摘要
目的探讨金天格胶囊预防大肠癌化疗后骨质疏松的临床疗效和安全性。方法 2008年2月-2009年2月天津市人民医院大肠癌术后辅助化疗患者年龄大于45岁者共250例纳入本次研究,患者采用FOLFOX4方案进行术后辅助化疗,采用随机数字表,122例入研究组,随访期间患者死亡或无法坚持服药而造成12例脱落,最终共110例(男61例,女49例,使用金天格胶囊辅助术后健骨治疗)纳入研究组,另128例入对照组,随访期间因死亡或无法坚持服药造成8例脱落,最终120例纳入对照组(男62例,女58例,术后仅常规使用钙剂健骨)。所有患者化疗前均行双光子骨密度检查。首次化疗后连续健骨治疗16个月,随访复查X光平片、骨密度检查,同时使用VAS评分评定化疗后四肢骨关节疼痛程度,所有指标的测量结果使用软件包SPSS13.0进行统计分析。结果治疗组骨密度与首次化疗前相比增加者82例(74.5%),而对照组仅为16例(13.3%),组间相比有显著差异(P<0.05);化疗后四肢疼痛VAS评分,治疗组化疗后一周(7.48±0.34)分,化疗后12个月(3.54±0.61)分,对照组化疗后一周(7.33±0.46)分,化疗后12个月(7.04±1.39)分,两组患者骨质疏松造成骨痛的改善程度存在显著差异;X光平片研究组3例出现骨质疏松相关病理性腰椎压缩骨折(2.72%),而对照组7例出现病理性腰椎压缩骨折(5.83%),骨折发生率两者相比存在显著差异(P<0.01)。结论金天格胶囊辅助健骨可以安全、高效地预防结大肠癌患者化疗后的骨质疏松和骨质疏松相关的严重骨痛和椎体骨折。
Objective To investigate the clinical efficacy and safety of Jintiange capsules on the prevention of osteoporosis after chemotherapy in patients with colorectal cancer. Methods From February 2008 to February 2009, 250 patients over 45 years old, who were diagnosed with colorectal cancer and underwent standard chemotherapy in Tianjin People＇ s Hospital, were involved in this study. All the patients received the chemotherapy according to FOLFOX4 regimen. The random number table was adopted and 122 patients were enrolled in study group. During the follow-up, 12 patients fall off the study because of death or unable to insist on taking medicine. Finally, 110 patients （61 men and 49 women） were included in study group and followed-up successfully. The patients were treated with Jintiange capsules combined with calcium. The other 128 patients were enrolled in control group, and 8 patients missed because of death or unable to insist on taking medicine. One hundred and twenty patients （62 men and 58 women） were included in control group and only treated with calcium. Bone mineral density （BMD） of all the patients before the chemotherapy was detected. After the first chemotherapy, the calcium treatment lasted for 16 months. During the follow-up, the X-ray and BMD were detected. The vision analogue scale （VAS） was used for the evaluation of the pain of the extremities and the joints after chemotherapy. All parameters were analyzed using a SPSS 13.0 software. Results In study group, BMD of 82 patients （74.5%） increased compared with that after the first chemotherapy. The number in control group was just 16 （ 13.3% ）, and the difference was significant （ P 〈 0.05 ）. The VAS score in study group at the 1st week and at the 12th month after the first chemotherapy was 7.48 ±0. 34 and 3.54±0.61, respectively. The score in control group was 7.33 ± 0. 46 and 7.04 ± 1.39, respectively. And the release of the pain induced by osteoporosis in two groups was significant different. Three patients （2. 72% ） in study group developed osteoporotic lumbar vertebral compression fractures on X-ray images, while 7 patients （5.83%） in control group had fractures, and the difference of the incidence in 2 groups was significant （ P 〈 O. 01 ）. Conclusion Jintiange capsules combined with calcium therapy can safely and efficiently prevent osteoporosis and osteoporosis associated severe pain and vertebral fractures after chemotherapy in patients with colorectal cancer.
出处
《中国骨质疏松杂志》
CAS
CSCD
北大核心
2013年第12期1265-1268,共4页
Chinese Journal of Osteoporosis
关键词
金天格胶囊
大肠癌
化疗后
骨质疏松
Jintiange capsules
Colorectal cancer
Chemotherapy
Osteoporosis
