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一项评估未缓解癌痛患者对胃肠外阿片类药物反应的前瞻性研究。

A prospective study evaluating the response of patients with unrelieved cancer pain to parenteral opioids.

作者信息

Enting Roelien H, Oldenmenger Wendy H, van der Rijt Carin C D, Wilms Erik B, Elfrink Erna J, Elswijk Ineke, Sillevis Smitt Peter A E

机构信息

Department of Neuro-Oncology, Daniel den Hoed Cancer Center, University Hospital Rotterdam, Rotterdam, The Netherlands.

出版信息

Cancer. 2002 Jun 1;94(11):3049-56. doi: 10.1002/cncr.10518.

DOI:10.1002/cncr.10518
PMID:12115396
Abstract

BACKGROUND

The initiation of continuous parenteral (subcutaneous or intravenous) opioids or a change of opioid (opioid rotation) are treatment options for patients who fail on oral or transdermal opioids. There are insufficient data on the efficacy of these strategies, and comparative data are unavailable.

METHODS

The authors prospectively evaluated the efficacy of the start of parenteral opioids in 100 patients with cancer pain who failed on conventional opioids. Pain intensity was rated at rest and during movement from 0 to 10 and was categorized as mild (0-4), moderate (5-6), or severe (7-10): Clinically important pain control was defined as a decrease >or= 2 points in pain intensity and pain intensity < 7. Pain control was evaluated on the second day and again when a clinical decision was made to continue or change parenteral opioid treatment after a median of 6 days. The presence of side effects (absent, mild, moderate, or severe) was evaluated.

RESULTS

The mean pain intensity at rest decreased significantly from 6.3 to 4.4 at 48 hours and to 3.4 at the end of treatment. The mean pain intensity during movement decreased significantly from 8.4 to 5.7 at 48 hours and to 4.6 at the end of treatment. Clinically important pain control at rest was seen in 52% of patients at 48 hours, in 71% of patients at the end of treatment; and clinically important pain control during movement was seen in 43% of patients at 48 hours and in 61% of patients at the end of treatment. The proportion of patients with mild pain increased significantly both at rest and during movement. Side effects were present in 78% of patients, and they resolved completely in 32% of patients. The median intravenous morphine equivalent dose increased from 80 mg per day to 135 mg per day at 48 hours and to 201 mg per day at the end of treatment. Results were not different for opioid rotation or for change of route only, nor did the start of antitumour treatment influence the results. In 34% of patients, it was decided to rotate to a second-line parenteral opioid or to start either spinal analgesia or a sedation procedure after a median of 6 days. During follow-up, 18% of patients who were dismissed with parenteral opioids (and 6% of all patients) needed a further change of treatment.

CONCLUSIONS

Parenteral opioids improved the balance between analgesia and side effects in patients with cancer pain who failed on conventional opioids, with an important improvement seen in 71% of patients. On the basis of this study, it is concluded that parenteral opioids are a good alternative to spinal opioids. Furthermore, it is suggested that a change of route alone is as effective as opioid rotation.

摘要

背景

对于口服或经皮使用阿片类药物治疗失败的患者,开始持续胃肠外(皮下或静脉)给予阿片类药物或更换阿片类药物(阿片类药物轮换)是治疗选择。关于这些策略疗效的数据不足,且尚无比较数据。

方法

作者前瞻性评估了100例常规阿片类药物治疗失败的癌症疼痛患者开始使用胃肠外阿片类药物的疗效。静息和活动时的疼痛强度按0至10分进行评分,并分为轻度(0 - 4分)、中度(5 - 6分)或重度(7 - 10分):临床上重要的疼痛控制定义为疼痛强度降低≥2分且疼痛强度<7分。在第2天评估疼痛控制情况,在中位时间6天后做出继续或更换胃肠外阿片类药物治疗的临床决策时再次评估。评估副作用的存在情况(无、轻度、中度或重度)。

结果

静息时的平均疼痛强度在48小时时从6.3显著降至4.4,在治疗结束时降至3.4。活动时的平均疼痛强度在48小时时从8.4显著降至5.7,在治疗结束时降至4.6。48小时时52%的患者在静息时有临床上重要的疼痛控制,治疗结束时为71%;48小时时43%的患者在活动时有临床上重要的疼痛控制,治疗结束时为61%。静息和活动时轻度疼痛患者的比例均显著增加。78%的患者出现副作用,其中32%的患者副作用完全缓解。静脉注射吗啡等效剂量的中位数在48小时时从每天80毫克增加到135毫克,在治疗结束时增加到每天201毫克。阿片类药物轮换或仅改变给药途径的结果无差异,开始抗肿瘤治疗也不影响结果。34%的患者在中位时间6天后决定换用二线胃肠外阿片类药物或开始脊髓镇痛或镇静程序。在随访期间,接受胃肠外阿片类药物治疗出院的患者中有18%(所有患者的6%)需要进一步更换治疗。

结论

胃肠外阿片类药物改善了常规阿片类药物治疗失败的癌症疼痛患者镇痛与副作用之间的平衡,71%的患者有显著改善。基于本研究,得出胃肠外阿片类药物是脊髓阿片类药物的良好替代方案的结论。此外,提示仅改变给药途径与阿片类药物轮换一样有效。

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