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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、耐受性较好
OBJECTIVE: To evaluate the safety and tolerability of single-dose intravenous injection of ebinate sodium in Chinese healthy volunteers. Methods: According to the guidelines of clinical trials of new drugs, 36 healthy adults aged 18 ~ 50 years, whose indexes were within the normal range after physical examination and laboratory examination, were randomly divided into two groups according to the randomized design. Randomly assigned to 1, 2, 3, 4, 5 and 6 mg dose groups, 6 subjects in each group, half male and half female. Observed indicators of clinical symptoms, vital signs, ECG, blood, urine, liver function, renal function, electrolytes and so on. Results: The single dose intravenous injection of epinephrine 1 ~ 6mg, volunteers body temperature, pulse rate, respiratory rate, blood pressure, ECG, blood, liver function, renal function, electrolyte and other indicators measured values ?? are in the normal range Only see the transient hypothyroidism associated with drugs such as decreased blood phosphorus, fever, sweating, bone pain, myalgia, and decreased serum calcium. The adverse reactions within 1 ~ 2wk after administration returned to normal. Conclusion: The single intravenous infusion of eppendronate sodium injection to a maximum dose of 6mg is safe and well tolerated