Zhang Gui-Min, Huang Zhi-Yan, Sun Rong, Ye Shi-Li, Feng Qun
Lunan Hope Pharmaceutical Co., Ltd., Linyi 276006, China.
Lunan Pharmaceutical Group Co., Ltd., State Key Laboratory of Generic Manufacture Technology of Chinese Traditional Medicine, Linyi 276006, China.
Evid Based Complement Alternat Med. 2020 Jul 19;2020:9740841. doi: 10.1155/2020/9740841. eCollection 2020.
This study was aimed at systematically evaluating the clinical effect and safety of Xiao'er Xiaoji Zhike oral liquid in the treatment of pneumonia (MPP) in children and providing evidence-based references for clinical application.
The databases like Chinese Biomedical Literature Database, China Network Knowledge Infrastructure, Wan Fang Database, Chinese Scientific Journal Database, PubMed, EmBase, and the Cochrane Library were systematically investigated via searching clinical trials about Xiao'er Xiaoji Zhike oral liquid in treating MPP from the establishment of these databases to Jun 8, 2020, the valid data from which were entered meta-analysis. The quality of evidence was assessed by GRADE criteria.
Totally, 15 trials and 1500 patients were involved in this review. It showed that clinical efficacy of trial group was more superior than control group at the outcome measures of cough disappearance time, lung rale disappearance time, fever subsidence time, total effective rate, lung X-ray infiltrates disappearing time, reduction of hospital stay, immunological indexes, and some other measures. And the differences between groups were statistically significant. There was no statistical difference in the adverse effects between two groups. Lung X-ray infiltrates disappearing time and cough disappearance time were separately high- and moderate-quality evidences while lung rale disappearance time and fever subsidence time were all low in accordance with GRADE criteria.
In accordance with trials with low methodological quality, Xiao'er Xiaoji Zhike oral liquid combined with azithromycin seems to be safe and superior to azithromycin alone for the treatment of MPP in children. However, further trials with rigorous methodology need to be implemented for these potential benefits.
本研究旨在系统评价小儿消积止咳口服液治疗儿童支原体肺炎(MPP)的临床疗效和安全性,为临床应用提供循证参考。
通过检索中国生物医学文献数据库、中国知网、万方数据库、维普数据库、PubMed、EmBase及Cochrane图书馆等数据库,全面检索自建库至2020年6月8日有关小儿消积止咳口服液治疗MPP的临床试验,将有效数据纳入荟萃分析。采用GRADE标准评估证据质量。
本综述共纳入15项试验,1500例患者。结果显示,在咳嗽消失时间、肺部啰音消失时间、发热消退时间、总有效率、肺部X线浸润影消失时间、住院时间缩短、免疫指标等结局指标上,试验组临床疗效优于对照组,组间差异有统计学意义。两组不良反应无统计学差异。根据GRADE标准,肺部X线浸润影消失时间和咳嗽消失时间分别为高质量和中等质量证据,而肺部啰音消失时间和发热消退时间均为低质量证据。
基于方法学质量较低的试验,小儿消积止咳口服液联合阿奇霉素治疗儿童MPP似乎安全且优于单用阿奇霉素。然而,需要开展进一步方法学严谨的试验来验证这些潜在益处。