<br>基线疼痛强度对布洛芬/咖啡因对术后急性牙痛患者镇痛效果的影响：随机对照试验的事后亚组分析。,Advances in Therapy

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基线疼痛强度对布洛芬/咖啡因对术后急性牙痛患者镇痛效果的影响：随机对照试验的事后亚组分析。
Advances in Therapy ( IF 3.4 ) Pub Date : 2020-04-24 , DOI: 10.1007/s12325-020-01297-y
Stefanie Förderreuther ₁ , Anette Lampert ₂ , Simon Hitier ₃ , Robert Lange ₄ , Thomas Weiser ₂

Affiliation

简介在一项 III 期随机对照试验中，布洛芬 400 mg 和咖啡因 100 mg 的固定剂量组合 (FDC) 已被证明比单独使用布洛芬 400 mg 更有效治疗术后急性牙痛。对来自主动/安慰剂对照、双盲、单中心、平行组研究的主要数据进行事后亚组分析，研究对象为基线中度或重度疼痛的患者。方法牙科手术后，患有中度或重度疼痛的患者接受单剂量布洛芬 400 mg/咖啡因 100 mg FDC，布洛芬采用 4 点言语评定量表（“无痛”至“重度疼痛”）进行确定。 400 毫克，咖啡因 100 毫克或安慰剂。在给予研究药物后0.25、0.5、0.75、1、1.5、2、3、4、5、6、7和8小时评估疼痛缓解（PAR）和疼痛强度。主要研究终点是 PAR 和疼痛强度差 (PID) 与给药前基线的时间加权总和，对 0 至 8 小时 (SPRID0-8h) 的所有给药后评估时间进行求和。结果基线时有 237 名患者患有中度疼痛，325 名患者患有重度疼痛。在中度和重度疼痛亚组中，与布洛芬、咖啡因和安慰剂相比，FDC 的 SPRID0-8h 显着改善。对于中度疼痛患者，FDC 与布洛芬的调整后平均 SPRID0-8 小时差异为 18.19 (p < 0.0001)，对于重度疼痛患者为 7.70 (p = 0.0409)。除了中度疼痛患者的 7 小时测量外，与布洛芬相比，FDC 在 0.5 至 8 小时的所有测量时间点上的 PID 均得到显着改善。在严重疼痛亚组中，给药后 0.5 至 3 小时内，FDC 与布洛芬相比，PID 得到显着改善，但此后没有显着差异。结论与布洛芬相比，布洛芬/咖啡因 FDC 的镇痛效果增强在基线时中等强度疼痛的患者中最为明显，在基线重度疼痛的患者中也很明显。试验注册 ClinicalTrials.gov 标识符，NCT01929031。非甾体类抗炎药（NSAID）布洛芬通常用于缓解轻度至中度疼痛。研究表明，布洛芬与咖啡因结合可以提高镇痛效果。此前，一项随机、双盲、安慰剂对照研究表明，这种布洛芬/咖啡因组合在缓解牙科手术（拔智齿）后的疼痛方面比单独使用布洛芬更有效。该研究中的患者患有中度或重度疼痛，因此研究人员对研究数据进行了另一项分析，以调查布洛芬/咖啡因组合对中度疼痛患者和重度疼痛患者的疗效如何。研究发现，对于中度疼痛和重度疼痛的患者，单剂量的布洛芬/咖啡因比单独使用布洛芬更有效。布洛芬/咖啡因的镇痛作用在中度疼痛患者中比在重度疼痛患者中更明显。这表明布洛芬/咖啡因对于中度疼痛的患者是有效的止痛药，对于重度疼痛的患者效果较小。

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The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial.

INTRODUCTION A fixed dose combination (FDC) of ibuprofen 400 mg and caffeine 100 mg has been shown to be more effective than ibuprofen 400 mg alone for the treatment of acute postoperative dental pain in a phase III randomised controlled trial. A post hoc subgroup analysis of the primary data from an active-/placebo-controlled, double-blind, single-centre, parallel-group study was conducted in patients with moderate or severe baseline pain. METHODS After dental surgery, patients with moderate or severe pain, which was determined on a 4-point verbal rating scale ('no pain' to 'severe pain'), received a single dose of ibuprofen 400 mg/caffeine 100 mg FDC, ibuprofen 400 mg, caffeine 100 mg or placebo. Pain relief (PAR) and pain intensity were assessed 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7 and 8 h after administration of study medication. The primary study endpoint was the time-weighted sum of PAR and pain intensity difference (PID) from pre-dose baseline, summed for all post-dose assessment times from 0 to 8 h (SPRID0-8h). RESULTS There were 237 patients with moderate pain and 325 with severe pain at baseline. SPRID0-8h was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups. Adjusted mean SPRID0-8h difference for the FDC versus ibuprofen was 18.19 (p < 0.0001) for patients with moderate pain and 7.70 (p = 0.0409) for patients with severe pain. With the exception of the 7-h measurement in patients with moderate pain, PID was significantly improved with the FDC versus ibuprofen at all measured time points from 0.5 to 8 h. In the severe pain subgroup, PID was significantly improved for the FDC versus ibuprofen from 0.5 to 3 h post-dose, but was not significantly different thereafter. CONCLUSION The enhanced analgesic efficacy of ibuprofen/caffeine FDC versus ibuprofen is most pronounced in patients with moderate intensity pain at baseline, and also evident in patients with severe baseline pain. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT01929031. The non-steroidal anti-inflammatory drug (NSAID) ibuprofen is commonly used to relieve mild to moderate pain. Research suggests that combining ibuprofen with caffeine can increase the analgesic efficacy. Previously, a randomised, double-blind, placebo-controlled study showed that this ibuprofen/caffeine combination was significantly more effective than ibuprofen alone for relieving pain after dental surgery (wisdom tooth removal). Patients in that study had moderate or severe pain, so the researchers conducted another analysis of the study data to investigate how well the ibuprofen/caffeine combination worked in patients with moderate pain and in patients with severe pain. The study found that a single dose of ibuprofen/caffeine was significantly more effective than ibuprofen alone in patients with moderate pain and in those with severe pain. The analgesic effects of ibuprofen/caffeine were more marked in patients with moderate pain than in those with severe pain. This indicates that ibuprofen/caffeine is an effective pain reliever for patients with moderate pain, and to a lesser extent in patients with severe pain.

更新日期：2020-04-24

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