目的 评价加味藿香正气软胶囊治疗胃肠型感冒（外感风寒、内伤湿滞证）的有效性和安全性。方法 采用随机、双盲双模拟、阳性药平行对照、多中心临床试验方法，于2013年1月-2013年7月收入组符合胃肠型感冒（外感风寒、内伤湿滞证）的患者共440例，随机分为试验组330例和对照组110例，试验组给予加味藿香正气软胶囊+藿香正气软胶囊模拟剂，对照组给予藿香正气软胶囊+加味藿香正气软胶囊模拟剂，治疗时长均为3 d。观察治疗前后症状、体征的变化，并进行血常规、尿常规、便常规+潜血、肝肾功能及心电图检查，同时观察有无不良反应。结果 在中医证候疗效方面，试验组和对照组的临床痊愈率分别为50.000%、35.455%（FAS分析）和50.464%、35.780%（PPS分析），总有效率分别为94.848%、76.364%（FAS分析）和96.285%、77.064%（PPS分析），两组间比较差异有统计学意义（P<0.05）。经FAS分析中医单项症状疗效，泄泻、恶心呕吐、鼻塞流涕、胸膈满闷和脘腹胀痛的临床痊愈率组间比较和总有效率组间比较，其差异均有统计学意义（P<0.05）。但在头痛昏重方面，仅有效率组间比较差异有统计学意义（P<0.05）。两组患者在用药过程中，均未见明显不良反应。结论 加味藿香正气软胶囊治疗胃肠型感冒（外感风寒、内伤湿滞证）疗效较好，且优于藿香正气软胶囊，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.