连朴饮加减治疗幽门螺杆菌感染慢性胃炎脾胃湿热证临床疗效与安全性评价

Clinical efficacy and safety evaluation of modified Lianpu Decoction in the treatment of chronic gastritis with syndrome of dampness-heat of spleen and stomach caused by Helicobacter pylori infection

目的探讨连朴饮加减治疗幽门螺杆菌(Hp)感染慢性胃炎脾胃湿热证的临床疗效和安全性。方法将2016年9月至2018年5月在北京市中西医结合医院呼吸消化科收治的120例Hp感染慢性胃炎脾胃湿热证患者随机分为两组,每组各60例,对照组开展为期两周的四联西医疗法治疗,治疗组除此之外进一步增加口服中药连朴饮加减治疗,观察两组的中医证候积分、临床疗效、Hp清除率等方面情况。结果经过治疗后,治疗组中医证候积分显著改善,低于对照组,差异有统计学意义(P<0.05);治疗组总有效率为96.67%(58/60),显著高于对照组的85.00%(51/60),差异有统计学意义(P<0.05);治疗组Hp清除率为86.67%,显著高于对照组的70.00%,差异有统计学意义(P<0.05);两组患者总不良反应发生率比较,差异无统计学意义(P>0.05),均较安全。结论连朴饮加减治疗Hp感染慢性胃炎脾胃湿热证疗效显著,能够有效改善临床症状,并有效提升Hp清除率且安全,可在基层医院和综合医院推广使用。

Objective To investigate the clinical efficacy and safety of modified Lianpu Decoction in the treatment of chronic gastritis with syndrome of dampness-heat of spleen and stomach caused by Helicobacter pylori infection.Methods A total of 120 patients with chronic gastritis with syndrome of dampness-heat of spleen and stomach caused by Helicobacter pylori infection admitted to the department of respiratory and digestive medicine in Beijing Hospital of Integrated Traditional Chinese and Western Medicine from September 2016 to May 2018 were divided into the treatment group(n=60)and the control group(n=60)according to the random principle.The control group was treated with western medicine quadruple therapy for 2 weeks,while the treatment group was treated with Chinese materia medica of modified Lianpu Decoction orally on the basis of quadruple therapy in the control group.The traditional Chinese medicine(TCM)syndrome scores,clinical efficacy and clearance rate of Helicobacter pylori of the two groups of patients were observed.Results After treatment,the TCM syndrome scores of the patients in the treatment group were improved significantly,which were lower than those in the control group,with statistically significant difference(P<0.05).After treatment,the total effective rate in the treatment group was 96.67%(58/60),which was significantly higher than 85.00%(51/60)in the control group,with statistically significant difference(P<0.05).The clearance rate of Helicobacter pylori in the treatment group was 86.67%,which was significantly higher than 70.00%in the control group,with statistically significant difference(P<0.05).There was no statistically significant difference in the incidence of total ADRs between the two groups of patients(P>0.05),and both were relatively safe.Conclusion Modified Lianpu Decoction has obvious therapeutic efficacy on chronic gastritis with syndrome of dampness-heat of spleen and stomach caused by Helicobacter pylori infection.It can effectively improve the clinical symptoms and raise the clearance rate of Helicobacter pylori.Therefore,it is safe and can be widely promoted and applied in grassroots hospitals and comprehensive hospitals.