清养透解合剂联合泼尼松片对SLE阴虚证患者Th1/Th2的影响

Effects of Qingyang Toujie Mixture in Combination with Prednisone Tablet on Th1/Th2 Cytokines in Patients Suffering from Systemic Lupus Erythematosus

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DOI：

中文关键词: 系统性红斑狼疮清养透解合剂阴虚证 Th1/Th2细胞因子

英文关键词:systemic lupus erythematosus Qingyang Toujie Mixture yin deficiency syndrome Th1/Th2 cytokine

基金项目:广东省科技计划项目（No.2008152）；广州中医药大学科技创新基金项目（No.09CX025）

作者	单位	E-mail
黄钢花,陈银环,段红妍,刘叶
钟嘉熙	广州中医药大学第一附属医院（广州510405）	hy1309@126.com

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中文摘要:

目的研究清养透解合剂联合泼尼松片对系统性红斑狼疮（systemic lupus erythematosus， SLE 阴虚证患者Th1/Th2的影响，探讨其治疗SLE的主要作用环节。方法选择42例2009年8月—2011年3月广州中医药大学第一附属医院内科门诊及住院SLE患者，按随机数字表分为治疗组（22例）和对照组（20例），另选择广州中医药大学第一附属医院职工和学生体检健康者12名作为健康对照组（健康组）。两组均采用口服泼尼松片治疗，剂量根据SLE活动性指数评分及病情调整：重度活动期用40～60 mg/d；中度活动期用20～40 mg/d，轻度活动期用15～20 mg/d；稳定期用小剂量（<15 mg/d）治疗；病情稳定1～2周后严格按激素减量法渐次减量。病情复发或合并狼疮肾炎、狼疮脑炎用口服激素难以控制病情时，加用标准环磷酰胺注射液冲击疗法（0.5～1.0 g/m2 体表面积，每4周1次）静脉滴注。治疗组加用清养透解合剂治疗，每天1剂，分早晚2次服用。对照组加用安慰剂，每天1剂，分早晚2次口服。两组均治疗6个月。健康组不予任何治疗措施。治疗前后取静脉血采用酶联免疫法检测Th1类细胞因子（IFN-γ、IL-12）、Th2类细胞因子（IL-10、IL-4）。结果与健康组比较，治疗组和对照组治疗前血清Th1类细胞因子（IL-12、IFN-γ）、Th2类细胞因子（IL-10、IL-4）升高，Th1/Th2 细胞因子比值（IFN-γ/IL-4、IL-12/IL-10）降低，差异均有统计学意义（P<0.01）；与本组治疗前比较，治疗组治疗后血清Th1类细胞因子（IL-12、IFN-γ）降低、Th2类细胞因子（IL-10、IL-4）降低（P<0.05），Th1/Th2 细胞因子比值（IFN-γ/IL-4、IL-12/IL-10）升高（P<0.05）；与对照组治疗后比较，治疗组IL-4降低，IFN-γ/IL-4升高（P<0.05）。治疗组不良反应例数少于对照组（P<0.01）。结论清养透解合剂联合泼尼松片能改善Th1/Th2 细胞群失衡，能减轻激素、免疫抑制剂的毒副作用。

英文摘要:

Objective To research the effects of Qingyang Toujie Mixture （QTM） in combination with prednisone tablet on the balance of Th1 and Th2 （Th1/Th2） of systemic lupus erythematosus （SLE） patients of yin deficiency syndrome （YDS）. Methods Totally 42 patients with SLE were recruited from clinics of internal medicine and hospitalization department of First Hospital Affiliated to Guangzhou University of Traditional Chinese Medicine from August 2009 to March 2011. They were randomly assigned to the treatment group （22 cases） and the control group （20 cases） according to the random digit table. Another 12 healthy subjects were recruited as the healthy control group from employees of First Hospital Affiliated to Guangzhou University of Traditional Chinese Medicine and healthy students in physical examinations. All patients took prednisone tablet. The dosage was adjusted according to the severity of SLE activity index and the condition： 40－60 mg per day for severe active stage； 20－40 mg per day for moderate active stage； 15－20 mg per day for light active stage； and less than 15 mg per day for those in the stable stage， respectively. When patients′ condition had been stabilized for 1 to 2 weeks， the dosage was gradually reduced according to the method of hormone reduction. In case of the recurrence of symptoms or when complicated with lupus nephritis or lupus encephalitis uncontrollable， standard shock therapy with Cyclophosphamide Injection （0.5－1 g/m2 body surface area， intravenous dripping， once every 4 weeks） was performed. Patients in the treatment group took QTM additionally， one dose daily， taken in two portions， once in the morning and once in the evening. Those in the control group took placebos additionally， one dose daily， taken in two portions， once in the morning and once in the evening. The therapeutic course was 6 months for all. No measure was taken for those in the healthy control group. Venous blood was withdrawal before and after treatment. Th1 cytokines （IFN-γ， IL-12） and Th2 cytokines （IL-10， IL-4） were detected by ELISA. ResultsCompared with the healthy control group， the serum Th1 cytokines such as IL-12 and IFN-γ， Th2 cytokines such as IL-10 and IL-4 increased， the Th1/Th2 ratios such as IFN-γ/IL-4 and IL-12/IL-10 decreased in the treatment group and the control group before treatment （P<0.01）. Compared with before treatment in the same group， the serum Th1 cytokines such as IL-12 and IFN-γ decreased，the serum Th2 cytokines such as IL-10 and IL-4 decreased， the ratios of Th1/Th2 cytokines such as IFN-γ/IL-4 and IL-12/IL-10 increased in the treatment group （all P<0.05）. Compared with the control group after treatment， IL-4 decreased， and the ratio of IFN-γ/IL-4 increased in the treatment group （P<0.05）. Fewer patients suffered from adverse reactions in the treatment group than in the control group （P<0.01）. Conclusion QTM in combination with prednisone tablet was effective to improve the balance of Th1/Th2 cytokines， and alleviate the toxic and adverse reactions of hormone or immune inhibitors.

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