清热养阴除湿丸治疗湿热型银屑病关节炎疗效及安全性的随机对照研究

Randomly controlled study on the therapeutic effect and safety of heat-clearing yin-nourishing dampnesseliminating Bolus on damp-heat type of psoriatic arthritis

目的评价清热养阴除湿丸(CSW)治疗湿热型银屑病关节炎(PsA)皮肤及关节病变的疗效与安全性。方法将60例湿热型PsA患者随机分为CSW组和甲氨蝶呤(MTX)组各30例,分别给予CSW、MTX治疗,疗程均为12周。以银屑病皮损面积和严重性指数(PASI)提高50%、75%(PASI 50、PASI 75)为银屑病皮损疗效指标。以PsA疗效标准(PsARC)为关节炎主要疗效指标,修订的美国风湿病学会疗效标准提高20%(ACR 20)为次要疗效指标,对关节病变进行评估,并比较2组压痛关节数、肿胀关节数、疼痛评分、健康评估问卷(HAQ)得分。结果治疗12周时CSW组、MTX组达到PASI 50的比例分别为51.8%、61.5%,达到PASI 75的比例分别为33.3%、38.5%,CSW组达到PASI50、PASI 75的比例略低于MTX组,但差异无统计学意义(P>0.05)。CSW组、MTX组达到ACR 20的比例分别为48.1%、57.7%。CSW组和MTX组PASI和HAQ得分、压痛关节数、肿胀关节数、疼痛评分均较治疗前显著降低(P<0.05),但2组间差异无统计学意义(P>0.05)。2组均未发生严重不良事件。结论CSW治疗PsA皮损及关节病变有一定疗效,安全性好。

Objective To evaluate the therapeutic effect and safety of heat-clearing yin-nourishing dampness-eliminating(CSW)bolus on damp-heat type of psoriatic arthritis(PsA)with the symptoms of skin and joint disorders.Methods Randomly controlled method was used to divide 60 cases of patients with damp-heat type of PsA into CSW group and MTX group.CSW group was given heat-clearing yin-nourishing dampness-eliminating bolus and non-steroidal anti-inflammatory drug,and MTX was given MTX and non-steroidal anti-inflammatory drug,both for 12 weeks.The lesion area and PASI,when improved by50%,75%(PASI50、PASI75)were considered to evaluate the lesion condition;PsARC as the main index to evaluate the condition of arthritis;revised American ACR20 as the secondary index.The scores of pain,the number of tender joints,and the number of swelling joints,PASI,health evaluation questionnaire of two groups were compared.Results When both groups were treated for 12 weeks,PASI50 reached to 51.8% and 61.5% respectively in CSW group and MTX group,PASI75 to33.3% and 38.5%,ACR20 to 48.1% and 57.7%.PASI,the number of tender joints,and the number of swelling joints were all lowered in both two groups compared with that before the treatment(P<0.05).HAQ of both groups were improved but the difference of two groups were not statistically significant(P >0.05).Adverse incidence was not found in both groups.Conclusion Heat-clearing yin-nourishing dampness-eliminating Bolus has certain effect on damp-heat type of psoriatic arthritis with safety.