Fox W
Bull World Health Organ. 1971;45(5):559-72.
This report draws attention to the wide use of the controlled clinical trial in the study of tuberculosis in certain countries and centres and to the remarkable neglect of this method in the great majority of countries. Its versatility has been demonstrated by many studies: it has been used to study not only alternative combinations of drugs but also drug dosages, rhythms of administration, the duration of treatment with supplementary drugs or the total duration of treatment, and drug toxicity and its prevention. A particularly valuable use of the method is in the study of policies of therapy-e.g., treatment at home compared with treatment in a sanatorium; the inclusion of routine home visiting in the supervision of patients; the carrying out of pretreatment sensitivity tests as a basis for the selection of chemotherapeutic regimens; and treatment programmes based on short (6-month) intensive courses, as opposed to long-term (18-month) standard courses. It is concluded that well planned controlled clinical trials can be of great help to the epidemiologist and public health administrator as well as to the clinician.
本报告提请注意在某些国家和中心,对照临床试验在结核病研究中得到广泛应用,而在绝大多数国家,这种方法却被严重忽视。许多研究已证明了其通用性:它不仅用于研究药物的替代组合,还用于研究药物剂量、给药节奏、辅助药物治疗的持续时间或总治疗持续时间,以及药物毒性及其预防。该方法的一个特别有价值的用途是在治疗政策的研究中,例如,在家治疗与在疗养院治疗的比较;在患者监督中纳入常规家访;进行治疗前敏感性试验作为选择化疗方案的基础;以及与长期(18个月)标准疗程相对的基于短期(6个月)强化疗程的治疗方案。结论是,精心规划的对照临床试验对流行病学家、公共卫生管理人员以及临床医生都有很大帮助。