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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 investigate the effect of Oral GuZhi capsules (disodium clodronate and sodium bicarbonate diphosphate) on the prevention of bone metastasis in early stage breast cancer in order to reduce or prevent the occurrence of bone metastasis in breast cancer. Methods: One hundred and three patients with stage Ⅰ ~ Ⅲ postoperative early breast cancer were treated with surgery and / or radiotherapy, with or without systemic hormone therapy and / or chemotherapy. Patients were randomly assigned to the treatment group according to the inclusion criteria according to the inclusion criteria And control group. 142 patients entered the oral fixed group, 158 patients entered the oral placebo group. Patients in the fastidious regimen started within 6 months of early treatment (surgery, radiotherapy, and tamoxifen), and patients took Guigang Capsule 1 600 mg twice daily for 2 years. Patients in the placebo group took placebo once a day for the above period. Results: The incidence of bone metastases in GuLing capsule group was 3.52% (5/142) in 2 years. The incidence of bone metastases in placebo group was 13.29% (21/158), and the incidence of bone metastases was decreased 73.51%, χ2 = 7.826 4, P = 0.005 1.5 years The observation was that the incidence of bone metastasis in GuLin capsule group was 5.63% (8/142); the incidence of bone metastasis in placebo group was 20.88% (33 / 158), the incidence of bone metastases decreased by 73.04%, χ2 = 13.48, P = 0.0002. Conclusion: Oral Gu Ling Capsule added to the standard adjuvant treatment of early postoperative breast cancer, significantly reduce the overall incidence of early bone cancer patients with bone metastases. And no serious long-term adverse reactions, can be used as adjuvant breast cancer treatment in a safe, long-term treatment.