Macy E, Richter P K, Falkoff R, Zeiger R
Department of Allergy, Kaiser Permanente San Diego Medical Center, University of California, San Diego School of Medicine, 92111, USA.
J Allergy Clin Immunol. 1997 Nov;100(5):586-91. doi: 10.1016/s0091-6749(97)70159-3.
Penicillin skin testing has been limited by the lack of commercially available penicilloate and penilloate reagents.
This project was proposed to produce a stable, well-characterized supply of penicilloate and penilloate for intrastate use by our health maintenance organization and to document clinical safety and efficacy.
An improved method of extraction for penicilloate and penilloate, which changed the solvents used during recrystallization, was developed. With these newly prepared reagents, penicillin skin testing was performed on 348 subjects. Skin testing was immediately followed by an oral challenge of 250 mg of amoxicillin in 215 of 288 (75%) subjects displaying a negative response to a battery of penicillin skin tests.
Nuclear magnetic resonance and mass spectrometry of the newly produced penicilloate and penilloate showed no evidence of organic contamination. Penicillin skin testing resulted in 17.2% (60 of 348) positive test results, with 20% of the subjects with positive results only responding to the newly produced minor determinants. The rate of mild adverse reactions to penicillin skin testing was 1.1% (4 of 348). The rate of mild acute adverse reactions was 5.1% (11 of 215), and the delayed reaction rate was 0.9% (2 of 215) with the amoxicillin challenge.
This improved penicillin minor determinant extraction method allows for the reproducible production of very pure preparations of penicilloate and penilloate. Large-scale penicillin skin testing, followed by amoxicillin challenge if results are negative is feasible in a large group model health maintenance organization operating within a single state with the use of internally produced penicilloate and penilloate and commercially available penicillin, amoxicillin, and penicilloyl polylysine.
由于缺乏市售的青霉酸盐和青霉噻唑酸盐试剂，青霉素皮肤试验受到限制。
本项目旨在生产稳定、特性明确的青霉酸盐和青霉噻唑酸盐，供我们的健康维护组织在州内使用，并记录其临床安全性和有效性。
开发了一种改进的青霉酸盐和青霉噻唑酸盐提取方法，该方法改变了重结晶过程中使用的溶剂。使用这些新制备的试剂，对348名受试者进行了青霉素皮肤试验。在288名对一系列青霉素皮肤试验呈阴性反应的受试者中，有215名（75%）在皮肤试验后立即口服250毫克阿莫西林进行激发试验。
新生产的青霉酸盐和青霉噻唑酸盐的核磁共振和质谱分析未显示有机污染的迹象。青霉素皮肤试验结果显示，阳性率为17.2%（348名受试者中的60名），其中20%的阳性受试者仅对新生产的次要决定簇有反应。青霉素皮肤试验的轻度不良反应发生率为1.1%（348名受试者中的4名）。阿莫西林激发试验的轻度急性不良反应发生率为5.1%（215名受试者中的11名），延迟反应发生率为0.9%（215名受试者中的2名）。
这种改进的青霉素次要决定簇提取方法能够可重复地生产出非常纯净的青霉酸盐和青霉噻唑酸盐制剂。在单一州内运营的大型团体模式健康维护组织中，使用内部生产的青霉酸盐和青霉噻唑酸盐以及市售的青霉素、阿莫西林和青霉素酰聚赖氨酸，先进行大规模青霉素皮肤试验，若结果为阴性则进行阿莫西林激发试验是可行的。
