消栓肠溶胶囊治疗急性脑梗死的Meta-分析和GRADE评价

Meta-analysis and GRADE evaluation of Xiaoshuan Enteric-coated Capsules in treatment of acute cerebral infarction

目的系统评价消栓肠溶胶囊治疗急性脑梗死的临床疗效和安全性。方法系统检索中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)和维普中文期刊全文数据库(VIP)、万方数据库、Pub Med、Cochrane Library和Web of science数据库,收集从建库至2020年5月消栓肠溶胶囊治疗急性脑梗死的临床随机对照试验(RCTs),应用Rev Man 5.3软件进行Meta-分析,最后采用GRADE系统对重要结局指标进行证据质量的评价并形成推荐意见。结果纳入14项RCTs,共1 093例患者。Meta-分析结果显示:在改善临床总有效率方面,消栓肠溶胶囊+常规治疗组优于常规治疗组[RR=1.23,95%CI=(1.15,1.32),P<0.000 01]和安慰剂+常规治疗组[RR=1.52,95%CI=(1.14,2.02),P=0.004];在改善神经功能缺损评分方面,消栓肠溶胶囊+常规治疗组优于常规治疗组[MDNIHSS=-2.70,95%CI=(-3.80,-1.59),P<0.000 01;MDNDS=-3.87,95%CI=(-4.64,-3.09),P<0.000 01]和安慰剂+常规治疗组[MDNIHSS=-1.87,95%CI=(-3.27,-0.47),P=0.009];在改善日常生活能力评分方面,消栓肠溶胶囊+常规治疗组优于常规治疗组[MD=14.60,95%CI=(6.17,23.02),P=0.000 7]和安慰剂+常规治疗组[MD=36.11,95%CI=(27.04,45.18),P<0.000 01];在不良事件发生率方面,消栓肠溶胶囊+常规治疗组与常规治疗组比较差异无统计学意义[RR=0.86,95%CI=(0.29,2.58),P=0.79]。GRADE系统评价临床总有效率、神经功能缺损评分、日常生活能力评分,显示证据等级为低或极低,推荐强度均为弱推荐。结论消栓肠溶胶囊在改善急性脑梗死患者临床总有效率、神经功能缺损程度及日常生活质量方面具有一定的疗效,且安全性较好。但因纳入研究的文献质量不高,证据等级较低,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。

Objective To systematically access the efficacy and safety of Xiaoshuan Enteric-coated Capsules for acute cerebral infarction. Methods Databases including CNKI, CBM, VIP, Wanfang Data, Pub Med, Cochrane Library and Web of science were searched to collect randomized controlled trials(RCTs) about Xiaoshuan Enteric-coated Capsules in treatment of patients with acute cerebral infarction from inception to May 2020. The included studies were put into Meta-analysis by RevMan 5.3 software. Finally,Evaluated the evidence quality of major outcome indicators and formed recommendations by the GRADE system. Results A total of 14 RCTs were included 1 093 patients. The results of Meta-analysis showed that the effective rate of Xiaoshuan Enteric-coated Capsules group was superior to routine medicine group [RR = 1.23, 95%CI =(1.15, 1.32), P < 0.000 01] and placebo group [RR =1.52, 95%CI =(1.14, 2.02), P=0.004]. On the improving of neurological deficit score, Xiaoshuan Enteric-coated Capsules group was better than routine medicine group [MDNIHSS=-2.70, 95%CI =(-3.80,-1.59), P < 0.000 01;MDNDS=-3.87, 95%CI(-4.64,-3.09),P < 0.000 01] and placebo group [MDNIHSS=-1.87, 95%CI =(-3.27,-0.47), P = 0.009]. On the improving activity of daily living score, also showed a better effectiveness of Xiaoshuan Enteric-coated Capsules group than routine medicine group [MD = 14.60,95%CI =(6.17, 23.02), P = 0.000 7] and placebo group [MD = 36.11, 95%CI =(27.04, 45.18), P < 0.000 01]. And the result showed no statistical significance in safety evaluation between Xiaoshuan Enteric-coated Capsules group and routine medicine group [RR =0.86, 95%CI =(0.29, 2.58), P = 0.79]. However, the results of the GRADE Evaluation showed that the evidence level of the effective rate, neurological deficit score and activity of daily living score were low or very low. The recommendations strength were weak. Conclusion Although the results support the conclusion that Xiaoshuan Enteric-coated Capsules is safe and superior to routine medicine group or placebo group on the improving the effective rate, neurological deficit score and activity of daily living score, due to the low study quality and low level of evidence, further large sample and high quality RCTs should be carried out.