| ReviewMembranous nephropathy (MN) is a common kidney disease in adults, the etiology of approximately 75% of MN is idiopathic(IMN)and the cause of IMN is still unknown. IMN is a glomerulopathy with characteristic histopathological features of subepithelial immunecomplex deposit and subsequent thickening of glomerular basement membrane. Patients with IMN usually present with severe proteinuria, edema, hypoalbuminemia. The treatment includes supportive care, immunosuppressive therapy and traditional Chinese medicine. Current clinical situation faces two aspects problems. On one hand, there are a variety of immunosuppressive agents could be used in clinic, but the efficacy comparisons of different agents still lack of evidence; on the other hand, although Traditional Chinese Medicine syndrome differentiation treatment has numerous experiences, but the lack of rigorous experimental study restrict a widely apply.Materials and methodsBased on the two issues discussed above, this research contains two studies:Study One:To complete a literature study of west medicine. By comprehensive search relative systematic reviews of immunosuppression treat IMN, we obtained four systematic reviews to meet the requirements for further analysis. Upon completion of a systematic review of methodological quality assessment and evaluation of the bias of the original clinical trials, we extracted relevant data from the 47 studies, to complete a typical Meta-analysis and a Network-Meta analysis for main outcome. To compare the efficacy and safety of each drug by complete a overview of immunosuppressive therapy of IMN, further more to discover existing problems.Study two:To conduct a retrospective-prospective cohort study, by screening patients from Xiyuan Hospital and Peking University Third Hospital, who met the study criteria to explore the efficacy of Traditional Chinese Medicine syndrome differentiation treatment. After the screening intervention in accordance with classification, patient was classified into two group:45 cases of Western medicine by using cyclophosphamide pulse steroids,41 cases of Traditional Chinese Medicine syndrome differentiation monotherapy. After six months of data review and clinical observation, analysis the primary efficacy indicators and outcome events, to explore the efficacy and safety of Traditional Chinese Medicine treating IMN.ResultsIn the overview of immunosuppressive therapy for IMN, the assessment of systematic review’s methodological quality and evaluation of bias in original clinical trials, showed a higher overall research level in this field. Directly comparison showed immunosuppressive therapy can significantly improve the complete/partial remission rate than placebo/symptomatic treatment, OR=2.71 (1.49,4.95).CTX has less remission rate than MMF, OR=0.44(0.21,0.91) According to the network Meta-analysis results, all immunosuppressive drugs showed no statistical significant difference when compared to each other, only cyclophosphamide, tacrolimus and mycophenolate mofetil have a better efficacy than placebo/symptomatic treatment. Also, mizoribine showed a more promising further, rather than other immunosuppressive drugs, future research may needed to confirm its effectiveness and safety. Tacrolimus and mycophenolate mofetil may have superior efficacy than cyclophosphamide, related clinical trials are needed to confirm the findings.The cohort study results shows TCM monotherapy compared to western standard treatment, cyclophosphamide plus corticosteroid, the overall clinical outcome comparison has no statistical significant. The main outcome, remission rate, has a same situation. In the Laboratory test value changes, serum creatinine showed no significant difference in the two groups before and after the study, which indicated a stable renal function. In TCM group,24 hour urinary protein decreased by an average of 2.74±3.35g, serum albumin increased by an average of 5.55±7.68g/L, while the western medicine group 24hour urinary protein decreased by an average of 4.49±4.14g, serum albumin increased by an average of 10.15+ 7.82g/L. Both treatment groups show clearly clinical changes, both can significantly reduce urinary protein and increase serum albumin. TCM group endpoint events occurrence rate is 4.88%. and western medicine group endpoint events occurrence rate is 4.44%, no statistical significant between the two groups.DiscussionOverview of systematic review as a new research method, can summary existed evidence, and explore the problems and shortages for new discovery. This study based on the actual problem in clinical practice, by completing a comprehensive overview of western medicine treatment for IMN,and exploring the clinical efficacy of TCM, provides evidence support for the treatment options in IMN.According to the overview of systematic review, available evidence supports the immunosuppressive therapy, and direct comparison show MMF is better than cyclophosphamide and network Meta-analysis show there was no statistical difference between different immunosuppressive drugs, so the first clinical choice is cyclophosphamide combined with corticosteroids treatment, which recommended by KIDGO’s guideline in 2012.Meanwhile, results suggest considering MMF go into the first choice if more studies can provide. In the prediction of drug, mizoribine showed a more promising further, but this conclusion is based on a small clinical trials included only 16 patient, so the conclusion maybe not stable. Also the overviews find immunosuppressive therapy facing problems with drug safety, so there is a need to find new therapy. Cohort study result shows TCM monotherapy compared to western standard treatment, cyclophosphamide plus corticosteroid, the overall clinical outcome comparison has no statistical significant, suggesting that TCM monotherapy can be considered as a optimal therapy for IMN.In addition, this study fails to observe and analyze drugs’ adverse reaction and long-term efficacy in both TCM and immunosuppressive treatment. We are looking forward to see more high-quality studies join in the further exploration and discovery.
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