Division of Nephrology and Hypertension, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.
Kidney and Hypertension Research Unit, University of Cape Town, Cape Town, South Africa.
BMC Nephrol. 2019 Feb 6;20(1):44. doi: 10.1186/s12882-019-1208-2.
The aim of this study was to assess, the efficacy and safety of add-on corticosteroids to antiretroviral therapy [ART] in patients with biopsy proven HIV associated nephropathy.
All included patients had histological evidence of either collapsing or non-collapsing focal segmental glomerulosclerosis (FSGS) or podocyte and/or parietal cell hypertrophy or hyperplasia. All patients had evidence of tubulointerstitial inflammation with microcysts. Patients were randomized to ART with the addition of 1 mg/kg of corticosteroids [ART+C] or remained in the group [ART Alone] and followed for 2 years. A repeat biopsy was performed at 6 months.
Twenty-one patients were randomized to [ART+C] and 17 to [ART Alone]. The baseline estimated glomerular filtration rate (eGFR) was significantly lower in the [ART+C] vs. [ART Alone] group [35mls/min/1.73m vs. 47 mls/min/1.73m, p = 0.015]. The [ART+C] cohort had a statistically significant improvement in median (eGFR) from baseline to last follow up compared with [ART Alone] i.e. [Δ = 25mls/min (IQR: 15;51) vs 9 mls/min (IQR: 0-24), p = 0.008]. There were no statistically significant differences between the groups when proteinuria and histology were analyzed. There were 8 deaths during the trial period, 7 from [ART+C] (Log rank p = 0.071).
In the [ART+C] cohort there was a significant improvement in eGFR over 2-years with increased mortality. Routine corticosteroid use cannot currently be recommended. Further investigation to define which subgroup of this cohort would safely benefit from the positive effects is required.
ISRCTN study ID ( 56112439 ] was retrospectively registered on the 5 September 2018.
本研究旨在评估在经活检证实的 HIV 相关肾病患者中，抗逆转录病毒治疗[ART]中添加皮质类固醇的疗效和安全性。
所有纳入的患者均有组织学证据表明存在塌陷或非塌陷局灶性节段性肾小球硬化（FSGS）或足细胞和/或壁细胞肥大或增生。所有患者均有微囊的肾小管间质炎症证据。患者被随机分配到接受 ART 加用 1mg/kg 皮质类固醇[ART+C]或仍留在[ART 单独]组，并随访 2 年。在 6 个月时进行重复活检。
21 名患者被随机分配到[ART+C]组，17 名患者被随机分配到[ART 单独]组。与[ART 单独]组相比，[ART+C]组的基线估计肾小球滤过率（eGFR）明显更低[35mls/min/1.73m 与 47 mls/min/1.73m，p=0.015]。与[ART 单独]组相比，[ART+C]组的中位（eGFR）从基线到最后随访时有统计学意义的改善，即[Δ=25mls/min（IQR：15；51）与 9 mls/min（IQR：0-24），p=0.008]。当分析蛋白尿和组织学时，两组之间没有统计学上的显著差异。在试验期间，有 8 例死亡，7 例来自[ART+C]（对数秩检验，p=0.071）。
在[ART+C]组中，2 年内 eGFR 显著改善，但死亡率增加。目前不能常规推荐使用皮质类固醇。需要进一步研究确定该队列的哪个亚组可以安全地从积极影响中受益。
ISRCTN 研究 ID（56112439）于 2018 年 9 月 5 日进行了回顾性注册。
