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比较伊维菌素重复剂量与伊维菌素加阿苯达唑治疗盘尾丝虫病的效果:一项随机、开放标签、临床试验。

Comparison of Repeated Doses of Ivermectin Versus Ivermectin Plus Albendazole for the Treatment of Onchocerciasis: A Randomized, Open-label, Clinical Trial.

机构信息

Kumasi Center for Collaborative Research, Kumasi, Ghana.

Department of Clinical Microbiology, School of Medicine and Dentistry, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.

出版信息

Clin Infect Dis. 2020 Aug 14;71(4):933-943. doi: 10.1093/cid/ciz889.

DOI:10.1093/cid/ciz889
PMID:31536624
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7428389/
Abstract

BACKGROUND

Improved treatment for onchocerciasis is needed to accelerate onchocerciasis elimination in Africa. Aiming to better exploit registered drugs, this study was undertaken to determine whether annual or semiannual treatment with ivermectin (IVM; 200 µg/kg) plus albendazole (ALB; 800 mg single dose) is superior to IVM alone.

METHODS

This trial was performed in Ghana and included 272 participants with microfilariae (MF), who were randomly assigned to 4 treatment arms: (1) IVM annually at 0, 12, and 24 months; (2) IVM semiannually at 0, 6, 12, 18, and 24 months; (3) IVM+ALB annually; or (4) IVM+ALB semiannually. Microfiladermia was determined pretreatment and at 6, 18, and 36 months. The primary outcome was the proportion of fertile and viable female worms in onchocercomata excised at 36 months.

RESULTS

Posttreatment nodule histology showed that 15/135 (11.1%), 22/155 (14.2%), 35/154 (22.7%), and 20/125 (16.0%) living female worms had normal embryogenesis in the IVM annual, IVM semiannual, IVM+ALB annual, and IVM+ALB semiannual groups, respectively (P = .1229). Proportions of dead worms also did not differ between the 4 groups (P = .9198). Proportions of patients without MF at 36 months (1 year after the last treatment) were 35/56 (63%) after annual IVM, 42/59 (71%) after semiannual IVM, 39/64 (61%) after annual IVM+ALB, and 43/53 (81%) after semiannual IVM+ALB.

CONCLUSIONS

The combination treatment of IVM plus ALB was no better than IVM alone for sterilizing, killing adult worms, or achieving sustained MF clearance. However, semiannual treatment was superior to annual treatment for achieving sustained clearance of Onchocerca volvulus MF from the skin (P = .024).

CLINICAL TRIALS REGISTRATION

ISRCTN50035143.

摘要

背景

为加速非洲盘尾丝虫病的消除,需要改进盘尾丝虫病的治疗方法。本研究旨在更好地利用已注册药物,旨在确定伊维菌素(IVM;200 µg/kg)加阿苯达唑(ALB;800 mg 单剂量)每年或每半年一次治疗是否优于单独使用 IVM。

方法

该试验在加纳进行,共纳入 272 名微丝蚴(MF)患者,他们被随机分配到 4 个治疗组:(1)每年 IVM 治疗,分别在 0、12 和 24 个月时进行;(2)每半年 IVM 治疗,分别在 0、6、12、18 和 24 个月时进行;(3)每年 IVM+ALB 治疗;或(4)每半年 IVM+ALB 治疗。预处理和治疗后 6、18 和 36 个月时测定微丝蚴血症。主要结局是 36 个月时切除的盘尾丝虫包囊内有生育力和有活力的雌性蠕虫的比例。

结果

治疗后结节组织学显示,IVM 每年、IVM 每半年、IVM+ALB 每年和 IVM+ALB 每半年组中分别有 15/135(11.1%)、22/155(14.2%)、35/154(22.7%)和 20/125(16.0%)的存活雌性蠕虫有正常的胚胎发生(P =.1229)。4 组之间死亡蠕虫的比例也没有差异(P =.9198)。36 个月(最后一次治疗后 1 年)时无微丝蚴的患者比例分别为:每年 IVM 组为 35/56(63%),每半年 IVM 组为 42/59(71%),每年 IVM+ALB 组为 39/64(61%),每半年 IVM+ALB 组为 43/53(81%)。

结论

伊维菌素加 ALB 的联合治疗在使成虫绝育、杀死成虫或持续清除微丝蚴方面并不优于单独使用伊维菌素。然而,半年一次的治疗在持续清除皮肤中的旋盘尾丝虫微丝蚴方面优于每年一次的治疗(P =.024)。

临床试验注册

ISRCTN50035143。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/352f/7428389/4fe88f0b4650/ciz889f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/352f/7428389/4ee0015f469b/ciz889f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/352f/7428389/8efc077027d1/ciz889f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/352f/7428389/bf06b8121bf9/ciz889f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/352f/7428389/4fe88f0b4650/ciz889f0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/352f/7428389/4ee0015f469b/ciz889f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/352f/7428389/8efc077027d1/ciz889f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/352f/7428389/bf06b8121bf9/ciz889f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/352f/7428389/4fe88f0b4650/ciz889f0004.jpg

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