| OBJECTIVE: 1. To investigate the efficacy and side effects of Zishenhuadu Formula(ZF) plus cyclophosphamide(CTX) pulse therapy in the treatment of active lupus nephritis (LN) . 2. To evaluate the chang of the expression of Fas Fas ligand (FasL) bcl-2 of peripheral blood lymphocytes (PBL) in LN patients treated with ZF plus CTX pulse therapy , and to explore the potential mechanism of action for clinical drug.MATERIALS AND METHODS: We studied 40 patients who met the following inclusion criteria: (1) systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria; (2) the lupus activity criteria count designed by Urowitz and creatinine (<265.2umol/L); (3) lupus nephritis class III, IV, or V according to the World Health Organization. (4) Excessive Noxious Heat (ENH) TCM syndrome. 40 patients were equally divided into 2 groups by random number table: group A (3 males, 17 females: mean ago 31.20?.85 years; median course of diseases 24.5 months,range 2 month to 155 months; 12 patients with relapses,8 patients diagnosed newly) and group B (2 males, 18 females: mean ago 32.00?.76 years; median course of diseases 23 months,range 1 month to 140 months; 9 patients with relapses, 11 patients diagnosed newly). All patients received steroid and cyclophosphamide (CTX) intermittent intravenous pulse therapy, but at the same time group A received Zishenhuadu Formula(ZF) therapy. We studied for 3 months. SLE Disease Activity Index (SLEDAI) score was assessed, and clinical and laboratory data, including creatinine(CREA), serum albumin(ALB),urine test, routine blood test, creatinine clearance(Ccr), 24-h urinary protein, complement factor C3, anti-dsDNA, ANA and analyses of Fas FasL bcl-2 of PBL, were collected monthly for 3 months. The expression of Fas FasL and bcl-2 were examined by immunohistochemical stain, and analyses of anti-dsDNA, and ANA were performed with indirect immunofluorescence.RESULTS: At the end of 3rd month, Clinical and laboratory data of group A , including SLEDAI, 24-h urinary protein,ALB, Hgb ,Ccr and C3,showed more marked improvement than that of group B at the corresponding period,difference is significant at the 0.05 level (2-tailed); The ascending range of Hgb,ALB and C3 was greater than that of group B difference is significant at the 0.05 level (2-tailed); Apparent rate of group A wassignificantly higher than that of group B(p<0.05); The results showed a significant decrement of the expression of Fas and FasL in two group and the expression of bcl-2 in group A (p< 0.01) ,and especially the greater descending range of the expression of Fas and FasL in group A (p<0.05). It was less toxicity including leucocytopenia(5.0%), liver toxicity(5.0%), thick coated tongue(40.0%) ,insomnia(25.0%) and acne(25.0%) (p<0.05) .CONCLUSION: The efficacy of ZF plus CTX pulse therapy in treating lupus nephriris were better than those of single CTX pulse therapy, especially in improving anemia, hypoalbuminemia and hypocomplementemia; and it was less toxicity including arrest of bone marrow, liver toxicity ,and damp-heat and Yin deficiency TCM syndrome induced by steroid. This study provides evidence that the regulation of Fas and FasL is a novel target for the therapy of lupus nephriris. |
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