两种双膦酸盐治疗恶性肿瘤骨转移疼痛的药物经济学分析

目的：研究唑来膦酸和伊班膦酸钠治疗恶性肿瘤骨转移疼痛的药物经济学。方法：45例恶性肿瘤骨转移疼痛的患者随机分为两组,一组接受4mg唑来膦酸治疗,另一组接受4mg伊班膦酸钠治疗,比较两组患者首次住院双膦酸盐治疗的总费用、费用组成、疼痛缓解率、不良反应,进行药物经济学的费用-效果分析。结果：唑来膦酸组（n=23）总费用低于伊班膦酸钠组（n=22）,分别为2 409.22元和3 903.64元（P〈0.05）;两组疼痛缓解有效率分别为78.3%和72.3%,无显著性差异（P〉0.05）;两组费用-效果比为31.75和53.99;不良反应发生率两组间无显著性差异（P〉0.05）。结论：唑来膦酸是治疗恶性肿瘤骨转移的安全、有效、经济的药物。     

负荷剂量伊班膦酸钠与常规剂量唑来膦酸治疗恶性肿瘤骨转移的疗效比较

目的对比分析负荷剂量伊班膦酸钠与常规剂量唑来膦酸在恶性肿瘤骨转移患者中的疗效和安全性。方法将江门市中心医院2015年6月至2016年9月收治的70例恶性肿瘤骨转移患者按随机抽签法平均分为伊班膦酸钠组(伊班膦酸钠首剂6 mg/d,连续3 d,随后6 mg/4周)和唑来膦酸组(唑来膦酸4 mg/4周),4周为1周期,两组均治疗4周期(16周),评价镇痛有效率、骨相关事件及药物不良反应发生率。结果负荷剂量伊班磷酸钠组与常规剂量唑来膦酸组相比,起效更快[(23.4±2.5)h比(67.1±5.3)h](P0.05),镇痛有效率更高(89.0%比66.6%)(P0.05),骨相关事件累计发生率较低(10.9%比24.3%)(P0.05);两组均无严重药物不良反应,但伊班膦酸钠的肾毒性更低。结论负荷剂量伊班磷酸钠对恶性肿瘤骨转移的疗效更好。     

唑来膦酸治疗恶性肿瘤骨转移引起疼痛的疗效分析

为了探讨唑来膦酸治疗骨转移引起疼痛的效果和不良反应,将恶性肿瘤骨转移引起疼痛的160例患者分为2组,治疗组78例,采用唑来膦酸4mg静脉滴入(15min以上),每4周重复1次;对照组82例采用帕米膦酸钠90mg静脉滴入6h,每4周重复1次。结果提示疼痛缓解总有效率在治疗组、对照组各为92.3%和82.9%,P=0.073。疼痛缓解后复发时间,治疗组和对照组各为16.4、12.6d,P=0.184;两组不良反应轻微,对照组发热发生率略高于治疗组。初步研究结果提示,唑来膦酸对骨转移引起的疼痛有良好的止痛效果,不良反应少。     

唑来膦酸注射液治疗恶性肿瘤骨转移疼痛的临床疗效观察

目的:评价唑来膦酸注射液治疗恶性肿瘤引起的骨转移疼痛的有效性和安全性。方法:将恶性肿瘤骨转移疼痛患者52例随机分为两组,治疗组给予唑来膦酸注射液4mg静脉滴注15min;对照组给予帕米膦酸二钠注射液90mg静脉滴注6h。结果:治疗组和对照组用药后止痛有效率分别为73.08%和69.23%,无显著性差异(P>0.05);用药后止痛中位起效时间分别为第5天和第7天,无显著性差异(P>0.05);两组用药后第7天ECOG评分,治疗组用药前后及两组间比较差异有统计学意义(P<0.001)。结论:唑来膦酸注射液治疗恶性肿瘤骨转移疼痛有效,用量少,用药时间短,能显著改善患者生活质量。     

唑来膦酸治疗骨转移疼痛的临床研究

[目的]观察唑来膦酸治疗恶性肿瘤骨转移疼痛的临床疗效.[方法]21例恶性肿瘤骨转移患者,分为实验组(11例)和对照组(10例),分别给予唑来膦酸和帕米膦酸二钠进行治疗.[结果]实验组和对照组有效率分别是54.55%和30.00%.临床获益率分别是63.64%和30.00%,两者差异无显著性(P＞0.05).唑来膦酸组在疗效维持时间上明显长于帕米膦酸二钠组(P＜0.05).[结论]唑来膦酸可缓解肿瘤骨转移的疼痛,疗效维持时间长,副作用小,耐受性好.     

唑来膦酸及依班膦酸钠治疗恶性肿瘤骨转移疼痛的临床疗效观察

目的 评价唑来膦酸及依班膦酸钠治疗恶性肿瘤引起骨疼痛的有效性和安全性.方法 入选恶性肿瘤骨转移疼痛60例,随机分为两组,一组给予唑来膦酸注射液4 mg,静脉滴注15 min;另一组给予依班膦酸钠注射液4 mg,静脉滴注3 h.采用平行对照研究方法,每组用药3～6个周期.观察止痛起效时间、临床获益及毒副反应.结果 唑来膦酸组和依班膦酸组用药后止痛有效率分别为75.02%和72.10%,差异无统计学意义(P>0.05);用药后冲位起效时间分别为第5天和第7天,差异无统计学意义(P>0.05);两组用药后7 d,ECOG评分改善,差异无统计学意义(P>0.05).结论 唑来膦酸及依班膦酸钠均能改善恶性肿瘤患者骨转移疼痛,显著改善生活质量,且毒副反应均可耐受.     

唑来膦酸治疗恶性肿瘤骨转移44例临床观察

目的观察唑来膦酸注射液治疗转移性骨肿瘤的疗效及安全性。方法44例恶性肿瘤骨转移患者采用唑来膦酸(天晴依泰)注射液4mg加入0.9%氯化钠注射液100ml静脉滴注15分钟以上;同时以35例恶性肿瘤骨转移患者使用帕米膦酸二钠(博宁)注射液60mg加入0.9%氯化钠注射液500ml静脉滴注4小时以上作为对照。两组均一次性给药后观察14天。结果治疗骨痛有效率唑来膦酸组为81.08%,帕米膦酸二钠组为69.70%,两组疗效差异有显著性(P<0.05)。活动能力有效率唑来膦酸组为40.91%,帕米膦酸二钠组为45.71%,两组疗效差异无显著性(P>0.05)。不良反应发生率唑来膦酸组为45.45%,帕米膦酸二钠组为42.86%,差异无显著性(P>0.05),均主要表现为发热、低钙血症、肌肉酸痛,予对症处理后症状消失。结论唑来膦酸是一种有效的第三代双膦酸盐制剂,可方便安全地用于恶性肿瘤骨转移的治疗。     

唑来膦酸治疗癌症骨转移疼痛临床观察

目的探讨唑来膦酸治疗恶性肿瘤骨转移疼痛的疗效和安全性.方法选择恶性肿瘤骨转移中、重度疼痛患者52例,随机双盲分成两组:A组(试验组)22例:唑来膦酸4mg溶于生理盐水50ml静滴;B组(对照组)30例:博宁90mg 生理盐水750ml静滴.结果唑来膦酸镇痛效果:显效(CR):4/22,部分缓解(PR):13/22,无效(NR):5/22,总有效率(CR PR):77.27%(17/22),疗效维持时间16.4天,KPS评分平均提高20分,主要不良反应为一过性骨痛加重,发热、恶心、呕吐.对照组总有效率(RR):77.33%,疗效维持时间14.8天.结论唑来膦酸对缓解癌症骨转移疼痛有效,安全性好,病人可耐受.     

唑来膦酸联合89 S r治疗恶性肿瘤晚期多发骨转移的疗效观察

目的 探讨恶性肿瘤晚期多发骨转移患者采用唑来膦酸联合89 Sr治疗的临床疗效.方法 将90例恶性肿瘤晚期多发骨转移患者,按照随机抛硬币法将其分组为对照组(唑来膦酸静脉滴注)与观察组(唑来膦酸静脉滴注联合89 Sr静脉注射),各45例.采用疼痛视觉模拟法(VAS)评价两组患者治疗前、后疼痛情况,通过问卷调查表调查两组患者治疗前、后生活质量改善情况,统计两组临床疗效及不良反应.结果 治疗后,两组患者VAS评分及生活质量各项指标均较治疗前明显改善,而观察组各项指标改善程度优于对照组,P<0.05.观察组治疗临床有效率为84.4%,明显高于对照组(66.7%),P<0.05;两组患者不良反应率比较,P>0.05.结论 唑来膦酸联合89 Sr治疗恶性肿瘤晚期多发骨转移可缓解患者疼痛,提高临床治疗效果,改善其生活质量,同时不会增加治疗期间所产生的不良反应,因此值得深入研究以利于其推广应用.     

唑来膦酸治疗恶性肿瘤骨转移疼痛的临床观察

目的:评价唑来膦酸治疗恶性肿瘤引起骨疼痛的有效性和安全性.方法:对62例确诊为恶性肿瘤骨转移的患者静脉注射唑来膦酸注射液4mg,静脉滴注15min,4周为1周期.3周期后评价疗效.结果:癌性骨转移疼痛止痛总有效率58.1%(36/62).其中初治组骨痛完全缓解23.5%(8/34),部分缓解47.1%(16/34),总有效率为70.6%(24/34).显著高于复治组42.9%(P<0.05).QOL较治疗前明显改善.主要不良反应为低热,无需特殊处理.结论:唑来膦酸能改善恶性肿瘤骨转移患者疼痛,显著改善生活质量,不良反应可耐受.     

Intravenous ibandronate reduces the incidence of skeletal complications in patients with breast cancer and bone metastases.

BACKGROUND: This phase III study compared the efficacy of the new potent bisphosphonate, ibandronate, with placebo as intravenous (i.v.) therapy in metastatic bone disease due to breast cancer. PATIENTS AND METHODS: A total of 466 patients were randomised to receive placebo (n = 158), or 2 mg (n = 154) or 6 mg (n = 154) ibandronate every 3-4 weeks for up to 2 years. The primary efficacy parameter was the number of 12-week periods with new bone complications, expressed as the skeletal morbidity period rate (SMPR). Bone pain, analgesic use and safety were evaluated monthly. Results SMPR was lower in both ibandronate groups compared with the placebo group; the difference was statistically significant for the ibandronate 6 mg group (P = 0.004 versus placebo). Consistent with the SMPR, ibandronate 6 mg significantly reduced the number of new bone events (by 38%) and increased time to first new bone event. Patients on ibandronate 6 mg also experienced decreased bone pain scores and analgesic use. Treatment with ibandronate was well tolerated. CONCLUSIONS: These results indicate that 6 mg i.v. ibandronate is effective and safe in the treatment of bone metastases from breast cancer.     

伊班膦酸钠联合化疗对肺癌骨转移的临床疗效

目的观察伊班膦酸钠(艾本)联合化疗对肺癌骨转移的止痛效果和不良反应。方法将67例患者分为A、B两组,A组为伊班膦酸钠联合化疗组,B组为单用伊班膦酸钠组。结果A、B两组止痛有效率分别为79.4%和72.7%,差异无显著性(P>0.05)。结论伊班膦酸钠可与化疗联合应用治疗肺癌骨转移性疼痛,且安全有效。     

放射治疗联合唑来膦酸治疗骨转移癌疗效观察

目的:分析放射治疗联合唑来膦酸治疗骨转移癌疼痛的疗效及不良反应。方法:应用局部止痛性外照射、唑来膦酸联合治疗34例骨转移癌疼痛患者,随访观察3个月,选择未联合使用唑来膦酸的38例患者作为对照。根据治疗后疼痛缓解和生活质量变化判断疗效,依据临床症状、血常规、电解质等变化观察不良反应。结果:综合治疗组总有效率为88.2%(30/34),其中完全缓解(CR)率52.9%(18/34),部分缓解(PR)率29.4%(10/34),无缓解(NR)率11.8%(4/34)。主要不良反应为恶心和食欲下降(8例),全身乏力(7例),一过性发热(2例)。用药前后血钙、血磷、血镁的差异无统计学意义(P>0.05)。与对照组相比,综合治疗更为有效(P<0.05)。结论:采用放射治疗联合唑来膦酸治疗骨转移癌疼痛是一种有效的综合治疗方法,可提高患者生存质量。     

依班膦酸钠联合放射治疗骨转移癌临床观察

目的观察依班膦酸钠联合放射治疗骨转移癌疼痛的疗效。方法59例骨转移癌患者随机分成观察组(30例)和对照组(29例)。观察组静脉滴注依班膦酸钠4 mg,联合放射治疗40Gy,1个月后再静脉滴注依班膦酸钠4 mg;对照组仅用放疗。结果观察组和对照组止痛有效率分别为90.0%和82.7%(P>0.05),多发骨转移癌观察组与对照组止痛有效率分别为86.7%和51.7%(P<0.05)。随访2个月后观察组与对照组止痛有效率分别为86.6%和62.0%(P<0.05〉。结论依班膦酸钠联合放射治疗骨转移癌疼痛疗效优于单纯放疗。     

双膦酸盐联合化疗治疗多发性骨髓瘤骨并发症的临床观察

 目的　比较唑来膦酸联合化疗及伊班膦酸联合化疗预防和治疗多发性骨髓瘤（MM）骨并发症的效果及其安全性。方法　选择2005年3月至2008年3月中山大学附属第一医院治疗的MM患者77例,按照用药情况分为唑来膦酸联合化疗组24例,伊班膦酸联合化疗组26例,单纯化疗组27例。结果　唑来膦酸联合化疗组、伊班膦酸联合化疗组和单纯化疗组患者发生1次骨相关事件（SRE）的比例分别为25.0 ％、26.9 ％、48.1 ％（P＝0.145）。唑来膦酸联合化疗组、伊班膦酸联合化疗组发生脊柱压缩性骨折（VCF）的比例分别为4.2 ％和7.7 ％,少于单纯化疗组的14.8 ％（P＝0.115）。三组的中位首次发生SRE时间（T-SRE）分别为7.5、6.5和4.5个月（P＜0.001）。唑来膦酸联合化疗组止痛有效率为66.7 ％,伊班膦酸联合化疗组有效率为69.2 ％,单纯化疗组为29.6 %,差异有统计学意义（P＝0.028）。唑来膦酸联合化疗组治疗后的血钙水平低于伊班膦酸联合化疗组（P＝0.016）,降至正常水平所需时间也较伊班膦酸联合化疗组短（P＝0.04）。唑来膦酸联合化疗组和伊班膦酸联合化疗组的不良反应发生率低,两组不良反应发生率差异无统计学意义（P＞0.05）。结论　应用双膦酸盐可减少MM患者SRE的发生率和VCF。唑来膦酸在减少VCF发生率、减轻骨痛上与伊班膦酸类似,优于单纯化疗组;唑来膦酸在降低血钙水平方面优于伊班膦酸。唑来膦酸临床应用不良反应少,患者均可耐受。     

双膦酸盐联合化疗治疗多发性骨髓瘤骨并发症的临床观察

目的 比较唑来膦酸联合化疗及伊班膦酸联合化疗预防和治疗多发性骨髓瘤(MM)骨并发症的效果及其安全性.方法 选择2005年3月至2008年3月中山大学附属第一医院治疗的MM患者77例,按照用药情况分为唑来膦酸联合化疗组24例,伊班膦酸联合化疗组26例.单纯化疗组27例.结果唑来膦酸联合化疗组、伊班膦酸联合化疗组和单纯化疗组患者发生1次骨相关事件(SRE)的比例分别为25.0%、26.9%、48.1%(P=0.145).唑来膦酸联合化疗组、伊班膦酸联合化疗组发生脊柱压缩性骨折(VCF)的比例分别为4.2%和7.7%,少于单纯化疗组的14.8%(P=0.115).三组的中位首次发生SRE时间(T-SRE)分别为7.5、6.5和4.5个月(P＜0.001).唑来瞵酸联合化疗组止痛有效率为66.7%,伊班膦酸联合化疗组有效率为69.2%,单纯化疗组为29.6%,差异有统计学意义(P=0.028).唑来膦酸联合化疗组治疗后的血钙水平低于伊班膦酸联合化疗组(P=0.016),降至正常水平所需时间也较伊班膦酸联合化疗组短(P=0.04).唑来膦酸联合化疗组和伊班瞵酸联合化疗组的不良反应发牛率低,两组不良反应发生率差异无统计学意义(P＞0.05).结论 应用双瞵酸盐可减少MM患者SRE的发生率和VCF.唑来膦酸在减少VCF发生率、减轻骨痛上与伊班膦酸类似,优于单纯化疗组;唑来膦酸在降低血钙水平方面优于伊班膦酸.唑来膦酸临床应用不良反应少.患者均可耐受.     

Oral ibandronate for the treatment of metastatic bone disease in breast cancer: efficacy and safety results from a randomized, double-blind, placebo-controlled trial.

BACKGROUND: We report the first results of a randomized trial assessing a new oral aminobisphosphonate, ibandronate, in patients with bone metastases from breast cancer. PATIENTS AND METHODS: Patients (n = 435) received placebo, or oral ibandronate 20 mg or 50 mg once-daily for 96 weeks. The primary efficacy measure was the number of 12-week periods with new bone complications [skeletal morbidity period rate (SMPR)]. Multivariate Poisson regression analysis assessed the relative risk reduction of skeletal-related events. Secondary efficacy analyses included bone pain and analgesic use. Adverse events were monitored. RESULTS: SMPR was significantly reduced with oral ibandronate [placebo 1.2, 20 mg group 0.97 (P = 0.024), 50 mg group 0.98 (P = 0.037)]. Ibandronate 50 mg significantly reduced the need for radiotherapy (P = 0.005 versus placebo). The relative risk of skeletal events was reduced by 38% (20 mg dose) and 39% (50 mg dose) versus placebo (P = 0.009 and P = 0.005). The tolerability profile of ibandronate was similar to placebo. CONCLUSIONS: Oral ibandronate is an effective and well-tolerated treatment for metastatic bone disease. The 50 mg dose is being further evaluated in clinical trials, and this dose was recently approved in the European Union for the prevention of skeletal events in patients with breast cancer and bone metastases.     

Bisphosphonate-induced osteonecrosis of the jaws: prospective study of 80 patients with multiple myeloma and other malignancies

A prospective study was performed in 80 patients receiving bisphosphonates in order to determine frequency of occurrence, risk factors, clinical presentation, radiology, pathology and proper treatment of osteonecrosis of the jaw (ONJ). Of 80 patients, 22 (28%) developed ONJ. There were 11 male and 11 female patients. Median age was 65 years. Ten patients (46%) had multiple myeloma (MM), 5 (23%) had breast cancer and 7 (32%) had other malignancies. Of 22 patients with ONJ, 14 patients (64%) received zoledronate, 3 (14%) received pamidronate, 4 (18%) received pamidronate later followed by zoledronate and 1 patient received ibandronate later followed by zoledronate. The median time of exposure in ONJ group was 32 months compared with 27 months in patients without ONJ. The mean induction time until bone exposure was 26 months for patients who received zoledronate, 54 months for pamidronate and 48 months for pamidronate followed by zoledronate. Thirteen patients (59%) had ONJ with bone exposure of mandible, 6 (27%) of maxilla and 3 (14%) of both jaws. ONJ occurred spontaneously in 5 patients (23%) and in 17 patients (77%) occurred after tooth extractions and surgical tooth removals (P<0.001). Nine patients (41%) had previous extractions of molars, 6 (27%) of premolars and 2 (9%) of front teeth. The cumulative hazard is significantly higher in zoledronate group (P=0.015). It was 3.48 times higher than the other group (pamidronate alone; pamidronate followed by zoledronate; ibandronate alone; etidronate alone; ibandronate followed by pamidronate; ibandronate followed by zoledronate; ibandronate followed by pamidronate and zoledronate). There was no association of ONJ with age, sex, use of high-dose or conventional chemotherapy or the use of corticosteroids, thalidomide or bortezomib (P>0.05). Patients diagnosed with multiple myeloma and breast cancer were found significantly associated with ONJ (P=0.001 and P=0.014, respectively). Long-term use of bisphosphonates (>2.5 years) increases the risk for development of ONJ. Intravenous application of zoledronate and previous dental extractions or surgical tooth removals are important risk factors of ONJ. Neither treatment with high-dose chemotherapy with autologous stem cell transplantation nor treatment with corticosteroids, thalidomide or bortezomib is a risk factor in this study.     

艾本与放疗联合治疗恶性肿瘤骨转移的临床疗效

目的:探讨艾本(伊班膦酸钠)全身用药与局部放疗相结合治疗恶性肿瘤局限性骨转移的临床疗效.方法:80例恶性肿瘤局限性骨转移患者随机分为两组,艾本静脉滴注加局部放疗40例(治疗组);单放组40例,只采用局部放疗(对照组).结果:治疗组疼痛缓解率为92.5%,对照组疼痛缓解率为82.5%,两组间比较无明显差异(P＞0.05);溶骨病灶再钙化的有效率治疗组为76.7%,而对照组仅为27.8%,两组比较有显著性差异(P＜0.001);治疗组出现第二部位骨转移的机率明显低于对照组(P＜0.05);1年生存率治疗组明显高于对照组(P＜0.05).两组患者不良反应的发生率相似,无显著性差异(P＞0.05).结论:艾本联合放疗治疗局限性骨转移,具有止痛快、疗效确切、高效修复溶骨病灶,并能防止新转移灶的发生及较高的生存率等优点.