金天格胶囊治疗原发性骨质疏松症疗效研究  

Effect study on Jintiange capsule in treatment of primary osteoporosis

作　　者：薛磊[1] 冉宇 李忠泽 陈劲松 陈江[2] XUE Lei;RAN Yu;LI Zhongze;CHEN Jinsong;CHEN Jiang(Department of Orthopaedic Trauma,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;不详)

机构地区：[1]中国中医科学院西苑医院创伤骨科,北京100091 [2]北京中医药大学东直门医院骨伤科一区,北京100700

出　　处：《陕西中医》2023年第7期873-876,共4页Shaanxi Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金资助项目(81603638);北京中医药大学东直门医院横向课题(HX-DZM-202134)。

摘　　要：目的:探讨原发性骨质疏松症(POP)经金天格胶囊治疗后的骨代谢变化。方法:采用随机数字表法将98例POP患者分为对照组、观察组,各49例。对照组给予钙尔奇D 3、骨化三醇,观察组在对照组基础上给予金天格胶囊。两组均持续治疗6个月。比较两组治疗6个月后的临床疗效,治疗前、治疗6个月后的疼痛程度、中医症状积分、骨密度值、骨代谢指标、生活质量评分以及治疗期间的用药安全性。结果:治疗6个月后,观察组总有效率为95.92%,高于对照组的79.59%(P<0.05)。治疗6个月后,两组疼痛视觉模拟评分(VAS)、各项中医证候积分、血清碱性磷酸酶(ALP)水平均低于治疗前,且观察组低于对照组,差异有统计学意义(均P<0.05)。治疗6个月后,两组腰椎L_(2-4)、股骨颈的骨密度T值、血钙(Ca)及骨钙素(OC)水平均高于治疗前,且观察组高于对照组,差异有统计学意义(均P<0.05)。治疗6个月后,两组简明健康状况量表(SF-36)评分高于治疗前;治疗3个月后,观察组高于对照组,差异有统计学意义(均P<0.05)。两组治疗期间的不良反应总发生率比较,差异无统计学意义(P>0.05)。结论:金天格胶囊治疗POP可缓解临床症状,促进骨密度、骨代谢指标改善,使患者疼痛程度得以缓解,有效提高生活质量,具有较高的临床疗效,且安全性良好。Objective:To investigate changes of bone metabolism in patients with primary osteoporosis(POP)before and after treatment with Jintiange capsule.Methods:98 patients with POP were divided into control group and observation group by random number table method,with 49 cases each group.The control group was given Calci D and calcitriol and the observation group given Jintiange capsule on the basis of the control group.Both groups were treated continuously for 6 months.After 6 months of treatment,the clinical efficacy,pain degree,TCM symptom score,bone density value,bone metabolism index,quality of life score,and drug safety during treatment were compared between the two groups.Results:After 6 months of treatment,the rate of total effective in the observation group was 95.92%higher than 79.59%in the control group(P<0.05).After 6 months treatment,the scores of visual analogue scale(VAS),traditional Chinese medicine syndrome and the levels of serum alkaline phosphatase(ALP)in the two groups were lower than before treatment,and the observation group lower than those in the control group,difference statistically significant(all P<0.05).The bone mineral density T value of the lumbar L_(2-4)and femoral neck,the levels of serum calcium(Ca)and osteocalcin(OC)were higher than before treatment,and the observation group higher than those in the control group,difference statistically significant(all P<0.05).After 6 months of treatment,the scores of short form of health(SF-36)in the two groups were higher than before and 3 months treatment,and the observation group higher than those in the control group,difference statistically significant(all P<0.05).There was no significant difference in the total incidence of adverse reactions between the two groups(P>0.05).Conclusion:Jintiange capsule treatment for POP could relieve clinical symptoms of patients,promote bone density and bone metabolism indicators,relieve the pain of patients,improve quality of life.It had high clinical efficacy with better safety.

关 键 词：原发性骨质疏松症 钙尔奇D 骨化三醇胶丸 金天格胶囊 骨代谢 骨密度 

分 类 号：R274[医药卫生—中医骨伤科学]