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玻璃体腔内注射高纯度绵羊透明质酸酶治疗玻璃体出血的两项Ⅲ期安全性试验结果

世界核心医学期刊文摘(眼科学分册) 2006年第2期 12-13页

作者： Kuppermann B.D Thomas E.l De Smet M.D grillone l.r. 桑延智 Department of Ophthalmology University of California Irvine 118 MedSurge I I rvineCA92697United States Dr.

PUrPOSE: To evaluate the safety of intravitreous ovine hyal.r.nidase for the management of vitreous hemorrhage. DESIGN: Two prospective, randomized, placebo-controll-ed, double-masked studies. Pooled efficacy data are presented in a companion article in this issue of THE JOUrNAl. METHODS: Subjects with vitreous hemorrhage re at entry and best corrected visual acuity (BCVA) worse than 20/200 in the study eye were randomized to 7.5 IU, 55 IU, 75 IU ovine hyal.r.nidase, saline, or no injection. Assessments occurred on day 1, week 1, months 1, 2, 3, 6, and then every 6 months for as long as 32 months. Assessments included history, ocul.r.symptoms, adverse events, BCVA, intraocul.r.pressure, external eye examination, slit-lamp biomicroscopy, fundus examination, B-scan ul.r.sonography, and fundus photography. rESUlTS: Of 1362 subjects in the safety population, 1344 received hyal.r.nidase or saline and 18 no treatment. Iritis was the most common ocul.r.adverse event, occurring in 33.3% , 62.1% , 58.9% , and 62.1% of saline, 7.5 IU, 55 IU, and 75 IU-treated subjects. In eyes with more than mild iritis, a dose response was observed: 8.9% , 20.2% , 33.7% , and 39.7% of saline, 7.5 IU, 55 IU, and 75 IU-treated subjects, respectively, were noted to have moderate or severe iritis. retinal detachments (rDs) were reported in 9.5% of study eyes: 26 (6.9% ), 22 (11.1% ), 35 (9.3% ), and 45 (11.5% ) in the saline, 7.5 IU, 55 IU, and 75 IU-treated subjects. Overall, 1.8% of study eyes had rhegmatogenous rD: 1.1% , 2.5% , 1.6% , and 2.3% of saline, 7.5, 55, and 75 IU treated subjects. Cataracts occurred simil.r.y across treatment groups. No injection-related infectious endophthalmitis was reported. CONClUSIONS: No serious safety issues were reported after a single intravitreous injection of ovine hyal.r.nidase. rD incidence was not statistically different between groups. Iritis manifesting as an acute self limited inflammation was the most common adverse event, occurred i

关键词：玻璃体腔内注射透明质酸酶玻璃体出血玻璃体积血绵羊高纯度

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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

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世界核心医学期刊文摘(眼科学分册) 2006年第3期 18-18页

作者： Kuppermann B.D Thomas E.l De Smet M.D grillone l.r. 秦雪娇 Department of Ophthalmology University of California Irvine 118 MedSurge I Irvine CA92697United StatesDr.

PUrPOSE: To evaluate the efficacy of intravitreous ovine hyal.r.nidase 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 ration; severe at entry with best corrected visual acuity (BCVA) worse than 20/200 were randomized to 55 IU or 75 IU ovine hyal.r.nidase 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: 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 (Prespectively). Key se condary endpoints confirmed the treatment effect at both doses and all timepoint s (P ≤.01). CONClUSIONS: Fifty-five IU ovine hyal.r.nidase 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 hyal.r.nidase in the management of vitreous hemorrhage.

关键词：透明质酸酶玻璃体出血玻璃体积血有效性绵羊

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