目的 評(píng)價(jià)新健胃片加倍劑量治療功能性消化不良肝胃郁熱證主要癥狀的有效性和安全性。方法 采用分層區(qū)組隨機(jī)、雙盲單模擬、平行對(duì)照、多中心臨床研究的方法。5家臨床試驗(yàn)單位納入240例受試者，按1∶1比例分為試驗(yàn)組和對(duì)照組。兩組均口服新健胃片，試驗(yàn)組4片/次、3次/d，對(duì)照組2片/次、3次/d，療程為2周。結(jié)果 治療后兩組（胃脘疼痛、燒心、胃脘脹悶、反酸吞酸等）主要癥狀有效率的比較，差異均有統(tǒng)計(jì)學(xué)意義，且試驗(yàn)組高于對(duì)照組，優(yōu)效性檢驗(yàn)成立；（呃逆、惡心嘔吐、納呆、口苦等）次要癥狀，組間差異有統(tǒng)計(jì)學(xué)意義，且試驗(yàn)組高于對(duì)照組（P<0.05）；中醫(yī)證候療效愈顯率、功能性消化不良療效總有效率的比較，試驗(yàn)組高于對(duì)照組，且差異有顯著性統(tǒng)計(jì)學(xué)意義（P<0.05）。試驗(yàn)組出現(xiàn)不良事件1例，經(jīng)研究者判斷，與試驗(yàn)藥物不可能有關(guān)，不屬于藥物的不良反應(yīng)；實(shí)驗(yàn)室檢查及生命體征未發(fā)現(xiàn)有臨床意義的改變。結(jié)論 本次以原劑量為對(duì)照的新健胃片治療功能性消化不良肝胃郁熱證臨床試驗(yàn)，加倍劑量后綜合療效均優(yōu)于原劑量，且未提示更高的臨床應(yīng)用風(fēng)險(xiǎn)，具有一定的臨床推廣價(jià)值。

Objective To evaluate the effectiveness and safety of Xin Jianwei Pian doubling dosage for functional dyspepsia stagnancy heat of liver and stomach syndrome. Methods Methods of parallel control, double blind, stratified random, multi-center clinical were used in this study. A total of 240 subjects were included in 5 clinical trial units, which were divided into treatment group and control group according to 1:1 ratio. Xin Jianwei Pian were used in both groups. The treatment course was 2 weeks, with 4 pills per time and 3 times per day in the treatment group and 2 pills per time and 3 times per day in the control group. Results There were significantly differences on effect lever and effective rate of main symptom (acid regurgitation, heartburn, gasteremphraxis, stomachache), and treatment group had higher effective rate than control group. There were significantly differences on syndrome of hiccup, nausea and vomiting, indigestion and bitter taste and treatment group had higher effective rate than control group (P<0.05). Treatment group had better TCM syndrome effect curative rate and disease total effective rate than control group, there were significantly differences (P<0.05). There was one cases in treatment group happened adverse event in this study but not caused by drug. There was no clinically change in laboratory examination and vital signs. Conclusions The clinical trial of Xin Jianwei Pian with the original dose as the control for functional dyspepsia and liver-stagnation syndrome was better than the original dose after double-dose, and did not suggest a higher clinical application risk. It has certain clinical promotion value.