Aspirin Enteric-coated Tablets Research Articles

Effectiveness of long-term low-dose aspirin in the prevention of gastric cancer after Helicobacter pylori eradication: study design and rationale of Ardabil gastric cancer randomized placebo-controlled prevention trial (AGCPT)

BackgroundIn addition to Helicobacter pylori (H. pylori) infection eradication, some medications, including aspirin, metformin, and statins, have been suggested to have protective effects against gastric cancer (GC) development in observational studies. We launched the Ardabil gastric cancer randomized placebo-controlled prevention trial (AGCPT) to evaluate the effectiveness of long-term low-dose aspirin use for the prevention of development and mortality of GC after H. pylori eradication.Methods/designAGCPT is a prospective population-based double-blind, randomized clinical trial. The study sample was targeted at 21,000 participants aged from 35 to 70 years old, both sexes, in Ardabil, a province in northwest Iran with relatively high rates of GC incidence and mortality. All eligible participants were initially tested for H. pylori infection using a H. pylori stool antigen test. Participants with positive tests undergo H. pylori eradication by standard treatment regimens. All participants with a negative test and those with a positive test with a subsequent confirmed H. pylori eradication test were entered into the intervention phase. In the intervention phase, participants were allocated randomly into either the treatment (daily oral consumption of 81 mg enteric-coated aspirin tablets) arm or the control (placebo) arm using permuted balanced blocks. Subjects will be followed for an average period of 10 years to evaluate the incidence and mortality rates of GC.DiscussionIn addition to preventing other diseases like cardiovascular events, aspirin may prevent GC incidence and mortality. AGCPT will investigate the difference between the two study arms in the proportion of the cumulative incidence and mortality rates of GC. The study’s results may help policymakers and researchers update the strategies for GC prevention.Trial registrationThis trial with the registry name of “The effect of Low-dose Aspirin in the Prevention of Gastric Cancer” was registered in the Iranian Registry of Clinical Trials, IRCT.ir, under the identifier IRCT201105082032N3. Registered on April 21, 2017.

Effect of particle size on gastric emptying of enteric-coated granules in fasted beagle dogs: Relationship with interdigestive migrating motor complex

This study investigates the particle size threshold at which the interdigestive migrating motor complex (IMMC) becomes active in gastric emptying for fasted beagle dogs. Enteric-coated granules containing cetirizine dihydrochloride (CET) were prepared in three particle sizes, 200, 660, and 1,200 µm (D50). To mark IMMC timing and water movement from the stomach, enteric-coated aspirin tablets and acetaminophen solution were used. To six fasted beagle dogs with 50 mL of acetaminophen solution was administered each granule size as a multiple-unit and a single enteric-coated aspirin tablet (3-period crossover study). No significant difference in pharmacokinetic parameters of CET after oral administration of different particle sizes was observed. However, the appearance time of CET in plasma with smaller granules (200 and 660 µm) was significantly faster than that of salicylic acid (a major metabolite of aspirin) in all dogs. In the case of the largest granules (1,200 µm), no significant time difference was observed in the appearance of both compounds in plasma. Furthermore, in two dogs, both compounds appeared at the same time, implying IMMC-regulated gastric emptying for the largest CET granules. These results support a particle size threshold between 660 and 1,200 µm for gastric emptying without IMMC action in fasted beagle dogs.

Analysis of the Therapeutic Effect of Clopidogrel Bisulfate Tablets + Aspirin Enteric-Coated Tablets on Acute Myocardial Infarction

Analysis of the Therapeutic Effect of Clopidogrel Bisulfate Tablets + Aspirin Enteric-Coated Tablets on Acute Myocardial Infarction

Selective fluorescence detection of acetylsalicylic acid, succinic acid and ascorbic acid based on a responsive lanthanide metal fluorescent coordination polymer.

A fluorescent sensor for highly selective and ultrasensitive detection of acetylsalicylic acid (ASA), succinic acid (SA), and ascorbic acid (AA) was reported. The water-soluble fluorescent ligand salicylic acid (Sal) was generated through catalyzing ASA by the hydrolase activity of zeolitic-imidazolate framework-8 (ZIF-8) or natural esterase (Est). The Sal can coordinate with 2-methylimidazole (2-MIm) and Ln(III) to form a fluorescent lanthanide coordination polymer (LCP), which has a fluorescence emission peak with the maximum wavelength at 412 nm (the excitation wavelength at 300 nm). Therefore, the detection of ASA can be achieved through the fluorescence intensity changes of LCPs in the system, which has comparable sensitivity and good selectivity (linear range of 0.031-1.00 mM and LODs of 11.72 and 3.22 μM) as compared to a direct reaction between Est/ZIF-8 and ASA for detecting ASA (linear range of 0.05-1.20 mM and limits of detection (LODs) of 4.43 and 4.58 μM). Furthermore, upon the addition of SA and AA, the fluorescence intensity of the reaction system can be enhanced and weakened through changing the energy resonance transfer pathways and affecting the enzymatic reaction process, respectively, realizing their sensitive and selective fluorescence detection. The established fluorescent sensors can work well in a wide linear range of SA concentrations from 0 to 2.50 mM (Est-based reaction system) and 0 to 1.50 mM (ZIF-8-based reaction system) with the LODs of 0.032 and 0.028 mM, respectively. The linear ranges of AA concentrations are from 0.0078 to 0.25 mM (Est-based reaction system) and 0.0078 to 0.13 mM (ZIF-8-based reaction system) with the LODs of 2.54 and 3.80 μM, respectively. The established sensors were successfully used in the detection of SA in rabbit plasma, with a recovery of 84.0%-98.7%. Additionally, the contents of ASA in Aspirin Enteric-Coated tablets and AA in vitamin C tablets were also determined by the developed methods.

Early vascular embolization improves neurological function in patients with intracranial aneurysm.

To investigate the effect of early vascular embolization for intracranial aneurysms and the effect of matrix metalloproteinase-9 (MMP-9) and nuclear factor-kappa B (NF-κB) on nerve function. This is a retrospective analysis study. A total of 90 patients with intracranial aneurysms admitted to our hospital from January 2017 to December 2021 were selected as research subjects. The patients were divided into a control group (n=47) and an observation group (n=43) according to different embolization timing. Both groups were treated with vascular embolization, the observation group received vascular embolization within 72 h after onset, while the control group received vascular embolization after 72 h. In addition, both groups were given clopidogrel bisulfate tablets and enteric-coated aspirin tablets from the day after operation for 3 months. The embolization at 3 months after operation, the occurrence of complications, the daily activities and neurological function before and 3 months after operation, serum levels of MMP-9 and NF-κB, the protein expression of MMP-9 and NF-κB, and the prognosis at 3 months after operation were compared between the two groups. The complete embolization rate (90.70%) in observation group was higher than that of the control group (72.34%) at 3 months after operation (P<0.05). The postoperative complications in the observation group (9.30%) were lower than those of the control group (27.66%) (P<0.05). The improvement in Modified Barthel index score, as well as serum levels of MMP-9 and NF-κB were better in the observation group than those of the control group 3 months after operation (P<0.05). The prognosis of patients in the observation group was better than those of the control group 3 months after operation (P<0.05). Early vascular embolization is an effective approach for intracranial aneurysm. It helps improve patients' neurological function, and reduce their serum and protein levels of both MMP-9 and NF-κB, thereby leading to favorable prognosis.

286 Genetic, laboratory and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia

OBJECTIVES/GOALS: Low-dose aspirin is an established treatment to prevent preeclampsia, a leading cause of maternal and perinatal complications. Nevertheless, aspirin failure is not uncommon. We are investigating whether a gain-of-function genetic polymorphism in a platelet thrombin receptor is associated with aspirin failure in the prevention of preeclampsia. METHODS/STUDY POPULATION: Women who had preeclampsia in an initial pregnancy who then received low-dose aspirin in a subsequent pregnancy will be evaluated. We will compare between women who developed preeclampsia despite aspirin (aspirin non-responders) to women who did not develop preeclampsia with aspirin treatment (aspirin responders). Specifically, we will evaluate the allelic frequency of a single nucleotide variant (rs773902) in PAR4 thrombin receptor on platelets. This variant is associated with increased platelet function and potentially aspirin resistance. In addition, we will analyze the platelet response to PAR4 activation before and 1 hour after administering a single 81 mg enteric-coated aspirin tablet. RESULTS/ANTICIPATED RESULTS: We hypothesize that the prevalence of the PAR4 variant will be significantly higher among women who had recurrence of preeclampsia despite aspirin therapy. We also postulate that women who developed preeclampsia despite aspirin prophylaxis and have the polymorphism will have increased platelet aggregation in response to activation of PAR4, either by thrombin or peptides that activate the receptor, both at baseline and 1 hour after aspirin administration. DISCUSSION/SIGNIFICANCE: If our hypothesis that aspirin failure in preeclampsia prevention is associated with the gain-of-function polymorphism in the platelet PAR4 thrombin receptor, there may be justification for additional experimental studies to assess whether better pregnancy outcomes can be obtained by targeting thrombin itself using low molecular weight heparin.

Effect of acupuncture for regulating spleen and stomach on aspirin resistance in patients with type 2 diabetes mellitus: a randomized controlled trial

To observe the effect of acupuncture for regulating spleen and stomach on aspirin resistance in patients with type 2 diabetes mellitus (T2DM) and explore the effect mechanism. A total of 68 T2DM patients complicated with aspirin resistance were randomized into an observation group and a control group, 34 cases in each one. On the base of the conventional treatment for diabetes, aspirin enteric-coated tablets were prescribed for oral administration, 100 mg each time, once daily in the control group. In the observation group, on the basis of the treatment as the control group, acupuncture was used for regulating spleen and stomach at Zhongwan (CV 12), Zusanli (ST 36), Yinlingquan (SP 9), Hegu (LI 4), etc., once daily. The treatment for 1 week was as one course and 4 courses of treatment were required totally in two groups. Before and After treatment, the indexes of platelet function (platelet aggregation rate [PAG] and salicylic acid concentration), the indexes of vascular endothelial function (6-keone prostaglandin F1α[6-keto-PGF1α], thromin B2 [TXB2] and cyclooxysynthase-2 [COX-2]), blood glucose (fasting plasma glucose [FPG], 2 h plasma glucose [2h PG] and glycosylated hemoglobin [HbA1c]), insulin resistance index (HOMA-IR), blood lipid indexes (total cholesterol [TC], triacylglycerol [TG], high-density lipoprotein cholesterol [HDL-C] and low-density lipoprotein cholesterol [LDL-C]) and the total score of TCM symptoms were observed in the patients of two groups. Clinical therapeutic effect and safety was compared in the patients between the two groups after treatment and the recurrence rate of cardiocerebrovascular events was followed up 6 months after treatment. After treatment, PAG, salicylic acid concentration, TXB2, COX-2, FPG, 2h PG, HbA1c, HOMA-IR, LDL-C, TC, TG and the total scores of TCM symptoms were all reduced as compared with those before treatment in the two groups (P<0.01, P<0.05), and 6-keto-PGF1αand HDL-C were increased as compared with those before treatment in the two groups (P<0.01, P<0.05). In comparison with the control group, the aforementioned indexes in the observation group were all improved significantly (P<0.01). The total effective rate was 91.2% (31/34) in the observation group, higher than 70.6% (24/34) in the control group (P<0.05). In follow up visit, the recurrence rate of cardiocerebrovascular events was 14.7% (5/34) in the observation group, lower than 29.4% (10/34) in the control group (P<0.05). The therapies were safe and had no obvious adverse reactions in both two groups. Acupuncture for regulating spleen and stomach combined with aspirin enteric-coated tablets relieve insulin resistance and reduces blood glucose and lipid as well as the recurrence rate of cardiocerebrovascular events in the patients with T2DM, which is probably related to the regulation of insulin resistance and the improvement of vascular endothelial function. This combined therapy achieves the better effect on aspirin resistance as compared with simple aspirin enteric-coated tablets.

Doppler Ultrasound under Image Denoising Algorithm in the Diagnosis and Treatment of Fetal Growth Restriction Using Aspirin Combined with Low-Molecular-Weight Heparin.

Objective This study explored the clinical application value of image denoising algorithm combined with Doppler ultrasound imaging in evaluation of aspirin combined with low-molecular-weight heparin (LMWH) on fetal growth restriction (FGR). Method A two-stage image denoising by principal component analysis (PCA) with local pixel grouping (LPG-PCA) denoising algorithm was constructed in this study. Eighty FGR pregnant women were included in the study, and they were rolled into an experimental group (aspirin enteric-coated tablets + LMWH calcium injection) and a control group (LMWH calcium injection) according to the different treatment plans, with 40 cases in each group. All patients were performed with Doppler ultrasound imaging. The blood flow parameters (BFPs) were recorded and compared before and after the treatment in two groups, including power index (PI), resistance index (RI), high systolic blood flow velocity (S), high diastolic blood flow velocity (D), S/D value, and peak systolic velocity (PSV). In addition, the middle cerebral artery (MCA) BFPs, cerebral placental rate (CPR), amniotic fluid index (AFI) and perinatal outcome (PO) of the two groups were compared. Results The total effective rate of treatment in group A (87.5%) was greatly higher than that in group B (62.5%), showing statistical difference (P < 0.05). The PI (0.72 ± 0.19), RI (0.57 ± 0.17), and S/D values (2.26 ± 0.43) in group A were dramatically lower than those in group B, which were 0.92 ± 0.21, 0.75 ± 0.14, and 2.64 ± 0.45, respectively (P < 0.05), and the AFI was higher (13.71 ± 2.2 cm vs 11.38 ± 2.16 cm) (P < 0.05). The Apgar score (9.17 ± 0.26), weight (3.57 ± 1.08), and gestational age (38.85 ± 2.50) of group A were all higher in contrast to those of group B, which were 7.33 ± 0.25, 2.61 ± 1.13, and 36.18 ± 2.25, respectively (P < 0.05). In addition, the fetal double parietal diameter (2.4 ± 0.9 mm), femur diameter (2.2 ± 0.6 mm), head circumference (1.2 ± 0.4 mm), abdominal circumference (1.3 ± 0.7 mm), and uterine height (0.8 ± 0.3 mm) in group A were obviously superior to those in group B, which were 1.8 ± 0.4 mm, 1.7 ± 0.5 mm, 0.8 ± 0.2 mm, 0.9 ± 0.4 mm, and 0.4 ± 0.6 mm, respectively, showing statistically observable differences (P < 0.05). Conclusion Doppler ultrasound based on image denoising algorithm can accurately evaluate the effect of aspirin combined with LMWH on the improvement of FGR and showed good application value.

Efficacy of simvastatin on carotid atherosclerotic plaque and its effects on serum inflammatory factors and cardiocerebrovascular events in elderly patients.

To investigate the efficacy of simvastatin on carotid atherosclerotic plaque (CAP) and its effects on serum inflammatory factors and cardiocerebrovascular events in elderly patients, 130 elderly patients with CAP were randomly divided into observation (n=65) and control groups (n=65). The control group was treated with 75 mg/day aspirin enteric-coated tablets, and the observation group was administered additional 20 mg/day simvastatin. Serum total cholesterol, triglyceride, and high- and low-density lipoprotein cholesterol levels (evaluated via the endpoint method) were determined in both groups. Furthermore, the length, thickness and number of CAPs was measured using color Doppler ultrasonography. In addition, levels of inflammatory biomarkers including high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), nitric oxide, D-dimer and fibrinogen, as well as change in microemboli count, were also compared After treatment, the observation group exhibited a significant reduction in size, thickness, and number of CAP and intima-media thickness compared with before treatment. However, no significant difference was found in the indicators of CAPs in the control group before and after treatment. The levels of total cholesterol, triglyceride, and low-density lipid cholesterol decreased, while high-density lipid cholesterol increased in the observation group after treatment, with notable changes in the observation group compared with in the control group. Overall response rate was higher in the observation group compared with the control group. TNF-α, IL-6, and hs-CRP levels in the observation group decreased after treatment compared with those before treatment and those in the control group. Furthermore, the rate of microemboli positivity was lower in the observation group than in the control group. Moreover, the overall incidence of acute cardiocerebrovascular events was lower in the observation group than in the control group. Therefore, it was demonstrated that simvastatin can reduce blood lipid levels, decrease the quantity and size of plaques, alleviate inflammatory response, reduce microemboli formation and reduce the risk of cardiocerebrovascular events in elderly patients with CAP.

False positive technetium-99m pyrophosphate scintigraphy in a patient with cardiac amyloidosis light chain

Introduction:Patients with cardiac amyloidosis light chain (AL) present with negative Tc-99m pyrophosphate (PYP) scintigraphy (absent or mild heart uptake). On the contrary, patients with cardiac amyloidosis transthyretin (ATTR) present with positive Tc-99m PYP scanning (intensive heart uptake). We present a false positive Tc-99m PYP scintigraphy (grade 2, the heart-to-contralateral ratio is 1.65) in a patient with AL.Patient concerns:A 42-year-old Chinese man complained of effort intolerance, chest discomfort, and short of breath progressively over 1 year. New York Heart Association Class III. Physical examination showed legs swelling. Laboratory revealed elevated brain natriuretic peptide of 23,031 ng/mL (0–88) and Troponin-T of 273.4 ng/mL (0–14).Diagnosis:Cardiac amyloidosis light chain. Evidences: free light chains (FLCs): decreased serum free kappa/lambda ratio of 0.043 (0.31–1.56). Immunofixation electrophoresis: a positive lambda light chain monoclonal protein. Cardiac biopsy: HE: Ambiguity Congo red strain. Myocardial immunofluorescence: positive lambda light chain. Myocardial immunohistochemistry: positive lambda light chain, negative kappa light chain, and TTR.Interventions:Furosemide 40 mg qd, torasemide 20 mg qd, spirolactone 20 mg qd, potassium chloride 10 mL per 500 mL urine, atorvastatin calcium tablet 20 mg qd, aspirin enteric-coated tablets 100 mg qd during the 2-weeks in-hospital.Outcomes:The patient died 2 months later after discharge.Conclusion:False positive Tc-99m PYP scintigraphy may rarely presented in patients with cardiac amyloidosis light chain. So, the clonal plasma cell process based on the FLCs and immunofixation is a base to rule out AL cardiac amyloidosis when we interpret a positive Tc-99m PYP scintigraphy.

Clinical effectiveness and safety of salvia miltiorrhiza depside salt combined with aspirin in patients with stable angina pectoris: A multicenter, pragmatic, randomized controlled trial

BackgroundSalvia Miltiorrhiza Depside Salt (SMDS) was extracted from Salvia miltiorrhiza with high-quality control of active principles. In 2005, China's FDA approved the use of SMDS for stable angina pectoris (SAP), but the evidence of SMDS combined with aspirin remains unclear. PurposeThe aim of this study was to assess the clinical effectiveness and safety of SMDS combined with aspirin in patients with SAP. MethodsA multicenter, pragmatic, three-armed parallel group and an individually randomized controlled superiority trial was designed. Participants aged 35 to 75 years old with SAP were recruited from four "Class Ⅲ Grade A" hospitals in China. Participants who were randomized into the SMDS group were treated with SMDS by intravenous drip. Participants in the control group received aspirin enteric-coated tablets (aspirin). Participants who were randomly assigned to the combination group received SMDS combined with aspirin. All participants received standard care from clinicians, without any restrictions. The primary outcome measure was thromboelastography (TEG). Secondary outcome measures included symptom score of the Seattle Angina Questionnaire (SAQ), visual analogue scale (VAS) score of traditional Chinese medicine (TCM) symptoms, platelet aggregation measured by light transmittance aggregometry (LTA), and fasting blood glucose. Effectiveness evaluation data were collected at baseline and ten days after treatment. Researchers followed up with participants for one month after treatment to determine whether adverse events (AEs) or adverse drug reactions (ADRs) such as bleeding tendency occurred. All statistical calculations were carried out with R 3.5.3 statistical analysis software. ResultsA total of 135 participants completed follow-up data on the primary outcome after ten days of treatment. Participants in the SMDS combined aspirin group had the highest improvement rate of sensitivity in AA% [p < 0.001, 95% CI (0.00–0.00)], from 30.6% before treatment to 81.6% after treatment. Participants with drug resistance (AA% < 20%) in the SMDS combined with aspirin group also had the highest sensitivity rate [p < 0.001, 95% CI (0.00–0.00)] after treatment (accounting for 81.0% of the combination group and 60.7% of the sensitive participants). The improvement of TCM symptoms in participants treated with SMDS combined with aspirin was significantly better than that of the aspirin group [MD = 1.71, 95% CI (0.15–3.27), p = 0.032]. There were no significant differences in other indexes (R, TPI, MA, K, CI, α value) of TEG, SAQ, platelet aggregation and fasting blood glucose among the three groups. No bleeding tendency or ADRs occurred in all participants. ConclusionSMDS combined with aspirin is a clinically effective and safe intervention to treat adults aged 35 and older with SAP. This trial shows that SMDS combined with aspirin can significantly improve the sensitivity rate of AA% in TEG and the VAS score of TCM symptoms. Further large samples and high-quality research are needed to determine if certain participants might benefit more from SMDS combined with aspirin. The study protocol was registered in the Clinical Trials USA registry (registration No. NCT02694848).

Effect of combined treatment with acupuncture, moxibustion and medication on endometrial receptivity and expression of serum HOXA10 in polycystic ovary syndrome of kidney deficiency and blood stagnation

To compare the clinical effect of the combined treatment of acupuncture, moxibustion, Chinese herbal medicine and western medication and simple western medication on polycystic ovary syndrome (PCOS) of kidney deficiency and blood stagnation pattern and explore the effect on endometrial receptivity and the expression of serum homeobox gene A10 (HOXA10). A total of 60 patients with PCOS of kidney deficiency and blood stagnation pattern were randomized into a combined treatment group and a western medication group, 30 cases in each one. In the western medication group, on the fifth day of menstruation, clomiphene citrate tablets were taken orally, 50 mg each time, once daily, consecutively for 5 days. On the day when the follicle diameter was ≥ 18 mm, chorionic gonadotrophin for muscular injection, a dose of 10 000 U was given. Before sleep, the aspirin enteric-coated tablets were taken orally, 50 mg (except during menstruation). In the combined treatment group, on the base of the treatment as the western medication group, acupuncture and moxibustion were adopted and the Chinese herbal for tonifying the kidney and activating blood circulation was taken orally. The acupoints were Guanyuan (CV 4), Qihai (CV 6), Zusanli (ST 36), Sanyinjiao (SP 6), Zigong (EX-CA 1), etc. Acupuncture was remained for 30 min each time, once every two days and discontinued during menstruation. Chinese herbal was given from the 3rd day of menstruation till the onset of the next menstruation, one dose each day. After consecutive treatment for 3 menstrual cycles in the two groups, the real-time polymerase chain reaction (RT-PCR) method was adopted to determine the expression of serum HOXA10 before and after treatment in the patients of the two groups. The endometrial thickness at ovulatory phase, uterine arterial flow 7 days after ovulation [including uterine arterial pulsatility index (PI), resistance index (RI), peak systolic velocity (PSV)/end diastolic velocity (EDV), meaning S/D], pregnancy rate and the score of Chinese medicine symptoms before and after treatment were compared in the patients between the two groups. ① After treatment, the expression of serum HOXA10 was higher than that before treatment in the patients of the two groups (P<0.01). The increase range in the combined treatment group was larger than the western medication group (P<0.01). ② After treatment, the endometrial thickness at the ovulatory phase was increased in the patients of the two groups (P<0.01). The increase range of the endometrial thickness in the combined treatment group was larger than the western medication group (P<0.01). ③ The pregnancy rate was 46.7% (14/30) in the combined treatment group, higher than 26.7% (8/30) in the western medication group (P<0.05). ④ After treatment, the bilateral uterine arterial PI, RI and S/D values, as well as TCM symptom score were all lower than those before treatment in the patients of the two groups (P<0.01). The decrease range of each index in the combined treatment group was greater than the western medication group (P<0.01, P<0.05). The combined treatment with acupuncture, moxibustion and medication effectively improves endometrial receptivity and uterine arterial flow in the patients with PCOS of kidney deficiency and blood stagnation pattern and increases pregnancy rate. The therapeutic effect is better than the simple western medication and its mechanism is probably related to the regulation of serum HOXA10 expression.

Efficacy of Getong Tongluo Capsule () for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial.

To evaluate whether the efficacy of Getong Tongluo Capsule (, GTC, consisted of total flavone of Radix Puerariae) on improving patients' quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba (EGB) for patients with convalescent-phase ischemic stroke and primary hypertension. This randomized, positive-drug- and placebo-controlled, double-blind trial was conducted from September 2015 to October 2017. Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions, twice a day for 12 weeks: (1) GTC 250 mg plus EGB-matching placebo 40 mg (237 cases, GTC group), (2) EGB 40 mg plus GTC-matching placebo 250 mg (120 cases, EGB group) or (3) GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg (120 cases, placebo group). Moreover, all patients were orally administered aspirin enteric-coated tablets 100 mg, once a day for 12 weeks. The primary outcome was the Barthel Index (BI). The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale (NIHSS) scores. The incidence and severity of adverse events (AEs) were calculated and assessed. The BI relative independence rates, the clinical recovery rates of NIHSS, and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment (P<0.05), and no statistical significance was found between the GTC and EGB groups (P>0.05). The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12, 18 and 24 weeks after treatment (P<0.01). There were no statistically significant differences in the incidences of AEs, adverse drug reactions, or serious AEs among the 3 groups (P>0.05). GTC exhibited significant efficacy in improving patients' quality of life as well as neurological function and controlling hypertension. (Registration No. ChiCTR1800016667).

Study on clinical characteristics of Danshen Chuanxiongqin Injection in treatment of cerebral infarction in real world

In this study, the clinical characteristics and drug combination rules of Danshen Chuanxiongqin Injection in the treatment of patients with cerebral infarction were analyzed. The inpatient information of 2 857 patients of cerebral infarction treated with Danshen Chuanxiongqin Injection in HIS database of 20 grade Ⅲ class A hospitals in China was collected, and a model was established by description analysis and Apriori algorithm, in order to explore the clinical characteristics and drug combination rules of Danshen Chuan-xiongqin Injection in the treatment of cerebral infarction. The results showed that among patients of cerebral infarction treated with Danshen Chuanxiongqin Injection, 1 727 patients were older than 65 years old, accounting for 69.61%, and 1 610 were males, accounting for 63.59%. Commonly used drugs included lipid-lowering agents, anticoagulant thrombolytic agents, antiplatelet agents, stimulants of brain metabolism, vasodilators and other Western drugs, as well as traditional Chinese medicines, such as blood-activating agents, heat-clearing agents and expectorant agents. The Western medicine with the highest use frequency in combination with Danshen Chuan-xiongqin Injection was aspirin enteric-coated tablets(1 528 cases, 53.48%). The traditional Chinese medicine with the highest use frequency in combination with Danshen Chuanxiongqin Injection was Xingnaojing Injection, with a total of 378 cases, accounting for 13.23%. Among them, the most commonly used Western drugs combined with Danshen Chuanxiongqin Injection were anticoagulant thrombolytic and antiplatelet drugs, with a usage rate as high as 83.48%. In order to further explore the drug combination rules of Danshen Chuanxiongqin Injection, the association analysis of drug combination in patients of cerebral infarction treated with Danshen Chuanxiongqin Injection was carried out. In clinical combination of two Western drugs, Atorvastatin Calcium Capsules+Cerebral Proteolytic Injection were the most common combination, with a support of 27.10%. In clinical combination with 3 Western drugs, Clopidogrel Bisulfate Tablets+Atorvastatin Calcium Capsules+Cerebral Proteolytic Injection were most commonly used, with a support of 15.90%. The results showed that the patients of cerebral infarction treated with Danshen Chuanxiongqin Injection were mainly elderly males, and often complicated with hypertension, coronary heart disease, diabetes and other basic diseases. The clinical application of Danshen Chuanxiongqin Injection was principally in line with the guidelines. In the treatment of cerebral infarction, it was often combined with Western medicine anticoagulant thrombolysis, antiplatelet drugs, traditional Chinese medicine blood-activating and stasis-dissolving prescription and other drugs with similar pharmacological effects, with an auxiliary therapeutic effect on patients of cerebral infarction complicated with other diseases, and can provide guidance for clinical medication.

Aspirin enhances the clinical efficacy of anti-tuberculosis therapy in pulmonary tuberculosis in patients with type 2 diabetes mellitus

Background: Tuberculosis in patients with diabetes mellitus is characterised by rapid disease progression, poor treatment efficacy, poor prognosis and poses a new challenge in tuberculosis treatment and control.Methods: Patients with pulmonary TB and type 2 DM were recruited at Yijishan Hospital of Wannan Medical College. A total of 348 patients were randomly assigned to two groups. The aspirin group (aspirin + TB/DM) included 174 patients who received anti-TB therapy and enteric-coated aspirin tablets (100 mg/tablet). The control group (placebo + TB/DM) included 174 patients who received anti-TB therapy and enteric-coated placebo tablets (an identical tablet containing no drug). Eighty-two patients in the aspirin group and 86 in the control group completed the trial and were included in the analysis. Clinical characteristics, laboratory test results, imaging data and side effects of aspirin were monitored.Results: Aspirin treatment affect certain signs and symptoms. The erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were lower in the aspirin group than in the control group after treatment (Both p = .000). The sputum-negative conversion rate was 86.7% in the aspirin group, significantly higher than in the control group (53.8%) (p = .031). After two months of treatment, the differences in the number of cases with cavities, the number of cavities, and maximum diameter of cavities in the aspirin group were statistically significant (p = .003, p = .023 and p = .015 respectively).Conclusion: Our findings suggest that aspirin may improve treatment in patients with pulmonary TB and type 2 DM.

A Systematic Review of the Efficacy and Safety of Aspirin When Delivered at Different Medication Times for the Primary and Secondary Prevention of Cardiovascular and Cerebrovascular Diseases.

Effective antiplatelet therapy can significantly reduce the incidence and mortality rate of cardiovascular and cerebrovascular diseases. Aspirin is widely used in the secondary prevention of cardiovascular and cerebrovascular diseases; however, there is widespread debate as to when patients should take an enteric-coated aspirin tablet on a daily basis. In the present study, we evaluated the efficacy and safety of different aspirin medication times (morning or before bedtime) in terms of the primary and secondary prevention of cardiovascular and cerebrovascular diseases using meta-analysis. Studies with randomized control trials (RCT) or crossover trials regarding to the usage of aspirin (morning or before bedtime) for the primary or secondary prevention of cardiovascular and cerebrovascular diseases were searched in Medline, EMbase, Cochrane Library, CNKI, Wanfang Data, VIP Database and CBM. Review Manager 5 (RevMan 5, v5.3), a Cochrane systematic reviews software, was used to perform meta-analysis based on the recommendation of the Cochrane Handbook for risk assessment tools. Meta-analysis showed that taking low-dose aspirin tablets before bed reduced systolic and diastolic blood pressure compared with taking it in the morning. At the same time, the number of studies on platelet aggregation rate, C-reactive protein (CRP), serum nitric oxide (NO) or thromboxane B2 (TXB2) is too small to be reliable. However, there was a large heterogeneity across the studies. The quality of some studies was not high enough. Additional blood pressure benefits can be achieved by taking aspirin before bedtime, but it does not affect its antiplatelet effect and does not pose a higher risk of bleeding.

PCV39 ECONOMIC IMPACT OF SWITCHING FROM ENTERIC COATED ASPIRIN TABLETS TO LIQUID FILLED CAPSULES WITH A NOVEL PHARMACEUTICAL LIPID-ASPIRIN COMPLEX IN PATIENTS SURVIVING AN ACUTE CARDIOVASCULAR EVENT

A new, pharmaceutical lipid-aspirin complex (PL-ASA) formulation has been specifically developed to reduce the risk of aspirin-induced gastric injury. In clinical studies PL-ASA liquid-filled capsules were shown to have significantly higher rates of complete aspirin response compared with the current standard of care (enteric coated aspirin tablets [EC-ASA]). Aspirin response has been linked to avoidance of ischemic events such as myocardial infarction MI) or stroke. In the current analysis we sought to determine the economic impact of switching patients from EC-ASA to PL-ASA for the first year following an index MI or stroke.

Abstract TP432: Bioavailability of Aspirin in Fasted and Fed States of a Novel Formulation of a Pharmaceutical Lipid-Aspirin Complex

Introduction: Lifelong aspirin therapy is recommended after a TIA or stroke, but dyspeptic symptoms frequently lead to non-adherence. Clinicians often recommend that daily doses be taken with food to reduce these side effects. However, food can interfere with absorption, especially with enteric coated aspirin tablets. Hypothesis: We evaluated whether food interferes with bioavailability of a new, pharmaceutical lipid-aspirin complex (PL-ASA) liquid-filled capsule formulation. Methods: This was a randomized, open label, crossover study in 20 healthy volunteers. Participants fasted for ≥10 hours prior to randomization; if assigned to “fasting” they then received the single 650 mg dose of PL-ASA. If they were randomized to “fed”, they first ate a standard high-fat meal and were dosed 30 minutes later. After a washout period of 10 days each participant crossed over to the other arm and was again dosed with a 650 mg dose of PL-ASA. The primary outcome was the comparison of PK parameters of the primary metabolite salicylic acid (SA) between fasting and fed states. Results: Mean age of participants was 36.8 years and 55% were male. The primary SA PK parameters of AUC 0-t and AUC 0- infinity in the fed state were within 88.7% and 88.8% of concentrations in the fasting state consistent with bio-equivalence (FDA guidance &gt;80%). Mean peak SA concentration was about 25% lower and occurred about 1.5 hours later in the fed state (Figure). Conclusions: Food had a modest effect on the time required to reach peak SA concentration and on the actual peak SA levels after PL-ASA administration, but did not impact the extent of exposure (area under the curve) compared with intake in a fasting state. These data demonstrate that PL-ASA may be co-administered with food without significant variability in absorption, a recognized limitation of coated aspirin formulations.

Sequential butylphthalide therapy combined with dual antiplatelet therapy in the treatment of acute cerebral infarction.

Objective:To observe the clinical efficacy of sequential butylphthalide therapy combined with dual antiplatelet therapy in the treatment of elderly patients with acute cerebral infarction (ACI).Methods:One hundred and twenty-two elderly patients with ACI who were admitted to the department of neurology of our hospital at May 2016-August 2018 were selected grouped into a control group and an observation group by random number table method, 61 in each group. On the basis of conventional treatment, the patients in the control group were given dual antiplatelet therapy (aspirin enteric-coated tablets + clopidogrel bisulfate tablets), while the patients in the observation group were given sequential butylphthalide therapy on the basis of the control group. The clinical effects of the two groups were compared after four weeks of treatment, and the changes of National Institutes of Health Stroke Scale (NIHSS), ADL score, plasma 3-mercaptopyruvate sulphurtransferase (3-MST) and Amyloid β42 (Aβ42) levels and the occurrence of adverse reactions during treatment were recorded.Results:The clinical efficacy of the observation group was better than that of the control group (P<0.05). There was no significant difference in NIHSS and ADL scores between the two groups before treatment (P>0.05). After treatment, the NIHSS and ADL scores of the observation group were better than those of the control group (P<0.05). There was no significant difference in plasma levels of 3-MST and AB42 between the two groups before treatment (P>0.05). The level of plasma 3-MST in the observation group was higher than that in the control group, and the level of plasma Aβ42 was lower than that in the control group (P<0.05). No serious adverse reactions occurred during the treatment period in both groups.Conclusion:Butylphthalide sequential therapy combined with dual antiplatelet therapy is effective in the treatment of elderly ACI. It can effectively improve the plasma level of 3-MST and decrease the plasma level of Aβ42, which is conducive to improving the living ability and neurological function of patients and has high safety.

Clinical efficacy of laparoscopic splenectomy combined with pericardial devascularization in the treatment of cirrhotic portal hypertension: a report of 425 cases

Objective To investigate the clinical efficacy of laparoscopic splenectomy combined with pericardial devascularization in the treatment of cirrhotic patients with cirrhotic portal hypertension. Methods The retrospective and descriptive study was conducted. The clinicopathological data of 425 patients with cirrhotic portal hypertension who were admitted to Northern Jiangsu People′s Hospital Affiliated to Yangzhou University were collected. There were 289 males and 136 females, aged (53±11)years, with a range from 21 to 79 years. All the patients were allocated into 3 periods according to the operation time, including 100 patients of early period from February 2012 to March 2014, 156 patients of mature technology period from April 2014 to August 2016, and 169 patients of technology innovation period from september 2016 to December 2018. The patients of early period and mature technology period underwent laparoscopic splenectomy combined with pericardial devascularization, and the patients of technology innovation period underwent vagus nerve-preserving laparoscopic splenectomy combined with pericardial devascularization. Observation indicators: (1) surgical situations; (2) postoperative situations; (3) follow-up. Patients were followed up by outpatient examination to detect the upper digestive rebleeding, gastric retention, and diarrhea up to March 2019. Sequential therapy of endoscopic variceal ligation (EVL) was slectively performed on patients based on results of gastroscopy. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was analyzed using ANOVA, and paired comparison was analyzed using the t test. Measurement data with skewed distribution were represented as M (range), and comparison between groups was anlyzed using the Kruskal-Wallis rank sum test, and paired comparison was analyzed using the rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test and Fisher exact probability. Results (1) Surgical situations: the operation time, volume of intraoperative blood loss, cases with intraoperative blood transfusion, cases with conversion to open surgery, and cases with emergency operation for bleeding were (187±46)minutes, 150 mL (range, 50-1 300 mL), 2, 2 , 1 for patients of early period, (164±22)minutes, 50 mL (range, 30-100 mL), 1, 1, 1 for patients of mature technology period, and (150±18)minutes, 50 mL (range, 10-300 mL), 0 , 0 , 0 for patients of technology innovation period, respectively. There were significant differences in the operation time and volume of intraoperative blood loss between the three groups (F=55.482, χ2=94.620, P 0.05). (2) Postoperative situations: 425 patients had oral aspirin enteric-coated tablets for prevention of thrombus, with no perioperative death. Duration of postoperative hospital stay, cases with portal vein thrombosis at postoperative 7 days, cases with pancreatic fistula, cases with pulmonary infection, and cases with abdominal infection were (11.0±2.9)days, 46, 2, 1, 0 for patients of early period, (9.9±1.7)days, 81, 3, 0, 0 for patients of mature technology period, and (8.8±1.3)days, 83, 2, 1, 1 for patients of technology innovation period, respectively. There was a significant difference in the duration of postoperative hospital stay between the three groups (F=39.836, P 0.05) and no significant difference in the cases with pancreatic fistula, cases with pulmonary infection, or cases with abdominal infection between the three groups (P>0.05). Patients with portal vein thrombosis at postoperative 7 days had oral aspirin enteric-coated tablets or warfarin for treatment. Patients with pancreatic fistula, pulmonary infection, and abdominal infection were cured and discharged after conservative treatment. (3) Follow-up: all the 425 patients were followed up for 1-72 months, with a median follow-up of 36 months. Of the 425 patients, 261 underwent postoperative sequential therapy of EVL, including 133 patients of mature technology period and 128 patients of technology innovation period. The incidence rate of upper digestive rebleeding was 3.83%(10/261) of the 261 patients undergoing postoperative sequential therapy of EVL and 17.68%(29/164) of 164 patients without postoperative sequential therapy of EVL, showing a significant difference between them (χ2=23.185, P<0.05). The incidence rates of gastric retention and diarrhea were 96.24%(128/133) and 61.65%(82/133) for 133 patients undergoing sequential therapy of EVL in mature technology period, and 1.56%(2/128) and 3.91%(5/128) for 128 patients undergoing sequential therapy of EVL in technology innovation period, showing significant differences between them (χ2=233.876, 97.883, P<0.05). Conclusions It is safe and feasible of laparoscopic splenectomy combined with pericardial devascularization for patients with cirrhotic portal hypertension, and intraoperative vagus nerve-preserving can reduce volume of intraoperative blood loss and incidence of postoperative complications. Key words: Liver cirrhosis; Portal hypertension; Splenectomy; Pericardial devascularization; Vagus nerve; Laparoscopy