复方丁香开胃贴治疗儿童功能性腹痛脾胃虚寒证上市后再评价

Post-marketing revaluation of Compound Dingxiang Kaiwei Paste in treatment of functional abdominal pain with deficient cold of spleen and stomach syndrome in children

目的评价复方丁香开胃贴治疗儿童功能性腹痛脾胃虚寒证的有效性及安全性。方法采用随机双盲、安慰剂平行对照、多中心的方法。计划纳入240例患儿,按照1:1的比例随机分为试验组和对照组。两组分别外用复方丁香开胃贴、模拟贴,疗程2周。结果共纳入239例患儿,230例进入全分析数据(FAS)集,217例进入符合方案数据(PPS)集,238例进入安全数据(SS)集。两组治疗第2周的腹痛发作天数平均值分别为1.600、2.026,经协方差分析,差异有统计学意义(P=0.0070),且试验组优于对照组。两组腹痛程度的改善率分别为80.00%、67.83%,中医证候有效率分别为86.09%、59.13%,组间比较,差异均有统计学意义(P=0.0355、 0.0001),试验组也优于对照组的。试验组发现不良事件9例(7.63%),对照组10例(8.33%);判断为不良反应者,试验组4例(3.39%),对照组3例(2.50%),均表现为皮肤刺激症状。不良事件、不良反应的组间比较,差异均无统计学意义。结论复方丁香开胃贴治疗儿童功能性腹痛脾胃虚寒证,可以减少腹痛发作天数,改善腹痛程度及中医证候,且安全性好。

Objective To reevaluate the clinical efficacy and safety of Compound Dingxiang Kaiwei Paste in the treatment of syndrome of deficient cold of spleen and stomach in children with functional abdominal pain.Methods A random,double-blind,placebo parallel controll and multi-centered observational clinical approach were used.The tir al intended to include 240 paients,who were randomly divided into treatment group and control group according to 1:1 ratio.The treatment group was given Compound Dingxiang Kaiwei Paste and the control group with placebo for 2 weeks.Results A total of 239 patients were assigned to this study,and 230 of which entered full analysis set.Totally 217 patients were fitted in per-protocol set and 238 in safety set.The frequency of abdominal pain in the second week,the treatment group and the control group were 1.600 and 2.026(covariance analysis,P=0.0070),respectively.Improvement rate of the intensity of abdominal pain in the second week were 80.00% and 67.83%(P=0.0355),respectively.And the effective rate of traditional Chinese medicine(TCM)syndromes were 86.09% and 59.13%(P=0.001),respectively.In this clinical trial,there were 9 cases(7.63%)of adverse events were reported in the treatment group and 10 cases(8.33%)in the control group(P >0.05).Four cases(3.39%)in the treatment group and 3 cases(2.50%)in the control group were judged by investigators as adverse reaction(P >0.05).Conclusion Compound Dingxiang Kaiwei Paste can reduce the frequency and the duration of abdominal pain and improve TCM syndromes functional abdominal pain with deficient cold of spleen and stomach syndrome in children,and the security is good.