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tramadol (Qdolo)

✓ Approved

Athena Bioscience, LLC · 小分子 · 小分子

什么是 tramadol？

tramadol 是一种小分子，由Athena Bioscience, LLC研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名Qdolo
公司Athena Bioscience, LLC
药物类别小分子
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, Athena Bioscience, LLC

治疗适应症

tramadol 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Gastrointestinal disordersAbdominal pain✓ Approved

相关研究文献

PubMedFrontiers in pharmacology2026-09-09

Sex-specific pharmacovigilance signals and time-to-onset patterns of drug-related myoclonus and epileptic seizures: a real-world pharmacovigilance analysis.

Zhang Fu F, Yuan Wenjun W, Yao Jingxi J, Wei Yushu Y et al.

Drug-related myoclonus and epileptic seizures are neurological adverse events that may cause trauma, impaired consciousness, hospitalization, treatment interruption, and life-threatening outcomes. In practice, these events may be difficult to distinguish from neurological diseases, metabolic abnormalities, disease progression, or complications of comorbidities and polypharmacy. Research has focused on individual drugs, case reports, or specific populations, leaving the risk-drug spectrum, sex-related reporting patterns, and onset characteristics insufficiently characterized. Systematic evaluation of these features is important for early identification, optimized monitoring, and individualized risk management. FAERS reports from 2004Q1 to 2025Q4 were analyzed. Drug names were standardized using RxNorm, and adverse events were identified using MedDRA 27.1 preferred terms. Primary suspect drugs were evaluated by reporting odds ratio (ROR)-based disproportionality analysis. Sex-stratified analysis, ATC classification, time-to-onset (TTO) analysis, Weibull modeling, and cross-database validation using CVARD were performed. Reports were concentrated in North America, Europe, and East Asia, with female predominance and most patients aged 18-65 years. A total of 165 myoclonus-related and 235 epileptic seizure-related risk drugs were identified. Nervous system agents predominated, while antiinfectives, antineoplastic and immunomodulating agents, metabolic drugs, and cardiovascular agents also contributed. Bupropion had the highest report count (1,412; 265 myoclonus and 1,147 epileptic seizure reports), followed by tramadol (829). For myoclonus, gabapentin showed strong signals in males (ROR = 23.31, 95% CI: 20.95-25.95) and females (ROR = 18.06, 95% CI: 16.24-20.08), whereas tranexamic acid showed the strongest male signal (ROR = 128.41, 95% CI: 98.29-167.75). For epileptic seizures, bupropion showed signals in males (ROR = 18.08, 95% CI: 16.21-20.17) and females (ROR = 20.21, 95% CI: 18.70-21.85), with tramadol signals in both sexes. Drugs exhibited early-failure Weibull patterns (β < 1). Median TTOs were 16.5 days for pregabalin-related myoclonus and 31.0 days for tramadol-related seizures, but 214.0 days for lamotrigine and 387.0 days for interferon beta-1a. CVARD identified 498 myoclonus-related and 940 seizure-related drugs and reproduced core signals, including clozapine, gabapentin, baclofen, pregabalin, sertraline, bupropion, quetiapine, and olanzapine. Integrating signal detection, sex-stratified analysis, TTO modeling, and cross-database validation identified core risk drugs and monitoring windows, supporting earlier recognition and individualized management of drug-related neurological adverse events.

PMID 42712776
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PubMedJMIR public health and surveillance2026-09-08

Multiyear Wastewater Monitoring of High-Risk Substances Surrounding an Annual Electronic Dance Music Festival, Las Vegas, Nevada, USA, 2023-2025: Surveillance Study.

Gerrity Daniel D, Barber Casey A CA, Trenholm Rebecca A RA, Vanderford Brett J BJ et al.

Prior studies involving music festivals (including on-site surveys, drug checking, and wastewater-based analyses) suggest that recreational substance use is common among festivalgoers, though preferred substances and usage may be region- and event-specific. However, multiyear, event-specific wastewater surveillance data in the United States are limited. This study aimed to characterize concentrations of high-risk substances (HRS) and their metabolites in wastewater surrounding an annual electronic dance music (EDM) festival in Las Vegas, Nevada, USA. Using a progressive sampling approach over 3 consecutive years (2023-2025), we assessed trends and examined comparisons by sample type, day, and location to inform situational awareness and future public health surveillance efforts and risk mitigation strategies. Wastewater samples were collected from utility access points at the festival site (2024-2025), off-site in the surrounding community (2023-2024), and at the downstream wastewater treatment plant (WWTP; 2023-2025) during the festival week and weekend. For comparison, samples from a nonfestival weekend were collected off-site and at the WWTP in 2023. Target analytes consisted of 24 parent compounds and metabolites, including stimulants, opioids, and sedatives, which were analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) with isotope dilution. Analyte selection prioritized substances associated with overdose risk and with prior festival-related surveillance. Cocaine (and 3 of 4 measured metabolites), methamphetamine, amphetamine, 11-nor-9-carboxy-Δ-9-tetrahydrocannabinol (THC-COOH), and tramadol were detected in 100% of festival weekend samples; 3,4-methylenedioxymethamphetamine (MDMA; ecstasy) was detected (at concentrations of up to nearly 2 mg/L) in all but 1 festival site sample collected prior to the start of the event in 2025. Festival-associated signals were most pronounced for stimulant-related analytes, which were also detected in WWTP and off-site samples during the festival. Compared with nonfestival weeks, MDMA concentrations were approximately 10 to 30 times higher at off-site locations and nearly 100 times higher at the downstream WWTP during the festival. Opioid-related concentrations were comparable at the WWTP and the festival site, although there were notable detections of norfentanyl and relatively high concentrations of tramadol in some festival site samples. MDMA- and cocaine-related analyte concentrations peaked during the final festival days in 2024 and 2025; the 2023 samples highlighted the presence of HRS in local wastewater during nonfestival weekends. Event-focused, multiyear wastewater surveillance detected stimulants and psychoactive substances, opioids, and Δ-9-tetrahydrocannabinol (THC) associated with an annual EDM festival weekend. Findings are consistent with previous wastewater-based studies of music and dance festivals, with MDMA concentrations among the highest reported in similar surveillance efforts. Codetection of opioid- and stimulant-related analytes suggests varied usage preferences, polysubstance use, and/or unintentional adulteration (eg, lacing). These findings demonstrate the value of wastewater monitoring as a complementary, population-level tool to support public health preparedness, harm-reduction strategies, and attendee safety during large-scale events. These data also inform wastewater utilities about expected influent composition during special events, with relevance for treatment operations and water reuse applications.

PMID 42710006
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PubMedArthroscopy, sports medicine, and rehabilitation2026-09-08

Preoperative Risk Factors for Opioid Use Predict Self-Reported Health and Function Up to 6 Months After Anterior Cruciate Ligament Reconstruction.

Neufeld Eric V EV, DeGouveia William W, Pinpin Camille C, Zinner Matthew M et al.

To identify risk factors that predict the need for rescue opioid use and patient-reported outcomes following an opioid-limiting postoperative analgesia protocol after anterior cruciate ligament reconstruction. This prospective cohort study recruited 44 patients undergoing primary arthroscopic-assisted anterior cruciate ligament reconstruction. Preoperatively, patients completed questionnaires including demographics, medical history, Visual Analog Scale (VAS), Brief Resilience Scale, Six-Item State-Trait Anxiety Inventory, Patient Health Questionnaire-2, Single Assessment Numeric Evaluation score, and patient-reported outcome measures (PROMs) including Patient-Reported Outcomes Measurement Information System physical component. Postoperatively, patients received acetaminophen, meloxicam, tramadol, gabapentin, and oxycodone. Morphine milligram equivalents (MMEs) and VAS were assessed at multiple timepoints through 6 months. PROMs were completed at 3 and 6 months. Patients were analyzed as a single group and partitioned by Brief Resilience Scale and Six-Item State-Trait Anxiety Inventory scores into low-normal (1.00-4.30) and high (4.31-5.00) resilience, and low (20-37) and moderate-high (38-80) anxiety groups, respectively. Prior opioid use positively predicted VAS and MME at 48 to 72 hours and MME at 6 weeks. Body mass index positively predicted MME at 2 weeks. Surgical history negatively predicted VAS at 48 to 72 hours, but positively predicted change in Single Assessment Numeric Evaluation score at 3 and 6 months and Patient-Reported Outcomes Measurement Information System physical component score at 6 months. Only 4.8% of patients required opioid medications more than 2 weeks postoperatively. Patients with prior opioid use exhibited greater postoperative pain and narcotic consumption. Higher body mass index linked to increased opioid use at 2 weeks, whereas individuals with prior surgical history reported less pain and improved PROMs postoperatively. Measurements of patient resilience and anxiety show little effect on postoperative pain, opioid consumption, and PROMs requiring further study. Level III, retrospective prognostic case series.

PMID 42707200
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PubMedPain research & management2026-09-07

Impact of CYP Enzyme Polymorphisms on Opioid Response in Anesthesia and Pain Medicine.

Yan Rongrong R, Quan Yingyao Y, Ma Junyang J, Cheng Jing J et al.

Opioids serve as the cornerstone for anesthesia, postoperative analgesia, and chronic pain management. However, significant interindividual variations exist in their efficacy and safety, posing substantial challenges to clinical practice. Genetic polymorphisms of Cytochrome P450 (CYP) enzymes, particularly CYP2D6 and CYP3A4/5, represent one of the primary contributors to these differences. This review aims to elucidate the mechanisms by which CYP enzyme gene polymorphisms influence opioid metabolism and discuss their clinical implications. Key conclusions indicate that the CYP2D6 genotype significantly influences the bioactivation of precursor drugs such as codeine and tramadol; ultrarapid metabolizers (UMs) are at substantial risk of toxicity when using codeine, whereas slow metabolizers (PM) are at increased risk of inadequate analgesia. Polymorphisms in CYP3A4/5 primarily affect the metabolism of agents such as fentanyl and sufentanil via drug-drug interactions, although evidence supporting genotype-guided dose adjustments independent of clinical factors remains insufficient. Additionally, CYP2B6 polymorphisms are critical for methadone metabolism. Although integrating pharmacogenomic testing into clinical practice holds significant potential, current evidence supports selective testing in specific clinical scenarios rather than routine implementation across all opioid prescriptions.

PMID 42703015
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PubMedCureus2026-09-06

Efficacy and Safety of Intravenous Paracetamol Compared With Intramuscular Tramadol for Labour Analgesia: A Randomised Comparative Study.

Nandi Mouli M, Mondal Priyadarshi P, Mondal Rana R

Labour pain is a major source of maternal distress, particularly in settings where epidural analgesia is not routinely available. This study primarily compared the change in labour-pain intensity from baseline to one hour after intravenous paracetamol or intramuscular tramadol and secondarily compared labour, maternal safety and neonatal outcomes. This was a prospective, single-blind, randomised controlled trial conducted in the Department of Obstetrics and Gynaecology, Nil Ratan Sircar Medical College and Hospital, Kolkata, India. A total of 11,002 healthy primigravidae aged 18-35 years in spontaneous labour were randomised to receive either intravenous paracetamol 1 g (n = 5,499) or intramuscular tramadol 100 mg (n = 5,503). Pain intensity was assessed using the Visual Analogue Scale before drug administration and at 10 minutes and one hour after administration. Labour duration, mode of delivery, maternal adverse events, and neonatal outcomes were recorded. Analyses were performed using both per-protocol (n = 9,945) and intention-to-treat approaches. Relative risks with 95% confidence intervals were calculated where appropriate. Both intravenous paracetamol and intramuscular tramadol significantly reduced labour pain. Tramadol produced slightly lower Visual Analogue Scale scores at 10 minutes and one hour, indicating marginally greater analgesic efficacy. However, tramadol was associated with higher maternal adverse effects, including nausea (35.3% vs 26.7%), vomiting (23% vs 10%), and decreased respiratory rate (6% vs 3%). Neonatal outcomes were also less favourable in the tramadol group, with higher rates of neonatal intensive care unit admission (12% vs 6%), depressed neonatal respiration (20% vs 7%), and lower Apgar scores (p < 0.0001). Intention-to-treat analysis confirmed the direction and magnitude of these findings, supporting the robustness of the results. Both intravenous paracetamol and intramuscular tramadol reduced labour-pain scores. Tramadol was associated with a small additional short-term reduction in pain, whereas intravenous paracetamol was associated with fewer maternal adverse effects and more favourable reported neonatal outcomes. Intravenous paracetamol may therefore represent a useful and better-tolerated non-opioid alternative where neuraxial analgesia is unavailable or unsuitable. However, the findings should be interpreted cautiously because of the single-centre design, incomplete blinding and post-randomisation exclusions and should not be considered definitive practice-changing evidence.

PMID 42699211
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PubMedFrontiers in veterinary science2026-09-06

Efficacy and safety of a fixed-dose oral tramadol-dipyrone combination for postoperative analgesia in dogs undergoing ovariohysterectomy and unilateral mastectomy: a randomized clinical trial.

Mastrocinque Sandra S, Yazbek Karina Velloso Braga KVB, Rossetti Richard Barrientos RB, Gomes Laura Damião LD et al.

To evaluate the analgesic efficacy and safety of an oral tramadol-dipyrone combination (Sindolor®) compared with tramadol or dipyrone alone in dogs undergoing ovariohysterectomy and unilateral mastectomy. Thirty client-owned female dogs undergoing elective ovariohysterectomy and unilateral mastectomy were randomly assigned to three treatment groups (n = 10/group): tramadol-dipyrone combination (GTD), tramadol alone (GT), or dipyrone alone (GD). At the end of surgery, all dogs received meloxicam and the first intravenous dose of the assigned treatment. Oral treatment began approximately 8 h later and continued every 8 h for 5 days. Postoperative pain was assessed using the Glasgow Composite Measure Pain Scale-Short Form (GCMPS-SF), a dynamic interactive visual analog scale (DIVAS), and serum cortisol concentrations. Rescue analgesia with intravenous morphine was administered when predefined thresholds were reached. Pain scores decreased significantly over time in all groups (p < 0.01). Despite concurrent meloxicam administration, dogs receiving dipyrone alone showed higher GCMPS-SF scores than those treated with the tramadol-dipyrone combination at D + 1 afternoon (p < 0.01). Pain incidence analysis demonstrated a higher proportion of pain-free dogs in the combination group during the early postoperative period. Overall rescue analgesia frequency did not differ significantly among groups; however, after initiation of oral treatment, rescue analgesia was required in two dogs from both GT and GD, whereas no dog in GTD required additional analgesia. Cortisol concentrations remained within the reference range in GTD, whereas transient increases above the reference interval were observed in GT and GD. No clinically relevant adverse effects were observed. The tramadol-dipyrone combination improved early postoperative pain control in dogs undergoing ovariohysterectomy and unilateral mastectomy while maintaining favorable tolerability. These findings support its clinical use as part of a multimodal postoperative analgesic protocol, particularly during the early postoperative period.

PMID 42699351
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