Furrer H
Medizinische Universitätspoliklinik, Inselspital Bern.
Schweiz Med Wochenschr. 1998 Jul 7;128(27-28):1079-88.
Surrogate endpoints are used extensively in clinical studies to evaluate the efficacy of therapy. The effect of a treatment on surrogate endpoints should predict efficacy with regard to clinical endpoints such as morbidity and death. Benefits and risks in the use of surrogate endpoints in clinical trials and daily practice are discussed using the example of HIV infection. CD4-lymphocyte counts and plasma HIV-RNA are powerful markers of disease progression in HIV infection. They are also increasingly used as surrogate endpoints to evaluate the efficacy of antiretroviral treatments. Surrogate endpoints should be biologically plausible and must be validated statistically. However, clinical endpoints are still of paramount importance in assessing the value of treatments for chronic diseases.
替代终点在临床研究中被广泛用于评估治疗效果。治疗对替代终点的影响应能预测其对诸如发病率和死亡率等临床终点的疗效。本文以HIV感染为例，讨论了在临床试验和日常实践中使用替代终点的益处和风险。CD4淋巴细胞计数和血浆HIV-RNA是HIV感染中疾病进展的有力标志物。它们也越来越多地被用作替代终点来评估抗逆转录病毒治疗的疗效。替代终点应在生物学上合理，并且必须经过统计学验证。然而，临床终点在评估慢性病治疗价值方面仍然至关重要。
