Mendonca Satish, Gupta Devika, Ali Sofia, Gupta Pooja
Department of Medicine, Armed Forces Medical College and Command Hospital, Pune, Maharashtra, India.
Department of Pathology and Laboratory Science, Armed Forces Medical College and Command Hospital, Pune, Maharashtra, India.
Saudi J Kidney Dis Transpl. 2017 Sep-Oct;28(5):1069-1077. doi: 10.4103/1319-2442.215147.
Mycophenolate mofetil (MMF) is used extensively for the induction therapy of lupus nephritis (LN) and has even outpaced intravenous (i.v.) cyclophosphamide (CyP) as the initial choice of therapy. There are no studies comparing the response of MMF with standard dose i.v. CyP in Indian patients with LN. We conducted a 24-week prospective, randomized, open-label trial comparing oral MMF with monthly i.v. CyP as induction therapy for active biopsy proven Class III and IV LN. The primary end-point was response to treatment at 24 weeks, and the secondary end-points were complete remission, Systemic Lupus Erythematosus Disease Activity Index scores (SLEDAI) and adverse reactions. Of the 40 patients, 17 were randomized to the MMF group and 23 to the i.v. CyP group. Complete remission was seen in nine (52.94%) patients in the MMF group and 11 (47.82%) in the i.v. CyP group. Partial remission was seen in six (35.30%) in the MMF group and nine (39.13%) in the i.v. CyP group. At six months, the cumulative probability of response was not statistically significant between the two groups (P = 1.000). MMF is comparable to i.v. CyP in the management of LN in Indian patients having an equal safety profile. The dose of MMF required was lower than the conventional doses used in other studies suggesting genetic or environmental factors in the Indian population influencing the metabolism of MMF, which requires further evaluation. The cost of MMF is a limiting factor in its use. The use of i.v. CyP is favorable as the monthly doses ensure compliance and is also cost-effective.
霉酚酸酯(MMF)被广泛用于狼疮性肾炎(LN)的诱导治疗,甚至已超过静脉注射(i.v.)环磷酰胺(CyP)成为初始治疗的首选。尚无研究比较MMF与标准剂量静脉注射CyP对印度LN患者的疗效。我们进行了一项为期24周的前瞻性、随机、开放标签试验,比较口服MMF与每月静脉注射CyP作为活动性活检证实的III级和IV级LN诱导治疗的效果。主要终点是24周时的治疗反应,次要终点是完全缓解、系统性红斑狼疮疾病活动指数评分(SLEDAI)和不良反应。40例患者中,17例随机分为MMF组,23例分为静脉注射CyP组。MMF组9例(52.94%)患者完全缓解,静脉注射CyP组11例(47.82%)患者完全缓解。MMF组6例(35.30%)患者部分缓解,静脉注射CyP组9例(39.13%)患者部分缓解。6个月时,两组间反应的累积概率无统计学差异(P = 1.000)。在安全性相同的印度LN患者管理中,MMF与静脉注射CyP相当。所需MMF剂量低于其他研究中使用的常规剂量,提示印度人群中存在影响MMF代谢的遗传或环境因素,这需要进一步评估。MMF的成本是其使用的限制因素。静脉注射CyP的使用更有利,因为每月给药确保了依从性,且具有成本效益。