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目的:评价风免一号方联合西药治疗阴虚内热型系统性红斑狼疮(SLE)的临床疗效。方法:将中医辨证为阴虚内热型轻度及中度活动的SLE患者随机分为治疗组与对照组各30例。两组均给予醋酸泼尼松片加硫酸羟基氯喹作为基本用药。治疗组再给予风免一号方加霉酚酸酯片。对照组再给予霉酚酸酯片。中药每日1剂,分两次煎汤,每次100 m L口服;霉酚酸酯片750 mg,每日2次口服。两组均以24周为1个疗程,疗程结束后观察两组患者的SLE疾病活动指数(SLE-DAI)积分、中医证侯评分、血沉、24 h尿蛋白定量、免疫指标[免疫球蛋白G(IgG)、免疫球蛋白M(IgM)、免疫球蛋白A(IgA)、补体C3(C3)、补体C4(C4)]与抗体[抗双链DNA(抗ds-DNA)]的变化以及并发症的发生率。结果:两组患者临床疗效比较:治疗组显效2例,有效23例,无效5例,对照组显效0例,有效17例,无效13例。治疗后两组中医证候积分、SLE-DAI积分组内比较,治疗组的差异有统计学意义(P<0.01);组间比较,治疗组中医证候积分改善优于对照组,差异有统计学意义(P<0.01)。治疗后两组组内比较,治疗组IgG、IgA差异有统计学意义(P<0.05)、治疗组IgM、C3差异有显著统计学意义(P<0.01);组间比较,治疗组IgG、C3改善优于对照组,差异有统计学意义(P<0.05)。治疗后两组组内比较,治疗组24 h尿蛋白定量、抗ds DNA抗体的差异有统计学意义(P<0.05)、对照组血沉、抗dsDNA抗体的差异有统计学意义(P<0.05);组间比较,治疗组24 h尿蛋白定量、抗ds DNA抗体改善优于对照组,差异有统计学意义(P<0.05)。治疗组并发症事件的总发生率与对照组比较有显著性差异(P<0.05)。结论:采用风免一号方联合西药治疗轻中度活动期系统性红斑狼疮(阴虚内热型)疗效确切,并发症发生少。
Objective: To evaluate the clinical efficacy of Fengli No.1 combined with western medicine in the treatment of Yin deficiency endogenous heat systemic lupus erythematosus (SLE). Methods: SLE patients with mild and moderate activity of Yin internal heat syndrome were randomly divided into treatment group (30 cases) and control group (30 cases). Both groups were given prednisone acetate tablets plus hydroxychloroquine sulfate as a basic medication. The treatment group was given wind-free one side plus mycophenolate mofetil. The control group was given mycophenolate mofetil again. Chinese medicine daily 1 dose, decoction twice in a row, each 100 m L oral; mycophenolate mofetil 750 mg, 2 times daily oral. The two groups were treated with 24 weeks as a course of treatment. After the course of treatment, the SLE disease activity index (SLE-DAI) score, TCM syndrome score, ESR, 24 h urinary protein quantitation, immune index [immunoglobulin G (Anti-ds-DNA)], as well as the changes of IgG, IgM, IgA, C3, C3 and anti-dsDNA The incidence of disease. Results: The clinical efficacy of the two groups were compared: two cases in the treatment group were markedly effective, 23 cases were effective and 5 cases were ineffective. The control group was markedly effective in 0 cases, effective in 17 cases and ineffective in 13 cases. After treatment, the scores of TCM syndromes in the two groups were significantly higher than those in the SLE-DAI group (P <0.01), and the scores of TCM syndromes in the treatment group were better than those in the control group Significance (P <0.01). After treatment, the difference of IgG and IgA in treatment group was statistically significant (P <0.05), the difference of IgM and C3 in treatment group was statistically significant (P <0.01) Improve better than the control group, the difference was statistically significant (P <0.05). After treatment, the difference of 24 h urine protein and anti-ds DNA antibody in the treatment group was statistically significant (P <0.05), and the difference of the ESR and anti-dsDNA antibody in the control group was statistically significant (P <0.05) Compared between two groups, 24 h proteinuria in treatment group was better than that in control group, and the difference was statistically significant (P <0.05). The overall incidence of complications in the treatment group compared with the control group were significantly different (P <0.05). Conclusion: The treatment of mild-moderate active systemic lupus erythematosus (Yin-type endogenous heat type) with Fengli No.1 and western medicine has definite effect and few complications.