钾离子竞争性酸阻滞剂治疗酸相关疾病有效性和安全性的Meta分析

Therapeutic efficacy and safety of potassium-competitive acid blockers for acid-related diseases:a Metaanalysis

目的:系统评价钾离子阻滞剂治疗酸相关疾病的有效性和安全性,为临床用药提供循证参考。方法:计算机搜索PubMed、Scopus、Embase、Cochrane Library、中国知网、中国生物医学文献数据库、维普和万方数据等,检索时限均为建库至2023年7月。收集数据库中发表的钾离子阻滞剂治疗酸相关疾病的临床随机对照试验文献,筛选文献,提取数据后,用Cochrane系统评价员手册5.1. 0推荐的偏倚风险评估工具对纳入文献质量进行评价,依据纳入、排除标准筛选文献、整理资料,采用RevMan 5.4进行Meta分析。结果:最终共纳入43篇文献,共10 840例患者。在幽门螺旋杆菌感染治疗分析中,意向治疗(ITT)分析和符合方案(PP)分析,试验组患者的总体根除率均较对照组显著升高,分别为87.41%vs. 79.86%[OR=1.80,95%CI(1.36,2.37),P<0.000 01]和89.95%vs. 83.54%[OR=1.87,95%CI(1.45,2.41),P<0.000 01]。在胃食管反流治疗分析中,试验组患者的临床有效率较对照组高,分别为66.27%vs. 58.38%[OR=1.84,95%CI(1.14,2.97),P=0.01]。在糜烂性食管炎治疗分析中,试验组患者的糜烂性食管炎愈合率明显高于对照组,分别为94.73%vs. 89.69%[OR=2.13,95%CI(1.59,2.86),P<0.000 01]。在溃疡治愈方面,试验组与对照组治疗效果相当。试验组患者的总体不良事件发生率较对照组显著降低,分别为28.9%vs. 32.05%[OR=0.85,95%CI(0.77,0.94),P=0.000 9]。结论:与质子泵抑制剂相比,钾离子阻滞剂治疗酸相关疾病的有效性和安全性较好。

OBJECTIVE To systematically evaluate the efficacy and safety of potassium-competitive acid blockers for acidrelated diseases and provide evidence-based references for clinical dosing. METHODS Computer searches of PubMed, Scopus, Embase, Cochrane library, China National Knowledge Infrastructure(CNKI), China Biomedical Literature Database, VIP and Wanfang were conducted from database inceptions until July 2023. The literature of clinical randomized controlled trials of potassium-competitive acid blockers for treating acid-related diseases was collected. After extracting the relevant data, quality of the included literature was evaluated by the risk-of-bias assessment tool recommended by the Cochrane Systematic Evaluator's Handbook 5. 1. 0. The data were organized according to the inclusion and exclusion criteria. And RevMan 5. 4 was utilized for Meta-analysis. RESULTS A total of 43 papers with a total of 10840 patients were recruited. During Helicobacter pylori infection treatment, intention-to-treat(ITT) analysis and protocol compliant(PP), trial group had significantly higher overall eradication rates than control group(87. 41% vs. 79. 86%)[OR=1. 80, 95%CI(1. 36, 2. 37), P<0. 000 01] and(89. 95% vs.83. 54%)[OR=1. 87, 95%CI(1. 45, 2. 41), P<0. 000 01]. Regarding gastroesophageal reflux treatment, clinical efficiency was higher in trial group than that in control group(66. 27% vs. 58. 38%)[OR=1. 84, 95%CI(1. 14, 2. 97), P=0. 01]. As for erosive esophagitis treatment, healing rate of erosive esophagitis was significantly higher in trial group than that in control group(94. 73% vs. 89. 69%)[OR=2. 13, 95%CI(1. 59, 2. 86), P<0. 000 01]. In terms of ulcer healing, trial group was comparable to control group. The overall incidence of adverse events was significantly lower in trial group than that in control group(28. 9%vs. 32. 05%)[OR=0. 85, 95%CI(0. 77, 0. 94), P=0. 000 9]. CONCLUSION The efficacy and safety of potassiumcompetitive acid blockers for acid-related disorders are superior to those of proton pump inhibitors.