Krasnova T N, Shilov E M, Tareeva I E, Gordovskaia N B, Lavrova O N, Miroshnichenko N G, Troepol'skaia O V, Ivanova L V, Ivanov A A
Ter Arkh. 1998;70(6):14-7.
Comparison of two cyclophosphamide (CPA) treatment regimens in chronic glomerulonephritis (CGN) patients: oral daily CPA versus intravenous CPA pulses (IV-CPA) MATERIALS AND METHODS: 31 nephrotic patients entered the trial: 12, 16 and 3 with membraneous, mesangial proliferative and mesangiocapillary CGN, respectively. The patients were randomized into two groups. 13 patients of group 1 received oral CPA (1.5-2.0 mg/kg/day for 6 months, while 18 patients of group 2 received IV-CPA pulses (20 mg/kg/monthly, at least 6 pulses) combined with oral prednisolone (40-6-mg/day during 1.5 mo with subsequent tapering). At entry, no statistical differences (p > 0.05) were found between groups 1 and 2 by age, gender, duration of the renal disease, serum creatinine levels, frequency of arterial hypertension. Mean duration of follow-up was 27.6 and 22.6 mo (p > 0.05) for group 1 and 2, respectively.
After 6 months of follow-up there was no difference in the rate of complete and partial remission between the groups (69 and 83% for group 1 and 2, respectively). The rate of renal function deterioration was also similar. Side effects occurred 3 times more frequently in group 1 than group 2. The mean cumulative course dose of CPA per 1 patient in group 1 was 35.6 g, in group 2--5.6 g.
The effectiveness of methods was similar irrespective of CGN morphological form, but in spite of similar rates of remission of nephrotic syndrome, pulse CPA is preferable being more safe as to possible complications.
比较两种环磷酰胺(CPA)治疗方案对慢性肾小球肾炎(CGN)患者的疗效:每日口服CPA与静脉注射CPA脉冲疗法(IV-CPA) 材料与方法:31例肾病患者进入试验:其中12例、16例和3例分别患有膜性、系膜增生性和系膜毛细血管性CGN。患者被随机分为两组。第1组13例患者接受口服CPA(1.5 - 2.0mg/kg/天,持续6个月),而第2组18例患者接受IV-CPA脉冲疗法(20mg/kg/月,至少6次脉冲)并联合口服泼尼松龙(1.5个月期间40 - 6mg/天,随后逐渐减量)。入组时,第1组和第2组在年龄、性别、肾病病程、血清肌酐水平、动脉高血压频率方面无统计学差异(p>0.05)。第1组和第2组的平均随访时间分别为27.6个月和22.6个月(p>0.05)。
随访6个月后,两组间完全缓解和部分缓解率无差异(第1组和第2组分别为69%和83%)。肾功能恶化率也相似。第1组副作用发生频率比第2组高3倍。第1组中每位患者CPA的平均累积疗程剂量为35.6g,第2组为5.6g。
无论CGN的形态学类型如何,两种方法的有效性相似,但尽管肾病综合征缓解率相似,脉冲式CPA在可能的并发症方面更安全,因此更可取。