Effectiveness and Safety of Etofenamate Gel Combined with Tizanidine on the Treatment of Acute Local Painful Muscle Spasms with Potential Gastrointestinal Risk_West China Medical Journal

Authors：

XU Kai ¹ , CHENG Weiting ² ,  GUO Fengjing ¹

1. Department of Orthopedics Surgery, Tongji Hospital; 2. Department of Oncology, Hospital of Chinese Traditional and Western Medicine; Huazhong University of Science and Technology, Wuhan, Hubei 430030, P. R. China;

Corresponding author：

GUO Fengjing, Email: Kai_Xu1979@hotmail.com

Keywords：

依托芬那酯凝胶; 胃肠道风险; 急性肌痉挛痛; 疗效; 安全性

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目的　观察非甾体抗炎药依托芬那酯凝胶联合中枢性肌松药替扎尼定对治疗有潜在胃肠道风险的急性痉挛性颈肩腰痛的疗效和安全性。方法　2012年3月－5月共诊断急性痉挛性颈肩痛及腰痛患者375例，依据排除标准排除33例，根据分组标准将有潜在胃肠道疾病风险者设为试验组（A组，n=63），明确无胃肠道疾病史者按照年龄、性别和疼痛部位与试验组进行配伍设为阳性对照组（B组，n=63）和安慰剂对照组（C组，n=63），未分组144例不纳入统计。试验组服用替扎尼定2 mg，2次/d，同时外用依托芬那酯凝胶5～10 cm均匀涂抹患处，3次/d；对照组服用替扎尼定2 mg，2次/d，同时口服塞来昔布0.2 g，2次/d；安慰剂对照组服用替扎尼定2 mg，2次/d，同时安慰剂1粒，2次/d。观察药物疗效和不良反应。结果　A组随访57例，平均起效时间为（2.17 ± 0.99） d，总有效44例（77.2%），胃肠道不良反应2例（3.5%）；B组随访54例，平均起效时间为（1.78 ± 0.96） d，总有效45例（83.3%），胃肠道不良反应发生3例（5.5%）；C组随访55例，平均起效时间（4.10 ± 1.63） d，总有效35例（63.6%），胃肠道不良反应发生2例（3.6%）。结论　依托芬那酯凝胶和口服非甾体抗炎药疗效和起效时间相当，胃肠道耐受性较好，联合用药效果优于单独使用肌松药。对于有潜在胃肠道风险的痉挛性颈肩腰背痛患者可选择外用非甾体抗炎药联合中枢性肌松药的治疗方案，以获得更好的疗效以及较高耐受性。

Citation： XU Kai,CHENG Weiting,GUO Fengjing. Effectiveness and Safety of Etofenamate Gel Combined with Tizanidine on the Treatment of Acute Local Painful Muscle Spasms with Potential Gastrointestinal Risk. West China Medical Journal, 2012, 27(12): 1784-1787. doi: Copy

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9.	Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group[J]. N Engl J Med, 2000, 343(21): 1520-1528.
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11.	Vanderstraeten G, Schuermans P. Study on the effect of etofenamate 10% cream in comparison with an oral NSAID in strains and sprains due to sports injuries[J]. Acta Belg Med Phys, 1990, 13(3): 139-141.
12.	Watanabe K, Watanabe H, Maeda-Hagiwara M, et al. Influence of a muscle relaxant, tizanidine, on gastric acid secretion and gastric ulcer in rats[J]. Nihon Yakurigaku Zasshi, 1983, 82(4): 237-245.
13.	Bijlsma JW. Treatment of endoscopy-negative NSAID-induced upper gastrointestinal symptoms with cimetidine: an international multicentre collaborative study[J]. Aliment Pharmacol Ther, 1988, 2(Suppl 1): 75-83.

1. 　张伯勋, 王岩. 现代颈肩腰腿痛诊断与治疗学[M]. 北京: 人民军医出版社, 2004: 248-264.
2. 　李端. 药理学 [M]. 5版. 北京: 人民卫生出版社, 2003: 166-177.
3. 　Lanas A, Esplugues JV, Zapardiel J, et al. Education-based approach to addressing non-evidence-based practice in preventing NSAID-associated gastrointestinal complications[J]. World J Gastroenterol, 2009, 15(47): 5953-5959.
4. 　杨岫岩, 许韩师. 非甾体抗炎药的化学分类及其对环氧合酶选择性的认识[J]. 中华内科杂志, 2002, 41(7): 496-497.
5. 　Morita I, Schindler M, Regier MK, et al. Different intracellular locations for prostaglandin endoperoxide H synthase-1 and -2[J]. J Biol Chem, 1995, 270(18): 10902-10908.
6. 　杨南萍, 左川, 苏白海. NSAIDs的作用机制研究进展[J]. 华西医学, 1999, 14(2): 254.
7. 　Whelton A. COX-1 sparing and COX-2 inhibitory drugs: the renal and hepatic safety and tolerability profiles of celecoxib[J]. Arch Intern Med, 2000, 7(3): 151-152.
8. 　Nadarajah A, Abrahan L, Lau FL, et al. Efficacy and tolerability of celecoxib compared with diclofenac slow release in the treatment of acute ankle sprain in an Asian population[J]. Singapore Med J, 2006, 47(6): 534-542.
9. 　Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group[J]. N Engl J Med, 2000, 343(21): 1520-1528.
10. 　Warden SJ. Prophylactic use of NSAIDs by athletes: a risk/benefit assessment[J]. Phys Sportsmed, 2010, 38(1): 132-138.
11. 　Vanderstraeten G, Schuermans P. Study on the effect of etofenamate 10% cream in comparison with an oral NSAID in strains and sprains due to sports injuries[J]. Acta Belg Med Phys, 1990, 13(3): 139-141.
12. 　Watanabe K, Watanabe H, Maeda-Hagiwara M, et al. Influence of a muscle relaxant, tizanidine, on gastric acid secretion and gastric ulcer in rats[J]. Nihon Yakurigaku Zasshi, 1983, 82(4): 237-245.
13. 　Bijlsma JW. Treatment of endoscopy-negative NSAID-induced upper gastrointestinal symptoms with cimetidine: an international multicentre collaborative study[J]. Aliment Pharmacol Ther, 1988, 2(Suppl 1): 75-83.

West China Medical Journal

Effectiveness and Safety of Etofenamate Gel Combined with Tizanidine on the Treatment of Acute Local Painful Muscle Spasms with Potential Gastrointestinal Risk

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