Schmid K, Boettcher M I, Pelz J O W, Meyer T, Korinth G, Angerer J, Drexler H
Institute and Outpatient Clinic of Occupational, Social and Environmental Medicine of the University Erlangen-Nuremberg, Schillerstrasse 25 + 29, D-91054 Erlangen, Germany.
Eur J Surg Oncol. 2006 Dec;32(10):1222-5. doi: 10.1016/j.ejso.2006.05.011. Epub 2006 Jun 19.
Previous safety monitoring of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) with Mitomycin C (MMC) did not demonstrate any detectable safety hazard to the personnel. Nevertheless, those results have been discussed controversially because of the methodological problems employed in the evaluation of potential exposure. We re-evaluated possible safety hazards of HIPEC by applying different monitoring strategies.
We monitored air samples in the operation room during HIPEC. In addition, we measured MMC in plasma of the surgeon with a newly developed analytical method. All samples were analysed by HPLC-UV at 360nm. The permeability of the gloves was tested using two in vitro techniques: diffusion cells and a glass cell chamber. In-use and worst-case exposure scenarios were imitated for in vitro experiments.
The analysis of the air samples (n=3) could not detect any MMC. We found no drug above the limit of detection (1microg MMC/L) in the plasma samples of the surgeons (n=5). A breakthrough of latex glove material was detected in only one (worst-case exposure scenario) of 40 diffusion cell experiments.
Established methods of safety monitoring could not reveal any detectable risk on in-use exposure conditions. The wearing of doubled latex gloves should prevent the surgeon from dermal exposure to MMC during HIPEC.
先前对丝裂霉素C(MMC)进行术中腹腔内热化疗(HIPEC)的安全性监测未显示对人员有任何可检测到的安全危害。然而,由于在评估潜在暴露时所采用的方法学问题,这些结果一直存在争议。我们通过应用不同的监测策略重新评估了HIPEC可能存在的安全危害。
我们在HIPEC期间对手术室中的空气样本进行了监测。此外,我们用一种新开发的分析方法测量了外科医生血浆中的MMC。所有样本均通过360nm的高效液相色谱-紫外检测法进行分析。使用两种体外技术测试手套的渗透性:扩散池和玻璃细胞室。在体外实验中模拟了实际使用和最坏情况暴露场景。
空气样本分析(n = 3)未检测到任何MMC。在外科医生的血浆样本(n = 5)中,我们未发现任何高于检测限(1μg MMC/L)的药物。在40次扩散池实验中,仅在一次(最坏情况暴露场景)检测到乳胶手套材料有破损。
既定的安全监测方法未能揭示在实际使用暴露条件下有任何可检测到的风险。佩戴双层乳胶手套应可防止外科医生在HIPEC期间皮肤接触MMC。