主要目的：以持证商为Accord UK Ltd的氨酚双氢可待因片(商品名：Co-dydramol®，规格：对乙酰氨基酚500 mg，酒石酸双氢可待因10 mg)为参比制剂，以陕西九州制药有限责任公司研究生产的氨酚双氢可待因片(规格：对乙酰氨基酚500 mg，酒石酸双氢可待因10 mg)为受试制剂，通过单中心、随机、开放、单剂量、双周期、交叉试验设计，评价两制剂在健康受试者空腹和餐后状态下单次口服给药的人体生物等效性。次要目的：观察及评价受试制剂和参比制剂在中国健康受试者中的安全性。

开始日期2023-08-05

申办/合作机构

陕西九州制药有限责任公司

CTR20231820 / RecruitingN/A

单中心、随机、开放、单剂量、双周期、交叉试验设计评价中国健康受试者空腹和餐后口服氨酚双氢可待因片的生物等效性试验

以持证商为Accord UK Ltd的氨酚双氢可待因片(商品名：Co-dydramol®，规格：对乙酰氨基酚500 mg，酒石酸双氢可待因10 mg)为参比制剂，以陕西九州制药有限责任公司研究生产的氨酚双氢可待因片(规格：对乙酰氨基酚500 mg，酒石酸双氢可待因10 mg)为受试制剂，通过单中心、随机、开放、单剂量、双周期、交叉试验设计，评价两制剂在健康受试者空腹和餐后状态下单次口服给药的人体生物等效性。

开始日期2023-06-09

申办/合作机构

陕西九州制药有限责任公司

IRCT20230221057473N1 / Recruiting临床1/2期IIT

Comparison of the effect of two drugs acetaminophen codeine and Anahil in combination with acetaminophen codeine on pain relief in patients needing dental implants after implant surgery

开始日期2023-04-30

申办/合作机构

Shiraz University of Medical Sciences

100 项与对乙酰氨基酚/酒石酸双氢可待因相关的临床结果

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100 项与对乙酰氨基酚/酒石酸双氢可待因相关的转化医学

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100 项与对乙酰氨基酚/酒石酸双氢可待因相关的专利（医药）

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项与对乙酰氨基酚/酒石酸双氢可待因相关的文献（医药）

2021-12-01·Journal of Orthopaedic Surgery and Research3区 · 医学

A retrospective analysis of the effects of different analgesics on the pain of patients with traumatic thoracolumbar fractures in the peri-treatment period

3区 · 医学

ArticleOA

作者: Wen, Song ; Xiong, Liu-Lin ; Li, Ting-Ting ; Chen, Jie ; Wang, Ya-Ting ; Yuan, Hao ; Chang, Quan-Yuan ; Gan, Zong-Jin

AbstractObjectiveTo analyze and compare the effects of peri-treatment analgesics on acute and chronic pain and postoperative functional recovery of patients with thoracolumbar fractures, so as to guide the clinical drug use.MethodsSeven hundred nineteen patients with thoracolumbar fractures were collected and divided into acetaminophen dihydrocodeine, celecoxib, and etoricoxib groups. The main indicators were the degree of postoperative pain (visual analog scale (VAS)), the incidence of chronic pain and postoperative functional recovery (Oswestry dysfunction index (ODI) and Japanese Orthopedics Association score (JOA)), which were continuously tracked through long-term telephone follow-up. The correlation analysis of ODI-pain score, peri-treatment VAS score, and ODI index was performed, and bivariate regression analysis was conducted to understand the risk factors for chronic pain.ResultsRegression analysis showed that severe spinal cord injury and peri-treatment use of acetaminophen dihydrocodeine were both one of the risk factors for postoperative chronic pain. But there were no statistically conspicuous differences in basic characteristics, preoperative injury, and intraoperative conditions. Compared with the other two groups, patients in the acetaminophen dihydrocodeine group had longer peri-therapeutic analgesic use, higher pain-related scores (VAS 1 day preoperatively, VAS 1 month postoperatively, and ODI-pain 1 year postoperatively), higher VAS variation, higher incidence of chronic pain 1 year after surgery, and higher ODI index. And other ODI items and JOA assessments showed no statistically significant differences. In addition, the correlation analysis showed that the peri-treatment pain score was correlated with the severity of postoperative chronic pain.ConclusionAlthough the peri-treatment analgesic effect of acetaminophen dihydrocodeine is good, it is still necessary to combine analgesics with different mechanisms of action for patients with severe preoperative pain of thoracolumbar fracture, so as to inhibit the incidence of postoperative chronic pain and improve the quality of postoperative rehabilitation.

100 项与对乙酰氨基酚/酒石酸双氢可待因相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	N02AJ01	-

研发状态

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适应症	国家/地区	公司	日期
疼痛	中国	威海路坦制药有限公司	2003-08-27

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临床结果

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03080493 (GABA, CTgov)	临床4期	疼痛 \| 先兆流产	121	acetaminophen/codeine+Ibuprofen+Gabapentin 600mg (Gabapentin)	糧築構積鏇網襯構獵獵(構願艱繭遞簾構廠製鹹) = 築鹹網餘齋廠觸製憲糧積鏇餘艱醖鑰鏇糧膚夢 (鹹餘鏇膚鑰鹹鏇壓鏇顧, 鏇選淵齋壓築製鹹壓範 ~ 獵衊憲顧願範製廠簾構) 更多	-	2020-04-14
				Placebo oral capsule+acetaminophen/codeine+Ibuprofen (Placebo Oral Capsule)	糧築構積鏇網襯構獵獵(構願艱繭遞簾構廠製鹹) = 積範艱鏇繭齋夢選鬱鹹積鏇餘艱醖鑰鏇糧膚夢 (鹹餘鏇膚鑰鹹鏇壓鏇顧, 願糧獵願齋願鏇蓋選觸 ~ 鹹窪顧糧廠願餘網築艱) 更多
NCT02647788 (CTgov)	临床4期	术后疼痛	144	Acetaminophen/Ibuprofen (Acetaminophen/Ibuprofen)	餘積壓觸觸範衊糧壓鬱(膚積繭衊淵鬱憲網鬱遞) = 製襯願鏇範鹹鹹範醖範獵積廠簾蓋觸獵鑰艱襯 (淵選鏇淵範淵願鏇網餘, 顧繭觸鑰選製醖製鹽遞 ~ 鬱蓋膚糧願艱憲鏇窪製) 更多	-	2019-02-18
				Acetaminophen/Codeine (Acetaminophen/Codeine)	餘積壓觸觸範衊糧壓鬱(膚積繭衊淵鬱憲網鬱遞) = 顧膚夢襯憲鑰繭壓製遞獵積廠簾蓋觸獵鑰艱襯 (淵選鏇淵範淵願鏇網餘, 選築鹹窪鏇鏇襯築衊餘 ~ 鬱鏇築網窪壓鏇鬱醖選) 更多