新健胃片加倍剂量治疗功能性消化不良肝胃郁热证的多中心临床研究  

Multi-center clinical study on Xin Jianwei Pian doubling dosage for functional dyspepsia liver and stomach heat accumulation syndrome

作　　者：杨强[1] 钟成梁[1] 李磊[2] 李学武 李慧臻[4] 龚枚[5] YANG Qiang;ZHONG Chengliang;LI Lei;LI Xuewu;LI Huizhen;GONG Mei(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Affiliated Hospital of Changchun University of Chinese Medicine,Changchun 130021,China;Shanxi Provincial Hospital of Traditional Chinese Medicine,Xi′an 710003,China;Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China;Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610075,China)

机构地区：[1]天津中医药大学第一附属医院,天津300193 [2]长春中医药大学附属医院,吉林长春130021 [3]陕西省中医医院,陕西西安710003 [4]天津中医药大学第二附属医院,天津300150 [5]成都中医药大学附属医院,四川成都610075

出　　处：《药物评价研究》2019年第10期2001-2005,共5页Drug Evaluation Research

摘　　要：目的评价新健胃片加倍剂量治疗功能性消化不良肝胃郁热证主要症状的有效性和安全性。方法采用分层区组随机、双盲单模拟、平行对照、多中心临床研究的方法。5家临床试验单位纳入240例受试者,按1∶1比例分为试验组和对照组。两组均口服新健胃片,试验组4片/次、3次/d,对照组2片/次、3次/d,疗程为2周。结果治疗后两组(胃脘疼痛、烧心、胃脘胀闷、反酸吞酸等)主要症状有效率的比较,差异均有统计学意义,且试验组高于对照组,优效性检验成立;(呃逆、恶心呕吐、纳呆、口苦等)次要症状,组间差异有统计学意义,且试验组高于对照组(P<0.05);中医证候疗效愈显率、功能性消化不良疗效总有效率的比较,试验组高于对照组,且差异有显著性统计学意义(P<0.05)。试验组出现不良事件1例,经研究者判断,与试验药物不可能有关,不属于药物的不良反应;实验室检查及生命体征未发现有临床意义的改变。结论本次以原剂量为对照的新健胃片治疗功能性消化不良肝胃郁热证临床试验,加倍剂量后综合疗效均优于原剂量,且未提示更高的临床应用风险,具有一定的临床推广价值。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, with4 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.

关 键 词：新健胃片 功能性消化不良 肝胃郁热证 多中心临床研究 

分 类 号：R975[医药卫生—药品]