Cyclosporine in patients with steroid-resistant membranous nephropathy: A randomized trial
Cyclosporine in patients with steroid-resistant membranous nephropathy: A randomized trial
复制标题
DOI：
10.1046/j.1523-1755.2001.0590041484.x
复制
发表时间：
2001-04-01
影响因子：
19.6
通讯作者：
Kunis, CL
中科院分区：
文献类型：
--
作者：
Cattran, DC;Appel, GB;Kunis, CL
背景对激素抵抗性膜性肾病（MGN）患者进行了环孢素的临床试验。虽然MGN仍然是成人型肾病综合征最常见的原因，但其治疗仍存在争议。环孢素已被证明是有效的进展MGN的情况下，但它还没有被用于在疾病的早期阶段的对照研究。我们在51例经活检证实的原发性MGN伴肾病范围蛋白尿患者中进行了一项随机试验，比较26周的环孢素+低剂量泼尼松治疗与安慰剂+泼尼松治疗。所有患者平均随访78周，评估对肾功能的短期和长期影响。在26周时，治疗组75%的患者蛋白尿部分或完全缓解，对照组22%的患者蛋白尿部分或完全缓解（P < 0.001）。到第52周，环孢素缓解组和安慰剂组分别有43%（N = 9）和40%（N = 2）的患者复发。然后，总人群中缓解的比例几乎保持不变，两组之间存在显著差异，直至研究结束（环孢霉素组39%，安慰剂组13%，P = 0.007）。在试验用药期间，两组的肾功能无变化且相等。在随后的随访中，两组各有2例患者出现肾功能不全（定义为基线肌酐加倍），但其余患者均保持稳定。本研究表明，环孢素是一种有效的治疗药物，在激素耐药的情况下，MGN的治疗。虽然复发率较高，但39%的治疗患者仍处于缓解状态，并且在治疗后至少一年内为亚肾病，对滤过功能无不良影响。
Background. A clinical trial of cyclosporine in patients with steroid-resistant membranous nephropathy (MGN) was conducted. Although MGN remains the most common cause of adult-onset nephrotic syndrome, its management is still controversial. Cyclosporine has been shown to be effective in cases of progressive MGN, but it has not been used in controlled studies at an early stage of the disease.Methods. We conducted a randomized trial in 51 biopsy-proven idiopathic MGN patients with nephrotic-range proteinuria comparing 26 weeks of cyclosporine treatment plus low-dose prednisone to placebo plus prednisone. All patients were followed for an average of 78 weeks, and the short- and longterm effects on renal function were assessed.Results. Seventy-five percent of the treatment group versus 22% of the control group (P < 0.001) had a partial or complete remission of their proteinuria by 26 weeks. Relapse occurred in 43% (N = 9) of the cyclosporine remission group and 40% (N = 2) of the placebo group by week 52. The fraction of the total population in remission then remained almost unchanged and significant different between the groups until the end of the study (cyclosporine 39%, placebo 13%, P = 0.007). Renal function was unchanged and equal in the two groups over the test medication period. Tn the subsequent follow-up, renal insufficiency, defined as doubling of baseline creatinine, was seen in two patients in each group, but remained equal and stable in all of the other patients.Conclusion. This study suggests that cyclosporine is an effective therapeutic agent in the treatment of steroid-resistant cases of MGN. Although a high relapse does occur, 39% of the treated patients remained in remission and were subnephrotic for at least one-year post-treatment, with no adverse effect on filtration function.