甘露聚糖肽皮试液不同浓度对皮试结果的影响

Impact of Different Concentrations of Mannatide Skin Test Solution on Skin Test Results

目的:探讨甘露聚糖肽注射液皮试液的最安全、可靠的浓度。方法:921例住院肿瘤患者按随机数字表法分为低浓度组、中浓度组和高浓度组,各307例,分别皮内注入0.1ml低浓度皮试液、中浓度皮试液、高浓度皮试液,观察记录皮肤(或皮内)敏感试验(皮试)结果。高浓度组皮试阳性患者和低浓度组皮试阴性患者者再用中浓度做皮试。结果:低浓度组皮试结果阳性率低于中浓度组,但两组比较差异无统计学意义(χ2=2.26,P=0.13)。高浓度组皮试结果阳性率明显高于中浓度组,两组比较差异具有统计学意义(χ2=13.01,P=0.0007)。低浓度皮试结果阴性患者和高浓度皮试结果阳性患者以中浓度皮试液进行第二次皮试,发现低浓度组假阴性率为0.98%,高浓度组假阳性率为3.26%。中浓度皮试阴性患者在静脉滴注甘露聚糖肽注射液过程和滴注24小时内,无一例Ⅰ型超敏反应。结论:将甘露聚糖肽注射液原液稀释100倍作为皮试液,能最大程度的筛选出甘露聚糖肽过敏患者,是最为合适的皮试液浓度。

Objective：To investigate the reliable concentration with highest security of Mannatide injection for skin test. Methods：921 cases of hospitalized cancer patients were randomly divided into low-dose group,middle dose group and high dose group,307 cases in each group,respectively.Each group were given intradermal injection of 0.1ml skin test in low concentration,moderate concentration and high concentration,the results of skin tests were observed and recorded.The test-positive patients in high concentration group and the test-negative patients in low concentration group were given additional moderate concentration test.Results：Patients with positive skin test results in low concentration group were less than that of the concentration group,but the difference was not statistically significant （χ2=2.26,P=0.13）.Patients with negative skin test results in high concentration group were more than that of the concentration group,but the difference was statistically significant （χ2=13.01,P=0.0007）.The test-positive patients in high concentration group and the test-negative patients in low concentration group were given additional moderate concentration test,and the false negative rate of low concentrations was 0.98%,the false-positive rate of high concentration group of 3.26%.During the infusion procedures and within 24 hours after the intravenous injection of Mannatide,there was no case of type I hypersensitivity hanppend among the test-negative patients in moderate concentrations group.Conclusion：100-fold dilution of Mannatide liquid injection as a skin test was the most appropriate skin test concentration,and can screen out the allergic patients to the greatest degree.