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。     

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.     

Reducing skeletal complications and bone pain with intravenous ibandronate for metastatic bone disease

Complications of metastatic bone disease substantially compromise patient independence and mobility. The goals of management include reducing the rate of skeletal complications and alleviating bone pain, to improve morbidity and patient quality of life. In a 96-week, randomised, double-blind, phase III trial, intravenous (i.v.) ibandronate 6 mg administered over 1–2 h every 3–4 weeks significantly reduced skeletal complications (assessed by the skeletal morbidity period rate [SMPR]) compared with placebo (P=0.004). Individual components of the SMPR were also significantly reduced with ibandronate (vertebral fractures, P=0.023 and need for bone radiotherapy, P=0.011 versus placebo). Ibandronate 6 mg also significantly reduced bone pain scores and maintained them below baseline over 2 years (P<0.001), an effect not reported with other bisphosphonates for metastatic bone disease. Bone pain alleviation was accompanied by significantly improved quality of life compared with placebo (P=0.004). An independent pilot study used intensive i.v. ibandronate treatment (16 mg over 4 days) to treat opioid-resistant bone pain in patients with metastatic bone disease from various tumour types. Supporting the results of the phase III clinical trial, bone pain was significantly reduced (P<0.001 versus baseline), and patients experienced significant improvement in their quality of life (P<0.05 versus baseline). The results of these studies suggest that i.v. ibandronate effectively reduces skeletal morbidity rate and provides significant bone pain and quality of life benefits that have not been demonstrated so far with other bisphosphonates.     

Efficacy and safety of ibandronate in the treatment of opioid-resistant bone pain associated with metastatic bone disease: a pilot study.

PURPOSE: Bone metastases are associated with severe and sometimes intractable pain, compromising patient quality of life (QOL). This open-label pilot study investigated the effects of short-term intensive treatment with intravenous (i.v.) ibandronate on opioid-resistant bone pain in patients with skeletal metastases. PATIENTS AND METHODS: Eighteen patients with advanced tumors and metastatic bone disease received nonstandard treatment with 4 mg of ibandronate administered i.v. (2-hour infusion) for 4 consecutive days (16-mg total dose). Baseline opioid analgesic use was equivalent to 400 mg/d of morphine. Patients were assessed for 6 weeks or until death. Changes from baseline were determined for bone pain, opioid consumption, patient functioning, QOL, performance status, and biochemical markers of calcium metabolism and bone turnover. Renal function was assessed by serum urea and creatinine measurement. RESULTS: Short-term, intensive ibandronate treatment significantly reduced bone pain scores within 7 days (P <.001). Pain reductions were sustained over the study period. Ibandronate significantly improved QOL, patient functioning, and performance status (P <.05). Mean values of the urinary cross-links pyridinoline and deoxypyridinoline tended to increase after day 21, returning close to baseline values by day 42. There was no correlation between the change in crosslinks values and the change in pain scores after ibandronate treatment. Ibandronate was well tolerated, with no evidence of renal toxicity. CONCLUSION: Nonstandard, intensive treatment with i.v. ibandronate seems to have a marked analgesic effect in patients with opioid-resistant bone pain from metastatic bone disease. Further investigation is warranted.     

Oral ibandronate is as active as intravenous zoledronic acid for reducing bone turnover markers in women with breast cancer and bone metastases.

BACKGROUND: Phase III study comparing the effect of oral ibandronate and intravenous zoledronic acid on bone markers. PATIENTS AND METHODS: Breast cancer patients with bone metastases received ibandronate 50 mg/day (n = 137) or zoledronic acid 4 mg every 4 weeks (n = 138) for 12 weeks. The primary end point was mean percentage change in serum levels of cross-linked C-terminal telopeptide of type I collagen (S-CTX) at week 12. Urinary CTX (U-CTX), bone alkaline phosphatase (ALP), amino-terminal procollagen propeptide of type I collagen (PINP) and osteocalcin (OC) were also measured and bone pain and safety assessed. RESULTS: Both bisphosphonates significantly reduced S-CTX (mean ibandronate 76% +/- 29 (SD) versus mean zoledronic acid 73% +/- 47; P < 0.001 for both versus baseline) and U-CTX (ibandronate 78% +/- 50 versus zoledronic acid 86% +/- 17; P < 0.001). The difference in S-CTX between treatments was 0.6% (confidence interval -1.7% to 3.0%), which was within the prespecified noninferiority margin. Bone ALP, PINP and OC decreased by 26%-47% compared with baseline with both bisphosphonates. Compared with zoledronic acid, ibandronate patients reported fewer adverse events overall (65.0% versus 75.9%), and on days 1-3 (8.0% versus 47.5%), including less pyrexia (overall incidence 0% versus 16.8%) and bone pain (5.8% versus 12.4%). CONCLUSIONS: Oral ibandronate was well tolerated and statistically noninferior to zoledronic acid for percentage change in the bone resorption marker, S-CTX.     

经皮椎体成形术联合放疗治疗脊椎骨转移瘤的临床观察

目的:探讨经皮成形术(PVP)联合放疗治疗脊椎骨转移瘤的方法及疗效.方法:对26例经病理学证实的42个病变椎体行PVP.骨水泥按粉、液、对比剂3:2:1比例配制.胸腰骶椎区均采用经椎弓根或椎体后外侧穿刺,在确定穿刺到位并无椎管内渗漏后,将骨水泥快速灌注至椎体内.灌注量为胸椎平均4.6ml,腰椎平均5.4ml,骶椎平均5.5ml.术后观察患者疼痛缓解程度,并于当日、1个月CT检查注射椎体.放疗在PVP后第3～4天开始,采用60C0照射,2～3Gy/次,总量35～45Gy/3～4周.结果:穿刺成功率100%本组26例单侧穿刺32个椎体,双侧穿刺10个椎体.CT检查骨水泥周围组织渗漏2例,但均未出现临床症状.26例放疗过程顺利.PVP后止痛有效率为80.8%(21/26),联合放疗后,止痛有效率上升至96.2%(25/26).随访4～10个月,止痛有效率在10个月内为88.5%(23/26).结论:PVP有靶区硬度压强和快速缓解疼痛的作用,放疗能强化对肿瘤的抑制,从而达到提高疗效的目的.     

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。     

Role of strontium-89 as adjuvant to palliative external beam radiotherapy is questionable: results of a double-blind randomized study

PURPOSE: To explore the efficacy of adjuvant (89)Sr applied with external beam radiotherapy (EBRT) to treat bone metastases. METHODS AND MATERIALS: Ninety-five patients were randomized to (89)Sr (Arm A) or saline (Arm B) on Day 1 of EBRT to demonstrate a reduction in 3-month physician-assessed subjective progression from 70% to 45%. RESULTS: At 3 and 6 months, no difference between treatment arms was observed in the progression rate. At 3 months, the physician-assessed response rate for all patients was 25%, with 46% of the patients progressing. The pretreatment use of opiates was independently associated with short progression-free survival. On the basis of the quality-of-life assessments, pain relief occurred in 50% of patients and 32% experienced improvement in global quality of life, without impact from (89)Sr. Differences were observed between the physician evaluation of radiotherapy efficacy and the patient assessment. In Arm A, serum alkaline phosphatase, but not serum prostate-specific antigen, decreased during the first 3 months after treatment. CONCLUSION: (89)Sr, adjuvant to ERBT, does not seem to reduce the number of patients with subjective progression at 3 months. Patients should be referred for palliative RT before their bone pain requires high doses of opiates. In radiotherapy trials, the evaluation of pain and pain relief remains problematic because of the confounding use of analgesics.     

骨结核合并多发骨梗死三例报告

目的探讨非潜水减压性多发骨结核合并骨梗死的诊断与治疗。方法收治3例多发性骨梗死伴疼痛的患者,1例患有系统性红斑狼疮并服用激素治疗,1例有长期大量饮酒病史,1例患有肾病综合征并服用激素治疗,3例患者术前均出现7个月至2年不等的膝关节及周围疼痛并逐渐加重。MRI显示骨梗死共10处,6处病灶内梗死的信号不典型,考虑合并感染可能。术前胸部X线片皆未发现活动性结核,并行视觉模拟评分法（visualanaloguescale,VAS）评估术前疼痛情况。对疼痛明显、梗死灶信号不典型的病变区域进行手术探查、行病灶清除、常规病理检查,病理诊断骨结核合并骨梗死,术后给予5联抗结核治疗。并观察其疗效。术后行视觉模拟评分法（VAS）评估疼痛情况。结果术后患者切口愈合良好,局部疼痛症状缓解, VAS评分改善为0～1分。随访12～24个月未出现疼痛及复发。结论在结核病高发区,晚期骨梗死患者,疼痛突然加重,MRI提示骨梗死灶内不典型信号,应考虑是否骨结核合并骨梗死。治疗上应按骨与关节结核进行。     

Preservation of oral health-related quality of life and salivary flow rates after inverse-planned intensity- modulated radiotherapy (IMRT) for head-and-neck cancer

PURPOSE: To assess whether comprehensive bilateral neck intensity-modulated radiotherapy (IMRT) for head-and-neck cancer results in preserving of oral health-related quality of life and sparing of salivary flow in the first year after therapy. METHODS AND MATERIALS: Twenty-three patients with head-and-neck cancer (primary sites: nasopharynx [5], oral cavity [12], oropharynx [3], and all others [3]) were accrued to a Phase I-II trial. Inverse planning was carried out with the following treatment goals: at least 1 spared parotid gland (defined as the volume of parotid gland outside the planning target volume [PTV]) to receive a median dose of less than 20 Gy; spinal cord, maximum 45 Gy; PTV(1) to receive a median dose of 50 Gy; PTV(2) to receive a median dose of 60 Gy (postoperative setting, n = 15) or 66-70 Gy (definitive radiotherapy setting, n = 8). Treatment was delivered with 6 and 15 MV photons using a "step-and-shoot" technique on a Varian 2300 EX linac with 120-leaf Millenium MLC. Unstimulated and stimulated whole-mouth salivary flow rates were measured, and patients completed the University of Washington instrument (UWQOL) and a separate xerostomia questionnaire (XQOL) in follow-up. RESULTS: Early functional outcome end point data are available at the 1-, 3-, and 12-month follow-up time points for 22, 22, and 18 patients, respectively. The combined mean parotid dose was 30.0 Gy (95% confidence interval: 26.9-33.1). The differences from baseline in mean overall UWQOL scores at 1, 3, and 12 months postradiotherapy were -0.24, 0.32, and 4.28, not significantly different from zero (p = 0.89, p = 0.87, p = 0.13). None of the UWQOL individual domain scores related to oral health (pain, eating-chewing, eating-swallowing, and speech) at 1, 3, or 12 months were significantly different from baseline. Both unstimulated and stimulated whole-mouth flow was variably preserved. Unstimulated salivary flow at 1 and 12 months was inversely correlated with combined mean parotid dose (p = 0.014, p = 0.0007), whereas stimulated salivary flow rates at 3 and 12 months were also correlated with combined mean parotid dose (p = 0.025, p = 0.0016). Combined maximum parotid dose was correlated with unstimulated flow rate at 12 months (p = 0.02, r = -0.56) and stimulated flow rate at 1 and 12 months (p = 0.036, r = -0.45; p = 0.0042, r = -0.66). The proportion of patients reporting total XQOL scores of 0 or 1 (no or mild xerostomia) did not diminish significantly from baseline at 1, 3, or 12 months (p = 0.72, p = 0.51, p = 1.0). Unstimulated and stimulated flow at 1 month was inversely correlated with total XQOL score at 12 months (p = 0.025, p = 0.029). CONCLUSIONS: Oral health-related quality of life (HRQOL) was highly preserved in the initial 12 months after IMRT, as assessed with separate, validated instruments for xerostomia-specific quality of life and oral HRQOL. In general, patients with better-preserved unstimulated salivary flow rates tended to report lower xerostomia scores. Whole-mouth salivary flow rates post IMRT were inversely correlated with combined mean parotid doses. Longer follow-up is required to assess to what extent HRQOL is favorably maintained.     

Improved quality of life after long-term treatment with the bisphosphonate ibandronate in patients with metastatic bone disease due to breast cancer

Bone metastases occur in most women with advanced breast cancer and can lead to considerable morbidity and a rapid deterioration in the patient's quality of life. It was the aim of the present study to assess changes in quality of life and bone pain due to intravenous (i.v.) ibandronate, a potent third-generation bisphosphonate. In a phase III randomised, double-blind, placebo-controlled trial in patients with bone metastases due to breast cancer, 466 women were randomised to receive placebo, 2 mg ibandronate or 6 mg ibandronate for up to 96 weeks. Treatment was administered i.v. at 3- or 4-weekly intervals. Clinical endpoints included the incidence of adverse events, quality of life (assessed using the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Scale - Core 30 questionnaire (QLQ-C30)), and bone pain (assessed on a 5-point scale from 0=none to 4=intolerable). Ibandronate was generally well tolerated. Compared with baseline measurements, the bone pain score was increased at the last assessment in both the placebo and 2 mg ibandronate groups, but was significantly reduced in the patients receiving 6 mg ibandronate (-0.28+/-1.11, P < 0.001). A significant improvement in quality of life was demonstrated for patients treated with ibandronate (P < 0.05) for all global health status. Overall, at the last assessment, the 6 mg ibandronate group showed significantly better functioning compared with placebo (P = 0.004), and had significantly better scores on the domains of physical, emotional, and social functioning, and in global health status (P < 0.05). Significant improvements in the symptoms of fatigue and pain were also observed in the 6 mg ibandronate group. I.v. ibandronate treatment leads to significant improvements in quality of life, and is an effective and well-tolerated palliative treatment in patients with bone metastases due to breast cancer.     

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。     

Is Response to Radiotherapy in Patients Related to the Severity of Pretreatment Pain?

PURPOSE: The primary objective of this study was to determine whether there is a relationship between the severity of pretreatment pain and response to palliative radiotherapy (RT) for painful bone metastases. METHODS AND MATERIALS: The database for patients with bone metastases seen at the Rapid Response Radiotherapy Program at the Odette Cancer Center from 1999 to 2006 was analyzed. The proportion of patients with mild (scores 1-4), moderate (scores 5-6), or severe (scores 7-10) pain at baseline who experienced a complete response, partial response, stable response, or progressive response after palliative RT was determined according to International Bone Metastases Consensus definitions. RESULTS: During the 7-year study period 1,053 patients received palliative radiation for bone metastases. The median age was 68 years and the median Karnofsky performance status was 70. Of the patients, 53% had a complete or partial response at 1 month, 52% at 2 months, and 54% at 3 months post-RT. CONCLUSIONS: There was no significant difference in terms of the proportion of responders (patients with complete or partial response) and nonresponders in terms of painful bone metastases among patients presenting with mild, moderate, or severe pain. Patients with moderate pain should be referred for palliative RT.     

放疗联合骨肿瘤切除术对不同分期骨癌患者的临床治疗效果评价

目的探讨并分析放疗联合骨肿瘤切除术对不同分期骨癌患者的临床疗效。方法选择60例骨癌患者为研究对象,根据其肿瘤分期及恶性程度分为低恶组和高恶组,两组均采用放疗联合骨肿瘤切除术进行治疗,术后采用VAS评分评估两组患者骨癌痛程度,统计两组治疗后随访6个月内局部肿瘤控制率、复发情况以及并发症发生率,并进行比较。结果①术后3 h,两组患者疼痛程度评分相比差异不具有统计学意义(P>0.05),术后1 d~2 d,低恶组患者放疗联合骨肿瘤切除术后疼痛程度评分均显著低于高恶组(P<0.05);②与低恶组相比,高恶组患者局部肿瘤控制有效率显著降低,生存期显著缩短,差异均具有统计学意义(P<0.05);③低恶组和高恶组复发率相比差异无统计学意义(P>0.05);④两组患者术后并发症相比,低恶组显著低于高恶组(P<0.05)。结论放疗联合骨肿瘤切除术对早期骨癌患者具有较好的治疗效果,术后疼痛程度和并发症降低、肿瘤控制有效率提升,从而使得患者生存期显著延长,推荐用于早期骨癌患者的临床治疗。     

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。     

Phase II study of vitamin E and pentoxifylline in patients with late side effects of pelvic radiotherapy.

BACKGROUND AND PURPOSE: Radiation-induced tissue fibrosis is a common adverse effect of curative treatment for pelvic cancer. Pilot studies testing alpha-tocopherol and pentoxifylline provide evidence of clinical regression of superficial radiation fibrosis after radiotherapy. PATIENTS AND METHODS: Twenty-seven eligible research volunteers with a minimum of one grade 3 or 4 disability (LENT SOMA) due to previous radiotherapy were entered into the study. Volunteers were given dl-alpha tocopheryl acetate 500 mg twice a day orally plus pentoxifylline 400mg twice a day orally over a period of 6 months. Clinical assessment of late side effects recorded using LENT SOMA scales was selected as the primary endpoint, taken at baseline and at 6 and 12 months post-registration. Patient self-assessment of function and quality of life was assessed as a secondary endpoint using the EORTC QLQ-C30 core questionnaire and the EORTC QLQ-CR38 pelvic module. Magnetic resonance imaging was undertaken in 13/23 evaluable volunteers before and after 6 months of therapy. RESULTS: At 12 months post-registration there were 4 out of 23 responders. At 6 months post-registration there was a statistically significant improvement (i.e. reduction) in the median of the LENT SOMA summed scores in all areas assessed apart from 'male sexual dysfunction', 'vulva' and 'vagina' which were unchanged at 6 months. The median total LENT SOMA score at baseline and 6 months was 49 and 34, respectively, with a median change in total LENT SOMA score between baseline and 6 months of 9 (IQR 7-18) (P<0.001). The maximum LENT SOMA scores improved over the study period, with a total number of 82 maximum grade 3 or 4 normal tissue scores at baseline (median of four complications per person) reduced to a total number of 67 maximum grade 3 or 4 scores at 6 months post-registration (median of 3 complications per person), i.e. a median reduction in severe complications of one per person. LENT SOMA scores at 12 months were similar to those observed at 6 month suggesting no further improvement nor deterioration in late side effects. These findings were, however, not reflected in the patient self-assessment of function and quality of life, raising question about the possibility of observer bias in recording LENT SOMA scores. No significant changes were reported on magnetic resonance images at 6 months from baseline. CONCLUSIONS: Despite only seeing four a priori defined responders in this pilot study testing dl-alpha tocopheryl acetate plus pentoxifylline in patients suffering complications of pelvic radiotherapy, changes in LENT SOMA scores suggest beneficial effects. However, we are not convinced that these effects are real, since no significant changes in symptoms and functional status were recorded by detailed prospective patient self-assessments.     

Pain flare following external beam radiotherapy and meaningful change in pain scores in the treatment of bone metastases.

BACKGROUND AND PURPOSE: To examine the incidence of pain flare following external beam radiotherapy and to determine what constitutes a meaningful change in pain scores in the treatment of bone metastases. PATIENTS AND METHODS: Patients with bone metastases treated with external beam radiotherapy were asked to score their pain on a scale of 0-10 before the treatment (baseline), daily during the treatment and for 10 days after completion of external beam radiation. Pain flare was defined as a two-point increase from baseline pain in the pain scale of 0-10 with no decrease in analgesic intake or a 25% increase in analgesic intake employing daily oral morphine equivalent with no decrease in pain score. To distinguish pain flare from progression of pain, we required the pain score and analgesic intake to return back to baseline levels after the increase/flare. They were also asked to indicate if their pain changed during that time compared to pre-treatment level. The change in pain score was compared with patient perception. RESULTS: Eighty-eight patients were evaluated in this study. There were 49 male and 39 female patients with the median age of 70 years. Twelve of 88 patients (14%) had pain flare on day 1. The overall incidence of pain flare during the study period ranged from 2 to 16%. A total of 797 pain scorings were obtained. Patients perceived an improvement in pain when their self-reported pain score decreased by at least two points. CONCLUSIONS: Our study confirms the occurrence of pain flare following the external beam radiotherapy in the treatment of bone metastases. Further studies are required to predict who are at risk for flare. Appropriate measures can be taken to alleviate the pain flare. The finding in the meaningful change in pain scores supports the investigator-defined partial response used in some clinical trials.     

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.     

伊班膦酸钠联合放疗治疗骨转移癌疼痛的临床疗效

目的观察伊班膦酸钠(艾本)联合放疗治疗骨转移癌患者疼痛的疗效。方法40例恶性肿瘤骨转移癌患者,艾本2mg~4mg溶于不含钙离子的0.9%生理盐水或5%葡萄液,缓慢静脉滴注(不少于2小时)。同时配合放疗,DT30Gy。结果治疗后完全缓解21例(52.5%),部分缓解13例(32.5%),疼痛总缓解率为85%,3例患者血钙均降至正常。结论艾本联合放疗治疗骨转移癌疼痛疗效确切,可降低高钙血症血钙浓度,预防病理性骨折的发生,提高了患者的生活质量,毒副反应轻,值得临床进一步观察。