黄芪总苷注射液人体耐受性Ⅰ期临床试验  

Phase Ⅰ clinical study of radix asragali total glycosides injection in healthy volunteers

作　　者：陈光宇[1] 丁红[2] 刘永家[1] 王若竹 张亚玲[4] 

机构地区：[1]成都中医药大学附属医院心血管科,610072 [2]成都中医药大学附属医院国家药物临床试验机构,610072 [3]成都地奥九泓制药厂 [4]成都中医药大学研究生院

出　　处：《环球中医药》2013年第7期514-518,共5页Global Traditional Chinese Medicine

摘　　要：目的评价健康受试者对黄芪总苷注射液的耐受性，为制定本品的Ⅱ期临床试验给药方案提供依据。方法单次给药组32名健康受试者按男性和女性分别根据体重编码排序随机分配至静脉滴注试验药25ml、50ml、75ml、100ml、150ml、200ml、250m17个剂量组。连续给药组12名健康受试者按男性和女性分别根据体重编码排序随机分配到100ml和200ml2个剂量组，1次／天，静脉滴注，连续10天。观察给药后健康人体对试验药反应及耐受性。结果单次给药耐受性实验中出现球蛋白轻度升高1例和白细胞减少1例，与试验药物的关系为无法判定；连续给药耐受性试验每组各有2例分别出现轻微头痛、头昏、恶心；腹痛、稀便，腓肠肌疼痛症状和甘油三酯、丙氨酸氨基转换酶升高，血清钙降低。继续试验用药，复查恢复正常，与试验药物的关系为可能有关或无法判定。结论健康受试者对黄芪总苷注射液静脉给药耐受性较好，推荐Ⅱ期临床试验的安全剂量范围为100—200ml／次，1天1次，并注意观察上述不良反应症状和化验指标。Objective This paper proposes a basis of dosage regimen for radix asragali total glycosides injection phase II clinical trial by estimating the tolerance of healthy volunteers. Method In the work, healthy volunteers were divided into single-dose group and continuous administration group with different drug infusion. The drug response and tolerance were analyzed after the administration. Results Globulin mildly elevated and leukopenia were appeared once of each in the single-dose tolerance experiments, the relationship with the study drug could not be determined ; Every continuous administration group had two subjects got mild headache, dizziness, nausea; abdominal pain, loose stools, gastrocnemius muscle pain and triglycerides, alanine aminotransferase, serum calcium decreased. Subjects back to normal during successive the drug use, the relationship with the study drug may be related to, or cannot be determined. Conclusion The healthy subjects have good tolerance of radix asragali total glycosides injection. This paper recommends the safe dose range of phase II clinical trials as 100 - 200 ml/time, once a day, and to keep on observing the adverse reaction symptoms and laboratory indicators.

关 键 词：黄芪总苷注射液 Ⅰ期临床试验 耐受性 安全性 

分 类 号：R969[医药卫生—药理学]