单位：[a]Department of Nephrology, Chinese People’s Liberation Army General Hospital, Chinese People’s Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China[b]Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300192, China[c]Department of Nephrology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China[d]Department of Nephrology, Shandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan 250011, Shandong Province, China[e]Department of Nephrology, Daping Hospital, Army Medical University, Chongqing 400042, China[f]Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University, Shanghai 200127, China[g]Department of Nephrology, Guang’anmen Hospital, China Academy of Traditional Chinese Medical Sciences, Beijing 100053, China[h]Department of Nephrology, Tianjin Medical University General Hospital, Tianjin 300052, China[i]Department of Nephrology, Changhai Hospital of Shanghai, Naval Medical University, Shanghai 200433, China[j]Department of Nephrology, West China Hospital, Chengdu 610083, Sichuan Province, China四川大学华西医院[k]Department of Nephrology, First Affiliated Hospital of Shanxi Medical University, Taiyuan 030001, Shanxi Province, China[l]Department of Nephrology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, Guangdong Province, China广东省中医院[m]Department of Nephrology, Shanxi Medical University Second Affiliated Hospital, Taiyuan 030001, Shanxi Province, China[n]Department of Nephrology, Shandong Provincial Hospital, Jinan 250021, Shandong Province, China[o]Department of Nephrology and Rheumatology, Affiliated Sixth People’s Hospital, Shanghai Jiao Tong University, Shanghai 200233, China[p]Department of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi’an 710003, Shaanxi Province, China[q]Department of Nephrology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China[r]Department of Nephrology, Jilin University Second Hospital, Changchun 130041, Jilin Province, China[s]Department of Nephrology, Xijing Hospital, Air Force Military Medical University, Xi’an 710032, Shaanxi Province, China[t]Department of Nephrology, Tangdu Hospital, Air Force Military Medical University, Xi’an 710038, Shaanxi Province, China[u]Department of Nephrology, the First Affiliated Hospital of Xi’an Jiao Tong University, Xi’an 710061, Shaanxi Province, China[v]Department of Nephrology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China[w]Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou 310007, Zhejiang Province, China[x]Department of Nephrology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China临床科室肾脏内科肾脏内科首都医科大学附属北京友谊医院[y]Department of Nephrology, the First Affiliated Hospital of Dalian Medical University, Dalian 116011, Liaoning Province, China大连医科大学附属第一医院[z]Department of Nephrology, the 174th Hospital of the People’s Liberation Army, Xiamen 361003, Fujian Province, China[aa]Department of Nephrology, 281th Hospital of Chinese People’s Liberation Army, Qinhuangdao 066100, Hebei Province, China[ab]Department of Nephrology, Teaching Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China[ac]Department of Nephrology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, Heilongjiang Province, China[ad]Department of Nephrology, 900th Hospital of the Joint Logistics Team of the Chinese People’s Liberation Army, Fuzhou 350001, Fujian Province, China[ae]Department of Nephrology, Henan Provincial People’s Hospital, Zhengzhou 450003, Henan Province, China[af]Department of Nephrology, Jiangsu Province Hospital, Nanjing 210029, Jiangsu Province, China江苏省人民医院[ag]Department of Nephrology, Jiangxi Provincial People’s Hospital, Nanchang 330006, Jiangxi Province, China[ah]Department of Nephrology, Shanxi Hospital of Integrated Traditional and Western Medicine, Taiyuan 030001, Shanxi Province, China[ai]Department of Nephrology, Shanxi Provincial People’s Hospital, Taiyuan 030012, Shanxi Province, China[aj]Department of Nephrology, the Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China[ak]Department of Nephrology, the Third Xiangya Hospital of Central South University, Changsha 410000, Hunan Province, China[al]Department of Nephrology, Tongde Hospital of Zhejiang Province, Hangzhou 310012, Zhejiang Province, China[am]Department of Nephrology, Xiangya Hospital of Central South University, Changsha 410008, Hunan Province, China[an]Department of Nephrology, Guangzhou First People’s Hospital, Guangzhou 510180, Guangdong Province, China[ao]Department of Nephrology, Zhejiang Provincial People’s Hospital, Hangzhou 310014, Zhejiang Province, China
Background: Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease. Objective: This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium. Design, setting, participants and intervention: This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure < 140/90 mmHg, estimated glomerular filtration rate (eGFR) > 45 mL/min per 1.73m(2), and 24-hour proteinuria level of 0.5-3.0 g, were recruited in 41 hospitals across 19 provinces in China and were randomly divided into five groups: SYKFT, losartan potassium 50 mg or 100 mg, SYKFT plus losartan potassium 50 mg or 100 mg. Main outcome measures: The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment. Results: A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% +/- 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% +/- 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% +/- 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% +/- 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, - 2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group. Conclusion: SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone. (C) 2021 Shanghai Changhai Hospital. Published by ELSEVIER B.V.
基金：
National Science and Technology Major Projects of China [2014ZX09201021]; Beijing Municipal Science and Technology Commission Major Projects [D181100000118002]
第一作者单位：[a]Department of Nephrology, Chinese People’s Liberation Army General Hospital, Chinese People’s Liberation Army Institute of Nephrology, State Key Laboratory of Kidney Diseases (2011DAV00088), National Clinical Research Center for Kidney Diseases, Beijing 100853, China
通讯作者：
推荐引用方式(GB/T 7714)：
Jie Wu,Shu-wei Duan,Hong-tao Yang,et al.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial[J].JOURNAL of INTEGRATIVE MEDICINE-JIM.2021,19(2):111-119.doi:10.1016/j.joim.2021.01.009.
APA：
Jie Wu,Shu-wei Duan,Hong-tao Yang,Yue-yi Deng,Wei Li...&Xiang-mei Chen.(2021).Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.JOURNAL of INTEGRATIVE MEDICINE-JIM,19,(2)
MLA：
Jie Wu,et al."Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial".JOURNAL of INTEGRATIVE MEDICINE-JIM 19..2(2021):111-119
