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白内障合并青光眼患者联合手术与单纯白内障手术的比较

Combined surgery versus cataract surgery alone for eyes with cataract and glaucoma.

作者信息

Zhang Mingjuan Lisa, Hirunyachote Phenpan, Jampel Henry

机构信息

Johns Hopkins University School of Medicine, 929 N. Wolfe St, Apt. 615, Baltimore, Maryland, USA, 21205.

出版信息

Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD008671. doi: 10.1002/14651858.CD008671.pub3.

Abstract

BACKGROUND

Cataract and glaucoma are leading causes of blindness worldwide, and their co-existence is common in elderly people. Glaucoma surgery can accelerate cataract progression, and performing both surgeries may increase the rate of postoperative complications and compromise the success of either surgery. However, cataract surgery may independently lower intraocular pressure (IOP), which may allow for greater IOP control among patients with co-existing cataract and glaucoma. The decision between undergoing combined glaucoma and cataract surgery versus cataract surgery alone is complex. Therefore, it is important to compare the effectiveness of these two interventions to aid clinicians and patients in choosing the better treatment approach.

OBJECTIVES

To assess the relative effectiveness and safety of combined surgery versus cataract surgery (phacoemulsification) alone for co-existing cataract and glaucoma. The secondary objectives include cost analyses for different surgical techniques for co-existing cataract and glaucoma.

SEARCH METHODS

We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (2014, Issue 10), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2014), EMBASE (January 1980 to October 2014), PubMed (January 1948 to October 2014), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to October 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (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 3 October 2014.We checked the reference lists of the included trials to identify further relevant trials. We used the Science Citation Index to search for references to publications that cited the studies included in the review. We also contacted investigators and experts in the field to identify additional trials.

SELECTION CRITERIA

We included randomized controlled trials (RCTs) of participants who had open-angle, pseudoexfoliative, or pigmentary glaucoma and age-related cataract. The comparison of interest was combined cataract surgery (phacoemulsification) and any type of glaucoma surgery versus cataract surgery (phacoemulsification) alone.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed study eligibility, collected data, and judged risk of bias for included studies. We used standard methodological procedures expected by the Cochrane Collaboration.

MAIN RESULTS

We included nine RCTs, with a total of 655 participants (657 eyes), and follow-up periods ranging from 12 to 30 months. Seven trials were conducted in Europe, one in Canada and South Africa, and one in the United States. We graded the overall quality of the evidence as low due to observed inconsistency in study results, imprecision in effect estimates, and risks of bias in the included studies.Glaucoma surgery type varied among the studies: three studies used trabeculectomy, three studies used iStent® implants, one study used trabeculotomy, and two studies used trabecular aspiration. All of these studies found a statistically significant greater decrease in mean IOP postoperatively in the combined surgery group compared with cataract surgery alone; the mean difference (MD) was -1.62 mmHg (95% confidence interval (CI) -2.61 to -0.64; 489 eyes) among six studies with data at one year follow-up. No study reported the proportion of participants with a reduction in the number of medications used after surgery, but two studies found the mean number of medications used postoperatively at one year was about one less in the combined surgery group than the cataract surgery alone group (MD -0.69, 95% CI -1.28 to -0.10; 301 eyes). Five studies showed that participants in the combined surgery group were about 50% less likely compared with the cataract surgery alone group to use one or more IOP-lowering medications one year postoperatively (risk ratio (RR) 0.47, 95% CI 0.28 to 0.80; 453 eyes). None of the studies reported the mean change in visual acuity or visual fields. However, six studies reported no significant differences in visual acuity and two studies reported no significant differences in visual fields between the two intervention groups postoperatively (data not analyzable). The effect of combined surgery versus cataract surgery alone on the need for reoperation to control IOP at one year was uncertain (RR 1.13, 95% CI 0.15 to 8.25; 382 eyes). Also uncertain was whether eyes in the combined surgery group required more interventions for surgical complications than those in the cataract surgery alone group (RR 1.06, 95% CI 0.34 to 3.35; 382 eyes). No study reported any vision-related quality of life data or cost outcome. Complications were reported at 12 months (two studies), 12 to 18 months (one study), and two years (four studies) after surgery. Due to the small number of events reported across studies and treatment groups, the difference between groups was uncertain for all reported adverse events.

AUTHORS' CONCLUSIONS: There is low quality evidence that combined cataract and glaucoma surgery may result in better IOP control at one year compared with cataract surgery alone. The evidence was uncertain in terms of complications from the surgeries. Furthermore, this Cochrane review has highlighted the lack of data regarding important measures of the patient experience, such as visual field tests, quality of life measurements, and economic outcomes after surgery, and long-term outcomes (five years or more). Additional high-quality RCTs measuring clinically meaningful and patient-important outcomes are required to provide evidence to support treatment recommendations.

摘要

背景

白内障和青光眼是全球失明的主要原因,二者并存于老年人中很常见。青光眼手术会加速白内障进展,同时进行这两种手术可能会增加术后并发症发生率并影响任何一种手术的成功率。然而,白内障手术可能会独立降低眼压(IOP),这可能使白内障和青光眼并存的患者获得更好的眼压控制。决定是进行青光眼和白内障联合手术还是单纯白内障手术很复杂。因此,比较这两种干预措施的有效性对于帮助临床医生和患者选择更好的治疗方法很重要。

目的

评估联合手术与单纯白内障手术(超声乳化术)治疗白内障和青光眼并存患者的相对有效性和安全性。次要目标包括对治疗白内障和青光眼并存患者的不同手术技术进行成本分析。

检索方法

我们检索了Cochrane中心对照试验注册库(CENTRAL)(2014年第10期,其中包含Cochrane眼科和视力组试验注册库)、Ovid MEDLINE、Ovid MEDLINE在研及其他未索引引文、Ovid MEDLINE每日更新、Ovid OLDMEDLINE(1946年1月至2014年10月)、EMBASE(1980年1月至2014年10月)、PubMed(1948年1月至2014年10月)、拉丁美洲和加勒比健康科学文献数据库(LILACS)(1982年1月至上述日期)、对照试验元注册库(mRCT)(www.controlled-trials.com)、ClinicalTrials.gov(www.clinicaltrials.gov)以及世界卫生组织(WHO)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,我们未使用任何日期或语言限制。我们最后一次检索电子数据库是在2014年10月3日。我们检查了纳入试验的参考文献列表以识别更多相关试验。我们使用科学引文索引来搜索引用该综述中纳入研究的出版物的参考文献。我们还联系了该领域的研究者和专家以识别其他试验。

选择标准

我们纳入了患有开角型、剥脱性或色素性青光眼以及年龄相关性白内障患者的随机对照试验(RCT)。感兴趣的比较是联合白内障手术(超声乳化术)与任何类型的青光眼手术联合与单纯白内障手术(超声乳化术)。

数据收集与分析

两位综述作者独立评估研究的纳入资格、收集数据并判断纳入研究的偏倚风险。我们采用了Cochrane协作网期望的标准方法程序。

主要结果

我们纳入了9项RCT,共655名参与者(657只眼),随访期为12至30个月。7项试验在欧洲进行,1项在加拿大和南非进行,1项在美国进行。由于研究结果存在不一致性、效应估计不精确以及纳入研究存在偏倚风险,我们将证据的整体质量评为低质量。各研究中青光眼手术类型不同:3项研究采用小梁切除术,3项研究采用iStent®植入术,1项研究采用小梁切开术,2项研究采用小梁抽吸术。所有这些研究均发现,与单纯白内障手术相比,联合手术组术后平均眼压下降在统计学上有显著更大幅度;在6项有一年随访数据的研究中,平均差值(MD)为-1.62 mmHg(95%置信区间(CI)-2.61至-0.64;489只眼)。没有研究报告术后使用药物数量减少的参与者比例,但有2项研究发现,联合手术组术后一年平均使用药物数量比单纯白内障手术组少约一种(MD -0.69,95% CI -1.28至-0.10;301只眼)。5项研究表明,与单纯白内障手术组相比,联合手术组参与者术后一年使用一种或多种降眼压药物的可能性降低约50%(风险比(RR)0.47,95% CI 0.28至0.80;453只眼)。没有研究报告视力或视野的平均变化。然而,6项研究报告两组术后视力无显著差异,2项研究报告两组术后视野无显著差异(数据无法分析)。联合手术与单纯白内障手术对一年后为控制眼压而进行再次手术的需求的影响尚不确定(RR 1.13,95% CI 0.15至8.25;382只眼)。联合手术组的眼睛是否比单纯白内障手术组需要更多的手术并发症干预也不确定(RR 1.06,95% CI 0.34至3.35;382只眼)。没有研究报告任何与视力相关的生活质量数据或成本结果。术后12个月(2项研究)、12至18个月(1项研究)和2年(4项研究)报告了并发症。由于各研究和治疗组报告的事件数量较少,所有报告的不良事件组间差异尚不确定。

作者结论

有低质量证据表明,与单纯白内障手术相比,白内障和青光眼联合手术可能在一年时导致更好的眼压控制。手术并发症方面的证据尚不确定。此外,本Cochrane综述强调了缺乏关于患者体验的重要指标的数据,如视野检查、生活质量测量以及术后经济结果和长期结果(五年或更长时间)。需要更多测量具有临床意义和对患者重要的结果的高质量RCT来提供证据以支持治疗建议。

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