Reduced incidence of intraoperative complications in a multicenter controlled clinical trial of triamcinolone in vitrectomy

Reduced incidence of intraoperative complications in a multicenter controlled clinical trial of triamcinolone in vitrectomy
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DOI:
10.1016/j.ophtha.2006.07.044
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发表时间:
2007-02-01
期刊:
影响因子:
13.7
通讯作者:
Ishibashi, Tatsuro
Ishibashi, Tatsuro
中科院分区:
医学1区
文献类型:
--
作者:
Yamakiri, Keita;Sakamoto, Taiji;Ishibashi, Tatsuro

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目的:评价在睫状体平坦部玻璃体切除术(PPV)中使用曲安奈德(TA)的益处和潜在并发症。设计:多中心、前瞻性、对照临床试验。参与者:共有来自8家日本医院的774例患者入组,其中391例患者接受TA辅助PPV,383例对照患者接受常规PPV。干预:术中使用TA来辅助玻璃体的可视化。主要结果测量:术中并发症的发生率,包括视网膜裂孔,进行了评价。术后早期并发症,眼内压(IOP),并发生在3个月内的option.Results:视网膜裂孔和术中视网膜脱离的发生率显着低于TA辅助PPV比传统PPV的不良事件也monitored。在接受TA辅助PPV的34只眼(8.7%)中观察到视网膜破裂,而接受传统PPV的54只眼(14.1%)中观察到视网膜破裂(比值比[OR],0.603; 95%置信区间[CI],0.381-0.955; P = 0.031)。使用TA组仅3只眼(0.8%)发生视网膜脱离,未使用TA组14只眼(3.7%)发生视网膜脱离(OR,0.204; 95%CI,0.057-0.727; P = 0.014)。术后随访3个月,TA辅助PPV组388眼(99.2%),常规PPV组374眼(97.6%)。尽管两组的平均术后IOP相当,但TA辅助组患者使用抗青光眼滴眼液的频率高于传统PPV组(OR,1.673; 95% CI,1.126-2.484; P = 0.011)。没有严重的不良事件,如眼内炎或视网膜变性,观察在任何group.Conclusions:术中使用TA减少视网膜裂孔和视网膜脱离的眼睛接受PPV的发病率。没有与术中使用TA相关的严重不良事件。尽管TA辅助PPV后比常规PPV后更频繁地需要抗青光眼滴眼液,但两组的IOP均得到良好控制。
Purpose: To evaluate the benefits and potential complications of using triamcinolone acetonide (TA) in pars plana vitrectomy (PPV).Design: Multicenter, prospective, controlled clinical trial.Participants: In total, 774 patients from 8 Japanese hospitals were enrolled, with 391 patients undergoing TA-assisted PPV and 383 control patients undergoing conventional PPV.Intervention: Intraoperative use of TA to aid visualization of the vitreous.Main Outcome Measures: The incidence of intraoperative complications, including retinal breaks, was evaluated. Early postoperative complications, intraocular pressure (IOP), and adverse events occurring within 3 months of the operation were also monitored.Results: The incidence of both retinal breaks and intraoperative retinal detachment was significantly lower in TA-assisted PPV than in conventional PPV. Retinal breaks were seen in 34 eyes (8.7%) undergoing TA-assisted PPV compared with 54 eyes (14.1%) undergoing conventional PPV (odds ratio [OR], 0.603; 95% confidence interval [CI], 0.381-0.955; P = 0.031). Retinal detachment was seen in only 3 eyes (0.8%) in which TA was used compared with 14 eyes (3.7%) in which TA was not used (OR, 0.204; 95% CI, 0.057-0.727; P = 0.014). In total, 388 eyes in the TA-assisted PPV group (99.2%) and 374 eyes in the conventional PPV group (97.6%) were followed up for 3 months after the operation. Although the mean postoperative IOPs were comparable in both groups, antiglaucoma eye drops were used more frequently by patients in the TA-assisted group than by those in the conventional PPV group (OR, 1.673; 95% CI, 1.126-2.484; P = 0.011). No serious adverse events, such as endophthalmitis or retinal degeneration, were observed in either group.Conclusions: Intraoperative use of TA reduced the incidence of retinal breaks and retinal detachments in eyes undergoing PPV. There were no serious adverse events related to the intraoperative use of TA. Although antiglaucoma eye drops were required more frequently after TA-assisted PPV than after conventional PPV, IOP was well-controlled in both groups.