[1]赵凡,刘全,吴连国.口服强骨饮联合碳酸钙D3片治疗绝经后骨质疏松症的临床研究[J].中医正骨,2019,31(04):26-30.
　ZHAO Fan,LIU Quan,WU Lianguo.Oral applications of Qianggu Yin(强骨饮)and calcium carbonate and Vitamin D3 tablets for treatment of postmenopausal osteoporosis:a clinical study[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2019,31(04):26-30.
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口服强骨饮联合碳酸钙D3片治疗绝经后骨质疏松症的临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第31卷
期数:
2019年04期
页码:
26-30
栏目:
临床研究
出版日期:
2019-04-30

文章信息/Info

Title:
Oral applications of Qianggu Yin(强骨饮)and calcium carbonate and Vitamin D3 tablets for treatment of postmenopausal osteoporosis:a clinical study
作者:
赵凡1; 刘全2; 吴连国2
(1.诸暨市中心医院,浙江 诸暨 311800; 2.浙江中医药大学附属第二医院,浙江 杭州 310005)
Author(s):
ZHAO Fan1; LIU Quan2; WU Lianguo2
1.Zhuji Central Hospital,Zhuji 311800,Zhejiang,China The Second Affiliated Hospital of Zhejiang Chinese Medical University,Hangzhou 310005,Zhejiang,China
关键词:
骨质疏松; 绝经后;  骨密度;  强骨饮;  Ⅰ型前胶原氨基端前肽;  Ⅰ型胶原羧基端交联端肽;  临床试验
Keywords:
osteoporosis; postmenopausal;  bone density;  Qianggu Yin;  N-terminal propeptide of typeⅠprecollagen;  C-terminal cross-linked telopeptide of typeⅠcollagen;  clinical trial
摘要:
目的:观察口服强骨饮联合碳酸钙D3片治疗绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)的临床疗效及安全性。方法:将符合要求的60例PMOP患者随机分为2组,每组30例,分别采用口服强骨饮联合碳酸钙D3片和口服阿仑膦酸钠维D3片联合碳酸钙D3片治疗。强骨饮,每日1剂,早晚各服用1次,每次200 mL; 碳酸钙D3片,每日1次,每次600 mg; 阿仑膦酸钠维D3片,每周1次,每次70 mg; 均连续治疗24周。分别于治疗前和治疗结束后测定患者的骨密度和血清Ⅰ型前胶原氨基端前肽(N-terminal propeptide of typeⅠprecollagen,PⅠNP)及Ⅰ型胶原羧基端交联端肽(C-terminal cross-linked telopeptide of typeⅠcollagen,CTX-Ⅰ)含量。试验期间定期检测患者的肝肾功能。结果:共3例患者退出试验,强骨饮组2例因未按规定用药退出,阿仑膦酸钠组1例因突发外伤事件退出。治疗前2组患者的骨密度比较,差异无统计学意义[(0.67±0.02)g·cm-2,(0.66±0.03)g·cm-2,t=1.257,P=0.128]; 治疗结束后强骨饮组的骨密度较治疗前增高(t=-13.876,P=0.003); 阿仑膦酸钠组的骨密度与治疗前相比,差异无统计学意义(t=-1.345,P=0.132); 治疗结束后,强骨饮组的骨密度高于阿仑膦酸钠组[(0.75±0.03)g·cm-2,(0.68±0.02)g·cm-2,t=12.942,P=0.003]。治疗前2组患者的血清PⅠNP含量比较,差异无统计学意义[(46.54±4.80)ng·L-1,(45.86±3.44)ng·L-1,t=1.753,P=0.088]; 治疗结束后2组患者的血清PⅠNP含量均较治疗前降低(t=7.673,P=0.002; t=4.345,P=0.008),强骨饮组的血清PⅠNP含量低于阿仑膦酸钠组[(37.55±4.28)ng·L-1,(40.68±3.03)ng·L-1,t=-3.941,P=0.004]。治疗前2组患者的血清CTX-Ⅰ含量比较,差异无统计学意义[(0.56±0.09)ng·L-1,(0.58±0.04)ng·L-1,t=-1.146,P=0.097]; 治疗结束后2组患者的血清CTX-Ⅰ含量均较治疗前降低(t=4.443,P=0.000; t=2.876,P=0.002),强骨饮组的血清CTX-Ⅰ含量低于阿仑膦酸钠组[(0.48±0.06)ng·L-1,(0.53±0.03)ng·L-1,t=-3.031,P=0.000]。试验期间所有患者均未出现肝肾功能损害,强骨饮组与阿仑膦酸钠组各有1例出现恶心、腹胀症状,调整服药时间后症状缓解。2组患者不良反应发生率比较,差异无统计学意义(χ2=0.000,P=1.000)。结论:口服强骨饮联合碳酸钙D3片可以降低PMOP患者的血清PⅠNP及CTX-Ⅰ含量,有助于增加患者的骨密度,且安全性较高。
Abstract:
Objective:To observe the clinical curative effects and safety of oral applications of Qianggu Yin(强骨饮,QGY)and calcium carbonate and Vitamin D3 tablets for treatment of postmenopausal osteoporosis(PMOP).Methods:Sixty patients with PMOP were enrolled in the study and were randomly divided into 2 groups,30 cases in each group.The patients were treated with combination therapy of oral applications of QGY and calcium carbonate and Vitamin D3 tablets(QGY group)and combination therapy of oral applications of alendronate sodium and Vitamin D3 tablets and calcium carbonate and Vitamin D3 tablets(alendronate sodium group)respectively.The QGY was taken one dose a day in the morning and evening,200 mL at a time for consecutive 24 weeks.The calcium carbonate and Vitamin D3 tablets were taken once a day,600 mg at a time for consecutive 24 weeks.The alendronate sodium and Vitamin D3 tablets were taken once a week,70 mg at a time for consecutive 24 weeks.The bone density and serum contents of N-terminal propeptide of typeⅠprecollagen(PⅠNP)and C-terminal cross-linked telopeptide of typeⅠcollagen(CTX-Ⅰ)were measured and compared between the 2 groups before the treatment and after the end of the treatment respectively.The patients' hepatorenal functions were periodically tested during the trial.Results:Two patients in QGY group and one patient in alendronate sodium group dropped out of the trial for failing to take medication as required and the unexpected trauma respectively.There was no statistical difference in the bone density between the 2 groups before the treatment(0.67+/-0.02 vs 0.66+/-0.03 g/cm(2),t=1.257,P=0.128).The bone density increased after the end of the treatment compared to pretreatment in QGY group(t=-13.876,P=0.003).There was no statistical difference in the bone density between pre-treatment and post-treatment in alendronate sodium group(t=-1.345,P=0.132).The bone density was higher in QGY group compared to alendronate sodium group after the end of the treatment(0.75+/-0.03 vs 0.68+/-0.02 g/cm(2),t=12.942,P=0.003).There was no statistical difference in serum contents of PⅠNP between the 2 groups before the treatment(46.54+/-4.80 vs 45.86+/-3.44 ng/L,t=1.753,P=0.088).The serum contents of PⅠNP decreased after the end of the treatment compared to pretreatment in the 2 groups(t=7.673,P=0.002; t=4.345,P=0.008),and were lower in QGY group compared to alendronate sodium group after the end of the treatment(37.55+/-4.28 vs 40.68+/-3.03 ng/L,t=-3.941,P=0.004).There was no statistical difference in serum contents of CTX-Ⅰbetween the 2 groups before the treatment(0.56+/-0.09 vs 0.58+/-0.04 ng/L,t=-1.146,P=0.097).The serum contents of CTX-Ⅰdecreased after the end of the treatment compared to pretreatment in the 2 groups(t=4.443,P=0.000; t=2.876,P=0.002),and were lower in QGY group compared to alendronate sodium group after the end of the treatment(0.48+/-0.06 vs 0.53+/-0.03 ng/L,t=-3.031,P=0.000).No damage to hepatorenal functions were found in the 2 groups during the trial.The adverse reactions such as nausea and abdominal distension were found in the 2 groups,1 case in each group.The symptoms were relieved after the medicine-taking time was adjusted.There was no statistical difference in the incidence rate of adverse reactions between the 2 groups(χ2=0.000,P=1.000).Conclusion:Oral applications of QGY and calcium carbonate and Vitamin D3 tablets can decrease the serum contents of PⅠNP and CTX-Ⅰand help to increase the bone density in patients with PMOP,moreover,it has high safty.

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备注/Memo

备注/Memo:
基金项目:浙江省中医药科技计划重点研究项目(2019ZZ012); 浙江省高等学校中青年学科带头人培养计划项目(浙教办高科[2017]68号) 通讯作者:吴连国 E-mail:mdwu8535@126.com(收稿日期:2019-01-16 本文编辑:郭毅曼)
更新日期/Last Update: 2019-10-08