替普瑞酮对幽门螺杆菌相关性胃病的有效性和安全性的Meta分析

Efficacy and Safety of Tepredone in the Treatment of Helicobacter pylori Associated Gastric Disease: A Meta-Analysis

摘要: 目的：探究替普瑞酮辅助治疗幽门螺杆菌相关性胃炎(Hp associated chronic gastritis, HpAG)或消化性溃疡(peptic ulcer, PU)的有效性和安全性。方法：计算机检索PubMed、Embase、the Cochrane library、中国知网(CNKI)、中国生物医学文献服务系统(CBM)和万方数据库中替普瑞酮与铋剂四联方案治疗HpAG或PU的随机对照试验(RCT)，检索时限自建库至2022年8月。按照纳入及排除标准筛选文献，应用RevMan 5.4软件进行Meta分析。结果：共纳入20项研究，2109例患者。Meta分析结果显示，替普瑞酮四联方案在Hp根除率(RR = 1.17, 95% CI 1.09~1.25, P < 0.00001)、临床总有效率(RR = 1.17, 95% CI 1.09~1.25, P < 0.00001)和溃疡愈合(RR = 1.21, 95% CI 1.11~1.32, P < 0.0001)方面较铋剂四联均更佳，且不良反应发生率更低(RR = 0.32, 95% CI 0.14~0.73, P = 0.007)。铋剂四联加用替普瑞酮对于Hp根除率(RR = 1.17, 95% CI 1.05~1.31, P = 0.0005)、临床总有效率(RR = 1.17, 95% CI 1.05~1.31, P = 0.0005)、症状改善率(RR = 1.20, 95% CI 1.13~1.28, P < 0.00001)和溃疡愈合率(RR = 1.21, 95% CI 1.16~1.27, P < 0.0001)方面均有提升；两组在不良反应发生率方面无统计学差异(RR = 0.85, 95% CI 0.39~1.84, P = 0.67)。结论：与铋剂四联方案相比，加用替普瑞酮或是以替普瑞酮替换铋剂，在Hp根除率、临床总有效率和促进溃疡愈合方面效果均更优，且替普瑞酮四联方案组的不良反应更低。

Abstract: Objective: To investigate the efficacy and safety of teprenone in the adjuvant treatment of Hp-as- so-ciated chronic gastritis or peptic ulcer. Methods: Databases of PubMed, Embase, the Cochrane li-brary, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Service (Si-noMed) and Wanfang were searched for randomized controlled trials (RCTs) of teprenone in com-bination with triple or quadruple regimens for the treatment of HpAG or PU from inception to Au-gust 2022. The literature was screened in conformity with inclusion and exclusion criteria, and Me-ta-analysis was performed using RevMan 5.4 software. Results: A total of 20 RCTs with 2109 pa-tients were included. The meta-analysis showed that the Hp eradication rate (RR = 1.17, 95% CI 1.09~1.25, P < 0.00001), the total clinical effectiveness rate (RR = 1.17, 95% CI 1.09~1.25, P < 0.00001) and the healing rate of PU (RR = 1.21, 95% CI 1.11~1.32, P < 0.0001) of teprenone quad-ruple regimen were superior to the bismuth quadruple regimen; furthermore, teprenone quadru-ple regimen showed a lower incidence of adverse reactions than bismuth quadruple regimen (RR = 0.32, 95% CI 0.14~0.73, P = 0.007). Compared with bismuth quadruple regimen, the supplement of teprenone increased the Hp eradication rate (RR = 1.17, 95% CI 1.05~1.31, P = 0.0005), the total clinical efficiency (RR = 1.17, 95% CI 1.05~1.31, P = 0.0005), the improvement rate of GI symptoms (RR = 1.20, 95% CI 1.13~1.28, P < 0.00001) and the healing rate of PU (RR = 1.21, 95% CI 1.16~1.27, P < 0.0001); however, there was no statistical difference in the incidence of adverse effects between the two groups (RR = 0.85, 95% CI 0.39~1.84, P = 0.67). Conclusion: Compared to the bismuth quadruple regimen, the addition of teprenone or the replacement of bismuth with teprenone was superior in terms of Hp eradication, overall clinical effectiveness and promotion of ulcer healing, and adverse effects were lower in the teprenone quadruple regimen group.