Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, Basel, Switzerland.
PLoS Negl Trop Dis. 2011 Sep;5(9):e1285. doi: 10.1371/journal.pntd.0001285. Epub 2011 Sep 6.
Fascioliasis is an emerging zoonotic disease of considerable veterinary and public health importance. Triclabendazole is the only available drug for treatment. Laboratory studies have documented promising fasciocidal properties of the artemisinins (e.g., artemether).
We carried out two exploratory phase-2 trials to assess the efficacy and safety of oral artemether administered at (i) 6×80 mg over 3 consecutive days, and (ii) 3×200 mg within 24 h in 36 Fasciola-infected individuals in Egypt. Efficacy was determined by cure rate (CR) and egg reduction rate (ERR) based on multiple Kato-Katz thick smears before and after drug administration. Patients who remained Fasciola-positive following artemether dosing were treated with single 10 mg/kg oral triclabendazole. In case of treatment failure, triclabendazole was re-administered at 20 mg/kg in two divided doses.
CRs achieved with 6×80 mg and 3×200 mg artemether were 35% and 6%, respectively. The corresponding ERRs were 63% and nil, respectively. Artemether was well tolerated. A high efficacy was observed with triclabendazole administered at 10 mg/kg (16 patients; CR: 67%, ERR: 94%) and 20 mg/kg (4 patients; CR: 75%, ERR: 96%).
CONCLUSIONS/SIGNIFICANCE: Artemether, administered at malaria treatment regimens, shows no or only little effect against fascioliasis, and hence does not represent an alternative to triclabendazole. The role of artemether and other artemisinin derivatives as partner drug in combination chemotherapy remains to be elucidated.
片形吸虫病是一种新兴的动物源性人畜共患疾病，具有重要的兽医和公共卫生意义。三氯苯达唑是唯一可用的治疗药物。实验室研究已经证明了青蒿素类药物（例如青蒿素）具有有前途的杀片形吸虫作用。
我们进行了两项探索性的 2 期临床试验，以评估在埃及 36 名感染片形吸虫的个体中连续 3 天每天给予 6×80 mg 青蒿琥酯和在 24 小时内给予 3×200 mg 青蒿琥酯的疗效和安全性。疗效根据药物治疗前后多次加藤厚涂片的治愈率（CR）和卵减少率（ERR）来确定。在青蒿琥酯给药后仍为阳性的患者用单次 10 mg/kg 口服三氯苯达唑治疗。如果治疗失败，用 20 mg/kg 三氯苯达唑分两次给药。
6×80 mg 和 3×200 mg 青蒿琥酯的 CR 分别为 35%和 6%，相应的 ERR 分别为 63%和 0。青蒿琥酯耐受性良好。给予 10 mg/kg（16 例；CR：67%，ERR：94%）和 20 mg/kg（4 例；CR：75%，ERR：96%）三氯苯达唑的疗效很高。
结论/意义：青蒿琥酯按疟疾治疗方案给药，对片形吸虫病没有或只有很小的作用，因此不能替代三氯苯达唑。青蒿琥酯和其他青蒿素衍生物作为联合化疗的协同药物的作用仍有待阐明。
