硫酸吗啡控释片与硫酸吗啡缓释片对重度癌痛患者镇痛效果的比较

背景吗啡是WHO倡导的治疗中重度癌症疼痛的首选药物.硫酸吗啡控释片与硫酸吗啡缓释片是口服长效吗啡.该药对解除肿瘤患者的疼痛、提高生活质量十分重要.目的观察硫酸吗啡控释片与硫酸吗啡缓释片对重度癌痛的止痛效果及对患者生活质量的影响.设计以患者为研究对象的病例分析.单位一所大学附属第一医院肿瘤科、外科、内科、中医科.对象1995-10/1998-06暨南大学附属第一医院确诊肿瘤伴重度疼痛的住院患者参加此次试验.方法182例经病理证实的中晚期重度癌痛患者,95例服用硫酸吗啡控释片,12例因药物的副作用、死亡、出院而失访,83例符合标准进入试验.87例服用硫酸吗啡缓释片,25例因药物的副作用、死亡、出院而失访,62例符合标准进入试验.初始剂量均为30 mg口服,每12 h 1次;据实际镇痛效果来调整用量,直到达到满意的镇痛效果.主要观察指标疼痛强度、疼痛缓解率及完全缓解率、缓解时间、副作用、治疗前后生活质量评分.结果硫酸吗啡控释片、硫酸吗啡缓释片的镇痛有效率分别为95%,94%.完全缓解率分别为82%,80%.镇痛有效时间分别为(9.1±4.1)h,(8.7±4.4)h.两药镇痛效果及镇痛有效时间经统计学处理差异无显著性意义(P＞0.05).治疗后分别有62例(75%),47例(76%)生活质量较前提高一个等级,治疗前后生活质量评分硫酸吗啡控释片组分别为(34.6±11.5),(52.6±13.0)分(P=0.000);硫酸吗啡缓释片组分别为(37.7±9 7),(49.8±12.9)分(P=0.000),治疗前后患者生活质量差异有显著性意义.两药对骨痛、内脏痛、软组织浸润痛效果好,对神经痛效果欠佳.结论硫酸吗啡控释片或硫酸吗啡缓释片对重度癌痛止痛效果相似,镇痛时间长,副作用小,改善了患者的生活质量.

Comparative study of the analgesic effects of controlled-release morphine sulfate tablets and sustained-release morphine sulfate tablets in patients with severe cancer pain

BACKGROUND: Morphine is the first choice for the pain of medium and advanced degrees due to cancer. This is advocated in the Pain Relieving Guide of the WHO. Controlled-release morphine sulfate tablets(CRM) and sustained-release morphine sulfate tablets (SRM) all belong to oral long-acting morphine. It plays an important role in relieving cancer pain effectively and improving their quality of life(QOL).OBJECTIVE: To observe the analgesic effect of CRM and SRM and to observe how they improve the QOL of the cancer patients with severe cancer pain.SETTING: Department of oncology, department of surgery, department of internal medicine and department of traditional chinese medicine in the first affiliated hospital of a university.PARTICIPANTS: During October 1995 to June 1998, all inpatients that were pathologically proved to suffer from malignant tumor with severe pain were recruited into our study.METHODS: There were 182 patients with severe pain due to advanced cancers pathologically proven. They all met the entry criterion of the study. Totally 95 patients were treated with CRM, of which 12 cases were lost in follow-up due to side effects, death, or discharge from the hospital, and the rest 83 cases entered the stage of clinical trial. Eighty-seven patients were treated with SRM. Of them 25 cases were lost in follow-up due to side effects, death, or discharge from the hospital, and the rest 62 cases entered the stage of clinical trial. The recommended initial dosage of CRM or SRM was 30 mg every 12 hours for all patients, and then the dosage was regulated according to the effects until the ideal anesthesia was achieved.MAIN OUTCOME MEASURES: Assessments included pain severity, the effective rate, complete remission rate, remission time, adverse reactions, and the QOL before and after the treatment.RESULTS: The effective rates of CRM and SRM were 95% and 94%respectively. The complete remission rates were 82% and 80% respectively, and the remission time was(9.1 ±4.1) hours and (8.7±4.4)hours respectively. Statistically, there was no significant difference in analgesic effect and remission time between CRM and SRM. QOL was elevated for a higher degree in 62(75% ) and 47(76% ) patients after the treatment. QOL scores of CRM were (34.6 ± 11.5 ) points before treatment and (52.6 ± 13.0) points after the treatment( P = 0. 000), while QOL scores of SRM were(37.7 ± 9.7) points before the treatment and points (49.8 ± 12.9) points after the treatment (P = 0. 000). There was significant difference in QOL after the treatment. They could relicve osteocope,visceral pain, soft tissue infiltrative pain more effectively than they do about neurological pain.CONCLUSION: Oral treatment with CRM and SRM for the patients with server cancer pain shows a similar analgesic effect. They are effective, safe,and convenient, and can improve the QOL.