玻璃体内注射药物后在无需局部使用抗生素情况下发生眼内炎的风险:糖尿病视网膜病变临床研究网络激光-雷珠单抗-曲安奈德临床试验
Risk of endophthalmitis after intravitreal drug injection when topical antibiotics are not required: the diabetic retinopathy clinical research network laser-ranibizumab-triamcinolone clinical trials.
作者信息
Bhavsar Abdhish R, Googe Joseph M, Stockdale Cynthia R, Bressler Neil M, Brucker Alexander J, Elman Michael J, Glassman Adam R
机构信息
Jaeb Center for Health Research, 15310 Amberly Dr, Ste 350, Tampa, FL 33647, USA.
出版信息
Arch Ophthalmol. 2009 Dec;127(12):1581-3. doi: 10.1001/archophthalmol.2009.304.
OBJECTIVE
To report the incidence of endophthalmitis after intravitreal drug injection by means of a standardized procedure that does not require topical antibiotics, sterile gloves, or a sterile drape.
METHODS
Intravitreal injections of preservative-free triamcinolone acetonide or ranibizumab were administered in 2 prospective randomized clinical trials performed by the Diabetic Retinopathy Clinical Research Network. The standardized procedure for these trials requires the use of a topical combination product of povidone-iodine, a sterile lid speculum, and topical anesthetic, but does not require the use of topical antibiotics before, on the day of, or after injection.
RESULTS
As of February 23, 2009, a total of 3226 intravitreal injections of ranibizumab and 612 injections of preservative-free triamcinolone had been administered. Topical antibiotics were given on the day of injection in 361 (9.4%) of the 3838 cases, for several days after injection in 813 cases (21.2%), on the day of injection and after injection in 1388 cases (36.2%), and neither on the day of injection nor after injection in 1276 cases (33.3%). Three cases of culture-positive endophthalmitis occurred after ranibizumab injections (0.09%), and no cases occurred after triamcinolone injections. In all 3 cases of endophthalmitis, topical antibiotics were given for several days after the injection but not before injection.
CONCLUSIONS
The results suggest that a low rate of endophthalmitis can be achieved by means of a protocol that includes use of topical povidone-iodine, a sterile lid speculum, and topical anesthetic, but does not require topical antibiotics, sterile gloves, or a sterile drape. Trial Registration clinicaltrials.gov Identifiers: NCT00444600 and NCT00445003.
目的
通过一种标准化程序报告玻璃体内注射药物后眼内炎的发生率,该程序无需局部使用抗生素、无菌手套或无菌手术巾。
方法
糖尿病视网膜病变临床研究网络进行的2项前瞻性随机临床试验中,给予玻璃体内注射无防腐剂的曲安奈德或雷珠单抗。这些试验的标准化程序要求使用聚维酮碘局部联合制剂、无菌眼睑撑开器和局部麻醉剂,但在注射前、注射当天或注射后无需使用局部抗生素。
结果
截至2009年2月23日,共进行了3226次雷珠单抗玻璃体内注射和612次无防腐剂曲安奈德注射。3838例病例中有361例(9.4%)在注射当天给予局部抗生素,813例(21.2%)在注射后数天给予,1388例(36.2%)在注射当天和注射后给予,1276例(33.3%)在注射当天和注射后均未给予。雷珠单抗注射后发生3例培养阳性的眼内炎(0.09%),曲安奈德注射后未发生病例。在所有3例眼内炎病例中,注射后数天给予了局部抗生素,但注射前未给予。
结论
结果表明,通过一种包括使用局部聚维酮碘、无菌眼睑撑开器和局部麻醉剂,但无需局部抗生素、无菌手套或无菌手术巾的方案,可实现较低的眼内炎发生率。试验注册 clinicaltrials.gov 标识符:NCT00444600和NCT00445003。