An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis
An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis
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DOI：
10.1017/s0031182000007423
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发表时间：
2000-01-01
期刊：
影响因子：
2.4
通讯作者：
Weerasooriya, MV
中科院分区：
文献类型：
--
作者：
Horton, J;Witt, C;Weerasooriya, MV
本次审查基于在斯里兰卡、印度、海地、加纳、坦桑尼亚、肯尼亚、厄瓜多尔、菲律宾、加蓬、巴布亚新几内亚和孟加拉国进行的 17 项研究，对消除淋巴丝虫病计划中使用的联合给药方案（阿苯达唑 + 伊维菌素或阿苯达唑 + 二乙基卡马嗪 [DEC]）的安全性进行了审查。总数据集包含 90635 名受试者暴露情况，包括所有年龄和性别的个人。结果包括基于医院的研究、实验室研究、对微丝蚴阳性和微丝蚴阴性个体的主动监测，以及对接受阿苯达唑 (n = 1538)、伊维菌素 (9822)、DEC (576)、阿苯达唑 + 伊维菌素 (7470)、阿苯达唑 + DEC (69020) 或安慰剂治疗的个体的社区研究和大规模治疗计划中的被动监测（1144）。最严格的监测，包括治疗前和治疗后的血液学和生化实验室参数，没有提供任何证据表明任何治疗都会引起一致的变化；大多数异常似乎是散发性的，在伊维菌素或 DEC 中添加阿苯达唑不会增加异常发生的频率。正如预期的那样，DEC 和伊维菌素都显示出与破坏微丝蚴相一致的不良事件特征。在单一药物治疗方案中添加阿苯达唑似乎不会增加这些微丝虫杀药物单独使用时出现的事件的频率或强度。直接观察表明，不良事件的水平（频率和强度）与微丝蚴血症的水平相关。在非微丝虫病个体中，这些人占大多数国家消除淋巴丝虫病 (LF) 公共卫生计划中接受治疗的“高危”人群的 80-90%，单独或联合使用化合物的事件概况与安慰剂的事件概况没有显着差异。关于伊维菌素 + 阿苯达唑在双重感染（盘尾丝虫病和 I,T;）或罗艾病（伴有或不伴有 LF）区域的使用数据仍然不足，需要进一步研究。还建议为感染马来丝虫的人群提供额外的数据，因为迄今为止大多数数据都来自感染班克罗夫蒂菌的人群。
This review of the safety of the co-administration regimens to be used in programmes to eliminate lymphatic filariasis (albendazole + ivermectin or albendazole + diethylcarbamazine [DEC]) is based on 17 studies conducted in Sri Lanka, India, Haiti, Ghana, Tanzania, Kenya, Ecuador, the Philippines, Gabon, Papua New Guinea, and Bangladesh. The total data set comprises 90635 subject exposures and includes individuals of all ages and both genders. Results are presented for hospital-based studies, laboratory studies, active surveillance of microfilaria-positive and microfilaria-negative individuals, and passive monitoring in both community-based studies and mass treatment programmes of individuals treated with albendazole (n = 1538), ivermectin (9822), DEC (576), albendazole + ivermectin (7470), albendazole + DEC (69020), or placebo (1144). The most rigorous monitoring, which includes haematological and biochemical laboratory parameters pre- and post-treatment, provides no evidence that consistent changes are induced by any treatment; the majority of abnormalities appear to be sporadic, and the addition of albendazole to either ivermectin or DEC does not increase the frequency of abnormalities. Both DEC and ivermectin show, as expected, an adverse event profile compatible with thr destruction of microfilariac. The addition of albendazole to either single-drug treatment regimen does not appear to increase the frequency or intensity of events seen with these microfilaricidal drugs when used alone. Direct observations indicated that the level of adverse events, both frequency and intensity, was correlated with the level of microfilaraemia. In non microfilaracmic individuals, who form 80 90% of the 'at risk' populations to be treated in most national public health programmes to eliminate lymphatic filariasis (LF), the event profile with the compounds alone or in combination does not differ significantly from that of placebo. Data on the use of ivermectin + albendazole in areas either of double infection (onchocerciasis and I,T;), or of loiais (with or without concurrent LF) are still inadequate and further studies are needed. Additional data are also recommended for populations infected with Brugia malayi, since most data thus far derive from populations infected with Wuchereria bancrofti.