Incidence Of Adverse Reactions Research Articles

Who can benefit more from its twelve-week treatment: A prospective cohort study of blonanserin for patients with schizophrenia

BACKGROUND Blonanserin (BNS) is a well-tolerated and effective drug for treating schizophrenia. AIM To investigate which types of patients would obtain the most benefit from BNS treatment. METHODS A total of 3306 participants were evaluated in a 12-week, prospective, multicenter, open-label post-marketing surveillance study of BNS. Brief psychiatric rating scale (BPRS) scores were calculated to evaluate the effectiveness of BNS, and its safety was assessed with the incidence of adverse drug reactions. Linear regression was used to screen the influencing factors for the reduction of BPRS total score, and logistic regression was used to identify patients with a better response to BNS. RESULTS The baseline BPRS total score (48.8 ± 15.03) decreased to 27.7 ± 10.08 at 12 weeks (P < 0.001). Extrapyramidal symptoms (14.6%) were found to be the most frequent adverse drug reactions. The acute phase, baseline BPRS total score, current episode duration, number of previous episodes, dose of concomitant antipsychotics, and number of types of sedative-hypnotic agents were found to be independent factors affecting the reduction of BPRS total score after treatment initiation. Specifically, patients in the acute phase with baseline BPRS total score ≥ 45, current episode duration < 3 months, and ≤ 3 previous episodes derived greater benefit from 12-week treatment with BNS. CONCLUSION Patients in the acute phase with more severe symptoms, shorter current episode duration, fewer previous episodes, and a lower psychotropic drug load derived the greatest benefit from treatment with BNS.

Impact of Antibiotic on Efficacy and Adverse Reactions of Chemoimmunotherapy in Non‐small Cell Lung Cancer Patients: A Retrospective Cohort Study

ABSTRACTBackgroundThis study aimed to evaluate the impact of antibiotic exposure on efficacy and adverse reactions in non‐small cell lung cancer (NSCLC) patients receiving chemoimmunotherapy, and to explore any specific associations on the basis of antibiotic class.MethodsA retrospective study was conducted on NSCLC patients who received chemoimmunotherapy in two Shandong hospitals between January 2018 and October 2023. The association between antibiotic exposure and progression‐free survival (PFS), overall survival (OS), objective response rate (ORR) and incidence of immune related adverse reactions (irAE) of patients were evaluated.ResultsOf the 316 patients, 134 (42.41%) received antibiotics (ATB group), and 182 (57.59%) did not (N‐ATB group). There was no significant difference in PFS (aHR = 1.009, 95% CI: 0.770–1.323; p = 0.946) or OS (aHR = 1.420, 95% CI: 0.986–2.047; p = 0.060) between ATB and N‐ATB groups. The impact on efficacy was related to the type of antibiotic. β‐Lactams (aHR = 1.737, 95% CI: 1.148–2.629; p = 0.009), in particular β‐lactam/β‐lactamase inhibitor combinations (BLBLIs) (aHR = 1.885, 95% CI: 1.207–2.944, p = 0.005) were associated with poorer OS. However, quinolones (aHR = 1.192, 95% CI: 0.861–1.650; p = 0.291) were not associated with OS. The incidence of irAEs was not significantly different between ATB and N‐ATB groups (p = 0.073), but was higher with BLBLIs (p = 0.013).ConclusionsIn NSCLC patients receiving chemoimmunotherapy, no significant difference was observed in efficacy and incidence of irAEs between the ATB and the n‐ATB groups. In antibiotic class analysis, β‐lactams and specifically BLBLIs were observed to be associated with worse OS.

The efficacy and safety of the prophylactic application of PEG-rhG-CSF in radiotherapy with weekly concurrent chemotherapy for cervical cancer.

To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) in preventing neutropenia during concurrent radiotherapy combined with weekly chemotherapy in patients with cervical cancer. From September 2019 to November 2020, 180 patients with cervical cancer who required concurrent chemoradiotherapy (CCRT) were enrolled in this study. The patients were randomly divided into the following three groups at a ratio of 1:1:1: Group A (PEG-rhG-CSF), Group B (PEG-rhG-CSF + rhG-CSF) and the control group (rhG-CSF). Cisplatin or carboplatin was administered weekly. The primary endpoint was the incidence of grade 3/4 neutropenia. The secondary endpoints were the incidence of febrile neutropenia (FN), delay of radiotherapy, chemotherapy dose reduction, rate of PFS at 2 years and 3 years, and incidence of adverse reactions. Sixty patients were randomly assigned to each group. Two patients in Group B withdrew from the trial for personal reasons. The incidence of grade 1/2 neutropenia in the Control group was significantly lower than that in Group A and Group B (P < 0.001). However, the incidence of grade 3/4 neutropenia in the Control group was significantly greater than that in Group A and Group B (P < 0.001). There was no significant difference in the incidence of FN among the three groups (P = 0.771). The rate of platinum dose reduction in Group A (6.7%) and Group B (5.2%) was significantly lower than that in the Control group (30.0%) (P < 0.001). The delay rate of radiotherapy in Group A (10%) and Group B (13.8%) was obviously inferior to that in the Control group (31.7%) (P = 0.006). The 2-year PFS rates of Group A, Group B, and the Control group were 93.3%, 98.3%, and 91.7%, respectively, with no statistically significant difference (P = 0.270). The 3-year PFS rates were 89.8%, 94.1%, and 84.9%, respectively, with no statistically significant difference (P = 0.178). No treatment-related serious adverse events occurred in any of the patients. In Group A and Group B, The prophylactic application of PEG-rhG-CSF during conventional chemoradiotherapy combined with weekly chemotherapy for patients with cervical cancer can reduce the incidence of grade 3/4 neutropenia and does not increase the incidence of adverse reactions when compared to Control group. chictr.org.cn, ChiCTR1900026309, registered 29 September 2019-prospectively registered.

Effectiveness analysis of a pharmacist-led intervention for orthopedic perioperative use of antibiotics: a retrospective cohort study

BackgroundFollowing the Chinese guidelines’ recommendation to completely cancel routine cephalosporin skin tests, the choice of cephalosporin as surgical prophylactic medication was affected. This was due to the limited cognition of the predictive value of cephalosporin skin test or the desire to avoid medical disputes. The aim of this retrospective study was to evaluate whether the pharmacist-led perioperative antibiotic prophylaxis model could improve clinicians’ medical behavior in choosing cephalosporin antibiotics for surgical prophylaxis.MethodsFrom July 2021 to May 2022, a retrospective analysis was conducted on the selection of surgical preventive medication, skin test, postoperative infection and adverse drug reactions in foot and ankle surgery. The study was divided into three period: the rountine cephalosporin skin test period (Period I: Skin Test), the period when the routine cephalosporin skin test was cancelled but the pharmacist did not intervene (Period II: Cancel Skin Test), and the period when the pharmacist-led perioperative antibiotic prophylaxis was implemented after the cancellation of the cephalosporin skin test (Period III: Pharmacist Intervention).ResultsA total of 1,583 patients were enrolled in this study. There was no significant difference in the utilization rate of cefuroxime between the routine skin test stage and the skin test cancelled stage [74.92% (Period I) vs. 74.54% (Period II), P &amp;gt; 0.05]. However, in the pharmacist intervention stage, the usage rate of cefuroxime significantly increased compared to the initial stage when the skin test was cancelled [87.07% (Period III) vs. 74.54% (Period II), P &amp;lt; 0.05]. The use of cephalosporins also increased in patients with self-reported beta-lactam allergies between these stages [41.94% (Period III) vs. 3.22% (Period II), P &amp;lt; 0.05)]. There was no significant difference in the incidence of postoperative infection and adverse drug reactions among the three periods.ConclusionThe pharmacist-led perioperative antibiotic prophylaxis model can significantly improve the medical behavior of clinicians in choosing cephalosporin antibiotics as surgical prophylactic medication and optimize the perioperative medication plan.

Efficacy and safety of intravitreal conbercept and triamcinolone acetonide for wet age-related macular degeneration in China: a meta-analysis.

Several studies have investigated the efficacy and safety of Conbercept versus Triamcinolone acetonide for the treatment of wet age-related macular degeneration (wAMD), but the results are controversial. Therefore, this meta-analysis aims to evaluate the efficacy and safety of Conbercept versus Triamcinolone acetonide for the treatment of wAMD. A total of seven databases were searched for literature on the treatment of wAMD with Conbercept, with the search period from database inception to May 2024. Patients in the experimental group received Conbercept treatment, while patients in the control group received Triamcinolone acetonide treatment. The observed indicators included central macular thickness, incidence of adverse reactions, clinical efficacy, and best-corrected visual acuity. Relative risk (RR) and mean difference (MD) were used as effect measures. A total of 12 studies with 864 patients were included in the meta-analysis. The results showed that the experimental group had a significantly better central macular thickness (MD = - 42.68, 95% CI = - 55.04 ~ - 30.32, P < 0.001), clinical response rate (RR = 1.25, 95% CI = 1.12 ~ 1.39, P < 0.001), and best-corrected visual acuity (MD = 0.16, 95% CI = 0.12 ~ 0.20, P < 0.001) compared to the control group. In terms of adverse events, the overall incidence of adverse events was lower in the experimental group (RR = 0.26, 95% CI = 0.14 ~ 0.51, P < 0.001) compared to the control group. Specifically, the incidence of intraocular pressure elevation (RR = 0.33, 95% CI = 0.12 ~ 0.94, P = 0.04) and intraocular inflammation (RR = 0.17, 95% CI = 0.03 ~ 0.97, P = 0.05) was lower in the experimental group compared to the control group, but there was no significant difference in the incidence of subconjunctival hemorrhage (RR = 0.7, 95% CI = 0.14 ~ 3.5, P = 0.66) and corneal edema (RR = 0.2, 95% CI = 0.04 ~ 1.12, P = 0.07). Conbercept demonstrated superior efficacy in treating wAMD compared to triamcinolone acetonide, with a lower incidence of adverse reactions. However, the current meta-analysis included a limited number of studies, with only two studies evaluating best-corrected visual acuity (BCVA). Further high-quality randomized controlled trials (RCTs) are warranted to validate these findings.

Retrospective analysis of the safety and efficacy of Pembroria® during non-medical switching from the original drug Keytruda® in patients with advanced malignancies of various localizations in real clinical practice

Introduction. The emergence of genetically engineered biological drugs is rightly considered a revolutionary event in medicine. In 2022, the first biosimilar of pembrolizumab, the Russian drug Pembroria®, was approved. One of the study types that can convincingly demonstrate the safety and efficacy of biosimilar is its use for switching from the original drug for non-medical indications (NMS, or non-medical switching) according to standard approaches of real clinical practice and the drug label. Aim. To assess the safety of NMS switching in patients with advanced malignancies of various localizations from the original drug Keytruda® to the biosimilar Pembroria® and to evaluate its effectiveness in real clinical practice. Materials and methods. We analyzed the data of 114 patients with advanced malignancies of various localizations and the last line of treatment with Keytruda® as monotherapy or in combination with other agents within the approved indications and switched to Pembroria® for NMS. After switching to Pemboria®, patients did not change treatment for another checkpoint inhibitor within this line of therapy. Results. The incidence of immune-mediated adverse reactions (imARs) of any severity during treatment with comparators differed slightly: 57% with Keytruda® and 54% with Pembroria®. The majority of imARs with both Keytruda® and Pembroria® were Grade 1 in severity (69% and 86%, respectively). All serious ARs were resolved and did not result in drug discontinuation. When analyzing the best objective response to treatment with Keytruda®, complete response, partial response, and stabilization were observed in 9 (7.9%), 28 (24.6%), and 61 (53.5%) cases, respectively, during treatment with Pemboria® – in 8 (7%), 24 (21%), 52 (45.6%) cases, respectively. Conclusion. The safety profile of Keytruda® and Pembroria® is acceptable and comparable: the imAR rate with Pembroria® when switching from Keytrada® did not exceed that with the original drug Keytruda®; in most patients, switching from Keytruda® to Pembroria® was not associated with an increase in the imAR rate or severity. The majority of patients maintained disease control when switched to Pembroria®.

Safe Use of Intraspinal Anesthesia in Geriatric Orthopedic Surgery and Its Effect on Coagulation Factors

Objective This study aimed to observe the safe use of intraspinal anesthesia in geriatric orthopedic surgery and its effect on coagulation factors. Methods The anesthesia indices, cognitive functions, hemodynamic indicators, along with coagulation function indices were compared. The duration of anesthesia was compared between the two groups. Adverse reactions occurring in the two groups of patients were compared. Results The time to awaken, time to open eyes, time to the verbal statement, the onset of anesthesia, duration of sensory blockade, and duration of motor nerve blockade were shorter while the duration of analgesia was longer in the observation group than in the control group. The observation group’s postoperative Mini-Mental State Examination scores were higher than those of the control group. Heart rate and mean arterial pressure of the patients in the observation group at 10 min after anesthesia and at the end of surgery were lower versus those in the control group. The observation group had lower levels of von Willebrand factor (%) and fibrinogen at 10 min after anesthesia and at the end of surgery than the control group, and lower levels of the thrombin-antithrombin complex at the end of surgery than the control group. The observation group exhibited a lower incidence of adverse reactions in contrast to the control group. Conclusion The application of intraspinal anesthesia in geriatric orthopedic surgery has a significant and remarkable effect, with less impact on patients’ hemodynamics and postoperative cognitive function, and can improve patients’ blood hypercoagulability.

Cost-effectiveness analysis of lorlatinib and crizotinib in the first-line treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer

ABSTRACT Objectives To assess the economic value of lorlatinib and crizotinib in the first-line treatment of anaplastic lymphoma kinase-positive non-small cell lung cancer at medical insurance negotiation prices from the viewpoint of China’s health system. Methods Based on data from the phase III clinical trial, a three-state partitioned survival model was established. In combination with parameters such as treatment costs, utility values, incidence of adverse reactions, and discount rates, the total incremental cost-effectiveness ratio (ICER) was simulated. Results The results of the fundamental analysis indicated that the patients in the lorlatinib group expended 709,671 yuan more than did the patients in the crizotinib group did but gained 3.09 quality-adjusted life years (QALYs). The ICER value was 229,782.6 yuan/QALY, which was lower than three times the per capita gross domestic product (GDP) of China. Conclusions Compared with crizotinib, lorlatinib may be a cost-effective first-line treatment choice for advanced ALK-positive NSCLC in China.

Clinical effects of anweiyang capsule and Pinellia decoction for eradication of Helicobacter pylori and healing of peptic ulcers

Peptic ulcers are a prevalent and often chronic condition within the digestive system, frequently prone to recurrence. This study aims to evaluate the clinical effects of Anweiyang capsule combined with Pinellia Heart-Draining Decoction on Helicobacter pylori eradication, ulcer healing rates, and improvement of Traditional Chinese Medicine (TCM) syndromes in patients with peptic ulcers. A total of 100 patients were randomly assigned to an observation group (n = 50), receiving the herbal combination, and a control group (n = 50), receiving standard Western medical treatment. The total effective rate was significantly (P < 0.05) higher in the observation group (96%) compared to the control group (80%). After 4 weeks of treatment, serum procalcitonin (PCT) and C-reactive protein (CRP) levels decreased, while prostaglandin E2 (PGE2) levels increased in both groups; however, the observation group exhibited better results (P < 0.05). The observation group achieved a H. pylori eradication rate of 94% and an ulcer healing rate of 82%, compared to 64% and 56% in the control group, respectively. Improvement in TCM syndrome scores was more significant in the observation group (P < 0.05). Moreover, the incidence of adverse reactions was significantly (P < 0.05) lower in the observation group (4%) compared to the control group (18%). In conclusion, Anweiyang capsule combined with Pinellia Heart-Draining Decoction significantly enhances the eradication rate of H. pylori and the ulcer healing rate without substantially increasing the risk of adverse reactions, demonstrating its safety and reliability for patients.

Clinical efficacy and outcomes of calcitriol combined with bisphosphonates in the treatment of postmenopausal osteoporosis: A quasi-experimental study.

A quasi-experimental study was conducted to investigate the clinical efficacy and outcomes of calcitriol combined with bisphosphonates in the treatment of postmenopausal osteoporosis (OP). A total of 152 patients with postmenopausal OP from March 2019 to June 2021 were enrolled. The patients who received calcitriol treatment were adopted as the control group, and the patients treated with calcitriol combined with bisphosphonates were considered as the intervention group. The treatment effects of patients were compared, and the pain degree of the joints of the patients was evaluated by Visual Analogue Scale/Score (VAS), the Barthel Index score was used to evaluate the daily living ability of patients, the hand and Oswestry Disability Index (ODI) were used to evaluate the dysfunction before and after treatment, and the bone metabolism indexes, immune cytokines and bone mineral density were detected before and after treatment, and the incidence of adverse reactions was calculated. Regarding the therapeutic effects, the intervention group indicated an effective rate of 96.05% while the effective rate was 84.21% in the control group. The total effective rate of treatment in the intervention group was higher than the control group. The VAS, ODI scores, and bone metabolism indexes of the intervention group were significantly lower than the control group at 1, 2, and 3 months after treatment. The Barthel Index scores and bone mineral density of the intervention group were higher than the control group at 1, 2, and 3 months after treatment. The improvement of immune cytokines in the intervention group was significantly better than the control group (P < .05). One patient in the intervention group developed dizziness and 1 patient developed chills, with an adverse reaction rate of 2.63%, while in the control group, 2 patients had fever, and 2 patients developed chills, with an adverse reaction rate of 5.26% (P > .05). Calcitriol combined with bisphosphonates has a significant clinical effect in the treatment of postmenopausal OP, which can significantly relieve bone pain in postmenopausal OP patients, enhance abnormal bone metabolism and immune function, and promote bone mineral density and daily living ability.

Application of CAR-T cell therapy in B-cell lymphoma: a meta-analysis of randomized controlled trials.

This study aims to compare the efficacy and safety of chimeric antigen receptor T-cell (CAR-T) immunotherapy with standard treatment for B-cell lymphoma, providing evidence-based support for the more efficient use of CAR-T cell immunotherapy. We conducted a comprehensive literature search of high-quality randomized controlled trials (RCTs) on CAR-T therapy for B-cell lymphoma in the following databases: Wanfang, Web of Science, CNKI, VIP database, and PubMed, up to February 2024. The outcome measures included objective remission rate (ORR), complete remission rate (CRR), and incidence of adverse reactions. Subgroup analysis was performed based on the differences in co-stimulatory domains. Meta-analysis was conducted using Review Manager 5.4 and Stata software. A total of five RCTs involving 1670 patients were included in this meta-analysis. The results showed that the CAR-T treatment group had significantly higher ORR (RR: 1.47, 95% CI 1.23-1.76, I2 = 80%, p < 0.0001), CRR (RR: 2.19, 95% CI 2.16-3.79, I2 = 93%, p = 0.005), cytokine release syndrome (CRS) incidence (RR: 34.51, 95% CI 2.27-523.78, I2 = 98%, p = 0.01), neurotoxicity (NT) incidence (RR: 6.00, 95% CI 1.82-19.75, I2 = 80%, p = 0.003), neutropenia incidence (RR: 1.39, 95% CI 1.02-1.88, I2 = 93%, p = 0.03), leukopenia incidence (RR: 1.39, 95% CI 1.04-1.87, I2 = 61%, p = 0.03), and headache incidence (RR: 1.56, 95% CI 1.25-1.95, I2 = 34%, p < 0.0001) compared to the standard treatment group. Subgroup analysis based on co-stimulatory domains revealed that the 4-1BB subgroup had higher incidences of CRR, CRS, NT and leukopenia than the CD28 subgroup; however, the CD28 subgroup exhibited higher ORR and neutropenia than the 4-1BB subgroup. CAR-T cell immunotherapy demonstrates superior efficacy compared to standard therapy in treating B-cell lymphoma. However, CAR-T treatment can lead to adverse reactions such as CRS and NT. Infusion of an appropriate dose of CAR-T cells (e.g., 100 × 106) may be a strategy to mitigate the risk of CRS and NT.

The intervention effect of psychological care combined with ondansetron, dexamethasone, and promethazine hydrochloride on chemotherapy in breast cancer surgical patients.

Breast cancer (BC) is one of the most common malignancies in women and imposes a significant health burden globally. According to data from the World Health Organization, the incidence of BC has been increasing steadily over the years. It has become one of the leading causes of cancer-related death among women worldwide. This work was to evaluate the combined intervention effect of psychological care along with the use of ondansetron, dexamethasone, and promethazine hydrochloride in breast cancer (BC) patients undergoing chemotherapy, including their impact on nausea and vomiting control, quality of life (QoL), and psychological status. 64 BC patients undergoing chemotherapy were collected and randomly rolled into a control group (Group C) and an intervention group (Group I). Group C received ondansetron combined with routine psychological support and counseling therapy, while Group I received a combination of ondansetron, dexamethasone, promethazine hydrochloride, and psychological care therapy. Self-assessment scores for anxiety, QoL ratings, white blood cell counts, and incidence of adverse reactions were assessed and compared between the two groups. Group I showed better control of nausea and vomiting versus Group C (P< 0.05). Marked improvements were also observed in the self-rating anxiety scale (SAS) scores, white blood cell counts, and nursing satisfaction in Group I versus Group C (P< 0.05). Nevertheless, the two groups had no significant difference regarding QoL scores (P> 0.05). the combination of psychological care with ondansetron, dexamethasone, and promethazine hydrochloride effectively controls nausea and vomiting symptoms in BC patients undergoing chemotherapy and provides higher levels of clinical nursing satisfaction.

Correlation Analysis of Serum 25-Hydroxyvitamin D Levels With Immune Function and Calcium-Phosphate Metabolism in Patients With Bronchial Asthma Treated With Combination Therapy

It was to investigate the clinical efficacy of the combination therapy of fluticasone propionate inhalation aerosol and vitamin D (VD) in pediatric bronchial asthma (BA) and analyze the correlation between serum 25-(OH)-D3 levels and immune function, as well as calcium-phosphorus metabolism. A total of 110 patients with BA were recruited. Regarding treatment plan, patients were randomly rolled into a single-drug treatment group (SDT, treated with fluticasone propionate inhalation aerosol alone) and a dual-drug treatment group (TDT, treated with the combination of fluticasone propionate inhalation aerosol and VD). The changes in serum 25-(OH)-D3 levels, immunoglobulins, T lymphocyte subsets, and inflammatory cytokine levels in children with BA under different treatment modalities were compared. Clinical symptom disappearance, asthma control, and quality of life (QoL) were assessed, and the total effective rate and adverse reactions (ARs) were compared. A control group consisting of 60 healthy children who underwent concurrent physical examinations was included. The differences in serum 25-(OH)-D3 levels, immunoglobulins, and T lymphocyte subset levels between children with BA and healthy controls were compared, and their correlations were analyzed. The TDT group showed a drastic reduction in the disappearance time of lung wheezing and dyspnea relative to the SDT group. Furthermore, the TDT group exhibited notable improvements in lung function parameters, including forced vital capacity (FVC), forced expiratory volume at one second (FEV1), FEV1/FVC, and peak expiratory flow (PEF). Blood gas analysis revealed a great decrease in PaCO2 and an increase in PaO2. The Childhood Asthma Control Test (C-ACT) scores for asthma control and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) scores for QoL showed marked increases in the TDT group. Moreover, the TDT group demonstrated notable increases in serum 25-(OH)-D3 levels, immunoglobulins (IgA, IgG, and IgM), T lymphocyte subsets (CD4+ and CD8+), as well as blood calcium and phosphorus levels. Additionally, the TDT group exhibited a prominent increase in the anti-inflammatory cytokine interleukin (IL)-10 level and a drastic decrease in the pro-inflammatory cytokines IL-6 and tumor necrosis factor alpha (TNF-α) levels (all P&lt;0.05). The total effective rates of treatment in the SDT group and TDT group were 83.64 % and 96.36 %, respectively, with AR rates of 16.36 % and 7.27 %. The TDT group exhibited a superior total effective rate and an inferior incidence of ARs to the SDT group (both P&lt;0.05). Additionally, in contrast to the control group, the BA group showed notable decreases in serum 25-(OH)-D3 levels, immunoglobulins (IgA, IgG, and IgM), T lymphocyte subsets (CD4+, CD8+, and CD4+/CD8+), as well as blood calcium and phosphorus levels (all P&lt;0.05). Prior to treatment, there was a positive correlation between serum 25-(OH)-D3 levels and immunoglobulins (IgA, IgG, and IgM), T lymphocyte subsets (CD4+ and CD8+), as well as blood calcium and phosphorus levels in children with BA (P&lt;0.05). In patients with BA, combined treatment with inhaled fluticasone propionate aerosol and VD may have a regulatory effect on serum 25-hydroxyVD levels, immune function, and calcium-phosphate metabolism. The correlation between serum 25-(OH)-D3 levels and immune function, as well as calcium-phosphate metabolism, suggested that VD may play a crucial role in the immune regulation and calcium-phosphate metabolism of BA.

Is the Use of a Buprenorphine Transdermal Patch More Effective Than Oral Medications for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair? A Randomized Clinical Trial.

Appropriate analgesic protocols for patients following arthroscopic rotator cuff repair remain controversial. Although transdermal buprenorphine patches might potentially provide better pain control and fewer side effects, it is worth noting that there is limited evidence for this given a lack of direct comparisons with oral pain regimens. Among patients undergoing arthroscopic rotator cuff repair, and compared with an analgesic approach using oral tramadol plus celecoxib: (1) Does perioperative use of buprenorphine patches provide better pain relief by a clinically important margin? (2) Does perioperative use of buprenorphine patches improve shoulder joint function recovery? (3) Does perioperative use of buprenorphine patches have a lower frequency of adverse reactions? This was a prospective, single-center, randomized controlled trial. We included patients who underwent arthroscopic rotator cuff repair for partial- or full-thickness rotator cuff tears < 3 cm in size in the anterior to posterior direction as estimated by preoperative MRI and excluded those who had obesity, were pregnant, had opioid dependence, had history of cardiac bypass surgery or ipsilateral rotator cuff repair, had allergies to trial medications, were taking anticoagulants or antidepressants, were being treated with other postsurgical pain management methods, or had severe liver or kidney dysfunction. Based on these criteria, 64% (72 of 112) of patients were eligible. The patients were randomly assigned into either the control group (oral tramadol and celecoxib) or the experimental group (buprenorphine patches). The control group received 100 mg of tramadol and 200 mg of celecoxib every 12 hours for 2 weeks after surgery. The experimental group received buprenorphine patches about 48 hours before surgery without any oral medication. A medication journal was given to the patients to self-report their compliance in taking the drugs. The dosage regimen adhered strictly to protocol. After enrollment, 11% (4 of 36) of patients in the control group and 17% (6 of 36) of patients in the experimental group could not be fully analyzed because of loss to follow-up or missing data. The surveillance period was 3 months, and there was no crossover between groups. The groups did not differ at baseline in terms of demographic parameters and relevant clinical characteristics, including age, gender, BMI, American Society of Anesthesiologists classification, tear size, concomitant procedures, and number of anchors. The outcomes were (1) numeric rating scale (NRS) for pain score at rest or with movement, which ranges from 0 to 10, where 0 indicates no pain, and 10 indicates the worst pain; (2) the American Shoulder and Elbow Surgeons (ASES) score for joint function, which ranges from 0 to 100, with higher scores indicating better shoulder joint function; and (3) the incidence of postoperative adverse reactions. We defined the minimum clinically important difference on the NRS as 2 of 10 points and on the ASES score as 15 of 100 points, based on anchor-based approaches reported in other studies. We found no clinically important between-group differences in NRS pain scores at any time point, either at rest or with movement. Likewise, we found no clinically important between-group differences in ASES scores at any time point. Postoperative dizziness or drowsiness (20% [6 of 30 patients] versus 44% [14 of 32 patients]; p = 0.04) and nausea (10% [3 of 30 patients] versus 34% [11 of 32 patients]; p = 0.02) during the hospital stay were slightly lower in the experimental group compared with the control group. In this randomized trial, we found no clinically important advantages in pain or function to the use of buprenorphine patches after arthroscopic rotator cuff repair, and insufficient evidence exists to confirm whether the minor differences in transient side effects could justify the use of a new and largely untested analgesic approach in this context. That being so, we recommend against the routine use of buprenorphine patches for this indication. In general, we found that pain levels were low after the procedure in both groups. Future studies, therefore, should focus on the efficacy of buprenorphine patches for more invasive or more painful procedures. Level I, therapeutic study.

Efficacy of Clarithromycin Combined with Fluticasone Propionate on Nasal Function, Nasal Mucociliary Transport Function, and Serum Inflammatory Markers in Chronic Rhinosinusitis Patients After Functional Endoscopic Sinus Surgery.

Objective: This study aims to assess the efficacy of clarithromycin (CAM) combined with fluticasone propionate (FP) in patients with chronic rhinosinusitis (CRS) after functional endoscopic sinus surgery (FESS), focusing on nasal function, nasal mucociliary transport (MCT) function, and serum inflammatory markers. Methods: The control group (n = 48) was treated with FESS alone, while the study group (n = 48) was treated with FESS plus CAM combined with FP. The clinical effects, symptom scores, nasal function, nasal MCT function, serum inflammatory marker levels, and the occurrence of adverse reactions were compared. Results: The total efficacy rate of the study group (95.83%) was significantly higher than that of the control group (83.33%). After treatment, the study group showed lower symptom scores for nasal congestion, runny nose, sneezing and dizziness, and headache compared to those in the control group. The study group also had lower nasal airway resistance, shorter distance from the minimal cross-sectional area to the nostril, and lower T&T olfactory scores. In contrast, their nasal cavity volume and minimal cross-sectional area were higher than those of the control group. Additionally, the nasal mucociliary clearance and MCT rates were higher in the study group. Serum levels of interleukin-6, interleukin-8, tumor necrosis factor-α, and procalcitonin were significantly lower in the study group compared to the control group (all P < .05). Conclusion: The use of CAM combined with FP in patients after FESS for CRS is effective, leading to the relief of clinical symptoms, improvement of nasal function, enhancement of MCT function, and reduction of inflammatory response, without increasing the incidence of adverse reactions.

Tegoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Eradication: A Prospective, Randomized, Multicenter Study in Fujian, China.

Few studies have investigated the efficacy and safety of tegoprazan-amoxicillin (TA) dual therapy for Helicobacter pylori eradication. We aim to evaluate the effectiveness and safety of different dosages of TA dual therapy for H. pylori eradication. This prospective, randomized, open-label, multicenter study was conducted at four centers in Fujian, China. H. pylori-infective patients were randomized 1:1:1 to receive one of the following treatments: bismuth quadruple therapy (BQT, esomeprazole 20 mg twice daily + potassium bismuth citrate 240 mg twice daily + amoxicillin 1 g twice daily + clarithromycin 500 mg twice daily), tegoprazan-amoxicillin dual therapies (TA-qd, tegoprazan 50 mg once daily + amoxicillin 1 g thrice daily; TA-bid, tegoprazan 50 mg twice daily + amoxicillin 1 g thrice daily) for 14 days. The primary outcome was noninferiority in eradication rates of the different TA groups compared to the BQT group. Secondary outcomes encompassed an assessment of adverse reactions and clinical symptom relief. Additionally, exploratory outcomes were focused on the shifts in gut microbiota and a cost-effectiveness analysis. A total of 321 patients were enrolled. The eradication rates in the BQT group, TA-qd group, and TA-bid group were 85.05% (91/107), 85.98% (92/107), and 85.98% (92/107) in the intention-to-treat analysis (ITT) (BQT vs. TA-qd, 95% CI -8.50% to 10.36%, noninferiority p = 0.012; BQT vs. TA-bid, 95% CI -8.50% to 10.36%, noninferiority p = 0.012); 91.00% (91/100), 91.09% (92/101), and 92.93% (92/99) in the modified intention-to-treat analysis (mITT) (BQT vs. TA-qd, 95% CI -7.81% to 7.98%, noninferiority p = 0.006; BQT vs. TA-bid, 95% CI -5.62% to 9.48%, noninferiority p < 0.001); 90.81% (89/98), 91.00% (91/100), and 93.81% (91/97) in the per-protocol analysis (PP) (BQT vs. TA-qd, 95% CI -7.83% to 8.19%, noninferiority p = 0.006; BQT vs. TA-bid, 95% CI 4.46% to 10.46%, noninferiority p < 0.001). The incidence of adverse reactions in the TA-qd and TA-bid groups was significantly lower than in the BQT group (13.33%, 14.56%, and 27.18%, respectively; p = 0.017). The complete remissions of clinical symptoms for BQT, TA-qd, and TA-bid were 36.89%, 65.71%, and 68.93%, respectively, had significant differences (p < 0.001). Two weeks of TA therapy altered gut microbiota diversity and composition, but that recovered 4 weeks after discontinuation. The cost-effectiveness ratios (CERs) for BQT, TA-qd, and TA-bid were 1.85 CNY, 2.08 CNY, and 3.69 CNY, respectively. Both TA dual therapies provided satisfactory eradication rates of > 90% for eradicating H. pylori, fewer adverse reactions, and greater clinical symptom relief compared to BQT, with a mild, reversible impact on gut microbiota. In addition, the TA dual therapy with low doses of tegoprazan showed better cost-effectiveness. Chinese Clinical Trial Register and registration No.: ChiCTR2300071997.

Efficacy and safety of edaravone combined with Ginkgo Leaf Extract and Dipyridamole in the treatment of acute cerebral infarction: A systematic review and meta-analysis.

To evaluate the clinical efficacy and safety of edaravone combined with Ginkgo Leaf Extract and Dipyridamole (GLED) versus edaravone alone in the treatment of acute cerebral infarction (ACI) by the method of meta-analysis. PubMed, Web of Science, Cochrane Library, China National Knowledge Infrastructure, WANFANG DATA, and Chinese Scientific Journal Database were searched to identify publications on edaravone combined with GLED for ACI from inception to June 20, 2024. Stata15.0 statistical software was applied for data analysis. The test group was treated with edaravone combined with GLED, while the control group received edaravone alone. A total of 12 records were involved in this meta-analysis. The combined results exhibited that the effective rate of edaravone combined with GLED was significantly higher than that of edaravone in the treatment of ACI (relative risk = 1.21, 95% confidence interval [CI] = 1.15-1.27, P < .001). The National Institute of Health stroke scale scores of edaravone combined with GLED were significantly lower than those of edaravone alone in the treatment of ACI (standardized mean difference = -1.93, 95% CI = -3.36 to -0.50, P = .008). The incidence of adverse reactions in the edaravone combined with GLED group was significantly lower than that in the edaravone alone group (relative risk = 0.48, 95% CI = 0.33-0.70, P < .001) in the treatment of ACI. The combination of edaravone with GLED for treating ACI has better efficacy and higher safety than edaravone alone. Given the limited number of studies identified and possibility of publication bias, the above findings should be verified by more high-quality trials in the future.

Shengji ointment combined with bromelain promotes granulation of exposed tendons in diabetic foot ulcers: A multicenter, randomized, positive-controlled clinical trial

BackgroundExposed, infected and necrotic tendons often occur in the middle and late stages of diabetic foot ulcers (DFUs). The exposed tendon is both a potential source and route of infection, which prolongs the treatment period and affects recovery, leading to amputation and even death. Therefore, management of the exposed tendon in patients with DFU is the key to treatment. This study aimed to evaluate the clinical efficacy of Shengji ointment combined with bromelain in the treatment of DFU with tendon exposure and to provide clinical treatment options and evidence-based medicine. MethodsThis study was a multicenter, nonblinded, randomized, positive controlled clinical trial involving 180 patients with DFU with tendon exposure at four tertiary-grade A-class hospitals. The included patients were randomly assigned 1:1 to an observation group (n = 90) that received Shengji ointment combined with bromelain and a control group (n = 90) that received hydrocolloid dressing, with dressing changes once daily for 4 weeks. Patients in both groups continued with conventional treatments, such as blood glucose and blood pressure medication, lipid regulation, and antiplatelets. The primary outcome measure was wound coverage with granulation tissue. The secondary outcome measures included the wound healing rate, time to granulation, Maryland foot score, time to debridement of necrotic tendon tissue, and granulation tissue score. We performed measurements before enrollment and after the end of treatment for comparison. ResultsThere was no significant difference in the baseline data between the two groups before treatment (P > 0.05). After treatment, the primary outcome indicators of the two groups were compared, and the wound granulation tissue coverage rate of the treatment group was greater than that of the control group (P = 0.003). For the secondary outcome outcomes, the wound healing rate, time to granulation, Maryland foot function score, time to debridement of necrotic tendon tissue, and granulation tissue score in the treatment group were significantly better than those in the control group (P < 0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P = 0.444). ConclusionsShengji ointment combined with bromelain effectively promotes the removal of exposed necrotic tendons in patients with DFU, promotes the regeneration of healthy granulation tissue, accelerates wound healing, and protects the limb and its function. It also appears to be safe as an intervention for the treatment of patients with DFU. Trial registrationThe study protocol was registered in the Chinese Clinical Trial Registry (ChiCTR) under the code ChiCTR2000039327 on October 23, 2020. The public title is “Study on evidence-based evaluation and therapeutic mechanism of integrated Chinese and Western medicine for treatment of diabetic foot - An evidence-based evaluation of The combination of Rubber Shengji Paste and compound bromelain to promote the healing of the exposed wound of diabetic foot tendon”.

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

ObjectivesIn 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.MethodsIn 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).ResultsThere 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 &amp;lt; 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 &amp;lt; 0.05) and the homocysteine levels of the treatment group were significantly reduced (P &amp;lt; 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 &amp;lt; 0.05). The activated partial thromboplastin time in the treatment group decreased significantly (P &amp;lt; 0.05). There was no statistically significant difference in the safety indicators and incidence of adverse reactions between the two groups.ConclusionTreatment 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.Clinical Trial Registrationhttps://www.chictr.org.cn/showprojEN.html?proj=235570, ChiCTR registry, ChiCTR1900023708.

Efficacy and safety of Chinese herbal medicines combined with biomedicine in the treatment of idiopathic membranous nephropathy: a systematic review and network meta-analysis.

Chinese herbal medicines have been extensively used to treat idiopathic membranous nephropathy (IMN). However, their efficacy and safety remain uncertain. Therefore, this study employed a network meta-analysis to evaluate the efficacy and safety of various Chinese herbal medicines in combination with biomedicines for treating IMN. A comprehensive literature search was performed across several databases, including PubMed, EMBASE, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), WanFang Data, VIP Database, and Chinese Biomedical Literature Database (CBM), to identify randomized controlled trials (RCTs) concerning the treatment of IMN using a combination of Chinese herbal medicines and biomedicine, up to 31 May 2024. Two researchers independently conducted the literature screening and data extraction. The quality of the included studies was assessed using the Cochrane quality review manual, and Stata 14.2 software was employed for network meta-analysis. A total of 31 RCTs involving 2195 IMN patients and 15 different Chinese herbal medicines were analyzed. The network meta-analysis revealed that QQC + BM (84.7%) was the most effective in reducing 24-hour urinary protein. For improving serum albumin, HZC + BM (86%) was the most effective. LGT + BM (77.2%) was the best for enhancing serum creatinine levels. MXC + BM demonstrated the highest effectiveness in lowering total cholesterol (89%) and triglycerides (97%). Lastly, WZC + BM (90.8%) was the most effective in reducing the incidence of adverse reactions. BM. The current evidence suggests that integrating Chinese herbal medicines with biomedicine may provide significant benefits in treating IMN. Specifically, QQC + BM appears to be the most effective in reducing 24-hour urinary protein, HZC + BM seems to excel in improving serum albumin levels, MXC + BM is noted for its effectiveness in lowering triglycerides and total cholesterol, LGT + BM is optimal for reducing serum creatinine, and WZC + BM shows the lowest rate of adverse reactions. Nevertheless, due to limitations in the quantity and quality of the included studies, further validation of these conclusions is necessary. [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024561028], identifier [CRD42024561028].