Kramer M S, Hutchinson T A, Rudnick S A, Leventhal J M, Feinstein A R
Clin Pharmacol Ther. 1980 Feb;27(2):149-55. doi: 10.1038/clpt.1980.23.
A recently developed algorithm for the diagnosis of adverse drug reaction (ADR) was used to investigate the quality of evidence in reported cases of ADRs to 1% gamma benzene hexachloride (GBH), a popular scabicide and pediculicide currently under suspicion as a cause of central nervous system (CNS) toxicity, especially in children. Of the 53 reported cases of alleged toxicity, 37 were associated with lindane insecticide (greater than 1% GBH), which is not a pharmaceutical preparation. Of these 37 cases, 34 scored as definite or probable reactions on the algorithm. Of the 26 reports associated with the drug, 1% GBH, none scored as definite and only 6 as probable ADRs. Of these 6 probable cases, 5 represented inappropriate application or unintended ingestion. The use of rigorous operational criteria, such as those developed in this algorithm, permits a scientifically disciplined assessment of whether or not a drug has been fairly indicted, and also provides valuable clinical information about other aspects of suspected drug toxicity.
一种最近开发的用于诊断药物不良反应（ADR）的算法，被用于调查报告的1%γ-六氯环己烷（GBH）药物不良反应病例的证据质量。GBH是一种常用的杀疥虫剂和杀虱剂，目前被怀疑是中枢神经系统（CNS）毒性的原因，尤其是在儿童中。在53例报告的所谓毒性病例中，37例与林丹杀虫剂（GBH含量大于1%）有关，林丹不是药物制剂。在这37例病例中，34例在该算法中被判定为明确或可能的反应。在与1%GBH药物相关的26份报告中，没有一份被判定为明确的ADR，只有6份被判定为可能的ADR。在这6例可能的病例中，5例代表了不当应用或意外摄入。使用严格的操作标准，如本算法中所制定的标准，能够对一种药物是否被合理指控进行科学严谨的评估，并且还能提供有关疑似药物毒性其他方面的有价值的临床信息。
