A randomized clinical trial comparing single- and multi-dose combination therapy with diethylcarbamazine and albendazole for treatment of bancroftian filariasis

A randomized clinical trial comparing single- and multi-dose combination therapy with diethylcarbamazine and albendazole for treatment of bancroftian filariasis
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DOI:
10.4269/ajtmh.2004.70.191
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发表时间:
2004-02-01
影响因子:
3.3
通讯作者:
Weil, GJ
Weil, GJ
中科院分区:
医学4区
文献类型:
--
作者:
El Setouhy, M;Ramzy, RMR;Weil, GJ

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消除淋巴丝虫病全球方案呼吁对撒哈拉以南非洲以外的流行人群进行大规模药物管理,每年使用一次乙胺嗪(DEC)和阿苯达唑(Alb),持续4-6年。单剂量DEC/Alb显著降低血液微丝蚴(MF)计数,但大多数治疗受试者在单剂量后未能完全清除MF。一个更有效的方案可能会减少消除计划所需的年数。我们在患有无症状微丝蚴血症的埃及成年人中进行了一项随机临床试验,以比较每日7次口服DEC(6 mg/kg)和Alb(400 mg)与单次口服相同组合的治疗。我们还研究了第一个疗程12个月后使用单剂量DEC/Alb重新治疗的效果。对于减少和清除微丝蚴血症,多次给药DEC/Alb比单次给药治疗显著更有效(12个月时MF/ml相对于治疗前计数的平均减少率为99.6% vs 85.7%,完全清除率为75% vs 23.1%)。这两种方案对丝虫蠕虫具有相似的活性,如系列超声评估所示。两种方案均未完全清除丝虫抗原血症。不良事件无差异,均为轻度至中度。再治疗后,血液微丝蚴和寄生虫抗原清除率增加。多剂量DEC/Alb可能是消除丝虫病计划的一个有用的选择,特别是在第一年(当大规模药物管理的热情和覆盖率很高时),以快速降低社区MF负荷和传播率。
The Global Program for Elimination of Lymphatic Filariasis calls for mass drug administration for endemic populations outside of sub-Saharan Africa with a single dose of diethylcarbamazine (DEC) and albendazole (Alb) annually for 4-6 years. Single-dose DEC/Alb dramatically reduces blood microfilaria (MF) counts, but most treated subjects fail to completely clear MF after a single dose. A more effective regimen might reduce the number of years required for elimination programs. We performed a randomized clinical trial in Egyptian adults with asymptomatic microfilaremia to compare treatment with seven daily doses of oral DEC (6 mg/kg) and Alb (400 mg) with a single dose of the same combination. We also studied the effect of re-treatment with single-dose DEC/Alb 12 months after the first treatment course. Multi-dose DEC/Alb was significantly more effective than single-dose therapy for reducing and clearing microfilaremia (mean reduction in MF/ml relative to pretreatment counts at 12 months, 99.6% versus 85.7%, with complete clearance in 75% versus 23.1%). The two regimens had similar activity against adult filarial worms, as indicated by serial ultrasound assessments. Neither regimen resulted in complete clearance of filarial antigenemia. There was no difference in adverse events, which were mild to moderate. Blood microfilaria and parasite antigen clearance rates increased following re-treatment. Multi-dose DEC/Alb may be a useful option for filariasis elimination programs, especially in the first year (when enthusiasm for mass drug administration and coverage rates are high), to quickly reduce community MF loads and transmission rates.