滋补肾阴法干预绝经后骨质疏松转子间骨折术后的临床研究
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摘要
目的：探讨中医学对绝经后骨质疏松症的认识,采用左归丸为治疗药物,以补益肾阴法治疗绝经后骨质疏松症髋骨骨折中的肾虚证患者,评估其实际的临床疗效。并与常用西药钙稳相比较。
方法：本实验通过回顾文献资料及过往左归丸的实验研究,运用随机对照分组原则建立了绝经后骨质疏松并髋骨骨折模型,采用双能X线吸收法(DEXA)、血清雌二醇、钙、碱性磷酸酶、髋关节功能评估表(Harris Hip score)问卷调查评分等指标,观察了左归丸对骨质疏松性骨折术后的影响,并分别与西药组(钙稳)及中西药并用组相对照,旨在探讨左归丸对绝经后骨质疏松性骨折的治疗效果,并揭示其作用机理。本试验是将确诊为绝经后骨质疏松性髋骨骨折术后之患者分为3组,第1组为中药组,每日服用左归丸1次；第2组为西药组,每日服用钙稳1次；第3组为中西药结合组,每日服用左归丸及钙稳1次；每组各30例,试验时间为6个月。分别于试验前,试验第3个月末、第6个月末记录每位患者之骨密度、髋关节功能评估表、血中钙、雌二醇、碱性磷酸酶水平及中医症候指标：腰脊疼痛、腰膝酸软,脊背疼痛、下肢痿软、不能持重、目眩耳鸣等指标。全部数据以SPSS15.0统计软件进行统计学分析。
结果：三种治疗方法对绝经后骨质疏松性髋骨骨折术后骨密度的增加皆为有效治疗方法。从实验结果得知,经过6个月治疗,不论从髋关节功能或症状表现皆可看出,各组前后之比较皆有统计上的差异。随着治疗时间的延伸,患者各项指标均逐渐改善。根据试验统计结果,中西药结合组在各项指标均较中药组及西药组为佳。中西药结合组之患者在骨密度、腰脊疼痛、腰膝酸软、总证候积分、血清雌二醇等项目皆优于其它两组且有明显统计学上的差异(P<0.05)。至于血清碱性磷酸酶、髋关节功能评估分数及骨折愈合率则是在数据上优于其它两组但却无统计学上的差异。安全性指标：肝肾功能检查均在正常范围。三组均未见不良反应。
结论：以中西药结合来治疗绝经后骨质疏松转子间骨折术后的患者疗效,优于中药单独使用,及西药单独使用。中西药结合既安全、又有效,具有广泛的应用前景。
Purpose:To discuss the understanding of traditional Chinese medicine about postmenopausal osteoporosis, adopting the Chinese medicine Zuogui pill and use the method of tonifying kidney Yin to treat the patients of postmenopausal osteoporotic hip fracture with kidney deficiency syndrome.To observe the therapeutic efficacy of this method and comparison with the efficacy of western medicine Evista.
Methods:A randomized controlled trial was conducted 90 patients with postmenopausal osteoporosis associated with femoral intertrochanteric fracture S/P internal fixation with DHS were randomly classified into three groups. In this study, we take advantage of previous experiment study of Zuogui pill and establish a model of postmenopausal osteoporotic fracture of femoral intertrochanter randomly. We used multiple items including DEXA、serum estradiol、serum calcium、serum ALP、Harris Hip score questionnaire to evaluate the efficacy of Zuogui pill, Evista and combined treatment. Each group includes 30 patients and 2 three-months course were followed up. The complete data carries on statistics analysis by the SPSS 15.0 statistics software.
Results:All three methods for treating postmenopausal osteoporotic fracture of femoral intertrochanter are effective.According to the results of this study, after 6 months treatment, the patients in every group got obvious improvement statistically in clinical presentation with comparison to pre-treatment status.With the treatment time went by, the data of the evaluation items improved progressively. According to the statistical results, the efficacy of combined group is better than that of Zuogui pill group and Evista group. The combined group is superior in the improvement of BMD, symptoms of Chinese medicine, serum estradiol statistically. As mention to the items of serum ALP and HHS score, the combined group is superior in appearance but not statistically. According to above results, we can say that the combined method for treating postmenopausal osteoporotic fracture of femoral intertrochanter achieves a comprehensive superiority. This viewpoint provides a new option for treating these patients.
Conclusion:Chinese medicine combined with western medicine of method in tonifying and enrich kidney Yin to treat the patients of postmenopausal osteoporotic hip fracture with kidney deficiency syndrome has sure curative efficacy. It is worth studying deeply and developing further.
方法：本实验通过回顾文献资料及过往左归丸的实验研究,运用随机对照分组原则建立了绝经后骨质疏松并髋骨骨折模型,采用双能X线吸收法(DEXA)、血清雌二醇、钙、碱性磷酸酶、髋关节功能评估表(Harris Hip score)问卷调查评分等指标,观察了左归丸对骨质疏松性骨折术后的影响,并分别与西药组(钙稳)及中西药并用组相对照,旨在探讨左归丸对绝经后骨质疏松性骨折的治疗效果,并揭示其作用机理。本试验是将确诊为绝经后骨质疏松性髋骨骨折术后之患者分为3组,第1组为中药组,每日服用左归丸1次；第2组为西药组,每日服用钙稳1次；第3组为中西药结合组,每日服用左归丸及钙稳1次；每组各30例,试验时间为6个月。分别于试验前,试验第3个月末、第6个月末记录每位患者之骨密度、髋关节功能评估表、血中钙、雌二醇、碱性磷酸酶水平及中医症候指标：腰脊疼痛、腰膝酸软,脊背疼痛、下肢痿软、不能持重、目眩耳鸣等指标。全部数据以SPSS15.0统计软件进行统计学分析。
结果：三种治疗方法对绝经后骨质疏松性髋骨骨折术后骨密度的增加皆为有效治疗方法。从实验结果得知,经过6个月治疗,不论从髋关节功能或症状表现皆可看出,各组前后之比较皆有统计上的差异。随着治疗时间的延伸,患者各项指标均逐渐改善。根据试验统计结果,中西药结合组在各项指标均较中药组及西药组为佳。中西药结合组之患者在骨密度、腰脊疼痛、腰膝酸软、总证候积分、血清雌二醇等项目皆优于其它两组且有明显统计学上的差异(P<0.05)。至于血清碱性磷酸酶、髋关节功能评估分数及骨折愈合率则是在数据上优于其它两组但却无统计学上的差异。安全性指标：肝肾功能检查均在正常范围。三组均未见不良反应。
结论：以中西药结合来治疗绝经后骨质疏松转子间骨折术后的患者疗效,优于中药单独使用,及西药单独使用。中西药结合既安全、又有效,具有广泛的应用前景。
Purpose:To discuss the understanding of traditional Chinese medicine about postmenopausal osteoporosis, adopting the Chinese medicine Zuogui pill and use the method of tonifying kidney Yin to treat the patients of postmenopausal osteoporotic hip fracture with kidney deficiency syndrome.To observe the therapeutic efficacy of this method and comparison with the efficacy of western medicine Evista.
Methods:A randomized controlled trial was conducted 90 patients with postmenopausal osteoporosis associated with femoral intertrochanteric fracture S/P internal fixation with DHS were randomly classified into three groups. In this study, we take advantage of previous experiment study of Zuogui pill and establish a model of postmenopausal osteoporotic fracture of femoral intertrochanter randomly. We used multiple items including DEXA、serum estradiol、serum calcium、serum ALP、Harris Hip score questionnaire to evaluate the efficacy of Zuogui pill, Evista and combined treatment. Each group includes 30 patients and 2 three-months course were followed up. The complete data carries on statistics analysis by the SPSS 15.0 statistics software.
Results:All three methods for treating postmenopausal osteoporotic fracture of femoral intertrochanter are effective.According to the results of this study, after 6 months treatment, the patients in every group got obvious improvement statistically in clinical presentation with comparison to pre-treatment status.With the treatment time went by, the data of the evaluation items improved progressively. According to the statistical results, the efficacy of combined group is better than that of Zuogui pill group and Evista group. The combined group is superior in the improvement of BMD, symptoms of Chinese medicine, serum estradiol statistically. As mention to the items of serum ALP and HHS score, the combined group is superior in appearance but not statistically. According to above results, we can say that the combined method for treating postmenopausal osteoporotic fracture of femoral intertrochanter achieves a comprehensive superiority. This viewpoint provides a new option for treating these patients.
Conclusion:Chinese medicine combined with western medicine of method in tonifying and enrich kidney Yin to treat the patients of postmenopausal osteoporotic hip fracture with kidney deficiency syndrome has sure curative efficacy. It is worth studying deeply and developing further.
引文
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[2]刘忠厚,骨质疏松学.科技出版社.北京.1998年5月第二版,142
[3]杨雅婷译Mayo clinical on osteoporosis-骨质疏松症.梅约医学中心着,2004
[4]中国老年医学骨质疏松委员会骨质疏松诊断标准学科组,中国人骨质疏松症建议诊断标准(第二稿)中国骨质疏松杂志2000,6(1)：1
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