幽门螺杆菌感染的二线根除方案比较

COMPARISON OF SECOND-LINE THERAPY FOR HELICOBACTER PYLORI INFECTION

目的比较8日含铋剂序贯方案、10日含铋剂序贯方案、10日序贯方案、10日铋剂四联方案,补救(二线)根除幽门螺杆菌(HP)的疗效及不良反应。方法 340例初次(一线)根除失败的HP感染患者分为四组。A组:前4日,雷贝拉唑10mg、阿莫西林1 000mg、果胶铋300mg;后4日,雷贝拉唑10mg、克拉霉素500mg、奥硝唑500mg、果胶铋300mg。B组:前5日,雷贝拉唑10mg、阿莫西林1 000mg、果胶铋300mg;后5日,雷贝拉唑10mg、克拉霉素500mg、奥硝唑500mg、果胶铋300mg。C组:前5日,雷贝拉唑10mg、阿莫西林1 000mg;后5日,雷贝拉唑10mg、克拉霉素500mg、奥硝唑500mg。D组:雷贝拉唑10mg、果胶铋300mg、阿莫西林1 000mg、呋喃唑酮100mg,疗程10d。各种药物每日服用2次。比较各组HP根除率和不良反应。结果采用按意向性治疗(ITT)分析和按符合方案(PP)分析,对HP根除率进行比较。A、B、C、D四组的根除率ITT分析分别为:89.4%、90.6%、76.5%、77.6%,PP分析分别为:92.7%、93.9%、78.3%、81.5%。2种分析方法均显示A组和B组的HP根除率明显高于C组和D组,差异有统计学意义(P<0.05),而A组和B组之间根除率差异无统计学意义(P>0.05)。四组的不良反应发生率分别为:6.1%、7.3%、6.0%、18.5%,A组、B组、C组低于D组,差异有统计学意义(P<0.05)。结论8日含铋剂序贯方案可作为一线根除HP失败后安全有效的短疗程二线根除方案。

Objective To compare the efficacy and side effect of 8-day bismuth-containing sequential therapy,10-day bismuth-containing sequential therapy,10-day sequential therapy and 10-day quadruple therapy as second-line regimens for eradication of Helicobacter pylori infection.Methods Three hundred and forty patients of initial treatment failure were divided into four groups randomly：group A,rabeprazole 10 mg,amoxicillin1 000 mg and colloidal bismuth pectin300 mg,at the first four days,followed rabeprazole 10 mg,clarithromycin500mg,ornidazole 500 mg and colloidal bismuth pectin300 mg,at the last four days;group B,rabeprazole 10 mg,amoxicillin 1 000 mg and colloidal bismuth pectin 300 mg,at the first five days,followed rabeprazole 10 mg,clarithromycin 500 mg,ornidazole 500 mg and colloidal bismuth pectin 300 mg,at the last five days;group C,rabeprazole 10 mg and amoxicillin 1 000 mg,at the first four days,followed rabeprazole 10 mg,clarithromycin500mg and ornidazole 500 mg at the last four days;group D,rabeprazole 10 mg,colloidal bismuth pectin 300 mg,amoxicillin 100 mg and furazolidone 1 000 mg,ten days.All drugs were given twice daily.Comparison of Helicobacter pylori eradication rate and adverse reaction were observed.Results The intention-to-treat（ITT）analysis and per protocol（PP）analysis were used to compare the eradication rates of Helicobacter pylori.ITT eradication rate and PP eradication rate of group A,group B,group C,group D were 89.4%,90.6%,76.5%,77.6% and 92.7%,93.9%,78.3%,81.5%,respectively.Two analysis methods showed that Helicobacter pylori eradication rates of group A and group B was significantly higher than group C and group D（P〈0.05）.No significantly difference was found between group A and group B（P〈0.05）.The incidence of adverse reactions in group A,group B and group C were lower than group D（P〈0.05）.Conclusion 8-day bismuth-containing sequential therapy is safe and effective second-line therapy after a failed first-line therapy.