荆花胃康三联疗法治疗幽门螺杆菌阳性慢性胃炎临床疗效的多中心随机双盲临床研究

Multicentric Randomized Double Blinded Clinical Study of Jinghua Weikang Triple Therapy against Helicobacter Pylori Positive Chronic Gastritis

目的探讨荆花胃康三联疗法与标准三联疗法治疗幽门螺杆菌(H.pylori)阳性慢性胃炎的临床疗效及安全性。方法采用多中心、随机、双盲、平行对照的方法,选择H.pylori阳性慢性胃炎患者101例为试验组,予以荆花胃康三联疗法治疗;102例为阳性对照组,予以标准三联疗法治疗。比较两组患者H.pylori根除率、临床疗效及不良反应有无差异。结果试验组和对照组的H.pylori根除率分别为62.4%和58.8%,两组根除率比较,差异无统计学意义(P>0.05)。治疗后10 d两组疗效比较,差异有统计学意义(P<0.05)。试验组、对照组不良反应发生率分别为8.1%和14.0%,两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论荆花胃康三联疗法与标准三联疗法治疗H.pylori阳性慢性胃炎具有等效性,且不良反应率无差异,不良反应均较轻,故荆花胃康三联疗法可以作为一种根除H.pylori的中西医结合新疗法。

Objective To explore the efficacy and safety of Jinghua Weikang triple therapy in treating patients with Helicobacter Pylori positive chronic gastritis. Methods A multicentric,randomized,double blinded and paralleled controlled tria1 was conducted,with 101 patients assigned into the trial group（treated with Jinhua Weikang triple therapy） and another 102 patients assigned into the control group（treated with standard triple therapy）.Eradication rates of Helicobacter Pylori,effective rates and adverse reactions in both groups were evaluated. Results Helicobacter Pylori eradication rates of the trial group and the control group were 62.4% and 58.8% respectively with no statistically significant difference（P0.05）.Effective rates were significantly different between the two groups after 10 days of treatment（P0.05）.Adverse event rates were 8.1% and 14.0% respectively with no statistically significant difference（P0.05）. Conclusion Jinghua Weikang triple therapy shows equivalent effectiveness as standard triple therapy in treating Helicobacter Pylori positive chronic gastritis with less severe adverse reactions and similar adverse reaction rate,which makes it an integrative new therapy in the eradication of Helicobacter Pylori.