VITAMIN INTERVENTION FOR STROKE PREVENTION

这是一项由NIH资助的多中心研究，旨在确定添加药理学剂量的叶酸、吡哆醇和氰钴胺是否可减少复发性脑梗死（作为主要终点）和心肌梗死或致死性冠心病（作为次要终点）。对1788例患者进行了基线筛查。 对符合临床标准的61例受试者进行了血液筛查。 其中，37例患者符合血浆同型半胱氨酸水平标准，24例受试者不合格。 截至1999年1月22日，在37例合格受试者中，26例已接受随机化。 有6名患者通过同型半胱氨酸浓度合格，但在抽血后拒绝参加。 7例受试者正在等待随机化。到目前为止，没有明显的不良副作用。 截至中心办公室的最后一份报告，其他任何研究中心均未报告重大不良副作用。从上述数字可以看出，主要的速率限制步骤（不受人类控制）是血浆同型半胱氨酸水平的结果。根据中心分析中心确定的血浆同型半胱氨酸浓度，发现约40%的临床合格受试者不合格，低于患者随机入组研究所需的浓度。 我们的目标是继续招募受试者，总计最多100例，或根据试验中心办公室的要求。

This is a multi-center study funded by NIH to determine whether the addition of pharmacological doses of folic acid, pyridoxine, and cyanocobalamin reduces recurrent cerebral infarction as a primary endpoint and myocardial infarction or fatal coronary heart disease as a secondary endpoint. Baseline screenings were performed in 1788 patients. Blood was screened in 61 subjects who were eligible from clinical criteria. Of these, 37 patients were eligible by plasma homocystein level criteria and 24 subjects were ineligible. Of the 37 eligible subjects, 26 have been randomized as of January 22, 1999. There were 6 patients who were eligible by homocystein concentrations that refused to participate after the blood draw. Seven subjects are awaiting randomization. To date there have been no significant adverse side-effects. As of the last report from the central office, no significant adverse side-effects have been reported in any of the other sites. As can be seen from the above numbers, the main rate limiting step, out of human control, is the results of the plasma homocysteine levels. Approximately 40% of subjects who were clinically eligible were found to be ineligible by virtue of plasma homocystein concentrations, as determined by the central site of analysis, being below the concentration required for patient randomization into the study. Our goal is to continue to recruit subjects, up to 100 total, or as required by the trial central office.