Li Meng, Wang Xiaolei, Meng Wenting, Dai Yun, Wang Weihong
Department of Gastroenterology, Peking University First Hospital, Beijing, China.
Department of Gastroenterology, Peking University First Hospital, No. 8 Xishiku Street, Beijing 100034, China.
Therap Adv Gastroenterol. 2023 Aug 31;16:17562848231196357. doi: 10.1177/17562848231196357. eCollection 2023.
The eradication rate of infection with empirical therapy has decreased due to increased drug resistance. The latest guidelines recommend genotypic resistance-guided therapy, but its clinical efficacy remains unclear.
The purpose of our study was to evaluate whether tailored therapy based on genotypic resistance is superior to empirical therapy for infection.
A systematic review and meta-analysis of randomized controlled trials (RCTs) comparing tailored therapy based on genotypic resistance with empirical therapy was performed.
We retrieved relevant studies from PubMed, Embase, and the Cochrane Library. The primary outcome was eradication rate and the adverse events (AEs) was the secondary outcome. A random-effect model was applied to compare pooled risk ratios (RRs) with related 95% confidence intervals (CIs).
A total of 12 qualified RCTs containing 3940 patients were identified in our systematic review and meta-analysis. The pooled eradication rates of tailored therapy based on the detection of genotypic resistance were consistently higher than those in the empirical treatment group, with no statistical significance. In triple therapy, the eradication rate was significantly higher in the tailored group than in the empirical group by intention-to-treat analysis (ITT) and per-protocol analysis (PP) analysis ( < 0.0001, RR: 1.20; 95% CI: 1.12-1.29; < 0.0001, RR: 1.20; 95% CI: 1.15-1.25). In quadruple therapy, the eradication rate was higher in the empirical group ( = 0.001, RR: 0.93; 95% CI: 0.89-0.97; = 0.009, RR: 0.95; 95% CI: 0.92-0.99). And this result was true for both bismuth quadruple therapy (BQT) and non-BQT. Regarding total AEs, the pooled rate was 34% in the tailored group and 37% in the empirical group, and no difference between the two groups was found ( = 0.17, RR: 0.88; 95% CI: 0.74-1.06).
In conclusion, tailored therapy based on molecular methods may offer better efficacy than empirical triple therapy, but it may not be superior to empirical quadruple therapy in eradicating infection. Larger and more individualized RCTs are needed to aid clinical decision-making.
CRD42023408688.
由于耐药性增加，经验性治疗的感染根除率有所下降。最新指南推荐基于基因型耐药性的指导治疗，但其临床疗效仍不明确。
我们研究的目的是评估基于基因型耐药性的个体化治疗在感染治疗中是否优于经验性治疗。
对比较基于基因型耐药性的个体化治疗与经验性治疗的随机对照试验（RCT）进行系统评价和荟萃分析。
我们从PubMed、Embase和Cochrane图书馆检索了相关研究。主要结局是根除率，不良事件（AEs）是次要结局。应用随机效应模型比较合并风险比（RRs）及相关的95%置信区间（CIs）。
在我们的系统评价和荟萃分析中，共纳入12项合格的RCT，包含3940例患者。基于基因型耐药性检测的个体化治疗的合并根除率始终高于经验性治疗组，但无统计学意义。在三联疗法中，通过意向性分析（ITT）和符合方案分析（PP），个体化治疗组的根除率显著高于经验性治疗组（<0.0001，RR：1.20；95%CI：1.12-1.29；<0.0001，RR：1.20；95%CI：1.15-1.25）。在四联疗法中，经验性治疗组根除率较高（=0.001，RR：0.93；95%CI：0.89-0.97；=0.009，RR：0.95；95%CI：0.92-0.99）。铋剂四联疗法（BQT）和非BQT均如此。关于总不良事件，个体化治疗组的合并发生率为34%，经验性治疗组为37%，两组之间未发现差异（=0.17，RR：0.88；95%CI：0.74-1.06）。
总之，基于分子方法的个体化治疗在疗效上可能优于经验性三联疗法，但在根除感染方面可能并不优于经验性四联疗法。需要更大规模、更个体化的RCT来辅助临床决策。
注册PROSPERO：CRD42023408688。
