Bagel Jerry, Levi Eugenia, Tyring Stephen, Knuckles Melissa L F
J Drugs Dermatol. 2014 Nov;13(11):1374-9.
Treatment with calcipotriene plus betamethasone dipropionate (CBD) fixed-combination topical suspension has been shown to be effective and well tolerated in patients with psoriasis vulgaris.
To document experiences with CBD topical suspension in a US clinical dermatology setting using patient-reported outcomes (PROs).
In total, 147 patients were enrolled in this 8-week, prospective, noninterventional, multicenter, one-arm study. Data were collected at baseline and week 8 at the office, and at one time at home (week 2). PROs were assessed using the Dermatology Life Quality Index (DLQI), Patient's Global Assessment of disease severity (PtGA) using a 5-point Likert scale, patient-reported level of itching using a 0-100 graduated visual analog scale, and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Treatment adherence and adverse events (AEs) were assessed at week 8.
After 8 weeks of treatment, DLQI score significantly improved compared with baseline (-5.5 ± 5.93; P<.0001), starting as early as week 2 (-4.2 ± 5.28; P<.0001). The level of itching was significantly reduced from baseline to week 2 (-19% ± 25.94%; P<.0001) and week 8 (-28.6% ± 29.14%; P<.0001). The percentage of patients with "controlled disease" (PtGA score of "clear" or "very mild") was 34.1% at week 2 and 60.2% at week 8. At the end of treatment, mean TSQM-9 scores for effectiveness, convenience, and satisfaction domains ranged from 68 to 74. Patients reported the need to use CBD topical suspension for an average of 53.62 ± 8.05 days. Treatment-emergent AEs occurred in 3 patients.
The results of this noninterventional study are consistent with previously reported data from interventional trials and suggest that treatment with CBD topical suspension is efficacious and well tolerated and improves quality of life in patients with psoriasis vulgaris.
已证明使用卡泊三醇倍他米松二丙酸酯（CBD）固定组合外用混悬液治疗寻常型银屑病患者有效且耐受性良好。
使用患者报告结局（PRO）记录CBD外用混悬液在美国临床皮肤科环境中的应用经验。
总共147名患者参加了这项为期8周的前瞻性、非干预性、多中心、单臂研究。在基线和第8周在办公室收集数据，并在第2周在家中收集一次数据。使用皮肤病生活质量指数（DLQI）、使用5点李克特量表的患者对疾病严重程度的整体评估（PtGA）、使用0-100分级视觉模拟量表的患者报告的瘙痒程度以及药物治疗满意度问卷-9（TSQM-9）评估PRO。在第8周评估治疗依从性和不良事件（AE）。
治疗8周后，DLQI评分与基线相比显著改善（-5.5±5.93；P<0.0001），早在第2周就开始改善（-4.2±5.28；P<0.0001）。从基线到第2周（-19%±25.94%；P<0.0001）和第8周（-28.6%±29.14%；P<0.0001），瘙痒程度显著降低。“疾病得到控制”（PtGA评分为“清除”或“非常轻度”）的患者百分比在第2周为34.1%，在第8周为60.2%。治疗结束时，有效性、便利性和满意度领域的平均TSQM-9评分为68至74。患者报告平均需要使用CBD外用混悬液53.62±8.05天。3名患者出现治疗中出现的AE。
这项非干预性研究的结果与先前干预试验报告的数据一致，表明使用CBD外用混悬液治疗有效且耐受性良好，并可改善寻常型银屑病患者生活质量。
