复方枸橼酸铋钾胶囊联合奥美拉唑根除幽门螺杆菌临床研究

Efficacy of compound bismuth potassium citrate capsules combined with omeprazole in eradication of Helicobacter pylori infection: a clinical study

目的:评价复方枸橼酸铋钾胶囊联合奥美拉唑根除幽门螺杆菌(Hp)的临床疗效性及安全性。方法:采用多中心、随机、盲法、阳性药物平行对照的临床试验,6个研究中心预计共120对(共240例)患者入组参加本研究,分别为枸橼酸铋钾片/替硝唑片/克拉霉素片联合奥美拉唑对照组和复方枸橼酸铋钾胶囊联合奥美拉唑试验组,每组各120例。采用SAS 6.12软件进行统计分析,采用χ2检验比较两组Hp根除率,采用t检验比较组内症状总分改善率,采用方差分析进行组间同期比较,采用Fisher精确概率法检验比较不良事件发生率。结果:共入选病例236例(对照组117例,试验组119例)。10例患者脱落(对照组2例,试验组8例),6例患者被剔除(对照组6例,试验组0例)。进入FAS、PPS、SS分析分别为236例、220例、236例。FAS和PPS分析结果均显示,对照组Hp根除率明显低于试验组(P<0.05)。两组患者在治疗后5 d、10 d、治疗结束后30 d均显著改善症状,组间同期比较显示两组患者症状改善率无显著差异。研究期间未发生严重不良事件,对照组和试验组不良事件的发生率差别不显著。试验组用药方案相比较对照组,成本效果比更高。结论:与枸橼酸铋钾片/替硝唑片/克拉霉素片联合奥美拉唑治疗Hp方案相比,复方枸橼酸铋钾胶囊联合奥美拉唑肠溶胶囊Hp根除率更高,更经济,并且安全,值得在临床推广使用。

Objective：To investigate the clinical efficacy and safety of compound bismuth potassium citrate capsules（CBPCC） combined with omeprazole capsules in eradication of Helicobacter pylori （H. pylori） infection. Methods： A total of 240 patients with gastric H. pylori infection were enrolled in this double-blinded, randomized controlled study. Patients in group A（control group） were given a combination of bismuth potassium citrate/tinidazole/clarithromycin tablets and ormprazole capsule（n= 120）; those in group B（ treatment group） were given compound bismuth potassium citrate capsules and ormprazole capsules （n = 120）. H. pylori eradication rates and clinical safety of both treatment regimens were analyzed using SAS 6. 12 software system. Results： A total of 236 patients from 6 resreach centers completed in this study,with 117 in group A and 119 in group B. Two patients in the contol group and 8 in the treatment group did not complete the experiment; six patients in the control group were excluded due to other reasons. There were 236 patients entered full analysis sets（FAS）, 220 entered per-protocol set（PPS）, and 236 entered safety analysis sets（SS）. FAS showed that the eradication rates of H. pylori were 84. 87% in group B and 74.36% in group A（P〈0. 05） ; PPS showed the eradication rates were 76. 15% in group A and 90. 09% in group B （P〈0.05）. Intragroup comparison showed that the symptoms of patients in both groups were effectively improved; intergroup comparison showed that the symptom improvement rates were similar between the 2 groups. The rates of adverse events were 14.53% in group A and 14.29% in group B（P〉0.05）, with no severe adverse event found in both groups. The treatment regimen in group B was more cost-effective than that in group A（P〈0.05）. Conclusion：This study demonstrates that compound bismuth potassium citrate capsules combined with orneprazole capsules have a high efficacy in eradication of H. pylori infection,and it is safe,cost-effective and worth popularizing in clinic.