Ipca Laboratories Limited, Mumbai, India.
Curr Med Res Opin. 2011 Nov;27(11):2107-15. doi: 10.1185/03007995.2011.619179. Epub 2011 Sep 23.
The objective of this study was to compare the analgesic efficacy of etodolac injection and diclofenac injection in patients with postoperative orthopedic pain.
This was multicentric, randomized, assessor-blind and parallel-group study. A group of 158 patients with moderate to severe pain following orthopedic surgery were randomly assigned to receive either etodolac 400 mg twice a day (n = 78) or diclofenac 75 mg thrice a day (n = 80).
The primary efficacy outcome measures were pain intensity difference, sum of pain intensity differences and pain relief whereas secondary efficacy variables included maximum fall in pain intensity, number of doses of study medication consumed, number of patients who required rescue medication and overall response to therapy.
Mean pain intensity differences assessed on 10 cm VAS were significantly better for etodolac arm compared to diclofenac arm at 4, 8, 20 and 24 hours (p < 0.05). Sum of pain intensity differences over the first 8 hours (-21.31 ± 6.26 for etodolac vs. -19.13 ± 6.98 for diclofenac; p = 0.041) and over the 24 hours (-39.83 ± 10.70 for etodolac vs. -35.25 ± 12.00 for diclofenac; p = 0.012) for the etodolac group was significantly superior than diclofenac group. Assessment of pain relief showed that etodolac injection was significantly more effective than diclofenac injection (p < 0.0001) over the 24 hour assessment period. Maximum fall in pain intensity score, number of doses of study medication consumed and patients' and investigators' overall response to the drug at the end of treatment period were also significantly superior in the etodolac arm as compared to the diclofenac arm (p < 0.05). However, the number of patients who were rescued was comparable in both the treatment arms. A change in emotional functioning of the patients was not captured in this study. Both the study medications were well tolerated with no incidence of SAE throughout the study.
Etodolac can be considered as an effective alternative to traditional NSAIDS in the treatment of post operative pain.
本研究旨在比较依托考昔注射液和双氯芬酸钠注射液在骨科术后疼痛患者中的镇痛效果。
这是一项多中心、随机、评估者盲法、平行组研究。将 158 例骨科手术后中重度疼痛患者随机分为依托考昔 400mg，每日 2 次（n=78）组和双氯芬酸钠 75mg，每日 3 次（n=80）组。
主要疗效指标为疼痛强度差、疼痛强度差总和和疼痛缓解率，次要疗效变量包括最大疼痛强度下降、研究药物消耗的剂量数、需要解救药物的患者数和总体治疗反应。
依托考昔组在 4、8、20 和 24 小时的疼痛强度差异评估值明显优于双氯芬酸钠组（p<0.05）。依托考昔组在 8 小时内（-21.31±6.26 对-19.13±6.98；p=0.041）和 24 小时内（-39.83±10.70 对-35.25±12.00；p=0.012）的疼痛强度差总和明显优于双氯芬酸钠组。疼痛缓解评估显示，依托考昔注射剂在 24 小时评估期内明显优于双氯芬酸钠注射剂（p<0.0001）。在治疗结束时，依托考昔组在最大疼痛强度评分下降、研究药物消耗剂量数、患者和研究者对药物的总体反应方面也明显优于双氯芬酸钠组（p<0.05）。然而，在治疗组中需要解救药物的患者数量相当。在这项研究中，没有捕捉到患者情感功能的变化。两种研究药物在整个研究过程中均耐受良好，没有发生严重不良事件。
依托考昔可作为传统 NSAIDs 治疗术后疼痛的有效替代药物。
