Meyrier A, Condamin M C, Broneer D
Hôpital Avicenne, Bobigny Medical School, Paris North University, France.
Clin Nephrol. 1991;35 Suppl 1:S37-42.
Two open studies were conducted to determine the efficacy and tolerance of cyclosporin A (CyA, Sandimmun) 5 mg/kg/day. Sixty-four patients received CyA as monotherapy, and efficacy was assessed at three months; in 48 other patients, CyA was given with prednisone 12-15 mg/kg/day, and efficacy was assessed at six months. Of these 112 patients, 14 withdrew prematurely because of adverse events or other reasons, and a further nine patients were excluded for protocol violation. The remaining 98 patients were considered valid for the evaluation of efficacy (52 with minimal-change disease [MCD] and 46 with focal-segmental glomerulosclerosis [FSGS]; 37/98 were steroid-dependent [SD], and 61/98 were steroid-resistant [SR]). The remission:failure rate depended on histology (36:16 in MCD, 11:35 in FSGS) and steroid response (25:12 in SD, 22:39 in SR). The rate of remission was highest in SD MCD (71%) and lowest in SR FSGS (20%; chi square = 18.6, p less than 0.001). Tolerance was assessed by serum creatinine and, in 36 cases, by repeat renal biopsy at six to 42 months. Serum creatinine was remarkably stable in MCD. Rising creatinines were observed mostly in cases of SR FSGS, particularly those who had pretreatment interstitial lesions; this was considered due to both an increase of interstitial lesions and progression of the glomerular lesions of FSGS.(ABSTRACT TRUNCATED AT 250 WORDS)
开展了两项开放性研究以确定每天5毫克/千克环孢素A(CyA,山地明)的疗效和耐受性。64例患者接受CyA单一疗法,并在三个月时评估疗效;另外48例患者接受CyA与每天12 - 15毫克/千克泼尼松联合治疗,并在六个月时评估疗效。在这112例患者中,14例因不良事件或其他原因提前退出,另有9例因违反方案被排除。其余98例患者被认为可有效评估疗效(52例为微小病变病[MCD],46例为局灶节段性肾小球硬化[FSGS];98例中有37例为激素依赖型[SD],61例为激素抵抗型[SR])。缓解:失败率取决于组织学类型(MCD中为36:16,FSGS中为11:35)和激素反应(SD中为25:12,SR中为22:39)。缓解率在SD MCD中最高(71%),在SR FSGS中最低(20%;卡方检验=18.6,p<0.001)。通过血清肌酐评估耐受性,36例患者在6至42个月时进行了重复肾活检。血清肌酐在MCD中非常稳定。肌酐升高主要见于SR FSGS患者,尤其是那些有预处理间质病变的患者;这被认为是由于间质病变增加和FSGS肾小球病变进展所致。(摘要截断于250字)