注射用红花黄色素在心脏瓣膜置换术术前应用的安全性研究  

The observation of the safety for injection Safflower yellow（SY） used in valve replacement surgery

作　　者：李晓密[1] 王镇龙[1] 祝岩[1] 尹宗涛[1] 张晓慧[1] 徐莉莹[1] 

机构地区：[1]沈阳军区总医院心外科,辽宁省沈阳市110016

出　　处：《中国心血管病研究》2017年第8期751-755,共5页Chinese Journal of Cardiovascular Research

摘　　要：目的 研究术前应用注射用红花黄色素对心脏瓣膜置换术患者的影响,评价其用药的安全性.方法 选取2015年1～12月于沈阳军区总医院心血管外科行心脏瓣膜置换（均为机械瓣膜）患者138例,随机分为试验组和对照组.试验组给予注射用红花黄色素（100 mg溶于250 ml生理盐水1次/d）静脉输液治疗至术前一天;对照组给予同等剂量生理盐水.观察两组患者血常规、肝肾功能、凝血变化;记录术中出血量,术后第1、2、3天引流量及药物不良反应.结果 两组患者术前基本情况差异无统计学意义（P＞0.05）.试验组患者用药前后比较,血常规（eg,WBC：t=1.726,P=0.261;HB：=0.526,P=0.691）、肝肾功能（eg,ALT：t=0.893,P=0.378;AST：t=0.557,P=0.581;CR：t=-0.286,P=0.777）未见统计学差异;凝血结果用药前略高于用药后（eg,PT：用药前13.26±0.98,用药后14.31±1.38,t=1.214,P=0.320;APTT：用药前37.92±5.84,用药后38.46±5.33,t=0.192,P=0.843;INR：用药前1.04±0.09,用药后1.03±0.12,t=-0.828,P=0.529）,但未见统计学差异（P＞0.05）.用药后试验组患者凝血结果略高于对照组患者（eg,PT：试验组14.31±1.38,对照组13.19±0.98,t=0.508,P=0.615;APTT：试验组38.46±5.33,对照组36.81±4.39,=0.204,P=0.751;INR：试验组1.03±0.12,对照组1.02±0.13,=0.443,P=0.660）,但未见统计学差异（P＞o.05）.两组患者术中及术后第1、2、3天及总引流量比较,未见统计学差异（P＞0.05）.试验组患者药物不良反应包括皮疹6例、恶心呕吐4例、转氨酶及肌酐轻度升高各1例.结论 心脏瓣膜置换术患者围术期应用注射用红花黄色素,对其血常规、肝肾功能、凝血无明显影响,用药不良反应少、安全性高.Objective To investigate the effect of injection Safflower yellow（SY） on patients before valve replacement surgery,and to evaluate the safety of injection Safflower yellow.Methods From January 2015 to December 2015,patients undergoing cardiac valve replacement surgery total of 138 cases （both mechanical valve） in the Shenyang Military Region General Hospital Cardiovascular Surgery.According to the random number table method,patients were divided into trim and control groups.The trial group received intravenous infusion therapy Safflower yellow （100 mg was dissolved in 250 ml physiological saline,once a day）,meanwhile the control group received the same dose of saline,until the surgery.The data were collected from two groups including blood routine examination,liver and kidney function,coagulation changes,the intraoperative,the first day、the second day and the third day blood loss and drug adverse reaction.Results There were no significant differences in base situation between the two groups （P＞0.05）.There were no significant differences in blood routine examination（eg：WBC：t =1.726,P=0.261;HB：t =0.526,P=0.691）,liver and kidney function between the two groups before and after medication （eg：ALT：t =0.893,P=0.378;AST：t=0.557,P =0.581;CR：t=-0.286,P=0.777）,the levels in trial group of coagulation before medication were higher than after medication （eg：PT：before 13.26±0.98,after 14.31 ±1.38,t=1.214,P=0.320;APTT：before 37.92±5.84,after 38.46t5.33,t=0.192,P=0.843;INR：before 1.04±0.09,after 1.03-±0.12,t=-0.828,P=0.529）;the levels in trial group of coagulation were higher than the control group （eg：PT：trial group 14.31 ± 1.38,control group 13.19-±0.98,t=0.508,P=0.6 t 5;APTT：trial group 38.46±5.33,control group 36.81±4.39,t=-0.204,P=0.751;INR：trial group 1.03±0.12,control group 1.02±0.13,t=0.443,P=0.660）,but the results were not statistically significant（P＞0.05）.There were no significant differences in the intraoperative,the first day,the seco

关 键 词：红花黄色素 瓣膜置换术 药物不良反应 药物安全性 

分 类 号：R654.2[医药卫生—外科学]