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目的:系统评价醒脾养儿颗粒联合酪酸梭菌活菌散治疗小儿消化不良性腹泻的有效性和安全性,旨在为临床用药提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国生物医学文献数据库、中国知网数据库、维普数据库、万方数据库等,收集醒脾养儿颗粒联合酪酸梭菌活菌散(试验组)对比单用酪酸梭菌活菌散(对照组)治疗小儿消化不良性腹泻的随机对照试验(RCT)。筛选文献、提取资料后采用Cochrane系统评价员手册5.1.0偏倚风险评估工具对纳入研究质量进行评价,采用Rev Man 5.3软件进行Meta分析。采用TSA 0.9软件进行试验序贯分析。结果:共纳入8项RCT,共计857例患儿。试验组患儿总有效率[RR=1.20,95%CI(1.13,1.28),P<0.000 01]显著高于对照组,腹痛缓解时间[MD=-1.18,95%CI(-1.42,-0.94),P<0.000 01]、腹胀缓解时间[MD=-1.32,95%CI(-1.94,-0.70),P<0.000 1]、腹泻缓解时间[MD=-2.07,95%CI(-2.38,-1.76),P<0.000 01]、大便性状恢复正常的时间[MD=-2.16,95%CI(-2.43,-1.88),P<0.000 01]均显著短于对照组,治疗后大便次数[MD=-1.72,95%CI(-2.18,-1.24),P<0.000 01]显著少于对照组;不良反应发生率显著低于对照组(P<0.05),或两组患儿不良反应发生率比较差异无统计学意义(P>0.05),或两组患儿均未见明显不良反应发生。序贯分析结果显示,醒脾养儿颗粒联合酪酸梭菌活菌散治疗小儿消化不良性腹泻总有效率证据确切。结论:醒脾养儿颗粒联合酪酸梭菌活菌散治疗小儿消化不良性腹泻的疗效和安全性均较好。
OBJECTIVE: To systematically evaluate the effectiveness and safety of Xingpi yang’er granules(XYG) combined with Clostridium butyricum live powder (CBLP) in the treatment of pediatric dyspeptic diarrhea, and provide evidence-based reference for clinical medication. METHODS: Retrieved from Cochrane Library, PubMed, Embase, CBM, CNKI, VIP and Wanfang database, randomized controlled trials (RCTs) about XYG combined with CBLP(trial group)vs. CBLP alone(control group)in the treatment of pediatric dyspeptic diarrhea were collected. After literature screening, data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0 bias risk evaluation tool, Meta-analysis was performed by using Rev Man 5.3 software. TSA 0.9 software was used for trail sequential analysis. RESULTS: A total of 8 RCTs with 857 participants were included. Total response rate of trial group [RR=1.20,95%CI(1.13,1.28),P<0.000 01] was significantly higher than that of control group. Abdominal pain relief time [MD=-1.18,95%CI(-1.42,-0.94),P<0.000 01], abdominal distension relief time [MD=-1.32, 95%CI(-1.94,-0.70),P<0.000 1], diarrhea relief time [MD=-2.07, 95%CI(-2.38,-1.76),P<0.000 01], the time of stool traits returned to normal[MD=-2.16,95%CI(-2.43,-1.88), P<0.000 01] in trial group were significantly shorter than control group. The stool frequency [MD=-1.72,95%CI(-2.18,-1.24), P<0.000 01] in trial group were significantly less than control group. The incidence of ADR in trial group was significantly lower than control group (P<0.05), or there was no statistical significance in the incidence of ADR between 2 groups (P>0.05), or no significant ADR was founded in 2 groups. Trial sequential analysis showed that the evidence of total response rate of XYG combined with CBLP in the treatment of pediatric dyspeptic diarrhea was accurate. CONCLUSIONS: XYG combined with CBLP is effective and safe for pediatric dyspeptic diarrhea.
醒脾养儿颗粒酪酸梭菌活菌散小儿消化不良性腹泻疗效安全性Meta分析试验序贯分析
Xingpi yang’er granulesClostridium butyricum live powderPediatric dyspeptic diarrheaTherapeutic efficacySafetyMeta-analysisTrial sequential analysis
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