盐酸吗啡缓释片治疗癌症疼痛的临床疗效分析

Effects of sustained release morphine hydrochloride tablets in management of cancer pain: a survey of 567 patients

目的 探讨癌症疼痛病人接受盐酸吗啡缓释片治疗的效果及其安全性。方法 全国13个省市 2 5家医院参加此项多中心开放性临床试验 ,共 5 6 7例癌症疼痛病人接受盐酸吗啡缓释片镇痛治疗 ,平均年龄 5 7 8岁 (16～ 91岁 )。结果 镇痛疗效 :治疗前病人疼痛程度 (NRS)为 7 0± 1 8,其中重度疼痛 382例 (6 7 4 % ) ,中度疼痛 16 0例 (2 8 2 % ) ,轻度疼痛 2 5例 (4 4 % )。治疗 1、5、10、15、2 0、2 5、30d疼痛程度分别降至 4 6± 2 4 ,2 8± 1 8,2 7± 1 8,2 6± 1 7,2 5± 1 6 ,2 3± 1 4 ,2 2± 1 4。与治疗前疼痛程度比较差异有显著意义 (均P =0 0 0 0 )。治疗 30d疼痛缓解总有效率89 8%。用药剂量 :盐酸吗啡缓释片的初始、15d和 30d剂量分别为 :10～ 6 90 (6 6± 5 6 )mg/d ,10～ 80 0 (84± 6 4 )mg/d和 10～ 80 0 (92± 6 7)mg/d ;治疗 30d剂量≤ 6 0mg/d的病人占 5 5 1% ,6 1～12 0mg/d占 35 1% ,12 1～ 2 4 0mg/d占 7 6 % ,≥ 2 4 1mg/d占 2 2 %。每日实际给药 2次的病人的百分比平均值为 91 6 % (89 4 %～ 95 8% )。生活质量 :治疗前生活质量差的病人占 90 5 % ,治疗 15d和 30d生活质量差的病人分别降至 5 6 8%和 4 9 6 % ,差异有显著意义 (P =0 0 0 0 0 ;P =0 0 0 0 9)。治疗

Objective To evaluate the effect and adverse effects of morphine hydrochloric sustained release for patients with cancer pain. Methods A total of 567 patients, 369 males (65.1%) and 198 females (34.9%), aged 65～90 with a mean age of 72.6, with cancer pain, 67.4% with severe pain, (28.2%) with moderate pain ,a and 4.4% with mild pain, that were treated in 25 hospitals from 13 provinces received oral morphine hydrochloric sustained release. The recommended initial dosage was 30 mg every 12 hours, and then the dosage was regulated according to the effects until the ideal anesthesia was achieved. All patients were asked to record the attacks of pain, quality of life, and any side effect of the treatment. Results The baseline mean pain intensity (NRS) was 7.0±1.8. On the day 1, 5, 10, 15, 20, 25 and 30, the mean pain scores were decreased to 4.6±2.6,2.8±1.8,2.7±1.8,2.6±1.7,2.5±1.6,2.3±(1.4,)and 2.2±1.4 respectively (all P =0.000). The general effective rate on day 30 was 89.8%. The mean dosages were 66±56 mg/d initially, 84±64 mg/d (10～800 mg/d) on day 15, and 92±67 mg/d (10～800 mg/d) on day 30. On the day 30, 55.1% of the patients received a dosage ≤60 mg/d, 35.1% of then received a dosage of 61～120 mg/day, 7.6% of then received a dosage of 121～240 mg/day,and (2.2%) of them received a dosage ≥241 mg/d.Ninety-one point six percent (89.4%～95.8%)of the patients took morphine orally twice daily. The poor quality of life rate in the patients was 90.5% before treatment, and were 56.8% and 49.6% respectively on the day 15 and day 30 ( P =0.000 0 and P =0.000 9). The incidence of side effects was 35.6% on day 1, and 15.1% on day 30. The common side effects were constipation (14.3%), nausea (13.4%), dizziness (3.4%), vomiting (2.8%), drowsiness (0.7%), dysuria (0.4%), mental symptoms (0.2%), and respiratory depression (0.2%). Sixty-eight point four percent of the patients preferred continuation of sustained release morphine hydrochloride treatment. Conclusion Oral treatment with sustained release morphine hydrochloride for patients with cancer pain is effective, safe, and convenient, and can improve the quality of life. Sustained release morphine hydrochloride is worth recommending as a first-line drug for the treatment of patients with moderate to severe cancer pain, and the usually dosage is 120 mg or less per day.