延参健胃胶囊治疗慢性萎缩性胃炎的临床研究

Efficacy and safety of yanshenjianwei capsules in treatment of patients with chronic atrophic gastritis

目的评价延参健胃胶囊治疗慢性萎缩性胃炎的临床疗效和安全性。方法采用随机、双盲双模拟与阳性对照药平行对照的方法,完成病例202例,其中试验组103例,对照组99例。观察中医证候表现及通过胃镜、胃粘膜活检了解胃粘膜腺体萎缩、肠上皮化生、不典型增生及幽门螺旋杆菌感染的变化。结果病理疗效试验组临床控制率21.36%,显效率28.16%,对照组临床控制率14.14%,显效率16.16%(P<0.05);证候疗效试验组临床痊愈率25.24%,显效率47.57%,对照组临床治愈率12.12%,显效率为36.36%(P<0.05)。临床试验过程中血、尿、便常规检查及心电图、肝、肾功能实验室检查,未见明显不良反应。结论延参健胃胶囊对慢性萎缩性胃炎,中医辨证属寒热错杂证的患者有确切的治疗作用,临床使用安全有效。

AIM: To evaluate the efficacy and safety of yanshenjianwei capsules in the treatment of patients with chronic atrophic gastritis. METHODS: Yanshenjianwei capsule was observed in a randomized, double blind, double modeling, and apositive drug controlled clinical trail. 202 patients were divided into two groups: yanshenjianwei capsule group (n=103) and control group (n=99). The symptoms of the traditional Chinese medicine were observed. Atrophy of glandular organ in gastric mucosa, intestinal metaplasia and atypical hyperplasia were observed by gastroscope and biopsy of gastric mucosa. RESULTS: The cure rate of the yanshenjianwei capsule group and the control group were 21.36 % and 14.14 % on the symptoms of pathology, and the effective rate were 28.16 % and 16.16 %, respectively. The yanshenjianwei capsule group was superior to the control group (P< 0.05 ). The cure rate of the yanshenjianwei capsule group and the control group were 25.24 % and 12.12 % on the symptoms of the traditional Chinese medicine, and the effective rate were 16.16 % and 36.36%, respectively. There was a significantly statistical difference between the two groups (P< 0.05 ). No serious side effects were found on blood routine, urine routine, stool routine, electrocardiogram, liver function and kidney function in the two groups. CONCLUSION: Yanshenjianwei capsule is an effective and safe drug for patients with chronic atrophic gastritis and cold heat complicated syndromes in TCM.