活血化瘀法治疗儿童重症肺炎随机对照试验的Meta分析

Meta Analysis of Randomized Controlled Trial of Traditional Chinese Medicine Promoting Blood Circulation and Removing Blood Stasis in Treatment of Children with Severe Pneumonia

目的系统评价中药活血化瘀法联合西药常规治疗儿童重症肺炎的疗效和安全性。方法检索PubMed、Embase、Cochrane Library、中国知网、万方数据、维普网、中国生物医学文献数据库,从建库至2020年3月20日收录的中文及英文文献,获取中药活血化瘀法联合西药常规治疗儿童重症肺炎的随机对照试验(RCT)。对纳入文献进行资料提取和偏倚风险评价,采用RevMan 5.3软件进行疗效及安全性评价,运用Cochrane评价员手册评价纳入文献的偏倚风险。结果最终纳入8篇文献,涉及915例重症肺炎患儿。Meta分析显示,中药活血化瘀法联合西药常规可提高重症肺炎总有效率[OR=6.11,95%CI(3.21,11.61),P<0.000 01];缩短患儿住院时间[MD=-1.79,95%CI(-2.26,-1.32),P<0.000 01];缩短咳嗽[MD=-1.83,95%CI(-2.18,-1.48),P<0.000 01]、肺部罗音[MD=-1.37,95%CI(-2.23,-0.50),P=0.002]、发热[MD=-1.39,95%CI(-1.68,-1.09),P<0.000 01]、喘息[MD=-1.29,95%CI(-2.29,-0.29),P=0.01]持续时间;改善SaO2水平[MD=0.10,95%CI(0.00,0.20),P=0.04]、改善TNF-α水平[SMD=-1.57,95%CI(-1.88,-1.26),P<0.000 01];中药活血化瘀法联合西药常规治疗有降低患者病死率趋势,但差异无统计学意义[OR=0.41,95%CI(0.17,1.02),P=0.05];改善PaO2水平无明显差异[SMD=0.13,95%CI(-2.60,2.86),P=0.93]、改善PaCO2水平无明显差异[SMD=0.38,95%CI(-2.64,1.88),P=0.74]。不良反应较轻,以皮疹、胃肠道反应、嗜睡为主。结论中药活血化瘀法辅助治疗儿童重症肺炎,疗效优于单用西医治疗。

Objective To systematically evaluate the efficacy and safety of traditional Chinese medicine combined with western medicine in the treatment of severe pneumonia in children. Methods The Chinese and English literature were searched from PubMed, Embase, Cochrane Library, CNKI,Wanfang Data, VIP,CBM. From the establishment of the database to March 20, 2020, and the randomized controlled trial(RCT) of traditional Chinese medicine combined with western medicine in the treatment of severe pneumonia in children. The data were extracted and the bias risk was evaluated. The efficacy and safety were evaluated by RevMan 5.3.The Cochrane evaluator manual was used to evaluate the bias risk. Results 8 articles were included, involving 915 children with severe pneumonia. Meta analysis showed that the method of activating blood circulation and removing blood stasis combined with western medicine could increase the total effective rate of severe pneumonia [OR=6.11,95% CI(3.21,11.61),P<0.000 01], shorten the hospitalization time of children [MD=-1.79,95%CI(-2.26,-1.32),P<0.000 01]. It shortened the duration of cough [MD=-1.83,95%CI(-2.18,-1.48),P<0.000 01],lung rale [MD=-1.37,95%CI(-2.23,-0.50),P=0.002], fever [MD=-1.39,95%CI(-1.68,-1.09),P<0.000 01], wheezing [MD=-1.29,95%CI(-2.29,-0.29),P=0.01]. Improve the level of SaO2 [MD=0.10,95% CI(0.00,0.20),P=0.04] and improve the level of TNF-α[SMD=-1.57,95%CI(-1.88,-1.26),P<0.000 01]. The method of activating blood circulation and removing blood stasis combined with routine treatment of western medicine has a tendency to reduce the mortality of patients, but the difference is not statistically significant [OR=0.41,95%CI(0.17,1.02),P=0.05]. There was no significant difference in improving the level of PaO2 [SMD=0.13,95%CI(-2.60,2.86),P=0.93], and there was no significant difference in improving the level of PaCO_(2) [SMD=0.38,95%CI(-2.64,1.88),P=0.74].The adverse reactions were mild, mainly skin rash, gastrointestinal reactions and somnolence.Conclusion The method of activating blood circulation and removing blood stasis with traditional Chinese medicine is better than western medicine alone in the treatment of severe pneumonia in children. However, due to the low quality of the included study, the conclusions of the study still need to be verified by more high-quality randomized controlled trials.