摘要
目的:评估黄连素联合经典三联方案在不同疗程时治疗幽门螺杆菌的疗效及安全性。方法:幽门螺杆菌阳性患者共265例,将其随机分成两组,即实验组(黄连素+三联方案)和对照组(三联方案),根据疗程不同,每组又分为7、10、14d亚组,各组均在治疗前和治疗后至少4周分别检测幽门螺杆菌的感染情况。结果:经根除幽门螺杆菌治疗后,实验组总根除率为88.6%,对照组总根除率为78.4%,实验组明显高于对照组(P<0.05),随着疗程的增加根除率也相应增加,10d亚组和14d亚组的根除率明显高于7d亚组(P<0.05),但10d亚组和14d亚组在根除率上无统计学差异(P>0.05);实验组和对照组的不良反应总发生率无统计学差异(P>0.05),但疗程越长其不良反应的发生率也有所增加;实验组和对照组在临床症状总缓解率上无统计学差异(P>0.05),随着疗程的增加各组缓解率相应增加,各疗程中,实验组的临床症状缓解率比对照组对应的要略高,其中实验组7d亚组明显高于对照组(P<0.05),10d亚组、14d亚组实验组虽高于对照组,但之间均无明显统计学意义(P>0.05)。结论:黄连素能提高经典一线三联方案幽门螺杆菌的根除率,且不增加不良反应及费用,故黄连素联合三联方案有效、安全,10、14d疗程均可获得好的疗效,综合根除率、不良反应发生率和临床症状缓解率,10d疗程最佳。
Objective: To evaluate the efficacy and safety of berberine with triple therapy in different time of treatment for Helicobacter pylori infection. Methods: 265 patients with Helicobacter pylori were randomly divided into experimental group( berberine with triple therapy) and control group( triple therapy). Each group was divided into tree subgroups( 7 days subgroup,10 days subgroup and 14 days subgroup) according to different time of treatment. All groups before treatment and at least four weeks after treatment of Helicobacter pylori infection were detected. Effectiveness of all groups were evaluated. Results: After Helicobacter pylori eradication treatment,the total eradication rate of the experimental group was 89. 4 %,the total eradication rate of the control group was 78. 5%. The total eradication rate of the experimental group was significantly higher than the control group( P < 0. 05),the rate also increased with the increase in treatment. The eradication rates of 10 days and 14 days subgroup eradication group were significantly higher than 7 days group( P < 0. 05),but there was no significant difference between 10 days subgroup and 14 days subgroup( P > 0. 05). There was no significant difference in the incidence of adverse reaction between experimental group and control group( P > 0. 05),but the longer time of treatment the incidence increased the incidence of adverse reaction. There was no statistical significance in the remission rate of clinical symptom between experimental group and control group( P > 0. 05). The remission rate of clinical symptom in each group increased with the increase of the time of treatment. The clinical remission rates of the experimental group were higher than corresponding to the subgroup of the control group. The clinical remission rates of the experimental group were significantly higher than the control group in 7 days subgroup( P < 0. 05). The rates of 10 days subgroup and 14 days subgroup of the experimental group were higher than the control group,but there was no statis