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癌症和非癌症疼痛患者中透皮芬太尼与透皮丁丙诺啡等效剂量:一项回顾性队列研究的结果

Equipotent doses of transdermal fentanyl and transdermal buprenorphine in patients with cancer and noncancer pain: results of a retrospective cohort study.

作者信息

Sittl Reinhard, Likar Rudolf, Nautrup Barbara Poulsen

机构信息

Pain Clinic, University of Erlangen, Erlangen, Germany.

出版信息

Clin Ther. 2005 Feb;27(2):225-37. doi: 10.1016/j.clinthera.2005.02.012.

Abstract

BACKGROUND

The equipotency ratio of transdermal (TD) fentanyl to oral morphine has been established as 1:100; for buprenorphine TD, a ratio of 1:75 has been proposed, although this ratio has not been confirmed in clinical studies. Growing evidence from clinical practice, in which much lower doses of buprenorphine are used, suggests that this conversion ratio may be too high.

OBJECTIVE

The aim of this study was to compare calculated equipotent oral morphine doses of fentanyl TD with equipotent oral morphine doses of buprenorphine TD prescribed in clinical practice.

METHODS

This retrospective study identified patients with cancer and noncancer pain who had received > or =1 prescription for fentanyl TD or buprenorphine TD (the all-patients groups) from the German IMS Disease Analyzer-mediplus database, which contains all relevant data concerning drug prescriptions from 400 practices in Germany. Also identified were subgroups of the all-patients groups who had received long-term treatment with fentanyl TD or buprenorphine TD and were considered to have similar pain intensity, as they had previously received similar analgesic medication (the identical-cohort groups). Mean prescribed daily doses for the all-patients and identical-cohort groups were calculated based on the distribution of prescribed patch strengths. Because patients could have applied >1 patch, mean prescribed daily doses were also calculated based on an assumption of double application when appropriate. Equipotent oral morphine doses were estimated using equipotency ratios of 1:100 for fentanyl TD and 1:75 for buprenorphine TD.

RESULTS

The all-patients groups consisted of 2198 patients with noncancer pain and 2544 patients with cancer pain; the identical-cohort groups consisted of 380 patients with noncancer pain and 496 patients with cancer pain (529 women, 347 men; mean age, 74 years [range, 25-101 years]). Equipotent doses of oral morphine were significantly lower in patients receiving buprenorphine TD compared with those receiving fentanyl TD (P < 0.001). In cancer patients, the equipotent oral morphine doses of fentanyl TD and buprenorphine TD were 130.9 to 138.9 mg and 85.2 to 88.8 mg, respectively; in noncancer patients, the corresponding values were 117.0 to 118.3 mg and 80.2 to 80.9 mg. Based on these results, an equipotency ratio of 1:110 to 1:115 for buprenorphine TD would appear to be more appropriate than the proposed ratio of 1:75.

CONCLUSIONS

The fact that this retrospective analysis conducted in identical cohorts showed lower calculated equipotent oral morphine doses in the buprenorphine TD groups compared with the fentanyl TD groups calls into question the proposed 1:75 ratio for conversion of buprenorphine TD to equipotent oral morphine doses. Based on the findings of the present study, an equipotency ratio of 1:110 to 1:115 may be more appropriate. However, confirmative data from prospective randomized clinical trials are needed.

摘要

背景

经皮(TD)芬太尼与口服吗啡的等效剂量比已确定为1:100;对于丁丙诺啡透皮贴剂,有人提出其比例为1:75,不过这一比例尚未在临床研究中得到证实。临床实践中越来越多的证据表明,实际使用的丁丙诺啡剂量要低得多,这表明该换算比例可能过高。

目的

本研究旨在比较临床实践中开具的芬太尼透皮贴剂等效口服吗啡剂量与丁丙诺啡透皮贴剂等效口服吗啡剂量。

方法

这项回顾性研究从德国IMS疾病分析器 - mediplus数据库中识别出接受过≥1次芬太尼透皮贴剂或丁丙诺啡透皮贴剂处方的癌症和非癌症疼痛患者(全患者组),该数据库包含德国400家医疗机构所有有关药物处方的相关数据。还识别出全患者组中接受芬太尼透皮贴剂或丁丙诺啡透皮贴剂长期治疗且被认为疼痛强度相似的亚组(同队列组),因为他们之前接受过相似的镇痛药物治疗。根据所开具贴剂强度的分布情况计算全患者组和同队列组的平均每日处方剂量。由于患者可能使用了>1片贴剂,所以在适当情况下还基于双倍使用的假设计算平均每日处方剂量。使用芬太尼透皮贴剂1:100和丁丙诺啡透皮贴剂1:75的等效剂量比来估算等效口服吗啡剂量。

结果

全患者组包括2198例非癌症疼痛患者和2544例癌症疼痛患者;同队列组包括380例非癌症疼痛患者和496例癌症疼痛患者(529名女性,347名男性;平均年龄74岁[范围25 - 101岁])。与接受芬太尼透皮贴剂的患者相比,接受丁丙诺啡透皮贴剂的患者等效口服吗啡剂量显著更低(P < 0.001)。在癌症患者中,芬太尼透皮贴剂和丁丙诺啡透皮贴剂的等效口服吗啡剂量分别为130.9至138.9毫克和85.2至88.8毫克;在非癌症患者中相应值分别为117.0至118.3毫克和80.2至80.9毫克。基于这些结果,丁丙诺啡透皮贴剂1:110至1:115的等效剂量比似乎比提议的1:75更合适。

结论

在同队列中进行的这项回顾性分析表明丁丙诺啡透皮贴剂组计算出的等效口服吗啡剂量低于芬太尼透皮贴剂组,这对提议的丁丙诺啡透皮贴剂转换为等效口服吗啡剂量的1:75比例提出了质疑。基于本研究结果,1:110至1:1 / 15的等效剂量比可能更合适。然而,需要前瞻性随机临床试验的确证数据。

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