Warner Danielle, Brietzke Scott E
Department of Otolaryngology, Walter Reed Army Medical Center, Washington, DC 20307, USA.
Otolaryngol Head Neck Surg. 2008 Jun;138(6):700-9. doi: 10.1016/j.otohns.2008.02.011.
Systematically review and critically evaluate all available published data on the use of topical mitomycin C (MMC) as an adjunctive in airway surgery.
Published studies indexed in MEDLINE, EMBASE, or Cochrane databases. Inclusion criteria were English language, sample size greater than five, and publication of data applicable to the analysis of topical MMC and airway surgery outcomes.
Evidence tables were compiled to include sample size, study design, and evidence level. Summary statistics, random-effects modeling, and subgroup analysis were performed.
Twenty manuscripts (eight human, 12 animal) met the inclusion criteria. Seven of eight (87.5%) of the human studies and eight of 12 (66%) animal studies concluded topical MMC was beneficial to airway surgical outcomes. Eleven of twelve animal studies included randomization and a control group, compared with only two of eight human studies. Random-effects modeling of human studies (k=7) indicated that 81.4 percent (95% CI, 72.0%-90.9%; P < 0.001) of patients had improved outcomes attributable to MMC. Random-effects modeling of animal data included modeling of change in airway diameter (Hedge's G = -0.03; 95% CI, -0.66-0.60; P = 0.924) and the change in histologic measures (Hedge's G = 1.26; 95% CI, 0.596-1.92; P < 0.001) in MMC-treated animals vs controls.
The majority of the published literature individually suggests the use of topical MMC improves airway surgery outcomes. However, heterogeneity within the clinical studies, the lack of controlled data, and the lack of significance in the pooled animal data (other than histologic outcomes) suggest that the utility of MMC is still undetermined.
系统回顾并严格评估所有已发表的关于局部使用丝裂霉素C(MMC)作为气道手术辅助治疗的数据。
MEDLINE、EMBASE或Cochrane数据库中收录的已发表研究。纳入标准为英文文献、样本量大于5,以及发表的数据适用于分析局部MMC与气道手术结局。
编制证据表,纳入样本量、研究设计和证据水平。进行汇总统计、随机效应模型分析和亚组分析。
20篇手稿(8篇人体研究,12篇动物研究)符合纳入标准。8篇人体研究中的7篇(87.5%)和12篇动物研究中的8篇(66%)得出结论,局部MMC对气道手术结局有益。12篇动物研究中有11篇包括随机分组和对照组,而8篇人体研究中只有2篇如此。对人体研究(k = 7)进行随机效应模型分析表明,81.4%(95%CI,72.0%-90.9%;P < 0.001)的患者因MMC而使结局得到改善。对动物数据进行随机效应模型分析,包括对MMC治疗动物与对照动物气道直径变化(Hedge's G = -0.03;95%CI,-0.66 - 0.60;P = 0.924)和组织学指标变化(Hedge's G = 1.26;95%CI,0.596 - 1.92;P < 0.001)的建模。
大多数已发表文献各自表明局部使用MMC可改善气道手术结局。然而,临床研究中的异质性、缺乏对照数据以及汇总动物数据(组织学结局除外)缺乏显著性,表明MMC的效用仍未确定。