荆花胃康胶丸治疗慢性非萎缩性胃炎(胃脘痛寒热错杂夹瘀证)多中心随机对照临床试验

摘要

Objective:To evaluate the efficacy and safety of Jinghua weikang capsules in the treatment of chronic non-atrophic gastritis (epigastric pain syndrome with chill and fever stasis).Methods:By using randomized,positive drug parallel controlled,multicenter clinical trial,there were 340 cases involved in study,including experimental group (n=255) and control group (n=85).The experimental group (given Jinghua weikang capsules+Xiangyu weishu mixture as simulation agent);the control group (given Xiangyu weishu mixture+ Jinghua weikang capsules as simulation agent),the period of treatment was 28 d.The changes after treatment in epigastric pain,swelling disappearance rate,symptoms and body should be observed and contrasted with the data acquired before treatment.The adverse reactions were recorded meanwhile.Body examination was performed after treatment such as blood,urine,stool routine,liver and kidney function,electrocardiogram,abdominal B ultrasound,endoscopy,biopsy,Helicobacter pylori and so on.Results:The figure of experimental group and control group after treatment in epigastric pain and swelling disappearance rate were respectively 58.3％ and 37.3％ (FAS set),and the difference between two groups was statistically significant(P＜0.05).In the aspect of curative effect of traditional Chinese medicine for experimental group,the total apparent rate was 75.3％ and the total effective rate was 92.4％.In control group,the total apparent rate was 51.8％ and the total effective rate was 83.1％ and the difference between two groups was statistically significant.Conclusion:Jinghua weikang capsule is effective medicine for treating chronic non-atrophic gastritis (epigastric pain syndrome with chill and fever stasis) and safe for patients.%目的:评价荆花胃康胶丸治疗慢性非萎缩性胃炎(胃脘痛寒热错杂夹瘀证)的安全性与有效性.方法:采用随机、阳性药平行对照、多中心临床试验的方法,纳入340例病例,分为试验组255例和对照组85例.试验组给予荆花胃康胶丸+香榆胃舒合剂模拟剂;对照组给予香榆胃舒合剂+荆花胃康胶丸模拟剂,疗程均为28 d.观察治疗前后胃脘疼痛、胀满消失率、症状、体征变化和有无不良反应,并进行血、尿、便常规、肝肾功能、心电图、腹部B超、胃镜检查、病理活检、幽门螺旋杆菌等检查.结果:治疗后试验组和对照组的胃脘疼痛及胃脘胀满消失率分别为58.3％、37.3％(FAS集),两组比较差异具有统计学意义(P＜0.05);中医证侯疗效试验组治疗后总显效率75.3％,总有效率92.4％;对照组总显效率51.8％,总有效率83.1％,两组间比较差异有统计学意义.结论:荆花胃康胶丸是治疗慢性非萎缩性胃炎(胃脘痛寒热错杂夹瘀证)的安全有效药.