Lancar R, Kramar A, Haie-Meder C, Lambin P, Bouzy J, Scalliet P, Gerbaulet A
Biostatistiques, institut Gustave-Roussy, Villejuif, France.
Bull Cancer. 1994 Jul;81(7):632-7.
When treatment complications are the main criteria of a study, the simplest way for estimating the complication rate over time is to use the Kaplan-Meier method. The failure is the onset of the first complication. A new way is proposed here which takes into account the time to an eventual second, and third complication, and their duration as well. Results from a phase III randomized trial comparing two preoperative brachytherapy low dose rates in localized stage cervix carcinoma patients are used to illustrate both methods. The new method showed a greater long term complication rate in the higher dose rate group.
当治疗并发症是一项研究的主要标准时，估计一段时间内并发症发生率的最简单方法是使用Kaplan-Meier法。失败是首次并发症的发生。本文提出了一种新方法，该方法同时考虑了最终第二次和第三次并发症的发生时间及其持续时间。一项比较局部晚期宫颈癌患者两种术前近距离放疗低剂量率的III期随机试验结果用于说明这两种方法。新方法显示，高剂量率组的长期并发症发生率更高。
