小儿七珍丸治疗小儿乳食积滞、痰火互结证404例

Efficacy and safety of Xiao'er Qizhen pellet in treatment of 404 cases of infantile dyspeptic gastroenteropathy

目的评价小儿七珍丸对小儿乳食积滞、痰火互结证的临床疗效和安全性。方法采用随机、单盲、阳性药物平行对照、多中心临床研究的方法进行,观察试验组患儿302例,对照组102例。试验组服用小儿七珍丸,对照组服用健儿药丸。疗程定为1d,晨起空腹服药一次,服药24h后对疗效与安全性指标进行评价。结果试验组痊愈率33.77%,总有效率94.04%;对照组痊愈率27.45%,总有效率89.22%,两组比较,无统计学意义(P>0.05)。试验组与对照组各中医症状比较无统计学差异(P>0.05)。试验组年龄、病程、病情与疗效无关(P>0.05)。未见明显不良反应。结论小儿七珍丸治疗小儿乳食积滞、痰火互结症疗效确切,临床使用安全。

Objective To evaluate the efficacy and safety of Xiao＇ er Qizhen pellet in treatment of infantile dyspeptic gastroenteropathy. Methods Multicenter, random, single-blinded and control method was used. A total of 404 cases were divided into treated group（ n = 302） and control group （ n = 102）. Results The clinical cure rate was 33.77 %, and total curative effect rate was 94.04 % in treated group; while in control group clinical cure rate was 27.45 %, and total curative effect rate was 89.22 %. There was no significant difference between the two groups（P 〉 0.05）. And there was no significant difference in clinical effect between two groups. There was no correlation between age, course and pathogenetic condition and therapeutic effect in treated group. The toxic and adverse drug reaction was not observed. Conclusion Xiao＇ er Qizhen pellet is effective and safe in treatment of infantile dyspeptic gastroenteropathy.