[关键词]
[摘要]
目的 利用网状Meta分析比较不同中药注射液治疗卒中后认知障碍(PSCI)的有效性和安全性。方法 检索中国学术期刊全文数据库(CNKI)、维普生物医学数据库(VIP)、万方数据库(Wanfang)、PubMed、Web of Science、Cochrane Library数据库建库至2024年3月中药注射液治疗PSCI的随机对照试验(RCT)文献,根据纳入与排除标准筛选文献,采用Cochrane偏倚风险评估工具评价文献质量,采用Stata 16.0软件进行统计分析。结果 最终纳入文献28篇,涉及患者2 942例,治疗方法包括西医常规和10种中药注射液:丹参多酚酸盐注射液(DSDF)、复方丹参注射液(FFDS)、银杏达莫注射液(YXDM)、醒脑静注射液(XNJ)、银杏叶注射液(YXY)、舒血宁注射液(SXN)、血塞通注射液(XST)、疏血通注射液(SXT)、丹红注射液(DH)、天麻素注射液(TMS)。网状Meta分析结果显示,在临床总有效率方面,累积概率排序为:YXY+西医常规治疗组(73.1%)>SXN+西医常规治疗组(62.9%)>TMS+西医常规治疗组(61.8%)>YXDM+西医常规治疗组(59.4%)>DSDF+西医常规治疗组(58.7%)>XNJ+西医常规治疗组(58.2%)>SXT+西医常规治疗组(39.3%)>DH+西医常规治疗组(36.0%)>西医常规治疗组(0.6%);在简易智力状态检查量表(MMSE)评分方面,累积概率排序为:TMS+西医常规治疗组(80.2%)>YXY+西医常规治疗组(70.4%)>YXDM+西医常规治疗组(60.7%)>XNJ+西医常规治疗组(58.8%)>XST+西医常规治疗组(51.8%)>SXN+西医常规治疗组(50.2%)>DSDF+西医常规治疗组(48.2%)>FFDS+西医常规治疗组(43.5%)>SXT+西医常规治疗组(41.6%)>DH+西医常规治疗组(34.6%)>西医常规治疗组(10.0%);在蒙特利尔认知评估量表(MoCA)方面,累积概率排序为:SXT+西医常规治疗组(86.0%)>YXY+西医常规治疗组(83.4%)>SXN+西医常规治疗组(74.9%)>TMS+西医常规治疗组(65.1%)>XNJ+西医常规治疗组(53.9%)>FFDS+西医常规治疗组(51.0%)>YXDM+西医常规治疗组(49.1%)>XST+西医常规治疗组(42.0%)>DH+西医常规治疗组(23.2%)>DSDF+西医常规治疗组(18.5%)>西医常规治疗组(2.9%)。在日常生活能力量表(ADL)评分方面,累积概率排序为:TMS+西医常规治疗组(85.4%)>YXDM+西医常规治疗组(63.7%)>DH+西医常规治疗组(59.7%)>SXT+西医常规治疗组(59.5%)>XNJ+西医常规治疗组(59.3%)>XST+西医常规治疗组(52.3%)>DSDF+西医常规治疗组(46.4%)>西医常规治疗组(14.9%)>SXN+西医常规治疗组(8.8%)。10项研究报道了不良反应,主要涉及消化系统。结论 中药注射液联合西医常规治疗可提高PSCI的临床疗效,MMSE评分、MoCA评分和ADL评分表明YXY和TMS优势显著,然而,由于纳入研究的质量受限且存在发表偏倚,当前结论仍需通过更为严谨的高质量研究加以验证。此举将有助于为制定中药注射液干预PSCI的诊疗方案提供更为坚实的循证医学依据。
[Key word]
[Abstract]
Objective To compare the efficacy and safety of Chinese medicine injection in the treatment of post-stroke cognitive impairment (PSCI) by network Meta-analysis. Methods The literature about RCTs of Chinese medicine injection in the treatment of PSCI was retrieved from databases such as CNKI, VIP, Wanfang Data, PubMed, Web of Science, Cochrane Library from the establishment of databases to March 2024. The literature was screened according to inclusion and exclusion criteria, and the Cochrane risk assessment tool was used for literature quality assessment. Stata 16.0 was used for statistical analysis. Results A total of 28 articles were included, involving 2 942 patients. The measures included 10 Chinese medicines injections, covering Danshen Duofen Injection (DSDF), Fufang Danshen Injection (FFDS), Yinxing Damo Injection (YXDM), Xingnaojing Injection (XNJ), Yinxingye Injection (YXY), Shuxuening Injection (SXN), Xuesaitong Injection (XST), Shuxuetong Injection (SXT), Danhong Injection (DH), Tianmasu Injection (TMS). In terms of improving the rate of clinical total effective, results of network Meta analysis showed that the rank of cumulative probability was: YXY+control subject (CS) (73.1%) > SXN+CS (62.9%) > TMS+CS (61.8%) > YXDM+CS (59.4%) > DSDF+CS (58.7%) > XNJ+CS (58.2%) > SXT+CS (39.3%) > DH+CS (36.0%) > CS (0.6%). On the part of MMSE, results of network Meta analysis showed that the rank of cumulative probability was: TMS+CS (80.2%) > YXY+CS (70.4%) > YXDM+CS (60.7%) > XNJ+CS (58.8%) > XST+CS (51.8%) > SXN+CS (50.2%) > DSDF+CS (48.2%) > FFDS+CS (43.5%) > SXT+CS (41.6%) > DH+CS (34.6%) > CS (10.0%). On the part of MoCA, results of network Meta analysis showed that the rank of cumulative probability was: SXT+CS (86.0%) > YXY+CS (83.4%) > SXN+CS (74.9%) > TMS+CS (65.1%) > XNJ+CS (53.9%) > FFDS+CS (51.0%) > YXDM+CS (49.1%) > XST+CS (42.0%) > DH+CS (23.2%) > DSDF+CS (18.5%) > CS (2.9%). On the part of ADL, results of network Meta analysis showed that the rank of cumulative probability was: TMS+CS (85.4%) > YXDM+CS (63.7%) > DH+CS (59.7%) > SXT+CS (59.5%) > XNJ+CS (59.3%) > XST+CS (52.3%) > DSDF+CS (46.4%) > CS (14.9%) > SXN+CS (8.8%). Ten studies reported adverse reactions, mainly involving digestive system. Conclusion Chinese medicine injection combined with C can improve the clinical efficacy in the treatment of PSCI. The MMSE score, MoCA score, and ADL score show that YXY and TMS have significant advantages in the treatment of PSCI. However, due to the limited quality and publication bias of the included studies, the current conclusions still need to be verified by more rigorous and high-quality studies. This will help to provide a more solid evidence-based medical basis for the development of treatment protocols for PSCI with herbal injections.
[中图分类号]
[基金项目]
国家自然科学基金青年科学基金项目(82104808)