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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (8): 762-766.doi: 10.3736/jcim20100806

• Original Clinical Research • Previous Articles     Next Articles

Efficacy of ginsenosides combined with prednisone in patients with systemic lupus erythematosus: a prospective, randomized, double-blind, placebo-controlled trial

Yan-li Youa, Ying-lu Fenga, Qing Caib, Jian-long Guanb, Lan-ling Zhangb, Mei-juan Xub, Xia Xub,Chang-quan Linga   

  1. a Department of Acupuncture and Massage, Changhai Hospital, Second Military Medical University, Shanghai 200433, China
    b Department of Rheumatology and Immunology, Changhai Hospital, Second Military Medical University, Shanghai 200433, China
  • Received:2010-02-05 Accepted:2010-05-07 Online:2010-08-20 Published:2010-08-15

Background

The side effects of glucocorticoid in treatment of systemic lupus erythematosus (SLE) have been the focus of debate, and our preliminary study indicates that ginsenosides can enhance the efficacy of dexamethasone.
Objective

To observe the effects of ginsenosides combined with prednisone in SLE patients.
Design, setting, participants and interventions

A total of 60 SLE patients from Department of Rheumatology and Immunology, Changhai Hospital, Second Military Medical University, were randomly divided into treatment group and control group, with 30 patients in each group. Patients in the treatment group were given routine treatment with prednisone plus ginsenosides, while those in the control group were given routine treatment with prednisone plus placebo. They were all treated for 3 months.
Main outcome measures

After three-month treatment, syndrome score in traditional Chinese medicine (TCM), total response rate and symptom improvement rate were measured and evaluated.
Results

Twenty-eight cases in treatment group and twenty-seven cases in control group were included in analysis. The total response rates in the treatment group and control group were 89.28% and 66.67% respectively, and there was a significant difference between the two groups (P<0.05). After treatment, the TCM syndrome scores in the two groups were lower than those before treatment (P<0.01), and prednisone plus ginsenosides was better in decreasing the TCM syndrome score than prednisone plus placebo (P<0.05). The symptoms were improved in the treatment group as compared with the control group (P<0.05).
Conclusion

Prednisone combined with ginsenosides can increase the clinical effective rate and improve the clinical symptoms of SLE patients.

Key words: Systemic lupus erythematosus, Qinsenosides, Prednisone, Prospective study, Double-blind study, Placebo, Randomized controlled trial

Figure 1

Flow diagram of this randomized trial"

Table 1

Effect analysis of common symptoms in two groups"

[1] Williams RC . Autoimmune disease etiology: a perplexing paradox or a turning leaf[J]. Autoimmun Rev, 2007,6(4):204
doi: 10.1016/j.autrev.2006.08.012 pmid: 17317608
[2] Petri M . Epidemiology of systemic lupus erythematosus[J]. Best Pratt Res Clin Rheumatol, 2002,16(5):847
doi: 10.1053/berh.2002.0259 pmid: 3316995
[3] Sandborg C, Ardoin SP, Schanberg L . Therapy Insight: cardiovascular disease in pediatric systemic lupus erythematosus[J]. Nat Clin Pract Rheumatol, 2008,4(5):258-265
[4] Chen H, Zhang W . Clinical use of glucocorticoids in treating systemic lupus erythematosus[J]. Nei Ke Li Lun Yu Shi Jian, 2008,3(3):175-179
陈华, 张文 . 糖皮质激素在系统性红斑狼疮治疗中的应用[J]. 内科理论与实践, 2008,3(3):175-179
[5] Wang YM . Progress of pharmacology research of ginseng[J]. Ren Shen Yan Jiu, 2001,13(3):2-10
doi: 10.3969/j.issn.1671-1521.2001.03.001
王筠默 . 人参药理研究的进展[J]. 人参研究, 2001,13(3):2-10
doi: 10.3969/j.issn.1671-1521.2001.03.001
[6] Ren JH, Chen LF, Zhang LH . Immuno-improving effect of ginsenoside Rg1[J]. Zhong Yao Xin Yao Yu Lin Chuang Yao Li, 2002,13(2):92-93
doi: 10.3321/j.issn:1003-9783.2002.02.010
任杰红, 陈林芳, 张路晗 . 人参皂苷Rg1的免疫促进作用[J]. 中药新药与临床药理, 2002,13(2):92-93
doi: 10.3321/j.issn:1003-9783.2002.02.010
[7] Guo CX, Yang XY, Lin ZF, Zhao L, Shan HW, Chen DC, Yan M . Clinical observation on effects of Shengmai injection on plasma vasoactive mediators in patients with systemic inflammatory response syndrome[J]. Zhongguo Zhong Xi Yi Jie He Ji Jiu Za Zhi, 2004,11(4):239-241
doi: 10.3321/j.issn:1008-9691.2004.04.008
郭昌星, 杨兴易, 林兆奋, 赵良, 单红卫, 陈德昌, 严鸣 . 生脉注射液对全身炎症反应综合征患者血浆血管活性介质影响的临床观察[J]. 中国中西医结合急救杂志, 2004,11(4):239-241
doi: 10.3321/j.issn:1008-9691.2004.04.008
[8] Niu YF, Chen XW . Observation on therapeutic efficacy of Shenmai Injection on cardiac damage due to systemic lupus erythematosus[J]. Zhong Xi Yi Jie He Shi Yong Lin Chuang Ji Jiu Za Zhi, 1998,5(12):553
牛云飞, 陈晓雯 . 参麦注射液治疗系统性红斑狼疮心脏损害疗效观察[J]. 中西医结合实用临床急救杂志, 1998,5(12):553
[9] Feng YL, Ling CQ, Zhu DZ, Yu CQ, Chen Z, Li B . Ginsenosides combined with dexamethasone in preventing and treating postembolization syndrome following transcatheter arterial chemoembolization: a randomized, controlled and double-blinded prospective trial[J]. J Chin Integr Med, 2005,3(2):99-103
封颖璐, 凌昌全, 朱德增, 俞超芹, 陈喆, 李柏 . 人参皂苷联合地塞米松防治经动脉化疗栓塞术后综合征的前瞻性双盲随机对照研究[J]. 中西医结合学报, 2005,3(2):99-103
[10] Zhou XY, Zheng JR . Diagnosis and treatment principles of atypical systemic lupus erythematosus in adult[J]. Guo Wai Yi Xue Pi Fu Xing Bing Xue Fen Ce, 2000,26(6):361-363
周小勇, 郑家润 . 成人系统性红斑狼疮的诊断和处理原则[J]. 国外医学皮肤性病学分册, 2000,26(6):361-363
[11] Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang CH . Derivation of the SLEDAI: a disease activity index for lupus patients[J]. Arthritis Rheum, 1992,35(6):630-640
doi: 10.1002/art.1780350606 pmid: 1599520
[12] Zheng XY. Guidelines for clinical research on Chinese new herbal medicines[M]. Beijing: China Medical Science and Technology Press,2002: 115
郑筱萸 . 中药新药临床研究指导原则[M]. 北京: 中国医药科技出版社,2002: 115
[13] Gladman DD, Urowitz MB, Doris F, Lewandowski K, Anhorn K . Glucocorticoid receptors in systemic lupus erythematosus[J]. J Rheumatol, 1991,18(5):681-684
pmid: 1865413
[14] Li JH, Shang YB, Li B, Zhai N, Song FJ . Detection of glucocorticoid, glucocorticoid receptor and soluble intercellular adhesion molecule-1 in patients with systemic lupus erythematosus[J]. Zhongguo Ma Feng Pi Fu Bing Za Zhi, 2005,21(10):777-778
李久宏, 尚英彬, 李波, 翟宁, 宋芳吉 . 系统性红斑狼疮患者糖皮质激素及受体与sICAM-1的检测[J]. 中国麻风皮肤病杂志, 2005,21(10):777-778
[15] Du J, Li M, Zhang DH, Zhu XY, Zhang WW, Gu W, Feng YL, Zhai XF, Ling CQ . Flow cytometry analysis of glucocorticoid receptor expression and binding in steroid-sensitive and steroid-resistant patients with systemic lupus erythematosus[J]. Arthritis Res Ther, 2009,11(4):R108
doi: 10.1186/ar2763
[16] Li JH, Li B, Bi GJ, Song FJ . Study on the relevance of glucocorticoid receptor and the mRNA in patients with systemic lupus erythematosus[J]. Zhonghua Pi Fu Ke Za Zhi, 2004,37(1):48-49
doi: 10.3969/j.issn.1009-1157.2005.06.001
李久宏, 李波, 毕桂姣, 宋芳吉 . 系统性红斑狼疮患者糖皮质激素及受体mRNA相关性研究[J]. 中华皮肤科杂志, 2004,37(1):48-49
doi: 10.3969/j.issn.1009-1157.2005.06.001
[17] Li ZJ, Yu YM, Li XF, Chen LJ, Sun JJ . Determination and clinical significance of the binding capacity of glucocorticoid receptor on peripheral leukocytes from patients with systemic lupus erythematosus[J]. Zhonghua Feng Shi Bing Xue Za Zhi, 2005,9(10):597-600
李志军, 余裕民, 李兴福, 陈琳洁, 孙俊杰 . 系统性红斑狼疮患者外周血白细胞糖皮质激素受体结合量测定的临床意义[J]. 中华风湿病学杂志, 2005,9(10):597-600
[18] Li XP, Wang Y, Yang L . Pharmacology and clinical applications of Radix Ginseng[J]. Zhonghua Lin Chuang Yi Xue Yan Jiu Za Zhi, 2006,12(17):2378
李晓平, 王宇, 杨玲 . 人参的药理作用与临床应用[J]. 中华临床医学研究杂志, 2006,12(17):2378
[19] Wang WX, Wang Q . Immunomodulatory effects and applications of ginseng saponins[J]. Zhonghua Zhong Yi Yao Za Zhi, 2005,20(4):234-236
doi: 10.3969/j.issn.1673-1727.2005.04.014
王卫霞, 王谦 . 人参皂苷的免疫调节作用及其应用[J]. 中华中医药杂志, 2005,20(4):234-236
doi: 10.3969/j.issn.1673-1727.2005.04.014
[20] Li M, Ling CQ, Huang XQ, Shen ZL . Effects of ginsenosides extracted from ginseng stem and leaves on glucocorticoid receptor in different viscera in heat-damaged rats[J]. J Chin Integr Med, 2006,4(2):156-159
李敏, 凌昌全, 黄雪强, 沈志雷 . 人参茎叶皂苷对热损伤大鼠不同脏器糖皮质激素受体的影响[J]. 中西医结合学报, 2006,4(2):156-159
[21] Li Y, Li M, Wang X, Hu X, Ling CQ . Experimantal study on the effect of ginsenosides of ginseng stem and leaf in enhancing the transactivation of glucocorticoid receptor induced by dexamethasone in vitro[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2004,24(8):710-713
doi: 10.7661/CJIM.2004.8.710
李勇, 李敏, 王喜, 胡侠, 凌昌全 . 人参茎叶皂甙增强糖皮质激素受体转录激活效应的实验研究[J]. 中国中西医结合杂志, 2004,24(8):710-713
doi: 10.7661/CJIM.2004.8.710
[22] Feng YL, Ling CQ, Chen Z, Li B, Gu W . Ginsenosides and dexamethasone in managing the liver injury and renal function after transcatheter arterial chemoembolization for hepatic carcinoma patient[J]. Zhonghua Zhong Liu Za Zhi, 2006,28(11):844-847
封颖璐, 凌昌全, 陈喆, 李柏, 顾伟 . 人参皂苷联合地塞米松防治经动脉化疗栓塞术后肝肾功能损伤的前瞻性研究[J]. 中华肿瘤杂志, 2006,28(11):844-847
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