唑来膦酸治疗恶性肿瘤骨转移疼痛临床观察

Clinical observation on zoledronic acid in treatment of the pain of metastatic bone cancer

目的评价注射用唑来膦酸治疗恶性肿瘤骨转移疼痛的疗效和安全性。方法46例患者随机分为A组(治疗组)和B组(对照组)各23例,分别给予唑来膦酸和帕米膦酸二钠进行治疗,两组均一次性给药后连续观察28d骨痛变化情况。结果A组有效率为73.9%,其中显效率为21.7%(5/23),有效率为52.2%(12/23)。B组有效率为60.9%,其中显效率为13.0%(3/23),有效率为47.8%(11/23),两组间比较差异无统计学意义(P>0.05)。平均起效时间:A组为(3.46±2.66)d,B组为(4.35±1.83)d,疗效维持时间分别为(28.40±2.35)d和(15.60±3.85)d,两组间比较差异有统计学意义(P<0.05)。A、B组不良反应发生率分别为56.5%和65.2%,主要表现为发热、流感样症状、一过性肌肉关节疼痛、恶心等,均为轻度,未做特殊处理,两组不良反应发生率比较差异无统计学意义(P>0.05)。结论唑来膦酸对于恶性肿瘤骨转移所引起的骨痛具有较好的治疗作用,疗效维持时间长,不良反应较轻,是较为理想的治疗恶性肿瘤骨转移的有效药物。

Objective To evaluate the efficacy and safety of zoledronic acid injection for the pain relief in patients with metastatic bone cancer. Methods A total of 46 patients were randominzed into group A（study group） and group B（confrol group） ,23 patients in each group,and received zoledronic acid and pamidronate disodium for treatment respectively. The patients were followed up for 28 days to assess the efficacy and safety of the single dose treatment. Results The reponse rate was 73.9 % in group A ,with 21.7% （5/23）CR and 52.2 % （12/23）PR While the response rate was 60.9% in group B , with 13.0 % （ 3/23） CR and 47.8 % （ 11/23） PR. There was no significant difference between the two groups （ P 〉0.05 ） . In group A and group B, the mean time to pain rdief was （3.46 ± 2.66） days and （4.35 ± 1.83） days respectivdy , and the mean duration of the pain relief was （28.4 ± 2.35） days and （15.6±3.85） days respectively, with no significant difference between the two groups （P〈0.05） . The total incidence of adverse effects was 56.5 % and 65.2 % respectively, including fever, flu - like symptom, temporary muscle and skeletal pain and nausea. All of the adverse effects were mild and no intervention was involved. There was no significant difference in the incidence of adverse effects in the two groups （P〉0.05）. Conclusions Zoledronic acid has a perfect therapeutic effect for the bone pain caused by metastatic bone cancer, with long duration of the pain rdief and mild side effects. Zoledronic acid is an effective drug for metastatic bone cancer.