A Retrospective Study Of Adverse Reactions Of Fundus Fluorescein Angiography

Background and ObjectiveFundus fluorescein angiography (FFA), found in 1961, has been widely applied in the clinical pathologic diagnosis, observation, pathogenesis and anatomy, pathology. It is one of the most important means in diagnosis of ocular fundus diseases. The basic principle is to use a fluorescent material such as fluorescein, which is inspired by the blue and emerge green fluorescence, and fundus cameras equipped with a special filter to observe and shoot to fundus cycle dynamic process. Sodium fluorescein is the most commonly used angiography agent and recognized relative safety and stability. Sodium fluorescein neither participates in the metabolism of decomposition, nor binds with the tissue firmly, thereofre, it has minimal toxicity. But there are mild adverse reactions which was often reported since application. According to Yannuzzi: mortality induced by FFA is 1:222000. In clinical, sodium fluorescein can also cause patient death, Xiang Fang insists that sodium fluorescein is not an absolute security dye reagent. The correlations between fluorescein angiography adverse reaction rate, clinical types and adverse reactions related factors were tested.Clinical data and methods1. To study the adverse reactions of 7977 cases after fluorescein angiography in our hospital in July 1991～July 2006.2. To pick out 5 literatures about the adverse reaction induced by fluorescein angiography in 2002-2006 from China National Knowledge Infrastructure (CNKI)and compare its data with data from our hospital.3. To collect the document data about the adverse reaction induced by fluorescein angiography in 1999-2007 from CNKI, screen those which include more than 500 samples, summarize and analyze to the adverse reaction of all patients including patients from our hospital.4. The rates of the adverse reaction were analysed statistically by one-way analysis of variance (ANOVA) with SPSS 11.0. Results are presented as means±SD. ResultsResultⅠ: The adverse reaction incidence and its related factors after fluorescein angiography in our hospital (7, 977 cases).There were 1, 258 adverse reaction events developed in 7, 977 cases (15. 73%) mainly including nausea and vomiting(1010 cases, 80. 29%). No patient died. The adverse reaction incidence rate in men is significantly higer than that in women. There is a young trend on the patient average age. No significant difference was detected between different batches of different manufacturers (Guangxi Wuzhou Pharmaceutical plant and Mingxing Guangzhou Pharmaceutical plant).ResultⅡ: The comparison of adverse reactions between our hospital and other hospitals.The incidence of nausea and vomiting caused by fluorescein angiography in our hospital was significantly higher than that in other hospitals. There were no differences in the incidence of other adverse reactions between our hospital and other hospital. The total incidence of adverse reactions in our hospital was significantly higher than that in other hospitals.ResultⅢ: The comprehesive analysis to the adverse reactions of all 49, 440 cases from our hospital and other hospitals.The incident of adverse reactions (2, 897 cases) was 6.45%. in the total of 44, 940 cases. The incidence of adverse reactions of nausea and vomiting was 5.07% account for the vast majority. The incidences of phlebitis, incontinence, glaucoma were low and can be ignored.Conclusions1. Sodium fluorescein is a relatively safe dye in angiography retinopathy. FFA is one of the most important means in the inspection of ophthalmology and diagnosis of ocular fundus diseases. The adverse reactions caused by sodium fluorescein are seldom and mild. The serious adverse reactions or dead cases are rare.2. Nausea and vomiting are the main adverse reactions. The incidence rate of male is higher than that of female, and the incidence rate of the young and middle-aged is higher than that of the older. Strong vagal reaction might be mainly responsible for nausea and vomiting.3. There were no significant differences in the effects of the preparation from different manufactures (Guangxi Wuzhou Pharmaceutical plant and Mingxing Guangzhou Pharmaceutical plant) on adverse reactions. The pure preparation has less adverse reactions.