脑心通胶囊辅助治疗血管性痴呆有效性与安全性的Meta分析

Efficacy and Safety of Naoxintong(脑心通)Capsules in Adjuvant Treatment of Vascular Dementia:A Meta-Analysis

目的:系统评价脑心通胶囊辅助治疗血管性痴呆的有效性和安全性。方法:计算机检索CNKI、WANFANG DATA、VIP、SinoMed、EMbase、PubMed、Cochrane Library数据库建库至2021年2月收录的脑心通胶囊辅助治疗血管性痴呆(VaD)的临床随机对照试验(RCT),用Cochrane偏倚风险评估工具对纳入文献进行质量评价,用RevMan5.4进行定量分析并用GRADE评价工具对结局指标进行证据质量分级。结果:最终纳入11个相关RCTs,涉及893例VaD患者(试验组452例,对照组441例)。Meta分析结果显示,与单纯西药治疗组相比,脑心通联合西药可有效改善MMES评分(MD=4.26,95%CI[3.62,4.90],P<0.01)、提高治疗总有效率(RR=1.24,95%CI[1.16,1.32],P<0.01)、改善ADL评分(MD=-5.31,95%CI[-6.00,-4.62],P<0.01),改善MoCA评分;安全性方面未发现脑心通联合西药有增加不良反应的风险。GRADE证据分级显示以上结局指标证据级别为极低级至中级。结论:联用脑心通治疗VaD可提高治疗有效率、改善认知功能、提高日常生活能力、减少临床痴呆程度,且未发现有增加不良反应的风险。但受限于文献质量及数量,联合用药的安全性仍需进一步验证,有效性需要更多高质量研究证实。

Objective:To systematically evaluate the efficacy and safety of Naoxintong Capsules in adjuvant treatment of vascular dementia(VaD). Methods: Randomized controlled trials(RCTs) of Naoxintong Capsules treating VaD were retrieved from CNKI,Wanfang Data, VIP,SinoMed, PubMed, EMbase and Cochrane Library from the establishment of the databases to February 2021. The quality of the included RCTs was assessed according to the recommendation standard in the Cochrane Handbook. RevMan5.4 was used for quantitative analysis, and the quality of evidence for outcome indicators was rated by GRADE system. Results: A total of 11 RCTs were included, involving 893 VaD patients(452 in experimental group and 441 in control group). Meta-analysis showed that compared with the control group(singlewestern medicine alone),Naoxintong Capsules combined with western medicine improved the Mini-mental State Examination(MMSE) score(MD=4.26,95%CI [3.62,4.90],P<0.01),Activity of Daily Living(ADL) score(MD=-5.31,95%CI [-6.00,-4.62],P<0.01),and Montreal Cognitive Assessment(MoCA) score and elevated the total effective rate(RR=1.24,95%CI [1.16,1.32],P<0.01),with statistically significant differences. In terms of safety, it has not been found that the combination of Naoxintong Capsules and western medicine has the risk of increasing adverse reactions. GRADE system revealed that the level of evidence for the above outcome indicators was very low to moderate. Conclusion:The combined use of Naoxintong Capsules in the treatment of VaD can boost the treatment efficacy, improve cognitive function, enhance the ability of daily living and reduce the degree of clinical dementia, without increasing the risk of adverse reactions. However, limited by the quality and quantity of literature, the safety of combination drugs needs to be further verified, and more high-quality studies are necessary to confirm the effectiveness.