原文:
We randomly assigned 108 patients between April 1, 1998, and March 31, 2008, at a steady rate of about one patient per month (figure 1). We discovered that two patients were ineligible after randomisation, so no follow-up data are available for them, and they weren’t included in the primary analysis. Of the 106 patients included in the intention-to-treat analysis, 37 were assigned to receive supportive therapy alone, 33 to prednisolone and chlorambucil, and 36 to ciclosporin. 37 of the 45 centres that obtained ethics approval entered patients into the trial. Angiotensin-converting enzyme inhibitor was given to 27 (82%) of 33 in the prednisolone andchlorambucil group, 36 (100%) of 36 patients in the ciclosporin group, and 34 (92%) of 37 of those who received supportive treatment only. We did not obtain information about angiotensin-receptor antagonist use.
译文:
自1998年4月1日至2008年3月31日共计随机纳入108名患者,每月约纳入1例患者,如图1。 两名患者随机分组后被淘汰,因此未获得相关随访数据,将其排除在主要分析之外。 意向治疗分析中纳入的106名患者中,37例接受单纯支持治疗,33例接受支持治疗联合泼尼松龙+苯丁酸氮芥治疗,36例接受支持治疗联合环孢素治疗。45个研究中心内有37个中心获得伦理审批,并征入患者。不同组进行类似的基线水平检测,如表1。与单纯支持治疗组相比,治疗组联合药物组随机化至基线水平测定的间隔较长,原因在于后者存在制定处方、传送处方及实施治疗造成的延误。