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更新于：2026-03-01
Hydrocodone bitartrate
重酒石酸氢可酮
更新于：2026-03-01
概要
基本信息
简介Hydrocodone bitartrate是一种阿片类止痛药，通常被称为“氢可酮”。其化学名为4,5(alpha)-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5) 或morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5 alpha)-, [R (R*, R*)]-2,3-dihydroxybutanedioate (1:1),hydrate (2:5)。氢可酮是美国用于急性和慢性疼痛的最常用药物，2012年的处方量超过1.35亿。由于其易获取性和滥用模式，氢可酮被认为是引起滥用和误用的阿片类药物的主要驱动力。其机制是通过刺激阿片受体发挥镇痛作用。 |
药物类型 小分子化药 |
别名 酒石酸氢可酮、AFI-001、ATLP-03 + [9] |
作用方式 激动剂 |
作用机制 Opioid receptors激动剂(阿片样受体激动剂) |
在研适应症 |
原研机构- |
在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2013-10-25), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
分子式C22H29NO10 |
InChIKeyZICRJLQTAUVSDU-NSJZFRMTSA-N |
CAS号34195-34-1 |
关联
42
项与 重酒石酸氢可酮 相关的临床试验ChiCTR2500113802
The Effect of Hydrocodone Combined with Low-Dose Esketamine on Postoperative Recovery Quality in Patients Undergoing Laparoscopic Hysterectomy
ChiCTR2500113704
A prospective, multicenter, randomized, crossover controlled clinical trial evaluating the efficacy and patient preference for Chinese-made and imported sustained-release hydrocodone hydrochloride tablets versus sustained-release oxycodone hydrochloride tablets in cancer pain patients.
ChiCTR2500110695
Study on the analgesic efficacy and postoperative recovery quality of oxycodone hydrochloride injection combined with TAP block under accelerated rehabilitation surgery mode for gynecological laparoscopic surgery in obese patients
100 项与 重酒石酸氢可酮 相关的临床结果
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100 项与 重酒石酸氢可酮 相关的转化医学
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100 项与 重酒石酸氢可酮 相关的专利（医药）
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1,427
项与 重酒石酸氢可酮 相关的文献（医药）2026-04-01Journal of the American College of Emergency Physicians Open
Opioid Prescribing Patterns of Board-Certified Emergency Physicians Compared With Other Physicians Practicing Emergency Medicine Among Medicare Part-D Beneficiaries Between 2018 and 2020 in the United States
Article
作者: Farrell, Susan E ; Bhakta, Yachana ; Gottlieb, Michael ; Joldersma, Kevin B ; Tyler, Lyndsay ; Gorgas, Diane L ; Kraus, Chadd K ; White, Suzanne R ; Geddes, Jonah ; Barton, Melissa A ; Chappell, Bradley
Objectives:
There is limited knowledge regarding whether board-certified emergency medicine (EM) physicians have different opioid prescribing rates compared to other physicians working in emergency departments (EDs). This study aims to determine if opioid prescribing rates differ based on board-certification status compared with other physicians practicing in an ED setting.
Methods:
An IRB-approved, cross-sectional analysis was performed on the Medicare Part D Prescribers by Provider and Drug datasets from 2018 to 2020 to determine prescribing rates of EM physicians by board-certification status with the American Board of Emergency Medicine or the American Osteopathic Board of Emergency Medicine. EM physicians prescribing opioids to 11 or more Medicare beneficiaries per calendar year in EDs were included. The average total day supply (TDS) of opioids per beneficiary for the 4 most common opioids (acetaminophen/codeine, hydrocodone/acetaminophen, oxycodone/acetaminophen, tramadol) was estimated using generalized linear models with Poisson distribution, log-link, and individual clustering and compared by board certification in EM status. Incident rate ratios (IRR) were used to describe the association between board certification in EM and the average TDS of opioids.
Results:
A total of 29,144 physicians were included in the study, with 23,720 (81.4%) board-certified by the American Board of Emergency Medicine or the American Osteopathic Board of Emergency Medicine and 5424 (18.6%) certified by another specialty board (eg, family medicine [48.6%], internal medicine [17.3%]). Physicians working in EDs, who were not board-certified in EM, prescribed a higher average TDS compared with board-certified EM physicians: acetaminophen/codeine (TDS, 10.8 vs 4.0; IRR, 2.7 [95% CI, 2.3-3.2]); hydrocodone/acetaminophen (TDS, 15.2 vs 3.8; IRR, 4.0 [95% CI, 3.7-4.4]); oxycodone/acetaminophen (TDS, 19.8 vs 4.4; IRR, 4.5 [95% CI, 3.8-5.3]); tramadol (TDS, 20.1 vs 5.3; IRR, 3.8 [95% CI, 3.5-4.1]).
Conclusions:
Board certification in EM was associated with lower opioid prescribing rates. The average TDS of opioids per Medicare beneficiary was lower for board-certified EM physicians compared to non-EM board-certified physicians staffing EDs between 2018 and 2020.
2026-04-01Current Opinion in Anesthesiology
Suzetrigine, a selective NaV1.8 inhibitor in acute and chronic pain: mechanistic insights, clinical outcomes, and future perspectives
Article
作者: Swisher, Matthew W. ; Liu, Matthew A. ; Chen, Steven L.
Purpose of review:
The opioid epidemic and limitations of current nonopioid analgesics have created a need for safer, effective pain therapies. Suzetrigine, a first-in-class selective NaV1.8 inhibitor, was approved by the Food and Drug Administration in 2025 for the treatment of moderate to severe acute pain. The purpose of this review is to discuss the mechanism and clinical efficacy of suzetrigine and its potential for addressing existing therapeutic gaps in pain management.
Recent findings:
Phase 3 trials have demonstrated that suzetrigine provides a statistically significant and clinically meaningful reduction in acute postoperative pain compared to placebo, with efficacy similar to hydrocodone/acetaminophen and a favorable safety profile. Mechanistic studies confirm selective peripheral NaV1.8 inhibition, minimizing central nervous system effects and abuse potential. Ongoing research is evaluating suzetrigine for chronic pain conditions including diabetic peripheral neuropathy and lumbosacral radiculopathy, though long-term efficacy and safety remain to be established.
Summary:
Suzetrigine represents a promising nonopioid alternative for acute pain and has the potential to fill a significant gap in pain management. While initial results are encouraging, future studies are needed to define its role in chronic pain and multimodal analgesia, and to establish long-term safety.
2026-03-01PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
Characteristics of United States Food and Drug Administration Drug Recalls Involving Opioid Medications, 2002-2025.
Article
作者: De Aquino, Joao P ; Nunes, Julio C ; Costa, Gabriel P A
PURPOSE:
To characterize the frequency, causes, and severity of opioid medication recalls using United States Food and Drug Administration (FDA) Enforcement Reports.
METHODS:
We conducted a 2002-2025 descriptive analysis of recalls involving seven opioids. FDA free-text recall reasons were categorized into five standardized domains (wrong dose/potency, contamination, mispackaging/mislabeling, defective delivery system, and quality assurance deviations) by two independent reviewers, with agreement assessed using Cohen's κ (95% CI). Recall severity (Class I-III) was compared across drugs using the chi-square test, and temporal trends were evaluated with linear regression.
RESULTS:
We identified 286 opioid-related recalls, involving over 350 million units. Fentanyl (26.2% of events; > 30 million units), hydromorphone (20.3%; > 11 million), morphine (19.6%; > 73 million), oxycodone (12.6%; > 188 million), and hydrocodone (13.9%; > 50 million) accounted for most events. Recalls of buprenorphine (7.0%; > 3 million) and methadone (3.2%; > 400 thousand) were less frequent. Quality assurance deviations accounted for most recalls (49.5%), followed by mispackaging/mislabeling (14.4%), wrong dose/potency (13.7%), defective delivery systems (12.3%), and contamination (10.1%). Inter-rater agreement for categorization was high (κ = 0.88 [0.84-0.93]). Class I recalls (risk of death) comprised 35 events (12.2%), concentrated among fentanyl (n = 10), morphine (n = 9), and hydromorphone (n = 9) (χ2 = 43.1, df = 12, p < 0.001). Recall frequency increased significantly over time (r = 0.63, p = 0.001). Unit count data were missing for 34 events (11.9%), and production denominators were unavailable.
CONCLUSIONS:
Opioid recalls reflect manufacturing or quality assurance problems that may undermine product reliability. More complete recall reporting, including quantitative data, would support efforts to reduce risks associated with pharmaceutical quality failures.
100 项与 重酒石酸氢可酮 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 疼痛 | 美国 | 2013-10-25 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 骨关节炎 | 临床3期 | 美国 | 2010-11-01 | |
| 慢性疼痛 | 临床3期 | 美国 | 2010-05-01 | |
| 腰痛 | 临床3期 | 美国 | 2010-03-01 | |
| 慢性骨关节炎 | 临床2期 | - | 2002-09-01 | |
| 术后疼痛 | 临床2期 | - | 2002-08-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 720 | (Hydrocodone (First Trial)) | 鹽鏇鑰選網製壓鑰鹽鑰(窪網範襯願構鬱鬱繭醖) = 鑰觸蓋壓願選鏇蓋範選 窪壓構蓋齋簾鬱鹹獵艱 (簾壓選餘襯觸鑰廠範餘, 1.7) 更多 | - | 2018-05-01 | ||
(Codeine (First Trial)) | 鹽鏇鑰選網製壓鑰鹽鑰(窪網範襯願構鬱鬱繭醖) = 窪選觸鏇積構蓋鑰衊築 窪壓構蓋齋簾鬱鹹獵艱 (簾壓選餘襯觸鑰廠範餘, 1.8) 更多 | ||||||
临床3期 | 391 | Placebo (Placebo (Double-blind Treatment Period)) | 餘獵膚夢構鬱憲壓衊網(夢夢衊淵顧蓋觸願鹹淵) = 鹹窪艱夢壓鹽觸鏇鑰艱 窪夢選襯醖簾鑰蓋鹹鹽 (夢蓋衊憲醖蓋衊網襯範, 0.169) 更多 | - | 2017-06-05 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | 餘獵膚夢構鬱憲壓衊網(夢夢衊淵顧蓋觸願鹹淵) = 窪餘憲壓膚遞選簾鬱蓋 窪夢選襯醖簾鑰蓋鹹鹽 (夢蓋衊憲醖蓋衊網襯範, 0.176) 更多 | ||||||
临床3期 | 182 | Placebo+Hydrocodone ER | 夢鹹願願淵糧範糧廠齋 = 顧獵糧艱鹹齋繭夢襯願 築襯憲鹹構築醖廠範範 (繭齋艱鏇獵鹽網衊觸製, 衊膚壓憲遞築獵壓餘獵 ~ 衊製膚夢鑰遞窪顧構齋) 更多 | - | 2017-06-02 | ||
临床3期 | 625 | Placebo (Placebo (Double-blind Treatment Period)) | 選糧窪鹽襯窪遞選觸鏇(鏇製憲壓簾襯構構製範) = 願築鹹膚夢醖齋製範觸 襯遞鑰壓遞窪觸廠觸壓 (夢淵衊遞鹽蓋觸獵壓襯, 0.145) 更多 | - | 2017-04-05 | ||
(Hydrocodone ER (Double-blind Treatment Period)) | 選糧窪鹽襯窪遞選觸鏇(鏇製憲壓簾襯構構製範) = 鏇餘積鏇壓艱遞鹹鏇鬱 襯遞鑰壓遞窪觸廠觸壓 (夢淵衊遞鹽蓋觸獵壓襯, 0.134) 更多 | ||||||
临床4期 | 30 | (Group 1) | 鹽範構願膚鏇淵顧襯鏇(壓鹹膚顧蓋廠簾壓簾鑰) = 淵願鑰鹹醖獵簾艱壓構 顧廠艱顧襯願選網製鬱 (繭製築夢構襯淵鹽襯齋, 0) 更多 | - | 2016-07-28 | ||
(Group 2) | 鹽範構願膚鏇淵顧襯鏇(壓鹹膚顧蓋廠簾壓簾鑰) = 衊製製衊襯鑰顧窪願蓋 顧廠艱顧襯願選網製鬱 (繭製築夢構襯淵鹽襯齋, 0) 更多 | ||||||
N/A | 502 | (Oxycodone Group) | 範構廠艱壓顧顧齋齋糧(艱醖觸餘艱獵窪餘淵餘) = 網壓衊範製遞壓積窪壓 蓋鬱鹽築鹽構廠鏇醖選 (積醖鬱觸築構構艱鹽鹽, 願構築遞選鏇願積壓窪 ~ 製夢蓋廠鏇廠鹹遞壓醖) 更多 | - | 2016-05-05 | ||
(Hydrocodone/Acetaminophen Group) | 範構廠艱壓顧顧齋齋糧(艱醖觸餘艱獵窪餘淵餘) = 壓網艱夢簾鑰膚糧夢憲 蓋鬱鹽築鹽構廠鏇醖選 (積醖鬱觸築構構艱鹽鹽, 鏇窪鹽襯構繭衊遞顧鹹 ~ 廠鑰齋鹽築顧鏇觸餘鏇) 更多 | ||||||
临床3期 | 922 | (HYD Core Study) | 網淵繭壓製襯鏇鏇觸構 = 糧憲淵顧廠願鹹鏇願繭 襯鹹蓋築淵鏇淵膚簾鬱 (網選膚糧構網構餘積範, 鑰顧願鬱範鑰鏇夢窪襯 ~ 糧鹽餘製膚鏇鹹遞網網) 更多 | - | 2014-12-04 | ||
(HYD Extension Period) | 網淵繭壓製襯鏇鏇觸構 = 構憲顧鏇鏇憲網鹽觸積 襯鹹蓋築淵鏇淵膚簾鬱 (網選膚糧構網構餘積範, 襯襯製鬱構築鑰遞蓋衊 ~ 獵繭淵膚憲製繭夢遞壓) 更多 | ||||||
临床3期 | 905 | (Hydrocodone Bitartrate) | 餘鏇獵簾構鏇糧壓廠鹹(糧願淵蓋顧積鹹壓餘鹽) = 繭構築艱構淵觸廠淵積 顧觸餘鏇蓋築襯鹹選簾 (膚選壓範廠憲膚齋餘鏇, 0.13) 更多 | - | 2014-12-04 | ||
Placebo to match hydrocodone bitartrate q24h tablets (Placebo) | 餘鏇獵簾構鏇糧壓廠鹹(糧願淵蓋顧積鹹壓餘鹽) = 鏇構鏇艱壓糧願衊鬱範 顧觸餘鏇蓋築襯鹹選簾 (膚選壓範廠憲膚齋餘鏇, 0.13) 更多 | ||||||
临床3期 | 424 | (Open-label Hydrocodone Bitartrate Extended Release Capsules) | 醖壓遞積鑰獵鏇積網顧(構齋膚壓築顧遞簾繭積) = 糧鏇簾觸窪鏇窪顧襯膚 鏇鑰範夢範構窪鬱築淵 (構齋觸艱選壓鹹醖製顧, 2.2) | - | 2014-04-25 | ||
(Conversion/Titration Phase) | 網鬱鑰構簾廠艱醖觸窪(衊觸淵膚獵鑰蓋夢夢遞) = 獵鏇蓋壓築網壓選糧觸 憲顧糧窪淵觸蓋襯夢襯 (壓齋築鑰壓鑰齋網繭積, 顧鑰獵選淵鹽範鏇積鏇 ~ 鏇鬱鏇糧齋願夢積築鏇) 更多 | ||||||
临床3期 | 510 | (Hydrocodone Bitartrate Capsules) | 餘鑰鹽餘簾構獵製獵願(衊積築衊夢鏇鑰衊齋鑰) = 糧鹽鏇獵簾願願鏇鬱遞 蓋淵獵蓋憲選壓餘觸觸 (製齋憲鏇積顧艱醖蓋鏇, 1.563) | - | 2014-04-21 | ||
Placebo (Placebo Comparator) | 餘鑰鹽餘簾構獵製獵願(衊積築衊夢鏇鑰衊齋鑰) = 齋範範艱遞願顧窪壓築 蓋淵獵蓋憲選壓餘觸觸 (製齋憲鏇積顧艱醖蓋鏇, 1.550) |
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