固令胶囊预防早期乳腺癌骨转移的临床研究  

Prevention effect of clodronate capsules on bone metastases of early breast cancer clinical research

作　　者：李全奎[1] 陈兴秀[1] 刘广升[1] 李广起[1] 杨金山[1] 

机构地区：[1]滨州市人民医院肿瘤二科,山东滨州256610

出　　处：《中华肿瘤防治杂志》2012年第10期774-776,共3页Chinese Journal of Cancer Prevention and Treatment

摘　　要：目的:探讨口服固令胶囊(氯膦酸二钠、双氯甲烷二磷酸钠)预防早期乳腺癌发生骨转移的研究,以期达到降低或预防乳腺癌发生骨转移的目的。方法:300例早期乳腺癌术后Ⅰ～Ⅲ期的患者;经过手术和(或)放疗的治疗,伴或不伴全身激素治疗和(或)化疗,根据入选标准按照信封法随机分配到治疗组及对照组中。142例进入口服固令组,158例进入口服安慰剂组。固令组患者在早期治疗(手术、放疗和服用他莫昔芬)的6个月内开始,患者在2年内服用固令胶囊1 600mg,1次/d。安慰剂组患者在上述的时间内服用安慰剂,1次/d。结果:2年的观察结果为固令胶囊组骨转移的发生率为3.52%(5/142);安慰剂组骨转移的发生率为13.29%(21/158),骨转移的发生率减少了73.51%,χ2=7.826 4,P=0.005 1。5年的观察结果为固令胶囊组骨转移的发生率为5.63%(8/142);安慰剂组骨转移的发生率为20.88%(33/158),骨转移的发生率减少了73.04%,χ2=13.48,P=0.000 2。结论:口服固令胶囊加入早期乳腺癌术后标准辅助治疗中,显著降低早期乳腺癌患者骨转移的总体发生率。且无严重的长期不良反应,可以作为乳腺癌辅助治疗中的一个安全、长期的治疗方法。OBJECTIVE： To explore the mechanism that disodium clodronate capsules can prevent bone metastases of early breast cancer. METHODS： Totally 300 patients with early breast cancer Ⅰ- Ⅲ issue were enrolled in this study, who were of the postoperative and（or） radiation therapy,the whole body hormone therapy and（or） chemotherapy. And 142 patients were randomized into the oral disodium clodronate capsules group and 158 patients into placebo group. Disodium clodronate group started with early treatment in the first 6 months and the dose was 1 600 mg/d with 2 years. The placebo group took the same dose placebo at the same time. RESULTS： The incidence of bone metastases of disodium clodronate group and placebo group was 3.52%（5/142） and 13.29%（21/158） separately in the 2 years observation which is reduced by 73.51%（Х^2= 7. 826 4,P=0. 005 1）,so as to 5.63% （8/142） and 20.88% in the 5 years observation which was reduced by 73.04 % （Х^2= 13.48, P = 0. 000 2）. CONCLUSIONS： Oral disodium clodronate is a good auxiliary treat ment after breast cancer operation which can reduce incidence of bone metastases significantly in the early breast cancer patients. So disodium clodronate capsules can be well accepted in the long term because of its therapeutic effect and mild side effects in the auxiliary treatment of breast cancer.

关 键 词：乳腺肿瘤 药物疗法 骨转移 固令胶囊 

分 类 号：R737.9[医药卫生—肿瘤]