正常吸毒者口服脱毒舒胶囊Ⅰ期临床耐受性试验

中国临床药理学与治疗学 ›› 2009, Vol. 14 ›› Issue (11): 1286-1291.

正常吸毒者口服脱毒舒胶囊Ⅰ期临床耐受性试验

贺建昌¹, 徐贵丽¹, 张青¹, 张滇民¹, 郝江², 沈亮¹, 冯恩富¹, 刘苗³

¹成都军区昆明总医院Ⅰ期临床试验研究室,²急诊科,³消化科, 昆明 650032, 云南

收稿日期:2009-09-28 修回日期:2009-11-09 发布日期:2020-10-26
通讯作者: 徐贵丽,女, 硕导, 研究方向:临床药理学。E-mail:guilixukm@163.com
作者简介:贺建昌, 男, 硕士, 研究方向:临床药理学。Tel(Fax):0871-5413120 　E-mail:kmhejc@163.com

Tolerance of Tuodushu capsule in normal drug addicts:A phase Ⅰclinical trial

HE Jian-chang¹, XU Gui-li¹, ZHANG Qing¹, ZHANG Dian-min¹, HAO Jiang², SHEN Liang¹, FENG En-fu¹, LIU Miao³

¹Research Section for Phase ⅠClinical Trial, Kunming General Hospital of ChengduMilitary Command, ²Department of Emergency Medicine, Kunming General Hospital of Chengdu Military Command, ³Department of Gastroenterology, Kunming General Hospital of Chengdu Military Command, Kunming 650032, Yunnan, China

Received:2009-09-28 Revised:2009-11-09 Published:2020-10-26

摘要/Abstract

摘要： 目的：评价正常吸毒者口服脱毒舒胶囊的安全性和耐受性。方法：43 名正常吸毒受试者进行单次及多次给药的耐受性试验。其中, 单次给药者31 人, 经筛选合格后随机分配到7 个剂量组(1 、2 、3 、4 、5 、6 和7 粒组) 。多次给药者12 人, 男女各半, 分为3 粒组和4 粒组, 连续给药6 d, 前3d 1 d 2 次, 1 次3(或4) 粒;后3 d 1 d 2 次, 1 次2粒。观察记录给药前后不同时间的体格检查、生命体征、心电图、血常规、尿常规、血液生化等指标。结果：给药后体格检查、体征未见有临床意义的改变。实验室检查中单次组共有4 组(3 、4 、5 、6粒给药组) 的BUN 值和两组(3 、7 粒给药组) 的Cr值试验前后变化有统计学意义(P <0.05), 多次给药两组的BUN 值和Cr 值试验前后变化都有统计学意义(P <0.05);少数病例的CK 值变化有临床意义, 但该组均数前后变化分析无统计学差异。试验中不良事件均为轻中度且为一过性, 未见严重不良事件发生。结论：脱毒舒胶囊单次给药1~ 7 粒, 受试者均可耐受;多次给药(前3 d 早晚各4 粒, 后3 d 早晚各2 粒) 受试者可以耐受。推荐II 期临床研究用药剂量为多次给药, 疗程6 d,前3 d 早晚各4(或3) 粒, 后3 d 早晚各2(或1)粒, 但需注意受试者睡眠、饮食、心肌酶和大小便等的变化。

关键词: 脱毒舒胶囊, 单次给药, 多次给药, 耐受性试验

Abstract: AIM: To assess the safety and tolerance of Tuodushu capsule in normal drug addictive volunteers. METHODS: 43 subjects were enrolled in the non-controlled single-dose trial or multiple-dose trial. Thirty-one subjects were randomized into 7 dose groups (1, 2, 3, 4, 5, 6 and 7 capsules group) for singledose trial.Twelve subjects, six males and six females, equally divided into two treatment groups (3 capsules or 4 capsules group), were orally given 3 or 4 capsules per times, b.i.d.in the first 3 days and 2 capsules per times, b.i.d.in the last 3 days for multiple-dose trial.The physical examination, vital signs, electrocardiogram, routine blood tests, routine urine tests, and blood biochemical tests were conducted on schedule and statistically evaluated. RESULTS: There were no significant clinical changes in physical examination and vital signs after administration.In single-dose trial, statistically significance (P <0.05) in BUN in 4 groups (3, 4, 5, 6 capsules group) and Cr in 2 groups (3, 7 capsules group) were found.In multiple-dose trial, statistically significances (P <0.05) in BUN and Cr between two groups were observed.There were significant clinical changes in CK in a small number of cases, but no differences between cases.All adverse events were mild to moderate and transient and no serious adverse events were found in the trial. CONCLUSION: Tuodushu capsule is safe and well tolerated in normal drug addictive volunteers at dose of 1-7 capsules once daily.In addition, the multiple-dose level of 4 capsules per times, b.i.d.in the first 3 days and 2 capsules per times, b.i.d.in the last 3 days is assessed as safe and well tolerated.The recommended oral dosage regimen for phase II clinical trial is 3 or 4 capsules per times, b.i.d.in the first 3 days and 1 or 2 capsules per times, b.i.d.in the last 3 days for multiple-dose trial.Attention should be paid to the changes in sleep, diet, Cr and defecation.

Key words: Tuodushu capsule, single-dose, multiple-dose, tolerance test

中图分类号:

R969

贺建昌, 徐贵丽, 张青, 张滇民, 郝江, 沈亮, 冯恩富, 刘苗. 正常吸毒者口服脱毒舒胶囊Ⅰ期临床耐受性试验[J]. 中国临床药理学与治疗学, 2009, 14(11): 1286-1291.

HE Jian-chang, XU Gui-li, ZHANG Qing, ZHANG Dian-min, HAO Jiang, SHEN Liang, FENG En-fu, LIU Miao. Tolerance of Tuodushu capsule in normal drug addicts:A phase Ⅰclinical trial[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(11): 1286-1291.

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