Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Directorate General of Health Services, Dhaka, Bangladesh.
Int J Rheum Dis. 2022 Feb;25(2):121-130. doi: 10.1111/1756-185X.14265. Epub 2021 Dec 11.
This study aimed to compare the efficacy of low-dose prednisolone with conventional high-dose regimen in proliferative lupus nephritis (LN) for remission.
This open-label randomized clinical trial was conducted in the Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh. A total of 32 LN patients were randomized into low-dose (experimental) and high-dose (control) groups. All subjects received standard dose of intravenous (I/V) methylprednisolone and pulse I/V cyclophosphamide. Oral prednisolone, 0.5 mg/kg/d and 1 mg/kg/d were given to experimental and control groups respectively for initially 4 weeks then tapered. The patients were followed for 24 weeks. The rates of renal remission (complete and partial) were assessed at 24 weeks. The disease activity, biochemical markers, and quality of life were evaluated at baseline and at 24 weeks.
Complete renal remission was achieved by 66.7% of patients in each group (P = .99). Renal remission (partial/complete) was achieved by 86.7% and 83.3% of patients in the prednisolone low-dose group and high-dose group respectively (P = .99). In between groups, no significant difference was observed in the improvement of active urinary sediments, serum creatinine level, anti-double-stranded DNA level, complements level, disease activity and Short Form-12 score. The prednisolone dose-related adverse events like cushingoid facies, abdominal stria, infections and serious adverse events like death occurred more in the high-dose prednisolone group.
It has been observed that low-dose prednisolone regimen may be effective in LN. Steroid dose-related side effects and rate of infections were lower in this group.
本研究旨在比较低剂量泼尼松与传统高剂量方案在增殖性狼疮肾炎(LN)缓解中的疗效。
本开放标签随机临床试验在孟加拉国达卡的 Bangabandhu Sheikh Mujib 医学大学(BSMMU)风湿病科进行。共纳入 32 例 LN 患者,随机分为低剂量(实验组)和高剂量(对照组)组。所有患者均接受标准剂量的静脉(IV)甲基泼尼松龙和脉冲 IV 环磷酰胺治疗。实验组和对照组分别给予 0.5mg/kg/d 和 1mg/kg/d 的口服泼尼松龙,最初 4 周内给予,然后逐渐减少剂量。患者随访 24 周。在第 24 周评估肾脏缓解率(完全缓解和部分缓解)。在基线和第 24 周评估疾病活动度、生化标志物和生活质量。
两组患者完全缓解率均为 66.7%(P=0.99)。低剂量泼尼松组和高剂量泼尼松组患者的肾脏缓解率(部分/完全)分别为 86.7%和 83.3%(P=0.99)。两组间,尿沉渣活动度、血清肌酐水平、抗双链 DNA 水平、补体水平、疾病活动度和 SF-12 评分的改善无显著差异。高剂量泼尼松组中,与泼尼松剂量相关的不良反应,如库欣面容、腹部条纹、感染以及严重不良事件,如死亡,更为常见。
低剂量泼尼松方案可能对 LN 有效。在该组中,类固醇剂量相关的副作用和感染发生率较低。