Pharmaceuticals and Cancer

描述（由申请人提供）：越来越多的儿童和成人定期服用药物，但相对较少的药物进行了充分的上市后不良反应监测，包括癌症发病率升高。 这项研究的主要目的是确定与癌症发病率较低或较高相关的药物，并检查这些相关性是否值得进一步研究。拟议的研究建立在过去30年凯撒永久健康计划内进行的药物监测计划的基础上。具体而言，我们建议： 1)从1991年开始，将在KPMCP全体成员（约300万人）中继续监测200种最常用的处方药是否有致癌作用。使用特定药物或药物组的癌症发病率将与预期的癌症发病率进行比较，基于整个KPMCP成员的发病率。 2)将对上述筛选分析中发现的选定药物-癌症关联进行试点病例对照研究，以确定这些关联是否可能是由于混杂因素造成的，如果不是，则是否有剂量反应效应的证据，或生物相容性的证据。 Kaiser Permanente的会员资格和数据库为研究潜在的药物-癌症关联提供了独特的资源。成员人数众多（310万），稳定，种族多样，几乎所有的保健都来自预付费综合医疗保健方案。每年约有2 000万张处方被分发给健康计划成员。拟议的研究将提供一种有价值的机制，以确定最常用药物可能致癌作用的早期迹象，或确保其在这方面的安全性。

DESCRIPTION (provided by applicant): A growing proportion of children and adults take medication regularly, yet relatively few drugs have undergone adequate post-marketing surveillance for adverse effects, including elevated cancer rates. The main objective of this study is to identify drugs that are associated with lower or higher rates of cancer and examine whether these associations deserve further study. The proposed research builds on a drug surveillance program conducted within the Kaiser Permanente health plan over the last 30 years. Specifically, we propose to: 1) Continue surveillance of the 200 most commonly used prescription drugs for possible carcinogenic effects will be conducted among the entire KPMCP membership, about 3 million persons, starting, in part, in 1991. Cancer incidence among users of specific medications or groups of medications will be compared with those expected, based on rates in entire KPMCP membership. 2) Conduct pilot case-control studies of selected drug-cancer associations found in the above screening analyses will be conducted to determine whether the associations are likely due to confounding and, if not, whether there is evidence of a dose-response effect, or evidence against biological plausibility. The Kaiser Permanente membership and databases provide a unique resource for studying potential drug-cancer associations. The membership is large (3.1 million), stable, ethnically diverse, and receives virtually all of its health care from the pre-paid, integrated medical care program. Each year approximately 20 million prescriptions are dispensed to health plan members. The proposed research will provide a valuable mechanism to identify early signs of possible carcinogenic effects of the most commonly used medications or reassurance as to their safety in this regard.