进口与国产荧光素钠在眼底血管造影中不良反应的对比研究

Contrastive research on side efforts of import and domestic fluorescein sodium injection in fundus fluorescein angiography

目的观察进口与国产荧光素钠注射液在眼底荧光血管造影中出现的不良反应,并比较两者是否存在差异性。方法将2008年至2010年在我院眼科门诊行眼底荧光血管造影术检查的患者按检查过程中所注射的进口和国产荧光素钠不同分成A、B两组:A组1156例,B组915例。A组在检查过程中注射美国爱尔康公司生产的100g.L-1荧光素钠,B组注射广州明兴制药股份有限公司生产的200g.L-1荧光素钠。在检查过程中观察患者有无不良反应,对出现不良反应者对症处理并记录症状、体征等病情。结果本研究2071例造影患者中共有186例出现不良反应,发生率为8.98%。轻度不良反应174例,占不良反应的94.05%;中度不良反应11例,占5.91%;重度不良反应1例,占0.54%。A组造影患者中共有82例出现不良反应,发生率为7.09%;B组造影患者中共有104例出现不良反应,发生率为11.37%。A组患者不良反应比B组少,差异有统计学意义(P<0.05)。A组患者轻度不良反应比B组少,差异有统计学意义(P<0.05);两组中度不良反应比较,差异无统计学意义(P>0.05);两组重度不良反应比较,差异无统计学意义(P>0.05)。结论荧光素钠注射液是一种相对安全的造影剂,不良反应发生率低,发生的不良反应多数轻微。进口荧光素钠产生的不良反应比国产荧光素钠少。

Objective To observe the side efforts of import and domestic fluorescein sodium used in fundus fluorescein angiography（FFA）,and compare their difference.Methods According to import and domestic fluorescein sodium injection in FFA,the patients underwent FFA in our hospital from 2008 to 2010 were divided into two groups：group A（1156 cases）,group B（915 cases）.The fluorescein sodium injection（US Alcon） with 100 g·L-1 was injected in group A,while 200 g·L-1 fluorescein sodium injection（Guangzhou Munich Drugs Manufacture Limited Company） in group B.The side efforts were observed,and the symptoms were processed and recorded.Results In 2071 cases,186 cases（8.98%） appeared the side efforts,in which the mild side efforts appeared in 174 cases（94.05%）,the moderate in 11 cases（5.91%） and severe in 1 case（0.54%）.In group A,82 cases（7.09%） presented the side efforts,which in group B was 104 cases（11.37%）,there was statistical difference between two groups（P0.05）.There was statistical difference in mild side efforts between two groups（P0.05）,but no difference in moderate and severe side efforts（all P0.05）.Conclusion The fluorescein sodium injection is one kind of relative security contrast medium,and the side efforts formation rate is low,most slight.The side efforts of import fluorescein sodium are less than that of domestic.