One-year results of a multicenter controlled clinical trial of triamcinolone in pars plana vitrectomy
One-year results of a multicenter controlled clinical trial of triamcinolone in pars plana vitrectomy
复制标题
DOI：
10.1007/s00417-008-0829-0
复制
发表时间：
2008-07-01
影响因子：
2.7
通讯作者：
Ishibashi, Tatsuro
中科院分区：
文献类型：
--
作者：
Yamakiri, Keita;Sakamoto, Taiji;Ishibashi, Tatsuro
目的 评价使用曲安奈德 (TA) 进行玻璃体切除术 (PPV) 的 1 年结果。设计多中心前瞻性对照临床试验。方法设置和研究人群：研究人群包括来自八家日本医院治疗的患者的 774 只眼，其中 391 只眼接受 TA 辅助 PPV，383 只对照眼接受传统 PPV。在参与的临床中心内使用单盲准随机方法将患者分配到两组。干预：术中使用 TA 来帮助观察玻璃体。主要观察指标：比较TA-PPV组与传统PPV组的视力变化、术后并发症（包括追加手术）以及术后1年内发生的不良事件。结果随着时间的推移，视力有所改善，两组之间无显着性差异（与TA相比，log-rank，改善P=0.98，恶化P=0.26）。 Logistic回归模型还显示，调整年龄、性别和诊断后，术中使用TA并不是视力改善的显着因素[P=0.91，优势比（OR）=1.10，95%置信区间（95%CI）=0.860-1.183）]。术中 TA 并不是需要额外手术的重要因素（对数秩检验 P=0.45，逻辑回归检验 P=0.35，OR=1.23，95%CI=0.797-1.911]。没有观察到与手术相关的严重不良事件。结论 这项对照临床试验的 1 年随访研究表明，TA 辅助的 PPV 对视力、视力下降的发生率既没有正面影响也没有负面影响。与传统 PPV 相比，额外的手术或不良事件。
Purpose To evaluate the 1-year results of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV).Design Multicenter prospective controlled clinical trial.Methods SETTING and STUDY POPULATION: the study population comprised 774 eyes from patients treated at eight Japanese hospitals, among which 391 eyes underwent TA-assisted PPV and 383 control eyes underwent conventional PPV. The patients were assigned to the two groups using a single-blind quasi-randomization approach within the participating clinical centers. INTERVENTION: intra-operative use of TA to aid visualization of the vitreous. MAIN OUTCOME MEASURES: changes of visual acuity, post-operative complications (including additional surgery), and adverse events occurring within 1 year of the operation were compared between the TA-PPV group and the conventional PPV group.Results The visual acuity improved over time, and no significant differences were found between the two groups (log-rank versus TA, P=0.98 for improvement, P=0.26 for deterioration). The logistic regression model also showed that the intra-operative use of TA was not a significant factor for the improvement of visual acuity [P=0.91, odds ratio (OR)=1.10, 95% confidence interval (95%CI)=0.860-1.183)] after adjustments for age, gender, and diagnosis. Intra-operative TA was not a significant factor for the need for additional surgery (log-rank test P=0.45, logistic regression test P=0.35, OR=1.23, 95%CI=0.797-1.911]. No serious adverse events related to surgery were observed.Conclusions This 1-year follow-up study of a controlled clinical trial showed that TA-assisted PPV had neither a positive nor a negative effect on visual acuity, the incidence of additional surgeries, or adverse events compared with conventional PPV.