Williams M P, Pounder R E
Royal Free Hospital School of Medicine, London, England.
Drugs. 1998 Jul;56(1):1-10. doi: 10.2165/00003495-199856010-00001.
The end-point of Helicobacter pylori eradication trials in peptic ulcer disease should be the presence or absence of continuing H. pylori infection, and not ulcer healing or recurrence. This is not to suggest that ulcer healing or prevention of recurrence is not the desired clinical end-point. It is to allow large trials to be conducted in a 'patient-friendly' manner and in a shorter time-scale, both of which reduce patient withdrawals, protocol violations and cost. For the same reasons, diagnosis of cure should be made by noninvasive means whenever possible. It is currently impossible to make anything other than generalisations regarding the relative efficacies of modern eradication regiments. As it seems unlikely that definitive head-to-head studies will be performed, the conduct and reporting of current trials needs to be improved and standardised, to allow meaningful comparisons. In particular, the course of each and every patient through the trial should be fully and clearly reported, especially withdrawals and dropouts. The primary efficacy analysis should be the intention-to-treat analysis, with per protocol and modified intention-to-treat analyses also reported, where appropriate.
消化性溃疡疾病中幽门螺杆菌根除试验的终点应该是幽门螺杆菌持续感染的存在与否，而非溃疡愈合或复发。这并非意味着溃疡愈合或预防复发不是期望的临床终点。这样做是为了能够以“患者友好”的方式并在更短的时间内开展大型试验，这两者都能减少患者退出、违反方案的情况以及成本。出于同样的原因，只要有可能，应通过非侵入性手段进行治愈诊断。目前，对于现代根除方案的相对疗效，除了进行概括之外，无法得出其他结论。由于似乎不太可能进行明确的直接比较研究，因此当前试验的实施和报告需要改进并标准化，以便进行有意义的比较。特别是，应全面、清晰地报告每位患者在试验中的过程，尤其是退出和失访情况。主要疗效分析应为意向性分析，同时在适当情况下也应报告符合方案分析和改良意向性分析。
