A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China
dc.contributor.author | Hou, Xun-Ya | |
dc.contributor.author | McManus, Donald P | |
dc.contributor.author | Gray, Darren | |
dc.contributor.author | Balen, Julie | |
dc.contributor.author | Luo, Xin-Song | |
dc.contributor.author | He, Yongkang | |
dc.contributor.author | Ellis, Magda | |
dc.contributor.author | Williams, Gail | |
dc.contributor.author | Li, Yue-Sheng | |
dc.date.accessioned | 2015-12-10T23:06:52Z | |
dc.date.issued | 2008 | |
dc.date.updated | 2016-02-24T10:13:10Z | |
dc.description.abstract | Objective: To evaluate the safety and efficacy of combining artemether (AM) and praziquantel (PZQ) in different regimens for treating acute schistosomiasis japonica. Methods: We undertook a randomized, double-blind, placebo-controlled trial within four specialized schistosomiasis hospitals in the Dongting Lake region, Hunan province, China, between May 2003 and December 2005. Study participants were randomized into one of four treatment regimes: group A received 60 mg/kg PZQ + 6 mg/kg AM; group B received 60 mg/kg PZQ + AM placebo; group C received 120 mg/kg PZQ + 6 mg/kg AM; and group D received 120 mg/kg PZQ + AM placebo. All participants were followed up over a 45-day period. The primary endpoint of the trial was human infection status (determined by positive stool examination). Secondary endpoints involved clinical observations and blood biochemistry, including monitoring haemoglobin and alanine aminotransferase levels over time. Findings: Treatment efficacies of the four different treatment regimens were 98.0%, 96.4%, 97.7% and 95.7% for group A, B, C, and D respectively (P > 0.05). The group B had a greater treatment efficacy (96.4%) than the group D (95.7%) (P > 0.05). Group A treatment was better for clearance of fever (P < 0.05) and resulted in a shorter hospitalization time (P < 0.05). Conclusion: This is the first report of a randomized, double-blind, placebo-controlled trial for evaluating combined chemotherapy with AM and two different dosages (60 mg/kg and 120 mg/kg) of PZQ in the treatment of acute schistosomiasis japonica in China. The combination of AM and PZQ chemotherapy did not improve treatment efficacy compared with PZQ alone. PZQ given as a dosage of 60 mg/kg (1 day, 3 x 20 mg/kg doses at 4-5 hour intervals) may be as effective as a dosage of 120 mg/kg (6 days, 20 mg/kg for each day split into 3 doses at 4-5 hour intervals). | |
dc.identifier.issn | 0042-9686 | |
dc.identifier.uri | http://hdl.handle.net/1885/62847 | |
dc.publisher | World Health Organization (WHO Press) | |
dc.source | Bulletin of the World Health Organization | |
dc.subject | Keywords: artemether; placebo; praziquantel; prednisone; blood; chemotherapy; comparative study; drug development; enzyme; health monitoring; health services; health survey; hemoglobin; schistosomiasis; temporal analysis; abdominal discomfort; adolescent; adult; al | |
dc.title | A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China | |
dc.type | Journal article | |
local.bibliographicCitation.issue | 10 | |
local.bibliographicCitation.lastpage | 795 | |
local.bibliographicCitation.startpage | 788 | |
local.contributor.affiliation | Hou, Xun-Ya, Hunan Institute of Parasitic Diseases | |
local.contributor.affiliation | McManus, Donald P, Queensland Institute of Medical Research | |
local.contributor.affiliation | Gray, Darren, College of Medicine, Biology and Environment, ANU | |
local.contributor.affiliation | Balen, Julie, Queensland Institute of Medical Research | |
local.contributor.affiliation | Luo, Xin-Song, Hunan Institute of Parasitic Diseases | |
local.contributor.affiliation | He, Yongkang, Hunan Institute of Parasitic Diseases | |
local.contributor.affiliation | Ellis, Magda, Queensland Institute of Medical Research | |
local.contributor.affiliation | Williams, Gail, University of Queensland | |
local.contributor.affiliation | Li, Yue-Sheng, Queensland Institute of Medical Research | |
local.contributor.authoremail | u5624503@anu.edu.au | |
local.contributor.authoruid | Gray, Darren, u5624503 | |
local.description.embargo | 2037-12-31 | |
local.description.notes | Imported from ARIES | |
local.identifier.absfor | 111706 - Epidemiology | |
local.identifier.ariespublication | U3488905xPUB743 | |
local.identifier.citationvolume | 86 | |
local.identifier.doi | 10.2471/BLT.08.053041 | |
local.identifier.scopusID | 2-s2.0-54249153209 | |
local.identifier.uidSubmittedBy | U3488905 | |
local.type.status | Published Version |
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