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[1]趙凡,劉全,吳連國.口服強(qiáng)骨飲聯(lián)合碳酸鈣D3片治療絕經(jīng)后骨質(zhì)疏松癥的臨床研究[J].中醫(yī)正骨,2019,31(04):26-30.
　ZHAO Fan,LIU Quan,WU Lianguo.Oral applications of Qianggu Yin(強(qiáng)骨飲)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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口服強(qiáng)骨飲聯(lián)合碳酸鈣D3片治療絕經(jīng)后骨質(zhì)疏松癥的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第31卷
期數(shù):
2019年04期
頁碼:
26-30
欄目:
臨床研究
出版日期:
2019-04-30

文章信息/Info

Title:
Oral applications of Qianggu Yin(強(qiáng)骨飲)and calcium carbonate and Vitamin D3 tablets for treatment of postmenopausal osteoporosis:a clinical study
作者:
趙凡1; 劉全2; 吳連國2
(1.諸暨市中心醫(yī)院,浙江 諸暨 311800; 2.浙江中醫(yī)藥大學(xué)附屬第二醫(yī)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
關(guān)鍵詞:
骨質(zhì)疏松; 絕經(jīng)后;  骨密度;  強(qiáng)骨飲;  Ⅰ型前膠原氨基端前肽;  Ⅰ型膠原羧基端交聯(lián)端肽;  臨床試驗
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:觀察口服強(qiáng)骨飲聯(lián)合碳酸鈣D3片治療絕經(jīng)后骨質(zhì)疏松癥(postmenopausal osteoporosis,PMOP)的臨床療效及安全性。方法:將符合要求的60例PMOP患者隨機(jī)分為2組,每組30例,分別采用口服強(qiáng)骨飲聯(lián)合碳酸鈣D3片和口服阿侖膦酸鈉維D3片聯(lián)合碳酸鈣D3片治療。強(qiáng)骨飲,每日1劑,早晚各服用1次,每次200 mL; 碳酸鈣D3片,每日1次,每次600 mg; 阿侖膦酸鈉維D3片,每周1次,每次70 mg; 均連續(xù)治療24周。分別于治療前和治療結(jié)束后測定患者的骨密度和血清Ⅰ型前膠原氨基端前肽(N-terminal propeptide of typeⅠprecollagen,PⅠNP)及Ⅰ型膠原羧基端交聯(lián)端肽(C-terminal cross-linked telopeptide of typeⅠcollagen,CTX-Ⅰ)含量。試驗期間定期檢測患者的肝腎功能。結(jié)果:共3例患者退出試驗,強(qiáng)骨飲組2例因未按規(guī)定用藥退出,阿侖膦酸鈉組1例因突發(fā)外傷事件退出。治療前2組患者的骨密度比較,差異無統(tǒng)計學(xué)意義[(0.67±0.02)g·cm-2,(0.66±0.03)g·cm-2,t=1.257,P=0.128]; 治療結(jié)束后強(qiáng)骨飲組的骨密度較治療前增高(t=-13.876,P=0.003); 阿侖膦酸鈉組的骨密度與治療前相比,差異無統(tǒng)計學(xué)意義(t=-1.345,P=0.132); 治療結(jié)束后,強(qiáng)骨飲組的骨密度高于阿侖膦酸鈉組[(0.75±0.03)g·cm-2,(0.68±0.02)g·cm-2,t=12.942,P=0.003]。治療前2組患者的血清PⅠNP含量比較,差異無統(tǒng)計學(xué)意義[(46.54±4.80)ng·L-1,(45.86±3.44)ng·L-1,t=1.753,P=0.088]; 治療結(jié)束后2組患者的血清PⅠNP含量均較治療前降低(t=7.673,P=0.002; t=4.345,P=0.008),強(qiáng)骨飲組的血清PⅠNP含量低于阿侖膦酸鈉組[(37.55±4.28)ng·L-1,(40.68±3.03)ng·L-1,t=-3.941,P=0.004]。治療前2組患者的血清CTX-Ⅰ含量比較,差異無統(tǒng)計學(xué)意義[(0.56±0.09)ng·L-1,(0.58±0.04)ng·L-1,t=-1.146,P=0.097]; 治療結(jié)束后2組患者的血清CTX-Ⅰ含量均較治療前降低(t=4.443,P=0.000; t=2.876,P=0.002),強(qiáng)骨飲組的血清CTX-Ⅰ含量低于阿侖膦酸鈉組[(0.48±0.06)ng·L-1,(0.53±0.03)ng·L-1,t=-3.031,P=0.000]。試驗期間所有患者均未出現(xiàn)肝腎功能損害,強(qiáng)骨飲組與阿侖膦酸鈉組各有1例出現(xiàn)惡心、腹脹癥狀,調(diào)整服藥時間后癥狀緩解。2組患者不良反應(yīng)發(fā)生率比較,差異無統(tǒng)計學(xué)意義(χ2=0.000,P=1.000)。結(jié)論:口服強(qiáng)骨飲聯(lián)合碳酸鈣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,且安全性較高。
Abstract:
Objective:To observe the clinical curative effects and safety of oral applications of Qianggu Yin(強(qiáng)骨飲,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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備注/Memo

備注/Memo:
基金項目:浙江省中醫(yī)藥科技計劃重點研究項目(2019ZZ012); 浙江省高等學(xué)校中青年學(xué)科帶頭人培養(yǎng)計劃項目(浙教辦高科[2017]68號) 通訊作者:吳連國 E-mail:[email protected](收稿日期:2019-01-16 本文編輯:郭毅曼)
更新日期/Last Update: 2019-10-08