英卡膦酸二钠治疗恶性肿瘤骨转移  

A Phase Ⅱ Clinical Trial of Incardronate in the Treatment of Cancer Patients with Bone Metastasis

作　　者：王宏羽[1] 冯奉仪[1] 周美珍[2] 李文举[2] 张永强[2] 宋三泰 刘晓晴 朱允中[4] 史鹤玲[4] 王杰军[5] 高勇[5] 何友谦 

机构地区：[1]中国医学科学院中国协和医科大学肿瘤医院内科,100021 [2]北京医院 [3]军科院附属医院 [4]北京市结核病胸部肿瘤医院 [5]上海长征医院 [6]中山医大肿瘤医院

出　　处：《医学研究通讯》2005年第1期19-22,共4页Bulletin of Medical Research

摘　　要：目的评价国产英卡膦酸二钠单次静脉滴注(注射剂)和连续口服(片剂)治疗恶性肿瘤骨转移疼痛的安全性,比较国产英卡膦酸二钠与国产氯屈膦酸二钠(洛屈)治疗骨转移疼痛的疗效和安全性。方法骨转移疼痛:多中心,开放,随机阳性药平行对照临床研究。A 组:英卡膦酸二钠注射液10mg,静注,d 1;英卡膦酸二钠片5mg,Po 3次/日,d 6～21。B组:氯屈膦酸二钠注射液300mg,静注,d 1～5;氯屈膦酸二钠胶囊800mg,Po 3次/日,d 6～21。结果 163例病人入组,其中109例可评价不良反应,100例可评价疗效,用药第6天,英卡膦酸二钠英和氯屈膦酸二钠镇痛的疗效分别为58.70%及55.07%,P=0.6457;第21天,疗效分别为70.09%及69.57%,P=0.3547;用药第6天,英卡膦酸二钠英与氯屈膦酸二钠改善活动能力的疗效分别为31.11%及30.43%,P=0.9271;第21天,疗效分别为41.11%及39.13%,P=0.8007。不良反应发热、骨肌肉一过性疼痛、恶心、呕吐、腹泻、皮疹的发生率,英卡膦酸二钠分别为29.79%、19.15%、8.51%、6.38%、4.26%、4.26%;氯屈膦酸二钠分别为7.25%、5.80%、13.04%、11.59%、2.90%、0%,发热的发生率两组差异有统计学显著意义(P=0.0002),骨肌肉一过性疼痛的发生率两组差异无统计学意义(P=0.0662)。对发热和骨肌肉一过性疼痛进行 Lo-gistic 回归分析,不同的试验组用药是影响发热的最显著因素,P=0.0071;组别并不是影响骨肌肉一过性疼痛的因素,P=0.0776。结论英卡膦酸二钠治疗恶性肿瘤骨转移引起的疼痛具有明显的疗效,并在一定程度上改善活动能力,不良反应易于耐受。Objective To study the efficacy and safety of Incardronate in the treatment of cancer patients with bone metastasis.Methods A muticenter randomized,open and parallel study comparing Incardronate and Clodronate was carried out,Incardronate or Clodronate was i.v.during d 1～5,and p.o.during 6～21.Results 163 Patients were enrolled,109 patients were evaluated as adverse effects,100 were eval- uated as response.The responsive rates of Incardronate and Clodronate in pain-relief were 58.70% and 55.07% respectively in d 6,P= 0.6457;70.09% and 69.57% respectively in d 21,P=0.3547;The responsive rates of Ineardronate and Clodronate in mobility improvement were 31.11% and 30.44% respectively in d 6,P=0.9271;41.11% and 39.13% respectively in d 21,P=0.8007.The incidence of ad- verse effects of fever、myalgia(temporary)、nausea、vomiting、diarrhea and rash were 29.79%、19.15%、8.51%、6.38%、4.26% and 4.26% in Incardronate;7.25%、5.80%、13.04%、11.59%、2.90% and 0% in Clodronate.The fever was significantly difference be- tween two drugs,(P=0.0002);a temporary myalgia was no significant difference between two drugs,(P=0.0662);further Logistic regres- sion analysis of fever and temporary myalgia showed that drug prescribed in different clinical trial group was the statistically significant factor influ- encing fever,P=0.0071;the group differentiation was not the factor influencing temporary myalgia,P=0.0776.Conclusion Incardronate was more effective in pain relief,and showed a little improvement in mobility in the treatment of cancer patients with bone metastasis,the inci- dence of its adverse effects was mild and well tolerated.

关 键 词：治疗 疼痛 氯屈膦酸二钠 恶性肿瘤骨转移 疗效 发热 不良反应 动能 连续 随机 

分 类 号：R738[医药卫生—肿瘤] R73-37[医药卫生—临床医学]