[关键词]
[摘要]
目的:总结舒血宁注射液治疗疾病的临床效应特点,并评价其证据质量,为舒血宁注射液的临床运用提供参考依据。方法:以“舒血宁”中英文检索式为主题词检索CNKI、CBM、万方、维普、EBbase、Pubmed、Cochrane数据库中的期刊论文、学术会议论文,筛选出全部形式的临床研究,分析疾病类型及频次,找出目前临床应用舒血宁注射液的优势病种,并提取其中的RCT,运用cochrane手册推荐方法对文献质量进行分级,评价其有效性和安全性。结果:所有临床研究结果分析显示,舒血宁注射液治疗疾病种类多达74种,其中主要为循环系统疾病和神经系统疾病,其次为内分系统泌疾病、呼吸系统疾病,剩余研究分散在其他10个疾病系统中,治疗人数最多、出现频次最高的疾病前三位的分别是脑梗死及其后遗症、冠心病心绞痛、糖尿病及其并发症。共纳入337篇RCT,文献质量均较差,总体上舒血宁注射液治疗组有效率明显高于对照组,总有效率84.48%,有21.96%的文献提到不良反应,但均为轻微不良反应,如皮疹、瘙痒等,停药后一般自行好转或治疗后好转。结论:舒血宁注射液临床应用广泛,且效果显著,尤其针对心脑血管方面的缺血性疾病有效性较好,且不良反应较少,比较安全。但证据质量总体较差,有待进一步研究。
[Key word]
[Abstract]
Objective: To summarize the clinical effects of Shuxuening Injection on diseases and evaluate the quality of evidence to provide reference for the clinical application of Shuxuening Injection. Methods: Journal articles andconference papers were retrieved from the databases CNKI, Wanfang, VIP, CBM, EMbase, Pubmed and Cochrane withthematic word“Shuxuening”in Chinese and English, then all forms of clinical studies were screened and the diseasetypes and frequency were analyzed, the dominant disease types of Shuxuening Injection were identified. Futhermore,RCT was extracted, and the literature quality was graded using the cochrane manual recommendation method, and itseffectiveness and safety were evaluated. Results: All clinical research results show that Shuxuening Injection to treatdisease with as many as 74 kinds of varieties, mainly circulation system disease and neural system disease, followed byendocrine disease, respiratory disease, scattered remaining research in ten other system diseases. These researchesappeared with the highest frequency of the three diseases were cerebral infarction and its aftermath, angina pectoris andcoronary heart disease, diabetes mellitus and its complication. A total of 337 RCT articles were included, all of whichwere of poor quality. In general, the efficiency of Shuxuening Injection treatment group was significantly higher than thatof the control group, with a total efficiency of 84.48%. There were 21.96% references to adverse reactions, but all of themwere minor adverse reactions, such as pruritus, which generally got better by itself or after treatment. Conclusion:Shuxuening Injection has a wide range of clinical application and remarkable effect, especially for the ischemic diseasesof cardiovascular and cerebrovascular diseases with good efficacy, less adverse reactions and safety. However, the qualityof evidence is generally poor, which needs further study.
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[基金项目]
中共中央组织部第二批国家“万人计划”(2016)经费资助项目(W02020052):第二批国家高层次人才特殊支持计划领军人才,负责人:商洪才;国家科技部重点研发计划“中医药现代化研究”重点专项课题(2017YFC1700402):心肌梗死介入围手术期中医通治方案循证优化研究,负责人:商洪才。