| 引用本文:韩树堂1，陈静1，田旭东2，刘启泉3，刘铁军4，周正华5.七蕊胃舒胶囊对慢性浅表性胃炎伴糜烂湿热瘀滞证随机、双盲、多中心平行对照临床试验[J].世界中医药,2022,(10):. |
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| 七蕊胃舒胶囊对慢性浅表性胃炎伴糜烂湿热瘀滞证随机、双盲、多中心平行对照临床试验 |
| Effect of Qirui Weishu Capsules on Chronic Superficial Gastritis with Erosion and Dampness-heat Stasis Syndrome：A Randomized，Double-blinded，Placebo-controlled Parallel Multi-center Trial |
| 投稿时间：2022-03-19 |
| DOI：10.3969/j.issn.1673-7202.2022.10.015 |
| 中文关键词: 七蕊胃舒胶囊 慢性浅表性胃炎 糜烂 湿热瘀滞 随机 双盲 多中心 |
| English Keywords:Qirui Weishu Capsules Chronic superficial gastritis Erosion Dampness-heat stasis Randomized Double-blinded Multi-center |
| 基金项目:国家科技重大专项（2018ZX09731-004） |
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| 中文摘要: |
| 目的：评价七蕊胃舒胶囊治疗慢性浅表性胃炎伴糜烂湿热瘀滞证的有效性和安全性。方法：选取2012年10月至2015年3月江苏省中医院、甘肃省中医院、河北省中医院、长春中医药大学附属医院、天津中医药大学附属医院等5家中心收治的慢性浅表性胃炎伴糜烂湿热瘀滞证患者231例作为研究对象。随机分为观察组、对照组及安慰剂组。观察组口服七蕊胃舒胶囊，对照组患者口服三九胃泰胶囊，安慰剂组患者口服安慰剂，3组均为4粒/次，2次/d，餐前半小时服用，疗程28 d。观察用药后各项症状的改变情况和不良反应。结果：观察组胃脘疼痛消失率高于对照组及安慰剂组，差异有统计学意义（P<0.05）；观察组胃黏膜糜烂痊愈率显著高于对照组及安慰剂组，差异有统计学意义（P<0.05）；观察组证候疗效的痊愈率及总显效率显著高于对照组及安慰剂组，差异有统计学意义（P<0.05）；观察组幽门螺杆菌根除率高于对照组及安慰剂组，其中，观察组与安慰剂组根除率差异有统计学意义（P<0.01），而与对照组差异无统计学意义（P>0.05）；观察组不良反应发生率为2.6%，对照组无不良反应记录，安慰剂组不良反应发生率为1.8%，3组差异无统计学意义（P>0.05）。结论：七蕊胃舒胶囊在治疗慢性浅表性胃炎伴糜烂湿热瘀滞证方面临床疗效显著，安全性较好。 |
| English Summary: |
| To evaluate the efficacy and safety of Qirui Weishu Capsules in the treatment of chronic superficial gastritis with erosion and dampness-heat stasis syndrome.Methods:A total of 231 patients with chronic superficial gastritis with erosion and dampness-heat stasis syndrome treated in the Jiangsu Province Hospital of Chinese Medicine，Gansu Provincial Hospital of Traditional Chinese Medicine，Hebei Provincial Hospital of Traditional Chinese Medicine，Affiliated Hospital of Changchun University of Chinese Medicine，and Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from October 2012 to March 2015 were enrolled and randomly divided into an observation group(Qirui Weishu Capsules)，a control group(Sanjiu Weitai Capsules)，and a placebo group(placebo).All patients were treated correspondingly 30 min before meals，4 capsules each time，two times a day for 28 days.The changes in symptoms and adverse reactions after treatment were observed.Results:The disappearance rate of epigastric pain in the observation group was higher than those in the control group and the placebo group(P<0.05).The recovery rate of gastric mucosal erosion in the observation group was higher than those in the control group and the placebo group(P<0.05).The cure rate and total effective rate in the experimental group were higher than those in the control group and the placebo group(P<0.05).The eradication rate of Helicobacter pylori in the observation group was higher than those in the control group and the placebo group，and the difference in the eradication rate between the observation group and the placebo group was statistically significant(P<0.01)，but there was no statistical difference between the observation group and the control group(P>0.05).The incidence of adverse reactions in the observation group was 2.6%，while no adverse reactions were recorded in the control group，and the incidence of adverse reactions in the placebo group was 1.8%，with no significant difference between the three groups(P>0.05).Conclusion:Qirui Weishu Capsules show significant clinical efficacy and good safety in the treatment of chronic superficial gastritis with erosion and dampness-heat stasis syndrome. |
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