延参健胃胶囊治疗慢性萎缩性胃炎的临床研究

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。

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

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, doubleblind, 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.