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地点﹕泰国南方的三家研究所,11家医院及38家社区医院。目的:评估泰国南方结核病医疗机构使用的抗结核药物质量及其管理系统。设计﹕利用访视、查阅文件、观察药物储存、检查药物并行异烟肼(IINH)、利福平(RMP)、吡嗪酰胺(PZA)及乙胺丁醇(EMB)样品的实验室分析。结果﹕任何级别单位均未发现有抗结核药物的脱销。13家医院/研究所(25%)撤去了EMB糖衣片的箔包装。11家医院/研究所(21%)将EMB糖衣片一分为二,作为200mg片分发。观察发现,在44%医院/研究所肉眼发现有变质受损的EMB。除了14%的EMB外,全部药物样品均通过了含量测定。INH与EMB均通过了溶解试验评价,但有62%的RMP及26%的PZA样本未通过。结论﹕在结核病控制方面,不达标的变质受损抗结核药物是一个严重问题。研究地区的抗结核药物管理也存在问题。关于抗结核药物包装、储存的培训及建立分发、清单管理,质量保证和督查的完整体系是主要的控制措施。
Location: Three institutes in southern Thailand, 11 hospitals and 38 community hospitals. Purpose: To assess the quality of anti-TB drugs and their management systems used in TB hospitals in Thailand. DESIGN: Laboratory analysis using a visit, access to documentation, observing drug storage, examining drug parallel isoniazid (IINH), rifampicin (RMP), pyrazinamide (PZA) and ethambutol (EMB) samples. Results: No anti-tuberculosis drugs were found out of stock at any level. Thirteen hospitals / research institutes (25%) removed the foil packaging of the EMB sugar-coated tablets. In 11 hospitals / institutes (21%), EMB sugar tablets were divided in half and distributed as 200 mg tablets. Observations found that in 44% of hospitals / research institute found macular degeneration EMB. Except for 14% of EMBs, all drug samples passed the assay. Both INH and EMB passed the dissolution test, but 62% of the RMPs and 26% of the PZA samples failed. Conclusion: Non-compliance of degeneratively damaged anti-TB drugs is a serious problem in tuberculosis control. There are also problems with the management of anti-TB drugs in the study area. Training on the packaging and storage of anti-TB drugs and the establishment of a complete system of distribution, inventory management, quality assurance and inspection are the main control measures.