Teng M, Khoo A L, Zhao Y J, Lin L, Lim B P, Wu T S, Dan Y Y
Pharmacy and Therapeutics Office, Group Corporate Development, National Healthcare Group, Singapore.
Department of Pharmacy, National University Hospital, Singapore.
J Clin Pharm Ther. 2015 Aug;40(4):368-75. doi: 10.1111/jcpt.12277. Epub 2015 Apr 20.
Proton pump inhibitors (PPIs) are one of the most widely used classes of drugs. However, the quantum clinical benefit of newer and more expensive PPIs over the older generation PPIs remains uncertain. This meta-analysis sought to assess the clinical and safety profiles of esomeprazole versus omeprazole at pharmacologically equivalent doses in healing gastroesophageal reflux disease (GERD), peptic ulcer disease and eradicating Helicobacter pylori (H. pylori) infection.
PubMed and the Cochrane Library were searched for randomized controlled trials comparing esomeprazole with omeprazole at all doses up to February 2015. Trials were assessed by two reviewers for eligibility according to predefined study inclusion criteria. Meta-analysis was conducted using a random effects model, and heterogeneity in the estimated effects was investigated using meta-regression. Sensitivity analysis was performed to test the robustness of the findings.
Fifteen trials were included and none of which compared esomeprazole with omeprazole in peptic ulcer disease. The included studies had not evaluated esomeprazole 20 mg versus omeprazole 40 mg. In GERD, esomeprazole 40 mg (relative risk (RR) = 1·07; 95% confidence interval (CI) 1·02 to 1·12) and 20 mg (RR=1·04; 95% CI 1·01 to 1·08) significantly improved esophagitis healing when compared with omeprazole 20 mg at week 8. The corresponding numbers needed to treat were 17 and 30, respectively. No significant difference was observed between esomeprazole 20 mg and omeprazole 20 mg at week 4. In H. pylori eradication, there was no difference in the treatment effects between esomeprazole 20 mg and omeprazole 20 mg (RR = 1·01;95% CI 0·96 to 1·05). Their safety profiles were comparable.
Esomeprazole demonstrated better esophagitis healing rate in patients with GERD than omeprazole at week 8. However, this clinical advantage diminished when both drugs were given at the same doses at week 4. Superiority of esomeprazole was not observed in the H. pylori eradication rates.
质子泵抑制剂（PPIs）是使用最为广泛的一类药物。然而，新一代且价格更高的PPIs相较于老一代PPIs在临床上的显著优势仍不明确。本荟萃分析旨在评估在治疗胃食管反流病（GERD）、消化性溃疡病以及根除幽门螺杆菌（H. pylori）感染方面，埃索美拉唑与奥美拉唑在药理学等效剂量下的临床和安全性特征。
检索PubMed和Cochrane图书馆，查找截至2015年2月所有剂量下比较埃索美拉唑与奥美拉唑的随机对照试验。两名评价者根据预先设定的研究纳入标准评估试验的合格性。采用随机效应模型进行荟萃分析，并使用荟萃回归研究估计效应中的异质性。进行敏感性分析以检验研究结果的稳健性。
纳入了15项试验，其中没有一项在消化性溃疡病中将埃索美拉唑与奥美拉唑进行比较。纳入的研究未评估埃索美拉唑20mg与奥美拉唑40mg的情况。在GERD中，与第8周时的奥美拉唑20mg相比，埃索美拉唑40mg（相对危险度（RR）=1.07；95%置信区间（CI）1.02至1.12）和20mg（RR = 1.04；95%CI 1.01至1.08）能显著提高食管炎愈合率。相应的治疗所需人数分别为17和30。在第4周时，埃索美拉唑20mg与奥美拉唑20mg之间未观察到显著差异。在根除幽门螺杆菌方面，埃索美拉唑20mg与奥美拉唑20mg的治疗效果没有差异（RR = 1.01；95%CI 0.96至1.05）。它们的安全性特征相当。
在第8周时相比于奥美拉唑，埃索美拉唑在GERD患者中显示出更好的食管炎愈合率。然而，当两种药物在第4周给予相同剂量时，这种临床优势减弱。在根除幽门螺杆菌率方面未观察到埃索美拉唑的优越性。
