目的 評價健康志愿受試者對通栓救心片的耐受性和安全性，為Ⅱ期臨床試驗給藥方案提供依據。 方法 2009年1月－4月，選擇健康受試者38例，隨機進入5個單次給藥組和2個連續給藥組。單次給藥組分別口服通栓救心片3、6、8、10、15片；連續給藥組口服通栓救心片2片/次和3片/次，3次/d，服藥7 d。觀察生命體征、實驗室檢查指標、臨床癥狀和不良反應。 結果 單次給藥8片和15片組各有1例有輕微頭痛、頭昏；連續給藥組有輕微頭昏或惡心的不良反應，均未經處理自動消失。 結論 健康人體對通栓救心片耐受性較好，臨床應用較安全，僅見輕微頭昏、頭痛或惡心。推薦Ⅱ期臨床試驗給藥劑量范圍是（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.