玻璃体内注射曲安奈德治疗黄斑水肿 临床研究的现状分析

目的分析玻璃体内注射曲安奈德(TA )治疗黄斑水肿临床研究现状。方法收集玻璃体内注射TA治疗黄斑水肿的国内外文献，按照循证医学要求进行系统评价。检索美国MEDLINE数据库、中国期刊全文数据库（CNKI）的中、英文文献。依据纳入标准和排除标准筛选出符合研究目的的文献51篇，其中，以疗效为主要研究目的的文献42篇，按照治疗性医学文献证据级别的判定标准进行证据分级。结果51篇文献中Ⅰ级证据0篇，Ⅱ级证据1篇，Ⅲ级证据7篇，Ⅳ级证据24篇，Ⅴ级证据19篇；得出的结论是：玻璃体内注射TA治疗黄斑水肿3个月内有显著效果，视力较治疗前有显著提高。23篇文献报告了治疗后黄斑水肿明显改善；20篇文献报道不良反应93眼次，平均发生率为31.41%，其中严重不良反应发生率为1.35%。结论玻璃体内注射TA短期内对黄斑水肿消退及视力改善有一定疗效，但目前文献缺少可作为判断治疗有效性金标准的Ⅰ级文献，缺乏判断长期有效性的研究以及再次治疗有效性和必要性的研究。对于不良事件特别是严重不良事件应予以足够重视并积极预防。(中华眼底病杂志, 2005,21:220-223)

Evidence-based medicine analysis on curative effects of intravitreous injection with triamcinolone acetonide for macular edema

ObjectiveTo seek the evidence based medicine (EBM) evidences of curative effects of intravitreous injection with triamcinolone acetonide (TA) for macular edema.MethodsAll articles of intravitreous injection TA for macular edema published in English or Chinese were picked up from databases of MEDLINE and CNKI and then evaluated according to EBM standard. The data in accord with research standard were selected by using excluding and including criteria, and classified according to the appraisal standard of clinical therapeutic documents. ResultsIn the selected papers, none in gradeⅠevidence; 1 in gradeⅡevidence; 7 in grade Ⅲ evidence; 24 in grade Ⅳ evidence; and 19 in gradeⅤevidence. Forty-two papers reported that intravitreous injection with TA had significant effect for macular edema within 3 months, and the improvement of visual acuity was recorded in these papers. Regression of macular edema was recorded in 23 papers. Among 20 papers, side-effect was found in 93 eyes (31.41%) and the serious side effect in 4 eyes (1.35%).ConclusionsIntravitreous injection with TA has some curative effects for macular edema in short term, but the quality of current study has not been encouraging. There are no grade I document and lack of the study of validity in long term and essentiality and validity of retreatment. The special attention should be payed on the increasing persistency of efficacy and preventing the serious side-effects in the future investigation.(Chin J Ocul Fundus Dis, 2005,21:220-223)