Outcome of Leflunomide in the Treatment of Proliferative Lupus Nephritis Compared to Cyclophosphamide  

作　　者：Shahida Mullah Muhammad Rafiqul Alam Shamim Ahmed Amanur Rasul Md. Faisal Anirban Kishor Singha A. K. M. Shahidur Rahman Diwakar Manandhar Asif Mahmud Bikram Bir Bajracharya S. M. Shamsuzzaman Rafi Nazrul Islam Md. Rezaul Alam Ferdous Jahan Shahida Mullah;Muhammad Rafiqul Alam;Shamim Ahmed;Amanur Rasul Md. Faisal;Anirban Kishor Singha;A. K. M. Shahidur Rahman;Diwakar Manandhar;Asif Mahmud;Bikram Bir Bajracharya;S. M. Shamsuzzaman;Rafi Nazrul Islam;Md. Rezaul Alam;Ferdous Jahan(Department of Medicine, Sarkari Karmachari Hospital, Dhaka, Bangladesh;Department of Nephrology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh;Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh;Department of Nephrology, Dhaka Medical College Hospital (DMCH), Dhaka, Bangladesh;Department of Nephrology, Kurmitola General Hospital, Dhaka, Bangladesh;Lecturer of Nephrology, Kist Medical College and Teaching Hospital, Kathmandu, Nepal;Clinical Fellow ST3+, Medicine and Specialties, Worcestershire Royal Hospital, Worcester, UK;Goshairhat Upazila Health Complex, Shariatpur, Bangladesh;Department of Nephrology & Dialysis, BIRDEM General Hospital, Dhaka, Bangladesh)

机构地区：[1]Department of Medicine, Sarkari Karmachari Hospital, Dhaka, Bangladesh [2]Department of Nephrology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh [3]Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh [4]Department of Nephrology, Dhaka Medical College Hospital (DMCH), Dhaka, Bangladesh [5]Department of Nephrology, Kurmitola General Hospital, Dhaka, Bangladesh [6]Lecturer of Nephrology, Kist Medical College and Teaching Hospital, Kathmandu, Nepal [7]Clinical Fellow ST3+, Medicine and Specialties, Worcestershire Royal Hospital, Worcester, UK [8]Goshairhat Upazila Health Complex, Shariatpur, Bangladesh [9]Department of Nephrology & Dialysis, BIRDEM General Hospital, Dhaka, Bangladesh

出　　处：《Journal of Biosciences and Medicines》2021年第3期64-76,共13页生物科学与医学（英文）

摘　　要：<strong>Background: </strong>Lupus nephritis (LN) is one of the most common presentations of Systemic lupus erythematosus (SLE). Cyclophosphamide is one of the key immunosuppressive agents for the management of LN. Leflunomide is an isoxazole immunomodulatory agent has been shown to be safe, well tolerated and effective in SLE and LN. <strong>Objective: </strong>To evaluate the outcome of leflunomide in the treatment of proliferative lupus nephritis compared to cyclophosphamide. <strong>Method: </strong>This randomized clinical trial was held in Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh from July 2017 to August 2019. A total of 66 patients of proliferative lupus nephritis who need induction therapy were enrolled in this study. Leflunomide 100 mg/day for consecutive 3 days followed by 0.5 mg/kg/day in divided dose was given in experimental group (n = 32) and intravenous cyclophosphamide 0.5 gm/m2 of body surface area monthly pulse was given in control group (n = 34). All study patients have received prednisolone and hydroxychloroquine according to KDIGO guideline then followed up monthly for 6 months. Outcomes were measured at 6th month by renal function [S. Creatinine, 24 hours urinary total protein (24-hr UTP)], changes in SELENA-SLEDAI score, anti-ds DNA level, serum complement levels (serum C3 & C4), remission (complete/partial) and adverse drug responses.<strong> Result:</strong> In experimental group, remission occurred in 18 (56.3%) patients and no remission in 14 (43.7%) patients. In control group, remission occurred in 24 (70.6%) patients and no remission in 10 (29.4%) patients. Adverse effects in experimental group were: elevated ALT (6.3%), hypertension (12.5%), infection (6.3%) and amenorrhea (12.5%). In control group, adverse effects were mainly leucopenia (5.9%), infection (17.7%) and amenorrhea (29.4%). Intergroup analysis for treatment responses and adverse effects showed no significant difference (p > 0.05). <strong>Conclusion:</strong> Leflunomide combined with predni<strong>Background: </strong>Lupus nephritis (LN) is one of the most common presentations of Systemic lupus erythematosus (SLE). Cyclophosphamide is one of the key immunosuppressive agents for the management of LN. Leflunomide is an isoxazole immunomodulatory agent has been shown to be safe, well tolerated and effective in SLE and LN. <strong>Objective: </strong>To evaluate the outcome of leflunomide in the treatment of proliferative lupus nephritis compared to cyclophosphamide. <strong>Method: </strong>This randomized clinical trial was held in Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh from July 2017 to August 2019. A total of 66 patients of proliferative lupus nephritis who need induction therapy were enrolled in this study. Leflunomide 100 mg/day for consecutive 3 days followed by 0.5 mg/kg/day in divided dose was given in experimental group (n = 32) and intravenous cyclophosphamide 0.5 gm/m2 of body surface area monthly pulse was given in control group (n = 34). All study patients have received prednisolone and hydroxychloroquine according to KDIGO guideline then followed up monthly for 6 months. Outcomes were measured at 6th month by renal function [S. Creatinine, 24 hours urinary total protein (24-hr UTP)], changes in SELENA-SLEDAI score, anti-ds DNA level, serum complement levels (serum C3 & C4), remission (complete/partial) and adverse drug responses.<strong> Result:</strong> In experimental group, remission occurred in 18 (56.3%) patients and no remission in 14 (43.7%) patients. In control group, remission occurred in 24 (70.6%) patients and no remission in 10 (29.4%) patients. Adverse effects in experimental group were: elevated ALT (6.3%), hypertension (12.5%), infection (6.3%) and amenorrhea (12.5%). In control group, adverse effects were mainly leucopenia (5.9%), infection (17.7%) and amenorrhea (29.4%). Intergroup analysis for treatment responses and adverse effects showed no significant difference (p > 0.05). <strong>Conclusion:</strong> Leflunomide combined with predni

关 键 词：CYCLOPHOSPHAMIDE LEFLUNOMIDE Lupus Nephritis (LN) Systemic Lupus Erythematosus (SLE) 

分 类 号：R73[医药卫生—肿瘤]