A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China
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 Do...
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| Language: | English |
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The World Health Organization
2008-10-01
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| Series: | Bulletin of the World Health Organization |
| Online Access: | http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862008001000015&lng=en&tlng=en |
| _version_ | 1797281797694816256 |
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| author | Xun-Ya Hou Donald P McManus Darren J Gray Julie Balen Xin-Song Luo Yong-Kang He Magda Ellis Gail M Williams Yue-Sheng Li |
| author_facet | Xun-Ya Hou Donald P McManus Darren J Gray Julie Balen Xin-Song Luo Yong-Kang He Magda Ellis Gail M Williams Yue-Sheng Li |
| author_sort | Xun-Ya Hou |
| collection | DOAJ |
| description | 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 × 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). |
| first_indexed | 2024-03-07T17:02:38Z |
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| id | doaj.art-2402102c0a8640ce8633e589ad515294 |
| institution | Directory Open Access Journal |
| issn | 0042-9686 |
| language | English |
| last_indexed | 2024-03-07T17:02:38Z |
| publishDate | 2008-10-01 |
| publisher | The World Health Organization |
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| series | Bulletin of the World Health Organization |
| spelling | doaj.art-2402102c0a8640ce8633e589ad5152942024-03-03T03:04:36ZengThe World Health OrganizationBulletin of the World Health Organization0042-96862008-10-018610788795S0042-96862008001000015A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in ChinaXun-Ya Hou0Donald P McManus1Darren J Gray2Julie Balen3Xin-Song Luo4Yong-Kang He5Magda Ellis6Gail M Williams7Yue-Sheng Li8Hunan Institute of Parasitic DiseasesQueensland Institute of Medical Research,Queensland Institute of Medical Research,Queensland Institute of Medical Research,Hunan Institute of Parasitic DiseasesHunan Institute of Parasitic DiseasesQueensland Institute of Medical Research,University of QueenslandQueensland Institute of Medical Research,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 × 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).http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862008001000015&lng=en&tlng=en |
| spellingShingle | Xun-Ya Hou Donald P McManus Darren J Gray Julie Balen Xin-Song Luo Yong-Kang He Magda Ellis Gail M Williams Yue-Sheng Li A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China Bulletin of the World Health Organization |
| title | A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China |
| title_full | A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China |
| title_fullStr | A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China |
| title_full_unstemmed | A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China |
| title_short | A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China |
| title_sort | randomized double blind placebo controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in china |
| url | http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862008001000015&lng=en&tlng=en |
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