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我们对英国医学研究委员会于1970年至1983年间在非洲和东亚地区开展的15项结核病治疗的试验研究结果进行了回顾。在574例复发病例中,447例(78%)的复发发生在停止治疗后6个月内,525例(91%)发生在停止治疗后12个月内。我们建议:研究者应考虑,在对纳入的最后1例病人完成6个月的治疗后随访时即停止,而对早期纳入病人的治疗后随访也在那时停止。与对所有病人均随访24个月相比,整个试验研究的时间缩短了18个月,而在非劣效试验研究设计中的病例数并未增加。
We review the results of a pilot study of 15 TB treatments conducted by the British Medical Research Council in Africa and East Asia between 1970 and 1983. Out of 574 recurrent cases, 447 (78%) relapses occurred within 6 months of cessation of treatment and 525 (91%) occurred within 12 months of cessation of treatment. We suggest that investigators consider that they stop after follow-up after 6 months of treatment of the last patient included, and cease follow-up after the early inclusion of patients. The overall pilot study was 18 months shorter compared to 24 months follow-up for all patients, while the number of non-inferior trial design studies did not increase.