目的 評價復方丁香開胃貼治療兒童功能性腹痛脾胃虛寒證的有效性及安全性。方法 采用隨機雙盲、安慰劑平行對照、多中心的方法。計劃納入240例患兒，按照1：1的比例隨機分為試驗組和對照組。兩組分別外用復方丁香開胃貼、模擬貼，療程2周。結(jié)果 共納入239例患兒，230例進入全分析數(shù)據(jù)（FAS）集，217例進入符合方案數(shù)據(jù)（PPS）集，238例進入安全數(shù)據(jù)（SS）集。兩組治療第2周的腹痛發(fā)作天數(shù)平均值分別為1.600、2.026，經(jīng)協(xié)方差分析，差異有統(tǒng)計學意義（P=0.0070），且試驗組優(yōu)于對照組。兩組腹痛程度的改善率分別為80.00%、67.83%，中醫(yī)證候有效率分別為86.09%、59.13%，組間比較，差異均有統(tǒng)計學意義（P=0.0355、0.0001），試驗組也優(yōu)于對照組的。試驗組發(fā)現(xiàn)不良事件9例（7.63%），對照組10例（8.33%）；判斷為不良反應者，試驗組4例（3.39%），對照組3例（2.50%），均表現(xiàn)為皮膚刺激癥狀。不良事件、不良反應的組間比較，差異均無統(tǒng)計學意義。結(jié)論 復方丁香開胃貼治療兒童功能性腹痛脾胃虛寒證，可以減少腹痛發(fā)作天數(shù)，改善腹痛程度及中醫(yī)證候，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.