Leung D Y, Hirsch R L, Schneider L, Moody C, Takaoka R, Li S H, Meyerson L A, Mariam S G, Goldstein G, Hanifin J M
Department of Pediatrics, Harvard Medical School, Boston, Mass.
J Allergy Clin Immunol. 1990 May;85(5):927-33. doi: 10.1016/0091-6749(90)90079-j.
One hundred patients with moderate to severe atopic dermatitis were entered into a two-center, double-blind trial. Patients were randomized to receive either thymopentin (Timunox, n = 48) or placebo (n = 52), administered as daily subcutaneous injections for 6 weeks. Clinical extent of disease and severity parameters were measured at baseline and at regular time intervals during the study. Both the placebo- and thymopentin-treated groups demonstrated a progressive and statistically significant (p less than 0.001) decline in the overall severity of their disease, but reduction in the clinical severity score was higher in the thymopentin-treated group and statistically significant (p = 0.04) in comparison with the placebo-treated group after 6 weeks of treatment. Of the individual symptoms comprising the total severity score, pruritus (p = 0.02) and erythema (p = 0.04) were reduced significantly when thymopentin therapy was compared to placebo therapy. In addition, both the extent of body involvement and severity index (a combined severity/extent index) were significantly reduced after 6 weeks in the thymopentin-treated group in comparison to the placebo-treated group (p = 0.04). There were no serious adverse experiences in either treatment group. We conclude that treatment with thymopentin is safe and offers significant therapeutic promise for atopic dermatitis.
100例中重度特应性皮炎患者进入一项双中心、双盲试验。患者被随机分为两组,分别接受胸腺五肽(替莫克,n = 48)或安慰剂(n = 52)治疗,每日皮下注射,为期6周。在研究的基线期和定期时间间隔测量疾病的临床范围和严重程度参数。安慰剂组和胸腺五肽治疗组的疾病总体严重程度均呈现逐渐下降且具有统计学意义(p < 0.001),但胸腺五肽治疗组的临床严重程度评分下降幅度更大,治疗6周后与安慰剂治疗组相比具有统计学意义(p = 0.04)。在构成总严重程度评分的各个症状中,与安慰剂治疗相比,胸腺五肽治疗时瘙痒(p = 0.02)和红斑(p = 0.04)明显减轻。此外,与安慰剂治疗组相比,胸腺五肽治疗组在6周后身体受累范围和严重程度指数(综合严重程度/范围指数)均显著降低(p = 0.04)。两个治疗组均未出现严重不良事件。我们得出结论,胸腺五肽治疗安全,对特应性皮炎具有显著的治疗前景。