Minckler D S, Vedula S S, Li T J, Mathew M C, Ayyala R S, Francis B A
Doheny Eye Institute, Department of Ophthalmology, 1450 San Pablo, Los Angeles, CA 90033, USA.
Cochrane Database Syst Rev. 2006 Apr 19(2):CD004918. doi: 10.1002/14651858.CD004918.pub2.
Aqueous shunts are employed for intraocular pressure (IOP) control in primary and secondary glaucomas that fail medical, laser, and other surgical therapies.
This review compares aqueous shunts for IOP control and safety.
We searched CENTRAL, MEDLINE, PubMed, EMBASE, NRR all in January 2006, LILACS to February 2004 and reference lists of included trials.
We included all randomized and quasi-randomized trials in which one arm of the study involved shunts.
Two authors independently extracted data for included studies and a third adjudicated discrepancies. We contacted investigators for missing information. We used fixed-effect models and summarized continuous outcomes using mean differences.
We included fifteen trials with a total of 1153 participants with mixed diagnoses. Five studies reported details sufficient to verify the method of randomization but only two had adequate allocation concealment. Data collection and follow-up times were variable.Meta-analysis of two trials comparing Ahmed implant with trabeculectomy found trabeculectomy resulted in lower mean IOPs 11 to 13 months later (mean difference 3.81 mm Hg, 95% CI 1.94 to 5.69 mm Hg). Meta-analysis of two trials comparing double-plate Molteno implant with the Schocket shunt was not done due to substantial heterogeneity. One study comparing ridged with standard double-plate Molteno implants found no clinically significant differences in outcome. Two trials investigating the effectiveness of adjunctive mitomycin (MMC) with the Molteno and Ahmed implants found no evidence of benefit with MMC. Two trials that investigated surgical technique variations with the Ahmed found no benefit with partial tube ligation or excision of Tenon's capsule. One study concluded there were outcome advantages with a double versus a single-plate Molteno implant and one trial comparing the 350 mm(2) and 500 mm(2) Baerveldt shunts found no clinically significant advantage of the larger device but neither of these trials included all patients randomized. One study suggested improved clinical outcome when MMC was employed with a newly described shunt including ultrasound supporting the conclusion. One small study did not demonstrate an outcome advantage to systemic steroid use postoperatively with single-plate Molteno shunts. One study comparing endocyclophotocoagulation (ECP) with Ahmed implant in complicated glaucomas found no evidence of better IOP control with Ahmed implant over ECP.
AUTHORS' CONCLUSIONS: Relatively few randomized trials have been published on aqueous shunts and methodology and data quality among them is poor. To date there is no evidence of superiority of one shunt over another.
对于药物、激光及其他手术治疗无效的原发性和继发性青光眼,可采用房水引流装置来控制眼内压(IOP)。
本综述比较用于控制IOP及安全性的房水引流装置。
我们于2006年1月检索了Cochrane临床对照试验中心注册库(CENTRAL)、医学索引数据库(MEDLINE)、医学期刊数据库(PubMed)、荷兰医学文摘数据库(EMBASE)、非随机研究的循证医学数据库(NRR),于2004年2月检索了拉丁美洲和加勒比地区健康科学文献数据库(LILACS),并检索了纳入试验的参考文献列表。
我们纳入了所有随机和半随机试验研究,其中一组涉及房水引流装置。
两位作者独立提取纳入研究的数据,第三位作者裁定分歧。我们联系研究者获取缺失信息。我们使用固定效应模型,并用平均差汇总连续结果。
我们纳入了15项试验,共1153名诊断各异的参与者。5项研究报告了足以验证随机化方法的细节,但只有2项有充分的分配隐藏。数据收集和随访时间各不相同。对两项比较Ahmed植入物与小梁切除术的试验进行的荟萃分析发现,小梁切除术在11至13个月后导致的平均IOP更低(平均差3.81 mmHg,95%置信区间1.94至5.69 mmHg)。由于存在实质性异质性,未对两项比较双盘Molteno植入物与Schocket分流器的试验进行荟萃分析。一项比较带脊与标准双盘Molteno植入物的研究发现,结果在临床上无显著差异。两项研究Molteno和Ahmed植入物联合丝裂霉素(MMC)有效性的试验未发现MMC有益处的证据。两项研究Ahmed手术技术差异的试验未发现部分管结扎或Tenon囊切除术有益处。一项研究得出结论,双盘Molteno植入物比单盘Molteno植入物在结果上有优势,一项比较350 mm²和500 mm² Baerveldt分流器的试验未发现较大装置在临床上有显著优势,但这两项试验均未纳入所有随机分组的患者。一项研究表明,使用新描述的分流器并联合MMC时临床结果有所改善,包括超声检查支持这一结论。一项小型研究未证明单盘Molteno分流器术后全身使用类固醇有结果优势。一项在复杂性青光眼中比较睫状体光凝术(ECP)与Ahmed植入物的研究未发现Ahmed植入物在控制IOP方面优于ECP的证据。
关于房水引流装置的随机试验发表相对较少,且其中的方法学和数据质量较差。迄今为止,没有证据表明一种分流器优于另一种。