Tan Di, Wu Jiarui, Liu Shi, Zhang Dan, Cui Yingying, Zhang Xiaomeng, Zhang Bing
Department of Clinical Pharmacology of Traditional Chinese Medicine, School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100102, China.
J Tradit Chin Med. 2018 Feb;38(1):1-11.
To assess the clinical effectiveness and safety of injections of ginkgo (GI) combined with Western Medicine (WM) for cerebral infarction (CI).
Randomized controlled trials (RCTs) of CI treated by GI were searched in China National Knowledge Infrastructure Database, Wanfang, China Science and Technology Journal Database, Web of Science, Cochrane library, Embase, PubMed and Chinese Biomedical Literature Database, with the publication data no later than April, 2016. The Cochrane risk of bias method was used to evaluate the methodological quality of the RCTs. The data were analyzed by Review Manager 5.3, Stata 13.0, and WinBUGS 14 software.
Totally 37 RCTs involving 4330 patients were included. By direct comparison, the results of GI group were significantly superior to the routine WM group in the total effective rates [OR = 3.61, 95% CI (2.93, 4.44), P < 0.0001], the neural function defect score (NFDS) [MD = -4.39, 95% CI (-5.47, -3.32), P < 0.0001]. Network Meta-analysis (NMA) results showed that, between 5 GIs in efficacy, the difference comparing ginaton injections (GbE) to ginkgo-dipyidamolum injections (GD) [OR = 1.74, 95% CI (0.73, 3.65)], shuxuening injections (SXN) [OR = 1.06, 95% CI (0.609, 1.697)] or ginkgolides injections (GK) [OR = 4.711, 95% CI (1.178, 13.21)] reach statistical significance; the difference comparing GD to GK reach statistical significance [OR = 2.791, 95% CI (0.866, 6.908)]; the difference comparing SXN to GK reach statistical significance [OR = 4.537, 95% CI (1.203, 12.41)]. Besides, there was no difference between 4 GIs in NFDS. Probability ranking result showed a great possibility for GK [Surface under the Cumulative Ranking curve (SUCRA) = 80.3%] in improving the total effective rates, which were followed by GD (SUCRA = 73.34%), SXN (SUCRA = 46.59%), GbE (SUCRA = 45.46%), floium ginkgo extract and tertram ethypyrazine sodium chloride injections (FT) (SUCRA = 35.64%). However, GK (SUCRA = 80.3%) or GbE (SUCRA = 69.4%) was better than other GIs in reducing NFDS.GK + WM is the best treatment measures to reduce NFDS in cerebral infarction, which were followed by SXN + WM (SUCRA = 51.6%), GD + WM (SUCRA = 48.1%).
GIs was more effectiveness on CI than the routine Western Medicine. But based on the limitations of the study, more high-quality randomized controlled trials will be necessary.
评估银杏注射液(GI)联合西药(WM)治疗脑梗死(CI)的临床有效性和安全性。
检索中国知网数据库、万方数据库、维普数据库、Web of Science、Cochrane图书馆、Embase、PubMed及中国生物医学文献数据库中关于GI治疗CI的随机对照试验(RCT),检索时间截至2016年4月。采用Cochrane偏倚风险评估方法评价纳入RCT的方法学质量。使用RevMan 5.3、Stata 13.0及WinBUGS 14软件进行数据分析。
共纳入37项RCT,涉及4330例患者。直接比较结果显示,GI组的总有效率[比值比(OR)=3.61,95%可信区间(CI)(2.93,4.44),P<0.0001]及神经功能缺损评分(NFDS)[均数差(MD)=-4.39,95%CI(-5.47,-3.32),P<0.0001]均显著优于常规WM组。网状Meta分析(NMA)结果显示,在5种GI的疗效比较中,银杏叶提取物注射液(GbE)与银杏达莫注射液(GD)[OR=1.74,95%CI(0.73,3.65)]、舒血宁注射液(SXN)[OR=1.06,95%CI(0.609,1.697)]或银杏内酯注射液(GK)[OR=4.711,95%CI(1.178,13.21)]的差异有统计学意义;GD与GK的差异有统计学意义[OR=2.791,95%CI(0.866,6.908)];SXN与GK的差异有统计学意义[OR=4.537,95%CI(1.203,12.41)]。此外,4种GI在NFDS方面差异无统计学意义。概率排序结果显示,GK在提高总有效率方面可能性最大[累积排序曲线下面积(SUCRA)=80.3%],其次为GD(SUCRA=73.34%)、SXN(SUCRA=46.59%)、GbE(SUCRA=45.46%)、银杏叶提取物和川芎嗪氯化钠注射液(FT)(SUCRA=35.64%)。然而,在降低NFDS方面,GK(SUCRA=80.3%)或GbE(SUCRA=69.4%)优于其他GI。GK+WM是降低脑梗死NFDS的最佳治疗措施,其次为SXN+WM(SUCRA=51.6%)、GD+WM(SUCRA=48.1%)。
GI治疗CI比常规西药更有效。但基于本研究的局限性,仍需要更多高质量的随机对照试验。