Bruera Eduardo, Palmer J Lynn, Bosnjak Snezana, Rico Maria Antonieta, Moyano Jairo, Sweeney Catherine, Strasser Florian, Willey Jie, Bertolino Mariela, Mathias Clarissa, Spruyt Odette, Fisch Michael J
Department of Palliative Care & Rehabilitation Medicine (Unit 0008), the University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030-0049, USA.
J Clin Oncol. 2004 Jan 1;22(1):185-92. doi: 10.1200/JCO.2004.03.172.
To compare the effectiveness and side effects of methadone and morphine as first-line treatment with opioids for cancer pain.
Patients in international palliative care clinics with pain requiring initiation of strong opioids were randomly assigned to receive methadone (7.5 mg orally every 12 hours and 5 mg every 4 hours as needed) or morphine (15 mg sustained release every 12 hours and 5 mg every 4 hours as needed). The study duration was 4 weeks.
A total of 103 patients were randomly assigned to treatment (49 in the methadone group and 54 in the morphine group). The groups had similar baseline scores for pain, sedation, nausea, confusion, and constipation. Patients receiving methadone had more opioid-related drop-outs (11 of 49; 22%) than those receiving morphine (three of 54; 6%; P =.019). The opioid escalation index at days 14 and 28 was similar between the two groups. More than three fourths of patients in each group reported a 20% or more reduction in pain intensity by day 8. The proportion of patients with a 20% or more improvement in pain at 4 weeks in the methadone group was 0.49 (95% CI, 0.34 to 0.64) and was similar in the morphine group (0.56; 95% CI, 0.41 to 0.70). The rates of patient-reported global benefit were nearly identical to the pain response rates and did not differ between the treatment groups.
Methadone did not produce superior analgesic efficiency or overall tolerability at 4 weeks compared with morphine as a first-line strong opioid for the treatment of cancer pain.
比较美沙酮和吗啡作为阿片类药物一线治疗癌症疼痛的有效性和副作用。
国际姑息治疗诊所中需要开始使用强效阿片类药物治疗疼痛的患者被随机分配接受美沙酮（每12小时口服7.5毫克，必要时每4小时口服5毫克）或吗啡（每12小时口服15毫克缓释剂，必要时每4小时口服5毫克）。研究持续时间为4周。
共有103名患者被随机分配接受治疗（美沙酮组49名，吗啡组54名）。两组在疼痛、镇静、恶心、意识模糊和便秘方面的基线评分相似。接受美沙酮治疗的患者与接受吗啡治疗的患者相比，与阿片类药物相关的退出率更高（49名中有11名；22%）（54名中有3名；6%；P = 0.019）。两组在第14天和第28天的阿片类药物升级指数相似。每组超过四分之三的患者报告到第8天时疼痛强度降低了20%或更多。美沙酮组在4周时疼痛改善20%或更多的患者比例为0.49（95%可信区间，0.34至0.64），吗啡组相似（0.56；95%可信区间，0.41至0.70）。患者报告的总体获益率与疼痛缓解率几乎相同，且治疗组之间无差异。
作为治疗癌症疼痛的一线强效阿片类药物，美沙酮在4周时与吗啡相比，并未产生更高的镇痛效率或总体耐受性。
