一种 12 小时快速滴定法治疗癌痛：一项随机、对照、开放标签研究。

A 12-hour rapid titration method for cancer pain: a randomized, controlled, open-label study.

机构信息

Department of Head and Neck/Thoracic Medical Oncology, The First People's Hospital of Foshan, Foshan, China.

Department of Head and Neck/Thoracic Medical Oncology, The First People's Hospital of Foshan, Foshan, China. Email:

出版信息

Ann Palliat Med. 2021 Jan;10(1):88-96. doi: 10.21037/apm-20-2336. Epub 2021 Jan 18.

DOI:10.21037/apm-20-2336

PMID:33474955

Abstract

BACKGROUND

Opioid titration is the best way to achieve a balance of pain relief and tolerable side effects for moderate-to-severe cancer pain. Rapid dose titration helps to achieve early analgesia. We explored the efficacy and safety of a 12-hour rapid dose titration in treating cancer pain.

METHODS

Opioid-naïve patients with moderate-to-severe cancer pain were randomly divided into oxycodone group and morphine group. The medicines were adjusted to oxycodone sustained-release tablets after 12 hours, and the dose of oxycodone sustained-release tablets was adjusted every 12 hours. The analgesic efficacy and adverse reactions during the treatment were observed until the 72nd hour.

RESULTS

A total of 106 patients were included in the analysis, with 51 patients in the oxycodone group and 55 in the morphine group. The pain control rate of all patients reached 96.2% 24 hours after treatment, and it was not significantly different between two groups (P=0.619). The proportion of Numeric Rating Scale (NRS) score that decreased by ≥50% was significantly higher in the oxycodone group than in the morphine group (P=0.013). In the first 12 hours and 24 hours, significantly lower proportions of patients in the oxycodone group experienced multiple episodes of breakthrough pain (BTP) than in the morphine group (P=0.032, P=0.021, respectively). The quality of life of the patients in the oxycodone group was significantly higher than that in the morphine group at the 24th hour (P=0.047), as was the degree to which the quality of life had improved (P<0.001). Only grade 1 or 2 adverse reactions were observed during the study period, and no significant difference between two groups.

CONCLUSIONS

The 12-hour rapid dose titration method can achieve early analgesia, with mild adverse reactions. In particular, the rapid titration method with background sustained-release oxycodone can reduce BTP episodes and achieve significant early pain relief.

摘要

背景

阿片类药物滴定是中度至重度癌痛患者实现缓解疼痛和可耐受副作用平衡的最佳方法。快速剂量滴定有助于实现早期镇痛。我们探索了 12 小时快速剂量滴定治疗癌痛的疗效和安全性。

方法

中度至重度癌痛的阿片类药物初治患者随机分为羟考酮组和吗啡组。12 小时后调整为羟考酮控释片，每 12 小时调整羟考酮控释片的剂量。观察治疗期间的镇痛效果和不良反应，直至第 72 小时。

结果

共纳入 106 例患者，羟考酮组 51 例，吗啡组 55 例。治疗后 24 小时所有患者疼痛控制率均达到 96.2%，两组间差异无统计学意义（P=0.619）。羟考酮组 NRS 评分降低≥50%的比例明显高于吗啡组（P=0.013）。在前 12 小时和 24 小时，羟考酮组发生多次爆发性疼痛（BTP）的患者比例明显低于吗啡组（P=0.032，P=0.021）。羟考酮组患者在第 24 小时的生活质量明显高于吗啡组（P=0.047），生活质量改善程度也明显高于吗啡组（P<0.001）。研究期间仅观察到 1 级或 2 级不良反应，两组间无显著差异。