Conjunctival autograft for pterygium.
Conjunctival autograft for pterygium.
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DOI：
10.1002/14651858.cd011349.pub2
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发表时间：
2016-02-11
影响因子：
8.4
通讯作者：
Kuo, Irene C.
中科院分区：
文献类型：
--
作者：
Clearfield, Elizabeth;Muthappan, Valliammai;Wang, Xue;Kuo, Irene C.
翼状胬肉是一种肉质、翼状的生长物，从结膜开始，穿过角膜缘到达角膜。世界各地的患病率范围广泛。有证据表明，紫外线是翼状胬肉形成的主要原因。翼状胬肉会损害视力，限制眼球运动，并可能导致眼睛刺激、异物感和干燥。在一些易感患者中，翼状胬肉可以生长在整个角膜表面，遮挡视轴。手术是翼状胬肉唯一有效的治疗方法，但复发很常见。据报道，采用简单的切除技术（即切除翼状胬肉并保留裸露的巩膜），复发风险高达 80%。翼状胬肉切除联合组织移植的复发风险较低。在自体结膜移植手术中，将人眼睛另一部分的结膜组织与角膜缘组织一起切除，并用于覆盖切除翼状胬肉的区域。另一种治疗翼状胬肉的组织移植手术是羊膜移植，即在翼状胬肉切除后将一块供体羊膜固定到剩余的角膜缘和裸露的巩膜区域。本综述的目的是评估自体结膜移植（有或没有辅助治疗）与羊膜移植（有或没有辅助治疗）治疗翼状胬肉的安全性和有效性。我们还计划确定使用 MMC 是否能产生更好的手术效果，并评估这些手术的直接和间接比较成本。我们检索了 CENTRAL（包含 Cochrane 眼睛和视力试验注册库）（2015 年第 10 期）、Ovid MEDLINE、Ovid MEDLINE 处理中和其他非索引引文、Ovid MEDLINE Daily、Ovid OLDMEDLINE（1946 年 1 月至 2015 年 11 月）、EMBASE（1980 年 1 月至 2015 年 11 月）、 PubMed（1948年至2015年11月）、拉丁美洲和加勒比健康科学文献数据库（LILACS）（1982年至2015年11月）、对照试验metaRegister（mRCT）（www.control-trials.com）（最后检索时间为2014年11月21日）、ClinicalTrials.gov（www.clinicaltrials.gov）和世界卫生组织（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中没有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2015年11月23日。我们在这篇综述中纳入了随机对照试验，这些试验对原发性或复发性翼状胬肉患者的自体结膜移植手术（有或没有辅助治疗）与羊膜移植手术（有或没有辅助治疗）进行了比较。两位综述作者独立筛选检索结果并评估潜在合格试验的全文报告。两位综述作者独立从纳入的试验中提取数据并评估试验特征和偏倚风险。主要结局是术后 3 个月和 6 个月翼状胬肉复发的风险。我们使用随机效应模型将个别研究的结果合并到荟萃分析中。使用风险比来比较自体结膜移植与羊膜移植，报告翼状胬肉复发的风险。我们确定了 20 项研究，这些研究分析了 1866 名参与者的总共 1947 只眼睛（个别研究的参与者范围为 8 至 346 名随机参与者）。这些研究在八个不同的国家进行：巴西 1 个、中国 3 个、古巴 3 个、埃及 1 个、伊朗 2 个、泰国 2 个、土耳其 7 个、委内瑞拉 1 个。总体偏倚风险尚不清楚，因为许多研究没有提供有关随机化方法或掩蔽的信息，以防止性能和检测偏倚。 3个月和6个月时，使用自体结膜移植与羊膜移植的翼状胬肉复发风险比分别为0.87（95%置信区间（CI）0.43至1.77）和0.53（95% CI 0.33至0.85）。这些估计包括患有原发性和复发性翼状胬肉的参与者。我们进行了亚组分析，以比较原发性翼状胬肉的参与者与复发性翼状胬肉的参与者。对于患有原发性翼状胬肉的参与者，3个月和6个月时的风险比分别为0.92（95% CI 0.37至2.30）和0.58（95% CI 0.27至1.27）。我们只能估计复发性翼状胬肉参与者在 6 个月时的翼状胬肉复发情况，自体结膜移植与羊膜移植的风险比为 0.45（95% CI 0.21 至 0.99）。其中一项纳入的研究是一篇博士论文，没有使用分配隐藏。当本研究被排除在敏感性分析中时，原发性和复发性翼状胬肉参与者在 6 个月随访时翼状胬肉复发的风险比为 0.43（95% CI 0.30 至 0.62）。仅在一项研究中分析了次要结果之一，即临床改善的参与者比例。该研究将临床结果报告为不复发风险，术后 3 个月时，自体结膜角膜缘移植组和羊膜移植组的参与者中有 93.8% 出现这种情况，羊膜移植组中有 93.3% 的参与者出现这种情况。由于报告这些结果的研究数量不足，我们没有分析有关重复手术的需要、与视力相关的生活质量以及手术的直接和间接费用的数据。十三项研究报告了与自体结膜移植手术和羊膜移植手术相关的不良事件。不止一项研究中发生的不良事件是肉芽肿和化脓性肉芽肿以及眼压升高。纳入的研究均未报告参与者出现了诱发性散光。与翼状胬肉切除相关，自体结膜移植术后六个月复发风险低于羊膜移植。与羊膜移植相比，患有复发性翼状胬肉的参与者在接受自体结膜移植手术时复发的风险较低。很少有研究比较这两种技术对视力结果的影响，而且我们没有发现任何研究报告与视力相关的生活质量或直接或间接成本。这两种程序在此类结果测量中的比较值得进一步研究。使用辅助丝裂霉素 C 来评估对自体结膜移植或羊膜移植后翼状胬肉复发的影响的研究数量不足。
A pterygium is a fleshy, wing-shaped growth from the conjunctiva, crossing over the limbus onto the cornea. Prevalence ranges widely around the world. Evidence suggests that ultraviolet light is a major contributor in the formation of pterygia. Pterygia impair vision, limit eye movements, and can cause eye irritation, foreign body sensation, and dryness. In some susceptible patients, the pterygium can grow over the entire corneal surface, blocking the visual axis. Surgery is the only effective treatment for pterygium, though recurrences are common. With simple excision techniques (that is, excising the pterygium and leaving bare sclera), the risk of recurrence has been reported to be upwards of 80%. Pterygium excision combined with a tissue graft has a lower risk of recurrence. In conjunctival autograft surgery, conjunctival tissue from another part of the person’s eye along with limbal tissue is resected in one piece and used to cover the area from which the pterygium was excised. Another type of tissue graft surgery for pterygium is amniotic membrane graft, whereby a piece of donor amniotic membrane is fixed to the remaining limbus and bare sclera area after the pterygium has been excised. The objective of this review was to assess the safety and effectiveness of conjunctival autograft (with or without adjunctive therapy) compared with amniotic membrane graft (with or without adjunctive therapy) for pterygium. We also planned to determine whether use of MMC yielded better surgical results and to assess the direct and indirect comparative costs of these procedures. We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (Issue 10, 2015), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to November 2015), EMBASE (January 1980 to November 2015), PubMed (1948 to November 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to November 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 21 November 2014), 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 search for trials. We last searched the electronic databases on 23 November 2015. We included in this review randomized controlled trials that had compared conjunctival autograft surgery (with or without adjunctive therapy) with amniotic membrane graft surgery (with or without adjunctive therapy) in people with primary or recurrent pterygium. Two review authors independently screened search results and assessed full-text reports from among the potentially eligible trials. Two review authors independently extracted data from the included trials and assessed the trial characteristics and risk of bias. The primary outcome was the risk of recurrence of pterygium at 3 months and 6 months after surgery. We combined results from individual studies in meta-analyses using random-effects models. Risk of recurrence of pterygium was reported using risk ratios to compare conjunctival autograft with amniotic membrane transplant. We identified 20 studies that had analyzed a total of 1947 eyes of 1866 participants (individual studies ranged from 8 to 346 participants who were randomized). The studies were conducted in eight different countries: one in Brazil, three in China, three in Cuba, one in Egypt, two in Iran, two in Thailand, seven in Turkey, and one in Venezuela. Overall risk of bias was unclear, as many studies did not provide information on randomization methods or masking to prevent performance and detection bias. The risk ratio for recurrence of pterygium using conjunctival autograft versus amniotic membrane transplant was 0.87 (95% confidence interval (CI) 0.43 to 1.77) and 0.53 (95% CI 0.33 to 0.85) at 3 months and 6 months, respectively. These estimates include participants with primary and recurrent pterygia. We performed a subgroup analysis to compare participants with primary pterygia with participants with recurrent pterygia. For participants with primary pterygia, the risk ratio was 0.92 (95% CI 0.37 to 2.30) and 0.58 (95% CI 0.27 to 1.27) at 3 months and 6 months, respectively. We were only able to estimate the recurrence of pterygia at 6 months for participants with recurrent pterygia, and the risk ratio comparing conjunctival autograft with amniotic membrane transplant was 0.45 (95% CI 0.21 to 0.99). One included study was a doctoral thesis and did not use allocation concealment. When this study was excluded in a sensitivity analysis, the risk ratio for pterygium recurrence at 6 months’ follow-up was 0.43 (95% CI 0.30 to 0.62) for participants with primary and recurrent pterygium. One of the secondary outcomes, the proportion of participants with clinical improvement, was analyzed in only one study. This study reported clinical outcome as the risk of non-recurrence, which was seen in 93.8% of participants in the conjunctival limbal autograft group and 93.3% in the amniotic membrane transplant group at 3 months after surgery. We did not analyze data on the need for repeat surgery, vision-related quality of life, and direct and indirect costs of surgery due to an insufficient number of studies reporting these outcomes. Thirteen studies reported adverse events associated with conjunctival autograft surgery and amniotic membrane transplant surgery. Adverse events that occurred in more than one study were granuloma and pyogenic granuloma and increased intraocular pressure. None of the included studies reported that participants had developed induced astigmatism. In association with pterygium excision, conjunctival autograft is associated with a lower risk of recurrence at six months’ after surgery than amniotic membrane transplant. Participants with recurrent pterygia in particular have a lower risk of recurrence when they receive conjunctival autograft surgery compared with amniotic membrane transplant. There are few studies comparing the two techniques with respect to visual acuity outcomes, and we identified no studies that reported on vision-related quality of life or direct or indirect costs. Comparison of these two procedures in such outcome measures bears further investigation. There were an insufficient number of studies that used adjunctive mitomycin C to estimate the effects on pterygium recurrence following conjunctival autograft or amniotic membrane transplant.