Sheehan M P, Stevens H, Ostlere L S, Atherton D J, Brostoff J, Rustin M H
Department of Dermatology, Royal Free Hospital, UK.
Clin Exp Dermatol. 1995 Mar;20(2):136-40. doi: 10.1111/j.1365-2230.1995.tb02717.x.
Adult patients with severe atopic eczema who had completed a double-blind placebo-controlled crossover trial of a specific formulation of Chinese herbal therapy were offered continued therapy for 1 year. Of 31 patients who completed the original placebo-controlled study and after a washout period and 2 months of further treatment, 17 continued treatment (group 1), 11 chose not to continue treatment (group 2), one was lost to follow-up and two patients originally in group 1 decided to stop treatment and became pregnant. At the end of the year, 12 of the patients in group 1 had greater than 90% reduction and the remaining five had greater than 60% reduction in clinical scores compared with baseline values. Clinical scores of patients in group 2 gradually deteriorated so that by the end of the year the difference between groups 1 and 2 was highly significant (P = 0.005 and P = 0.002 for erythema and surface damage, respectively). At the end of the year no patient in group 1 felt able to discontinue treatment permanently, but eight patients were on an alternate-day regimen by 6 months and remained on this regimen until the end of the year, and seven were able to control their eczema with a 1 in every 3 day treatment by the end of the year. The remaining two patients continued on daily treatments. Toxicology screening revealed no abnormalities in either full blood counts or biochemical parameters in any patient on continued treatment. Improvement in disease was not associated with any significant change in serum IgE level or peripheral blood lymphocyte subsets.(ABSTRACT TRUNCATED AT 250 WORDS)
对完成特定配方中药疗法双盲安慰剂对照交叉试验的重度特应性皮炎成年患者提供为期1年的持续治疗。在完成原始安慰剂对照研究的31例患者中,经过洗脱期和2个月的进一步治疗后,17例继续治疗(第1组),11例选择不继续治疗(第2组),1例失访,最初在第1组的2例患者决定停止治疗并怀孕。到年底时,与基线值相比,第1组中有12例患者临床评分降低超过90%,其余5例降低超过60%。第2组患者的临床评分逐渐恶化,到年底时第1组和第2组之间的差异非常显著(红斑和表面损伤的P值分别为0.005和0.002)。年底时,第1组中没有患者觉得能够永久停止治疗,但到6个月时,有8例患者采用隔日疗法,并一直维持该疗法直到年底,到年底时,有7例患者能够通过每3天治疗1次来控制湿疹。其余2例患者继续每日治疗。毒理学筛查显示,继续治疗的任何患者的全血细胞计数或生化参数均无异常。疾病的改善与血清IgE水平或外周血淋巴细胞亚群的任何显著变化均无关。(摘要截选至250字)