芬太尼透皮贴剂治疗老年癌痛病人

目的老年癌症疼痛病人未得到足够止痛治疗的情况较常见。探讨老年癌症疼痛病人接受芬太尼透皮贴剂治疗的止痛疗效及安全性。方法全国23省市136家医院参加了此项多中心开放性临床试验,共计1664例年龄≥65岁的老年癌痛病人接受芬太尼透皮贴剂治疗的止痛治疗,平均年龄72.6岁(65～90岁)。结果治疗前疼痛程度评分均值为7.34。治疗 d1、d3、d6、d9、d15、d30疼痛程度评分均值分别降低至3.82,2.80,2.43,2.11,1.83,1.79(P=0.000),总有效率97.18%。芬太尼透皮贴剂的初始、15d 和30d 用药剂量均值分别为31.34μg/h,40.59 μg/h 和47.50μg/h(25～200μg/h)。连续用药15d,91.8%病人的用药剂量仍然维持在25～50μg/h,7.5%病人用药量75～100μg/h,仅0.8%病人的用量为125～200μg/h。治疗前25.4%病人生活质量良好,治疗后15d 和30d,71.15%和73.04%病人生活质量良好(P=0.0000)。不良反应:便秘10.70%,恶心11.96%,头晕6.85%,呕吐3.85%,嗜睡2.40%,呼吸抑制0.12%。86.2%病人选择继续用芬太尼透皮贴剂。结论芬太尼透皮贴剂治疗老年癌痛病人安全有效,病人满意度高。推荐老年病人的初始剂量为25μg/h。     

芬太尼透皮贴剂治疗癌症疼痛多中心临床研究

目的 对芬太尼透皮贴剂治疗中重度癌症疼痛进行多中心开放性临床试验,研究该药对国人的止痛疗效及耐受性。方法 16家医院多中心临床研究,458例中度及重度癌症疼痛病人接受芬太尼透皮贴剂止痛治疗。所有病人至少用药15天(范围15-523天)。用药前后记录疼痛程度、生活质量及不良反应。结果 治疗前,458例癌痛病人疼痛程度评分均值为7.92(范围4-10),治疗第1、3、6、9、15、30天,疼痛程度评分平均值分别降低至6.05、4.28、3.58、3.06、2.33、1.29,P值均<0.001。86.3％的病人止痛显效时间在用药第1天;用药第5天达稳定止痛作用。治疗后生活质量明显改善。与其他部位疼痛相比较,骨转移疼痛程度(8.25)较重,止痛疗效相对较差。芬太尼透皮贴剂用药30天内,剂量范围25-150μg/h,用药>30天病人剂量范围25-750μg/h。常见不良反应包括便秘、恶心、头晕、嗜睡、胃不适、呕吐、排尿困难。便秘与年龄因素相关,呕吐及排尿困难与性别相关。结论 芬太尼透皮贴剂止痛作用强、疗效持续稳定、用药安全方便。     

芬太尼透皮贴剂治疗老年癌痛病人

目的 老年癌症疼痛病人未得到足够止痛治疗的情况较常见。探讨老年癌症疼痛病人接受芬太尼透皮贴剂治疗的止痛疗效及安 全性。 方法 全国23省市136家医院参加了此项多中心开放性临床试验,共计1664例年龄≥65岁的老年癌痛病人接受芬太尼透皮贴剂 治疗的止痛治疗,平均年龄72．6岁(65～90岁)。 结果 治疗前疼痛程度评分均值为7．34。治疗d1、d3、d6、d9、d15、d30疼痛程度评分均值分别降低至3．82,2．80,2．43,2．11,1．83, 1．79(P=0．000),总有效率97．18％。芬太尼透皮贴剂的初始、15d和30d用药剂量均值分别为31．34μg/h,40．59μg／h和47．50 μg／h(25～200μg／h)。连续用药15d,91．8％病人的用药剂量仍然维持在25～50μg／h,7．5％病人用药量75～100μg/h,仅0．8％ 病人的用量为125～200μg/h。治疗前25．4％病人生活质量良好,治疗后15d和30d,71．15％和73．04％病人生活质量良好(P=0． 0000)。不良反应：便秘10．70％,恶心11．96％,头晕6．85％,呕吐3．85％,嗜睡2．40％,呼吸抑制0．12％。86．2％病人选择继续用 芬太尼透皮贴剂。结论 芬太尼透皮贴剂治疗老年癌痛病人安全有效,病人满意度高。推荐老年病人的初始剂量为25μg／h。     

芬太尼透皮贴剂治疗中重度癌痛3日内临床疗效及安全性观察

目的评价芬太尼透皮贴剂对中重度癌痛患者3日内镇痛的临床疗效及安全性。方法通过开放性多中心临床观察,将234例中重度癌痛患者分为两组:口服盐酸吗啡片滴定后转换为芬太尼透皮贴剂组(A组);芬太尼透皮贴剂直接滴定组(B组)。评估治疗前和芬太尼使用3天后患者的疼痛程度、生活质量及不良反应。疼痛减轻程度大于初始评估50%以上者判定为疼痛治疗有效。结果 A组和B组疼痛总缓解率分别为87%(87/100)和85.1%(114/134),P=0.675,治疗前和治疗3日后A组患者NRS均值分别为6.55±0.58、2.53±0.93(P=0.000);B组患者NRS均值分别为6.83±0.81,2.33±1.05(P=0.000);A组和B组芬太尼透皮贴剂初始剂量均值分别为(59.0±78.5)μg/h和(45.4±77.0)μg/h,使用3日后调整的剂量均值分别为(65.6±78.9)μg/h和(57.9±81.3)μg/h,组间比较差异无统计学意义;3日内A组对芬太尼进行剂量调整的患者占31%(31/100),明显低于B组60.4%(81/134)(P=0.000);A组1周内出现爆发痛的比例(19%,19/100)亦明显低于B组(52.2%,70/134)(P=0.000)。A、B两组出现的便秘、恶心呕吐、嗜睡、皮肤瘙痒、尿潴留等不良反应差异无统计学意义。A、B两组的生活质量(quality of life,QOL)评分在用药3日后均明显高于治疗前(P=0.000),组间比较差异无统计学意义。结论芬太尼透皮贴剂3日内镇痛效果满意,直接滴定治疗安全有效,但存在爆发痛风险,需调整治疗剂量;推荐即释吗啡滴定联合芬太尼透皮贴剂作为中重度癌痛治疗的首选组合之一。     

大剂量芬太尼透皮贴剂治疗晚期癌痛的临床观察

目的:观察大剂量芬太尼透皮贴剂治疗晚期癌痛的近期疗效及不良反应,评价其安全性。方法:使用大剂量芬太尼透皮贴剂（剂量≥300μg/h）治疗晚期癌痛5例,观察其止痛疗效及不良反应。结果:5例患者疼痛得到较好控制。出现便秘3例,1例患者出现头晕,1例患者出现嗜睡,经对症处理后均可缓解。未出现呼吸抑制、肝肾功能损害等不良反应。未出现治疗相关性死亡。结论:大剂量芬太尼透皮贴剂治疗晚期癌痛疗效满意,合理用药是安全有效的,其毒副反应可以耐受。     

芬太尼透皮贴剂治疗晚期癌痛60例临床观察

[目的]观察芬太尼透皮贴剂(多瑞吉)治疗中、重度癌痛患者的临床效果、不良反应.[方法]60例中、重度癌痛患者给予芬太尼透皮贴剂镇痛治疗,初始剂量25μg/h,每3天更换1次,然后根据疼痛情况调整剂量,直到患者无痛或基本无痛,每位患者至少连续治疗16天.[结果]总疼痛缓解率达95.0%(25/60).患者生活质量明显提高,不良反应少且轻.[结论]芬太尼透皮贴剂治疗晚期癌症中、重度疼痛疗效满意,使用简单、无创.     

晚期肺癌癌痛患者口服吗啡转换为芬太尼贴剂的临床疗效

目的探讨晚期肺癌癌痛患者由口服吗啡转换应用芬太尼透皮贴剂的临床疗效。方法59例口服吗啡镇痛不满意的晚期肺癌伴重度癌痛患者,换用芬太尼透皮贴剂止痛,剂量换算公式为：芬太尼透皮贴剂72h剂量（μg/h）=口服吗啡（mg/d）×0．5,根据疼痛评分调整剂量,将疼痛控制在3分以下。数字评分法记录疼痛强度、生活质量和不良反应评分。结果59例晚期肺癌癌痛患者药物转换后疼痛强度明显降低,转换前疼痛评分均值为（6．27±1．15）分,转换后6d为（2．15±0．87）分,15d为（2．03±0．68）分,30d为（1．95±0．73）分（P〈0．01）。总的疼痛缓解率81．35％。转换后生活质量评分明显提高（P〈0．05）,不良反应如恶心／呕吐和便秘发生率降低,但皮肤瘙痒的发生率提高（P〈0．05）。结论无法应用口服吗啡镇痛的晚期肺癌癌痛患者,转换应用芬太尼贴剂后,镇痛效果提高,生活质量得到明显改善。     

治疗肺癌晚期癌痛芬太尼透皮贴剂的疗效观察

目的　观察芬太尼透皮贴剂治疗肺癌癌痛的效果及其不良反应。方法　 40例肺癌中、重度癌痛的患者 ,使用芬太尼透皮贴剂。采用多中心随机开放实验 ,初始剂量 2 5 μg/h或参照吗啡与贴剂折算表使用 ,每 3天更换 1次 ,并根据疼痛情况调整剂量 ,直至患者达到满意的镇痛。结果　疼痛中度以上缓解达到 10 0 % ,其中完全缓解 62 5 % ,明显缓解 37 5 %。芬太尼贴剂的主要不良反应为便秘、头晕、恶心、嗜睡、皮肤搔痒 ,未出现呼吸抑制等严重不良反应。结论　芬太尼透皮贴剂治疗肺癌晚期癌痛疗效可靠     

治疗肺癌晚期癌痛芬太尼透皮贴剂的疗效观察

目的 观察芬太尼透皮贴剂治疗肺癌癌痛的效果及其不良反应。方法 40例肺癌中、重度癌痛的患者，使用芬太尼透皮贴剂。采用多中心随机开放实验，初始剂量25μg／h或参照吗啡与贴剂折算表使用，每3天更换1次，并根据疼痛情况调整剂量，直至患者达到满意的镇痛。结果 疼痛中度以上缓解达到100％，其中完全缓解62．5％，明显缓解37．5％。芬太尼贴剂的主要不良反应为便秘、头晕、恶心、嗜睡、皮肤搔痒，未出现呼吸抑制等严重不良反应。结论 芬太尼透皮贴剂治疗肺癌晚期癌痛疗效可靠。     

芬太尼透皮贴剂治疗中重度癌痛54例临床观察

[目的]观察芬太尼透皮贴剂(多瑞吉)治疗中重度癌痛的疗效、副作用。[方法]54例中重度癌痛患者，给予芬太尼透皮贴剂在皮肤贴敷，滴定初始剂量，根据疼痛变化情况每60～72小时调整剂量．直至疼痛级别转为轻度疼痛，维持剂量为25μg/h～250μg/h，出现暴发痛者给予即释吗啡肌注。观察治疗前后的疼痛评分变化，以食欲、睡眠、精神状态、日常活动、与人交往5项指标评价生活质量．对治疗前后的评分进行统计分析。[结果]采用VAS评分法，疼痛完全缓解率为22．2％(12／54)，止痛有效率为96．3％(52／54)。胃肠道反应、头晕、便秘、局部皮肤红肿的发生率分别为29．6％、13．0％、5．6％、5．6％．治疗后患者生活质量评分较治疗前提高。[结论]芬太尼透皮贴剂可有效地治疗中重度癌痛，使用方便，副作用轻，能提高癌痛患者的生活质量。     

芬太尼透皮贴剂治疗30例中度、重度癌痛

目的：研究芬太尼透皮贴剂用于癌痛患者的镇痛效果、不良反应及使用后患者生活质量的改善。方法：30例中度或重度癌痛的患者，使用芬太尼透皮贴剂。记录有后的疼痛强度、生活质量评分及用药后的不良反应，加以归纳总结。结果：芬太尼透皮贴剂使用后，全部患者均获中度以上缓解。其中安全缓解13例（43.33%)，明显缓解16例（53.33%），中度缓解1例（3.33%）。不良反应有恶心、呕吐、便秘、头晕及嗜睡等，但发生率较低，患者的生活质量均得到明显改善。结论：对于中度或重度癌痛的患者，使用芬太尼透皮贴剂，能安全、有效和简单的控制癌痛，改善生活质量且不良反应发生率较低。     

芬太尼透皮贴剂治疗中重度癌痛433例临床观察

目的:进一步评价芬太尼透皮贴剂治疗中、重度疼痛的疗效、安全性及对生活质量的影响,为临床合理用药提供参考资料.方法:采用多中心随机开放方法,对433例中、重度疼痛患者使用芬太尼透皮贴剂进行观察,芬太尼的初始剂量是2.5mg或参照吗啡芬太尼折算表计算,贴膜每3日更换1次,在使用期间根据疼痛情况进行剂量调整,直到患者无痛或基本无痛.结果:可评价患者336例,其癌痛缓解率100%,41.6%的患者第1次使用后未再进行剂量调整,57.3%的患者调整过1～3次.芬太尼的中位剂量7.5mg,其中92.9%患者在2.5～10mg之内.不良反应轻,主要为恶心、便秘、头晕、呕吐、嗜睡、排尿困难等.治疗后生活质量有明显改善.结论:芬太尼透皮贴剂治疗中、重度疼痛的疗效显著,使用方便,不良反应轻,能明显改善患者的生活质量,绝大多数患者的调整次数在3次以内,大多数患者的使用剂量在每3天2.5～10mg.     

Efficacy and adverse effects of transdermal fentanyl and sustained-release oral morphine in treating moderate-severe cancer pain in Chinese population: a systematic review and meta-analysis

Background

Previous meta-analysis suggested that transdermal fentanyl was not inferior to sustained-release oral morphine in treating moderate-severe cancer pain with less adverse effects. Now, we updated the data and performed a systematic review.

Methods

Updated cohort studies on transdermal fentanyl and oral morphine in the treatment of cancer pain were searched in electronic databases including CBMdisc, CNKI, VIP, Medline, EMBASE and Cochrane Library. Primary end points assessed by meta-analysis were remission rate of pain and incidence of adverse effects. Quality of life was assessed by systematic review, which was the second end point.

Results

32 cohort studies, which included 2651 patients, were included in present study. The remission rate in transdermal fentanyl group and sustained-release oral morphine group were 86.60% and 88.31% respectively, there was no significant difference [RR = 1.13, 95% CI (0.92, 1.38), P = 0.23]. Compared with oral morphine group, there were less adverse effects in terms of constipation [RR = 0.35, 95% CI (0.27, 0.45), P < 0.00001], nausea/vomiting [RR = 0.57, 95% CI (0.49, 0.67), P < 0.00001], and vertigo/somnolence [RR = 0.59, 95% CI (0.51, 0.68), P < 0.00001] in transdermal fentanyl group. Six of selected trials supported either transdermal fentanyl or sustained-release oral morphine improved QOL of cancer patients and one of them showed more patients got better QOL after sustained-release oral morphine transferred to transdermal fentanyl.

Conclusions

Our study showed again that both transdermal fentanyl and oral morphine had the same efficacy in the treatment of moderate-severe cancer pain in Chinese population, but the former might have less adverse effects and better quality of life.     

Use of TTS fentanyl as a single opioid for cancer pain relief: a safety and efficacy clinical trial in patients naive to mild or strong opioids.

BACKGROUND: Up to now, a transdermal therapeutic system (TTS) of fentanyl has been applied to cancer patients on opioid analgesics previously treated with mild opioids or morphine. The aim of this study was to investigate the efficacy and safety of TTS fentanyl (patch) administration as an analgesic to patients treated with opioid analgesics for moderate-to-severe cancer pain, with immediate-release oral morphine only as rescue medication. The prior analgesic medication of the patients did not include mild or strong opioids. METHODS: The study group consisted of 113 patients (54 men and 59 women; age range: 21-87 years, mean +/- SD 61.3 +/- 14.84 years) with undertreated chronic cancer pain. The study period was 42 days. The patients were hospitalized for the first 3 days of the study; thereafter they were transferred to their home for the rest of the study. Daily cards were completed, noting their pain score (0-10 VAS), nausea, vomiting, constipation, skin reactions, dizziness or any other complaints. Vital signs were also recorded. Data assessments were made at baseline, on days 1, 2 and 3 (during hospitalization) and thereafter on days 7, 14, 21, 28, 35, and 42 after hospital discharge. The initial TTS fentanyl delivery rate was chosen depending on the patient's analgesic requirements. All patients were given an oral morphine solution (5-10 mg), every 4-6 h, for the first 12 h, as rescue medication. RESULTS: Baseline pain score was between 6 and 10 (mean +/- SD 7.1 +/- 1.7). The initial TTS fentanyl delivery rate was between 25 and 50 microg/h (mean +/- SD 36.5 +/- 15.7). On day 3, 95 patients (84%) reported a pain score < or = 3 (mean +/- SD 0.5 +/- 0.8), 14 patients (12.4%) a pain score of 4 and 4 patients (3.5%) of 5-8. No adverse effects suggesting the discontinuation of the study were reported. From day 7 until the completion of the study, the mean pain score was between 1.3 and 0.16 while the TTS fentanyl delivery rate on day 42 was between 25 and 400 microg/h (mean +/- SD 122.1 +/- 81.2 microg/h). CONCLUSION: Analgesic treatment with TTS fentanyl used as a single opioid is effective and safe for cancer pain relief, given that is cautiously applied, in patients requiring strong opioid analgesics even if they were naive to strong or mild opioids.     

Home palliative care--2 case reports: a long-term cancer pain management with transdermal fentanyl

Transdermal Fentanyl was released in March 2002 in Japan after the acceptance of the insurance under the office of public health. Transdermal therapy is especially effective for patients having difficulty of oral intakes, and for home care cancer patients who suffer from chronic pain only if the therapy is feasible on the long-term basis. We report our cases for long-term cancer pain management with transdermal fentanyl. A total of 52 long-term patients with chronic cancer pain (28 men and 24 women with an average age of 63.5 years, range 46-74 years) were evaluated. The most prevalent cancers were colorectum (n=14), stomach (n=10), breast (n=8), esophagus (n=6), pancreas (n=6), and others. The duration of the transdermal therapy varied from minimum of 2 days to maximum of 630 days. Two patients on this therapy were longer than 500 days. The transdermal therapy was discontinued 2-37 days for 8 patients due to uncontrolled pain relief. Case report 1: A 72-year-old woman suffering from a relapse of pancreatic cancer with chronic back pain experienced a good pain relief after switching from 60 mg/day sustained oral release morphine to 2.5 mg transdermal fentanyl. During the long-term treatment, the transdermal fentanyl dosage had to be increased. Transdermal therapy was continued until the patient's death on day 601. The last fentanyl dosage was 7.5 mg. Transdermal therapy was given 319/601 days at home and 282/601 days in the hospital. Meanwhile, a little rescue suppository morphine was used as an adjuvant during the duration of transdermal therapy. Case report 2: A 73-year-old man suffered a relapse of rectal cancer. He experienced adequate pain relief with 40 mg oral sustained release morphine, but he was switched to 2.5 mg transdermal fentanyl. Transdermal therapy was continued until today on day 630. At present, fentanyl dosage is 20 mg. The patient has been treated at home for 622/630 days. He was hospitalized only once for 8 days because of dehydrations, and has been treated at home. Only a little rescue powder morphine was needed as an adjuvant during the duration of transdermal therapy. In these 2 cases of long-term cancer pain management, transdermal therapy has resulted in good pain reduction and the side effects with transdermal therapy were not noted. Transdermal fentanyl can be recommended for treatment of palliative cancer pain at home.     

盐酸羟考酮控释片与芬太尼透皮贴治疗中重度癌痛的疗效比较

目的：探讨盐酸羟考酮控释片和芬太尼透皮贴治疗中重度癌痛的效果,寻找治疗中重度癌痛的有效方法。方法选取中重度癌痛患者80例,利用随机数字表法分成盐酸羟考酮控释片组40例和芬太尼透皮贴剂组40例,比较两组患者用药后的疗效及不良反应。结果盐酸羟考酮控释片组患者不良反应如恶心、呕吐、便秘不良反应发生率高于芬太尼透皮贴剂组,差异具有统计学意义（P﹤0.05）;两组患者镇痛效果比较,差异无统计学意义（P﹥0.05）。结论芬太尼透皮贴在治疗中重度癌痛中能达到和盐酸羟考酮控释片相似的镇痛效果,且不良反应发生率低于盐酸羟考酮控释片,安全性较好,可作为治疗中重度癌痛的方案之一。