目的 评价健康志愿受试者对通栓救心片的耐受性和安全性，为Ⅱ期临床试验给药方案提供依据。 方法 2009年1月－4月，选择健康受试者38例，随机进入5个单次给药组和2个连续给药组。单次给药组分别口服通栓救心片3、6、8、10、15片；连续给药组口服通栓救心片2片/次和3片/次，3次/d，服药7 d。观察生命体征、实验室检查指标、临床症状和不良反应。 结果 单次给药8片和15片组各有1例有轻微头痛、头昏；连续给药组有轻微头昏或恶心的不良反应，均未经处理自动消失。 结论 健康人体对通栓救心片耐受性较好，临床应用较安全，仅见轻微头昏、头痛或恶心。推荐Ⅱ期临床试验给药剂量范围是（2～3）片/次，3次/d 。
Objective To investigate the role of red cell distribution width ( RDW) in coronary artery diseases patients complicated with obstructive sleep apnea-hypopnea syndrome ( OSAHS) . Methods 134 coronary artery diseases patients who had at least one-vessel disease confirmed by coronary angiography were investigated by polysomnography for OSAHS. The patients were classified according to theapneahypopnea index(AHI) . The level of RDW, triglyceride, cholesterol, high density lipoprotein, low density lipoprotein, hemoglobin, white blood cells and hematocritwere measured. The receiver operating characteristic curve was drawn to predict the moderate-severe OSAHS in coronary artery diseases patients according to RDW value. Results When 134 coronary artery diseases patients were classified into a control group and an OSAHS group according to the AHI, the level of RDW in two groups was not significantly different [ ( 13.44 ±1.30) % vs. ( 13.12 ±0.92) % , P gt; 0.05] . When 134 coronary artery diseases patients were classified into a control and mild OSAHS group and a moderate-severe OSAHS group according to the AHI, the level of RDW in two groups was significantly different [ ( 13.07 ±0.94) vs. ( 14.02 ±1.41) % , P lt; 0.05] . And no difference was found in hemoglobin, triglyceride, cholesterol, high density lipoprotein, low density lipoprotein, platelet, and hematocrit between two groups. The ROC curve analysis revealed that the area under ROC curve was 0.748 ( 0.523-0.972) , and the best cut-off for moderate-severe OSAHS was 13.95% with sensitivity of 71.43% and specificity of 82.98% . Conclusion RDW may be a useful and simple tool to predict moderate-severe OSAHS in coronary artery diseases patients.