisartan in patients with Coronary Artery Disease and type 2 Diabetes Mellitus on the basis of Metabolic Syndrome aids in reducing the level of Thyroid-stimulating hormone and increase in free Thyroxine (within the reference values), confirming participation in the correction of metabolic changes.

Tongxinluo capsule in combination with conventional therapies for stable angina pectoris: A meta-analysis and systematic review.

This study aimed to assess the efficacy and safety of Tongxinluo capsule (TXLC) in combination with conventional therapies for treating stable angina pectoris (SAP) through a comprehensive meta-analysis and systematic review. We conducted a systematic search of the China National Knowledge Infrastructure, Wanfang, VIP, PubMed, Embase, and CENTRAL databases for randomized controlled trials investigating the use of TXLC as adjuvant therapy for SAP published up to June 2023. The Cochrane Handbook was used to evaluate the risk of bias. Meta-analysis was performed using Review Manager 5.4.1, and publication bias was assessed using Begg test and Egger test in the Stata SE 12.0 software. GRADEpro was used to assess the quality of the evidence. This meta-analysis included 26 randomized controlled trials with a total of 2352 patients. TXLC co-administration demonstrated significant reduction in angina attack frequency (mean difference (MD) -0.91, 95% confidence interval (CI) -0.97 to -0.84, P < .00001) and duration (MD -1.71, 95% CI -2.24 to -1.19, P < .00001), decreased use of nitroglycerin tablets (MD -6.28, 95% CI -7.16 to -5.41, P < .00001), lowered C-reactive protein (MD -1.19, 95% CI -1.35 to -1.03, P < .00001) and low-density lipoprotein cholesterol levels (MD -0.68, 95% CI -0.86 to -0.51, P < .00001). TXLC co-administration did not increase gastrointestinal reactions (RR 1.17, 95% CI 0.38 to 3.57, P = .78). The Begg test and Egger test results indicated no publication bias. The evidence quality was rated as very low for frequency of angina attack, duration of angina attack, and nitroglycerin usage, and low for C-reactive protein, low-density lipoprotein cholesterol levels, and gastrointestinal reaction events. This meta-analysis supports TXLC as a beneficial adjunct treatment for SAP.

Outcome indicators in clinical trials on traditional Chinese medicine treatment of microvascular angina

This study reviewed the current status of the use of outcome indicators in randomized controlled trial(RCT) on traditional Chinese medicine(TCM) treatment of microvascular angina(MVA) and analyzed the existing problems and possible solutions, aiming to provide a basis for the design of high-quality RCT and the establishment of core outcome sets for MVA. CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, and 2 clinical trial registries were searched for the RCT on TCM treatment of MVA according to pre-defined criteria. The Cochrane's risk of bias assessment tool was used to evaluate the methodological quality of the included RCT and the use of outcome indicators was summarized. A total of 69 RCTs were included, from which 100 outcome indicators were extracted, with the frequency of 430. The extracted outcome indicators belonged to 8 domains: response rate, symptoms and signs, physical and chemical examinations, TCM efficacy, safety, quality of life, economic evaluation, and long-term prognosis. The indicators of physical and chemical examinations were the most(70 indicators with the frequency of 211), followed by those of response rate(7 indicators with the frequency of 73) and symptoms and signs(7 indicators with the frequency of 54). The outcome indicators with higher frequency were adverse reactions, angina attack frequency, clinical efficacy, endothelin-1, total duration of treadmill exercise, and hypersensitive C-reactive protein. The RCT on TCM treatment of MVA had the following problems: irregular reporting of adverse reactions, diverse indicators with low frequency, lack of attention to the application of endpoint indicators, insufficient use of TCM differentiation and efficacy indicators, non-standard evaluation criteria and failure to reflect the basic characteristics of TCM. A unified MVA syndrome differentiation standard should be established, on the basis of which an MVA treatment efficacy evaluation system and core outcome indicator set that highlights the characteristics of TCM with patient-reported outcomes as the starting point should be established to improve the clinical research and research value.

Efficacy and safety of the endothelin-1 receptor antagonist macitentan in epicardial and microvascular vasospasm; a proof-of-concept study

BackgroundTreatment of patients diagnosed with angina due to epicardial or microvascular coronary artery spasm (CAS) is challenging because patients often remain symptomatic despite conventional pharmacological therapy. In this prospective, randomized, double-blind, placebo-controlled, sequential cross-over proof-of-concept study, we compared the efficacy and safety of macitentan, a potent inhibitor of the endothelin-1 receptor, to placebo in symptomatic patients with CAS despite background pharmacological treatment. MethodsPatients with CAS diagnosed by invasive spasm provocation testing with >3 anginal attacks per week despite pharmacological treatment were considered for participation. Participants received either 10 mg of macitentan or placebo daily for 28 days as add-on treatment. After a wash-out period patients were crossed over to the alternate treatment arm. The primary endpoint was the difference in anginal burden calculated as [1] the duration (in minutes) * severity (on a Visual Analogue Scale (VAS) pain scale 1–10); and [2] the frequency of angina attacks * severity during medication use compared to the run-in phase. Results28 patients of whom 22 females (79%) and a mean age of 55.3 ± 7.6 completed the entire study protocol (epicardial CAS n = 19 (68), microvascular CAS n = 9 (32)). Change in both indices of anginal burden were not different during treatment with add-on macitentan as compared to add-on placebo (duration*severity: −9 [−134 78] vs −45 [−353 11], p = 0.136 and frequency*severity: −1.7 [−5.8 1.2] vs −1.8 [−6.2 0.3], p = 0.767). The occurrence and nature of self-reported adverse events were closely similar between the treatment phase with macitentan and placebo. ConclusionIn patients with angina due to epicardial or microvascular CAS despite background pharmacological treatment, 28 days of add-on treatment with the ET-1 receptor antagonist, macitentan 10 mg daily, did not reduce anginal burden compared to add-on treatment with placebo.Trial Registrationhttps://trialsearch.who.int/, Identifier: EUCTR2018-002623-42-NL. Registration date: 20 February 2019.

Secondary Prevention and Quality of Life of Patients with Stable Coronary Heart Disease

Aim. To assess the quality of life of patients with stable coronary heart disease (CHD) initially and 12 months after drug and non-drug secondary prophylaxis according to clinical guidelines.Material and methods. 73 patients (57 men, 16 women) with confirmed stable coronary artery disease were included in the study, of which 44 patients described a clinic for angina pectoris of functional class I-IV. The study included 2 patient visits: an initial treatment visit (V0) and a repeat visit after 12 months (V2). At both visits, blood pressure (BP), low-density lipoprotein cholesterol (LDL-c), quality of life (QL) were assessed using SAQ (Seattle Angina Questionnaire), drug therapy. Compliance with 5 basic principles of prevention was also assessed, which included: (1) healthy lifestyle (healthy lifestyle) (rejection of bad habits (smoking), moderate physical activity, lowcholesterol and low-carb diet); (2) normalization of body weight; (3) optimal drug therapy (the frequency of taking medications was evaluated using the original questionnaire); (4) achievement of target values of LDL-c in the entire group; (5) blood pressure in hypertensive patients. During V0, if necessary, drug therapy was adjusted in accordance with clinical recommendations. During V2, 57 patients (47 men and 10 women) were examined. The response was 80.8%.Results. After 12 months of follow-up, a statistically significant improvement in exercise tolerance (p=0.003), angina stability index (p=0.045) and the frequency of stress angina attacks (p=0.003) was noted when assessing the median of QL indicators. After 12 months of follow-up, 59% of patients used optimal drug therapy, including 4 drugs according to clinical guidelines. A healthy lifestyle (regular physical activity and smoking cessation) was achieved in 20.4% after 12 months of follow-up, the target level of LDL-c ˂ 1.8 mmol/L was achieved in 44.5% of patients, and the target blood pressure was achieved in 74,6%. The achievement of all 5 principles of secondary prevention of coronary heart disease according to the results of the work carried out by the visit after 12 months of follow-up was revealed only in 7% of patients (4 patients), and the implementation of 4 principles of prevention was noted in a quarter of patients from the group (24.5%, n=14).Conclusions. With drug and non-drug secondary prevention of coronary heart disease in patients with stable CHD after a year of follow-up, a statistically significant increase in QL indicators was noted due to increased exercise tolerance and a decrease in the frequency of angina attacks. Nevertheless, the basic principles of prevention were fully implemented only in 7% of patients.

The efficacy of sodium ferulate combination therapy in coronary heart disease: A systematic review and meta-analysis

BackgroundSodium ferulate (SF), a derivative of ferulic acid, is one of the active constituents in medicinal plants thought to be useful in fighting cardiovascular diseases. However, there still lacks a systematic review of the efficacy and safety of SF in treating coronary heart disease (CHD). It is therefore the purpose of this study to comprehensively review all clinical randomized controlled trials (RCTs) of SF in CHD to assess its efficacy and safety. MethodsAll analysis is based on 8 databases as of February 2023, which includes 35 outcomes of RCTs that investigate the effect of SF combination therapy in CHD. The present study evaluates the quality and bias of selected literature by the Jadad scale and Cochrane Collaboration's tools, and also the quality of evidence by GRADE Profiler. Furthermore, it applies sensitivity analysis to assess the high heterogeneity impact of outcomes and conducted subgroup analysis to estimate the influence factors in these studies. The study protocol was set documented, and published beforehand in PROSPERO (Registration No.CRD42022348841). ResultsThe meta-analysis of 36 studies (with 3207 patients) shows that SF combined with conventional drugs has improved clinical effectiveness for patients with CHD [RR: 1.21 (95% CI 1.17,1.26); p < 0.00001]. Statistically significant results of meta-analyses are also seen in electrocardiography (ECG) efficacy, frequency of angina attacks, endothelium-dependent flow-mediated vasodilation (FMD), nitric oxide (NO), endothelin (ET), whole Blood low shear rate (LS), platelet aggregation test (PAgT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL6), triglyceride (TG). Adverse events are reported in 6 RCTs. By GRADE approaches, 2 outcomes (clinical efficacy, CRP) indicate a moderate quality of evidence, 17 outcomes indicate low quality of evidence, with the other 16 very low-quality. ConclusionSF combination therapy has a better curative effect than conventional therapy. However, due to items with low-quality evidence demonstrated in the study, the presence of clinical heterogeneity, and imprecision in partial outcome measures, all these led to limitations in the evidence of this study. Thus, the conclusion needs to be further verified by more in-depth research.

COMPLEX REHABILITATION OF ISCHEMIC HEART DISEASE PATIENTS AFTER CORONARY BYPASS OPERATION WITH THE USE OF BIOLOGICALLY ACTIVE ADDITIVES

Aim: The purpose of the work was to study the possibility of using Dihydroquercetin in rehabilitation programs for patients with coronary artery disease after Coronary artery bypass grafting (CABG) surgery in order to increase the effectiveness of rehabilitation, which has notable scientific and practical significance. Materials and Methods: The methodological basis of the research is based on systemic, historical, terminological, and informational approaches. Results: The results of the study showed the high clinical effectiveness of Dihydroquercetin in the complex medical rehabilitation of patients with coronary artery disease who underwent the operation. The pill intake did not affect indicators of carbohydrate and lipid metabolism, which indicates its metabolic neutrality. None of the patients had any worsening of the condition, increased frequency of angina attacks, or episodes of painless ischemia. All patients indicated good tolerability of the drug, and improvement in general well-being (reduction or disappearance of shortness of breath, decrease in pain intensity, increase in activity, improvement in sleep). The implementation of the optimized rehabilitation program also contributed to the improvement of the psycho-emotional state of the patients. Conclusions: Сomplex medical rehabilitation of patients with coronary heart disease after Coronary artery bypass grafting surgery according to a program with the inclusion of Dihydroquercetin helps to improve the rheological properties of blood, strengthen the active vasomotor mechanisms of MC regulation, improve indicators of central and peripheral hemodynamics, blood oxygenation, increase in exercise tolerance, improve psycho-emotional the condition, which ultimately ensure an increase in the rehabilitation effect.

Real-world data from the use of ranolazine in patients with stable angina pectoris: the RANGER study

Abstract Background Although ranolazine is available since years as a second-line treatment to reduce angina attacks in patients with stable angina pectoris, real-world data on effectiveness, tolerability and safety of ranolazine are limited. Methods A non-interventional, prospective study conducted to assess the effectiveness and safety of ranolazine. Patients eligible for enrolment had a baseline assessment between one and fourteen days after initiating ranolazine for the first time and a follow-up visit three months later. Primary endpoints comprised the weekly frequency of angina attacks, total adverse events and ranolazine discontinuation rate. Secondary endpoints included the use of short-acting nitrates, changes on the Canadian Cardiovascular Society (CCS) angina classification score and quality of life scale score (QoL). Results In total, 1,101 patients were enrolled in 214 sites. Mean weekly angina attacks were reduced from 3.6±2.9 to 0.4±0.9 (p&amp;lt;0.0001) and the mean weekly consumption of short-acting nitrates decreased by 1.7±2.2 (p&amp;lt;0.0001). CCS class and QoL were also improved (p&amp;lt;0.0001). Adverse events were reported by 11 (1%) patients totally, while 2 of them (0.2%) were characterized as serious. Treatment was discontinued for any reason in 23 patients (2.1%) after the follow-up period. Ranolazine treatment was equally effective in all subgroups tested, with larger benefits observed in patients with more frequent angina and CCS angina class III and IV. Up-titration of ranolazine during the study improved the outcomes. Conclusion Ranolazine was well-tolerated and effectively reduced angina attacks with simultaneous improvement of CCS class and QoL score in patients with stable angina. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): The study was sponsored by Menarini Hellas. The study sponsor was involved in the study concept and design and in the interpretation of the data included in this publication, but not in the data collection and analysis. Menarini Hellas also funded the medical writing support for this publication.

Effectiveness and Safety of Treating Negative Emotions after PCI from the Perspective of Qi and Blood: A Systematic Review and Meta-Analysis.

Background Many patients undergoing PCI have been reported to suffer from psychological distress and negative emotions. Several lines of evidence have indicated that PCI patients with negative emotions are particularly vulnerable to myocardial reperfusion injury when they face psychological challenges. As proven by clinical trials and research, traditional Chinese medicine (TCM) has certain advantages in alleviating psychological symptoms in PCI patients. The level of evidence for TCM is not yet high. There is no existing systematic review to evaluate the effectiveness and safety of TCM in post-PCI patients. Methods PubMed, EMBASE, Cochrane Library, Web of Science, CNKI, VIP, Wanfang Database, and CBM were searched to identify randomized controlled trials (RCTs) that treated negative emotions after PCI using qi and blood cotherapy. The search period was from database inception to March 1, 2022. After applying the inclusion and exclusion criteria to the RCTs, research quality evaluation and data extraction were conducted, and a meta-analysis of the articles was performed using Revman 5.3 and Stata 12.1. Results A total of 14 RCTs involving 1314 patients were included. Meta-analysis results indicated that compared with the anti-anxiety and depression medications group, the qi-blood harmony group was more effective in clinical outcomes (RR = 1.19, 95% CI (1.13, 1.25), P < 0.00001), maintaining the stability of angina pectoris (SMD = 0.65, 95% CI (0.29, 1.01), P=0.0004), increasing the degree of patients' satisfaction (SMD = 0.95, 95% CI (0.25, 1.65), P=0.008), reducing the frequency of attacks (SMD = 0.64, 95% CI (0.11, 1.18), P=0.02), and the incidence of adverse reactions (RR = 0.54, 95% CI (0.43, 0.68), P < 0.00001). The HAMA and HAMD scores were significantly lower after treatment, and there was no significant difference between the two groups (HAMA: RR = 1.03, 95% CI (0.95, 1.12), P=0.4). The efficacy of the two groups was comparable. In terms of reduction of the HAMD score, after sensitivity analysis, the literature by Liang was found to be significantly influencing the results, and after excluding the results of Liang, the qi-blood harmony group was superior to the Western medicine group for reducing the HAMD score (RR = 1.12, 95% CI (1.01, 1.24), P < 0.05), which was significantly different. The results of this review, combined with the grade evaluation, suggest that the HAMA posttreatment score reduction, the efficacy of TCM treatment, and the incidence of adverse reactions were supported by moderate evidence, and the HAMD posttreatment score reduction and the SAQ score were supported by low-quality evidence. Conclusion Treating negative emotions after PCI based on the idea of “harmonization of qi and blood” can effectively improve the clinical efficacy, the stability of angina pectoris and the degree of patient satisfaction, and can reduce the frequency of angina attacks and the incidence of adverse events. There was no significant difference between the two groups for reductions in the HAMA and HAMD scores. However, more high-quality, large sample, multicentre RCTs are still needed for further verification. PROSPERO Registration Number: PROSPERO CRD42022313169.

The Effect of Enhanced External Counterpulsation on the Vascular State, Indicators of Glycemic Control and Quality of Life in Patients with Coronary Artery Disease and Type 2 Diabetes Mellitus

Aim. To study the effect of enhanced external counterpulsation (EECP) on the functional status, quality of life, structural and functional state of the vascular bed, and markers of glycemic control in patients with coronary artery disease (CAD) and type 2 diabetes mellitus (DM).Material and methods. A pilot prospective randomized study included 30 patients with CAD and DM. Using a random number generator, patients were randomized into 2 groups: EECP (n=15) and a comparison group (n=15). All patients (n=30) received optimal medical therapy (OMT) during 3 months of follow-up. Patients in the EECP group underwent a course of EECP (35 hours, cuff pressure: 220-280 mmHg) during the first 7 weeks of the study. At baseline and after 3 months of follow-up, patients in both groups underwent an assessment of clinical status, quality of life (based on the SF-36 questionnaire), as well as a 6-minute walk test to assess exercise tolerance. The dynamics of fasting glucose, postprandial glucose, insulin resistance index (HOMA-IR) and glycated hemoglobin were assessed. Photoplethysmography and applanation tonometry were performed to assess the state of the vascular bed.Results. In the EECP group, after 3 months, there was a decrease in the frequency of angina attacks and an improvement in the functional class of angina according to the Canadian Cardiovascular Society (CCS) classification. A significant improvement in exercise tolerance was revealed [an increase in the 6-minute walking distance by 51 (35; 65) m, p&lt;0.05], as well as an improvement in the physical and mental components of health according to the SF-36 questionnaire. A positive dynamics was shown in relation to the indicators of the state of both large vessels and the microvasculature (p&gt;0.05), with the exception of the reflection index and the stiffness index (p&lt;0.05). There was also a significant decrease in the HOMA-IR [-9.9% (-26.5; -4.0) vs 7.7% (-7.9; 13.8), p=0.004], as well as in the levels of fasting glucose [-10.5% (-15.8; -4.0) vs -2.7 (-8.3; 5.9), p=0.012] in the EECP group, compared with the OMT group.Conclusion. EECP course therapy in addition to OMT has a positive effect on the functional status and quality of life of patients with CAD and DM. After 3 months of observation, there was noted a positive dynamics of the vascular state, as well as markers of glycemic control, and these changes were more pronounced in the EECP group. The results obtained may indicate the effectiveness of EECP as an add-on treatment for this group of patients.

Impact of intravenous administration of anisodamine on coronary microvascular dysfunction in patients with obstructive epicardial coronary artery disease after percutaneous coronary intervention

Purpose: To analyze intravenous administration of anisodamine’s impact on coronary microvasculardysfunction (CMD) in obstructive epicardial coronary artery disease (CAD) patients who had undergone percutaneous coronary intervention (PCI).Methods: Enrollment of 210 patients in Shanghai Chest Hospital, Shanghai Jiaotong University with CMD was done in a randomized-controlled study. They were divided randomly into groups, viz, anisodamine (A) group and nitrate (N) group. A 14-day course of treatment was carried out in each group. 99mTc-MIBI myocardial perfusion imaging (MPI), treadmill exercise test (TET) and two dimensional echocardiography (TDE) were performed, and the symptoms of angina pectoris were recorded before and after treatment according to the classification, frequency, and duration of angina, as defined by Canadian Cardiovascular Society (CCS).Results: After treatment, summed stress score (SSS) and summed rest score (SRS) of MPI in group A significantly decreased after treatment (p &lt; 0.001, respectively) and were remarkably lower than those in group N (p &lt; 0.001, respectively). The CCS class in group A improved after treatment (p &lt; 0.001) and was also better than in group N (p &lt; 0.001). The frequency and duration of angina attack in group A significantly reduced after treatment (p &lt; 0.001, respectively) and were notably lower than in group N (p &lt; 0.001, respectively). Left ventricular ejection fraction in group A after treatment was higher than that before treatment (p = 0.046) and than that in group N (p = 0.048). Furthermore, the side effects of anisodamine were slight and tolerable.Conclusion: Intravenous administration of anisodamine is a potentially suitable optional treatment for CMD in patients with obstructive epicardial CAD who have undergone PCI.

Status of Clinical Application of Yufeng Ningxin Preparations and the Meta-Analysis of Its Efficacy and Safety in the Treatment of Cardiovascular and Cerebrovascular Diseases

Abstract Objective The objective of this study was to analyze the status of the clinical application of Yufeng Ningxin (YFNX) preparations and systematically evaluate their efficacy and safety in the treatment of cardiovascular and cerebrovascular diseases. Methods Through searching databases of China National Knowledge Infrastructure, Wanfang, SinoMed, VIP, PubMed, Embase, and the Cochrane Library, the literature of clinical research on YFNX preparations in treating malignant tumors of cardiovascular and cerebrovascular diseases from the establishment of the databases to February 2021 was collected. The clinical randomized controlled trials and case–control studies of cardiovascular and cerebrovascular diseases treated with these preparations were analyzed. Two reviewers independently screened literature, extracted data, and assessed the risk of bias in the included studies, and meta-analysis was performed by using ReMan 5.3 software to analyze the efficacy and safety of YFNX preparations in the treatment of cardiovascular and cerebrovascular diseases. Results A total of 29 clinical studies were finally included. The dosage forms were dropping pills, tablets, capsules, and granules. The preparations were used for the treatment of coronary heart disease, hypertension, neuropathic headache, etc. This study systematically evaluated the efficacy and safety of YFNX preparations in the treatment of coronary heart disease, hypertension, and nervous headache. A total of 1,162 cases were included in 13 studies, 582 cases of the YFNX preparation group and 580 cases of the Western medicine group. The results of meta-analysis showed that the clinical efficacy of YFNX preparations combined with the Western medicine group in the treatment of coronary heart disease and hypertension, improving electrocardiogram and reducing the frequency and duration of angina attacks, was better than that of the simple Western medicine group, and the difference was statistically significant. Conclusion YFNX preparations are effective for coronary heart disease, hypertension, and neuropathic headache, and the adverse reactions are few.

Effects of Tirofiban and Nicorandil on Effective Reperfusion and the Levels of IL-4 and sICAM-1 After PCI for Chronic Coronary Total Occlusion

Aim: The effects of tirofiban combined with nicorandil on effective reperfusion, and the levels of interleukin-4 (IL-4) and soluble intercellular adhesion molecule-1 (sICAM-1) after percutaneous coronary intervention (PCI) for chronic coronary total occlusion (CTO) were investigated. Method: From January 1, 2017, to June 31, 2019, a total of 40 patients with CTO receiving PCI in Shandong Qianfoshan Hospital were randomly divided into a control group (treated with single tirofiban) and a cocktail group (treated with nicorandil combined with tirofiban). Effective reperfusion was compared between groups. In addition, differences in coronary serum IL-4 and sICAM-1 levels before and 10 min after the operation were compared between groups, and the incidence rates of adverse reactions were observed. Finally, patient follow-up occurred at 1 month and 6 months, and the total incidence rates of adverse cardiac events in both groups were assessed. Results: The levels of IL-4 and sICAM-1 in the cocktail group significantly decreased after the operation (P&lt;0.05). In addition, after the operation, significantly greater decreases in the IL-4 and sICAM-1 levels were observed in the cocktail group than the control group (P&lt;0.05). The Seattle Angina Scale (SAQ) score of the cocktail group, compared with the control group, showed a significant improvement after vessel opening in the patients with CTO. At the 1-month follow-up, the SAQ score of the cocktail group, compared with the control group, indicated further improvements in terms of angina attack frequency. No significant differences were observed in the incidence rates of adverse reactions between groups (P&gt;0.05). Conclusion: The treatment of patients with CTO undergoing PCI with nicorandil and tirofiban alleviated the inflammatory response, improved the SAQ scores, and decreased the occurrence of angina pectoris in patients. Moreover, this treatment is safe and reliable, and has important clinical significance.