title: [Treatment of chronic primary glomerulopathy patients of Shen deficiency and dampness heat syndrome by yishen qingli granule combined low-dose Tripterygium wilfordii multiglycoside tablet: a clinical efficacy observation].
abstract: OBJECTIVE
  To evaluate the clinical efficacy and safety of treatment of chronic primary glomerulopathy (CPG) patients of Shen deficiency and dampness heat syndrome (SDDHS) by Yishen Qingli Granule (YQG) combined with low-dose Tripterygium Wilfordii multiglycoside Tablet (TWT).
  
  
  METHODS
  Totally 231 CPG patients of SDDHS were enrolled in this study (including 60 patients from First Affiliated Hospital of Nanjing University of Chinese Medicine, 58 from First Affiliated Hospital of Nanjing Medical University, 46 from Xinqiao Hospital of Third Military Medical University, 35 from First Affiliated Hospital of Guangzhou University of Chinese Medicine, 14 from First Affiliated Hospital of Soochow University, and 18 from Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine). They were randomly assigned to the control group (116 cases) and the trial group (115 cases) according to block group method. There were 217 cases in the safety analysis set (109 cases in the trial group vs 108 cases in the control group), and 203 cases in the full analysis set (99 cases in the trial group vs 104 cases in the control group). All patients received basic treatment such as ACEI/ARB. Furthermore, YQG (consisting of raw astragalus 10 g, prepared Polygonum Multiflorum 10 g, Pyrrosia 10 g, 1.5 g each package, containing 10 g of crude drugs) was additionally given to patients in the trial group, each package, twice daily. The TWT (10 mg) was given, twice a day. The TWT dose was adjusted according to 24 h urinary total protein (UTP). The placebos of YQG and TWT were administered to those in the control group. The treatment course consisted of 24 weeks and the follow-up visit lasted for 24 weeks. The biochemical indices were observed before and after treatment including 24 h UTP, urine red cell count (U(RBC)), renal functions (BUN, SCr), blood routine test (WBC), and liver functions (SGPT, SGOT). Reverse reactions such as gastrointestinal discomfort, skin rash, and irregular menstruation were also observed.
  
  
  RESULTS
  Compared with the control group, the total effective rate was better in the trial group (82.83% vs 61.54%, P < 0.01). Results of stratified comparison of UTP showed better efficacy in the trial group (0.8-3.0 g/24 h, P < 0.01). The UTP decline occurred in the trial group after 8 weeks of treatment, with stable action, showing statistical difference when compared with the control group (P < 0.01). In the trial group, U(RBC) level decreased after treatment but changed more significantly. But there was no statistical difference in the changes when compared with the control group (P > 0.05). After treatment, there were no statistical difference in safety indicators such as WBC, SGPT, and SGOT between the two groups after treatment (P > 0.05).
  
  
  CONCLUSIONS
  On the basis of basic treatment such as ACEI/ARB, application of YQG combined with low-dose TWT had better effect in controlling proteinuria of CPG patients, and could help stabilizing their conditions with less adverse reactions.
authors: Department of Nephrology, The First Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China. dr.smx@163.com
authors: Mei-Xiao
authors: MX
authors: Sheng
authors: Department of Nephrology, The First Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.
authors: Wei
authors: W
authors: Sun
authors: Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.
authors: Chang-Ying
authors: CY
authors: Xing
authors: Department of Nephrology, Xinqiao Hospital of Third Military Medical University, Sichuan 400037, China.
authors: Fa-Huan
authors: FH
authors: Yuan
authors: Third Department of Internal Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.
authors: Shui-Fu
authors: SF
authors: Tang
authors: Department of Integrated Traditional and Western Medicine, The First Affiliated Hospital of Soochow University, Jiangsu 215006, China.
authors: Pei-Hua
authors: PH
authors: Xiong
authors: Department of Nephrology, Wuxi Affiliated Hospital of Nanjing University of Chinese medicine, Jiangsu 214001, China.
authors: Ji-Pei
authors: JP
authors: Ma
authors: Department of Nephrology, The First Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.
authors: Dong
authors: D
authors: Zhou
authors: Department of Nephrology, The First Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.
authors: Kun
authors: K
authors: Gao
authors: Department of Nephrology, The First Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.
authors: Yan
authors: Y
authors: Jiang
authors: Department of Nephrology, The First Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.
authors: Ji-Hong
authors: JH
authors: Chen
authors: Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China.
authors: Hui-Juan
authors: HJ
authors: Mao
authors: Department of Nephrology, Xinqiao Hospital of Third Military Medical University, Sichuan 400037, China.
authors: Jiao
authors: J
authors: Mou
authors: Third Department of Internal Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.
authors: Yue-Zhong
authors: YZ
authors: Luo
authors: Department of Integrated Traditional and Western Medicine, The First Affiliated Hospital of Soochow University, Jiangsu 215006, China.
authors: Ming-Gang
authors: MG
authors: Wei
authors: Department of Nephrology, Wuxi Affiliated Hospital of Nanjing University of Chinese medicine, Jiangsu 214001, China.
authors: Cai-Xiang
authors: CX
authors: Liu
mesh_terms: D000328:Adult; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007674:Kidney Diseases / Q000175:diagnosis* / Q000188:drug therapy*; D007678:Kidney Glomerulus / Q000473:pathology; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D016896:Treatment Outcome; D029757:Tripterygium
chemical_list: D004365:Drugs, Chinese Herbal; C525740:yishen