Guenther L C, Poulin Y P, Pariser D M
Private practice and University of Western Ontario, London, Canada.
Clin Ther. 2000 Oct;22(10):1225-38. doi: 10.1016/s0149-2918(00)83065-9.
Both tazarotene (a retinoid prodrug) and calcipotriene (a synthetic analog of vitamin D3) are effective in the treatment of plaque psoriasis, but no reports in the literature directly compare the efficacy and tolerability of these 2 drugs. Tazarotene is commonly used in conjunction with a topical corticosteroid. In this study, tazarotene was used with mometasone furoate (a synthetic corticosteroid), and the 2-drug regimen was compared with calcipotriene monotherapy.
This study was conducted to compare the efficacy and tolerability of tazarotene 0.1% gel once daily plus mometasone furoate 0.1% cream once daily with those of calcipotriene 0.005% ointment twice daily in the treatment of plaque psoriasis.
In this multicenter, investigator-blinded, parallel-group study, adult patients with chronic, stable plaque psoriasis affecting 5% to 20% of their body surface area were randomly allocated to receive up to 8 weeks of treatment with either tazarotene 0.1% gel once daily (in the evening) plus mometasone furoate 0.1% cream once daily (in the morning) or calcipotriene 0.005% ointment twice daily. Patients were assessed at baseline and at weeks 2, 4, and 8 of treatment. Patients who demonstrated complete clearance of plaque psoriasis after 2 or 4 weeks of treatment and those whose psoriasis had improved > or = 50% after 8 weeks of treatment entered a 12-week posttreatment follow-up phase during which they applied only moisturizer. Patients were reassessed after 4, 8, and 12 weeks of posttreatment follow-up. Physician-rated measures of efficacy included global improvement, plaque elevation, scaling, erythema, and percentage of body surface area involvement. Patient-rated assessments included efficacy of study treatment compared with previous therapies, comfort of treated skin, outlook for long-term control of psoriasis, and overall impression of treatment.
Of 120 patients with moderate to severe psoriasis enrolled from 3 centers, 106 (88%) completed the study. No significant differences in baseline clinical variables were observed between the 2 groups. Twenty-seven patients (45%) in the tazarotene plus cortico-steroid group achieved marked improvement (> or = 75% global improvement) after 2 weeks of treatment compared with 15 patients (26%) in the calcipotriene group (P < or = 0.05). Between-group comparisons of the percentage of patients achieving complete or almost complete clearance (> or = 90% global improvement) did not reach statistical significance at any time point. When compared with the calcipotriene regimen, the tazarotene plus corticosteroid regimen resulted in significantly greater efficacy on trunk lesions in reducing plaque elevation (at the end of treatment and at week 4 of the posttreatment phase, P < or = 0.05), scaling (week 4 of treatment and week 4 of the posttreatment phase, P < or = 0.05), erythema (week 4 of treatment and at the end of treatment, P < or = 0.05), and percentage of body surface area involvement (weeks 2 and 4 of treatment, P < or = 0.01). In addition, the tazarotene plus corticosteroid regimen was significantly more effective in reducing the percentage of body surface area involvement in upper limb lesions (weeks 2 [P < or = 0.05] and 4 [P < or = 0.01] of treatment). Forty-two of 55 patients (76%) in the tazarotene plus corticosteroid group rated their medication as more or much more effective than previous therapies compared with 30 of 52 patients (58%) in the calcipotriene group (P < or = 0.05). Although adverse events (burning, pruritus, irritation, and erythema) occurred in a significantly greater proportion of patients who received tazarotene plus corticosteroid than in those who received calcipotriene (P < or = 0.05), 47 of 55 patients (85%) in both groups rated the comfort of their treated skin as "somewhat comfortable" or better and both groups had similar discontinuation rates due to treatment-related adverse events (3% and 5%, respectively). CONCL
他扎罗汀（一种维甲酸前体药物）和卡泊三醇（维生素D3的合成类似物）在治疗斑块状银屑病方面均有效，但文献中没有直接比较这两种药物疗效和耐受性的报道。他扎罗汀通常与外用糖皮质激素联合使用。在本研究中，他扎罗汀与糠酸莫米松（一种合成糖皮质激素）联合使用，并将这种两药方案与卡泊三醇单一疗法进行比较。
本研究旨在比较每日一次外用0.1%他扎罗汀凝胶加每日一次外用0.1%糠酸莫米松乳膏与每日两次外用0.005%卡泊三醇软膏治疗斑块状银屑病的疗效和耐受性。
在这项多中心、研究者设盲、平行组研究中，将慢性、稳定的斑块状银屑病累及体表面积5%至20%的成年患者随机分配，接受长达8周的治疗，治疗方案为每日一次（晚上）外用0.1%他扎罗汀凝胶加每日一次（早上）外用0.1%糠酸莫米松乳膏，或每日两次外用0.005%卡泊三醇软膏。在基线以及治疗的第2、4和8周对患者进行评估。在治疗2周或4周后斑块状银屑病完全清除的患者，以及在治疗8周后银屑病改善≥50%的患者进入为期12周的治疗后随访阶段，在此期间他们仅使用保湿剂。在治疗后随访的第4、8和12周对患者重新进行评估。医生评估的疗效指标包括整体改善情况、斑块隆起、脱屑、红斑以及体表面积受累百分比。患者评估包括与先前治疗相比研究治疗的疗效、治疗皮肤的舒适度、银屑病长期控制的前景以及对治疗的总体印象。
从3个中心招募的120例中度至重度银屑病患者中，106例（88%）完成了研究。两组之间在基线临床变量方面未观察到显著差异。他扎罗汀加糖皮质激素组27例患者（45%）在治疗2周后达到显著改善（整体改善≥75%），而卡泊三醇组为15例患者（26%）（P≤0.05）。在任何时间点，两组间达到完全或几乎完全清除（整体改善≥90%）的患者百分比的组间比较均未达到统计学显著性。与卡泊三醇方案相比，他扎罗汀加糖皮质激素方案在减少躯干皮损的斑块隆起方面（治疗结束时和治疗后阶段第4周，P≤0.05）、脱屑方面（治疗第4周和治疗后阶段第4周，P≤0.05）、红斑方面（治疗第4周和治疗结束时，P≤0.05）以及体表面积受累百分比方面（治疗第2周和第4周，P≤0.01）疗效显著更优。此外，他扎罗汀加糖皮质激素方案在减少上肢皮损的体表面积受累百分比方面（治疗第2周[P≤0.05]和第4周[P≤0.01]）显著更有效。他扎罗汀加糖皮质激素组55例患者中有42例（76%）认为其药物比先前治疗更有效或有效得多，而卡泊三醇组52例患者中有30例（58%）（P≤0.05）。虽然接受他扎罗汀加糖皮质激素治疗的患者发生不良事件（烧灼感、瘙痒、刺激和红斑）的比例显著高于接受卡泊三醇治疗的患者（P≤0.05），但两组中55例患者中有47例（85%）将其治疗皮肤的舒适度评为“有点舒适”或更好，且两组因治疗相关不良事件导致的停药率相似（分别为3%和5%）。结论
