氟吡汀与吡罗昔康用于下肢手术患者术后疼痛的疗效和安全性比较研究。

A comparative study of efficacy and safety of flupirtine versus piroxicam in postoperative pain in patients undergoing lower limb surgery.

作者信息

Chinnaiyan Sowmya, Sarala Narayana, Arun Heddur Shanthappa

机构信息

Department of Pharmacology.

Department of Orthopaedics, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India.

出版信息

J Pain Res. 2017 Oct 16;10:2471-2477. doi: 10.2147/JPR.S144647. eCollection 2017.

DOI:10.2147/JPR.S144647

PMID:29081669

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5652919/

Abstract

BACKGROUND

Effective control of pain postoperatively is essential in providing enhanced patient care and a cost-effective hospital stay. Though many treatment modalities exist for postoperative pain management in orthopedic surgeries they are often accompanied by adverse effects. This study was carried out to assess the efficacy of flupirtine and piroxicam in postoperative pain reduction using visual analog scale (VAS) score.

MATERIALS AND METHODS

An open-label, parallel group, comparative study was conducted on patients undergoing lower limb orthopedic surgery, randomized into two groups of 38 patients each. They received either flupirtine 100 mg or piroxicam 20 mg 6 hours after surgery and then twice daily orally for 5 days. Pain was measured using VAS score, total pain relief score (TOTPAR), and patient satisfaction score (PSS); the other scales used were behavioral pain assessment scale (BPAS) and functional activity score (FAS). Rescue medication used was tramadol 100 mg intravenously. WHO causality scale was used for assessing adverse effects. Descriptive and inferential statistics were used for assessment of various parameters.

RESULTS

A total of 76 patients with mean ± standard deviation age of 35.08±10.3 years were recruited; 34 in the flupirtine and 37 in the piroxicam groups completed the study. Patients in both groups were comparable in baseline characteristics. Flupirtine and piroxicam reduced VAS score 48 hours postoperatively compared to baseline (=0.006 and 0.001) and piroxicam produced significant reduction in pain at 8, 12, and 120 hours compared to flupirtine (=0.028, 0.032, 0.021). TOTPAR and PSS at 24 hours were comparable between the treatments. BPAS scores at 24 hours were reduced significantly in patients receiving either drug (=0.001). FAS improved at 72 hours in patients receiving piroxicam. Adverse effects were similar with both the medications.

CONCLUSION

Flupirtine and piroxicam reduced pain effectively but the onset of pain relief was earlier with piroxicam.

摘要

背景

有效控制术后疼痛对于提供优质的患者护理和实现经济高效的住院治疗至关重要。尽管骨科手术术后疼痛管理存在多种治疗方式，但它们往往伴有不良反应。本研究旨在使用视觉模拟量表（VAS）评分评估氟吡汀和吡罗昔康在减轻术后疼痛方面的疗效。

材料与方法

对接受下肢骨科手术的患者进行了一项开放标签、平行组比较研究，随机分为两组，每组38例患者。术后6小时，他们分别接受100毫克氟吡汀或20毫克吡罗昔康治疗，然后每天口服两次，持续5天。使用VAS评分、总疼痛缓解评分（TOTPAR）和患者满意度评分（PSS）来测量疼痛；使用的其他量表包括行为疼痛评估量表（BPAS）和功能活动评分（FAS）。使用的解救药物是100毫克静脉注射曲马多。采用WHO因果关系量表评估不良反应。使用描述性和推断性统计来评估各种参数。

结果

共招募了76例平均年龄±标准差为35.08±10.3岁的患者；氟吡汀组34例，吡罗昔康组37例完成了研究。两组患者的基线特征具有可比性。与基线相比，氟吡汀和吡罗昔康在术后48小时降低了VAS评分（=0.006和0.001），与氟吡汀相比，吡罗昔康在8、12和120小时时疼痛显著减轻（=0.028、0.032、0.021）。治疗之间24小时的TOTPAR和PSS具有可比性。接受任何一种药物治疗的患者在24小时时的BPAS评分均显著降低（=0.001）。接受吡罗昔康治疗的患者在72小时时FAS有所改善。两种药物的不良反应相似。