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口服吡罗昔康速溶片与舌下芬太尼治疗骨转移引起的突发性爆发性疼痛的疗效:一项双盲随机研究。

The efficacy of oral piroxicam fast-dissolving tablets versus sublingual fentanyl in incident breakthrough pain due to bone metastases: a double-blinded randomized study.

机构信息

Pain Unit, Anesthesia Department, Faculty of Medicine, Tanta University, 7 Moheb street, Tanta, Egypt.

出版信息

Support Care Cancer. 2019 Jun;27(6):2171-2177. doi: 10.1007/s00520-018-4469-6. Epub 2018 Oct 10.

DOI:10.1007/s00520-018-4469-6
PMID:30306325
Abstract

PURPOSE

Breakthrough pain (BTP) is a transient exacerbation of pain occurring in a patient with chronic, persistent pain. The most common type is incident pain that is mostly related to bone metastases. The oral mucosa is an attractive route for drug delivery. Sublingual fentanyl preparations are a very attractive agent in controlling attacks of BTP due to its rapid absorption through the oral mucosa. Non-steroidal anti-inflammatory drugs (NSAIDs) play a key role as a first step in treatment of cancer pain; piroxicam sublingual formulations could be a useful alternative in controlling incident pain. Our study hypothesis is to evaluate the efficacy of sublingual fentanyl versus oral piroxicam fast-dissolving tablets in patients with incident pain and its impact on functional status.

PATIENTS AND METHODS

A cohort of 100 adults of both genders suffering from bone metastases. Patients were assigned to receive either sublingual fentanyl tablet (group 1) or oral piroxicam fast-dissolving tablets (group 2). The pain intensity reduction on a 0-10 visual analog scale (VAS), frequency of BTP attacks, and onset of pain relief. Secondary end points included the functional interference items of the Brief Pain Inventory (BPI).

RESULTS

There is no significant difference between the two groups regarding the patients' demographics. Significant decline of the VAS in each group in comparison to the pretreatment values (p = 0.001). Non-significant changes of the VAS, duration of pain attacks, and number of rescue doses in comparing both groups were measured. There was significant reduction in group 2 BPI regarding the relation with others, sleep pattern and enjoyment of life parameters at 2 and 4 weeks (p = 0.001).

CONCLUSION

Our study demonstrated that oral piroxicam fast-dissolving tablet is an analgesic alternative to sublingual fentanyl in patients with bone metastasis to control incidental BTP attacks with more favorable cost-benefit values.

摘要

目的

爆发性疼痛(BTP)是一种慢性持续性疼痛患者中出现的短暂性疼痛加剧。最常见的类型是与骨转移相关的突发性疼痛。口腔黏膜是药物输送的一个有吸引力的途径。舌下芬太尼制剂因其通过口腔黏膜的快速吸收而成为控制 BTP 发作的非常有吸引力的药物。非甾体抗炎药(NSAIDs)在治疗癌症疼痛方面起着关键作用,作为第一步治疗;吡罗昔康舌下制剂可能是控制突发性疼痛的一种有用替代药物。我们的研究假设是评估舌下芬太尼与口服吡罗昔康速溶片在突发性疼痛患者中的疗效及其对功能状态的影响。

患者和方法

一组 100 名患有骨转移的成年男女患者。患者被分配接受舌下芬太尼片(第 1 组)或口服吡罗昔康速溶片(第 2 组)治疗。采用 0-10 视觉模拟评分(VAS)评估疼痛强度减轻程度、BTP 发作频率和疼痛缓解起效时间。次要终点包括简明疼痛量表(BPI)的功能干扰项目。

结果

两组患者的人口统计学特征无显著差异。与治疗前相比,两组 VAS 均显著下降(p=0.001)。比较两组后,VAS、疼痛发作持续时间和解救剂量无显著变化。与其他人、睡眠模式和生活享受相关的 BPI 参数在第 2 周和第 4 周时在第 2 组中显著降低(p=0.001)。

结论

我们的研究表明,口服吡罗昔康速溶片是控制骨转移患者突发性 BTP 发作的一种替代舌下芬太尼的镇痛药物,具有更有利的成本效益比。

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