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作 者:丰依明 李智成 谢瑞芳[1] 孔维崧 周桂 周昕[1] FENG Yiming;LI Zhicheng;XIE Ruifang;KONG Weisong;ZHOU Gui;ZHOU Xin(Department of Pharmacy,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Department of Thoracic Surgery,Shanghai Pu Dong Hospital,Shanghai 201399,China)
机构地区:[1]上海中医药大学附属龙华医院药学部,上海200032 [2]上海市浦东医院胸外科,上海201399
出 处:《药物评价研究》2022年第4期768-779,共12页Drug Evaluation Research
基 金:上海市科学技术委员会支撑项目(20S21901400)。
摘 要:目的 系统评价麻杏石甘汤联合阿奇霉素治疗小儿支原体肺炎(MPP)的疗效及安全性。方法 检索中国学术期刊全文数据库(CNKI)、万方数据库、维普中文期刊全文数据库(VIP)、中国生物医学数据库(CBM),Cochrane Library、Embase和PubMed数据库中麻杏石甘汤联合阿奇霉素治疗小儿支原体肺炎的随机对照试验(RCT),检索时间均为建库至2021年2月,使用Revman 5.4.1和Stata 14.0软件评价纳入文献质量并进行Meta分析。结果 共纳入13篇RCTs,包括1 240例患者,试验组总有效率[RR=1.17,95%CI(1.12,1.23),P<0.000 01]优于对照组,且不存在发表偏倚(P=0.542)。试验组止咳时间[SMD=-0.78,95%CI(-0.98,-0.58)]、退热时间[SMD=-1.48,95%CI(-1.95,-1.01)]、肺啰音消失时间[SMD=-0.96,95%CI(-1.23,-0.69)]、肺部胸片影像恢复时间[SMD=-0.80,95%CI(-1.00,-0.61)]均短于对照组,差异有统计学意义(P<0.000 01)。安全性评价得出试验组发生不良反应的次数[RR=0.39,95%CI(0.24,0.64),P=0.000 2]少于对照组。结论 麻杏石甘汤联合阿奇霉素治疗小儿MPP较单用阿奇霉素疗效显著,安全性高,有良好的临床应用价值,由于存在一定局限性,上述结论需更多高质量的研究来进行验证。Objective To systematically evaluate the efficacy and safety of combining Maxing Shigan Decoction with azithromycin in the treatment of Mycoplasma pneumonia pneumonia(MPP) in children. Methods Randomised controlled trials(RCT) of Maxing Shigan Decoction combined with azithromycin in the treatment of MPP in paediatric patients were searched in the Chinese National Knowledge Infrastructure(CNKI), Wanfang Database, China Science and Technology Journal Database(VIP), China Biomedical Literature Database(CBM), Cochrane Library, Embase and PubMed, all from built to February 2021. Revman 5.4.1 and Stata 14.0was used to evaluate the quality of included literatures and Meta-analysis. Results A total of 13 RCT s involving 1 240 patients were included. According to the results, the effective rate of the trial group [RR = 1.17, 95%CI(1.12, 1.23), P < 0.000 01] was better than that of the control group. The funnel chart and Begg’s test indicated that there was no publication bias(P = 0.542). The cough disappearance time [SMD =-0.78, 95%CI(-0.98,-0.58)], body temperature recovery time [SMD =-1.48, 95%CI(-1.95,-1.01)],disappearance time of pulmonary rales [SMD =-0.96, 95%CI(-1.23,-0.69)] and lung X-ray recovery time [SMD =-0.80, 95%CI(-1.00,-0.61)] of the trial group were all significantly lower than the control group(P < 0.000 01). Safety evaluation showed that the frequency of adverse reactions in the test group [RR = 0.39, 95%CI(0.24, 0.64), P = 0.000 2] was less than the control group.Conclusion The combination of Maxing Shigan Decoction and azithromycin is more effective and safer than azithromycin alone in the treatment of children with MPP, and has good clinical application value. Due to some limitations, more high-quality studies are needed for further verification.
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