本研究通过对中成药治疗心力衰竭的临床随机对照试验(randomized controlled trial,RCT)进行系统收集与分析,拟制定治疗心力衰竭的中成药推荐意见,为临床医生合理使用中成药提供参考。基于3个国际电子数据库(PubMed,Embase和Cochrane li...本研究通过对中成药治疗心力衰竭的临床随机对照试验(randomized controlled trial,RCT)进行系统收集与分析,拟制定治疗心力衰竭的中成药推荐意见,为临床医生合理使用中成药提供参考。基于3个国际电子数据库(PubMed,Embase和Cochrane library)和3个中文文献数据库[中国期刊全文数据库、万方医学数据库和中文科技期刊数据库(维普)],纳入各数据库建立至2022年7月1日所有相关的RCTs,共检索到83种中成药,最终纳入15种中成药作为心力衰竭的临床用药推荐,包括注射液7种和口服中成药8种。对比分析了15种中成药的基本信息、研究规模、干预方案及结局指标,采用GRADE(Grades of Recommendations Assessment Development and Evaluation)分级方法对纳入中成药疗效的证据质量进行评价,评估其对射血分数降低的心力衰竭(heart failure with reduced ejection fraction,HFrEF)、射血分数保留的心力衰竭(heart failure with preserved ejection fraction,HFpEF)及急性心力衰竭(acute heart failure,AHF)的疗效和安全性。本研究结合循证医学方法,综合评价目前使用较多、证据较为充足的治疗心力衰竭的15种中成药,拟为临床医师合理使用中成药提供一定依据。展开更多
Objective： To evaluate the effect and safety of Kuanxiong Aerosol （宽胸气雾剂, KA） on patients with angina pectoris. Methods： Block randomization was performed to randomly allocate 750 patients into KA （376 cases...Objective： To evaluate the effect and safety of Kuanxiong Aerosol （宽胸气雾剂, KA） on patients with angina pectoris. Methods： Block randomization was performed to randomly allocate 750 patients into KA （376 cases） and control groups （374 cases）. During an angina attack, the KA group received 3 consecutive sublingual sprays of KA （0.6 mL per spray）. The control group received 1 sublingual nitroglycerin tablet （NT, 0.5 rag/tablet）. Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment （1,2, 3, 4, 5, and 〉5 min）. Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society （CCS） classes of angina. Results： The 5-min remission rates in the KA and control groups were not significantly different （94.41% vs. 90.64%, P〉0.05）. The angina CCS class significantly influenced the rate of remission （95% confidence interval = 0.483-0.740, P〈0.01）. In the CCS subgroup analysis, the 3- and 5-min remission rates for KA and NT were similar in the CCS I and IV subgroups （P〉0.05）, while they were significantly better for KA in the CCS Ⅱ and Ⅲ subgroups （P〈0.05 or P〈0.01）. Furthermore, the inciden0ce of adverse reactions was significantly lower in the KA group than in the control group for the CCS Ⅱ and Ⅲ subgroups （9.29% vs. 26.22%, 10.13% vs. 20.88%, P〈0.05 or P〈0.01）. Conclusions： KA is not inferior to NT in the remission of angina. Furthermore, in CCS Ⅱ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions. （Registration No. ChiCTR- IPR-15007204）展开更多
文摘本研究通过对中成药治疗心力衰竭的临床随机对照试验(randomized controlled trial,RCT)进行系统收集与分析,拟制定治疗心力衰竭的中成药推荐意见,为临床医生合理使用中成药提供参考。基于3个国际电子数据库(PubMed,Embase和Cochrane library)和3个中文文献数据库[中国期刊全文数据库、万方医学数据库和中文科技期刊数据库(维普)],纳入各数据库建立至2022年7月1日所有相关的RCTs,共检索到83种中成药,最终纳入15种中成药作为心力衰竭的临床用药推荐,包括注射液7种和口服中成药8种。对比分析了15种中成药的基本信息、研究规模、干预方案及结局指标,采用GRADE(Grades of Recommendations Assessment Development and Evaluation)分级方法对纳入中成药疗效的证据质量进行评价,评估其对射血分数降低的心力衰竭(heart failure with reduced ejection fraction,HFrEF)、射血分数保留的心力衰竭(heart failure with preserved ejection fraction,HFpEF)及急性心力衰竭(acute heart failure,AHF)的疗效和安全性。本研究结合循证医学方法,综合评价目前使用较多、证据较为充足的治疗心力衰竭的15种中成药,拟为临床医师合理使用中成药提供一定依据。
基金Supported by the Traditional Chinese Medicine Public Welfare Scientific Research Project,State Administration of Traditional Chinese Medicine of China(No.201007001)
文摘Objective： To evaluate the effect and safety of Kuanxiong Aerosol （宽胸气雾剂, KA） on patients with angina pectoris. Methods： Block randomization was performed to randomly allocate 750 patients into KA （376 cases） and control groups （374 cases）. During an angina attack, the KA group received 3 consecutive sublingual sprays of KA （0.6 mL per spray）. The control group received 1 sublingual nitroglycerin tablet （NT, 0.5 rag/tablet）. Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment （1,2, 3, 4, 5, and 〉5 min）. Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society （CCS） classes of angina. Results： The 5-min remission rates in the KA and control groups were not significantly different （94.41% vs. 90.64%, P〉0.05）. The angina CCS class significantly influenced the rate of remission （95% confidence interval = 0.483-0.740, P〈0.01）. In the CCS subgroup analysis, the 3- and 5-min remission rates for KA and NT were similar in the CCS I and IV subgroups （P〉0.05）, while they were significantly better for KA in the CCS Ⅱ and Ⅲ subgroups （P〈0.05 or P〈0.01）. Furthermore, the inciden0ce of adverse reactions was significantly lower in the KA group than in the control group for the CCS Ⅱ and Ⅲ subgroups （9.29% vs. 26.22%, 10.13% vs. 20.88%, P〈0.05 or P〈0.01）. Conclusions： KA is not inferior to NT in the remission of angina. Furthermore, in CCS Ⅱ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions. （Registration No. ChiCTR- IPR-15007204）
