口服中成药辅助治疗血管性痴呆的网状Meta分析

Network Meta-analysis of oral Chinese patent medicine in adjuvant treatment of vascular dementia

目的基于频率学网状Meta分析评价不同中成药辅助治疗血管性痴呆的有效性及安全性。方法计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、SinoMed、EMbase、PubMed、Cochrane Library数据库收录的中成药联合胆碱酯酶抑制剂或N-甲基-D-天冬氨酸受体受体拮抗剂治疗血管性痴呆的随机临床试验(randomized clinical trial,RCT),检索时限为建库至2021年1月。2名调查员进行独立文献筛选、数据提取并对RCT进行偏倚风险评价,用RevMan5.4、Stata/MP15.1进行数据分析。结果最终纳入30个RCT,涉及天智颗粒、养血清脑颗粒、银杏叶、脑心通胶囊、脑脉泰胶囊、脉血康胶囊、复方海蛇胶囊、脉血疏口服液8种中成药。网状Meta分析结果显示:①改善认知功能[简易智力状态评分量表(mini-mental state examination,MMSE)]方面,最优的前3种方案为化学药联合脑心通胶囊(88.2%)>联合脑脉泰胶囊(78.6%)>联合天智颗粒(56.3%);②治疗有效率方面,最优的前3种方案为化学药联合复方海蛇胶囊(86.4%)>联合脉血康胶囊(73.3%)>联合脑心通胶囊(72.3%);③提高日常生活能力方面,最优的前3种方案为化学药联合银杏叶(90.2%)>联合脑心通胶囊(71.7%)>联合养血清脑颗粒(65.3%);④改善痴呆程度[蒙特利尔认知评估量表(montreal cognitive assessmen,MoCA)]方面,最优的前3种方案为化学药联合脑心通胶囊(99.9%)>联合天智颗粒(67.7%)>联合脑脉泰胶囊(57.3%);⑤安全性方面,最优的前3种方案为化学药联合银杏叶(62.8%)>联合复方海蛇胶囊(62.2%)>单用化学药(60.1%)。结论中成药联合化学药在治疗有效率、改善认知功能、提高日常生活能力、减少临床痴呆程度方面均优于单用化学药,且未发现有增加不良反应的风险。但由于纳入研究方法学质量偏低,结论仍待高质量的研究加以验证。

Objective To evaluate the efficacy and safety of different oral Chinese patent medicine in the treatment of vascular dementia(VaD)with Frequency Network Meta-analysis.Methods The Randomized controlled trials of Chinese patent medicines for VaD were searched from databases such as CNKI,SinoMed,Wanfang,VIP,PubMed,EMbase and Cochrane Library databases by computer from the establishment of the database to January 2021.Two investigators conducted independent literature screening,data extraction and RCTs bias risk assessment,The data were analyzed by RevMan5.4 and Stata/MP15.1.Results Eight kinds of Chinese patent medicines and 30 RCTs were included:Tianzhi Granule(天智颗粒),Yangxue Qingnao Granule(养血清脑颗粒),Yinxingye(银杏叶),Naoxintong Capsule(脑心通胶囊),Naomaitai Capsule(脑脉泰胶囊),Maixuekang Capsule(脉血康胶囊),Fufang Haishe Capsule(复方海蛇胶囊),and Maixueshu Oral Liquid(脉血疏口服液).The results of the network Meta-analysis indicated that in terms of improving cognitive function(mini-mental state examination,MMSE),the top three optimal medication regimens were Western medicine combined with Naoxintong Capsule(88.2%)>combined with Naomaitai Capsule(78.6%)>combined with Tianzhi Granule(56.3%);In terms of treatment efficiency,the top three optimal medication regimens were Western medicine combined with Fufang Haishe Capsule(86.4%)>combined with Naoxuekang Capsule(73.3%)>combined with Naoxintong Capsule(72.3%);In terms of improving daily self-care ability(ADL),the top three optimal medication regimens were Western medicine combined with Yinxingye(90.2%)>combined with Naoxintong Capsule(71.7%)>combined with Yangxue Qingnao Granule(65.3%);In terms of improving cognitive function(MoCA),the top three optimal medication regimens were Western medicine combined with Naoxintong Capsule(99.9%)>combined with Tianzhi Granule(67.7%)>combined with Naomaitai Capsule(57.3%);In terms of safety,the top three optimal medication regimens were Western medicine combined with Yinxingye(62.8%)>combined with Fufang Haishe Capsule(62.2%)>Western medicine alone(60.1%).Conclusion The results showed that Chinese patent medicine combined with Western medicine was superior to western medicine alone in terms of treatment efficiency,improvement of cognitive function,improvement of daily living ability,and reduction of clinical dementia,and no risk of increased adverse reactions has been found.However,because of the low methodological quality of the included studies,the conclusions need to be verified by high-quality studies.