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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40～60mg/d;中度活动期用20～40mg/d,轻度活动期用15～20mg/d;稳定期用小剂量(<15mg/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(0.5～1.0g/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。
Objective To study the effect of Qingjianntojie decoction combined with prednisone tablets on the Th1 / Th2 in patients with systemic lupus erythematosus (SLE), and to explore its main role in the treatment of SLE.Methods Forty-two patients - 2011 March Guangzhou First Affiliated Hospital of Internal Medicine outpatient and hospitalized patients with SLE, random number table is divided into treatment group (22 cases) and control group (20 cases), and the other Guangzhou University of Chinese Medicine First Affiliated Hospital 12 healthy workers and students as healthy control group (healthy group) .The two groups were treated with oral prednisone tablets.The dosage was adjusted according to the score of SLE activity index and condition adjustment: 40 ~ 60mg / d Moderate activity with 20 ~ 40mg / d, mild active use of 15 ~ 20mg / d; stable period with a small dose (<15mg / d) treatment; stable condition 1 to 2 weeks after the gradual reduction by hormone reduction method .Recurrence or combination of lupus nephritis, lupus encephalitis with oral hormones difficult to control the disease, plus standard cyclophosphamide shock therapy (0.5 ~ 1.0g / m2 body surface area, once every 4 weeks) intravenous infusion. Group plus clearing up Jiexiu mixture treatment, 1 day, minutes and nights 2 times Control group plus placebo, day 1, divided into 2 times a day sooner or later, both groups were treated for 6 months.No treatment was taken in the healthy group.The venous blood before and after treatment was detected by enzyme-linked immunosorbent assay Th1 cytokines (IL-10, IL-4) .Results Compared with the healthy group, the levels of Th1 cytokines (IL-12 and IFN-γ ), Th2 type cytokines (IL-10, IL-4) and Th1 / Th2 cytokine ratio (IFN-γ / IL-4, IL-12 / IL-10) P <0.01). Compared with the pretreatment group, the levels of Th1 cytokines (IL-12 and IFN-γ) and the levels of Th2 cytokines (IL-10 and IL- ) And Th1 / Th2 cytokines (P <0.05). Compared with the control group, the levels of IL-4 and IFN-γ in the treatment group were decreased / IL-4 increased (P <0.05), and the number of adverse reactions in the treatment group was less than that in the control group (P0.01) .Conclusion Qingzuruntangjie decoction combined with prednisone tablets can improve the imbalance of Th1 / Th2 cell population, Hormones, side effects of immunosuppressive agents.