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[1]戴 宁,赵 敏,夏 庆,等.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[J].天津医科大学学报,2017,23(05):442-445.
　DAI Ning,ZHAO Min,XIA Qing,et al.Multicenter randomized controlled clinical trial on chronic non-atrophic gastritis treated with JinghuaWeikang capsule[J].Journal of Tianjin Medical University,2017,23(05):442-445.
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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(PDF)
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《天津医科大学学报》[ISSN:1006-8147/CN:12-1259/R]

卷:
23卷
期数:
2017年05期
页码:
442-445
栏目:
临床医学
出版日期:
2017-09-20

文章信息/Info

Title:
Multicenter randomized controlled clinical trial on chronic non-atrophic gastritis treated with JinghuaWeikang capsule
文章编号:
1006-8147(2017)05-0442-04
作者:
戴 宁1; 赵 敏2; 夏 庆3; 江一平4
（1.天津中医药大学, 天津 300193; 2.天津天士力控股集团研究院,?天津?300410；3.四川大学华西医院，成都 610041；4.江西中医学院附属医院，南昌 330006）
Author(s):
DAI Ning1; ZHAO Min2; XIA Qing3; JIANG Yi-ping4
(1.Tianjin University of Traditional Chinese Medicine， Tianjin? 300193,China；2.Tasly Group Institute, Tianjin 300410, China; 3.West China Hospital Sichuan University，Chengdu 610041, China； 4.The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine，Nanchang 330006, China)
关键词:
荆花胃康胶丸; 慢性非萎缩性胃炎; 胃脘痛寒热错杂夹瘀证; 随机对照试验
Keywords:
JinghuaWeikang capsule; chronic non-atrophic gastritis; epigastric pain syndrome with chill and fever stasis; randomized controlled trial
分类号:
R969.4
DOI:
-
文献标志码:
A
摘要:
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，试验组（n=255）和对照组（n=85）。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28d。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。
Abstract:
Objective: To evaluate the efficacy and safety of Jinghuaweikang 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 casesinvolved in study, including experimental group (n=255) and control group (n=85). The experimental group (given JinghuaWeikang capsules + XiangyuWeishuMixture as simulation agent); the control group (given XiangyuWeishu Mixture + JinghuaWeikang capsules as simulation agent), the period of treatment was 28d. The changesafter 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 ofcurative 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% andthe difference between two groups was statistically significant. Conclusion: JinghuaWeikang capsule is effective medicine for treating chronic non-atrophic gastritis (epigastric pain syndrome with chill and fever stasis)and safe for patients.

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备注/Memo

备注/Memo:
作者简介戴宁（1976-），女，高级工程师，学士，研究方向：中药学，E-mail: daining96@163.com。
更新日期/Last Update: 2017-09-20