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眼局部环丙甲羟二羟吗啡酮的安全

Ocular Safety of Topical Naltrexone

作者:Sassani, J. W.; Liang, D.; Bowie, E. 作者单位:Milton S. Hershey Medical Center, PA. 加工时间:2015-03-20 信息来源:科技报告(AD) 索取原文[89 页]
关键词:剂量;眼疾;医药;药店;冲突;家常便饭;数据采集;数据处理;错误;眼睛;观察家;角膜磨损;眼药水;阿片拮抗物;角膜伤口愈合;阿片样物质;治疗
摘 要:We have obtained continuing approval from our Institutional Review Board and Conflict of Interest (COI) Committees. Dr. Sassani has assisted Dr. David Liang and Dr. Esther Bowie in data collection. All observers are masked. Nevertheless, at the request of our COI Committee he does not participate in data analysis or interpretation. We completed testing in 4 volunteers in each of the once daily and 4 times daily, 1 x 10-6 M cohorts; four times daily, 1 x 10-6, 5 x 10- 6, and 1 x 10-5 M dosages of topical Naltrexone in Vigamox eyedrops. Due to a pharmacy error, one additional cohort of 4 individuals was treated at a lower than scheduled dose of 5 X 10-6M and this cohort had to be repeated at the higher dosage of 1 x 10-5M, thereby further delaying the research. No significant untoward side effects were noted in any groups of volunteers. Although this officially is our Final Report, we are committed to completing the terms of our original grant. Therefore, we have recruited our final cohort of volunteers and within one week will have treated them with the four times daily, 5 x 10-5 M Naltrexone dosage. Thus, we will have completed the protocol fully.
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