Hartnick C J, Hartley B E, Lacy P D, Liu J, Bean J A, Willging J P, Myer C M, Cotton R T
Department of Pediatric Otolaryngology, Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Arch Otolaryngol Head Neck Surg. 2001 Oct;127(10):1260-4. doi: 10.1001/archotol.127.10.1260.
To explore the effect of mitomycin treatment on the pediatric airway following laryngotracheal reconstruction.
Randomized, double-blind, placebo-controlled trial.
Children aged 2 to 17 years with subglottic or upper tracheal stenosis undergoing laryngotracheal reconstruction at a single, tertiary care, children's hospital.
At the time of extubation or stent removal, the children underwent bronchoscopy and 0.4 mg/mL (2 mL of a 0.2-mg/mL solution of either mitomycin or an equal volume of isotonic sodium chloride was directly applied to the subglottic region for a single application of 2 minutes. These children then underwent interval endoscopy at 2 weeks, 6 weeks, and 3 months postoperatively for assessment of their airways.
Granulation tissue was graded on a scale of 0 (none) to 4 (near-total or total occlusion). Videotapes of endoscopies were independently observed and graded by 3 pediatric otolaryngology fellows with a subsequent interobserver agreement of 91.6%. The results were then dichotomized to represent a single cohort in which further surgical intervention would be required and another separate cohort in which further surgery would not be required. At the 1-year mark, interim analysis was performed by a Data Safety and Monitoring Committee. At this time, 13 children had been randomized to the mitomycin-treated arm of the study and 11 children to the placebo-treated arm. A 2-tailed Fisher exact test revealed a value of 1.00. The Data Monitoring and Safety Committee advised that the trial should be stopped because the distributions between the 2 populations were almost identical.
We cannot reject the null hypothesis that a single topical dose of mitomycin exerts an equal benefit as does isotonic sodium chloride when applied to the pediatric airway after laryngotracheal reconstruction.
探讨丝裂霉素治疗对小儿喉气管重建术后气道的影响。
随机、双盲、安慰剂对照试验。
年龄在2至17岁之间，在一家三级医疗儿童医院接受喉气管重建术治疗声门下或气管上段狭窄的儿童。
在拔管或取出支架时，对患儿进行支气管镜检查，并将0.4mg/mL（2mL 0.2mg/mL的丝裂霉素溶液或等体积的等渗氯化钠溶液）直接应用于声门下区域，单次应用2分钟。这些患儿随后在术后2周、6周和3个月接受定期内镜检查，以评估其气道情况。
肉芽组织按0级（无）至4级（几乎完全或完全阻塞）进行分级。内镜录像由3名儿科耳鼻喉科住院医师独立观察并分级，观察者间一致性为91.6%。然后将结果分为两类，一类表示需要进一步手术干预的单一队列，另一类表示不需要进一步手术的单独队列。在1年时，数据安全监测委员会进行了中期分析。此时，13名儿童被随机分配到研究的丝裂霉素治疗组，11名儿童被分配到安慰剂治疗组。双侧Fisher精确检验显示值为1.00。数据监测与安全委员会建议停止试验，因为两组人群之间的分布几乎相同。
我们不能拒绝这样的零假设，即单次局部应用丝裂霉素与等渗氯化钠在小儿喉气管重建术后应用于气道时具有相同的益处。
