Department of Integration of Traditional Chinese and Western Medicine, China Medical University Hospital, Taichung, Taiwan, ROC.
Int Arch Allergy Immunol. 2011;155(2):141-8. doi: 10.1159/000318861. Epub 2010 Dec 22.
Severe and widespread atopic dermatitis often fails to respond adequately to topical steroids and oral antihistamines and requires immunomodulatory drugs which, although effective, have undesirable toxic effects.
In this prospective, randomized, double-blind, placebo-controlled trial, 71 patients with severe intractable atopic dermatitis were given an 8-week treatment with oral Xiao-Feng-San (XFS; 47 patients) or placebo (24 patients). Total lesion score, erythema score, surface damage score, pruritus score and sleep score were measured at 4-week intervals.
Fifty-six patients completed both the treatment and follow-up periods. The decrease in the total lesion score in the treatment group at 8 weeks was significantly greater than that of the placebo group (79.7 ± 5.8% vs. 13.5 ± 7.64%; p < 0.001). There was also a statistically significant difference between the treatment and placebo groups with regard to erythema, surface damage, pruritus and sleep scores. The difference between the 2 groups was still significant for all outcome measures except the erythema score at the 12-week follow-up, 4 weeks after the 8-week treatment had ended. Patients reported no side effects from treatment, although some commented on the unpalatability of the medication.
Our study results suggest that the traditional Chinese herbal medicine XFS may be an alternative choice of therapy for severe, refractory, extensive and nonexudative atopic dermatitis.
严重且广泛的特应性皮炎常对外用类固醇和口服抗组胺药反应不足，需要使用免疫调节剂，虽然这些药物有效，但具有不良的毒性作用。
在这项前瞻性、随机、双盲、安慰剂对照试验中，71 例严重难治性特应性皮炎患者接受了 8 周的口服消风散（XFS；47 例）或安慰剂（24 例）治疗。在 4 周的间隔内测量总病变评分、红斑评分、表面损伤评分、瘙痒评分和睡眠评分。
56 例患者完成了治疗和随访期。治疗组在 8 周时总病变评分的下降明显大于安慰剂组（79.7±5.8%对 13.5±7.64%；p<0.001）。在红斑、表面损伤、瘙痒和睡眠评分方面，治疗组与安慰剂组之间也存在统计学差异。在 8 周治疗结束后 4 周的 12 周随访时，除红斑评分外，两组之间的差异在所有疗效指标上仍有显著差异。患者报告治疗无副作用，但有些患者认为药物味道不佳。
我们的研究结果表明，传统中药消风散可能是治疗严重、难治性、广泛和非渗出性特应性皮炎的另一种选择。
