Burr Jennifer, Azuara-Blanco Augusto, Avenell Alison, Tuulonen Anja
School of Medicine, Medical and Biological Sciences Building, University of St Andrews, Fife, UK.
Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD004399. doi: 10.1002/14651858.CD004399.pub3.
Open angle glaucoma (OAG) is a common cause of blindness.
To assess the effects of medication compared with initial surgery in adults with OAG.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 7), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2012), EMBASE (January 1980 to August 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to August 2012), Biosciences Information Service (BIOSIS) (January 1969 to August 2012), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (January 1937 to August 2012), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/), Zetoc, the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 1 August 2012. The National Research Register (NRR) was last searched in 2007 after which the database was archived. We also checked the reference lists of articles and contacted researchers in the field.
We included randomised controlled trials (RCTs) comparing medications with surgery in adults with OAG.
Two authors independently assessed trial quality and extracted data. We contacted study authors for missing information.
Four trials involving 888 participants with previously untreated OAG were included. Surgery was Scheie's procedure in one trial and trabeculectomy in three trials. In three trials, primary medication was usually pilocarpine, in one trial it was a beta-blocker.The most recent trial included participants with on average mild OAG. At five years, the risk of progressive visual field loss, based on a three unit change of a composite visual field score, was not significantly different according to initial medication or initial trabeculectomy (odds ratio (OR) 0.74, 95% confidence interval (CI) 0.54 to 1.01). In an analysis based on mean difference (MD) as a single index of visual field loss, the between treatment group difference in MD was -0.20 decibel (dB) (95% CI -1.31 to 0.91). For a subgroup with more severe glaucoma (MD -10 dB), findings from an exploratory analysis suggest that initial trabeculectomy was associated with marginally less visual field loss at five years than initial medication, (mean difference 0.74 dB (95% CI -0.00 to 1.48). Initial trabeculectomy was associated with lower average intraocular pressure (IOP) (mean difference 2.20 mmHg (95% CI 1.63 to 2.77) but more eye symptoms than medication (P = 0.0053). Beyond five years, visual acuity did not differ according to initial treatment (OR 1.48, 95% CI 0.58 to 3.81).From three trials in more severe OAG, there is some evidence that medication was associated with more progressive visual field loss and 3 to 8 mmHg less IOP lowering than surgery. In the longer-term (two trials) the risk of failure of the randomised treatment was greater with medication than trabeculectomy (OR 3.90, 95% CI 1.60 to 9.53; hazard ratio (HR) 7.27, 95% CI 2.23 to 25.71). Medications and surgery have evolved since these trials were undertaken.In three trials the risk of developing cataract was higher with trabeculectomy (OR 2.69, 95% CI 1.64 to 4.42). Evidence from one trial suggests that, beyond five years, the risk of needing cataract surgery did not differ according to initial treatment policy (OR 0.63, 95% CI 0.15 to 2.62).Methodological weaknesses were identified in all the trials.
AUTHORS' CONCLUSIONS: Primary surgery lowers IOP more than primary medication but is associated with more eye discomfort. One trial suggests that visual field restriction at five years is not significantly different whether initial treatment is medication or trabeculectomy. There is some evidence from two small trials in more severe OAG, that initial medication (pilocarpine, now rarely used as first line medication) is associated with more glaucoma progression than surgery. Beyond five years, there is no evidence of a difference in the need for cataract surgery according to initial treatment.The clinical and cost-effectiveness of contemporary medication (prostaglandin analogues, alpha2-agonists and topical carbonic anhydrase inhibitors) compared with primary surgery is not known.Further RCTs of current medical treatments compared with surgery are required, particularly for people with severe glaucoma and in black ethnic groups. Outcomes should include those reported by patients. Economic evaluations are required to inform treatment policy.
开角型青光眼(OAG)是导致失明的常见原因。
评估药物治疗与初始手术治疗对成年开角型青光眼患者的效果。
我们检索了Cochrane中心对照临床试验注册库(CENTRAL)(其中包含Cochrane眼科和视力组试验注册库)(《Cochrane图书馆》2012年第7期)、Ovid MEDLINE、Ovid MEDLINE在研及其他非索引引文、Ovid MEDLINE每日更新、Ovid OLDMEDLINE(1946年1月至2012年8月)、EMBASE(1980年1月至2012年8月)、拉丁美洲和加勒比健康科学文献数据库(LILACS)(1982年1月至2012年8月)、生物科学信息服务数据库(BIOSIS)(1969年1月至2012年8月)、护理学与健康相关文献累积索引数据库(CINAHL)(1937年1月至2012年8月)、OpenGrey(欧洲灰色文献信息系统)(www.opengrey.eu/)、Zetoc数据库、对照试验元注册库(mRCT)(www.controlled-trials.com)以及世界卫生组织国际临床试验注册平台(ICTRP)(www.who.int/ictrp/search/en)。在电子检索试验时,我们未设置任何日期或语言限制。我们最近一次检索电子数据库是在2012年8月1日。国家研究注册库(NRR)在2007年最后一次检索,之后该数据库被存档。我们还检查了文章的参考文献列表,并联系了该领域的研究人员。
我们纳入了比较药物治疗与手术治疗成年开角型青光眼患者的随机对照试验(RCT)。
两位作者独立评估试验质量并提取数据。我们联系了研究作者以获取缺失信息。
纳入了四项试验,共888例未经治疗的开角型青光眼患者。一项试验中的手术为Scheie手术,三项试验中的手术为小梁切除术。在三项试验中,主要药物通常为毛果芸香碱,一项试验中为β受体阻滞剂。最近的一项试验纳入了平均患有轻度开角型青光眼的患者。五年时,基于复合视野评分三个单位变化的进行性视野丧失风险,根据初始药物治疗或初始小梁切除术并无显著差异(优势比(OR)0.74,95%置信区间(CI)0.54至1.01)。在以平均差(MD)作为视野丧失单一指标的分析中,治疗组之间MD的差异为-0.20分贝(dB)(95%CI -1.31至0.91)。对于患有更严重青光眼(MD -10 dB)的亚组,探索性分析结果表明,初始小梁切除术在五年时与比初始药物治疗略少的视野丧失相关(平均差0.74 dB(95%CI -0.00至1.48)。初始小梁切除术与较低的平均眼压(IOP)相关(平均差2.20 mmHg(95%CI 1.63至2.77),但眼部症状比药物治疗更多(P = 0.0053)。五年后,根据初始治疗,视力并无差异(OR 1.48,95%CI 0.58至3.81)。在三项针对更严重开角型青光眼的试验中,有一些证据表明药物治疗与更多的进行性视野丧失相关,且眼压降低比手术少3至8 mmHg。在长期(两项试验)中,随机治疗失败的风险药物治疗比小梁切除术更大(OR 3.90,95%CI 1.60至9.53;风险比(HR)7.27,95%CI 2.23至25.71)。自这些试验开展以来,药物和手术都有了发展。在三项试验中,小梁切除术导致白内障发生的风险更高(OR 2.69,95%CI 1.64至4.42)。一项试验的证据表明,五年后,根据初始治疗策略,需要进行白内障手术的风险并无差异(OR 0.63,95%CI 0.15至2.62)。所有试验均存在方法学上的弱点。
初始手术比初始药物治疗能更有效地降低眼压,但与更多的眼部不适相关。一项试验表明,初始治疗是药物治疗还是小梁切除术,五年时视野受限并无显著差异。在两项针对更严重开角型青光眼的小型试验中有一些证据表明,初始药物治疗(毛果芸香碱,现在很少用作一线药物)比手术与更多的青光眼进展相关。五年后,根据初始治疗,白内障手术需求并无差异的证据。与初始手术相比,当代药物(前列腺素类似物、α2受体激动剂和局部碳酸酐酶抑制剂)的临床和成本效益尚不清楚。需要进一步开展与手术相比的当代药物治疗的随机对照试验,特别是针对严重青光眼患者和黑人种族群体。结局应包括患者报告的那些指标。需要进行经济评估以指导治疗策略。