MONOCLONAL ANTIBODY-STANDARDIZED CAT EXTRACT IMMUNOTHERAPY - RISK-BENEFIT EFFECTS FROM A DOUBLE-BLIND PLACEBO STUDY
MONOCLONAL ANTIBODY-STANDARDIZED CAT EXTRACT IMMUNOTHERAPY - RISK-BENEFIT EFFECTS FROM A DOUBLE-BLIND PLACEBO STUDY
复制标题
DOI：
10.1016/s0091-6749(94)70067-2
复制
发表时间：
1994-03-01
影响因子：
14.2
通讯作者：
BLANCOQUIROS, A
中科院分区：
文献类型：
--
作者：
ALVAREZCUESTA, E;CUESTAHERRANZ, J;BLANCOQUIROS, A
28名患有猫过敏引起的鼻结膜炎和哮喘的患者（14名在活性治疗组，14名在安慰剂组）参加了一项安慰剂对照、随机、双盲研究，以评价相当于13.2 μ g Fel d I抗原的维持剂量的风险-获益商。将猫提取物进行生物标准化，并用单克隆抗体定量（100个生物单位）。33 μ g Fel d I抗原、650 μ g白蛋白和99 μ g Fel d Bd/K30抗原）。治疗1年后，猫提取物免疫疗法的全身反应轻微且罕见。与安慰剂组相比，活性治疗组的药物症状评分（p < 0.001）、皮肤点刺试验（p <0.001）、结膜激发试验（p <0.001）和过敏原支气管激发试验（p < 0.05）结果以及乙酰甲胆碱测定的非特异性支气管高反应性均有所改善，但无统计学意义。 本研究证明了13.2 μ g剂量的Fel d I抗原的有利风险-获益商数，这可以作为未来确定猫提取物免疫治疗中应给予的最佳剂量和适当抗原比例的参考。
Twenty-eight patients (14 in an active treatment group and 14 in a placebo group) with rhinoconjunctivitis and asthma caused by cat hypersensitivity took part in a placebo-controlled, randomized, double-blind study to evaluate the risk-benefit quotient of the maintenance dose corresponding to 13.2 mug Fel d I antigen. The cat extract was biologically standardized and quantified with monoclonal antibodies (100 biological units. 33 mug of Fel d I antigen, 650 mug of albumin, and 99 mug of Fel d Bd/K30 antigen). After 1 year of treatment, the systemic reactions to cat extract immunotherapy were mild and infrequent. Improvement was observed in the active treatment group in comparison with the placebo group in the medication-symptoms score (p < 0.001); in skin prick test (p < 0.001), conjunctival provocation test (p < 0.001), and allergen bronchoprovocation test (p < 0.05) results, and in nonspecific bronchial hyperreactivity measured with methacholine, which was not statistically significant. This study demonstrates the favorable risk-benefit quotient of the dose of 13.2 mug of Fel d I antigen, which may serve as a future reference in defining the optimum dose and appropriate proportion of antigens that should be administered in cat extract immunotherapy.