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[连续皮下注射复方羟考酮在癌痛管理中的疗效与安全性:首个4年审计]

[Efficacy and safety of continuous subcutaneous injection of the compound oxycodone in cancer pain management: the first 4-year audit].

作者信息

Yoshimoto Tetsusuke, Hisada Atsuo, Hasegawa Toru, Nozaki Yasuhiro, Matoba Motohiro

机构信息

Palliative Care Team, Social Insurance Chukyo Hospital.

出版信息

Gan To Kagaku Ryoho. 2009 Oct;36(10):1683-9.

Abstract

The compound oxycodone injection, but not pure oxycodone, has been available since the 1920's in Japan. The compound, containing oxycodone and hydrocotarnine, can be subcutaneously administered. Hydrocotarnine is a non-narcotic opium alkaloid. Nowadays, along with the increase in the prescription frequency of oral oxycodone, the compound oxycodone injection is regarded as an important alternative in palliative care. However, few clinical reports about this drug have been documented in Japan. We have intensively introduced the compound for cancer pain control since 4 years ago and we report a study on the safety and efficacy of the continuous subcutaneous administration of the compound injection. Ninety-seven patients were naively administered the compound for cancer pain control and the mean administered period was 18. 0+/-15. 5 days. 61. 9% of all cases were switched from oral oxycodone. The efficacy in cancer pain control was evaluated for the first two weeks using a numeric rating scale (NRS: 0, no pain, and 10, imaginary worst ). They had statically shown pain control improvement from 6. 8+/-2. 8 on administration to 2. 4+/-2. 5 one week later, 1. 7+/-1. 9 two weeks later, and 2. 3 +/-2. 6 on the last observation day of the study (p<0. 001). One week later on administration, no significant adverse effects were found in the serology, conscious level, and subjective symptoms of nausea and vomiting. But adverse effects difficult to manage were experienced in 7. 2%, including delirium, constipation, nausea and vomiting, vertigo, and local skin toxicity on the injected site. All episodes were experienced within 16 days of compound administration, which had been followed by switching to fentanyl or subcutaneous morphine injection. The conversion ratio from compound oxycodone injection to oral oxycodone was 1. 43 without adjustment required(n=35). We speculate that the compound can be regarded as a pure oxycodone injection using continuous subcutaneous administration. While our clinical audit is a primitive one, we may conclude that the continuous subcutaneous administration of the compound oxycodone injection should be effective and safe in clinical use for cancer pain control.

摘要

复方羟考酮注射液自20世纪20年代起在日本就已存在,但纯羟考酮并非如此。该复方制剂含有羟考酮和氢化可待因,可皮下注射。氢化可待因是一种非麻醉性鸦片生物碱。如今,随着口服羟考酮处方频率的增加,复方羟考酮注射液被视为姑息治疗中的一种重要替代药物。然而,在日本,关于这种药物的临床报告很少。自4年前起,我们就大力引入该复方制剂用于控制癌痛,在此报告一项关于复方注射液持续皮下给药的安全性和有效性的研究。97例患者首次接受该复方制剂用于控制癌痛,平均给药期为18.0±15.5天。所有病例中有61.9%是从口服羟考酮转换而来。使用数字评分量表(NRS:0表示无疼痛,10表示想象中的最严重疼痛)在前两周评估癌痛控制效果。数据显示,给药时疼痛评分为6.8±2.8,一周后降至2.4±2.5,两周后为1.7±1.9,在研究的最后观察日为2.3±2.6,疼痛控制有显著改善(p<0.001)。给药一周后,在血清学、意识水平以及恶心和呕吐的主观症状方面未发现明显不良反应。但有7.2%的患者出现了难以处理的不良反应,包括谵妄、便秘、恶心和呕吐、眩晕以及注射部位的局部皮肤毒性。所有这些不良反应均在复方给药的16天内出现,之后改用芬太尼或皮下注射吗啡。复方羟考酮注射液转换为口服羟考酮的转换率为1.43,无需调整(n=35)。我们推测该复方制剂可被视为持续皮下给药的纯羟考酮注射液。虽然我们的临床审核较为初步,但我们可以得出结论,复方羟考酮注射液持续皮下给药在临床用于控制癌痛时应是有效且安全的。

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