出 处:《中国全科医学》2017年第18期2237-2240,共4页Chinese General Practice
摘 要:目的明确含米诺环素的四联方案在幽门螺杆菌(H.pylori)感染复治患者中应用的安全性、患者依从性、根除治疗成功率及其影响因素,以期为临床H.pylori感染复治患者的根除治疗提供新的选择。方法选择2013年8月—2015年8月于北京积水潭医院就诊的H.pylori感染复治患者180例为研究对象。采用含米诺环素的四联方案,具体为雷贝拉唑(10 mg/次,2次/d)+阿莫西林(1.0 g/次,2次/d)+米诺环素(0.1 g/次,2次/d)+枸橼酸铋钾(220 mg/次,2次/d);疗程14 d。治疗结束后3~7 d观察患者不良反应情况、依从性;治疗结束后4~12周通过意向性治疗(ITT)分析及遵循方案(PP)分析评估根除治疗成功率。结果 ITT分析纳入180例患者;6例患者因失联、未按时复查,4例患者因依从性差予以剔除,PP分析纳入170例患者。共有56例(31.1%)患者出现不良反应,其中腹泻者31例(55.4%),头晕失眠者28例(50.0%),上腹不适、恶心者各23例(41.1%),各不良反应在停药后均完全消失。依从性好者165例(91.7%)。ITT分析根除治疗成功率为79.4%(143/180),PP分析根除治疗成功率为84.1%(143/170)。女性患者PP分析根除治疗成功率高于男性(P<0.05);不同年龄、吸烟情况、既往根除治疗次数、既往根除治疗方案患者PP分析根除治疗成功率比较,差异无统计学意义(P>0.05)。多元Logistic回归分析结果显示,性别、年龄、吸烟情况、既往根除治疗次数、既往根除治疗方案均不是PP分析根除治疗成功率影响因素(P>0.05)。结论含米诺环素的四联方案在H.pylori感染患者复治中有较好的根除治疗成功率,安全性及依从性尚可,是H.pylori感染患者复治的新选择。Objective To observe the safety,compliance,success rate of Helicobacter pylori(H.pylori) eradication and associated factors of minocycline-based quadruple therapy in the retreatment of H.pylori infection,so as to provide a new regimen for the retreatment of H.pylori infection.Methods One hundred and eighty patients retreated for H.pylori infection in Beijing Jishuitan Hospital from August 2013 to August 2015 were selected as the subjects.Patients were assigned to a 14-day treatment with minocycline-based quadruple therapy comprising of rabeprazole(twice a day,10 mg each time),amoxicillin(twice a day,1.0 g each time),minocycline(twice a day,0.1 g each time),colloidal bismuth subcitrate(twice a day,220 mg each time).The adverse reactions and compliance were observed 3-7 days after treatment and eradication rate of H.pylori was evaluated by intention to treat(ITT) analysis and per-protocol(PP) analysis 4-12 weeks after treatment.Results ITT analysis included 180 patients.PP analysis enrolled in 170 patients,the other 10 were excluded due to loss to follow-up and untimely reviewing(6 cases),and poor compliance(4 cases).There were 31.1% patients(56/180) with adverse reactions.Among them,55.4%(31/56) had diarrhea,50.0%(28/56) had dizziness and insomnia,41.1%(23/56) with epigastric discomfort and 41.1%(23/56) with nausea.All of the adverse reactions completely disappeared after treatment.One hundred and sixty-five(91.7% of 180) cases had good compliance.The success rate of H.pylori eradication by the treatment was 79.4%(143/180) showed by ITT analysis,and 84.1%(143/170) revealed by PP analysis.Female patients had higher eradication rate of H.pylori by the treatment than male patients demonstrated by PP analysis(P〈0.05).PP analysis found that,age,history of smoking,number and regimens of previous eradication treatment of H.pylori did not cause the differences in the success rate of H.pylori eradication between the subjects(P〉0.05).PP analysis
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