CAJ | 학술논문

目的探讨卡泊三醇倍他米松软膏联合窄谱中波紫外线(NB-UVB)治疗斑块状银屑病的疗效及安全性.方法随机、单盲平行对照、多中心临床试验,108例斑块状银屑病患者随机纳入试验组或对照组,疗程4周.对照组单纯进行NB-UVB照射；试验组NB-UVB照射方法同对照组,卡泊三醇倍他米松软膏每晚外用.治疗前、治疗2周、4周时观察疗效及安全性,治疗结束后1、2、4周进行随访.结果两组患者治疗2周后,试验组有效率15.09％,对照组有效率2.04％,总体疗效分析差异有统计学意义.治疗4周后,试验组有效率77.36％,对照组26.53％,两组差异有统计学意义(P＜0.01).治疗前两组PASI评分比较,差异无统计学意义；治疗2周、4周以及随访1周、2周、4周时,两组PASI评分比较,差异均有统计学意义.试验组未发现不良反应,对照组有1例双小腿非皮疹部位出现疼痛性红斑.两组间不良反应发生率比较,差异无统计学意义.结论卡泊三醇倍他米松软膏联合NB-UVB治疗斑块状银屑病是一种见效快、安全的治疗方法.
목적 탐토잡박삼순배타미송연고연합착보중파자외선(NB-UVB)치료반괴상은설병적료효급안전성.방법 수궤、단맹평행대조、다중심림상시험,108례반괴상은설병환자수궤납입시험조혹대조조,료정4주.대조조단순진행NB-UVB조사；시험조NB-UVB조사방법동대조조,잡박삼순배타미송연고매만외용.치료전、치료2주、4주시관찰료효급안전성,치료결속후1、2、4주진행수방.결과 량조환자치료2주후,시험조유효솔15.09％,대조조유효솔2.04％,총체료효분석차이유통계학의의.치료4주후,시험조유효솔77.36％,대조조26.53％,량조차이유통계학의의(P＜0.01).치료전량조PASI평분비교,차이무통계학의의；치료2주、4주이급수방1주、2주、4주시,량조PASI평분비교,차이균유통계학의의.시험조미발현불량반응,대조조유1례쌍소퇴비피진부위출현동통성홍반.량조간불량반응발생솔비교,차이무통계학의의.결론 잡박삼순배타미송연고연합NB-UVB치료반괴상은설병시일충견효쾌、안전적치료방법.
Objective To assess the efficacy and safety of calcipotriol betamethasone ointment combined with narrow band-ultraviolet B (NB-UVB) for the treatment of plaque-type psoriasis.Methods A randomized,single-blind,parallel-controlled,multi-center clinical trial was conducted.Totally,108 patients with plaque-type psoriasis were randomly divided into the experiment group (treated with NB-UVB plus topical calcipotriol betamethasone ointment once daily in the evening) and control group (treated with NB-UVB only).The treatment lasted four weeks.The safety and efficacy were evaluated at the baseline,as well as two and four weeks after the beginning of treatment.Patients were scheduled for follow-up on week 1,2 and 4 after the end of treatment.Results The response rate was 15.09％ in the experiment group and 2.04％ in the control group after two-week treatment (P ＜ 0.01),77.36％ in the experiment group and 26.53％ in the control group at the end of treatment (P ＜ 0.01).Psoriasis area and severity index (PASI) score was similar between the two groups at the baseline,but significantly different from week 2 to week 8 after the beginning of treatment (all P ＜ 0.0I).Adverse reaction was observed in none of these patients,except for one patient in the control group who developed painful erythema in non-lesional sites of both legs.There was no significant difference in the incidence of adverse reactions between the two groups.Conclusion Calcipotriol betamethasone ointment combined with NB-UVB is a safe and effective treatment choice for plaque-type psoriasis with rapid onset of action.