[关键词]
[摘要]
目的 运用网状Meta分析法比较不同三七类口服制剂治疗急性脑梗死的临床疗效和安全性。方法 系统检索中国知网数据库(CNKI)、万方数据库、重庆维普中文科技期刊数据库(VIP)、中国生物医学文献数据库(SinoMed)、PubMed、Cochrane Library和Web of Science数据库,收集从建库至2021年3月,4种三七类口服制剂治疗急性脑梗死的随机对照试验,经预先设定的纳排标准筛选后,对纳入的文献进行资料提取,采用Cochrane协作网研发的“偏倚风险评估工具”评价研究质量,运用STATA 16软件进行网状Meta分析。结果 共纳入29项研究,共2787例患者,均为开放临床对照试验,涉及西医常规治疗(conventional Western medicine,CWM)、血栓通胶囊(Xueshuantong Capsule,XC)、血塞通软胶囊(Xuesaitong Soft Capsule,XSC)、三七通舒胶囊(Sanqi Tongshu Capsule,STC)、复方血栓通胶囊(Compound Xueshuantong Capsule,CXC)5种干预措施。网状Meta分析结果显示,在改善临床总有效率方面,当疗程≤15 d时排序为:CWM+XC(85.7%)>CWM+CXC(61.9%)>CWM+STC(57.2%)>CWM+XSC(43.3%)>CWM(2.0%);当疗程>15 d时排序为:CWM+CXC(82.7%)>CWM+STC(66.1%)>CWM+XC(65.8%)>CWM+XSC(34.1%)>CWM(1.3%)。在降低神经功能缺损程度评分方面,当疗程≤15 d时排序为:CWM+CXC(88.8%)>CWM+XC(77.5%)>CWM+STC(51.1%)>CWM+XSC(20.3%)>CWM(12.3%);当疗程>15 d时排序为:CWM+XC(93.9%)>CWM+STC(70.2%)>CWM+CXC(43.9%)>CWM+XSC(32.2%)>CWM(9.8%)。在提高日常生活能力评分方面,排序为:CWM+STC(70.1%)>CWM+XSC(68.6%)>CWM+XC(52.6%)>CWM+CXC(51.7%)>CWM(7.0%)。定性分析显示三七类口服制剂治疗急性脑梗死的不良反应发生率较低。结论 对于急性脑梗死患者,三七类口服制剂联合西医常规治疗的疗效优于单纯西医常规治疗,当治疗疗程较短时,建议优先选择血栓通胶囊;当治疗疗程较长时,建议优先选择复方血栓通胶囊或三七通舒胶囊,患者获益的可能性最大。但因纳入研究的文献质量不高,故需要样本量更大、质量更高、设计更严格的随机对照试验作进一步论证。
[Key word]
[Abstract]
Objective To assess the clinical efficacy and safety of different Panax notoginseng oral preparations for acute cerebral infarction by using network Meta-analysis method. Methods Databases including CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, and Web of Science were searched to collect randomized controlled trials about four kinds of P. notoginseng oral preparations in treatment of patients with acute cerebral infarction from inception to March 2021. Studies were screened and extracted according to the pre-established inclusion and exclusion criteria. The Cochrane risk of bias assessment tool was used to evaluate the quality of studies, and STATA 16 software was used for the Meta-analysis of the data. Results A total of 29 studies were included 2787 patients, of which were open-label controlled, involving conventional Western medicine (CWM), Xueshuantong Capsule (血栓通胶囊, XC), Xuesaitong Soft Capsule (血塞通软胶囊, XSC), Sanqi Tongshu Capsule (三七通舒胶囊, STC), and Compound Xueshuantong Capsule (复方血栓通胶囊, CXC). The results of network Meta-analysis showed that in terms of improving total effective rate, the ranking was CWM+XC (85.7%) > CWM+CXC (61.9%) > CWM+STC (57.2%) > CWM+XSC (43.3%) > CWM (2.0%) when the therapeutic duration was less than 15 d. However, the ranking was CWM+CXC (82.7%) > CWM+STC (66.1%) > CWM+XC (65.8%) > CWM+XSC (34.1%) > CWM (1.3%) when the therapeutic duration was more than15 d. In terms of decreasing neurological deficit score, the ranking was CWM+CXC (88.8%) > CWM+XC (77.5%) > CWM+STC (51.1%) > CWM+XSC (20.3%) > CWM (12.3%) when the therapeutic duration was less than 15 d. When the therapeutic duration was more than 15 d, the ranking was CWM+XC (93.9%) > CWM+STC (70.2%) > CWM+CXC (43.9%) > CWM+XSC (32.2%) > CWM (9.8%). In terms of increasing the activity of daily living score, the ranking was CWM+STC (70.1%) > CWM+XSC (68.6%) > CWM+XC (52.6%) > CWM+CXC (51.7%) > CWM (7.0%). Qualitative analysis showed that the incidence of adverse reactions of P. notoginseng oral preparations combined with conventional Western medicine in the treatment of acute cerebral infarction was low. Conclusion For patients with acute cerebral infarction, the clinical efficacy of P. notoginseng oral preparations combined with conventional Western medicine was better than conventional Western medicine alone. XC was given priority when the therapeutic duration was short, and when the therapeutic duration was longer, it was recommended to choose CXC or STC. However, due to the low quality of studies, further large sample and high quality randomized controlled trials should be carried out.
[中图分类号]
R285.64
[基金项目]
国家重点研发计划——中医药现代化专项(2018YFC1705000,2018YFC1705001)