ABSTRACT
OBJECTIVE@#To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles () for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction.@*METHODS@#Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks (146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) after completion of the open-label treatment period.@*RESULTS@#After the double-blind period, the median (interquartile range) changes in Scr were 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively (P=0.008), and the median changes in eGFRs were-0.2 (-4.3-2.7) and-2.21 (-5.7-0.8) mL•min•1.73 m, respectively (P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0 (-10.0-41.9) and 17.5 (-6.0-50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively (P=0.214), and the median changes in eGFRs were-2.3 (-6.4-1.9) and-3.7 (-7.5-1.1) mL•min•1.73 m, respectively (P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 mL•min•1.73 m per year.@*CONCLUSION@#Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function. (Trial registration No. ChiCTR-TRC-12002448).
Subject(s)
Adult , Female , Humans , Male , Middle Aged , Disease Progression , Double-Blind Method , Drugs, Chinese Herbal , Therapeutic Uses , Follow-Up Studies , Glomerular Filtration Rate , Kidney Diseases , Drug Therapy , Outcome Assessment, Health CareABSTRACT
Objective: To evaluate the efficacy and safety of a long-term adding metformin to a basic treatment strategy in systemic lupus erythematosus (SLE), and analyze whether the beneficial effects of metformin add-on treatment during the open-label proof-of-concept trial persisted during a posttrial follow-up (the metabolic memory effect), as there is a paucity of systematically collected data concerning long-term metformin use in SLE. Methods: Subjects who had participated in the open-label proof-of-concept trial and gave informed consent to this study were enrolled, and the disease flares and long-term adverse effects between metformin group and control group were compared. In addition, whether the benefit regarding decreased disease flare persisted after metformin withdrawal during the post-trial follow-up was investigated. Results: Twenty-nine subjects in the former metformin add-on strategy group and 28 subjects in the former control group were enrolled. No adverse reactions of metformin occurred during the study. The risk of disease flare in the control group was higher than that in the continuous metformin group, but the difference was not statistically significant (P=0.326). After metformin withdrawal, the risk of disease flare in the metformin group gradually increased to the control group (P=0.998). There was no significant difference between the two continuous metformin use groups whose metformin using duration are 2.56 years and 5.00 years respectively (P=0.802). Conclusion: A long-term metformin add-on treatment is security, and can keep SLE patients in a lower risk of disease flare. The metabolic regulation of metformin in SLE immune disorder may present a time-dependent metabolic memory effect.