硫酸吗啡栓治疗癌痛的Ⅱ期临床试验

[摘要]目的：评价硫酸吗啡栓直肠给药治疗中重度慢性癌痛的有效性和安全性。方法：采用多中心、随机、双盲、双模拟、阳性药物平行对照临床试验,将132例中重度慢性癌痛患者随机分为试验组和对照组,试验组患者每次经肛门给予硫酸吗啡栓1枚,同时口服硫酸吗啡片模拟片1片,对照组患者每次口服硫酸吗啡片1片,同时经肛门给予硫酸吗啡栓模拟药1枚。每日硫酸吗啡栓用量不得超过100mg,共按需给药7d。结果：试验组、对照组患者d1第1次、第2次用药后疼痛强度（PI）较治疗前均明显下降(P<0.05),与用药前相比的疼痛强度差两组之间相比,差异无统计学意义(P>0.05);硫酸吗啡栓能明显缓解患者的疼痛症状,与对照组相比,差异无统计学意义(P>0.05);试验组有效率与对照组相比,差异无统计学意义(P>0.05)。两组患者在d2~d7疼痛强度进行组间比较,差异无统计学意义(P>0.05)。结论：硫酸吗啡栓直肠给药治疗中重度慢性癌痛安全有效。     

硫酸吗啡控释片治疗癌痛的临床疗效观察

目的观察硫酸吗啡控释片(美施康定)对晚期癌症疼痛患者的止痛效果和不良反应.方法选择100例应用第二阶梯止痛药不能缓解的中、重度癌痛患者,给予美施康定口服治疗,在用药后15天评价疼痛缓解率及不良反应.结果中度疼痛组镇痛后缓解率为91.8%,重度疼痛组缓解率为96.8%,总的疼痛缓解率为95%,副作用较轻,多为便秘、恶心呕吐及头晕等,未发现呼吸抑制及成瘾现象.结论美施康定具有使用方便、止痛效果确切、维持时间长、毒副作用小等优点,值得临床作为第三阶梯止痛药推广应用.     

硫酸吗啡控释片治疗癌痛体会

硫酸吗啡控释片为阿片类药物 ,治疗中晚期癌痛疗效显著 ,对 1997年以来 ,使用该药 80例患者的疗效及各种副反应进行回顾性分析 ,现报告如下。对象与方法一、对象 :80例患者 ,男性 5 1例 ,女性 2 9例。年龄 9～ 88岁 ,平均年龄 5 4 6岁。全部为中晚期癌症患者 ,其中肺癌 30例 ,乳腺癌、胃癌各 8例 ,结肠癌 7例 ,肝癌 5例 ,食管癌、胰腺癌各 4例 ,鼻咽癌、骨肉瘤、前列腺癌各 2例 ,肾癌、多发性骨髓瘤、淋巴瘤各 1例 ,不明原因骨转移癌 5例。疼痛程度 :重度疼痛 6 5例 ,中度疼痛 15例。疼痛类型包括 :骨痛、内脏痛、软组织浸润性痛、神经痛及…     

硫酸吗啡控释片结合放疗治疗骨转移中重度癌痛的临床观察

目的　观察硫酸吗啡控释片 (美施康定 )结合放疗治疗骨转移引起中重度癌痛的镇痛效果。方法　将 12 0例骨转移引起中重度癌痛患者随机分为A、B两组 ,各 6 0例 ,A组 :美施康定结合放射治疗 ;B组 :单口服美施康定。结果　疼痛完全缓解率 ,A组为 83 3% ,B组为 5 6 7% ,P <0 0 2 5 ;镇痛显著有效率 ,A组为 98 3% ,B组为 86 7% ,P <0 0 5。A组 4 9例病人在放疗后 ,可以停用美施康定而不出现药物依赖 ,也无明显戒断症状。结论　美施康定结合放疗综合治疗中重度癌痛 ,镇痛效果迅速且较持久 ,放疗后可以停用美施康定 ,由于结合放疗缩短了用药时间 ,不出现依赖作用 ,且无明显的戒断症状 ,同时提高了晚期肿瘤病人生活质量。     

度洛西汀与硫酸吗啡联合治疗癌痛的临床疗效观察

目的：对比观察度洛西汀与硫酸吗啡缓释片与单用硫酸吗啡治疗癌痛的疗效与安全性。方法将60例中重度癌痛患者随机分为单药治疗组（硫酸吗啡缓释片,100-200mg/d）和合并治疗组（同等剂量的硫酸吗啡缓释片＋度洛西汀,前2周30mg/d,2周后60mg/d）,分别在基线及用药7、14、28d以NRS评分方法、SDS及HRSD量表评估疼痛分数及抑郁严重程度,指导用药并记录毒副反应。并持续观察脱落率。结果两组治疗前NRS评分无显著差异,用药第28d评分有显著差异（P〈0.05）;两组治疗前SDS评分无显著差异,用药第28d评分有显著差异（P〈0.05）;两组治疗前HRSD评分无显著差异,用药第28d评分有显著差异（P〈0.05）;2组脱落率相似（第4周8.9％vs 10.0％,第8周15.6％vs 17.8％及第12周23.3％vs 25.6％,均P〉0.05）。两组均未发生严重毒副反应,虽然便秘、出汗和心悸的不良反应频数合并治疗组较高,但差异未达统计学意义。结论洛西汀和硫酸吗啡缓释片用于癌症患者止痛效果优于单纯应用硫酸吗啡缓释片,而且对改善患者情绪和生活质量效果也好。     

硫酸吗啡控释片治疗重度癌痛的个体化用药

癌症患者最令人恐惧的并发症是疼痛,疼痛仍是目前诊断、治疗过程中非常棘手的问题.有效控制癌痛,最大程度提高生活质量,是患者的权利,也是医师的职责.按照世界卫生组织(WHO)三阶梯止痛治疗原则进行癌痛的规范化治疗,目前绝大多数癌性疼痛患者的疼痛可得到较好缓解.     

硫酸吗啡控释片大剂量口服治疗癌痛一例报道

我科一晚期肿瘤患者口服硫酸吗啡控释片(美施康定)时间长达２０个月,最高剂量达到１２００ｍｇ．ｄ-１。现报道如下:患者,女,年龄４６ａ,身高１７０ｃｍ,体重５１ｋｇ,职业:护士。１９８９年７月初以右颌下肿块起病。８月９日在本市九院行“口底部癌根治术”,手术病理:右口底腺样囊性癌(筛状型)。术后化疗２次。９月１９日始在肿瘤医院放疗。此后病情稳定。１９９２年１月在上海胸科医院经胸片及ＣＴ检查证实癌肿两肺广泛转移,以右侧为主。１９９６年３月癌肿累及胸壁,１９９７年６月又累及膈肌和肋骨。其间先后在上海肿瘤医院和我院化疗…     

硫酸吗啡缓释片治疗100例中、重度癌痛的疗效分析

目的:探讨硫酸吗啡缓释片治疗中、重度癌痛的临床效果.方法 :选取我院住院并应用硫酸吗啡缓释片治疗的中、重度癌痛患者100例,对其临床资料进行回顾性分析,总结其VAS评分、临床疗效以及不良反应等情况.结果:患者应用硫酸吗啡缓释片控制疼痛的总有效率为92%,硫酸吗啡缓释片每12 h使用剂量从10 mg/次到300 mg/次;至首次稳定止痛平均用量为(39.25±12.60)mg/12 h;持续用药时间7~180 d,平均持续用药时间(38.56±16.22)d;不良反应发生率随用药时间延长而逐渐降低,在持续用药≥6周的68例患者中,不良反应发生率从第1周的48.5%(33/68)降低到第6周的10.3%(7/68).结论 :硫酸吗啡缓释片治疗中、重度癌痛疗效显著,且不良反应随用药时间延长而逐渐降低,是临床控制中、重度癌痛的理想选择之一.     

硫酸吗啡控释片联合复方苦参注射液治疗癌痛的疗效评价

目的:观察硫酸吗啡控释片(美施康定)联合复方苦参注射液治疗癌痛的近期疗效。方法:120例癌痛患者随机分成治疗组和对照组,分别给予硫酸吗啡控释片联合复方苦参注射液治疗和单用硫酸吗啡控释片治疗。结果:治疗组癌痛显效52例,有效4例,总有效率93.33%;对照组癌痛显效41例,有效8例,总有效率81.67%。两组间显效率有显著性差异(P<0.05)。结论:硫酸吗啡控释片(美施康定)联合复方苦参注射液治疗癌痛疗效较好。     

硫酸吗啡与盐酸吗啡普通片对照治疗中、重度癌痛84例

目的:评价硫酸吗啡与盐酸吗啡普通片对癌症疼痛的镇痛疗效及不良反应.方法:采用多中心随机对照试验,试验组(n=44)用硫酸吗啡,对照组(n=40)用盐酸吗啡,起始量均为10～30mg,每4～6h用1次,进行个体剂量滴定,达到无痛或基本无痛的维持量继续应用,共7d.结果:2组的疼痛完全缓解率分别为77.3%与77.5%,显著缓解率为95.5%与97.5%,总有效率为100%.结论:硫酸吗啡与盐酸吗啡片治疗中、重度癌痛均有显著疗效.     

硫酸吗啡缓释片治疗中重度癌性疼痛的临床研究

目的研究用硫酸吗啡缓释片控制中重度癌性疼痛的临床疗效。方法对240例中重度癌性疼痛患者使用硫酸吗啡缓释片进行止痛治疗,初始剂量10～30 mg/次,每12小时用药1次,个体化用药,同时给予辅助药物增强止痛效果,减轻或避免不良反应。结果疼痛缓解率95.8%,平均维持剂量为80 mg/d,最大剂量为360 mg/d,其中47.5%患者不需要增加初始剂量,52.5%增加范围在50%～300%,不良反应均能耐受,无一例出现精神依赖性。结论硫酸吗啡缓释片可以作为中重度癌性疼痛的首选用药。     

Meta-analysis of the clinical efficacy and safety of oxycodone and morphine in cancer pain treatment

In the present study, the efficacy and safety of oxycodone and morphine in the treatment of cancer pain were compared in a meta-analysis with the goal of providing a reference for drug selection in clinical practice. Electronic literature databases were searched for articles published through February 2015, including PubMed, MEDLINE, the Cochrane library, and Embase; and the China National Knowledge Internet, VIP Databases and Wanfang Databases for studies published in Chinese. Only randomized controlled trials were selected. The primary outcome measures were efficacy and the incidence of adverse drug reactions (ADRs). Data were extracted from the studies by two independent reviewers. A total of 15 studies containing 1338 patients were included in the analysis. The studies were divided into two subgroups according to different scoring methods. The pain relief efficacies of oxycodone and morphine were rated by the numerical rating scale (NRS) (risk ratio [RR]: 1.04; 95% confidence interval [CI]: 0.97–1.11). Others were rated by the visual analog scale (VAS) (RR: 1.03; 95% CI: 0.97–1.10). Five studies showed that pain intensity scores did notsignificantly differ between oxycodone and morphine treatments (standard mean difference [SMD] = 0.16, 95% CI: –0.01~0.33, P = 0.06). Regarding ADRs, the incidence of constipation was lower in the oxycodone group (RR: 0.70; 95% CI: 0.58–0.85). No statistical difference was observed among other ADRs. The efficacies of oxycodone and morphine were similar in treating cancer pain. However, the incidence of constipation was lower in patients treated with oxycodone.     

系统评价塞来昔布联用阿片类药物治疗中重度癌性疼痛的有效性和安全性

目的 系统评价塞来昔布联用阿片类药物（吗啡、羟考酮）治疗中重度癌性疼痛的临床疗效和安全性。方法 检索Cochrane Library、PubMed、中国生物医学文献数据库（CBM）、中国学术期刊全文数据库（CNKI）、维普中文期刊全文数据库（VIP）和万方数据库关于塞来昔布联用阿片药物对比单用阿片类药物治疗中重度癌性疼痛的随机对照试验（RCTs）,检索时间为2000年1月—2019年7月。由2名研究者独立提取数据、评价质量,并交叉核对。采用RevMan 5.3软件进行Meta-分析。结果 共纳入12项RCTs,1 292例患者。Meta-分析结果显示相对于单用阿片,塞来昔布联用阿片药物能显著提高疼痛缓解率（OR=1.94,95%CI=1.64～2.59）、减少日均阿片药物用量（MD=-10.64,95%CI=-15.03～-6.26）和提高生活质量（MD=3.53,95%CI=1.34～5.72）,差异均有统计学意义（P<0.01）,按照阿片药物类别进行亚组分析结果与上述Meta-分析结果一致。在安全性方面,塞来昔布能显著降低吗啡便秘、恶心呕吐、嗜睡、头痛头晕发生率和羟考酮便秘发生率（P<0.01）,对阿片药物致排尿困难发生率无影响。结论 塞来昔布联用阿片药物用于中重度癌痛患者镇痛疗效确切,同时可显著降低便秘和恶心呕吐等发生率。     

Systematic review of efficacy and safety of buprenorphine versus fentanyl or morphine in patients with chronic moderate to severe pain

Abstract

Objective:

To systematically assess efficacy and safety of buprenorphine patch versus fentanyl patch in patients with chronic moderate to severe pain.     

Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain

ABSTRACT

Objective: To assess the long-term efficacy, tolerability and safety of polymer-coated extended- release morphine sulfate (P-ERMS) (KADIAN) compared with controlled-release oxycodone HCl (CRO) (OxyContin) in treating chronic, nonmalignant, moderate to severe pain in a community- based outpatient population.

Design: Phase IV, prospective, randomized, open-label.

Participants: Adults (N = 112) with chronic, nonmalignant, moderate to severe pain with visual numeric scale (VNS) scores ≥ 4 (0 = no pain; 10 = worst pain).

Interventions: Patients were randomized to receive either P-ERMS once-daily (QD) dosing or CRO twice-daily (BID) dosing for a 24‐week treatment period. Upward titration of dose and switching P-ERMS to BID or CRO to thrice-daily (TID) dosing was allowed Weeks 2–24.

Main outcome measures: Quality of life (Physical [PCS] and Mental [MCS] Component Summary scores of the SF-36v2 Health Survey), pain and sleep scores (0–10), and patient and clinician assessments of current therapy (–4 to +4).

Results: Patients in both treatment groups experienced significant improvements in PCS scores (P-ERMS, +2.6; CRO, +3.1; p < 0.05 vs. baseline); patients taking CRO also demonstrated improvements in MCS scores (+4.7, p < 0.05 vs. baseline). Both groups attained significant reductions from baseline to 24 weeks in pain (P-ERMS, –2.0; CRO, –1.4; p ≤ 0.001 vs. baseline); the reduction with P-ERMS was clinically meaningful (as defined by at least a 2‐point reduction in VNS score). Patients attained significant improvement in sleep scores (P-ERMS, –2.6; CRO, –1.6; p < 0.001 vs. baseline; p < 0.05, P-ERMS vs. CRO). At Week 24, both groups indicated significantly increased patient (P-ERMS, +2.6; CRO, +1.7; p < 0.001 vs. baseline) and clinician (P-ERMS, +4.0; CRO, +3.1; p < 0.001 vs. baseline) global assessments of therapy. After 24 weeks, all patients on P-ERMS were dosing within the FDA-approved frequencies (65% QD, 35% BID); 56% of patients on CRO dosed BID, but 38% dosed TID and 6% dosed four times daily (QID). Most common adverse events were constipation, nausea, and somnolence, with no significant difference between treatment groups.

Conclusions: P-ERMS and CRO both relieved chronic nonmalignant pain in this community-based population; however, patients taking P-ERMS dosed in accordance with FDA-approved frequencies (QD/BID); 44% of those taking CRO dosed more frequently (TID/QID).     

Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain

OBJECTIVE: To assess the long-term efficacy, tolerability and safety of polymer-coated extended-release morphine sulfate (P-ERMS) (KADIAN) compared with controlled-release oxycodone HCl (CRO) (OxyContin) in treating chronic, nonmalignant, moderate to severe pain in a community-based outpatient population.DESIGN: Phase IV, prospective, randomized, open-label. PARTICIPANTS: Adults (N = 112) with chronic, nonmalignant, moderate to severe pain with visual numeric scale (VNS) scores > or = 4 (0 = no pain; 10 = worst pain). INTERVENTIONS: Patients were randomized to receive either P-ERMS once-daily (QD) dosing or CRO twice-daily (BID) dosing for a 24-week treatment period. Upward titration of dose and switching P-ERMS to BID or CRO to thrice-daily (TID) dosing was allowed Weeks 2-24. MAIN OUTCOME MEASURES: Quality of life (Physical [PCS] and Mental [MCS] Component Summary scores of the SF-36v2 Health Survey), pain and sleep scores (0-10), and patient and clinician assessments of current therapy (-4 to +4). RESULTS: Patients in both treatment groups experienced significant improvements in PCS scores (P-ERMS, +2.6; CRO, +3.1; p < 0.05 vs. baseline); patients taking CRO also demonstrated improvements in MCS scores (+4.7, p < 0.05 vs. baseline). Both groups attained significant reductions from baseline to 24 weeks in pain (P-ERMS, -2.0; CRO, -1.4; p < or = 0.001 vs. baseline); the reduction with P-ERMS was clinically meaningful (as defined by at least a 2-point reduction in VNS score). Patients attained significant improvement in sleep scores (P-ERMS, -2.6; CRO, -1.6; p < 0.001 vs. baseline; p < 0.05, P-ERMS vs. CRO). At Week 24, both groups indicated significantly increased patient (P-ERMS, +2.6; CRO, +1.7; p < 0.001 vs. baseline) and clinician (P-ERMS, +4.0; CRO, +3.1; p < 0.001 vs. baseline) global assessments of therapy. After 24 weeks, all patients on P-ERMS were dosing within the FDA-approved frequencies (65% QD, 35% BID); 56% of patients on CRO dosed BID, but 38% dosed TID and 6% dosed four times daily (QID). Most common adverse events were constipation, nausea, and somnolence, with no significant difference between treatment groups. CONCLUSIONS: P-ERMS and CRO both relieved chronic nonmalignant pain in this community-based population; however, patients taking P-ERMS dosed in accordance with FDA-approved frequencies (QD/BID); 44% of those taking CRO dosed more frequently (TID/QID).