摘要
目的:评价国产注射用唑来膦酸(博来宁)治疗癌性骨痛的临床疗效和安全性。方法:采用多中心、随机双盲对照试验将237例癌性骨痛患者随机分为试验组和对照组,试验组接受唑来膦酸4mg,静脉滴注15min,对照组接受帕米膦酸二钠(博宁)90mg,静脉滴注4h。用药4周内逐日评价骨痛的变化及不良反应。结果:可评价疗效219例,其中试验组112例,对照组107例;临床观察指标:疗后14天内最佳疗效:试验组完全缓解(CR)10.08%(12/112),部分缓解(PR)53.78%(64/112),临床获益率(CR+PR+MR)90.75%;对照组完全缓解5.08%(6/107),部分缓解54.24%(64/107),临床获益率83.90%,两组比较无显著性差异(P>0.05)。次要观察指标:1)疗后14天内每天的临床疗效:试验组给药后第5、7～12天共7天试验组每日临床疗效优于对照组(P<0.05)。2)疗后28天内最佳疗效:两组比较无显著性差异(P>0.05)。3)疗后14天内缓解的维持时间:试验组和对照组完全缓解的维持时间分别为5.51和3.01天(P=0.0302),有效维持时间分别为9.02和8.02天(P>0.05)。4)首次达临床有效(CR或PR)时间:试验组6天,对照组8天(P=0.0182)。不良反应主要有发热、低钙血症、疲劳等,试验组和对照组不良反应发生率分别为20.17%和24.58%(P>0.05),试验组和对照组均未见有严重肝肾功能、心电图异常等发生。结论:唑来膦酸能够有效缓解癌症骨转移患者的疼痛,其有效率及不良反应发生率与帕米膦酸二钠相当,使用安全、方便。
Objective： To evaluate the clinical effect and safety profiles of zoledronic acid in the treatment of hone metastasis pain in cancer patients. Methods： A multicenter, double-blind and double-dim clinical trial on pamidronate was conducted in 237 cancer patients with bone metastasis pain from 12 centers in China. The patients were randomized into 2 groups, i.e., the experiment group and control group. Zoledronic acid （4 mg） was injected for 15 min in the experiment group and pamidronate （90 mg） i.v. within 4 h in the controls. The daily change of bone ache recorded by a visual analog scale （VAS） and the side effects were observed within 4 weeks as well. Results： The total 219 of 239 cases were eligible for final analysis, 112 from experimental group and 107 from control group were involved in the clinical response evluation. For the best clinical response within 14 days, after injection with those two biphosphanates, the complete response rate （CR rate）, partial response rate （PR rate ） and clinical benefit rate was 10.08%, 53.78% and 90.75% respectively in the experiment group, compared with those data of 5.08%, 54.24% and 83.90% in the control group. There was no significant difference between the 2 groups. The daily clinical improvements of pain reduction and/or relief in the experiment group during the 5th, 7th till 12th day were absolutely better than those from the controls. There was no significant difference between the 2 groups for the consideration of pain improvement with 28 days . The medium maintain time （MMT） of complete response within 14 days were 5.51 and 3.01 days respectively between the 2 groups （P=0.0302）, with the contrast of the MMT of effective responses （CR＋PR） were 9.02 and 8.02 days （P〉0.05）. The incidence rate of the main side effects, like fever, hypocalcaemia, and fatigue was 23.94% and 27.98% respectively in the experiment group and the controls. No severe side effect was found in both groups. Conclusion： Zoledronic acid can effectively relieve bone metastasis pain. The response rate and side effect were similar to those of pamidronate.
出处
《中国肿瘤临床》
CAS
CSCD
北大核心
2006年第20期1169-1172,共4页
Chinese Journal of Clinical Oncology
关键词
唑来膦酸
帕米膦酸二钠
癌性骨痛
Ⅱ期临床试验
随机双盲双模拟
Zoledronic acid
Pamidronate
Cancerous bone ache
Phase Ⅱ clinical trial ；Randomized double blind and double dim
