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甲苯咪唑与塞克硝唑治疗成人贾第虫病的比较:一项随机、非劣效性、开放性临床试验。

Mebendazole compared with secnidazole in the treatment of adult giardiasis: a randomised, no-inferiority, open clinical trial.

作者信息

Almirall Pedro, Escobedo Angel A, Ayala Idalia, Alfonso Maydel, Salazar Yohana, Cañete Roberto, Cimerman Sergio, Galloso Martha, Olivero Ilmaems, Robaina Maytee, Tornés Karen

机构信息

Faculty of Medicine "Manuel Fajardo", 10400 Havana City, Cuba.

出版信息

J Parasitol Res. 2011;2011:636857. doi: 10.1155/2011/636857. Epub 2011 Nov 20.

Abstract

To compare the efficacy and safety of mebendazole and secnidazole in the treatment of giardiasis in adult patients, a single-centre, parallel group, open-label, randomized non-inferiority trial was carried out. One-hundred and 26 participants who had symptomatic Giardia mono-infection took part in the study. Direct wet mount and/or Ritchie concentration techniques and physical examinations were conducted at the time of enrolment and at the follow-up visit. The primary outcome measure was parasitological cure, performed at 3, 5, 10 days post-treatment. Negative faecal specimens for Giardia were ensured by the same parasitological techniques. At follow up (day 10) the parasitological cure rate for the per protocol populations was 88.7% (55/62) for MBZ and 91.8% (56/61) for SNZ. For the intention to treat populations the cure rate at the end of treatment was 85.9% (55/64) for MBZ and 90.3% (56/62) for SNZ. Both analyzes showed there was not significant statistical difference between MBZ and SNZ treatment efficacy. Both drugs were well tolerated, only mild, transient and self-limited side effects were reported and did not require discontinuation of treatment. A 3-day course of mebendazole seems to be as efficacious and safe for treatment of giardiasis as a single dose of secnidazole in adults.

摘要

为比较甲苯达唑和塞克硝唑治疗成年贾第虫病患者的疗效和安全性,开展了一项单中心、平行组、开放标签、随机非劣效性试验。126名有症状的贾第虫单一感染参与者参加了该研究。在入组时和随访时进行直接湿片法和/或里奇浓缩技术及体格检查。主要结局指标是治疗后3天、5天和10天的寄生虫学治愈情况。通过相同的寄生虫学技术确保贾第虫粪便标本呈阴性。在随访(第10天)时,按方案人群中甲苯达唑的寄生虫学治愈率为88.7%(55/62),塞克硝唑为91.8%(56/61)。在意向性治疗人群中,治疗结束时甲苯达唑的治愈率为85.9%(55/64),塞克硝唑为90.3%(56/62)。两项分析均显示甲苯达唑和塞克硝唑的治疗效果无显著统计学差异。两种药物耐受性良好,仅报告有轻微、短暂和自限性副作用,无需停药。对于成年贾第虫病治疗,3天疗程的甲苯达唑似乎与单剂量塞克硝唑一样有效且安全。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a268/3228287/032a381bf837/JPR2011-636857.001.jpg

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