Olds G Richard
Department of Medicine, Medical College of Wisconsin, 9200 W Wisconsin Ave, Suite 4100, Milwaukee, WI 53226, USA.
Acta Trop. 2003 May;86(2-3):185-95. doi: 10.1016/s0001-706x(03)00033-0.
Praziquantel (PZQ) is the safest of all anti-helminthics and now forms the backbone for all national control programs against schistosomiasis (Med. Res. Rev. 3 (1983) 147-200; Bull. WHO 57 (1979) 767-771; Wegner, D.H.G, Therapeutic Drugs (1991), Churchill Livingstone; Adv. Intern. Med. 32 (1987) 193-206; Drugs 42 (1991) 379-405; Pharmac. Ther. 68 (1995) 35-85; Ann. Intern. Med. 110 (1989) 290-296). Despite its lack of known toxicity, the drug was not tested on pregnant or lactating women prior to release. It is currently listed as Pregnancy Category B by the US FDA, which is a drug presumed safe based in animal studies. Unfortunately, this has been interpreted by most national control programs and WHO (1998) to exclude lactating and pregnant women from treatment. In fact, some experts advocate excluding adolescent girls from mass treatment campaigns over this issue. As a result, a large number of women living in endemic countries are currently left untreated or have treatment significantly delayed. A review of the current known toxicology of PZQ, combined with over two decades of clinical experience with this drug, suggest very low potential for adverse effects on either the mother or her unborn child. In contrast, significant animal and human data are presented in this review that suggest both the pregnant woman and her unborn fetus suffer morbid sequella from schistosomiasis. A double-blind placebo-controlled trial that could resolve this issue would require a very large and expensive study and in light of the above facts might not now be ethically appropriate. The author concludes that pregnant women should be treated with PZQ, that women of childbearing age should be included in all mass treatment programs and that lactating women are not systematically excluded from treatment.
吡喹酮（PZQ）是所有抗蠕虫药中最安全的，目前是所有国家血吸虫病控制项目的支柱药物（《医学研究评论》3（1983年）147 - 200；《世界卫生组织公报》57（1979年）767 - 771；韦格纳，D.H.G，《治疗药物》（1991年），丘吉尔·利文斯通出版社；《内科医学进展》32（1987年）193 - 206；《药物》42（1991年）379 - 405；《药理学治疗》68（1995年）35 - 85；《内科学年鉴》110（1989年）290 - 296）。尽管其尚无已知毒性，但该药物在上市前未对孕妇或哺乳期妇女进行测试。目前美国食品药品监督管理局（FDA）将其列为B类妊娠用药，即一种基于动物研究推测为安全的药物。不幸的是，大多数国家控制项目和世界卫生组织（1998年）据此将哺乳期和孕妇排除在治疗之外。事实上，一些专家基于这个问题主张将青春期女孩排除在群体治疗活动之外。结果，大量生活在流行国家的妇女目前得不到治疗或治疗被显著推迟。对吡喹酮目前已知毒理学的回顾，结合二十多年来使用该药物的临床经验，表明其对母亲或其未出生胎儿产生不良反应的可能性非常低。相比之下，本综述中呈现的大量动物和人体数据表明，孕妇及其未出生的胎儿都会因血吸虫病而出现病态后遗症。一项能够解决这个问题的双盲安慰剂对照试验需要一项规模非常大且成本高昂的研究，鉴于上述事实，现在从伦理角度来看可能不合适。作者得出结论，孕妇应该用吡喹酮进行治疗，育龄妇女应该纳入所有群体治疗项目，哺乳期妇女不应被系统性地排除在治疗之外。
