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目的系统评价金莲清热泡腾片治疗小儿手足口病的临床疗效。方法计算机检索EMBase、PubMed、中国生物医学文献数据库、维普数据库、中国期刊全文数据库、万方科技数据库关于金莲清热泡腾片治疗小儿手足口病的临床随机对照试验(各数据库检索时间均从创建至2016年02月),纳入金莲清热泡腾片治疗儿童手足口病的相关文献,同时进行方法学质量评价和采用RevMan5.2软件进行Meta分析。结果共纳入9篇文献,包括1188例患儿。Meta分析结果显示,金莲清热泡腾片总有效率与对照组相比有显著性差异[OR=4.53,95%CI(2.51,8.19)];退热时间[MD=-1.71,95%CI(-2.48,-0.93)]、疱疹消退时间[MD=-1.28,95%CI(-1.71,-0.85)]、皮疹消退时间[MD=-2.02,95%CI(-2.59,-1.45)]、口腔溃疡好转时间[MD=-1.62,95%CI(-2.13,-1.11)]、临床痊愈时间[MD=-2.12,95%CI(-2.25,-2.00)]也均具有显著性差异。结论基于现有临床数据表明,金莲清热泡腾片治疗小儿手足口病具有确切的临床疗效。但因本研究纳入文献数量较少,研究质量不高,此结论还需更多高质量、大样本临床随机对照试验予以证实。
Objective To systematically evaluate the clinical efficacy of Jinlian heat effervescent tablet in the treatment of hand-foot-mouth disease in children. Methods A computerized randomized controlled clinical trial was conducted in EMBASE, PubMed, China Biomedical Literature Database, VIP database, Chinese Journal Full-text Database, Wanfang Science and Technology Database about the treatment of children’s hand, foot and mouth disease 2016 Feb.), included the relevant literature about the treatment of children’s hand, foot and mouth disease with the method of heat-clearing effervescent tablet of Jin Lian, and the methodological quality evaluation and the Meta-analysis using RevMan5.2 software. Results A total of 9 articles were included, including 1188 children. Meta-analysis showed that the total effective rate of the heat-clearing effervescent tablets was significantly different from that of the control group (OR = 4.53, 95% CI 2.51, 8.19); the antipyretic time [MD = -1.71, 95% CI -2.48, -0.93), herpes regression time (MD = -1.28,95% CI -1.71, -0.85), rash regression time (MD = -2.02, 95% CI -2.59, -1.45) The improvement of oral ulcer time [MD = -1.62,95% CI (-2.13, -1.11)], clinical recovery time [MD = -2.12,95% CI (-2.25, -2.00)] also had significant differences. Conclusions Based on the available clinical data, it is indicated that the exact clinical efficacy of Cleopatra’s effervescent tablets in the treatment of children’s hand, foot and mouth disease. However, due to the small number of articles included in this study and the poor quality of the study, more high-quality, large-sample clinical randomized controlled trials are needed to confirm this conclusion.