含PPI标准三联疗法联合替普瑞酮根除幽门螺杆菌疗效研究

Efficacy of PPI-based Standard Triple Therapy Combined with Teprenone for Treatment of Helicobacter pylori Infection

背景:近年来标准三联疗法的幽门螺杆菌(Hp)根除率逐渐下降,含铋剂四联疗法成为根除Hp的一线治疗方案,然而铋剂的应用具有一定局限性。目的:探讨含质子泵抑制剂(PPI)标准三联疗法联合替普瑞酮根除Hp的疗效。方法:纳入2013年1月—2014年12月于航天中心医院诊断为慢性胃炎伴Hp感染的患者155例。将患者随机分为标准三联组、含铋剂四联组和含替普瑞酮四联组。标准三联组给予雷贝拉唑钠20 mg+阿莫西林克拉维酸钾914 mg+克拉霉素500 mg,bid;含铋剂四联组在标准三联组治疗方案的基础上加用枸橼酸铋钾0.6 g bid;含替普瑞酮四联组在标准三联组治疗方案的基础上加用替普瑞酮50 mg bid。疗程均为10 d。分别于治疗前后评估患者临床症状,并于治疗结束4周后复查^(13)C-尿素呼气试验(UBT)评估Hp根除情况。结果:152例患者按方案完成治疗。标准三联组、含铋剂四联组、含替普瑞酮四联组的ITT根除率分别为69.8%(37/53)、86.5%(45/52)和88.0%(44/50),PP根除率分别为71.2%(37/52)、88.2%(45/51)和89.8%(44/49),含铋剂四联组和含替普瑞酮四联组的ITT和PP根除率均显著高于标准三联组(P<0.05),此两组间差异则无统计学意义(P>0.05)。含铋剂四联组、含替普瑞酮四联组腹痛、腹胀、嗳气缓解率均高于标准三联组,但仅腹痛缓解率在含替普瑞酮四联组与标准三联组间差异有统计学意义(88.9%对70.3%,P<0.05)。不良反应有一过性轻微恶心、腹泻、粪便变黑等。结论:含替普瑞酮四联疗法可有效根除Hp并显著改善患者临床症状,与含铋剂四联疗法疗效相当,且无明显不良反应发生。

Background:The efficacy of standard triple therapy for eradication of Helicobacter pylori（ Hp） is decreasing in recent years,and bismuth-containing quadruple regimen becomes the first-line therapy for Hp infection.However,the application of bismuth has some limitations.Aims:To investigate the efficacy of proton pump inhibitor（ PPI）-based standard triple therapy combined with teprenone for Hp eradication.Methods:A total of 155 Hp-infected chronic gastritis patients were enrolled from Jan.2013 to Dec.2014 at Aerospace Center Hospital,and were randomly assigned into standard triple therapy group,bismuth-containing quadruple therapy group and teprenone-containing quadruple therapy group.Patients in standard triple therapy group were given rabeprazole sodium 20 mg +amoxicillin and clavulanate potassium 914 mg +clarithromycin 500 mg bid for 10 days.Patients in bismuth-containing quadruple therapy group were given standard triple therapy combined with bismuth potassium citrate 0.6 g bid for 10 days.Patients in teprenone-containing quadruple therapy group were given standard triple therapy combined with teprenone 50 mg bid for 10 days.Symptoms of patients were evaluated before and after eradication therapy.Four weeks after the end of therapy,13C-urea breath test（ UBT） was reexamined to assess the status of Hp infection.Results:One hundred and fifty-two patients completed the treatment course.By ITT analysis,the eradication rates of standard triple therapy group,bismuth-containing quadruple therapy group and teprenone-containing quadruple therapy group were 69.8%（ 37 /53）,86.5%（ 45 /52） and 88.0%（ 44 /50）,respectively;by PP analysis,the eradication rates of the three groups were 71.2%（ 37 /52）,88.2%（ 45 /51） and89.8%（ 44 /49）,respectively.Eradication rates analyzed by ITT and PP in bismuth-containing quadruple therapy group and teprenone-containing quadruple therapy group were significantly higher than those in standard triple therapy group（ P <0.05）,but no statistically significant difference was found between these two groups（ P > 0.05）.Relieving rates of abdominal pain,abdominal distention and belching in bismuth-containing quadruple therapy group and teprenone-containing quadruple therapy group were higher than those in standard triple therapy group,but statistically significant difference was only found in relieving of abdominal pain between teprenone-containing quadruple therapy group and standard triple therapy group（ 88.9% vs.70.3%,P < 0.05）.Adverse effects included transient and mild nausea,diarrhea and black stool,etc.Conclusions:Teprenone-containing quadruple regimen are effective for Hp eradication and symptoms relieving with no severe adverse effects,the efficacy is comparable with bismuth-containing quadruple regimen.