Hecker D, Lebwohl M
Department of Dermatology, Mount Sinai School of Medicine, New York, USA.
Int J Dermatol. 1997 Apr;36(4):302-3. doi: 10.1046/j.1365-4362.1997.00203.x.
A total of 20 patients with symmetric plaque-type psoriasis were recruited for a controlled, investigator-blinded, right-left study. None of the patients had used any therapy other than emollients for 2 months prior to starting in the trial. All patients had a negative antinuclear antibody. By history, all patients had previously improved upon exposure to sunlight or ultraviolet light. Two symmetrical sites of equal severity were selected as target areas. Each patient was treated on one side with mineral oil twice daily and on the opposite side with calcipotriene 0.005% ointment twice daily. The investigator was blinded as to which site received which topical treatment. Both sides were treated with equal doses of ultraviolet B (UVB) three times weekly in graduated suberythemogenic doses. Ultraviolet B radiation was emitted by a group of 6-ft fluorescent bulbs (Light Sources FS72 T12 UVB HO) in a standard phototherapy unit. The above regimen was continued for a total of 12 weeks. The severity of psoriasis in the target sites was rated by the examiner at baseline and at weekly intervals for the 12 weeks of study. Target sites were rated by severity of erythema, scaling, plaque elevation, and pruritus, with each of these parameters being assigned a score on a four-point scale: 0, clear; 1, mild; 2, moderate; 3, severe. The four scores were added together to arrive at a total severity score for each of the target sites. Statistical analysis was performed using the paired t test, P values less than 0.05 were considered statistically significant. Eleven of the 20 patients (55%) showed a greater decrease in the severity of their psoriasis with UVB plus calcipotriene compared with UVB plus mineral oil. The difference in severity scores between the two groups was statistically significant as early as week 1 (P < 0.05). The difference between the UVB and calcipotriene group versus the UVB and mineral oil group peaked between weeks 3 and 6. The differences then decreased but remained statistically significant through to week 12 (Fig. 1). There were no instances of local cutaneous irritation, but mild photosensitivity occurred symmetrically on both sides in three patients.
总共招募了20名对称斑块型银屑病患者进行一项对照、研究者设盲的左右对照研究。在开始试验前2个月,所有患者除使用润肤剂外未使用任何其他治疗方法。所有患者抗核抗体均为阴性。根据病史,所有患者既往暴露于阳光或紫外线下病情均有改善。选择两个严重程度相同的对称部位作为靶区。每位患者一侧每天涂抹两次矿物油,另一侧每天涂抹两次0.005%的卡泊三醇软膏。研究者对哪个部位接受哪种局部治疗设盲。两侧均每周接受三次剂量递增的亚红斑量的紫外线B(UVB)照射。UVB由标准光疗设备中的一组6英尺荧光灯泡(光源FS72 T12 UVB HO)发出。上述方案共持续12周。在研究的12周内,检查者在基线和每周对靶区银屑病的严重程度进行评分。靶区根据红斑、鳞屑、斑块隆起和瘙痒的严重程度进行评分,每个参数在四点量表上进行评分:0,清除;1,轻度;2,中度;3,重度。将四个评分相加得出每个靶区的总严重程度评分。采用配对t检验进行统计分析,P值小于0.05被认为具有统计学意义。20名患者中有11名(55%)与UVB加矿物油相比,UVB加卡泊三醇使银屑病严重程度下降更明显。两组之间的严重程度评分差异早在第1周就具有统计学意义(P<0.05)。UVB和卡泊三醇组与UVB和矿物油组之间的差异在第3至6周达到峰值。然后差异减小,但直到第12周仍具有统计学意义(图1)。未出现局部皮肤刺激情况,但有3名患者两侧对称出现轻度光敏反应。