单次静滴埃本膦酸钠注射液耐受性试验

Investigation on the tolerance of ibandronate by a single intravenous infusion

目的 :在中国健康志愿者中评价单剂静滴埃本膦酸钠注射液的安全性、耐受性。方法 :根据新药临床试验指导原则 ,经体检及实验室检查 ,各项指标均在正常范围内的 36名 18～ 5 0岁健康成人 ,用区组随机化设计方法 ,按随机表将受试者随机分配至1、2、3、4、5和 6mg剂量组 ,每组 6名受试者 ,男女各半。观察指标为临床症状、生命体征、心电图、血常规、尿常规、肝功能、肾功能、电解质等。结果 :单剂静滴埃本膦酸钠注射液 1～ 6mg ,志愿者体温、脉搏、呼吸频率、血压、心电图、血常规、肝功能、肾功能、电解质等各项指标测定值均在正常范围内 ,仅见血磷降低、发热、出汗、骨痛、肌痛、血钙降低等与药物可能有关的一过性轻微不良反应。该不良反应于给药后 1～ 2wk内恢复正常。结论 :单次静滴埃本膦酸钠注射液最大剂量至 6mg比较安全。

AIM: To evaluate the safety and tolerance of ibandronate in Chinese healthy volunteers. METHODS: The trial protocol was designed according to the Good Clinical Practice(GCP). After physical examination and laboratory tests were performed, 36 healthy volunteers were divided randomly into 6 dose groups, including 1 mg , 2 mg , 3 mg , 4 mg , 5 mg and 6 mg , with 6 subjects in each group(3 male and 3 female). Clinical symptoms, vital signs, routine blood tests, routine urine tests, hepatic function, renal function, blood electrolytes, electrocardiogram, and electroencephalogram were observed or examined before and after a single intravenous infusion of ibandronate. RESULTS: After single intravenous infusion doses of 1- 6 mg , the vital signs, clinical symptoms and laboratory tests were all in the normal range, but there were some slight ADRs concerned with the drug, such as hypophosphataemia, increased body temperature, perspiring,pain of bone or muscle and hypocalcaemia. But the ADRs were found vanishing in one or two weeks. CONCLUSION: Single intravenous infusion (up to 6 mg ) of domestic ibandronate in 36 chinese healthy volunteers is safe and tolerable.