ABSTRACT
Background: 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. Methods: 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. Results: 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 (p < 0.001) and to 0.27 g/d at 24°months (p = 0.003); serum albumin increased from 28 g/L to 37.2 g/L at 12°months (p < 0.001) and to 41.3 g/L at 24°months (p = 0.003); eGFR improved from 100.25 ml/min/1.73 m2 to 118.39 ml/min/1.73 m2 at 6°months (p < 0.001) and finally to 111.62 ml/min/1.73 m2at 24°months (p = 0.008). Only two patients developed subsequent relapse. Conclusion: 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. Clinical Trial registration: http://www.chictr.org.cn, Chinese Clinical Trials Registry [ChiCTR1800019351].
ABSTRACT
Massa Medicata Fermentata (MMF) has been used for a long time by the Chinese. MMF is used widely in feed additives and human medicinal applications throughout the world; however, there have only been a few reports about the biostudy of its fermentation mechanism and medicinal ingredients. To safely use MMF, we observed the changes in the ingredients and amylase activity for several raw materials during the fermentation process of MMF. We are going to explore the basis of pharmacodynamic substances and the purpose of MMF to provide support for safe use in clinics. This biostudy data demonstrated that the ingredients such as amygdalin, benzaldehyde, and rutin were gradually degraded during the process of fermentation, and the fermented MMF did not contain amygdalin and benzaldehyde. The HPLC fingerprint of fermented MMF for 7 days is similar to the chemical composition of the original unfermented MMF with a similarity of only 0.106. Meanwhile, the activities of amylase in fermented MMF had gradually increased, and the content of organic acids also had increased. According to our biostudy, we found that the raw material chemical composition of MMF in the process of fermentation was affected by microorganisms and various substances. The conclusions of our study determined that the initial components of MMF are not identical to the pharmacodynamic components. We also conclude that amylase activity explains the pharmacological activity of MMF to a certain extent, but it is likely not the only factor. The implication not only provides the initial knowledge of MMF but also implies the further exploration of this popular traditional medicine.
