Gower Emily W, Lindsley Kristina, Tulenko Samantha E, Nanji Afshan A, Leyngold Ilya, McDonnell Peter J
University of North Carolina, Gillings School of Global Public Health, 135 Dauer Drive, 2102A McGavran Greenberg, CB#7435, Chapel Hill, North Carolina, USA, 27599.
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Mail Room E6132, Baltimore, Maryland, USA, 21205.
Cochrane Database Syst Rev. 2017 Feb 13;2(2):CD006364. doi: 10.1002/14651858.CD006364.pub3.
Endophthalmitis is a severe inflammation of the anterior or posterior (or both) chambers of the eye that may be sterile or associated with infection. It is a potentially vision-threatening complication of cataract surgery. Prophylactic measures for endophthalmitis are targeted against various sources of infection.
To evaluate the effects of perioperative antibiotic prophylaxis for endophthalmitis following cataract surgery compared with no prophylaxis or other form of prophylaxis.
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 12), Ovid MEDLINE, Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE Daily (January 1946 to December 2016), Embase (January 1980 to December 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to December 2016),the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We used no date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 6 December 2016. We also searched for additional studies that cited any included trials using the Science Citation Index.
We included randomized controlled trials that enrolled adults undergoing cataract surgery (any method and incision type) for lens opacities due to any origin. We included trials that evaluated preoperative antibiotics, intraoperative (intracameral, subconjunctival or systemic), or postoperative antibiotic prophylaxis for acute endophthalmitis. We excluded studies that evaluated antiseptic preoperative preparations using agents such as povidone iodine or antibiotics for treating acute endophthalmitis after cataract surgery.
Two review authors independently reviewed abstracts and full-text articles for eligibility, assessed the risk of bias for each included study, and abstracted data.
Five studies met the inclusion criteria for this review, including 101,005 adults and 132 endophthalmitis cases. While the sample size was very large, the heterogeneity of the study designs and modes of antibiotic delivery made it impossible to conduct a formal meta-analysis. Interventions investigated included the utility of adding vancomycin and gentamycin to the irrigating solution compared with standard balanced saline solution irrigation alone, use of intracameral cefuroxime with or without topical levofloxacin perioperatively, periocular penicillin injections and topical chloramphenicol-sulfadimidine drops compared with topical antibiotics alone, and mode of antibiotic delivery (subconjunctival versus retrobulbar injections; fixed versus separate instillation of gatifloxacin and prednisolone). The risk of bias among studies was low to unclear due to information not being reported. We identified one ongoing study.Two studies compared any antibiotic with no antibiotic. One study, which compared irrigation with antibiotics in balanced salt solution (BSS) versus BSS alone, was not sufficiently powered to detect differences in endophthalmitis between groups (very low-certainty evidence). One study found reduced risk of endophthalmitis when combining intracameral cefuroxime and topical levofloxacin (risk ratio (RR) 0.14, 95% confidence interval (CI) 0.03 to 0.63; 8106 participants; high-certainty evidence) or using intracameral cefuroxime alone (RR 0.21, CI 0.06 to 0.74; 8110 participants; high-certainty evidence) compared with placebo, and an uncertain effect when using topical levofloxacin alone compared with placebo (RR 0.72, CI 0.32 to 1.61; 8103 participants; moderate-certainty evidence).Two studies found reduced risk of endophthalmitis when combining antibiotic injections during surgery and topical antibiotics compared with topical antibiotics alone (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.12 to 0.92 (periocular penicillin and topical chloramphenicol-sulfadimidine; 6618 participants; moderate-certainty evidence); and RR 0.20, 95% CI 0.04 to 0.91 (intracameral cefuroxime and topical levofloxacin; 8101 participants; high-certainty evidence)).One study, which compared fixed versus separate instillation of gatifloxacin and prednisolone, was not sufficiently powered to detect differences in endophthalmitis between groups (very low-certainty evidence). Another study found no evidence of a difference in endophthalmitis when comparing subconjunctival versus retrobulbar antibiotic injections (RR 0.85, 95% CI 0.55 to 1.32; 77,015 participants; moderate-certainty evidence).Two studies reported any visual acuity outcome; one study, which compared fixed versus separate instillation of gatifloxacin and prednisolone, reported only that mean visual acuity was the same for both groups at 20 days postoperation. In the other study, the difference in the proportion of eyes with final visual acuity greater than 20/40 following endophthalmitis between groups receiving intracameral cefuroxime with or without topical levofloxacin compared with no intracameral cefuroxime was uncertain (RR 0.69, 95% CI 0.22 to 2.11; 29 participants; moderate-certainty evidence).Only one study reported adverse events (1 of 129 eyes had pupillary membrane in front of the intraocular lens and 8 eyes showed posterior capsule opacity). No study reported outcomes related to quality of life or economic outcomes.
AUTHORS' CONCLUSIONS: Multiple measures for preventing endophthalmitis following cataract surgery have been studied. High-certainty evidence shows that injection with cefuroxime with or without topical levofloxacin lowers the chance of endophthalmitis after surgery, and there is moderate-certainty evidence to suggest that using antibiotic eye drops in addition to antibiotic injection probably lowers the chance of endophthalmitis compared with using injections or eye drops alone. Clinical trials with rare outcomes require very large sample sizes and are quite costly to conduct; thus, it is unlikely that many additional clinical trials will be conducted to evaluate currently available prophylaxis. Practitioners should rely on current evidence to make informed decisions regarding prophylaxis choices.
眼内炎是一种眼内前房或后房(或两者)的严重炎症,可能是无菌性的,也可能与感染有关。它是白内障手术潜在的视力威胁性并发症。眼内炎的预防措施针对各种感染源。
评估白内障手术后围手术期抗生素预防眼内炎的效果,并与不预防或其他预防形式进行比较。
我们检索了CENTRAL(其中包含Cochrane眼科和视力试验注册库)(2016年第12期)、Ovid MEDLINE、印刷前的Epub、在研及其他未索引的参考文献、Ovid MEDLINE日报(1946年1月至2016年12月)、Embase(1980年1月至2016年12月)、拉丁美洲和加勒比卫生科学文献数据库(LILACS)(1982年至2016年12月)、ISRCTN注册库(www.isrctn.com/editAdvancedSearch)、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)。我们在电子检索试验时没有设置日期或语言限制。我们最后一次检索电子数据库是在2016年12月6日。我们还使用科学引文索引搜索了引用任何纳入试验的其他研究。
我们纳入了因任何原因导致晶状体混浊而接受白内障手术(任何方法和切口类型)的成年人的随机对照试验。我们纳入了评估术前抗生素、术中(前房内、结膜下或全身)或术后抗生素预防急性眼内炎的试验。我们排除了评估使用聚维酮碘等制剂进行术前消毒准备或评估白内障手术后治疗急性眼内炎的抗生素的研究。
两位综述作者独立审查摘要和全文文章以确定其是否符合纳入标准,评估每个纳入研究的偏倚风险,并提取数据。
五项研究符合本综述的纳入标准,包括101,005名成年人和132例眼内炎病例。虽然样本量非常大,但研究设计和抗生素给药方式的异质性使得无法进行正式的荟萃分析。研究的干预措施包括与单独使用标准平衡盐溶液冲洗相比,在冲洗液中添加万古霉素和庆大霉素的效用;围手术期使用或不使用局部左氧氟沙星的前房内头孢呋辛;眼周注射青霉素和局部使用氯霉素 - 磺胺嘧啶滴眼液与单独使用局部抗生素相比;以及抗生素给药方式(结膜下注射与球后注射;加替沙星和泼尼松龙的固定滴注与分开滴注)。由于未报告相关信息,研究间的偏倚风险为低到不清楚。我们确定了一项正在进行的研究。两项研究比较了任何抗生素与不使用抗生素的情况。一项研究比较了平衡盐溶液(BSS)中添加抗生素冲洗与单独使用BSS冲洗,该研究的样本量不足以检测组间眼内炎的差异(极低确定性证据)。一项研究发现,与安慰剂相比,联合使用前房内头孢呋辛和局部左氧氟沙星(风险比(RR)0.14,95%置信区间(CI)0.03至0.63;8106名参与者;高确定性证据)或单独使用前房内头孢呋辛(RR 0.21,CI 0.06至0.74;8110名参与者;高确定性证据)时,眼内炎风险降低,而单独使用局部左氧氟沙星与安慰剂相比,效果不确定(RR 0.7 , CI 0.32至1.61;8103名参与者;中等确定性证据)。两项研究发现,与单独使用局部抗生素相比,手术期间联合使用抗生素注射和局部抗生素时眼内炎风险降低(风险比(RR)0.33,95%置信区间(CI)0.1至0.92(眼周注射青霉素和局部使用氯霉素 - 磺胺嘧啶;6618名参与者;中等确定性证据);RR 0.20,95% CI 0.04至0.91(前房内头孢呋辛和局部左氧氟沙星;8101名参与者;高确定性证据))。一项比较加替沙星和泼尼松龙固定滴注与分开滴注的研究,样本量不足以检测组间眼内炎的差异(极低确定性证据)。另一项研究发现,比较结膜下与球后抗生素注射时眼内炎无差异(RR 0.85,95% CI 0.55至1.32;77,015名参与者;中等确定性证据)。两项研究报告了任何视力结果;一项比较加替沙星和泼尼松龙固定滴注与分开滴注的研究仅报告两组术后20天时平均视力相同。在另一项研究中,接受前房内头孢呋辛联合或不联合局部左氧氟沙星与不接受前房内头孢呋辛的组之间,眼内炎后最终视力大于20/40的眼比例差异不确定(RR 0.69,95% CI 0.22至2.11;29名参与者;中等确定性证据)。只有一项研究报告了不良事件(129只眼中有1只眼在人工晶状体前有瞳孔膜,8只眼显示后囊膜混浊)。没有研究报告与生活质量或经济结果相关的结果。
已经研究了多种预防白内障手术后眼内炎的措施。高确定性证据表明,注射头孢呋辛联合或不联合局部左氧氟沙星可降低术后眼内炎的发生率,中等确定性证据表明,与单独使用注射剂或滴眼液相比,除抗生素注射外使用抗生素滴眼液可能会降低眼内炎的发生率。具有罕见结果的临床试验需要非常大的样本量,且进行成本相当高;因此,不太可能进行许多额外的临床试验来评估目前可用的预防措施。从业者应依靠当前证据就预防措施的选择做出明智的决策。