Wilkins M, Indar A, Wormald R
Moorfields Eye Hospital, City Road, London, UK, EC1V 2PD.
Cochrane Database Syst Rev. 2001(1):CD002897. doi: 10.1002/14651858.CD002897.
Trabeculectomy is performed as a treatment for many types of glaucoma in an attempt to lower the intra-ocular pressure. Mitomycin C is an antimetabolite applied between the sclera and conjunctiva during the initial stages of a trabeculectomy to prevent excessive post-operative scarring and thus reduce the risk of failure.
The objective of this review is to assess the effects of intra-operative application of mitomycin C in eyes of people undergoing trabeculectomy.
We searched the Cochrane Eyes and Vision Group specialised register, The Cochrane Controlled Trials Register - CENTRAL, MEDLINE, EMBASE and the reference lists of relevant articles. We used the Science Citation Index to search for articles that cited the included studies. We contacted investigators and experts for details of additional relevant trials.
We included randomised trials of intra-operative mitomycin C compared to placebo in trabeculectomy.
Two reviewers independently assessed trial quality and extracted data. We contacted trial investigators for missing information. Data were summarised using relative risk, odds ratio and weighted mean difference.
This review includes 11 trials involving a total of 698 participants. The trials included three types of participants (those at high risk of failure, those undergoing trabeculectomy combined with cataract surgery, and those with no previous surgical intervention). Mitomycin C appears to be effective in reducing the relative risk of failure of trabeculectomy both in eyes at high risk of failure (relative risk 0.32, 95% confidence interval 0.20 to 0.53) and those undergoing surgery for the first time (relative risk 0.29, 95% confidence interval 0.16 to 0.53). No significant effect on failure was noted in the group undergoing trabeculectomy combined with cataract extraction. Mean intra-ocular pressure was significantly reduced at 12 months in all three participant groups receiving mitomycin C compared to placebo. No significant increase in permanent sight threatening complications was detected. Some evidence exists that mitomycin C increases the risk of cataract. The quality of trial reporting is poor in eight trials. Repeat analysis with three trials rated as low risk of bias did not yield different results.
REVIEWER'S CONCLUSIONS: Intra-operative mitomycin C reduces the risk of surgical failure in eyes that have undergone no previous surgery and in eyes at high risk of failure. Compared to placebo it reduces mean intra-ocular pressure at 12 months in all groups of participants in this review. Apart from an increase in cataract formation following mitomycin C, no demonstrable significant increase in other side effects was detected.
小梁切除术用于治疗多种类型的青光眼,旨在降低眼压。丝裂霉素C是一种抗代谢药物,在小梁切除术初期应用于巩膜与结膜之间,以防止术后过度瘢痕形成,从而降低手术失败风险。
本综述旨在评估小梁切除术中应用丝裂霉素C对接受手术者眼部的影响。
我们检索了Cochrane眼科与视力组专业注册库、Cochrane对照试验注册库(CENTRAL)、MEDLINE、EMBASE以及相关文章的参考文献列表。我们使用科学引文索引搜索引用纳入研究的文章。我们联系了研究者和专家以获取其他相关试验的详细信息。
我们纳入了小梁切除术中术用丝裂霉素C与安慰剂对比的随机试验。
两名评价员独立评估试验质量并提取数据。我们联系试验研究者获取缺失信息。数据采用相对危险度、比值比和加权均数差值进行汇总。
本综述纳入11项试验,共698名参与者。试验纳入了三种类型的参与者(手术失败高危者、接受小梁切除术联合白内障手术者以及既往未接受过手术干预者)。丝裂霉素C似乎能有效降低手术失败高危眼(相对危险度0.32,95%置信区间0.20至0.53)和首次接受手术者(相对危险度0.29,95%置信区间0.16至0.53)小梁切除术失败的相对危险度。在接受小梁切除术联合白内障摘除术的组中,未发现对手术失败有显著影响。与安慰剂相比,接受丝裂霉素C的所有三个参与者组在12个月时平均眼压均显著降低。未检测到永久性视力威胁性并发症显著增加。有证据表明丝裂霉素C会增加白内障风险。八项试验的报告质量较差。对三项偏倚风险低的试验进行重复分析未得出不同结果。
小梁切除术中应用丝裂霉素C可降低既往未接受过手术的眼和手术失败高危眼的手术失败风险。与安慰剂相比,在本综述的所有参与者组中,它在12个月时可降低平均眼压。除丝裂霉素C后白内障形成增加外,未检测到其他副作用有明显显著增加。