Johnson Sandra Marchese, LeVine Paul
Johnson Dermatology, Fort Smith, AR, USA.
J Drugs Dermatol. 2011 Dec;10(12):1376-81.
This survey program was designed to evaluate patients' experiences with doxycycline, USP, 40 mg capsules (30 mg immediate release, 10 mg delayed release beads, ORACEA®; Galderma Laboratories, L.P.) as a treatment for the inflammatory lesions of rosacea and to provide patient-reported feedback to physicians.
This prospective, cross-sectional survey was implemented in January 2010. One thousand, two hundred and ninety-five physicians identified patients eligible for treatment with doxycycline, USP, 40 mg capsules and provided them with information about the program. Patients voluntarily participated by contacting a program coordinator or by enrolling online, providing consent, and responding to a series of questions prior to medication use and approximately four weeks post-treatment initiation. Surveys were completed through an automated interactive voice response system or a dedicated, secure website and included questions regarding patients' perceptions of when the treatment first started working, patients' symptom severity, interference of symptoms with work and social activities, and confidence in appearance. Patients were also asked about prior medication use, adjunct medication use, and treatment satisfaction. Reports of patient progress and responses to these survey questions were sent directly to each patient's treating physician within a few days of survey completion. Paired t-tests were used to evaluate the statistical significance of differences in symptom severity, interference and confidence ratings before and after treatment.
Two thousand, eight hundred ninety-eight patients enrolled in the survey program and completed the baseline survey. Of these, a total of 1,346 patients completed the baseline and four-week survey (mean age 50 years; 75% female). Most (58%) reported use of a prior prescription medication to treat rosacea. Over half the patients (52%) responded that the product began to work within two weeks of use. After four weeks of using doxycycline, USP, 40 mg capsules, patients felt that the severities of redness as well as bumps/blemishes were significantly reduced (P<.05). Patients also reported having more confidence with their skin's appearance (P<.05). In addition, with use of doxycycline, USP, 40 mg capsules, patients reported significant reductions in the interference of symptoms with work and social activities (P<.05). Satisfaction with doxycycline, USP, 40 mg capsules averaged 6.8 on a scale of 1 (not at all satisfied) to 9 (very satisfied) for patients using only doxycycline, USP, 40 mg capsules; mean satisfaction was 6.7 for those using it with adjunct medication. Seven patients reported 11 adverse events during the program, including lack of efficacy, joint injury with fatigue, dizziness, back pain, bloating and constipation, increased facial redness and pimples, yeast infection, sore throat, increased bruising and worsening of rosacea.
Satisfaction with doxycycline, USP, 40 mg capsules for the treatment of papulopustular rosacea was apparent from patient-rated measures of treatment impact. Patients with papulopustular rosacea reported improvement in symptoms, reductions in the interference of symptoms with life's activities and satisfaction with treatment with doxycycline, USP, 40 mg capsules.
本调查项目旨在评估患者使用40毫克盐酸多西环素USP胶囊(30毫克速释,10毫克缓释微丸,商品名ORACEA®;高德美实验室公司)治疗玫瑰痤疮炎性皮损的体验,并向医生提供患者报告的反馈信息。
这项前瞻性横断面调查于2010年1月开展。1295名医生确定了符合使用40毫克盐酸多西环素USP胶囊治疗条件的患者,并向他们提供了有关该项目的信息。患者通过联系项目协调员或在线注册自愿参与,提供同意书,并在用药前及治疗开始约四周后回答一系列问题。调查通过自动交互式语音应答系统或专用安全网站完成,包括关于患者对治疗何时开始起效的看法、患者症状严重程度、症状对工作和社交活动的干扰以及对外表的信心等问题。还询问了患者之前的用药情况、辅助用药情况以及治疗满意度。患者进展报告和对这些调查问题的回答在调查完成后的几天内直接发送给每位患者的主治医生。采用配对t检验评估治疗前后症状严重程度、干扰程度和信心评分差异的统计学显著性。
2898名患者参与了调查项目并完成了基线调查。其中,共有1346名患者完成了基线和四周调查(平均年龄50岁;75%为女性)。大多数(58%)报告曾使用过处方药物治疗玫瑰痤疮。超过一半的患者(52%)回答该产品在使用两周内开始起效。使用40毫克盐酸多西环素USP胶囊四周后,患者感觉发红以及丘疹/脓疱的严重程度显著降低(P<0.05)。患者还报告对自己皮肤外观更有信心(P<0.05)。此外,使用40毫克盐酸多西环素USP胶囊后,患者报告症状对工作和社交活动的干扰显著减少(P<0.05)。仅使用40毫克盐酸多西环素USP胶囊的患者对其满意度在1(完全不满意)至9(非常满意)的量表上平均为6.8;与辅助药物联合使用的患者平均满意度为6.7。7名患者在项目期间报告了11起不良事件,包括疗效不佳、关节损伤伴疲劳、头晕、背痛、腹胀和便秘、面部发红和丘疹增多、酵母菌感染、喉咙痛、瘀伤增加以及玫瑰痤疮恶化。
从患者对治疗效果的评分来看,患者对40毫克盐酸多西环素USP胶囊治疗丘疹脓疱型玫瑰痤疮的满意度明显。丘疹脓疱型玫瑰痤疮患者报告症状有所改善,症状对生活活动的干扰减少,对40毫克盐酸多西环素USP胶囊治疗感到满意。