摘要
目的 探究伏诺拉生联合高剂量阿莫西林二联方案在幽门螺杆菌(Hp)初次根除治疗中的临床疗效.方法 选取Hp感染且既往未行Hp根除治疗的 200 例患者作为研究对象,利用随机数表法将其分为观察组和对照组各 100 例,观察组给予伏诺拉生联合高剂量阿莫西林二联方案(伏诺拉生 20 mg,2 次/天+阿莫西林 1 g,3 次/天),持续治疗 14 d;对照组给予铋剂四联方案(艾司奥美拉唑 20 mg,2 次/天+枸橼酸铋钾 220 mg,2 次/天+阿莫西林 1.0 g,2 次/天+克拉霉素 0.5 g,2 次/天),持续治疗 14 d,对比 2 组患者的Hp根除率及服药后的不良反应发生率.结果 研究对象中有 8 例患者出现失访,3 例患者服药依从性差,未能按疗程服用药物,最终完成研究 189 例(观察组 96 例,对照组 93 例).按意向性分析(ITT)和符合方案集分析(PP),观察组的Hp根除率高于对照组(分别为91.0%vs.79.0%,PITT = 0.017;94.8%vs.84.9%,PPP= 0.024),差异有统计学意义.观察组与对照组不良反应发生率分别为 4%和 5%,差异无统计学意义(χ 2<0.001,P>0.999).结论 伏诺拉生联合高剂量阿莫西林二联方案是根除Hp有效的治疗方案,且安全性较好,可在基层医院推广.
Abstract
Objective To evaluate clinical efficacy of the combination of Vonoprazan and high-dose Amoxicillin in the initial eradication treatment of Helicobacter pylori(Hp).Methods Select 200 patients with Hp infection who have not undergone Hp eradication treatment in the past as the research subjects.All patients were randomly divided into the observation group(n = 100)and control group(n = 100)using random number table method.In the observation group,a combination regimen of Vonoprazan(20 mg twice a day)and Amoxicillin(1 g three times a day)was given for 14 days.In the control group,a bismuth quadruple therapy was delivered for 14 days,which included Esomeprazole(20 mg twice a day),Bismuth Potassium Citrate(220 mg twice a day),Amoxicillin(1 g twice a day)and Clarithromycin(0.5 g twice a day).The Hp eradication rate and incidence of adverse reactions after medication were compared between two groups.Results Of 200 patients,11 patients were excluded from subsequent analysis,including 8 cases lost to follow-up and 3 cases with poor compliance of medication.The remaining 189 patients(96 in the observation group and 93 in the control group)completed the entire procedure.According to intention-to-treat(ITT)and per-protocol(PP)set analyses,the Hp eradication rate in the observation group was significantly higher than that in the control group(91.0%vs.79.0%,PITT = 0.017;94.8%vs.84.9%,PPP= 0.024).The incidence of adverse reactions did not significantly differ between two groups(4%vs.5%,χ 2<0.001,P>0.999).Conclusion The combination therapy of Vonoprazan and high-dose Amoxicillin is an efficacious and safe therapeutic option for patients with initial Hp infection,which is worthy of promotion in grassroot-level hospitals.
基金项目
东莞市社会科技发展一般项目(201750715015268)
维普
万方数据