复方IV由1000mg对乙酰氨基酚和300mg布洛芬组成，溶液用于IV输液。
2023年10月18日,美国食品药品监督管理局（FDA）已批准Combogesic®IV（在美国以外被称为Maxigesic®IV），这是一种由对乙酰氨基酚和布洛芬静脉注射（IV）制剂，用于治疗术后疼痛。
复方IV由1000mg对乙酰氨基酚和300mg布洛芬组成，溶液用于IV输液。这一批准得到了两项3期研究（ClinicalTrials.gov标识符：NCT02689063和NCT04005755）的数据的支持，这两项研究评估了复方镇痛药IV对成人术后疼痛的影响。
在第一项研究中，276名拇囊切除术后急性术后疼痛的患者被随机分配接受1000mg/300mg复方镇痛药、1000mg对乙酰氨基酚、300mg布洛芬或安慰剂的静脉输注。结果显示，与相同剂量的布洛芬IV或对乙酰氨基酚IV单独使用相比，复方镇痛剂IV起效更快，疼痛缓解更大。与对乙酰氨基酚IV和布洛芬IV相比，联合镇痛IV治疗也与阿片类药物消耗减少有关（P<.005）。
第二项安全性研究包括232名接受普通、整形或整形手术的患者。患者每6小时接受一次1000mg/300mg的复合镇痛剂静脉注射，持续5天（至少48小时）。结果表明，联合治疗是安全的，耐受性良好。
新药申请（NDA）的批准是基于第三阶段项目的积极数据，在该项目中，Maxgesic®IV证明与对乙酰氨基酚IV（对乙酰氨基苯酚IV）、布洛芬IV以及安慰剂相比，它具有良好的耐受性，起效更快，疼痛缓解更高。Maxigestic®IV的卓越镇痛效果也得到了一系列次要终点的支持，包括阿片类药物使用率的降低。
请参阅随附的Combogesic® IV完整处方信息：
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215320s000lbl.pdf
信息来源：https://www.aftpharm.com/zh-hans/product/combogesic-iv-healthcare/
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Combogesic® IV
Paracetamol 1000 mg and ibuprofen 300 mg in 100 mL solution for infusion
A new treatment for postoperative pain management
Combogesic® IV’s patented 3.3 to 1 paracetamol to ibuprofen ratio has been proven to provide significantly better pain relief than the same dose of either paracetamol IV or ibuprofen IV alone.1
Combogesic® IV was developed to provide a combination analgesic therapy with the administration of a single formulation in postoperative patients unable to receive oral analgesics
Effective treatment for
postoperative pain management
New clinical data demonstrates that Combogesic® IV provides significantly more analgesia than comparable doses of paracetamol IV, ibuprofen IV and placebo.
All study medicines were administered to patients intravenously over 15 minutes every 6 hours over a 48-hour period, for a total of 8 doses.
Combogesic® IV provided significantly superior pain relief than comparable doses of ibuprofen or paracetamol, and placebo.
The Combogesic® IV treatment group was found to have:
Significantly reduced odds of requiring opioid analgesia for breakthrough pain than all three comparators.
A longer time to the first dose of breakthrough analgesia than all three comparators.
Significantly lower consumption of oxycodone breakthrough analgesia than all three comparators.
Why is this important?
Immediate-release formulations of prescription opioids have been described as a gateway to addiction.
The potential harm from extended opioid treatments and escalating usage of opioid based treatments has been a strong focus of pain medicine research and forums.
Effective pain solutions are needed that allow for an easy opioid-free IV to tablet switch for pain management in the clinic and at home. |
