Bruera E, Sloan P, Mount B, Scott J, Suarez-Almazor M
Division of Palliative Care Medicine, University of Alberta, Edmonton, Canada.
J Clin Oncol. 1996 May;14(5):1713-7. doi: 10.1200/JCO.1996.14.5.1713.
To evaluate the safety and efficacy of a new slow-release preparation of hydromorphone (SRH) in the treatment of cancer pain.
Ninety-five adult patients from three Canadian Palliative Care Centers with no evidence of mental impairment received treatment for cancer pain with an oral opioid analgesic. After informed consent was obtained, patients underwent titration to a stable dose of immediate-release hydromorphone (IRH) for 48 hours, and were then randomized to receive IRH or SRH for 5 days in a double-blind basis. During day 6, a crossover took place, and patients received the alternate drug for 5 days. Pain intensity was assessed using a visual analog scale (VAS) and ordinal scale (OS). Side effects were assessed using VAS. Patients and investigators made a blinded global rating of efficacy a blinded final choice between SRH and IRH.
In 75 assessable patients, pain intensity of the VAS and OS were (mean +/- SD) 27 +/- 21 and 1.3 +/- 0.6 on IRH, versus 29 +/- 21 (P = .13) and 1.3 +/- 0.6 (P = .19) on SRH, respectively. The total number of extra doses of opioids, global rating, and final blinded choice by both patients and investigators were not significantly different between IRH and SRH. Differences in side effects were not significant.
Our findings suggest that SRH is as safe and effective as IRH in the treatment of cancer pain.
评估一种新型氢吗啡酮缓释制剂（SRH）治疗癌痛的安全性和有效性。
来自加拿大三个姑息治疗中心的95名无精神障碍证据的成年患者接受口服阿片类镇痛药治疗癌痛。在获得知情同意后，患者接受48小时的即释氢吗啡酮（IRH）滴定至稳定剂量，然后随机分为双盲接受IRH或SRH治疗5天。在第6天进行交叉，患者接受另一种药物治疗5天。使用视觉模拟量表（VAS）和序数量表（OS）评估疼痛强度。使用VAS评估副作用。患者和研究者对疗效进行盲法整体评分，在SRH和IRH之间进行盲法最终选择。
在75名可评估患者中，IRH治疗时VAS和OS的疼痛强度分别为（均值±标准差）27±21和1.3±0.6，SRH治疗时分别为29±21（P = 0.13）和1.3±0.6（P = 0.19）。IRH和SRH之间阿片类药物额外剂量的总数、整体评分以及患者和研究者的最终盲法选择均无显著差异。副作用差异不显著。
我们的研究结果表明，SRH在治疗癌痛方面与IRH一样安全有效。
