伊班磷酸钠治疗恶性肿瘤骨转移性骨痛的临床研究

Clinical study of ibandronate in relieving bone-pain in malignant tumour patients with bone metastasis

目的 :评价伊班磷酸钠治疗恶性肿瘤骨转移引起的骨痛及其不良反应 .方法 :将 1 8例恶性肿瘤骨转移骨痛的患者 ,采用随机、阳性对照方法 ,随机分为治疗组 (组A ,n =8)用伊班磷酸钠 4mg ,阳性对照组 (组B ,n =1 0 )用帕米磷酸二钠90mg ,均单次iv滴注 ,观察 2 1d评价止痛效果 .结果 :1 8例入组患者 ,均可评价疗效和不良反应 .组A患者 ,有效率 4 / 8;组B患者 ,有效率 3/ 1 0 .组A 4例有效患者 ,3～ 6 (平均 4 .5 )d起效 ,观察期间均无复发 ;组B 3例有效患者 ,6～ 9(平均 7.5 )d起效 ,2例于治疗后 1 1～ 1 4 (平均 1 2 .5 )d复发 .不良反应组B为发热 ,组A主要是恶心呕吐、骨肌肉疼痛、水肿和手足麻木等 ,但发生率较低 ,程度均轻 .结论 :伊班磷酸钠对恶性肿瘤骨转移所引起的骨痛具有一定的治疗作用 ,耐受性良好 .

AIM: To evaluate the efficacy of Ibandronate in relieving bone pain and the tolerability in malignant tumor patients with bone metastases. METHODS: By using randomized and positive control method, Ibandronate 4 mg and Pamidronate 90 mg were intravenously given once daily to patients with bone metastasized bone pain (group A, n =8) and patients in positive control group (group B, n =10), respectively. A twenty one day observation was performed. RESULTS: Four of 8 patients in group A and 3 of 10 in group B were found to have their pain relieved. No relapsed case was found in group A, while two relapsed cases were found in group B approximately 12.5 d after the treatment. The side effects were mainly nausea, myalgia, edema and numb hands and feet in both group A and group B. CONCLUSION: Ibandronate is effective in bone pain relief and is well tolerated in malignant tumor patients with bone metastases.