伊班膦酸钠配合局部放疗治疗恶性肿瘤骨转移疼痛临床疗效

目的观察伊班膦酸钠(艾本)配合局部放疗治疗恶性肿瘤骨转移疼痛临床疗效。方法对确诊为恶性肿瘤骨转移42例患者予局部放疗,同时应用伊班膦酸钠治疗。结果治疗的42例患者中,完全缓解(CR)16例,部分缓解(PR)20例,有效率(CR PR)为85.7%,效果比较显著。毒副作用轻,患者容易耐受。结论用伊班膦酸钠配合局部放疗治疗恶性肿瘤骨转移引起的疼痛有良好疗效。     

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。     

帕米膦酸二钠联合放疗治疗骨转移癌的疗效观察

目的：观察帕米膦酸二钠（博宁）联合放射治疗骨转移癌所致骨痛和高血钙的疗效。方法：对照组30例骨转移癌患者行单纯常规放疗，DT30GY／3GY／10f；治疗组34例骨转移癌患者行放射治疗前给予帕米膦酸二钠90mg加入生理盐水中缓慢静脉滴注4—6h（可分为2天用药），接着行放射治疗，照射方法同对照组，每4周为1个周期，至少连用6个周期。以放疗结束时及结束后6个月的疼痛缓解率及血钙下降率作为评价标准。结果：治疗组疼痛缓解率和血钙下降率与对照组比较无明显差异；结束6个月后治疗组疼痛缓解率和血钙下降率均高于对照组（P〈0．05）结论：帕米膦酸二钠（博宁）联合放疗可显著缓解骨转移引起的疼痛，降低高血钙，临床应用方便，患者耐受性好。     

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.     

艾本加放疗治疗骨转移癌的临床观察

目的观察艾本加放疗与单放疗治疗骨转移癌的疗效差异.方法采用2002年7月至2003年7月间的单发性骨转移患者40例,随机分为两组.结果单放疗组疼痛总缓解率为85.0%,放疗＋艾本组为90.0%,两组比较无显著性差异（P〉0.05）.但放疗＋艾本组止痛起效较快且新的骨转移发生少（P〈0.05）.结论艾本与放疗合并使用治疗恶性肿瘤单发性骨转移止痛快,并能防止新的骨转移发生.     

艾本合并化疗治疗骨转移癌35例近期疗效分析

目的观察艾本(伊班膦酸钠)加化疗治疗骨转移癌的临床疗效。方法35例患者接受艾本联合化疗方案治疗。结果治疗后止痛总有效率为91·4%。其中CR13例(37·1%),PR12例(34·3%),MR7例(20·1%)。Karnofsky分值平均增加30分,范围在10~70分。结论艾本加化疗治疗骨转移癌疗效显著,与同类药物相比具有效果好和用药方便等优点。     

唑来膦酸联合放疗治疗骨转移癌临床研究

目的观察唑来膦酸联合放疗治疗骨转移癌的疗效。方法将60例骨转移癌患者随机分为观察组（30例）和对照组（30例）。观察组静脉点滴唑来膦酸4mg加局部放疗30Gy/10f/2w，对照组则单纯行放疗。结果观察组与对照组疼痛总缓解率分别为93.3%和73.3%，有显著性差异（P〈0.05）。观察组和对照组KPS评分改善有效率分别为90.0%和66.7%，两组差异有显著性差异（P〈0.05）。结论唑来膦酸联合放疗治疗骨转移癌疼痛疗效优于单纯放疗，明显提高患者生存质量。     

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。     

康莱特注射液联合放疗治疗50例骨转移癌的疗效分析

目的: 观察康莱特注射液联合放疗对骨转移癌疼痛的临床疗效.方法: 100例骨转移癌患者随机分为观察组(n=50)与对照组(n=50),两组均采用局部放疗30Gy/10F,观察组同时采用康莱特注射液200 ml/d静脉滴入,连用20d,观察两组治疗前后骨痛评分及生活质量评价.结果: 观察组病灶部位疼痛明显减轻(P<0.05),患者生活质量评价优于对照组(P<0.05).结论: 康莱特注射液联合放疗对骨转移癌的疗效优于单纯放疗.     

放疗联合内生场热疗对骨转移癌疗效的临床研究

目的观察热疗联合放疗治疗骨转移癌的疗效。方法经X线、CT、MRI或ECT证实的骨转移癌患者56例,随机分为治疗组和对照组,各28例;对照组行单纯放疗,治疗组在放疗后采用迈达NRL-002型内生场肿瘤热疗机加热60min,每周2次;观察疼痛缓解、体力状况、骨病灶好转情况及不良反应。结果治疗组疼痛缓解总有效率（显效＋有效）82.14%,明显优于对照组（57.14%）;治疗后1周内起效者20例（71.42%）,体力改善总有效率78.57%,骨病灶疗效总有效率75%,无严重不良反应发生。结论放疗配合内生场热疗治疗骨转移癌较单纯放疗更为有效,能明显地缓解疼痛,提高患者的生活质量。     

Combination ibandronate and radiotherapy for the treatment of bone metastases: clinical evaluation and radiologic assessment

PURPOSE: Ibandronate is a single-nitrogen, noncyclic bisphosphonate with proven efficacy for reducing metastatic bone pain. In this study, we assessed the palliative effects of combined ibandronate and radiotherapy. METHODS AND MATERIALS: Forty-five patients with bone metastases from various solid tumors received external-beam radiotherapy, 30-40 Gy over 3-4.5, weeks combined with 10 cycles of monthly intravenous ibandronate, 6 mg. RESULTS: After combined therapy, mean bone pain scores (graded from 0 to 10) were reduced from 6.3 at baseline to 0.8 after 3 months, with further reductions at later time points (all p < 0.001). Opioid use decreased from 84% of patients at baseline (38/45) to 24% (11/45) at 3 months, with further subsequent reductions (all p < 0.001). Mean performance status and functioning scores also significantly improved. Bone density (assessed by computed tomography scan) increased by 20% vs. baseline at 3 months, 46% at 6 months, and 73% at 10 months (all p < 0.001). Lesion improvement was also demonstrated by magnetic resonance imaging. Treatment was well tolerated with no renal toxicity. CONCLUSIONS: In this pilot study, combined radiotherapy and ibandronate provided substantial bone pain relief and increased bone density. Computed tomography-based or magnetic resonance imaging-based evaluations offer objective methods for assessing therapeutic outcomes.     

伊班膦酸钠联合化疗治疗转移性骨肿瘤45例疗效观察

目的 探讨伊班膦酸钠(艾本)联合化疗治疗恶性肿瘤骨转移的临床疗效.方法 45例恶性肿瘤骨转移,均用伊班膦酸钠联合化疗.结果 患者疼痛总缓解率为84%,骨病灶控制总有效率为29%,无明显毒副反应.结论 伊班膦酸钠联合化疗是目前治疗晚期恶性肿瘤骨转移的优选方案.     

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。     

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.     

伊班膦酸钠联合化疗对乳腺癌骨转移的临床疗效

目的 观察伊班膦酸钠（艾本）联合化疗对乳腺癌骨转移的止痛效果和不良反应。方法 将65例晚期乳腺癌并骨转移患者随机分为A、B2个组，A组给予伊班膦酸钠4rng，静脉滴注，每4周1次，连用2～4次，并给长春瑞宾25mg／m^2，静脉注射，第1、8天；表阿霉素50-70mg／m^2，静脉注射，第2天；每21～28天为1个周期，连用2～4个周期。B组为单用伊班膦酸钠，剂量和用法同A组。结果 A、B2组止痛有效率分别为87．5％（28／32）和81.3％（26／32），经统计学分析，无显著性差异（P〉0．05）；A组不良反应较B组多，主要是化疗后骨髓抑制及消化道反应。结论 对乳腺癌骨转移性疼痛，采用伊班膦酸钠治疗，可获得较好的疗效，若再加化疗，并不能进一步提高近期镇痛效果。     

Effects of long-term intravenous ibandronate therapy on skeletal-related events, survival, and bone resorption markers in patients with advanced multiple myeloma.

PURPOSE: Bisphosphonates have been found to reduce the incidence of skeletal-related events (SREs) in patients with multiple myeloma. This is the first double-blind, randomized, placebo-controlled study to assess the efficacy of ibandronate, a third-generation amino-bisphosphonate, in preventing SREs in advanced-stage multiple myeloma patients. PATIENTS AND METHODS: Patients with multiple myeloma stage II or III were randomly assigned to receive either ibandronate 2 mg or placebo as a monthly intravenous (IV) bolus injection for 12 to 24 months in addition to conventional chemotherapy. SREs such as peripheral pathologic or vertebral fractures, hypercalcemia, severe bone pain, and bone radiotherapy or surgery were analyzed. Bone-turnover markers were also studied. Finally, post hoc analyses of bone morbidity and survival were performed. RESULTS: Ninety-nine patients per treatment group were assessable for efficacy analysis. The occurrence of SRE per patient year and the time to first SRE were not significantly different between the two treatment groups. In overall evaluation, no differences were found between the treatment groups regarding bone pain, analgesic drug use, quality of life, and median survival (33.1 v 28.2 months, respectively). Explorative post hoc analyses revealed that ibandronate patients with strongly suppressed bone-turnover markers (> or = 30% and > or = 50% mean reduction of serum osteocalcin and urinary C-terminal telopeptides) developed significantly less bone morbidity. Ibandronate was tolerated well during as many as 25 therapy cycles. CONCLUSION: Monthly injections of ibandronate 2 mg IV neither reduced bone morbidity nor prolonged survival in the overall population of stage II/III multiple myeloma patients.     

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(英文)

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。     

Oral ibandronate reduces the risk of skeletal complications in breast cancer patients with metastatic bone disease: results from two randomised, placebo-controlled phase III studies

Although intravenous (i.v.) bisphosphonates are the standard of care for metastatic bone disease, they are less than ideal for many patients due to infusion-related adverse events (AEs), an increased risk of renal toxicity and the inconvenience of regular hospital visits. The use of oral bisphosphonate therapy is limited by concerns over efficacy and gastrointestinal (GI) side effects. There remains a clinical need for an oral bisphosphonate that offers equivalent efficacy to i.v. bisphosphonates, good tolerability and dosing convenience. Oral ibandronate, a highly potent, third-generation aminobisphosphonate, has been evaluated in phase III clinical trials of patients with bone metastases from breast cancer. In two pooled phase III studies, patients with breast cancer and bone metastases were randomised to receive oral ibandronate 50 mg (n=287) or placebo (n=277) once daily for up to 96 weeks. The primary end point was the skeletal morbidity period rate (SMPR), defined as the number of 12-week periods with new skeletal complications. Multivariate Poisson's regression analysis was used to assess the relative risk of skeletal-related events in each treatment group during the study period. Oral ibandronate 50 mg significantly reduced the mean SMPR compared with placebo (0.95 vs 1.18, P=0.004). There was a significant reduction in the mean number of events requiring radiotherapy (0.73 vs 0.98, P<0.001) and events requiring surgery (0.47 vs 0.53, P=0.037). Poisson's regression analysis confirmed that oral ibandronate significantly reduced the risk of a skeletal event compared with placebo (hazard ratio 0.62, 95% CI=0.48, 0.79; P=0.0001). The incidence of mild treatment-related upper GI AEs was slightly higher in the oral ibandronate 50 mg group compared with placebo, but very few serious drug-related AEs were reported. Oral ibandronate 50 mg is an effective, well-tolerated and convenient treatment for the prevention of skeletal complications of metastatic bone disease.