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| 上市药品生脉饮健康志愿者临床耐受性再评价 |
| Clinical Reevaluate of the Tolerance of Marketed Drug-Shengmai Drink |
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| DOI： |
| 中文关键词: 生脉饮 健康志愿者 临床耐受性 人参 麦冬 五味子 心电图 实验室检查 安全性 心血管疾病 |
| 英文关键词:Shengmai drink,Normal volunteers,Tolerance,Drug reevaluate |
| 基金项目: |
| 李艳红 徐戎 龚培力 曾繁典 |
华中科技大学同济医学院临床药理研究所 武汉430030
(李艳红，徐戎，龚培力)
，华中科技大学同济医学院临床药理研究所 武汉430030(曾繁典)
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| 中文摘要: |
| 目的：评价健康志愿者单次口服生脉饮的安全性和耐受性。方法：健康成人志愿受试者36例，随机分为4组，分别单次口服生脉饮100、150、200和300mL，观察受试者对生脉饮的耐受性。结果：生脉饮300mL组受试者DBP下降显著，其余生命体征、实验室检查及心电图变化各组均在正常范围。不良反应仅发生在200mL及300mL组，主要症状为轻度头晕，能耐受，无须药物处理可自行消失。结论：36例健康受试者单次口服生脉饮，仅300mL组DBP下降，大剂量组(200—300mL)见少数一过性头晕等轻微不良反应。在常规治疗剂量(100—150mL)范围内，耐受性良好，未见不良反应发生。 |
| 英文摘要: |
| Objective: To evaluate the safety and tolerability of shengmai drink in healthy volunteers.Method: 36 healthy volunteers were randomly divided into four groups to receive a single oral dose of 100, 150, 200 and 300ml of shengmai drink respectively. The changes of vital signs and laboratory data were recorded.Result: 300ml shengmai drink caused an obvious decrease of diastolic blood pressure. Their records of the cardiovascular system, liver and renal functions were in normal range. The volunteers at a high dose of 200 ml and 300 ml complained of some slight snuffle, which would disappear without any disposal.Conclusion: The results suggested that 300ml shengmai drink caused decrease of diastolic blood pressure and only a large dose of 200 ml and 300 ml led to some slight reversible snuffle. In a routine dose of 100 ml and 150 ml, no adverse effects had been observed. |
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