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皮肤科疾病治疗中的超说明书用药

Off-label prescribing in the treatment of dermatologic disease.

作者信息

Sugarman Joel H, Fleischer Alan B, Feldman Steven R

机构信息

Bristol Myers-Squibb Center for Dermatology Research and the Department of Dermatology Wake Forest University School of Medicine, Winston-Salem, NC 27157-1071, USA.

出版信息

J Am Acad Dermatol. 2002 Aug;47(2):217-23. doi: 10.1067/mjd.2002.120469.

Abstract

BACKGROUND

It is common practice for physicians to treat dermatologic conditions with medications that are not indicated for the specific condition being treated. These "off-label" prescriptions are often for medications that have both well accepted therapeutic value in the medical community and proven efficacy on the basis of results of clinical trials.

OBJECTIVE

Our purpose was to quantify the use of off-label prescriptions for dermatologic disease by a representative sample of physicians in the United States.

METHODS

Data from the 1990-1997 National Ambulatory Medical Care Survey, performed by the National Center for Health Statistics, were used to assess medications prescribed at office visits for dermatologic disease. We identified the most common diagnoses listed at office visits in which the primary and only diagnosis listed was dermatologic. For the leading 10 dermatologic conditions for which medications are indicated, we categorized each primary drug mention by indication.

RESULTS

We found that the range of off-label prescribing varied from 17% to 73%, with a weighted mean (+/- SD) of 32% +/- 18%. The conditions most frequently managed with off-label prescriptions were acne rosacea (73%) and actinic keratosis (52%), whereas those with the fewest off-label prescriptions were atopic dermatitis (17%) and psoriasis (16%). The use of off-label prescriptions by dermatologists in the diseases studied ranged from 7% to 73% with a weighted mean (+/- SD) of 24% (+/- 24%), whereas the range for nondermatologists was 18% to 96% with a weighted mean (+/- SD) of 34% (+/- 18%).

CONCLUSION

Off-label prescribing is common in the management of dermatologic conditions. From these data, we conclude that it is currently within the standard of care to use off-label prescriptions in the treatment of dermatologic disease.

摘要

背景

医生使用未被批准用于特定治疗疾病的药物来治疗皮肤病是常见的做法。这些“非标签”处方通常用于在医学界具有广泛认可的治疗价值且基于临床试验结果已证实疗效的药物。

目的

我们的目的是通过美国医生的代表性样本对皮肤病非标签处方的使用情况进行量化。

方法

利用国家卫生统计中心进行的1990 - 1997年国家门诊医疗护理调查的数据,评估在皮肤科疾病门诊就诊时开具的药物。我们确定了门诊就诊时列出的最常见诊断,其中主要且唯一列出的诊断为皮肤科疾病。对于有药物适应证的前10种主要皮肤病,我们按适应证对每种主要提及的药物进行分类。

结果

我们发现非标签处方的范围从17%到73%不等,加权平均值(±标准差)为32%±18%。最常使用非标签处方治疗的疾病是酒渣鼻(73%)和光化性角化病(52%),而非标签处方最少的是特应性皮炎(17%)和银屑病(16%)。在所研究的疾病中,皮肤科医生使用非标签处方的比例范围为7%到73%,加权平均值(±标准差)为24%(±24%),而非皮肤科医生的范围为18%到96%,加权平均值(±标准差)为34%(±18%)。

结论

非标签处方在皮肤病治疗中很常见。从这些数据中,我们得出结论,目前在皮肤病治疗中使用非标签处方属于医疗护理标准范围。

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