期刊论文

Phase Ⅳ clinical trial of Liqi Nuanwei granules in the treatment of chronic superficial gastritis

中文

中国临床药理学杂志

1001-6821

2020

36

22

3608-3611

10.13699/j.cnki.1001-6821.2020.22.009

本校为第一机构

目的评价理气暖胃颗粒在广泛使用条件下治疗慢性浅表性胃炎(肝胃不和挟寒证)的有效性和安全性。方法用开放性、单臂、多中心临床试验设计,选择中医辩证为肝胃不和挟寒证、慢性浅表性胃炎患者2103例。给予理气暖胃颗粒每次1袋,每日3次,温开水冲服。治疗4周后,评价有效性和安全性各种指标。结果治疗4周后,理气暖胃颗粒治疗慢性浅表性胃炎患者总有效率达89.52%。试验期间发生不良事件共计54例次(1.09%)。结论理气暖胃颗粒治疗慢性浅表性胃炎(肝胃不和挟寒证)安全有效。

Objective To evaluate the efficacy and safety of Liqi Nuanwei granules in the treatment of chronic superficial gastritis(Liver-stomach disharmony with cold syndrome) under widely used conditions. Methods With the open, single arm, multi-center clinical trial design, 2103 patients with chronic superficial gastritis and liver stomach disharmony with cold syndrome were selected. Give one bag of Liqi nuaiwei granules three times a day, and take it with warm boiled water. After 4 weeks of treatment, the efficacy and safety were evaluated. Results After 4 weeks of treatment, Liqi Nuanwei granules we...