A randomised, double-blind pilot study of enzyme-potentiated desensitisation for prophylaxis of large local reactions to mosquito bites.

Journal of allergy Pub Date : 2012-01-01 Epub Date: 2012-03-22 DOI:10.1155/2012/106069
S Berkovitz, N Hill, M Radcliffe, G Ambler
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Abstract

Primary Objective. To test the hypothesis that two injections of enzyme-potentiated mosquito antigen significantly reduce the size of experimental mosquito bites in participants with LLR-MB. Design. Randomised, double-blind, placebo-controlled, parallel group comparison over 3 months. Setting. Hospital outpatient clinic. Participants. Fifty adult participants of both sexes. Interventions. Two injections of mosquito antigen or matching placebo, 6 weeks apart. Main Outcome Measures. Early (1 hour) and late (24 hours) mean square root of erythema area (SREA) following controlled mosquito bite with the second bite given at least 6 weeks following the final injection. Results. At 1 hour, mean SREA was slightly higher in the EPD group compared to placebo after adjusting for baseline values (0.46, 95% CI -6.11 to 7.03), but this was not statistically significant (P = 0.89, ANCOVA analysis); neither were the results at 24 hours (-2.58, 95% CI -11.73 to 6.57) (P = 0.57). The proportion of participants experiencing a decrease in wheal size at 1 or 24 hours was similar between groups. Conclusions. EPD was not demonstrated to be effective for immediate or delayed LLR-MB. Methodological problems included a high variability in LLR-MB between subjects, suggesting that a crossover design should be used in future.

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酶促脱敏法预防蚊虫叮咬引起的大面积局部反应的随机双盲试验研究。
主要目的验证以下假设:注射两次酶促蚊虫抗原可明显减少低密度脂蛋白胆固醇血症患者实验性蚊虫叮咬的面积。设计。随机、双盲、安慰剂对照、平行组比较,为期 3 个月。设置。医院门诊。参与者。50 名成年男女参与者。干预。两次注射蚊子抗原或相应的安慰剂,每次间隔 6 周。主要结果指标。在最后一次注射后至少 6 周进行第二次受控蚊虫叮咬后,早期(1 小时)和晚期(24 小时)平均红斑面积平方根(SREA)。结果显示调整基线值后,1小时后,EPD组的平均红斑面积平方根略高于安慰剂组(0.46,95% CI -6.11至7.03),但无统计学意义(P = 0.89,方差分析);24小时后的结果也是(-2.58,95% CI -11.73至6.57)(P = 0.57)。在 1 小时或 24 小时内出现麦粒肿缩小的参与者比例在各组之间相似。结论。EPD未被证明对即时或延迟LLR-MB有效。研究方法上的问题包括受试者之间的 LLR-MB 变异性较高,这表明今后应采用交叉设计。
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