Shan Wenjun, Guan Haiyu, Gu Haowen, Wang Rongrong, Huang Xiaoyan, Li Ping, Xie Ying, Bao Kun, Qin Xindong
State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
Nephrology Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Heliyon. 2024 Mar 31;10(7):e28836. doi: 10.1016/j.heliyon.2024.e28836. eCollection 2024 Apr 15.
Idiopathic membranous nephropathy (IMN) is a rare autoimmune disorder that causes nephrotic syndromes in adults. Conventional immunosuppressive therapies often exhibit limited efficacy in achieving remission and may result in notable adverse reactions, warranting the exploration of novel therapeutic approaches for IMN treatment. Traditional Chinese medicine (TCM), which is extensively used for kidney disease management, is a promising alternative.
This study aimed to examine the safety and efficacy of TCM alone or in combination with Western medicine for the management of patients diagnosed with IMN.
This study employed a systematic search of English and Chinese electronic databases to identify randomized controlled trials (RCTs) that examined the application of TCM in the treatment of IMN. RCTs that met the predetermined inclusion and exclusion criteria and assessed the safety and efficacy of TCM alone or in combination with Western medicine in patients with IMN were included in the analysis. The methodological quality of the included studies was evaluated by using a risk-of-bias tool. All statistical analyses were performed using the RevMan software (version 5.4.2). The evidence was evaluated on the https://www.gradepro.org/website.
This study included 29 randomized controlled trials (RCTs) involving 1982 patients with moderate methodological quality that met the inclusion criteria. The results showed that, compared to Western medicine alone therapy, the use of TCM alone or in combination with Western medicine significantly improved total remission (TR) rate (risk ratios [RR] 1.38, 95% confidence interval [CI] 1.29-1.46, I = 0%, P < 0.00001), complete remission (CR) rate (RR 1.78, 95% CI 1.48-2.15, I = 0, P < 0.00001), partial remission (PR) rate (RR 1.27, 95% CI 1.161.40, I = 0%, P < 0.00001), and serum albumin (ALB) levels (MD: 4.05, 95% CI: 3.02-5.09, I = 91%, P < 0.00001). TCM alone or in combination with Western medicine also reduced proteinuria levels (mean difference [MD]: 1.05, 95% CI: 1.30 to -0.79, I = 95%, P < 0.00001), serum creatinine (SCr) levels (MD: 7.47, 95% CI: 13.70 to -1.24, I = 97%, P = 0.02), and serum antibodies against M-type phospholipase A2 receptor levels (aPLA2Rab) (MD: 19.24, 95% CI: 33.56 to -4.93, I = 87%, P = 0.008). Moreover, the efficacy of combined TCM and Western medicine is superior to that of Western medicine alone in reducing the incidence of infection, hepatotoxicity, and thrombosis. Although the primary and secondary outcomes were consistent, the evidence was generally moderate.
The results of this study suggest that TCM alone or in combination with Western medicine may be a feasible alternative therapeutic approach for the treatment of IMN. Nevertheless, additional, rigorously designed, high-quality, and extensive clinical trials are imperative to provide substantial evidence regarding the effectiveness of TCM in managing IMN.
特发性膜性肾病（IMN）是一种罕见的自身免疫性疾病，可导致成人肾病综合征。传统免疫抑制疗法在实现缓解方面往往疗效有限，并可能导致显著的不良反应，因此有必要探索治疗IMN的新型治疗方法。广泛用于肾脏疾病管理的传统中医（TCM）是一种有前景的替代方法。
本研究旨在探讨单用中药或中西医结合治疗IMN患者的安全性和有效性。
本研究系统检索了英文和中文电子数据库，以识别研究中药在IMN治疗中应用的随机对照试验（RCT）。符合预定纳入和排除标准并评估单用中药或中西医结合治疗IMN患者的安全性和有效性的RCT被纳入分析。使用偏倚风险工具评估纳入研究的方法学质量。所有统计分析均使用RevMan软件（5.4.2版）进行。证据在https://www.gradepro.org/网站上进行评估。
本研究纳入了29项随机对照试验（RCT），涉及1982例方法学质量中等且符合纳入标准的患者。结果显示，与单用西药治疗相比，单用中药或中西医结合显著提高了完全缓解（TR）率（风险比[RR]1.38，95%置信区间[CI]1.29 - 1.46，I = 0%，P < 0.00001）、完全缓解（CR）率（RR 1.78，95% CI 1.48 - 2.15，I = 0，P < 0.00001）、部分缓解（PR）率（RR 1.27，95% CI 1.16 - 1.40，I = 0%，P < 0.00001）以及血清白蛋白（ALB）水平（MD：4.05，95% CI：3.02 - 5.09，I = 91%，P < 0.00001）。单用中药或中西医结合还降低了蛋白尿水平（平均差[MD]：1.05，95% CI： - 1.30至 - 0.79，I = 95%，P < 0.00001）、血清肌酐（SCr）水平（MD：7.47，95% CI： - 13.70至 - 1.24，I = 97%，P = 0.02）以及抗M型磷脂酶A2受体血清抗体（aPLA2Rab）水平（MD：19.24，95% CI： - 33.56至 - 4.93，I = 87%，P = 0.008）。此外，中西医结合在降低感染、肝毒性和血栓形成发生率方面的疗效优于单用西药。尽管主要和次要结果一致，但证据总体为中等质量。
本研究结果表明，单用中药或中西医结合可能是治疗IMN的一种可行的替代治疗方法。然而，必须进行更多设计严谨、高质量且广泛的临床试验，以提供关于中药治疗IMN有效性的充分证据。
