De Conno F, Groff L, Brunelli C, Zecca E, Ventafridda V, Ripamonti C
Division of Pain Therapy, National Cancer Institute, Milano, Italy.
J Clin Oncol. 1996 Oct;14(10):2836-42. doi: 10.1200/JCO.1996.14.10.2836.
The aims of this study were to describe the analgesia, side effects, and dosage and the causes of suspension of treatment in a large sample of advanced cancer patients with pain after treatment with oral methadone from 7 to 90 days.
In a retrospective study, data collected for 196 advanced cancer outpatients with moderate to severe pain treated at 8-hour intervals with oral methadone in solution form from February 1993 to February 1995 were analyzed at baseline (time 0) and then at 7, 15, 30, 45, 60, and 90 days. The following parameters were assessed: Karnofsky Performance Status, intensity of pain (using the Integrated Pain Score [IPS], intensity of pain, insomnia, drowsiness, confusion, dry mouth, nausea, vomiting, constipation, and dyspnea (using the Therapy Impact Questionnaire [TIQ], mean daily dose of drug administered, and reasons for withdrawal from study. The period when pain was reduced by > or = 35% with respect to baseline was evaluated with the Palliation Index. The association of the degree of palliation of pain with the age of the patients, tumor site, analgesic treatment taken at baseline, and daily mean dose of methadone administered during the follow-up period was analyzed by means of the Kruskal-Wallis test.
A reduction in pain intensity with respect to baseline occurred at each analysis time, and in 55.1% of the patients the reduction during the follow-up period was > or = 35% according to the Palliation Index. The mean dose of oral methadone ranged from 14 mg at day 7 to 23.65 mg at day 90. There was an overall worsening of the other symptoms, but a high percentage of the patients reported an amelioration of insomnia with respect to baseline. There was a statistically significant association (P < .0001) between the Palliation Index and the analgesic therapy administered at baseline. Only 11.2% of the patients withdrew from the study due to analgesic inefficacy and 6.6% due to methadone-related side effects (10 patients with drowsiness and three with severe constipation.
Oral methadone administered every 8 hours was shown to be an appropriate analgesic therapy in the treatment of advanced cancer-related pain. The worsening of the other symptoms under study can be considered linked to the progression of the disease, and in fact, only a small percentage of the patients reported methadone-related side effects that warranted suspension of treatment. We consider oral methadone to be a useful analgesic therapy, and it should be considered in clinical practice for the treatment of cancer pain.
本研究旨在描述口服美沙酮治疗7至90天的晚期癌症疼痛患者大样本中的镇痛效果、副作用、剂量以及治疗中断原因。
在一项回顾性研究中,分析了1993年2月至1995年2月期间以溶液形式每8小时口服美沙酮治疗的196例中重度疼痛的晚期癌症门诊患者的数据,在基线期(0时间点)以及之后的第7、15、30、45、60和90天进行分析。评估了以下参数:卡氏评分、疼痛强度(使用综合疼痛评分[IPS])、疼痛强度、失眠、嗜睡、意识模糊、口干、恶心、呕吐、便秘和呼吸困难(使用治疗影响问卷[TIQ])、每日平均给药剂量以及退出研究的原因。使用姑息指数评估疼痛相对于基线降低≥35%的时间段。通过Kruskal-Wallis检验分析疼痛缓解程度与患者年龄、肿瘤部位、基线时接受的镇痛治疗以及随访期间美沙酮每日平均剂量之间的关联。
在每个分析时间点,疼痛强度相对于基线均有所降低,根据姑息指数,55.1%的患者在随访期间疼痛降低≥35%。口服美沙酮的平均剂量从第7天的14毫克到第90天的23.65毫克不等。其他症状总体有所恶化,但高比例患者报告相对于基线失眠有所改善。姑息指数与基线时给予的镇痛治疗之间存在统计学显著关联(P <.0001)。仅11.2%的患者因镇痛无效退出研究,6.6%的患者因美沙酮相关副作用退出(10例嗜睡患者和3例严重便秘患者)。
每8小时口服美沙酮被证明是治疗晚期癌症相关疼痛的合适镇痛疗法。所研究的其他症状的恶化可被认为与疾病进展有关,事实上,只有一小部分患者报告了需要暂停治疗的美沙酮相关副作用。我们认为口服美沙酮是一种有用的镇痛疗法,在临床实践中应考虑用于治疗癌症疼痛。