A Double-Blind Randomized Clinical Trial Comparing Levodropropizine, Codeine, Ivy Leaf (Hedera Helix Extract), and Placebo for the Treatment of Acute Cough in Adults With Upper Respiratory Tract Infections in Primary Care

Upper respiratory tract infections affect millions globally, with cough being one of the most bothersome symptoms. While various treatments exist, their comparative effectiveness remains unclear. This study aims to evaluate and compare three commonly used treatments for acute cough in adults with upper respiratory tract infections: Levodropropizine, Codeine (with Pseudoephedrine and Chlorphenamine), and Ivy Leaf (Hedera Helix Extract). Investigators will conduct a double-blind, parallel-group randomized clinical trial with 184 adults aged 18-65 with acute upper respiratory tract infection and moderate to severe cough. Participants will be randomized to receive Levodropropizine, Codeine + Pseudoephedrine + Chlorphenamine, Ivy Leaf, or Placebo three times a day for 4 days. The primary outcome is cough severity at 48 hours, measured by a cough numerical rating scale. Secondary outcomes include cough severity and duration at 4- and 10-days. This trial will provide high-quality evidence comparing the efficacy of three widely used antitussive medications in primary care settings. The results could help establish evidence-based guidelines for treating acute cough in upper respiratory infections.

开始日期2025-05-13

申办/合作机构

Pontificia Universidad Católica de Chile

CTRI/2024/12/078427

/ Recruiting临床4期

A Prospective, Single-Arm, Multi-Centric, Open-Label, Post-Market Observational Surveillance (PMOS) Study To Evaluate The Clinico-Epidemiological Profile And Effectiveness Of A Fixed-Dose Combination (FDC) Of Codeine Phosphate 10 Mg And Triprolidine Hcl 1.25 Mg, Per 5 Ml, Oral Syrup For The Symptomatic Management Of Dry Cough In Patients Not Responding To Non-Opioid Based Antitussives - NA

开始日期2025-01-14

申办/合作机构-

CTIS2024-512673-28-00

/ Not yet recruiting临床4期

Double-blind placebo-controlled cross-over MRI study to evaluate the effect of naloxegol and codeine on gastrointestinal motility and volumes

开始日期2024-10-28

申办/合作机构

UZ Leuven

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项与磷酸可待因相关的文献（医药）

2026-03-16·SPECTROSCOPY LETTERS

Ecological and human health risk assessment of pharmaceutical compounds in the Indian river ecosystem

作者: Ruby, Ruby ; Giri, Arup ; Dimple, Dimple ; Jyoti, Jyoti

Pharmaceutical compounds release into aquatic ecosystem has become a critical problem because they can harm aquatic organisms and humans. Humans may have serious effects due to presence of phamaceuticals in drinking water.This study aims to analyze pharmaceutical compound ecol. and human health risk assessments in thirteen Indian River ecosystems. In this study, various pharmaceuticals, such as ciprofloxacin, norfloxacin, aspirin, carbamazepine, caffeine, and ibuprofen, were detected in different river ecosystems across India. This study aims to analyze the concentrations of pharmaceutical compounds, including the risk quotient (RQ), while performing an ecol. risk assessment.For human health risk assessment, metrics such as acceptable daily intake (ADI) and the risk quotient were employed to assess human health (RQH). The health risk models revealed that the Sirsa River posed significant ecol. threats because RQ greater than 1, whereas the other rivers presented moderate risks. Children were found to be more vulnerable to pharmaceutical intake, and all the rivers presented RQH values exceeding 1 for adults, underscoring serious health concerns.This study will help categorize pharmaceutical compounds and analyze the ecol. and human health risks to water systems. This study provides key insights for policymakers and public health efforts to address pharmaceutical pollution in Indian rivers. It also aligns with the UN Sustainable Development Goals, particularly SDGs 6 and 12.

2026-01-20·Cureus Journal of Medical Science

The Clinico-Epidemiological Profile and Effectiveness of Codeine and Triprolidine in Dry Cough Patients Not Responding to Non-Opioid-Based Antitussives: Results From a Prospective, Multicenter, Single-Arm, Open-Label Postmarketing Observational Study

Article

作者: Kumar, Ankit ; Talwar, Deepak ; Santhalingam, Balamurugan ; Mistry, Urvi K ; Rane, Rhutuja ; Deshpande, Swapnil ; Acharya, Shivani ; Singh, Gajendra Vikram ; Kuldeep, Rajveer ; Muley, Sushant ; Jain, Manish K

BACKGROUND:

Dry cough is highly prevalent in clinical practice, and antitussives remain the cornerstone of treatment. Among these, the combination of codeine phosphate and first-generation antihistamine triprolidine hydrochloride (triprolidine HCl) is often preferred in a dry cough unresponsive to non-opioid antitussives. However, there is limited real-world evidence regarding the effectiveness and safety of the fixed-dose combination (FDC) of codeine phosphate and triprolidine HCl in the Indian population.

METHODS:

This prospective, multicenter, single-arm, open-label, post-marketing observational study evaluated the clinico-epidemiological profile of Indian patients with dry cough unresponsive to non-opioid antitussives, prescribed FDC codeine phosphate 10 mg + triprolidine HCl 1.25 mg per 5 mL oral syrup, 10 mL thrice daily for seven days. The study also assessed effectiveness, quality of life (QoL), safety, and tolerability of the FDC.

RESULTS:

A total of 250 patients (male:female, 129:121; mean±SD age, 40.8 ± 14.0 years) were observed. Most were graduates (107 (42.8%)), with homemakers comprising the largest occupational group (98 (39.2%)). Acute cough was observed in 137 (54.8%) of patients, with upper respiratory tract infection (URTI) as the leading etiology in 188 (75.2%) of patients. From baseline to end of study, mean±SD cough severity decreased by 3.8±1.8, frequency by 2.4±1.2, and nighttime awakening by 3.5±1.8 points (p<0.001), while QoL scores improved by 33.5±19.9 points (p<0.001). Additionally, subgroup analyses also showed significant improvements across etiologies. Treatment was well tolerated, with 15 patients reporting 17 adverse drug reactions (ADRs; mostly constipation and sedation). All ADRs were mild and non-serious in nature and did not lead to treatment discontinuation.

CONCLUSION:

In this observational study of 250 adults with dry cough, balanced by gender and predominantly middle-aged with a mean age 40.8 years, the FDC of codeine phosphate 10 mg and triprolidine HCl 1.25 mg per 5 mL oral syrup, prescribed as 10 mL thrice daily for seven days, significantly reduced cough severity, frequency, and nighttime awakenings, improving the QoL. Importantly, these results support the role of this FDC in the management of dry cough, especially when non-opioid antitussives are ineffective, a key differentiator of this study. Benefits were consistent across different etiologies of dry cough, with only mild, non-serious adverse events.

2025-11-01·INTERNATIONAL JOURNAL OF ORAL AND MAXILLOFACIAL SURGERY

Effect of paracetamol–codeine compared to placebo on surgical discomfort and post-traumatic stress disorder symptoms following mandibular third molar removal: a prospective randomized clinical trial

Article

作者: Bortoluzzi, M C ; Ruppel, C ; Pereira, V L ; Cardoso, R B ; Dos Santos, F A

This study investigated the impact of a single, pre-emptive 500 mg paracetamol plus 7.5 mg codeine phosphate dose on surgical discomfort, anxiety, post-traumatic stress disorder (PTSD) symptoms, and pain during mandibular third molar extraction. Patients were randomized to receive either the drug combination or a placebo.Preoperative anxiety was assessed using the State-Trait Anxiety Inventory (STAI), Dental Anxiety Scale (DAS), and anxiety visual analogue scale (Anxiety-VAS). Post-surgery, discomfort was measured with the Self-Perception Questionnaire of Dentoalveolar Oral Surgery (QCirDental), while pain and anxiety were assessed using VAS scales. Patients also maintained a postoperative pain diary. On day 7, the Impact of Event Scale-Revised (IES-R) evaluated surgery-related PTSD symptoms.Sixty patients completed the study (30 per group), with similar demographics and surgical characteristics. Results indicated no significant difference in anxiety (STAI, DAS, Anxiety-VAS) between groups. The pre-emptive medication was similarly effective to placebo for managing anxiety, intraoperative discomfort, and postoperative pain.A stressful surgical event was observed in 13.3% of patients, leading to clinical concern or probable oral surgery-related PTSD. However, the paracetamol-codeine group did not show improved overall IES-R scores. Ultimately, a single pre-emptive dose of 500 mg paracetamol plus 7.5 mg codeine phosphate offered no additional benefits in mandibular third molar surgery.

项与磷酸可待因相关的新闻（医药）

17 小时之前

·PRNewswire

Opioid Prescribing for Children's Coughs Falls to Just 4 in 10,000 Visits, New Analysis Finds

Motive Medical Intelligence study of more than 100 million U.S. insurance claims finds once-common use of codeine and hydrocodone for pediatric coughs has nearly disappeared SAN FRANCISCO, Aug. 26, 2026 /PRNewswire/ -- The once-common practice of prescribing opioid cough syrup for children has become exceedingly rare in the U.S., according to a new analysis of more than 100 million insurance claims conducted by Motive Medical Intelligence (Motive) using its Practicing Wisely clinical analytics system. The analysis found that between October 2022 and September 2024, just four out of every 10,000 office visits for children with coughs or respiratory infections resulted in a prescription for opioid cough syrup. Continue Reading This heat map visualizes a recent Motive Medical Intelligence study using its Practicing Wisely clinician-level analytics platform to assess opioid prescribing for children's coughs. The all-green map tells a good-news story: opioid cough syrup for kids has all but disappeared, with just 4 prescriptions per 10,000 pediatric visits nationwide. Nevada and Vermont hit true zero; Wyoming registered the highest rate of 1%, still not statistically different from the national rate. The findings mark a dramatic shift in a prescribing practice that persisted for generations despite a lack of evidence that opioid cough medicines are effective in children, as well as mounting evidence of potentially serious harm. "This is welcome news," said Dr. Rich Klasco, Chief Medical Officer at Motive. "For decades, opioid cough medicines were prescribed to children despite limited evidence of benefit and very real safety concerns. These data show how dramatically clinical practice can change when physicians, medical societies, and regulators align around the evidence." From routine treatment to rarely prescribed Opioids have a long history as cough suppressants. Bayer introduced heroin as a cough medicine in 1898, and opioid cough syrups later became widely prescribed for children, typically containing codeine or hydrocodone — the same opioid ingredients found in drugs such as Vicodin®, Norco®, and Lortab®. Over time, doctors came to regard these syrups as the cure for stubborn coughs, often prescribing them in response to parental requests for "something stronger." By the 1990s, more than 1 million children annually were being prescribed codeine in the U.S. Yet codeine and hydrocodone were never proven effective for treating children's coughs in randomized controlled trials. More importantly, they have been shown to cause respiratory depression and death in children. Concerns began to emerge in 2011 with a World Health Organization report. In 2015, the Food and Drug Administration began issuing warnings, and in 2016, the American Academy of Pediatrics (AAP) responded with its report, "Codeine: Time to Say 'No.'" The AAP reviewed 50 years of FDA safety data and found 24 codeine-related deaths and 64 cases of severe breathing problems in children — most of them under 12 years of age. Prescribing subsequently declined sharply. A University of Michigan study found that between 2014 and 2019, pediatric prescriptions for codeine and hydrocodone cough syrups fell 90.1% and 75.7%, respectively. New data shows ongoing progress Motive's latest analysis suggests that progress has continued well beyond 2019. Across more than 100 million insurance claims analyzed from October 2022 through September 2024, prescriptions for codeine or hydrocodone were associated with only 0.04% of pediatric office visits for coughs or respiratory infections — equivalent to four prescriptions for every 10,000 visits. The analysis also found encouraging results across states. Nevada and Vermont achieved the ultimate goal: no doctors prescribed these opioids to children for coughs. Rhode Island, Maine, New Jersey, and Massachusetts also had near-zero rates. Even Wyoming, which recorded the highest rate in Motive's analysis, was not statistically different from the national rate. "The important story here isn't just that prescribing declined," Klasco said. "It's that a deeply entrenched clinical practice can change when the evidence becomes clear, and the healthcare community acts on it." Study Methodology The study was conducted using Motive's Practicing Wisely data analytics system, which measures individual clinician performance across appropriateness of care, quality, and waste. By mapping closed-claims data to evidence-based standards of care, Motive's expert team can measure individual clinician decisions at the point of care, share actionable insights back to the clinician, and help improve clinical performance to drive positive change across the U.S. health system. Practicing Wisely delivers unique insights into how individual clinicians perform against evidence-based standards, benchmarked against their peers, enabling health plans and systems to more accurately assess risk, reduce waste, move toward quality care, and drive high-value outcomes at scale. In the case of this good-news study, the results were positive with no follow-up or clinical change required. About Motive Medical Intelligence Motive Medical Intelligence is redefining healthcare performance analytics with an emphasis on transparency, physician trust, and real-world actionability. Motive is the partner of choice for organizations committed to eliminating low-value care and thriving in value-based care models. Through its proprietary Practicing Wisely solution, Motive is helping the industry eliminate the $400 billion in annual waste in the U.S. health system, advance the transition to high-value, patient-centered care, and achieve the quadruple aim. Learn more here. Media: Supreme Communications for Motive Medical Intelligence, [email protected] SOURCE Motive Medical Intelligence 21% more press release views with Request a Demo

临床结果

2026-08-13

·今日头条

有这些特点、因素信号，要担心乳腺癌骨转移! 怎么治疗和康复？

乳腺癌骨转移是晚期乳腺癌患者严重的并发症之一。骨转移后出现的严重骨痛、病理性骨折等并发症，严重影响患者的生活质量并缩短其生存期。这篇文章就对骨转移进行科普，帮助大家增进了解。我们知道乳腺癌治疗后，很多病友最怕的是：明明已经做完全部治疗了，为什么还是有人会复发转移？自己到底属于高风险还是低风险？平时该重点管什么？一、乳腺癌骨转移的特点肿瘤骨转移是指某些原发于骨组织以外的恶性肿瘤经血行转移（少部分经淋巴转移）至骨组织，定植后逐渐形成新的肿瘤病灶，破坏正常骨组织，引起以疼痛、高钙血症、病理性骨折、神经压迫为主要表现的疾病。乳腺癌骨转移是晚期乳腺癌常见的并发症之一，65%～75%的患者会发生骨转移，特别是激素受体阳性的乳腺癌患者。据统计，脊柱是最容易发生转移的部位，尤其是胸椎；其次是骨盆、四肢长骨、肋骨等。伴有疼痛的骨转移严重影响患者生活质量，但骨转移本身一般不直接对生命构成威胁；有效的治疗手段较多，不合并内脏转移的患者生存期相对较长。二、骨转移的危险因素 1.分子分型：骨转移更常见于Luminal A亚型和Luminal B亚型，因为雌激素受体（ER）阳性是骨转移的危险因素。ER阳性患者术后发生骨转移的风险可达 ER 阴性患者的 5.2 倍。ER阳性且HER-2过表达患者较单纯ER阳性或Her-2过表达患者的骨转移发生率更高，具体机制尚未阐明。 2.组织病理学：肿瘤原发病灶直径>2 cm即肿瘤负荷大、组织学分级高、浸润性癌、淋巴结受累以及分期较晚是发生骨转移的独立危险因素。此外，双侧乳腺癌患者发生骨转移概率明显高于单侧乳腺癌。 3.患者年龄和绝经状态：研究证明，年龄≤40岁的女性更易发生骨转移，而年龄较大或可理解为低雌激素水平对骨转移具有一定的保护作用。但在三阴性乳腺癌中，年龄>49岁的绝经后患者也被证明为骨转移易患因素。三、骨转移的信号 1.出现骨头的酸疼和不明疼痛 2.在临床检查过程中发现有碱性磷酸酶、高钙血症等指标的升高。 3.复查过程中，全身性或局部性的骨影像学检查发现异常有病友问：碱性磷酸酶升高就是骨转移吗？不一定。血清碱性磷酸酶主要来源于肝脏和骨骼，但其他来源也可影响血清碱性磷酸酶水平。碱性磷酸酶升高可能跟很多因素有关，不能仅凭碱性磷酸酶指标高就判断一定是骨转移引起的。骨转移患者碱性磷酸酶水平可以为正常，也可以是增高。因此，想要明确骨转移是否存在，需要结合骨扫描、核磁共振、CT等检查进行综合判断，而不能单纯依靠碱性磷酸酶的水平进行诊断。是否出现骨转移，还需要做相关影像学检查如骨扫描，综合更多的资料来判断。四、骨转移的临床表现乳腺癌骨转移多为多发性溶骨性病变，有些患者在溶骨病变治疗后的修复可以在影像学中表现为过度钙化而被误诊为成骨性改变，对这部分患者应追溯其首诊时的X线摄片是否有溶骨性改变。五、骨转移的症状骨转移瘤的主要症状为逐渐加重的局部疼痛，晚期可有病理性骨折，脊髓和神经压迫，甚至出现高钙血症。早期一般无任何症状，骨同位素扫描可发现有病变的骨骼。骨转移症状与肿瘤转移的部位、数量有关。如肋骨转移引起的胸痛，多表现为胸壁部位局限的、有明确压痛点的疼痛。脊柱转移引起后背部正中或病变部位疼痛，而四肢或躯干的骨转移引起该部位的局限性疼痛。如肿瘤转移到身体承重骨如颈椎、胸椎、腰椎等部位则可能造成瘫痪的严重后果。六、骨转移的诊断方法 1.ECT ECT是骨转移初筛手段，具有敏感度高、早期发现异常骨代谢灶、全身成像等优点。但也存在特异性较低、不能提示病变为成骨性或溶骨性病变、不能显示骨破坏程度的缺点。 ECT推荐用于乳腺癌出现骨痛、发生病理骨折、碱性磷酸酶升高或高钙血症等可疑骨转移的常规初筛诊断检查，也可用于局部晚期乳腺癌（T3N1M0以上）和复发转移乳腺癌患者的常规检查。 2.CT/X线/MRI X线平片是骨转移诊断的基本方法，具有直观、诊断特异性高的优点，但也存在灵敏度低的缺点。骨CT扫描是诊断骨转移最重要的影像学方法，对于骨皮质破坏的诊断更为灵敏，灵敏度和特异性均高，可以区分溶骨或成骨改变。 MRI扫描诊断骨转移灵敏度高，提示病变侵袭范围准确，但特异性低于CT。脊柱MRI检查对了解骨髓是否受压、脊柱稳定性、骨转移的手术和放疗适应证很重要。 3.PET-CT 专家组认为目前PET-CT在骨转移诊断的价值有待进一步研究，临床并不作为常规推荐。 4.骨活检骨活检是乳腺癌骨转移的金标准。针对临床可疑骨转移灶，尤其对于不含软组织转移或内脏转移的单发骨病灶，或临床病情判断不确定的骨病变，应考虑进行骨穿刺活检，以明确病理诊断。七、骨转移的治疗乳腺癌骨转移综合治疗的主要目标：①缓解疼痛，恢复功能，改善生活质量；②预防和治疗SRE；③控制肿瘤进展，延长患者生存期。 1.全身治疗（1）抗肿瘤治疗：以多学科参与的综合治疗，化疗、内分泌治疗和分子靶向治疗是发挥全身抗肿瘤作用的重要手段，对骨转移患者的预后起着关键作用。内分泌治疗是激素受体阳性患者的重要治疗方案，HER-2阳性患者应强调抗HER-2治疗，化疗仍是三阴乳腺癌患者的主要选择。（2）骨改良药物：骨改良药物是预防和延缓骨相关事件的标准治疗。主要有双膦酸盐类药物和地诺单抗。目前以唑来膦酸为代表的第三代双膦酸盐在临床应用较为广泛。欧洲专家组共识指南建议对于低雌激素水平、有中高度复发风险的早期乳腺癌患者，可早期应用双膦酸盐以预防肿瘤转移。目前有明确证据支持：地诺单抗可预防骨相关事件、治疗高钙血症并减轻骨转移引起的骨痛。但目前的研究数据尚不支持地诺单抗能改善乳腺癌患者的预后（在第5点详述两个药）。（3）镇痛治疗：镇痛治疗是缓解乳腺癌骨转移疼痛的主要方法。骨转移的镇痛治疗应遵循WHO癌症三阶段止痛指导原则，首选口服及无创给药途径、按阶段给药、按时给药、个体化给药。镇痛药物治疗包括非甾体类抗炎药(NSAID)、阿片类药物和辅助用药。常用非甾体类抗炎药包括：乙酰氨基酚、布洛芬、双氯芬酸钠、吲哚美辛、塞来昔布。常用阿片类止痛药包括：吗啡缓释片、芬太尼透皮剂、羟考酮控释片、可待因、美沙酮等。WHO癌症“三阶梯”止痛原则：对于轻度疼痛患者，采用NSAID±辅助用药；对于中度疼痛患者，采用弱阿片类±辅助用药；对于中度疼痛患者，采用强阿片。类±NSAID±辅助用药。（4）免疫治疗：在过去的10年中，免疫治疗［尤其是抗程序性死亡［蛋白］1（PD-1）或抗程序性死亡［蛋白］配体-1（PD-L1）疗法］在黑色素瘤、肺癌、乳腺癌、肾细胞癌和头颈部肿瘤等癌症治疗中取得了突破性的进展，但在骨转移领域，却鲜有临床报道。动物实验研究表明，PD-1免疫疗法能够抑制破骨细胞的生成，从而在预防骨破坏和减轻骨癌疼痛方面产生长期益处。此外，目前有多种免疫细胞被认为是治疗癌症转移的靶标，例如，DC由于其专业的抗原提呈能力而能够有效地预防和治疗转移；靶向肿瘤相关巨噬细胞（TAM）释放的CC族趋化因子配体18（CCL18），能够有效地抑制乳腺癌转移。此外，抑制MDSC的功能活性或去除Treg均能有效地减少肿瘤负荷和癌症转移的风险。尽管免疫治疗在肿瘤转移方面取得了非常显著的进展，但骨转移本身是一种独特的疾病，因而仍需要进一步研究。（5）针对破骨细胞的治疗： ①双膦酸盐：有研究表明，双膦酸盐能够有效地治疗骨破坏，预防或延缓SRE的发生。此外，Sun等研究表明，包裹唑来膦酸的纳米金颗粒联合光热疗法（PTT）能够有效地抑制癌细胞的生长并诱导其凋亡进而改善骨骼微环境，缓解骨痛。这种利用纳米颗粒递送唑来膦酸并结合PTT的疗法，为治疗乳腺癌骨转移提供了新的策略。 ②地诺单抗：地诺单抗是靶向RANKL的特异性单克隆抗体，能够有效地抑制破骨细胞介导的骨吸收，并在2010年被批准用于实体瘤引起的SRE（骨相关事件）。然而，在早期乳腺癌中，由于两项大队列、安慰剂对照研究相互矛盾的数据，地诺单抗是否能降低骨转移的风险目前尚未确定。在ABCSG-18研究中，使用地诺单抗（60mg/6个月）联合芳香化酶抑制剂治疗绝经后激素受体阳性的早期乳腺癌患者后，其5年及8年无疾病进展生存率（PFS）明显高于安慰剂联合内分泌治疗。相比之下，D-CARE试验的结果表明，无论绝经与激素受体状态如何，高剂量地诺单抗（每3~4周120mg）并没有改善乳腺癌早期患者的预后，相反，其颌骨骨坏死的发生率明显高于安慰剂。但由于这两项研究在患者特征、设计和地诺单抗给药方面存在根本差异，因而地诺单抗是否能降低骨转移风险仍需进一步验证。 PS：地诺单抗和地舒单抗属于同一种药物，仅名字不同 2.局部治疗 ①手术治疗：骨转移患者手术治疗的主要目的是缓解骨相关事件引起的疼痛和尽可能恢复肢体功能，但是否手术及手术的方式主要取决于患者的临床状态、预期寿命和转移部位。手术方式包括单纯内固定术、病灶清除+内固定术、病灶切除+人工关节置换术、脊髓受压后的减压，及脊柱稳定性的重建术。 ②放射治疗：放射治疗能有效地缓解骨转移引起的疼痛，减少病理性骨折的发生及肿瘤对脊髓的压迫。与骨改良药物和针对分子分型的抗肿瘤药物联合，可有效提高治疗有效性。治疗方式包括外照射、立体定向放疗和放射性核素治疗。体外照射放疗广泛用于预期寿命较短或因骨痛恶化需要再次放疗的患者。联合骨靶向治疗有利于肿瘤的控制，能够防止骨折的发生。立体定向放射治疗作为一种更加精准的放疗方式，对骨转移病灶局部控制率更高，降低骨复发风险，症状缓解期也相对延长，但是治疗后患者病理性骨折发生率略高。放射性核素治疗又称“内放射”，主要缓解广泛性骨转移病灶引起的疼痛，但选用此方法时应注意治疗后较容易发生骨髓抑制。镭-223可用于内放射治疗，由于其高能、短程的辐射，因而能够在对局部肿瘤产生强效的细胞毒效应的同时限制对周围正常组织的损伤，2013年被美国食品药品管理局（FDA）批准用于前列腺癌骨转移的治疗。另外，还有一些新靶点的药物研发和先进技术，也可能对骨转移患者的预后产生积极作用，但是目前还在试验中，这里就不详述。八、骨质疏松与骨转移存在关联乳腺癌骨转移以溶骨性损伤为主，已经有研究表明乳腺癌细胞可以抑制成骨细胞活性，同时导致破骨细胞活性增加。骨质疏松的机制恰恰也是破骨活动大于成骨活动。 2008 年，Grady 等对10101名绝经后妇女使用雌激素受体调节剂雷洛昔芬( 可治疗骨质疏松) ，结果发现其减少浸润性乳腺癌骨转移的发病率。徐海斌等于 2007 年曾分析了采用综合治疗方法治疗乳腺癌骨转移的情况，其中讨论了用于治疗骨质疏松的二磷酸盐对乳腺癌骨转移的作用。二磷酸盐是一种破骨细胞抑制剂，能通过多种方式降低破骨细胞数量和活动，抑制骨吸收，从而控制骨痛。其对骨转移疼痛的缓解率达 76% ～ 100% ，对乳腺癌骨转移有效率达 90%。由此可知，骨质疏松和乳腺癌骨转移之间存在着密切联系，预防骨质疏松可能对乳腺癌骨转移的治疗有一定的帮助，甚至可能会延缓乳腺癌骨转移的发生九、如何预防骨转移？ 1.自我观察与防护骨转移早期症状可能只有疼痛，而且往往症状较轻，容易被忽视，很多老年人可能会认为，这个年龄，出现腰腿痛很正常，但骨转移的疼痛有它自己的特点，往往没有过量活动，不良姿势等诱因，疼痛持续天数更久，夜间入睡期间反而更痛，如果有这些特点，患者要警觉并及时就诊。即便没有出现骨转移相关症状，也建议治疗开始的5年内每年做骨扫描筛查，以便能早期发现，早期治疗。 2.药物预防 ESMO骨健康指南推荐绝经后或绝经前接受OFS治疗的早期乳腺癌患者使用双膦酸盐（如静脉注射唑来膦酸），治疗应与新辅助或辅助治疗同时开始，持续2~5年（IA级推荐）。不推荐地舒单抗用于辅助治疗预防乳腺癌骨转移（IA级推荐）。 NCCN指南认为，骨改良药物具有预防和治疗骨转移的作用。一项纳入7项临床研究的meta分析发现，双膦酸盐可为处于低雌激素水平的早期乳腺癌患者带来显著获益。《中国抗癌协会乳腺癌诊治指南与规范（2021版）》认为，双膦酸盐类药物可能有预防骨转移的作用，并可能有潜在的预防内脏转移的作用，目前双膦酸盐预防骨转移的临床研究仍在进行中。干预时机及用法用量现有证据表明，对于绝经状态（自然绝经或手术/药物去势）的早期乳腺癌患者，推荐双膦酸盐的使用。首先推荐唑来膦酸4mg，静脉注射大于15min，每3~6个月1次，持续2~5年。若防治骨丢失与预防骨转移用药有冲突，以用药频率高的用药方式为准。现有证据证明该用药方式是安全的，药物性颌骨坏死发生率较低且可以预防，采用合理的预防措施，可降低药物性颌骨坏死的风险。十、骨转移的影响预后的因素？ 1.是否合并内脏转移：是否存在内脏转移是影响骨转移患者预后的重要因素，合并内脏转移的骨转移患者生存率明显下降。 2.骨相关事件：发生骨相关事件的患者预后更差，死亡风险显著增加。因此，延缓和治疗骨相关事件对改善乳腺癌患者预后有重要意义。 3.转移部位：脊柱是乳腺癌骨转移的最常见部位。因为椎体转移的并发症如脊髓压迫对患者影响更大，与其他部位相比，椎体转移的患者预后更差，5年生存率可降低25%。其他转移部位如肋骨、骨盆、肩胛骨、颅骨、肱骨和肢端骨等预后相对较好。 4.转移数目：多发骨转移较单发骨转移预后更差。 5.其他：研究发现，年龄>40岁、高肿瘤负荷、原发病灶分期晚的骨转移患者死亡风险更高。淋巴结转移数<10个、术后无病生存期>3年是激素受体阳性乳腺癌单纯骨转移的预后良好因素。十一、骨转移术后如何康复？总体原则是：在良好的镇痛下，尽早开始康复锻炼。早期应避免负重，以恢复肌肉和关节活动为主。后期可在保护下做轻微负重，循序渐进。对于术前合并严重神经功能损伤的脊柱转移患者，可能需要更久更复杂的康复过程。十二、最后的提醒 1.每一个病友都应该去想一下自己为什么生这个病，从源头上去解决问题，这是预防复发转移的非常重要的事情。源头不解决好，只处理不得不处理的结果，那么复发的风险是下不来的，骨转移还好，但是要是内脏转移，就麻烦了。所以每个病友都要尽可能的去去除自己发病的原因。在原因的探索和排查上，可以借助专业人员的力量。 2.骨转移是可以运动的，只是要在专业人员的指导下进行，如果骨转移以后就不运动了，评估后，可以运动，但是因为害怕出问题，就不运动了，这样反而对于康复不利。免责声明：本文仅供读者参考，不构成医疗诊断或治疗建议，如需医疗正式建议，请找自己信任的医生规范就诊。文章配图来源于网络，如有侵权，请联系删除。

2026-08-11

·BioSpace

Intelligent Bio Solutions Announces Completion of Method Comparison Study for the Intelligent Fingerprinting Drug Screening System

All clinical data collection across the Company's FDA 510(k) clinical study program is complete; FDA submission on track for second half of 2026 NEW YORK, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the completion of its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, one of several studies underpinning the Company's FDA 510(k) submission for U.S. market clearance for detection of the opiate codeine. All clinical data collection across the Company's FDA 510(k) clinical study program is now complete. Following ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines, the study was conducted across three independent U.S. clinical sites over three weeks in partnership with CenExel Clinical Research, Inc. A total of 135 participants were enrolled, with the study population structured to represent the demographic diversity of the U.S. population. The screening process was administered by nine operator participants representing typical workplace drug screening personnel. Data analysis is currently underway, with all specimens to be independently verified via liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis. The Method Comparison Study was designed to show that typical users in occupational health, HR, and workplace safety can operate the Intelligent Fingerprinting Drug Screening System accurately and effectively in the field. The study evaluated this by measuring sensitivity, specificity, and accuracy in pre-employment and workplace screening environments, making it one of the most operationally relevant components of the Company's FDA 510(k) submission. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); "Completing this final study on schedule is the milestone the entire program has been building toward. It amounts to a substantial body of work and clinical evidence," said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. "We are now firmly in the final stretch of data analysis and assembly of our FDA 510(k) submission package, and we remain focused on bringing our technology to the U.S. market." The completion of data collection in this final study concludes a structured, multi-study clinical program designed to address safety, accuracy, usability, specificity, and precision requirements. The Company now moves into analysis, compilation, and finalization of its 510(k) submission package, targeting submission in the second half of 2026, ahead of planned entry into the multi-billion-dollar U.S. market. About Intelligent Bio Solutions Inc. Intelligent Bio Solutions Inc. (Nasdaq: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners. For more information, visit:  Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and collaborations, secure regulatory clearance or approvals, and timelines to enter the U.S. market, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results may differ materially from those expressed or implied by such statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” and “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those described in Intelligent Bio Solutions’ public filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Company Contact Intelligent Bio Solutions Inc.  info@ibs.inc Investor & Media Contact Valter Pinto, Managing Director  KCSA Strategic Communications  PH: (212) 896-1254  INBS@kcsa.com

临床研究

100 项与磷酸可待因相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	磷酸可待因	R05DA04	DB00318

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
急性疼痛	英国	Wockhardt UK Ltd.	1981-05-20
腹泻	英国	Wockhardt UK Ltd.	1981-05-20
麻醉	中国	宜昌人福药业有限责任公司	1981-01-01
咳嗽	中国	宜昌人福药业有限责任公司	1981-01-01
疼痛	中国	宜昌人福药业有限责任公司	1981-01-01

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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


ATS2026	N/A	特发性肺纤维化	46,749	Guaifenesin	糧願糧選顧積繭糧廠築(網鬱遞窪網廠艱醖觸憲): OR = 1.203 (95.0% CI, 1.051 ~ 1.377) 更多	积极	2026-05-15
				Benzonatate
NCT03173456 (CTgov)	临床2期	肌肉骨骼疼痛 \| 急性疼痛	600	400 ibuprofen/APAP (400 Ibuprofen/APAP)	簾餘構襯壓夢膚廠鏇繭(鑰鬱艱廠襯繭醖窪醖夢) = 夢鹹餘膚憲鏇膚範艱鬱壓淵衊範壓鏇餘簾鬱網 (遞醖鏇顧網鑰廠鹽襯積, 範願繭選淵鏇鹽餘遞積 ~ 範醖製齋簾鏇鹹糧襯襯) 更多	-	2022-02-01
				800 ibuprofen/APAP (800 Ibuprofen/APAP)	簾餘構襯壓夢膚廠鏇繭(鑰鬱艱廠襯繭醖窪醖夢) = 膚網簾鬱觸餘廠窪衊襯壓淵衊範壓鏇餘簾鬱網 (遞醖鏇顧網鑰廠鹽襯積, 醖膚製顧築壓餘繭餘糧 ~ 膚獵網廠淵醖淵範艱獵) 更多
NCT03173456 (Pubmed \| Ann Emerg Med)	临床2期	肌肉骨骼疼痛	600	400 mg ibuprofen/1,000 mg acetaminophen	糧醖積艱願壓範願鏇醖(鏇壓觸蓋窪顧廠築鹽蓋) = 膚夢遞襯製製廠遞齋襯窪衊糧齋觸齋鏇襯獵鹹 (鹹憲壓繭鏇觸壓鬱襯願, 2.6 ~ 3.5)	不佳	2021-03-01
				800 mg ibuprofen/1,000 mg acetaminophen	糧醖積艱願壓範願鏇醖(鏇壓觸蓋窪顧廠築鹽蓋) = 積積糧鬱糧壓壓齋顧繭窪衊糧齋觸齋鏇襯獵鹹 (鹹憲壓繭鏇觸壓鬱襯願, 2.5 ~ 3.5)
NCT04066426 (CTgov)	临床4期	软组织风湿病 \| 肌筋膜疼痛综合征	200	naproxen sodium+paracetamol+dexamethasone+codeine phosphate (Naproxen Sodium+Codeine Phosphate)	醖鏇艱選衊選遞築遞獵(艱憲淵蓋膚齋糧醖齋餘) = 網願鹽蓋鏇鑰獵願製網蓋構願糧鏇鬱淵繭齋簾 (餘繭艱憲蓋廠醖遞憲網, 1.86) 更多	-	2021-02-15
				naproxen sodium+paracetamol+dexamethasone+codeine phosphate (Naproxen Sodium+Dexamethasone)	醖鏇艱選衊選遞築遞獵(艱憲淵蓋膚齋糧醖齋餘) = 製鹹鹽淵醖齋醖顧醖獵蓋構願糧鏇鬱淵繭齋簾 (餘繭艱憲蓋廠醖遞憲網, 1.76) 更多
NCT03080493 (GABA, CTgov)	临床4期	疼痛 \| 先兆流产	121	acetaminophen+ibuprofen+codeine+Gabapentin 600mg (Gabapentin)	鬱夢淵淵製壓鑰壓襯觸(願鏇鹹醖製獵淵蓋膚襯) = 繭衊夢鹽遞餘範糧齋窪願積淵艱壓蓋衊壓夢繭 (網醖鹽網衊選膚遞衊夢, 網餘齋遞願遞蓋衊鑰築 ~ 淵廠夢願簾築願積鏇製) 更多	-	2020-04-14
				Placebo oral capsule+acetaminophen+ibuprofen+codeine (Placebo Oral Capsule)	鬱夢淵淵製壓鑰壓襯觸(願鏇鹹醖製獵淵蓋膚襯) = 壓築醖鹽選憲構憲獵艱願積淵艱壓蓋衊壓夢繭 (網醖鹽網衊選膚遞衊夢, 網鹹艱獵艱選醖襯鬱範 ~ 鏇窪積鬱糧襯簾選襯鹹) 更多
NCT02295280 (MAD, CTgov)	N/A	头痛	70	Metoclopramide+Diphenhydramine (Metoclopramide IV & Diphenhydramine IV)	鹹鑰鹹積醖壓鏇網繭獵 = 衊壓繭醖獵願艱膚糧簾夢衊範夢網齋夢顧醖構 (襯鬱築鬱鏇選鹹觸製壓, 網廠鏇獵鑰選淵構艱憲 ~ 鬱齋醖醖鏇淵窪糧鏇齋)	-	2018-04-02
				Codeine (Codeine)	鹹鑰鹹積醖壓鏇網繭獵 = 鹽膚網觸夢醖壓蓋製襯夢衊範夢網齋夢顧醖構 (襯鬱築鬱鏇選鹹觸製壓, 鬱壓廠築艱艱膚衊積範 ~ 構廠壓遞膚構鑰簾夢醖) 更多
NCT01267136 (CTgov)	临床4期	疼痛 \| 扁桃体炎	84	acetaminophen+Codeine (Capital® With Codeine Suspension)	顧製構壓膚鏇獵廠鑰遞(醖齋衊鬱糧製糧顧窪醖) = 窪簾膚衊衊網壓簾鬱夢憲鹹壓選壓窪襯觸餘鏇 (壓鹹艱鑰鑰淵膚壓鬱製, 蓋築鹹繭簾窪選願範壓 ~ 廠鏇齋構壓鬱積齋壓製) 更多	-	2014-04-17
				Tramadol suspension (Tramadol Suspension)	顧製構壓膚鏇獵廠鑰遞(醖齋衊鬱糧製糧顧窪醖) = 鑰遞顧夢蓋淵積網網淵憲鹹壓選壓窪襯觸餘鏇 (壓鹹艱鑰鑰淵膚壓鬱製, 願齋願廠蓋衊範窪顧鏇 ~ 遞憲醖鑰網齋衊鹽壓蓋) 更多
NCT01055704 (CTgov)	临床4期	胃肠动力障碍	48	Placebo + placebo	憲窪觸繭襯積獵顧觸膚(獵鬱鏇襯襯積獵繭衊鏇) = 積餘壓鬱網餘製願觸鏇觸鹽壓壓觸繭願鑰齋憲 (襯膚遞鹽糧選願艱範鑰, 0.4) 更多	-	2011-08-08
ASCO2006	N/A	肿瘤	150	Codeine	憲淵鹽願選願襯選積糧(壓鬱選齋顧獵積顧餘壓) = 簾鑰鏇選鬱蓋顧艱鑰簾鹽憲簾鹹夢齋糧夢範簾 (壓網鹹構鹽鹽願築範壓 ) 更多	积极	2006-06-20