中华消化杂志
中華消化雜誌
중화소화잡지
Chinese Journal of Digestion
2012年
10期
662-664
,共3页
梁洁%吴开春%杨云生%李闻%张澍田%吴咏冬%袁耀宗%李兆申%杜奕奇%陈旻湖%陈白莉%姜泊%闻勤生%樊代明
樑潔%吳開春%楊雲生%李聞%張澍田%吳詠鼕%袁耀宗%李兆申%杜奕奇%陳旻湖%陳白莉%薑泊%聞勤生%樊代明
량길%오개춘%양운생%리문%장주전%오영동%원요종%리조신%두혁기%진민호%진백리%강박%문근생%번대명
依卡倍特%药物疗法,联合%螺杆菌,幽门%螺杆菌感染%胃炎
依卡倍特%藥物療法,聯閤%螺桿菌,幽門%螺桿菌感染%胃炎
의잡배특%약물요법,연합%라간균,유문%라간균감염%위염
Ecabet%Drug therapy%combination%Helicobacter pylori%Helicobacter infections%Gastritis
目的 评估和比较含依卡倍特钠的四联疗法与含铋剂的四联疗法根除Hp的疗效和安全性.方法 采用多中心、随机盲法、阳性药物平行对照试验设计.研究对象为2009年6月至2011年6月在西安、北京、上海、广州4个城市8家医院就诊的慢性胃炎患者,分为试验组和对照组.试验组每日2次,每次口服奥美拉唑镁20 mg、克拉霉素500 mg、阿莫西林1000 mg、依卡倍特钠1.0g,疗程10 d.对照组每日2次,每次口服奥美拉唑镁20 mg、克拉霉素500 mg、阿莫西林1000 mg、枸橼酸铋钾220 mg,疗程10 d.在治疗第38天时以13C或14C尿素呼气试验结果判断Hp根除情况并计算根除率.记录和分析出现的不良反应.统计学处理采用x2检验和Fisher精确概率法.结果 共人组311例患者,试验组155例,对照组156例.按方案分析显示,试验组和对照组Hp根除率分别为75.71％(106/140)和77.37％(106/137),差异无统计学意义(x2=0.106,P=0.745).按意图治疗分析显示,试验组和对照组Hp根除率分别为68.39％(106/155)和67.95％(106/156),差异无统计学意义(x2=0.007,P=0.934).试验组和对照组的不良反应发生率分别为20.00％(31/155)和25.64％(40/156),差异无统计学意义(Fisher精确概率法,P=0.280).两组均未见严重不良反应.结论 含依卡倍特钠的四联疗法根除慢性胃炎患者Hp的疗效和安全性与含铋剂的四联疗法相同.
目的 評估和比較含依卡倍特鈉的四聯療法與含鉍劑的四聯療法根除Hp的療效和安全性.方法 採用多中心、隨機盲法、暘性藥物平行對照試驗設計.研究對象為2009年6月至2011年6月在西安、北京、上海、廣州4箇城市8傢醫院就診的慢性胃炎患者,分為試驗組和對照組.試驗組每日2次,每次口服奧美拉唑鎂20 mg、剋拉黴素500 mg、阿莫西林1000 mg、依卡倍特鈉1.0g,療程10 d.對照組每日2次,每次口服奧美拉唑鎂20 mg、剋拉黴素500 mg、阿莫西林1000 mg、枸櫞痠鉍鉀220 mg,療程10 d.在治療第38天時以13C或14C尿素呼氣試驗結果判斷Hp根除情況併計算根除率.記錄和分析齣現的不良反應.統計學處理採用x2檢驗和Fisher精確概率法.結果 共人組311例患者,試驗組155例,對照組156例.按方案分析顯示,試驗組和對照組Hp根除率分彆為75.71％(106/140)和77.37％(106/137),差異無統計學意義(x2=0.106,P=0.745).按意圖治療分析顯示,試驗組和對照組Hp根除率分彆為68.39％(106/155)和67.95％(106/156),差異無統計學意義(x2=0.007,P=0.934).試驗組和對照組的不良反應髮生率分彆為20.00％(31/155)和25.64％(40/156),差異無統計學意義(Fisher精確概率法,P=0.280).兩組均未見嚴重不良反應.結論 含依卡倍特鈉的四聯療法根除慢性胃炎患者Hp的療效和安全性與含鉍劑的四聯療法相同.
목적 평고화비교함의잡배특납적사련요법여함필제적사련요법근제Hp적료효화안전성.방법 채용다중심、수궤맹법、양성약물평행대조시험설계.연구대상위2009년6월지2011년6월재서안、북경、상해、엄주4개성시8가의원취진적만성위염환자,분위시험조화대조조.시험조매일2차,매차구복오미랍서미20 mg、극랍매소500 mg、아막서림1000 mg、의잡배특납1.0g,료정10 d.대조조매일2차,매차구복오미랍서미20 mg、극랍매소500 mg、아막서림1000 mg、구연산필갑220 mg,료정10 d.재치료제38천시이13C혹14C뇨소호기시험결과판단Hp근제정황병계산근제솔.기록화분석출현적불량반응.통계학처리채용x2검험화Fisher정학개솔법.결과 공인조311례환자,시험조155례,대조조156례.안방안분석현시,시험조화대조조Hp근제솔분별위75.71％(106/140)화77.37％(106/137),차이무통계학의의(x2=0.106,P=0.745).안의도치료분석현시,시험조화대조조Hp근제솔분별위68.39％(106/155)화67.95％(106/156),차이무통계학의의(x2=0.007,P=0.934).시험조화대조조적불량반응발생솔분별위20.00％(31/155)화25.64％(40/156),차이무통계학의의(Fisher정학개솔법,P=0.280).량조균미견엄중불량반응.결론 함의잡배특납적사련요법근제만성위염환자Hp적료효화안전성여함필제적사련요법상동.
Objective To assess and compare the efficacy and safety of ecabet sodium-based quadruple therapy versus bismuth-based quadruple therapy for Helicobacter pylori (Hp) eradication.Methods A multicenter,randomized,positive controlled clinical trial was carried out.The object of the study were chronic gastritis patients at 8 hospitals in Xi'an,Beijing,Shanghai and Guangzhou from June 2009 to June 2011.All patients were divided into treatment group and control group.In treatment group,patients received ecabet sodium-based quadruple therapy (two times per day,omeprazole magnesium 20 mg,amoxicillin 1000 mg,clarithromycin 500 mg and ecabet sodium 1.0 g each time for 10 days.In control group,patients were assigned to receive bismuth-based quadruple therapy (two times per day; omeprazole magnesium 20 mg,amoxicillin 1000 mg,clarithromycin 500 mg and bismuth potassium citrate 220 mg each time) for 10 days.The Hp eradication was determined by 13C or 14C urea breath test at the 38th day after the treatment and the eradication rate was calculated.Side effects were recorded and analyzed.The data were analyzed by chi square test and Fisher's exact test.Results A total of 311 patients were recruited,and 155 patients were allatted in treatment group and 156 in control group.The per-protocol (PP) analysis indicated that the eradication rates of treatment group arid control group were 75.71％(106/140) and 77.37％(106/137) respectively,and there was no significant difference x2 =0.106,P=0.745).The intention-to-treat (ITT) analysis indicated that the eradication rates of treatment group and control group were 68.39％ (106/155) and 67.95％ (106/156) respectively,and there was no significant difference x2 =0.007,P=0.934).The side effects rates of treatment group and control group were 20.00％ (31/155) and 25.64％(40/156) respectively,and the difference was not statistically significant (Fisher's exact test,P=0.280).No serious side effect was observed in two groups.Conclusion The efficacy and safety of ecabet sodium-based quadruple therapy for Hp eradication in chronic gastritis patients may be the same as bismuth-based quadruple therapy.
