玻璃体腔内单次注射高纯度绵羊透明质酸酶治疗玻璃体出血的有效性——两个国际随机对照临床试验中心的有效研究汇总结果
Pooled efficacy results from two multinational randomized controlled clinical trials of a single intravitreous injection of highly purified ovine hyaluronidase （Vitrase）-for the management of vitreous hemorrhage作者机构：Department of Ophthalmology University of California Irvine 118 MedSurge I Irvine CA92697United StatesDr.
出 版 物：《世界核心医学期刊文摘(眼科学分册)》 (Digest of the World Core Medical Journals)
年 卷 期：2006年第3期
页 面：18-18页
学科分类：1002[医学-临床医学] 100212[医学-眼科学] 10[医学]
摘 要：PURPOSE: To evaluate the efficacy of intravitreous ovine hyaluronidase for the management of vitreous hemorrhage. DESIGN: Two prospective, randomized, placebo-controlled, double-masked studies. Safety data are presented in a companion article in the journal. METHODS: Eligible patients with vitreous hemorrhage 1 month duration; severe at entry with best corrected visual acuity (BCVA) worse than 20/200 were randomized to 55 IU or 75 IU ovine hyaluronidase or saline. Primary efficacy (clearance of hemorrhage sufficient to see the underlying pathology and completion of treatment when indicated) was measured at months 1, 2, and 3. Key seco ndary endpoints were: 3-line improvement in BCVA; hemorrhage density reduction; and therapeutic utility assessment. RESULTS: The intent-to-treat population for common dose groups (55 IU, 75 IU, saline) consisted of 1125 patients. At baseline, 76.3%had diabetes, 90.4%were not able to read any letters on the eye c hart, and mean hemorrhage duration was 120 days. Statistical significance was re ached in the 55 IU dose group by months 1 and 2 for the primary efficacy endpoin t based on an adjusted P-value. By months 1, 2, and 3, 13.2%, 25.5%, and 32.9 %of patients (55 IU) reached primary efficacy compared with 5.5%, 16.2%, and 25.6%of saline-treated patients (P.001; P=.002; P=.025, respectively). Key se condary endpoints confirmed the treatment effect at both doses and all timepoint s (P ≤.01). CONCLUSIONS: Fifty-five IU ovine hyaluronidase showed statistically significant efficacy as early as months 1 and 2. These results were supported by outcomes for three key secondary endpoints. These results suggest a therapeutic utility of ovine hyaluronidase in the management of vitreous hemorrhage.
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