|本期目录/Table of Contents|

[1]陈光宇,丁红,刘永家,等.黄芪总苷注射液人体耐受性Ⅰ期临床试验[J].环球中医药,2013,6(07):514-0.
　CHEN Guang yu,DING Hong,LIU Yong jia,et al.Phase I clinical study of radix asragali total glycosides injection in healthy volunteers[J].,2013,6(07):514-0.
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黄芪总苷注射液人体耐受性Ⅰ期临床试验()
     
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《环球中医药》[ISSN:1006-6977/CN:61-1281/TN]

卷:
第6卷
期数:
2013年07期
页码:
514-0
栏目:
论著
出版日期:
2013-07-06

文章信息/Info

Title:
Phase I clinical study of radix asragali total glycosides injection in healthy volunteers
作者:
陈光宇;丁红;刘永家;王若竹;张亚玲;
Author(s):
CHEN Guangyu;  DING Hong; LIU Yongjia; et al.
Department of cardiology the Teaching Hospital of Chengdu traditional Chinese medicine, Sichuan 610000,China
关键词:
黄芪总苷注射液; Ⅰ期临床试验; 耐受性; 安全性
Keywords:
Radix asragali total glycosides Injection; Phase I clinical trial; Resistance; Safety
分类号:
R969
DOI:
-
文献标志码:
A
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、250ml7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
Abstract:
ObjectiveThis paper proposes a basis of dosage regimen for radix asragali total glycosides injection phase II clinical trial by estimating the tolerance of healthy volunteers.MethodIn 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.ResultsGlobulin 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. ConclusionThe 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.

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备注/Memo

备注/Memo:

作者单位：610072 成都中医药大学附属医院心血管科(陈光宇、刘永家)，国家药物临床试验机构(丁红)；成都地奥九泓制药厂（王若竹）；成都中医药大学研究生院［张亚玲(硕士研究生)］
作者简介：陈光宇(1959- )，本科，副主任医师。研究方向：心血管疾病。Email: cdzydgy@126.com
通讯作者：丁红（1964- ），女，本科，主任医师。研究方向：中医内科及中医临床药理。Email：gcpdh@163.com
更新日期/Last Update: 1900-01-01