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[缓释替利定/纳洛酮在慢性疼痛和多种疾病中的长期给药。一项为期2年观察的长期耐受性和有效性的多中心研究]

[Tilidine/naloxon retard in long-term administration in chronic pain and multimorbidity. Multicenter study of long-term tolerance and effectiveness in 2 years observation].

作者信息

Flöter Th, Brunnmüller U

机构信息

Schmerzzentrum Frankfurt.

出版信息

Fortschr Med Orig. 2002;120(1):29-35.

Abstract

BACKGROUND AND METHOD

335 patients (51% female, 49% male, mean age 56 years) with chronic pain and multimorbidity have been included in a multi-center 2-years' study with slow release Tilidine/Naloxone for efficacy and safety which included detailed laboratory examinations. 316 patients had already been treated with analgesics. 159 patients (47.5%) finished the study as planned, 176 patients finished the study earlier.

RESULTS

Parameters of quality of life such as persistent pain, sleep, mood and activity have improved. Tolerance has not been observed. In 85 patients (25%) adverse events had occurred (nausea, vomiting, dizziness) which are related to the study-medication. Constipation was documented in only 4 patients. After 2 years of therapy with Tilidine/Naloxone there has been no relevant changes in laboratory findings. There has been no sign of organ damage or interactions with concomitant medication.

CONCLUSION

Tilidine/Naloxone is an effective and safe analgesic (WHO II) suitable for the longterm treatment of patients with chronic pain.

摘要

背景与方法

335例慢性疼痛和多种疾病并存的患者(51%为女性,49%为男性,平均年龄56岁)被纳入一项为期两年的多中心研究,该研究使用缓释替利定/纳洛酮评估其疗效和安全性,研究包括详细的实验室检查。316例患者此前已接受过镇痛药治疗。159例患者(47.5%)按计划完成了研究,176例患者提前完成了研究。

结果

生活质量参数,如持续性疼痛、睡眠、情绪和活动等均有所改善。未观察到耐受性问题。85例患者(25%)出现了与研究药物相关的不良事件(恶心、呕吐、头晕)。仅4例患者记录有便秘情况。使用替利定/纳洛酮治疗两年后,实验室检查结果无相关变化。未出现器官损害迹象,也未发现与合并用药的相互作用。

结论

替利定/纳洛酮是一种有效且安全的镇痛药(世界卫生组织二类),适用于慢性疼痛患者的长期治疗。

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