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基于Meta分析的热毒宁注射剂联合阿奇霉素治疗小儿支原体肺炎临床评价研究

Meta analysis of Reduning Injection Combined with Azithromycin in the Treatment of Mycoplasma Pneumoniae in Children

DOI：

中文关键词: 热毒宁注射剂阿奇霉素支原体肺炎 Meta分析随机对照试验

英文关键词:Reduning injection Azithromycin Mycoplasma Pneumoniae Meta analysis Randomized controlled trial

基金项目:国家自然科学基金项目(编号:81473547、81673829)

作者	单位
王旗星段笑娇吴嘉瑞何欣王凯欢	北京中医药大学中药学院北京 102488

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中文摘要:

摘要目的：系统评价热毒宁注射剂联合阿奇霉素治疗小儿支原体肺炎的临床疗效与安全性，为临床使用提供科学依据。方法：计算机检索CNKI、VIP、WanFang Data、SinoMed、PubMed、the Cochrane Library、Embase数据库，搜集关于热毒宁注射剂联合阿奇霉素治疗小儿支原体肺炎的随机对照试验（RCTs），检索时限均为建库至2018年9月14日，由两名研究人员独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用RevMan 5.3软件进行Meta分析。结果：共纳入35个RCTs，涉及3 104例患儿。Meta分析结果显示，与单独使用阿奇霉素相比，阿奇霉素联合热毒宁注射剂治疗小儿支原体肺炎可明显提高临床总有效率[RR=1.17，95%CI（1.14，1.21），P＜0.000 01]，还可有效缩短止咳时间[MD=-2.29，95%CI（-2.67，-1.91），P＜0.000 01]、退热时间[MD=-2.01，95%CI（-2.37，-1.65），P＜0.000 01]、肺部啰音消失时间[MD=-2.05，95%CI（-2.51，-1.59），P＜0.000 01]、住院时间[MD=-2.41，95%CI（-2.90，-1.91），P＜0.000 01]和X线胸片病灶消失时间[MD=-2.37，95%CI（-2.93，-1.81），P＜0.000 01]，且可有效降低C反应蛋白（CRP）水平[SMD=-5.23，95%CI（-7.13，-3.34），P＜0.000 01]、白细胞介素6（IL 6）水平[SMD=-3.49，95%CI（-5.26，-1.72），P=0.000 1]。纳入的35项研究中，16项研究明确说明出现药品不良反应（ADR），共涉及123例患儿，2项研究未出现ADR，其余研究对ADR未进行说明。结论：当前证据表明热毒宁注射剂联合阿奇霉素治疗小儿支原体肺炎在改善临床总有效率、临床症状指标等方面优于单独使用阿奇霉素治疗。纳入研究中出现的ADR均符合热毒宁注射剂说明书及相关研究描述。但热毒宁注射剂的安全性，还需要更多高质量研究支持。

英文摘要:

ABSTRACT Objective: To systematically evaluate the clinical effectiveness and safety of Reduning injection (RI) combined with azithromycin in the treatment of mycoplasma pneumoniae in children, and provide scientific evidence for clinical decision. Methods:CNKI, VIP, WanFang, SinoMed, PubMed, the Cochrane Library and Embase databases were electronically searched to collect randomized controlled trials (RCTs) of mycoplasma pneumoniae in children treated by RI from inception to September 14, 2018. Two reviewers independently screened literatures, extracted data and assessed risk of bias of included studies. Then Meta analysis was performed by RevMan 5.3 software. Results:35 RCTs involving 3 104 patients were included. The results of Meta analysis showed that: on the basis of azithromycin treatment, RI could significantly improve the total clinical efficiency compared with azithromycin alone (RR=1.17, 95%CI 1.14 to 1.21, P＜0.000 01). In addition, RI combined with azithromycin could effectively shorten cough time (MD=-2.29, 95%CI -2.67 to -1.91, P＜0.000 01), antipyretic tim (MD=-2.01, 95%CI -2.37 to -1.65, P＜0.000 01), lung rales disappeared time (MD=-2.05, 95%CI -2.51 to -1.59, P＜0.000 01), hospital stays (MD=-2.41, 95%CI -2.90 to -1.91, P＜0.000 01) and nidus disappeared time in X ray (MD=-2.37, 95%CI -2.93 to -1.81, P＜0.000 01). Furthermore, when compared with azithromycin alone, RI combined with azithromycin could reduce the level of C reactive protein (SMD=-5.23, 95%CI -7.13 to -3.34, P＜0.000 01) and interleukin 6 (SMD=-3.49, 95%CI -5.26 to -1.72, P=0.000 1). In the 35 included studies, 16 studies reported 123 cases of adverse drug reactions (ADRs), and two articles cleared that there was no ADRs in the studies. The rest studies didn’t mention ADRs. Conclusion:The current evidence indicates that RI combineed with azithromycin in the treatment of mycoplasma pneumoniae in children was superior to azithromycin alone in improving the clinical total efficiency and clinical indicators. Adverse drug reaction was consistent with RI’s instruction and related research descriptions. However, the safety of RI required more high quality research to support.

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