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奥施康定片缓解中度至重度带状疱疹后神经痛疼痛的上市后监测研究。

Postmarketing surveillance study of OxyContin tablets for relieving moderate to severe postherpetic neuralgia pain.

作者信息

Fan Bi Fa

机构信息

Department of Pain Management, Sino-Japan Friendship Hospital, Beijing, PR China.

出版信息

Oncology. 2008;74 Suppl 1:66-71. doi: 10.1159/000143222. Epub 2008 Aug 28.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of OxyContin tablets(controlled-release oxycodone hydrochloride: 5, 10, 20, and 40 mg) in relieving moderate to severe postherpetic neuralgia (PHN) pain.

METHOD

A multicenter, open-label, prospective, self-controlled clinical observation.

RESULTS

Pain was relieved in 17.3% of patients within 30 min and in 94.1% patients within 1 h after drug administration. OxyContin tablets showed good clinical efficacy in relieving both moderate and severe PHN pain. Response rate reached 98.4% at the end of the 8th week of treatment. After the 1st week of treatment, stable pain relief was achieved, and pain scores on a Visual Analogue Scale decreased dramatically in most patients. During treatment with controlled-release OxyContin tablets, the use of concomitant medications was significantly decreased. Some patients developed adverse drug reactions (ADRs) in the 1st week, which decreased significantly during the following weeks of treatment. Nausea (18.1%) was the most commonly reported ADR, followed by constipation (10.1%) and dizziness (10.1%). A number of ADRs disappeared during treatment.

CONCLUSION

Controlled-release OxyContin tablets demonstrated fast onset of PHN pain control, superior efficacy in relieving both moderate and severe PHN pain, and a good safety profile.

摘要

目的

评估奥施康定片(控释盐酸羟考酮:5、10、20和40毫克)缓解中重度带状疱疹后神经痛(PHN)疼痛的疗效和安全性。

方法

一项多中心、开放标签、前瞻性、自身对照的临床观察。

结果

给药后30分钟内17.3%的患者疼痛得到缓解,1小时内94.1%的患者疼痛得到缓解。奥施康定片在缓解中重度PHN疼痛方面显示出良好的临床疗效。治疗第8周结束时缓解率达到98.4%。治疗第1周后,疼痛缓解稳定,大多数患者视觉模拟量表的疼痛评分显著下降。在使用控释奥施康定片治疗期间,伴随用药显著减少。一些患者在第1周出现药物不良反应(ADR),在随后的治疗周内显著减少。最常报告的ADR是恶心(18.1%),其次是便秘(10.1%)和头晕(10.1%)。许多ADR在治疗期间消失。

结论

控释奥施康定片在控制PHN疼痛方面起效快,在缓解中重度PHN疼痛方面疗效优异,且安全性良好。

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