Pittler M H, Armstrong N C, Cox A, Collier P M, Hart A, Ernst E
Department of Complementary Medicine, Peninsula Medical School, University of Exeter, Exeter EX2 4NT, UK.
Br J Dermatol. 2003 Feb;148(2):307-13. doi: 10.1046/j.1365-2133.2003.04921.x.
Autologous blood therapy (ABT) is used for treating atopic dermatitis (AD) in some European countries and is promoted on internet sites for this condition. However, there is little evidence from rigorous clinical trials to suggest that it is effective.
To test the effectiveness of ABT for the symptomatic treatment of patients with AD.
Fifty subjects responded to press advertisements, and 31 were randomized within strata of severity at recruitment. Patients were included into a double-blind, placebo-controlled trial and received ABT or placebo once weekly for 5 weeks. Assessments were performed at baseline, at weekly intervals and after a 5-week follow up. The Six Area, Six Sign AD (SASSAD) severity index was predefined as the primary outcome measure. The Dermatology Life Quality Index and patient ratings of pruritus, quality of sleep and skin appearance on 100-mm visual analogue scales were defined as secondary outcome measures. Success of patient blinding and adverse events were assessed.
Data were analysed on an intention-to-treat basis. Analysis of covariance suggested a significant differential change of the SASSAD score between baseline and the end of the follow-up period in favour of ABT. The mean reduction in SASSAD score was 13.5 points (95% confidence interval, CI 6.6-20.4, P < 0.001) over and above placebo; the corresponding value at the end of treatment was 9.6 (95% CI 4.2-14.9, P = 0.001). No clear significant intergroup differences in any of the secondary outcome measures were found. Six patients in the ABT group and seven in the placebo group reported minor and transient adverse events.
These data suggest that, according to the SASSAD score, ABT has beneficial effects in the treatment of AD, although this was not confirmed by the patient-rated assessments. The improvement in observer-rated skin condition suggested by this study needs confirmation in larger trials.
在一些欧洲国家，自体血疗法（ABT）被用于治疗特应性皮炎（AD），并且在相关网站上也有针对这种病症的推广。然而，严格的临床试验几乎没有证据表明其有效。
测试ABT对AD患者进行症状治疗的有效性。
五十名受试者回应了报刊广告，其中31名在招募时按严重程度分层随机分组。患者被纳入一项双盲、安慰剂对照试验，每周接受一次ABT或安慰剂治疗，共治疗5周。在基线、每周以及5周随访后进行评估。预先将六区域、六体征AD（SASSAD）严重程度指数定义为主要结局指标。将皮肤病生活质量指数以及患者在100毫米视觉模拟量表上对瘙痒、睡眠质量和皮肤外观的评分定义为次要结局指标。评估患者盲法的成功情况以及不良事件。
按照意向性分析原则对数据进行分析。协方差分析表明，在基线和随访期末，SASSAD评分有显著差异变化，有利于ABT组。SASSAD评分的平均降低幅度在安慰剂之上为13.5分（95%置信区间，CI 6.6 - 20.4，P < 0.001）；治疗结束时的相应值为9.6（95%CI 4.2 - 14.9，P = 0.001）。在任何次要结局指标中均未发现明显的组间显著差异。ABT组有6名患者，安慰剂组有7名患者报告了轻微且短暂的不良事件。
这些数据表明，根据SASSAD评分，ABT在AD治疗中具有有益效果，尽管患者自我评估未证实这一点。本研究中观察到的观察者评定的皮肤状况改善情况需要在更大规模的试验中得到证实。
