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【目的】观察疗程10 d序贯治疗以及14 d中西医结合序贯治疗与14 d标准三联疗法作为幽门螺杆菌(Hp)感染一线治疗方案的有效性。【方法】将90例年龄在18岁及以上的Hp感染者,按1︰1︰1比例随机分为10 d序贯方案组(S-10组)、14 d中西医结合序贯方案组(S-14组)以及14 d标准三联方案组(T-14组)各30例。序贯方案组选择最初7 d(或者5 d)口服埃索美拉唑20 mg及阿莫西林1.0 g,序贯7 d(或者5 d)服用埃索美拉唑20 mg及克拉霉素500 mg、甲硝唑500 mg,S-10组与S-14组的疗程分别为10 d和14 d,其中S-14组同时给予辨证服用中药汤剂;T-14组选择口服埃索美拉唑20 mg,阿莫西林1.0 g及克拉霉素500 mg,疗程为14 d。观察各组患者的Hp根除率、不良事件发生率以及患者的依从性,并对可能影响根除率的因素进行分析。【结果】(1)S-14、S-10、T-14组的根除率分别为90.0%、86.7%、83.3%,S-14组的根除率显著高于T-14组(P﹤0.05),而S-14组与S-10组,S-10组与T-14组之间的治疗结局比较,差异均无统计学意义(P>0.05)。(2)3组之间不良反应的发生率和患者依从性比较,差异均无统计学意义(P>0.05)。(3)影响根除率的因素分析结果显示:克拉霉素的耐药性会降低序贯疗法和三联标准疗法的有效性,而甲硝唑的耐药性会降低序贯疗法的有效性。【结论】本次临床试验结果支持将序贯治疗作为抗Hp感染的一线治疗方案。
【Objective】 The purpose of this study was to evaluate the efficacy of sequential treatment of 10 days and 14 days of combination of TCM and WM with 14 days of standard triple therapy as first-line treatment for H.pylori infection. 【Methods】 Ninety Hp infected patients aged 18 years and above were randomly divided into 10-day sequential group (S-10 group) and 14-day integrated traditional and western medicine sequential group S-14 group) and 14-day standard triple therapy group (T-14 group). In the sequential regimen group, 20 mg of esomeprazole and 1.0 g of amoxicillin were administered for the first 7 days (or 5 days), and 20 mg of esomeprazole and clarithromycin 500 mg, metronidazole 500 mg, S-10 group and S-14 group were treated for 10 days and 14 days, S-14 group were treated with traditional Chinese medicine decoction; decoction of T-14 group Azole 20 mg, amoxicillin 1.0 g and clarithromycin 500 mg for a course of 14 days. Hp eradication rate, incidence of adverse events and compliance of patients in each group were observed, and the factors that may affect the eradication rate were analyzed. 【Results】 (1) The eradication rates of S-14, S-10 and T-14 groups were 90.0%, 86.7% and 83.3% respectively. The eradication rates of S-14 group were significantly higher than those of T-14 group ). There was no significant difference in the treatment outcome between S-14 group and S-10 group, S-10 group and T-14 group (P> 0.05). (2) There was no significant difference in the incidence of adverse reactions and patient compliance between the three groups (P> 0.05). (3) The analysis of the factors influencing the eradication rate showed that the drug resistance of clarithromycin would reduce the effectiveness of sequential therapy and triple standard therapy, while the metronidazole resistance would reduce the effectiveness of sequential therapy. 【Conclusion】 The results of this clinical trial support sequential therapy as the first-line treatment for anti-Hp infection.