A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China
A randomized, double-blind, placebo-controlled trial of safety and efficacy of combined praziquantel and artemether treatment for acute schistosomiasis japonica in China
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DOI：
10.2471/blt.08.053041
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发表时间：
2008-10-01
期刊：
影响因子：
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通讯作者：
Li, Yue-Sheng
中科院分区：
文献类型：
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作者：
Hou, Xun-Ya;McManus, Donald P;Li, Yue-Sheng
目的评价蒿甲醚（AM）联合吡喹酮（PZQ）不同治疗方案治疗急性日本血吸虫病的安全性和有效性。方法2003年5月至2005年12月，在湖南省洞庭湖区四家血吸虫病专科医院进行随机、双盲、安慰剂对照试验。研究参与者被随机分为四种治疗方案：A组接受60 mg/kg PZQ + 6 mg/kg AM；B组给予PZQ + AM安慰剂60 mg/kg；C组给予PZQ 120 mg/kg + AM 6 mg/kg；D组给予PZQ + AM安慰剂120 mg/kg。所有参与者都接受了为期45天的随访。试验的主要终点是人类感染状态（通过粪便阳性检查确定）。次要终点包括临床观察和血液生化，包括监测血红蛋白和丙氨酸转氨酶随时间的水平。结果A、B、C、D组4种治疗方案的治疗有效率分别为98.0%、96.4%、97.7%、95.7% （P < 0.05）。B组治疗有效率（96.4%）高于D组（95.7%）（P < 0.05）。A组患者退热效果较好（P < 0.05），住院时间较短（P < 0.05）。结论本研究是国内首次报道的一项随机、双盲、安慰剂对照的试验，旨在评价AM联合两种不同剂量（60mg /kg和120mg /kg） PZQ治疗急性日本血吸虫病的疗效。与单用PZQ相比，AM联合PZQ化疗并没有提高治疗效果。PZQ 60mg /kg（1天，3 × 20mg /kg，间隔4-5小时）的剂量可能与120mg /kg（6天，每天20mg /kg，分成3次，间隔4-5小时）的剂量一样有效。世界卫生组织公报2008；86:788-795。
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). Bulletin of the World Health Organization 2008;86:788-795.