Grober Ethan D, Garbens Alaina, Božović Andrea, Kulasingam Vathany, Fanipour Majid, Diamandis Eleftherios P
Department of Surgery, Division of Urology, Mount Sinai and Women's College Hospital, Toronto, Ontario, Canada.
Laboratory Medicine Program, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.
J Sex Med. 2015 Jun;12(6):1381-8. doi: 10.1111/jsm.12898. Epub 2015 May 12.
This study aims to evaluate the accuracy of the testosterone concentrations within testosterone gels and creams manufactured by compounding pharmacies.
Ten compounding pharmacies within Toronto area were included. Pharmacies were blinded as to the nature of the study. A standardized prescription for 50 mg of compounded testosterone gel/cream applied once daily was presented to each pharmacy. Two independently compounded batches were analyzed from each pharmacy 1 month apart. Testosterone concentrations in a 5-g sachet of Androgel® 1% (Abbott) and 5-g tube of Testim®1% (Auxilium) were evaluated as controls. Samples were analyzed independently and in a blinded fashion by the Laboratory Medicine Program at the University Health Network. Measurement of testosterone concentration was performed using a modified liquid chromatography tandem mass spectrometry validated for serum testosterone.
Compounded formulations included seven gels and three creams with a volume/daily dose ranging from 0.2 mL to 1.25 mL. Product cost ranged from $57.32 to $160.71 for a 30-day supply. There was significant variability both within and between pharmacies with respect to the measured concentration of testosterone in the compounded products. In contrast, the concentration of testosterone within Androgel and Testim was consistent and accurate. Collectively, only 50% (batch 1) and 30% (batch 2) of the compounding pharmacies provided a product with a testosterone concentration within ± 20% of the prescribed dose. Two pharmacies compounded products with >20% of the prescribed dose. One pharmacy compounded a product with essentially no testosterone.
Testosterone concentrations in compounded testosterone products can be variable and potentially compromise the efficacy and safety of treatment.
本研究旨在评估由配制药房生产的睾酮凝胶和乳膏中睾酮浓度的准确性。
纳入多伦多地区的十家配制药房。各药房对研究性质不知情。向每家药房提供一份每日一次涂抹50毫克复方睾酮凝胶/乳膏的标准化处方。从每家药房相隔1个月分别分析两个独立配制的批次。对1%的安特尔（雅培公司）5克小包装和1%的爱斯妥（奥西利姆公司）5克管装产品中的睾酮浓度进行评估作为对照。样品由大学健康网络的检验医学项目独立且在不知情的情况下进行分析。使用经过血清睾酮验证的改良液相色谱串联质谱法测定睾酮浓度。
复方制剂包括七种凝胶和三种乳膏，体积/每日剂量范围为0.2毫升至1.25毫升。30天供应量的产品成本在57.32美元至160.71美元之间。复方产品中测得的睾酮浓度在各药房内部和之间均存在显著差异。相比之下，安特尔和爱斯妥中的睾酮浓度是一致且准确的。总体而言，只有50%（第1批）和30%（第2批）的配制药房提供的产品睾酮浓度在规定剂量的±20%范围内。两家药房配制的产品睾酮浓度超过规定剂量的20%。一家药房配制的产品基本不含睾酮。
复方睾酮产品中的睾酮浓度可能存在差异，并可能影响治疗的疗效和安全性。
