目的 評價(jià)加味藿香正氣軟膠囊治療胃腸型感冒（外感風(fēng)寒、內(nèi)傷濕滯證）的有效性和安全性。方法 采用隨機(jī)、雙盲雙模擬、陽性藥平行對照、多中心臨床試驗(yàn)方法，于2013年1月-2013年7月收入組符合胃腸型感冒（外感風(fēng)寒、內(nèi)傷濕滯證）的患者共440例，隨機(jī)分為試驗(yàn)組330例和對照組110例，試驗(yàn)組給予加味藿香正氣軟膠囊+藿香正氣軟膠囊模擬劑，對照組給予藿香正氣軟膠囊+加味藿香正氣軟膠囊模擬劑，治療時(shí)長均為3 d。觀察治療前后癥狀、體征的變化，并進(jìn)行血常規(guī)、尿常規(guī)、便常規(guī)+潛血、肝腎功能及心電圖檢查，同時(shí)觀察有無不良反應(yīng)。結(jié)果 在中醫(yī)證候療效方面，試驗(yàn)組和對照組的臨床痊愈率分別為50.000%、35.455%（FAS分析）和50.464%、35.780%（PPS分析），總有效率分別為94.848%、76.364%（FAS分析）和96.285%、77.064%（PPS分析），兩組間比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。經(jīng)FAS分析中醫(yī)單項(xiàng)癥狀療效，泄瀉、惡心嘔吐、鼻塞流涕、胸膈滿悶和脘腹脹痛的臨床痊愈率組間比較和總有效率組間比較，其差異均有統(tǒng)計(jì)學(xué)意義（P<0.05）。但在頭痛昏重方面，僅有效率組間比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。兩組患者在用藥過程中，均未見明顯不良反應(yīng)。結(jié)論 加味藿香正氣軟膠囊治療胃腸型感冒（外感風(fēng)寒、內(nèi)傷濕滯證）療效較好，且優(yōu)于藿香正氣軟膠囊，安全性良好。

Objective To evaluate the efficacy and safety of Modified Huoxiang Zhengqi Soft Capsule in treatment of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome. Methods A multi-center and double-blind double-dummy randomized controlled trial was conducted. 440 patients of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome were enrolled from Januarary to July 2013. They were randomly divided into two groups, the trial group of 330 cases and the control group of 110 cases. The trial group was given Modified Huoxiang Zhengqi Soft Capsule and Huoxiang Zhengqi Soft Capsule analogue three times a day for 3 days. The control group received Huoxiang Zhengqi Soft Capsule and Modified Huoxiang Zhengqi Soft Capsule analogue three times a day for 3 days. Clinical symptoms, signs and symptoms and adverse effect were observed and blood test, routine urine and stool test, feces occult blood, hepatorenal function and electrocardiogram were examined before and after treatment. Results In terms of traditional Chinese medicine syndrome and efficacy after treatment, the clinical healing rates of the trial group and the control group were 50.000%, 35.455% for full analysis set and50.464%, 35.780% for per protocol set. The overall effective rates were 94.848%, 76.364% for full analysis set and 96.285%, 77.064% for per protocol set. There were significant differences between the two groups (P<0.05). In addition, there were significant differences in clinical healing rates and overall effective rates of symptoms including diarrhea, nausea and vomiting, rhinobyon and rhinorrhea, fullness and oppression in the chest and diaphragm and abdominal swelling and pain between two groups (P<0.05). However, the difference in overall effective rates of headache and lightheadedness symptom were significant (P<0.05) except for clinical healing rate. No adverse effects were found in the trial. Conclusion Modified Huoxiang Zhengqi Soft Capsule is effective and safe in treatment of gastrointestinal type cold with exogenous wind-cold and endogenous damp stagnation syndrome and its effect is better than that of Huoxiang Zhengqi Soft Capsule.