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国产加贝酯耐受性试验研究

A Study on the tolerance test of domestic gabexate mesilate

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【作者】 熊诗松赵敏巴秋菊周灵杰单英刘欣买凯

【Author】 XiongShisong;ZhaoMin;BaQiujiu;ZhouLingjie;ShanYing;LiuXin;MaiKai(Henan Institute of Medical Sciences,Zhengzhou 450052)

【机构】 河南省医学科学研究所

【摘要】 健康成年人自愿受试者10例,随机分为3组,分别住院静脉注射加贝酯200mg/d、300mg/d、400mg/d。结果除高浓度(300mg加贝酯溶于5%G-S500ml)组,在滴速60滴/min时,1例出现局部发红,疼痛及2例于停药后1周出现轻度表浅静脉炎外,未发现过敏,血压下降,ECG改变,肝、肾功能损伤等其它不良反应,说明国产加贝酯注射剂临床应用安全,成人每d可用100~400mg,以100~200mg溶于5%葡萄糖液500ml静滴为宜,但10例中有6例(60%)因药液外渗,引起局部刺激症状,故应尽量避免高浓度,快速静滴,并防止液体外溢皮下。

【Abstract】 The healthy volunteers were admitted and divided at random into three dose-groups.Each of them received a single dose of gabexate mesilate(GM):200 mg/d,300 mg/d,400 mg/d by intravenous infusion respectively.The result showed that one volunteer had redness and pain in the local skin when the infusion at the rate of 60 drips/per minute in the high dose group.No allergy,decrease of blood pressure,change in ECG and injury to the function of the liver or the kindey were found in the three groups.It indicates that domestic GM is safe for clinical use.The dosage levels of 100~400 mg/d are suitable for grown-ups,with 100~200 mg GM dissolued in 500 ml of 5% glucose infused intravenously.In 6 out of the 10 volunteers,the leakage of drug resulted in the symptoms of local excitation,and so high dose and speed of infusion should be avoided.

【关键词】 加贝酯耐受性试验中国
【Key words】 gabexate mesilatetolerance
【基金】 卫生部药政局资助
  • 【文献出处】 河南医科大学学报 ,JOURNA OF HENAN MEDICAL UNIVERSITY , 编辑部邮箱 ,1994年04期
  • 【分类号】R965.3
  • 【下载频次】58
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