金天格胶囊治疗绝经后乳癌患者术后骨质疏松的临床观察

摘要

目的：探讨金天格胶囊治疗绝经后乳癌患者术后骨质疏松的临床疗效和安全性。方法2010年2月－2012年2月我院肿瘤科接诊绝经后乳癌术后治疗患者78例，其中雌激素受体（ ER）阳性者70例，均在术后行4周期多西紫杉醇序贯4周期环磷酰胺联合表阿霉素辅助化疗，化疗后采用第三代芳香化酶抑制剂阿那曲唑内分泌治疗1年，70例患者均获得了16个月的随访，纳入本次研究。治疗开始前即采用随机数字表选取患者入组，35例入研究组，即从化疗开始就采用金天格胶囊联合钙剂健骨治疗16个月，另35例入对照组，化疗开始后仅常规使用钙剂健骨16个月。所有患者化疗前均行双光子骨密度检查，并在化疗与内分泌治疗后和随访期间使用VAS评分评定四肢骨关节疼痛程度，复查X光平片、骨密度检查。所有指标的测量结果使用软件包SPSS13．0进行统计分析。结果随访16个月，无死亡，无再手术病例，研究组最终骨密度与首次化疗前相比增加者24例（68．6％）；而对照组仅为5例（14．3％），组间相比有显著差异（卡方检验，P＜0．05）；内分泌治疗后四肢疼痛VAS评估，研究组内分泌治疗后4周为7．48±0．34分，随访终结时为3．54±0．61分，对照组内分泌治疗后4周7．33±0．46分，随访终结时7．04±1．39，两组患者骨质疏松造成骨痛的改善程度存在显著差异；影像学分析研究组1例出现骨质疏松相关病理性腰椎压缩骨折（2．86％），而对照组3例出现病理性腰椎压缩骨折（8．57％），骨折发生率两者相比存在显著差异（卡方检验，P＜0．01）。结论金天格胶囊联合钙剂的综合健骨治疗可以预防绝经后乳癌患者术后治疗期间骨质疏松的发生，同时可以显著降低此类患者术后延续治疗期间骨质疏松相关的严重骨痛和椎体骨折。%Objective To observe the clinical efficacy and safety of the treatment of osteoporosis with Jintiange capsules for postmenopausal breast cancer ( PBC) patients after surgery.Methods From Feb 2010 to Feb 2012, 78 PBC cases, who were admitted in oncology department in Tianjin Medicine Center after surgical treatment, were recruited in our study in which 70 cases were estrogen receptor ( ER) positive.All 70 cases were treated with routine chemo-therapy and sequential endocrine-therapy and successfully followed up for 16 months.The patients were randomly divided to study group (35 cases) who were treated with Jintiange capsules accompanied with calcium tablet for 16 months and to control group (35 cases) who were treated with calcium tablet alone for 16 months.Bone mineral density ( BMD) , vision analogue scale ( VAS) , and lumbar X-ray images were examined and the results were analyzed statistically using a SPSS 13.0 software.Results During the 16-month follow up, no death and re-operation case was reported.The patients with increase of BMD after the treatment were 24 cases (68.6%) in study group, which was different compared to those in control group (5 cases, 14.3%, P<0.05).The VAS score was 7.48 ±0.34 after endocrine-therapy and 3.54 ±0.61 at the final follow up in study group, and 7.33 ±0.46 and 7.04 ±1.39 in control group, respectively.The extent of bone pain relieve was significantly different between the 2 groups.Image study showed that 1 case in study group (2.86%) and 3 cases in control group (8.57%) developed compressed fractures.The fracture rate was significantly different between the 2 groups.Conclusion The combining treatment with Jintiange capsules prevents the occurrence of osteoporosis during the postoperational therapy in PBC patients.It also reduces severe osteoporotic bone pain and vertebral fractures.