关于苄星青霉素 G 用于风湿热二级预防的首选产品特性的初步咨询。
Preliminary consultation on preferred product characteristics of benzathine penicillin G for secondary prophylaxis of rheumatic fever.
机构信息
Telethon Kids Institute, University of Western Australia, 100 Roberts Road, Subiaco, Western Australia, 6008, Australia.
Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University (Parkville Campus), Parkville, Australia.
出版信息
Drug Deliv Transl Res. 2016 Oct;6(5):572-8. doi: 10.1007/s13346-016-0313-z.
Rheumatic fever is caused by an abnormal immune reaction to group A streptococcal infection. Secondary prophylaxis with antibiotics is recommended for people after their initial episode of rheumatic fever to prevent recurrent group A streptococcal infections, recurrences of rheumatic fever and progression to rheumatic heart disease. This secondary prophylaxis must be maintained for at least a decade after the last episode of rheumatic fever. Benzathine penicillin G is the first line antibiotic for secondary prophylaxis, delivered intramuscularly every 2 to 4 weeks. However, adherence to recommended secondary prophylaxis regimens is a global challenge. This paper outlines a consultation with global experts in rheumatic heart disease on the characteristics of benzathine penicillin G formulations which could be changed to improve adherence with secondary prophylaxis. Characteristics included dose interval, pain, administration mechanism, cold chain independence and cost. A sample target product profile for reformulated benzathine penicillin G is presented.
风湿热是由 A 组链球菌感染引起的异常免疫反应引起的。建议对初次风湿热发作后的患者进行抗生素二级预防，以预防 A 组链球菌反复感染、风湿热复发和发展为风湿性心脏病。在最后一次风湿热发作后，这种二级预防必须至少维持十年。苄星青霉素 G 是二级预防的一线抗生素，每 2 至 4 周肌内注射一次。然而，全球范围内在坚持推荐的二级预防方案方面都面临着挑战。本文概述了对风湿性心脏病全球专家的咨询意见，讨论了可以改变苄星青霉素 G 制剂特性以提高二级预防依从性的问题。特性包括剂量间隔、疼痛、给药机制、冷链独立性和成本。本文还提出了改良型苄星青霉素 G 的目标产品特征草案。
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