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伊维菌素和阿苯达唑单独及联合使用治疗海地儿童班氏吴策线虫微丝蚴血症的随机安慰剂对照比较

Randomised placebo-controlled comparison of ivermectin and albendazole alone and in combination for Wuchereria bancrofti microfilaraemia in Haitian children.

作者信息

Addiss D G, Beach M J, Streit T G, Lutwick S, LeConte F H, Lafontant J G, Hightower A W, Lammie P J

机构信息

Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30341, USA.

出版信息

Lancet. 1997 Aug 16;350(9076):480-4. doi: 10.1016/S0140-6736(97)02231-9.

DOI:10.1016/S0140-6736(97)02231-9
PMID:9274584
Abstract

BACKGROUND

Lymphatic filariasis and intestinal helminth infections are important disorders in tropical areas. Periodic treatment with albendazole is now used in many school-based intestinal helminth-control programmes. However, few such programmes exist for lymphatic filariasis, despite evidence that single-dose treatment with ivermectin can greatly reduce the concentration of Wuchereria bancrofti microfilariae in the blood for months to years. We aimed to assess the potential for school-based control of lymphatic filariasis by investigating the efficacy and tolerability or combined ivermectin and albendazole in Haitian schoolchildren.

METHODS

In January, 1996, we collected 832 20 microL capillary blood samples for inclusion in a randomised controlled study from children aged 5-11 years, and examined them by microscopy for W bancrofti microfilariae. Infected children were randomly assigned treatment with placebo (n = 29), a single 200-400 micrograms/kg dose of ivermectin (mean, 273 micrograms/kg, n = 28), 400 mg albendazole (n = 29), or a combination of 200-400 micrograms/kg ivermectin and 400 mg albendazole (n = 24). Children with high concentrations of microfilariae in the blood were admitted to hospital and adverse reactions were monitored for 3-5 days, otherwise children were examined at school or during a visit to their home. 4 months after treatment, we examined blood samples again for microfilariae.

FINDINGS

113 microfilaraemic children were enrolled (mean age 7.8 years). 4 months after treatment, the proportion of children who remained positive for microfilariae was significantly lower in the ivermectin plus albendazole group (four [17%]), but there were no significant changes in the other three groups (20 [69%] placebo, 22 [76%] albendazole alone, 17 [61%] ivermectin alone remained positive; p = 0.004). Geometric mean microfilarial concentration decreased from 9.3 to 5.3 per 20 microL blood among children who received placebo; from 15.5 to 1.5 per 20 microL blood among those who received ivermectin only (p = 0.032); from 14.1 to 5.1 per 20 microL blood among those who received albendazole alone; and from 13.7 to 0.3 per 20 microL blood among those who received both ivermectin and albendazole (p = 0.0001). Systemic adverse reactions did not differ significantly between children who received ivermectin alone and those who were treated with ivermectin and albendazole [corrected].

INTERPRETATION

For children with W bancrofti microfilaraemia, combined treatment with ivermectin and albendazole was more effective than treatment with ivermectin only, with no measurable increase in severity of adverse reactions.

摘要

背景

淋巴丝虫病和肠道蠕虫感染是热带地区的重要疾病。目前,阿苯达唑定期治疗被用于许多以学校为基础的肠道蠕虫控制项目。然而,尽管有证据表明单剂量伊维菌素治疗可在数月至数年时间内大幅降低血液中班氏吴策线虫微丝蚴的浓度,但针对淋巴丝虫病的此类项目却很少。我们旨在通过研究伊维菌素和阿苯达唑联合用药在海地学童中的疗效和耐受性,评估以学校为基础控制淋巴丝虫病的潜力。

方法

1996年1月,我们从5至11岁的儿童中采集了832份20微升的毛细血管血样,纳入一项随机对照研究,并通过显微镜检查血样中的班氏吴策线虫微丝蚴。将感染儿童随机分配接受安慰剂治疗(n = 29)、单剂量200 - 400微克/千克伊维菌素(平均273微克/千克,n = 28)、400毫克阿苯达唑(n = 29)或200 - 400微克/千克伊维菌素与400毫克阿苯达唑联合治疗(n = 24)。血液中微丝蚴浓度高的儿童入院治疗,监测3 - 5天的不良反应,否则在学校或家访时对儿童进行检查。治疗4个月后,再次检查血样中的微丝蚴。

结果

113名微丝蚴血症儿童入组(平均年龄7.8岁)。治疗4个月后,伊维菌素加阿苯达唑组中微丝蚴仍呈阳性的儿童比例显著较低(4名[17%]),但其他三组无显著变化(安慰剂组20名[69%]、仅用阿苯达唑组22名[76%]、仅用伊维菌素组17名[61%]仍呈阳性;p = 0.004)。接受安慰剂治疗的儿童每20微升血液中微丝蚴几何平均浓度从9.3降至5.3;仅接受伊维菌素治疗的儿童从15.5降至1.5每20微升血液(p = 0.032);仅接受阿苯达唑治疗的儿童从14.1降至5.1每20微升血液;接受伊维菌素和阿苯达唑联合治疗的儿童从13.7降至0.3每20微升血液(p = 0.0001)。仅接受伊维菌素治疗的儿童与接受伊维菌素和阿苯达唑联合治疗的儿童[校正后]全身不良反应无显著差异。

解读

对于班氏吴策线虫微丝蚴血症儿童,伊维菌素和阿苯达唑联合治疗比仅用伊维菌素治疗更有效,且不良反应严重程度无明显增加。

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