复方首乌口服液治疗斑秃的效果和安全性评估

Evaluation of clinical efficacy and safety of compound shouwu oral liquid in the treatment of alopecia areata

目的评估复方首乌口服液治疗斑秃的临床效果和安全性。方法采用随机、平行对照的研究方法,将214例斑秃患者随机分为复方首乌口服液组(试验组)和活力苏口服液组(对照组),每组107例。治疗8周后,比较两组的疗效和不良反应发生情况。结果复方首乌口服液组93例和活力苏口服液组94例完成研究。患者口服复方首乌口服液有效率为81.72%(76/93),口服活力苏口服液有效率为77.66%(73/94),两组有效率无显著性差异(P>0.05)。复方首乌口服液组的疗效指数为(30.07±18.52)%,活力苏口服液组的疗效指数为(29.22±22.02)%,两组疗效指数无显著性差异(P>0.05)。复方首乌口服液组治疗前平均皮肤病生活质量指数(dermatology life quality index,DLQI)评分为(5.14±2.43)分,治疗后平均评分为(2.41±3.03)分,DLQI评分治疗后较治疗前明显降低(P<0.01);活力苏口服液组的治疗前平均DLQI评分评分为(5.66±4.78)分,治疗后平均评分为(2.04±2.47)分,DLQI评分治疗后较治疗前亦明显降低(P<0.01);两组DLQI比较,差异无统计学意义(P>0.05)。复方首乌口服液组的不良反应发生率为1.87%(2/107),活力苏口服液组无不良反应,两组间差异无统计学意义(P>0.05)。结论复方首乌口服液对斑秃有较好疗效,与活力苏口服液疗效相当,且患者耐受性好,安全性高。

Objective To evaluate the efficacy and safety of compound shouwu oral liquid in the treatment of alopecia areata.Methods The trial design was randomand parallel control.A total of 214 alopecia areata patients were randomly devided into compound shouwu oral liquid group(treatment group)and huolisu oral liquid group(control group),each group 107 cases.And after 8 weeks of treatment,efficacy and occurrence of adverse events were compared between the two groups.Results A total of 93 patients in compound shouwu oral liquid group and 94 patients in huolisu oral liquid group finished the trial.After 8 weeks,the efficacy rate of compound shouwu oral liquid group was 81.72%(76/93)and similarly,that of huolisu oral liquid group was 77.66%(73/94,P>0.05).The response index of compound shouwu oral liquid group was(30.07±18.52)%,and also similar to that of huolisu oral liquid group which was(29.22±22.02)%(P>0.05).The baseline mean dermatology life quality index(DLQI)score of compound shouwu oral liquid group was(5.14±2.43)points,dropping to(2.41±3.03)points after 8 weeks(P<0.01),and likewisely.The baseline mean DLQI score of huolisu oral liquid group was(5.66±4.78)points,dropping to(2.04±2.47)points after 8 weeks(P<0.01).No significant difference was found between the two groups at baseline and after treatment(P>0.05).Moreover,the side effect rate of compound shouwu oral liquid group was 1.87%(2/107),while no adverse event occurred in huolisu oral liquid group,and also there was no significant difference between the two groups(P>0.05).Conclusion Compound shouwu oral liquid shows great efficacy in the treatment of alopecia areata,just as huolisu oral liquid,and both are safe and well tolerated.