National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention, Shanghai, People's Republic of China.
Clin Infect Dis. 2013 Apr;56(7):e76-82. doi: 10.1093/cid/cis1011. Epub 2012 Dec 7.
Clonorchiasis is of considerable public health importance, particularly in the People's Republic of China (PR China), where most of the 15 million individuals infected with Clonorchis sinensis are currently concentrated. Praziquantel is the drug of choice, but tribendimidine might be an alternative.
We performed a randomized open-label trial in Guangxi, PR China, to assess the efficacy and safety of 400 mg tribendimidine once, 400 mg tribendimidine daily for 3 days, and 75 mg/kg praziquantel in 1 day divided in 3 doses against parasitological-confirmed C. sinensis infections. Cure and egg reduction rates were determined 3 weeks posttreatment using available case analysis. Clinical symptoms were documented at baseline, and adverse events were recorded and graded 3 and 24 hours after each dose.
A total of 74 patients were included in the final analysis. Single-dose tribendimidine achieved a cure rate of 44%, whereas cure rates of 58% and 56% were obtained for tribendimidine administered for 3 days and praziquantel, respectively. High egg reduction rates (97.6%-98.8%) were observed for all treatment regimens. Single-dose tribendimidine was the best-tolerated treatment scheme. Patients treated with praziquantel experienced significantly more adverse events than did tribendimidine recipients (P < .05).
Tribendimidine has an efficacy comparable to praziquantel in the treatment of C. sinensis infection and resulted in fewer adverse events compared to praziquantel. Larger clinical trials are warranted among C. sinensis-infected patients to determine the potential of tribendimidine against clonorchiasis and other helminthiases. Clinical Trials Registration.Controlled-Trials.com, ISRCTN80829842.
华支睾吸虫病具有相当重要的公共卫生意义，特别是在中国（中华人民共和国），目前约有 1500 万感染华支睾吸虫的患者集中于此。吡喹酮是首选药物，但三苯双脒可能是一种替代药物。
我们在中国广西进行了一项随机、开放标签试验，以评估 400mg 三苯双脒单次给药、400mg 三苯双脒连续 3 天每日给药和 75mg/kg 吡喹酮在 1 天内分为 3 次给药对寄生虫学证实的华支睾吸虫感染的疗效和安全性。治疗后 3 周采用可评估病例分析评估治愈率和卵减少率。在基线时记录临床症状，并在每次给药后 3 和 24 小时记录和分级不良反应。
共有 74 例患者纳入最终分析。单剂量三苯双脒的治愈率为 44%，而连续 3 天给药和吡喹酮的治愈率分别为 58%和 56%。所有治疗方案的卵减少率均较高（97.6%-98.8%）。单剂量三苯双脒是最耐受的治疗方案。接受吡喹酮治疗的患者比三苯双脒治疗的患者发生更多的不良反应（P<0.05）。
三苯双脒治疗华支睾吸虫感染的疗效与吡喹酮相当，且与吡喹酮相比不良反应更少。需要在华支睾吸虫感染患者中进行更大规模的临床试验，以确定三苯双脒治疗华支睾吸虫病和其他寄生虫病的潜力。临床试验注册。controlled-trials.com，ISRCTN80829842。
