Armand J P, Dormont J, Schwebig A
Institut Gustave Roussy, Villejuif, France.
Therapie. 1998 Jul-Aug;53(4):385-9.
Medicine combinations for AIDS and cancer treatment are becoming common practice in most clinical stages. These combinations are based on clinical developments which do not follow established guidelines such as those for fixed combinations. There are no current recommendations which can guide these developments and we have tried to identify the critical steps. The main difficulty is to balance the fast development required by the poor prognosis of these diseases and the protection of patients who can only be subjected to combinations for which reasonable expectation of a favourable therapeutic index is foreseen. For each pathology, the pre-clinical evidence-needed before pilot clinical studies and the surrogate clinical end-points are considered (viral load for AIDS and response rate for cancer). These are prerequisities for randomized clinical trials, which are the only means of definitive assessment of new combinations versus existing therapies.
用于治疗艾滋病和癌症的药物组合在大多数临床阶段正变得越来越普遍。这些组合是基于临床进展而来，并不遵循既定指南，如固定组合的指南。目前没有能够指导这些进展的建议，我们试图确定关键步骤。主要困难在于平衡这些疾病预后不良所要求的快速发展与保护患者，这些患者只能接受那些预期有合理有利治疗指数的组合治疗。对于每种病症，都要考虑在开展初步临床研究之前所需的临床前证据以及替代临床终点（艾滋病的病毒载量和癌症的缓解率）。这些是进行随机临床试验的先决条件，而随机临床试验是明确评估新组合与现有疗法的唯一手段。
