Albonico Marco, Mathema Pragya, Montresor Antonio, Khakurel Balkrishna, Reggi Valerio, Pandey Sharada, Savioli Lorenzo
Fondazione Ivo de Carneri, Via IV Marzo 14, 10122 Torino, Italy.
Trans R Soc Trop Med Hyg. 2007 May;101(5):454-60. doi: 10.1016/j.trstmh.2006.09.003. Epub 2006 Nov 28.
The quality and efficacy of two locally manufactured generic albendazole (ABZ) products (Curex and Royal Drug) used for deworming children in Nepal since 1999 were tested against the originator product (GlaxoSmithKline (GSK)). The study included disintegration and dissolution testing according to the Indian Pharmacopoeia (IP) and the United States Pharmacopeia (USP), respectively, as well as a randomised controlled clinical trial comparing cure rates (CR) and egg reduction rates (ERR) for Ascaris lumbricoides, Trichuris trichiura and hookworm infections. Stool samples from 1277 children were examined before and 21 days after treatment. For A. lumbricoides, GSK (97.0%) and Royal Drug (95.0%) ABZ achieved significantly higher CRs than Curex ABZ (82.6%); however, all products achieved ERRs >90%. For T. trichiura, Curex ABZ showed significantly lower ERRs (63.2%). For hookworms, GSK ABZ performed significantly better (CR 74.3%, ERR 87.1%) than Royal Drug ABZ (CR 53.3%, ERR 80.8%) and Curex ABZ (CR 50.7%, ERR 73.1%). Only the GSK product passed both disintegration and dissolution tests according to the IP and USP. Both generic products failed the dissolution tests. Curex ABZ showed poor disintegration. Despite its lower efficacy, the cheaper Curex product achieved good results in controlling morbidity due to soil-transmitted helminth infections. This study shows that the cost effectiveness of drugs used in mass deworming campaigns should not be inferred on the basis of a single quality testing parameter.
自1999年以来，在尼泊尔用于儿童驱虫的两种本地生产的阿苯达唑（ABZ）仿制药（Curex和Royal Drug）的质量和疗效与原研产品（葛兰素史克公司（GSK））进行了对比测试。该研究分别根据《印度药典》（IP）和《美国药典》（USP）进行了崩解和溶出度测试，以及一项随机对照临床试验，比较了蛔虫、鞭虫和钩虫感染的治愈率（CR）和虫卵减少率（ERR）。在治疗前和治疗21天后检查了1277名儿童的粪便样本。对于蛔虫感染，GSK（97.0%）和Royal Drug（95.0%）的阿苯达唑治愈率显著高于Curex阿苯达唑（82.6%）；然而，所有产品的虫卵减少率均>90%。对于鞭虫感染，Curex阿苯达唑的虫卵减少率显著较低（63.2%）。对于钩虫感染，GSK阿苯达唑的表现明显优于Royal Drug阿苯达唑（治愈率53.3%，虫卵减少率80.8%）和Curex阿苯达唑（治愈率50.7%，虫卵减少率73.1%）。只有GSK产品通过了IP和USP的崩解和溶出度测试。两种仿制药的溶出度测试均未通过。Curex阿苯达唑的崩解性较差。尽管疗效较低，但较便宜的Curex产品在控制土壤传播的蠕虫感染所致发病率方面取得了良好效果。这项研究表明，大规模驱虫运动中使用的药物的成本效益不应仅基于单一的质量测试参数来推断。
