PDF(Pubmed)
Abstract：
Helminthiasis remains a public health issue in endemic areas. Various drugs have been proposed to improve efficacy against helminths. The study aimed to assess the safety and efficacy of three different anthelmintic combinations to treat Trichuris trichiura infections. We conducted a randomized assessors-blind clinical trial involving children aged 2-17 years with T. trichiura. Participants were randomly assigned to one of three treatment arms. On the first and third days, all participants got albendazole 400 mg, and on the second day, albendazole (arm A), mebendazole 500 mg (arm B), or pyrantel 125 mg/kg (arm C). We assessed treatment efficacy using the cure rate (CR) and egg reduction rate (ERR) at 3 and 6 weeks post-treatment. At 3 weeks post-treatment, ERR and CR were highest in study arm A [ERR = 94%, 95% confidence interval (CI): 92-95; CR = 71%; 95% CI: 58-81] compared to the B and C arms. Decrease in ERR was significant only for arm B versus arm A (P-value <0.001); decrease in ERR was significant for arms B and C (P-value <0.001). No statistical difference was observed in CR when comparing arms A and B (P-value =1.00) and C (P-value =0.27). At 6 weeks, a decrease in ERR was observed in three arms, significant only for arm C, 81% (95% CI: 78-83). A significant increase in egg counts was observed between 3 and 6 weeks post-treatment. All treatments were safe with mild adverse events. Albendazole 400 mg/day (arm A) showed the highest efficacy against trichuriasis. Nonetheless, this treatment regimen was able to cure half of the treated individuals highlighting concerns about controlling the transmission of T. trichiura.CLINICAL TRIALRegistered at ClinicalTrials.gov (NCT04326868).
摘要：
蠕虫病仍然是流行地区的公共卫生问题。已经提出了各种药物来提高对抗蠕虫的功效。该研究旨在评估三种不同驱虫药组合治疗Trichuris感染的安全性和有效性。我们进行了一项随机评估盲临床试验，涉及2-17岁的T.trichiura儿童。参与者被随机分配到三个治疗组之一。在第一天和第三天，所有参与者服用阿苯达唑400毫克，第二天,阿苯达唑（A臂），甲苯咪唑500毫克（B臂），或吡喃酮125毫克/千克（臂C）。我们使用治疗后3周和6周的治愈率（CR）和减蛋率（ERR）评估治疗效果。治疗后3周，研究A组的ERR和CR最高[ERR=94%，与B组和C组相比，95％置信区间（CI）：92-95；CR=71％；95％CI：58-81]。仅在B臂与A臂相比，ERR的降低是显著的（P值<0.001）；在B和C臂中，ERR的降低是显著的（P值<0.001）。当比较A和B组（P值=1.00）和C组（P值=0.27）时，CR没有观察到统计学差异。在6周,在三个组中观察到ERR的减少，仅对C臂有意义，81%（95%CI：78-83）。在处理后3和6周之间观察到卵数的显著增加。所有治疗均安全，有轻度不良事件。阿苯达唑400mg/天（A组）对毛虫病的疗效最高。尽管如此，该治疗方案能够治愈一半的治疗个体,这突出了对控制T.trichiura传播的担忧.临床试验在ClinicalTrials.gov（NCT04326868）注册。
