Abstract: In order to provide basis for clinical rational application, the clinical therapeutic effect and target ainimal safety of 30% praziquantel injection were investigated. The clinical therapeutic effect of praziquantel injection on sick buffalos naturally infected with Schistosoma japonicum was studied by experimental clinical trials and expanded clinical trials. The target animal safety of praziquantel injection in buffalos was evaluated by comparing clinical signs, blood routine and serum biochemical indexes before and after administration. In experimental clinical trials, the praziquantel injection groups with high (20 mg/kg), middle (10 mg/kg) and low (5 mg/kg) dose, their negative conversion rates of miracidium were 100% (8/8), 100% (9/9), and 77.8% (7/9), respectively. In expanded clinical trials, the praziquantel injection groups with recommended dose of 10 mg/kg, its negative conversion rate of miracidium was 100% (52/52). In target animal safety test, within the intramuscular administration at 3-fold recommended dose of 30 mg/kg (P>0.05), the praziquantel injection was safe and had no adverse reactions to blood routine and serum biochemical indexes of buffalos. 30% praziquantel injection is safe and effective in clinical treatment of cattle schistosomiasis at the recommended dose of 10 mg/kg.

Key words: praziquantel injection, clinical therapeutic effect, target animal safety, schistosomiasis, buffalos

摘要： 研究30%吡喹酮注射液的临床药效和靶动物安全性，为其临床合理用药提供依据。通过实验性临床试验和扩大临床试验，考察吡喹酮注射液对自然感染血吸虫病牛的临床治疗效果。通过给药前后临床体征、血常规及血清生化指标的比较，评价吡喹酮注射液对靶动物水牛的安全性。实验性临床试验中，吡喹酮注射液高（20 mg/kg）、中（10 mg/kg）、低（5 mg/kg）剂量组的毛蚴转阴率分别为100%（8/8）、100%（9/9）、77.8%（7/9）。扩大临床试验中，吡喹酮注射液推荐剂量组（10 mg/kg）的毛蚴转阴率为100%（52/52）。靶动物安全性试验中，吡喹酮注射液至少在3倍推荐剂量（30 mg/kg）范围内对靶动物水牛的血常规和血清生化指标无明显影响(P>0.05)。30%吡喹酮注射液按推荐剂量（10 mg/kg）肌内注射给药，对牛血吸虫病具有良好的治疗效果，临床应用安全。

关键词: 吡喹酮注射液, 临床药效, 靶动物安全性, 血吸虫病, 水牛