目的 系统评价泮托拉唑钠与奥美拉唑治疗十二指肠溃疡的有效性和安全性。 方法 以“pantoprazole”“omeprazole”“ulcer”“randomized controlled trial”“泮托拉唑钠”“奥美拉唑”“溃疡”“随机对照试验”为检索词,检索Pub Med、Embase、Cochrane Library、中国知网、维普和万方数据库(均为建库至2014年9月),筛选出泮托拉唑钠与奥美拉唑比较治疗十二指肠溃疡的随机对照试验(RCT),根据干预措施的不同分为泮托拉唑钠组和奥美拉唑组,用药方式包括包括口服或静脉,采用Rev Man 5.2软件进行Meta分析,结局指标为溃疡治愈率、腹痛缓解率及缓解时间、不良反应发生率和半年复发率。 结果 共纳入17个RCT,包括患者1 847例,其中泮托拉唑钠组1 008例,奥美拉唑组839例。17个研究中有12个研究是口服给药,5个研究是静脉给药,对2种给药方式分别进行Meta分析。结果显示,口服泮托拉唑钠治疗2、4周患者的溃疡治愈率、治疗1、2、4周患者的腹痛缓解率与口服奥美拉唑相同疗程患者比较差异均无统计学意义,仅治疗3 d患者的腹痛缓解率高于口服奥美拉唑3 d患者[相对危险度(RR)=1.27, 95%置信区间(CI)为1.03~1.57,P=0.03];口服泮托拉唑钠患者腹痛缓解时间、不良反应发生率以及半年复发率与口服奥美拉唑患者比较差异均无统计学意义。静脉应用泮托拉唑钠患者的溃疡治愈率、腹痛缓解率、不良反应发生率、半年复发率与静脉应用奥美拉唑患者比较差异均无统计学意义。 结论 泮托拉唑钠与奥美拉唑都是治疗十二指肠溃疡较为安全、有效的药物。
Objective To systematically evaluate the effectiveness and safety of pantoprazole sodium(PAN) and omeprazole(OME) treatments in patients with duodenal ulcer. Methods "Pantoprazole sodium", "omeprazole", "ulcer", and "randomized controlled trial" were selected as key words and Pub Med, Embase, the Cochrane Library, VIP, CNKI, and Wanfang databases from the inception to September 2014 were searched. Randomized controlled trials(RCT) on comparison of PAN and OME treatments in patients with duodenal ulcer were selected. According to the intervention measures, the subjects were divided into the PAN group and the OME group. The medication comprised oral and intravenous administration. The Meta-analysis was performed using Rev Man 5.2 software.The outcomes included the ulcer healing rate, the pain relief rate and time, the incidence of adverse drug reactions, and the recurrence rate at six months. Results A total of 17 RCTs involving 1 847 patients were entered, including 1 008 in the PAN group and 839 in the OME group. The patients in 12 RCTs received drugs by mouth and the patients in other 5 RCTs received intravenously and the Meta-analysis was performed respectively. The ulcer healing rates in patients with 2 or 4 weeks of oral PAN treatment, the pain relief rates in patients with 1, 2 or 4 weeks of oral PAN treatment were compared with those in patients with oral OME treatment at the same period and the differences were not significant. The pain relief rates in patients with 3 days of oral PAN treatment were higher than those in patients with 3 days of oral OME treatment [relative risk(RR)=1.27, 95% confidence interval(CI): 1.03-1.57, P=0.03]. The differences of the pain relief time, the incidence of adverse drug reactions, and the recurrence rates of six months between the patients with oral PAN treatment and the patients with OME treatment were not significant. The differences of the ulcer healing rates, the pain relief rates, the incidence of adverse drug reactions, and the recurrence rates of six months between the patients with intravenous PAN treatment and the patients with intravenous OME treatment were not significant. Conclusion Both PAN and OME are safe and effective drugs for duodenal ulcer treatment.
张家兴,王忠元,谢娟,等. 泮托拉唑钠与奥美拉唑治疗十二指肠溃疡疗效和安全性的Meta分析 : [J]. 药物不良反应杂志,2015,17(01)：3-10.
DOI:10.3760/cma.j.issn.1008-5734.2015.01.002
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