唑来膦酸和伊班膦酸钠治疗乳腺癌骨转移的疗效和安全性比较

Comparative study on the efficacy and safety of zoledronic acid and sodium ibandronate in treating bonemetastasis in breast cancer patients

目的评价发生骨转移的乳腺癌患者在接受唑来膦酸和伊班膦酸钠治疗的有效性和安全性。方法47例发生骨转移的乳腺癌分别接受唑来膦酸和伊班膦酸钠治疗。用Kaplan-Meier曲线及Log-rank检验骨相关事件（skeletal related event，SRE）生存时间及总生存率差异，止痛效果及不良反应发生率用x。检验。结果①止痛总有效率唑来膦酸组和伊班膦酸钠组分别为88．9％（24／27）和85％（17／20）（P=0．467）。②1、2、3年无SRE生存率唑来膦酸组分别为88．7％、44．4％、24．2％，伊班膦酸钠组分别为94．7％、40．5％、5．8％（P=0．744）。（觐、3、4年总生存率唑来膦酸组分别为70．4％、40．7％、23．1％，伊班膦酸钠组分别为85％、46．7％、17．5％（P=0．994）。①②③差异均无统计学意义。④1、2、3年无SRE生存率首发表现单纯骨转移组为92％、50．8％、23．8％，首发合并局部复发及其他脏器转移组为85．4％、21．4％、5．3％（P=0．012）。⑤2、3年总生存率首发单纯骨转移组95．8％、74．2％，首发合并局部复发及其他脏器转移组为56．5％、10．1％（P〈0．001）。④⑤差异有统计学意义。不良反应发生2组无明显差别。结论唑来膦酸在延迟乳腺癌骨转移SRE发生及总生存方面不优于伊班膦酸钠，首发合并其他脏器转移患者预后不良，在不良反应发生率及疼痛控制方面2者疗效相当。

Objective To retrospectively evaluate the efficacy and safety of zoledronic acid and sodium ibandronate in treating bone metastasis in breast cancer patients. Methods The study included 47 patients who were treated with zoledronic acid and sodium ibandronate respectively from Aug. 2006 to Mar. 2011. Kaplan- Meier curve and Log rank test were adopted to detect the difference in survival time of skeletal related event （SRE） and survival rate between patients treated with different medicine, andx2 test was used to reveal the rate difference of pain killing effects and adverse effects. Results 1. The total effective rate of pain killing was 88.9% and 85% respectively. The difference had no statistical significance（P =0. 467）. 2. The 1, 2 and 3- year-survival rate in zoledronic acid group and sodium ibandronate group was 88. 7%, 44.4%, 24. 2% vs 94. 7%, 40. 5%, 5.8%. The difference had no statistical significance（P =0. 744）. 3. The 2, 3, and 4-year- survival rate in zoledronic acid group and sodium ibandronate group was 70. 4% , 40. 7% , 23.1% vs 85% , 46. 7% , 17. 5%. The difference had no statistical significance（P =0. 994）. 4. The 1, 2 and 3-year SRE-free overall survival rate of the group with metastasis first to bone only was 92%, 50. 8% , and 23.8% ,while the rate of the group with first metastasis to visceral organs was 85.4% , 21.4% , and 5.3% （P =0.012）. 5. The 2 and 3-year overall survival rate of the group with metastasis first to bone only was 95.8% and 74. 2% respectively, while the rate of the group with first metastasis to visceral organs was 56. 5% and 10. 1% （ P 〈 0. 001 ）. The differ- ence of 4 and 5 had statistical significance. The difference of zoledronic acid group and sodium ibandronate group in rate of adverse effects had no statistical significance. Conclusions Compared to sodium ibandronate, zole- dronic acid has no superiority in either delaying the occurrence of SRE or improving overall survival rate. The 2 are similar in incidence of adverse effects and pain control. The prognosis of patients whose first presentation is complicated by metastasis to other organs is poor.