益肾固发方联合小剂量激素治疗系统性红斑狼疮脱发的临床研究

Clinical Study of Yishen Gufa Recipe Combined with Low-dose Hormone in Treating Alopecia in Systemic Lupus Erythematosus Patients

【目的】观察益肾固发方联合小剂量激素治疗系统性红斑狼疮脱发的临床疗效及安全性。【方法】采用随机平行对照方法,将59例系统性红斑狼疮脱发患者分为对照组29例与试验组30例。对照组给予口服醋酸泼尼松片(每次10 mg,每天1次),试验组给予口服醋酸泼尼松片(用量同对照组)及中药益肾固发方汤剂,3个月为1个疗程,观察2组患者治疗前后脱发的改善情况、系统性红斑狼疮疾病活动指数(SLEDAI)评分、补体水平和血沉(ESR)、C反应蛋白(CRP)的变化情况及用药安全性。【结果】(1)研究过程中,试验组1例脱落,1例失访,对照组2例脱落,无失访病例,最终55例患者(对照组27例、试验组28例)完成了1个疗程的评估。(2)治疗3个月后,试验组的总有效率为89.3%,对照组为59.3%,试验组的疗效明显优于对照组,差异有统计学意义(P<0.05)。(3)治疗后,试验组患者的毛发数量、毛发颜色和毛发光泽均较治疗前明显改善(P<0.05),而对照组患者仅毛发光泽较治疗前明显改善(P<0.05),毛发数量和毛发颜色虽较治疗前有所改善,但差异无统计学意义(P>0.05);组间比较,试验组在改善患者的毛发数量、毛发颜色和毛发光泽方面均明显优于对照组(P<0.05)。(4)治疗后,2组患者的SLEDAI评分、补体C3、C4和ESR、CRP水平均较治疗前明显改善(P<0.05),但治疗后组间比较,差异均无统计学意义(P>0.05)。(5)对照组和试验组不良反应发生率分别为10.34%、13.33%,组间比较,差异无统计学意义(P>0.05)。【结论】益肾固发方联合西药治疗系统性红斑狼疮脱发疗效确切,且安全性高。

Objective To observe the clinical efficacy and safety of Yishen Gufa Recipe combined with low-dose hormone for the treatment of alopecia in systemic lupus erythematosus(SLE)patients.Methods A total of 59 alopecia patients with SLE were divided into control group(29 cases)and trial group(30 cases)by randomized parallel-controlled method.The control group was given oral use of Prednisone Acetate Tablets(10 mg,qd),and the trial group was given oral use of the decoction of Yishen Gufa Recipe combined with Prednisone Acetate Tablets(10 mg,qd).Three months constituted one treatment course.Before and after treatment,the improvement in hair loss,levels of complements,erythrocyte sedimentation rate(ESR)and C-reactive protein(CRP),and medication safety in the two groups were observed.Results(1)During the trial,there was one case dropped out and one case lost to follow-up service in the trial group,and were 2 cases dropped out and none case lost to followup service in the control group;finally,a total of 55 cases(27 from the control group and 28 from the trial group)completed the trial for one course.(2)After treatment for 3 months,the total effective rate of the trial group was89.3%and that of the control group was 59.3%,and the difference between the two groups was statistically significant(P<0.05),indicating that the clinical efficacy of the trial group was superior to that of the control group.(3)After treatment,the amount,color and luster of the hair in the trial group were much improved(P<0.05 compared with those before treatment),and in the control group,only the hair luster was significantly improved(P<0.05)while the improvement of hair amount and hair color did not differ from those before treatment(P>0.05).The inter-group comparison showed that the improvement of the amount,color and luster of the hair in the trial group was superior to that in the control group(P<0.05).(4)After treatment,scores of SLE disease activity index(SLEDAI)and the levels of complements(C3 and C4),ESR and CRP level in the two groups were much improved(P<0.05 compared with those before treatment),but the post-treatment inter-group differences were insignificant(P>0.05).(5)The incidence of adverse reactions in the control group was 10.34%and that in the trial group was 13.33%,the difference between the two groups being not statistically significant(P>0.05).Conclusion Yishen Gufa Recipe combined with western medicine is effective and safe for the treatment of alopecia in SLE patients.