Cui Hailan, Fu Frank Qiang, Liu Baoli, Liu Wei Jing, Liu Yu Ning
Beijing Changping Hospital of Traditional Chinese Medicine, Beijing, China.
Renal Research Institution of Beijing University of Chinese Medicine, Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing and Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Front Pharmacol. 2021 May 10;12:675406. doi: 10.3389/fphar.2021.675406. eCollection 2021.
Treatment for adult patients with refractory idiopathic membranous nephropathy (RIMN) by conventional immunosuppressive regimens is not satisfactory. This study aims to evaluate the effectiveness of Chinese herbal medicine, Shulifenxiao formula, as a promising regimen. A total of 31 RIMN patients resistant to corticosteroid or immunosuppressive agents were retrospectively analyzed. Shulifenxiao treatment lasted a minimum of 12°months in all patients and extended to 24°months in 11 patients. The primary outcomes [the complete remission (CR) and partial remission (PR)] and secondary outcomes (the serum creatinine and estimated glomerular filtration rate (eGFR) levels) were measured at 6, 12, 18, and 24°months. The data provided an average follow-up of 21 ± 9.16°months from baseline. The remission was attained in 25/31 patients (80.7%: CR 29.0% and PR 51.6%) at 12°months and in 10/11 patients (90.9%: CR 54.6% and PR 36.4%) at 24°months, respectively. Proteinuria reduced from 6.02 g/d at baseline to 0.98 g/d at 12°months ( < 0.001) and to 0.27 g/d at 24°months ( = 0.003); serum albumin increased from 28 g/L to 37.2 g/L at 12°months ( < 0.001) and to 41.3 g/L at 24°months ( = 0.003); eGFR improved from 100.25 ml/min/1.73 m to 118.39 ml/min/1.73 m at 6°months ( < 0.001) and finally to 111.62 ml/min/1.73 mat 24°months ( = 0.008). Only two patients developed subsequent relapse. Shulifenxiao formula as a clinical cocktail therapy serves as an alternative therapeutic option for steroid and immunosuppressant-resistant RIMN patients, with a favourable safety profile, though further studies are warranted. http://www.chictr.org.cn, Chinese Clinical Trials Registry [ChiCTR1800019351].
采用传统免疫抑制方案治疗成人难治性特发性膜性肾病（RIMN）的效果并不理想。本研究旨在评估中药疏利分消方作为一种有前景的治疗方案的有效性。对31例对皮质类固醇或免疫抑制剂耐药的RIMN患者进行了回顾性分析。所有患者的疏利分消方治疗至少持续12个月，11例患者延长至24个月。在6、12、18和24个月时测量主要结局指标[完全缓解（CR）和部分缓解（PR）]以及次要结局指标（血清肌酐和估计肾小球滤过率（eGFR）水平）。数据显示从基线开始的平均随访时间为21±9.16个月。12个月时，31例患者中有25例（80.7%：CR为29.0%，PR为51.6%）达到缓解，24个月时，11例患者中有10例（90.9%：CR为54.6%，PR为36.4%）达到缓解。蛋白尿从基线时的6.02g/d降至12个月时的0.98g/d（<0.001），并在24个月时降至0.27g/d（=0.003）；血清白蛋白从12个月时的28g/L升至37.2g/L（<0.001），并在24个月时升至41.3g/L（=0.003）；eGFR在6个月时从100.25ml/min/1.73m²改善至118.39ml/min/1.73m²（<0.001），最终在24个月时改善至111.62ml/min/1.73m²（=0.008）。只有2例患者随后复发。疏利分消方作为一种临床联合治疗方法，为对类固醇和免疫抑制剂耐药的RIMN患者提供了一种替代治疗选择，具有良好的安全性，不过仍需进一步研究。http://www.chictr.org.cn，中国临床试验注册中心[ChiCTR1800019351]
