复方生地合剂治疗系统性红斑狼疮(阴虚内热型)的有效性与安全性评价

Evaluation on Efficacy and Safety of “Compound Shengdi Mixture” in Treating Systemic Lupus Erythematosus of Yin-deficiency and Interior-heat Type

目的:评价复方生地合剂治疗阴虚内热型系统性红斑狼疮(SLE)的临床疗效及其安全性。方法:选择阴虚内热型SLE患者65例,随机分为治疗组31例和对照组34例。两组均以糖皮质激素作为基础用药,治疗组给予复方生地合剂,对照组给予硫酸羟基氯喹治疗,疗程12周。观察两组的临床疗效、系统性红斑狼疮疾病活动指数(SLEDAI)、免疫学指标及安全性指标。结果:治疗后,治疗组和对照组的总有效率分别为60.0%和56.7%,两组比较差异无统计学意义(P>0.05)。治疗后,两组患者的SLEDAI、抗ds-DNA水平均显著降低(P<0.01,P<0.05),但两组比较差异无统计学意义(P>0.05)。治疗过程中,治疗组和对照组的不良反应事件发生率分别为10.0%和34.3%,治疗组明显低于对照组(P<0.05)。结论:复方生地合剂对SLE有一定的免疫抑制作用,且能降低SLE的活动度,毒副反应较少。

Objective： To evaluate the therapeutic effect and safety of “Compound Shengdi Mixture” in treating systemic lupus erythematosus （SLE） of yin-deficiency and interior-heat type. Methods ： Sixty-five patients with SLE of yin-deficiency and interior-heat type were selected and randomly divided into treatment group （n =31 ） and control group （ n =34）. The treatment group was treated with “Compound Shengdi Mixture” plus glucocorticoids and the control group was treated with hydroxychloroquine sulfate plus glucucortieoids, with a course of 12 weeks. The clinical effect, SLEDAI, immunological indexes and safety indexes were observed. Results： After treatment, the total effective rates of treatment group and control group were 60.0% and 56.7%, with no statistical difference between two groups （P 〉0.05 ）. The levels of SLEDAI and ds-DNA antibody were Significantly decreased in both groups （P 〈0.01 ,P 〈0.05 ）, with no difference between two groups （P 〉0.05 ）. In the course of treatment, the incidence rates of adverse reaction of treatment group and control group were 10% and 34.3% respectively, with statistical difference between two groups （P 〈 0.05 ）. Conclusion： “Compound Shengdi Mixture” has some immunosuppressive function and reduces the SLEDAI with less adverse reaction.