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用于治疗非癌性和癌性疼痛的透皮丁丙诺啡和透皮芬太尼的剂量变化模式:德国的一项回顾性数据分析

Patterns of dosage changes with transdermal buprenorphine and transdermal fentanyl for the treatment of noncancer and cancer pain: a retrospective data analysis in Germany.

作者信息

Sittl Reinhard, Nuijten Mark, Poulsen Nautrup Barbara

机构信息

Pain Clinic, University of Erlangen, Erlangen, Germany.

Erasmus University, Rotterdam, The Netherlands.

出版信息

Clin Ther. 2006 Aug;28(8):1144-1154. doi: 10.1016/j.clinthera.2006.08.002.

Abstract

BACKGROUND

Previous studies have suggested that buprenorphine may have a low association with tolerance development compared with other strong opioids. In a previous study by our group, mean cohort and intraindividual dosage increases over an entire course of treatment and on a per-day basis were significantly lower with transdermal (TD) buprenorphine than with TD fentanyl. However, no information concerning the relationship between qualitative and quantitative dose changes is available.

OBJECTIVE

The aim of this study was to compare TD buprenorphine and TD fentanyl with respect to dosage increases, dosage stability, and the nature of dosage changes.

METHODS

This retrospective analysis used data from the IMS Disease Analyzer-Mediplus database, which contains patient-related data documented by 400 medical practices in Germany. Data from patients with noncancer or cancer pain treated with TD buprenorphine or TD fentanyl for at least 3 months between May 2002 and April 2005 were analyzed. Daily dosages were directly determined from the prescribed patch strength, taking into account the possibility of multiple patches applied simultaneously. To determine dosage stability, patients were classified based on the type of dosage change (stable, increase, alternating, or decrease) of the prescribed dosages. From the prescribed daily dosages, mean percentage increases were calculated on a per-patient basis for the entire treatment period and per day, and these were assessed in relation to the type of dosage change.

RESULTS

In total, 631 patients with noncancer pain and 605 patients with cancer pain were included in the analysis (782 women, 454 men; mean age, 76.3 years [range, 29-100 years]). Treatment indications included osteoarthritis, low back pain, osteoporosis (noncancer groups), and neoplasm (cancer groups). Patients had similar analgesic premedication requirements based on steps 1 to 3 of the World Health Organization analgesic ladder. Comedication requirements for breakthrough pain were also similar between the TD buprenorphine and TD fentanyl groups. The mean percentage increases per day were 0.10% (TD buprenorphine) and 0.25% (TD fentanyl) in the noncancer groups and 0.19% (TD buprenorphine) and 0.47% (TD fentanyl) in the cancer groups (both, P < 0.05). A significantly larger proportion of patients receiving TD buprenorphine had stable dosages over the entire treatment period compared with patients receiving TD fentanyl (noncancer groups: 56.9% vs 41.6%; cancer groups: 50.0% vs 26.2% [both, P < 0.05]). Compared with TD buprenorphine, the proportion of patients with alternating dosage changes was significantly greater in patients receiving TD fentanyl (noncancer groups: 22.7% vs 13.1%; cancer groups: 30.6% vs 11.8% [both, P < 0.05]).

CONCLUSIONS

In this retrospective data analysis, compared with TD buprenorphine, the increase in mean daily dosage was significantly greater in patients treated with TD fentanyl. Also, compared with TD buprenorphine, alternating dosage changes were seen in a significantly greater proportion of patients receiving TD fentanyl. On the other hand, a significantly greater proportion of patients treated with TD buprenorphine had stable dosages over their entire treatment periods.

摘要

背景

此前的研究表明,与其他强效阿片类药物相比,丁丙诺啡产生耐受性的可能性较低。在我们团队之前的一项研究中,经皮丁丙诺啡整个治疗过程中的平均队列剂量增加和个体每日剂量增加显著低于经皮芬太尼。然而,关于定性和定量剂量变化之间的关系尚无相关信息。

目的

本研究旨在比较经皮丁丙诺啡和经皮芬太尼在剂量增加、剂量稳定性及剂量变化性质方面的差异。

方法

这项回顾性分析使用了来自IMS疾病分析器 - 医加数据库的数据,该数据库包含德国400家医疗机构记录的患者相关数据。分析了2002年5月至2005年4月期间使用经皮丁丙诺啡或经皮芬太尼治疗非癌性或癌性疼痛至少3个月的患者数据。每日剂量根据所开具的贴剂强度直接确定,同时考虑到可能同时使用多个贴剂的情况。为确定剂量稳定性,根据所开具剂量的变化类型(稳定、增加、交替或减少)对患者进行分类。从所开具的每日剂量中,计算出每位患者在整个治疗期间及每日的平均百分比增加量,并根据剂量变化类型进行评估。

结果

总共631例非癌性疼痛患者和605例癌性疼痛患者纳入分析(782例女性,454例男性;平均年龄76.3岁[范围29 - 100岁])。治疗适应证包括骨关节炎、腰痛、骨质疏松(非癌组)和肿瘤(癌组)。根据世界卫生组织镇痛阶梯的第1至3步,患者的镇痛预处理需求相似。经皮丁丙诺啡组和经皮芬太尼组对于爆发性疼痛的辅助用药需求也相似。非癌组中,每日平均百分比增加量分别为0.10%(经皮丁丙诺啡)和0.25%(经皮芬太尼),癌组中分别为0.19%(经皮丁丙诺啡)和0.47%(经皮芬太尼)(均P < 0.05)。与接受经皮芬太尼的患者相比,接受经皮丁丙诺啡的患者在整个治疗期间剂量稳定的比例显著更高(非癌组:56.9%对41.6%;癌组:50.0%对26.2%[均P < 0.05])。与经皮丁丙诺啡相比,接受经皮芬太尼的患者中剂量交替变化的比例显著更高(非癌组:二22.7%对13.1%;癌组:30.6%对11.8%[均P < 0.05])。

结论

在这项回顾性数据分析中,与经皮丁丙诺啡相比,接受经皮芬太尼治疗的患者每日平均剂量增加显著更大。此外,与经皮丁丙诺啡相比,接受经皮芬太尼的患者中出现剂量交替变化的比例显著更高。另一方面,接受经皮丁丙诺啡治疗的患者在整个治疗期间剂量稳定的比例显著更高。

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