Park H S, Kim M S
Department of Ophthalmology, Kangnam St. Mary's Hospital, Catholic University of Korea, Medical College, Seoul, Korea.
Korean J Ophthalmol. 1997 Jun;11(1):51-9. doi: 10.3341/kjo.1997.11.1.51.
Surgical glove powders have been implicated in serious postoperative foreign body reactions due to contamination of the operative field. Inflammatory responses to glove lubricants or mold release agents have to date been studied to a lesser extent in ocular tissues than other body tissues, although powder contamination of intraocular lenses, with severe postoperative anterior chamber inflammatory responses, have been reported. The object of this study was to grade and quantitate the inflammatory response of surgical glove lubricants, namely Biosorb, Keoflo, calcium carbonate and Hydrocote (a hydrogel polymer film used in powderless gloves), as introduced into the posterior chamber on New Zealand white rabbits. In a double masked GLP study, a total of 150 eyes were evaluated. For each of the four test samples, a dose response curve was obtained at 10 micrograms (Keoflo only), 125 micrograms, 250 micrograms, 500 micrograms, 1000 micrograms, and 1500 micrograms. Study parameters were the quantitation of inflammatory cells in the aqueous and vitreous, and ocular irritation and inflammation, as graded by the rabbit inflammation score system, at 0 and 48 hours post-injection. A Wilcoxen signed-rank test used to evaluate statistical significance (p < 0.05). A test vitreal cell count was less that 50 cells/mm3 and the overall mean clinical response was less than 2.0. This study established that Keoflo at all concentrations 10 micrograms-1000 micrograms), and Biosorb at concentrations greater than 1000 micrograms were inflammatory. Calcium carbonate and Hydrocote were non-inflammatory at concentration of 125 micrograms-1500 micrograms. The unoperated, sham, vehicle and Ocugel controls were all non-inflammatory. The positive Zymozan A controls were defined as inflammatory. In conclusion, no glove powder is totally safe, even small amounts of glove powder (10 micrograms) can elicit an inflammatory immune response. If all glove powder averages 700mg/pair, this should be removed prior to contact with a patients tissue. Powder-free gloves and greatly reduce the potential inflammatory risk associated with powdered gloves.
手术手套上的粉末因污染手术区域而与严重的术后异物反应有关。与其他身体组织相比，目前对眼部组织中手套润滑剂或脱模剂的炎症反应研究较少，尽管已有报道称人工晶状体受到粉末污染会导致严重的术后前房炎症反应。本研究的目的是对手术手套润滑剂（即 Biosorb、Keoflo、碳酸钙和 Hydrocote，一种用于无粉手套的水凝胶聚合物薄膜）注入新西兰白兔后房引起的炎症反应进行分级和定量。在一项双盲 GLP 研究中，共评估了 150 只眼睛。对于四个测试样品中的每一个，分别在 10 微克（仅 Keoflo）、125 微克、250 微克、500 微克、1000 微克和 1500 微克的剂量下获得剂量反应曲线。研究参数包括在注射后 0 小时和 48 小时通过兔炎症评分系统对房水和玻璃体中的炎症细胞进行定量，以及眼部刺激和炎症情况。使用 Wilcoxon 符号秩检验评估统计学意义（p < 0.05）。测试玻璃体细胞计数小于 50 个细胞/mm³，总体平均临床反应小于 2.0。本研究表明，所有浓度（10 微克 - 1000 微克）的 Keoflo 以及浓度大于 1000 微克的 Biosorb 具有炎症性。碳酸钙和 Hydrocote 在 125 微克 - 1500 微克的浓度下无炎症性。未手术、假手术、载体和 Ocugel 对照组均无炎症性。阳性 Zymozan A 对照组被定义为具有炎症性。总之，没有一种手套粉末是完全安全的，即使是少量的手套粉末（10 微克）也能引发炎症免疫反应。如果每副手套的粉末平均含量为 700 毫克，则应在接触患者组织之前将其去除。无粉手套可大大降低与有粉手套相关的潜在炎症风险。
