胃苏颗粒联合奥美拉唑治疗活动期胃溃疡的临床研究

Evaluation of Weisu Particles Combined with Omeprazole in Treatment of Gastric Ulcer of Clinical Trial

关键词:  胃溃疡  胃苏颗粒  溃疡愈合质量  生命质量

Key words:  gastric ulcer  Weisu particles  quality of ulcer healing  quality of life

摘要:

目的 比较胃苏颗粒联用奥美拉唑治疗成人活动期胃溃疡患者的临床症状改善情况、内镜下溃疡愈合率以及组织学溃疡愈合质量、生命质量改善程度。方法 采用随机对照研究，将92例经胃镜证实伴幽门螺杆菌感染的成人活动期胃溃疡患者，随机分为试验组(47例)和对照组(45例)。治疗第1~2周，2组均予幽门螺杆菌根除四联疗法，试验组同时给予胃苏颗粒5 g·次^-1，3次·d^-1，泡服。第3~8周，试验组给予胃苏颗粒(剂量服法同前)联合奥美拉唑胶囊，每次20 mg，1 次·d^-1，口服。对照组仅给予奥美拉唑胶囊20 mg·次^-1，1次·d^-1，口服。结果 治疗第2周末，试验组改善腹痛、腹胀、反酸、嗳气、烧心的发生频率显著优于对照组(P<0.01)，试验组改善腹痛程度亦显著优于对照组(P<0.01)。治疗8周后，2组内镜下溃疡愈合总有效率差异无统计学意义。病理组织学检查显示试验组腺体密度和腺管形态恢复显著优于对照组(P<0.05)。治疗后试验组与对照组的生命质量改善程度比较，在心理功能、社会功能的变化上差异均有统计学意义(P<0.01)，在生理功能变化上差异无统计学意义。结论 治疗活动期胃溃疡，在质子泵抑制剂有效抑酸基础上，联合应用中成药胃苏颗粒，能更快缓解多种临床症状，能显著促进胃黏膜组织形态结构的恢复，提高溃疡愈合质量，同时改善心理功能、社会功能。

Abstract:

OBJECTIVE To evaluate the clinical symptoms relief, ulcer healing rate and the histologic quality of ulcer healing and quality of life after the treatment of Weisu particles combined with omeprazole in the patients with active gastric ulcer. METHODS A randomized controlled clinical study was conducted. Ninety-two patients with active gastric ulcer and Helicobacter pylori (Hp) infection were randomized into the study group (n=47) and control group(n=45). In the 1-2 week, both of the two groups received Hp eradication regimen. The study group received Weisu particles 5 g three times a day additionally. In the 3nd to 8th week, the study group received omeprazole 20 mg once a day with Weisu particles 5 g three times a day. The control group only received omeprazole 20 mg once a day. RESULTS At the end of two weeks, the study group was significantly more effective than the control group in reducing frequencies of abdominal pain, abdominal distension, acid reflux, belching, heartburn(P<0.01). The study group was significantly more effective than the control group in reducing severity of abdominal pain(P<0.01). There was no significant difference between the two groups on the ulcer healing rate evaluated by endoscopy. A better mueosa restoration on gland density and morphology was observed in the study group(P<0.05) at the end of 8 weeks. There was no significant difference between the two groups in physiological function changes. A more better improvement in psychological function, social function of life was observed in the study group(P<0.01) at the end of 8 weeks. CONCLUSION In active gastric ulcer, the treatment of Weisu particles combined with omeprazole can better relieve the dyspeptic symptoms and improve the quality of ulcer healing on histology and the psychological function, social function as well.