Ghani Azra C
Department of Infectious Disease Epidemiology, Imperial College, Norfolk Place, London W2 1PG, UK.
Expert Rev Anti Infect Ther. 2003 Dec;1(4):551-62. doi: 10.1586/14787210.1.4.551.
Observational data are increasingly used in various therapeutic areas to evaluate the use, effectiveness and side effects of new treatments. Whilst randomized clinical trials remain the gold standard for evaluating the efficacy of new agents, they have a number of limitations for HIV, including the limited number of combinations that are compared and the costs of long-term follow-up. Observational data from seroconverter and clinical cohorts have been used to compare the short- and longer-term effectiveness of different therapy combinations and to evaluate the longer-term risks associated with antiretroviral therapy. Furthermore, they provide the opportunity to evaluate the relative success of more complex patterns of therapy, such as sequencing of different regimens over time. However, because of the nature of these data, a number of potential biases may arise which can influence interpretation.
观察性数据在各个治疗领域越来越多地用于评估新疗法的使用情况、有效性和副作用。虽然随机临床试验仍然是评估新药疗效的金标准，但它们在评估HIV方面存在一些局限性，包括所比较的组合数量有限以及长期随访的成本。来自血清转化者和临床队列的观察性数据已被用于比较不同治疗组合的短期和长期有效性，并评估与抗逆转录病毒治疗相关的长期风险。此外，它们提供了评估更复杂治疗模式（如不同治疗方案随时间的排序）相对成功性的机会。然而，由于这些数据的性质，可能会出现一些潜在偏差，从而影响对结果的解读。
