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[1]曹俊青,鄭劍南,張麟.右歸丸聯(lián)合阿侖膦酸鈉口服治療絕經(jīng)后骨質(zhì)疏松癥腎陽虛證的臨床研究[J].中醫(yī)正骨,2018,30(05):20-23.
　CAO Junqing,ZHENG Jiannan,ZHANG Lin.A clinical study of oral application of Yougui Wan(右歸丸)and alendronate sodium for treatment of postmenopausal osteoporosis with kidney-yang deficiency syndrome[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2018,30(05):20-23.
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右歸丸聯(lián)合阿侖膦酸鈉口服治療絕經(jīng)后骨質(zhì)疏松癥腎陽虛證的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第30卷
期數(shù):
2018年05期
頁碼:
20-23
欄目:
臨床研究
出版日期:
2018-05-20

文章信息/Info

Title:
A clinical study of oral application of Yougui Wan(右歸丸)and alendronate sodium for treatment of postmenopausal osteoporosis with kidney-yang deficiency syndrome
作者:
曹俊青1; 鄭劍南2; 張麟1
1.湖北省武漢市第一醫(yī)院,湖北 武漢 430022; 2.湖北省疾病預(yù)防控制中心,湖北 武漢 430079
Author(s):
CAO Junqing1; ZHENG Jiannan2; ZHANG Lin1
1.The First Hospital of Wuhan,Wuhan 430022,Hubei,China 2.Hubei Center for Disease Control and Prevention,Wuhan 430079,Hubei,China
關(guān)鍵詞:
骨質(zhì)疏松; 絕經(jīng)后;  腎陽虛;  右歸丸;  腰痛;  骨密度;  疲勞;  阿侖膦酸鈉;  臨床試驗
Keywords:
osteoporosis; postmenopausal;  kidney-yang deficiency;  Yougui pill;  low back pain; bone density;  fatigue;  alendronate sodium;  clinical trial
文獻標(biāo)志碼:
A
摘要:
目的:觀察右歸丸聯(lián)合阿侖膦酸鈉口服治療絕經(jīng)后骨質(zhì)疏松癥腎陽虛證的臨床療效。方法:將64例絕經(jīng)后骨質(zhì)疏松癥腎陽虛證患者隨機分為2組,每組32例,分別采用右歸丸聯(lián)合阿侖膦酸鈉口服和單純阿侖膦酸鈉口服治療。阿侖膦酸鈉口服,每周1片,連續(xù)服用1年; 右歸丸口服,每次9 g,每日3次,連續(xù)服用1年。分別于治療前和治療開始后1年記錄并比較2組患者腰背部疼痛視覺模擬量表(visual analogue scale,VAS)評分、腰椎骨密度T值及總疲勞評分; 并于治療開始后1年,參照《中藥新藥臨床研究指導(dǎo)原則》中骨質(zhì)疏松癥的評定標(biāo)準(zhǔn)評價綜合療效。結(jié)果:①腰背部疼痛VAS評分。治療前和治療開始后1年,2組患者腰背部疼痛VAS評分比較,組間差異均無統(tǒng)計學(xué)意義[(7.54±1.52)分,(7.81±1.48)分,t=0.723,P=0.473;(1.99±0.22)分,(2.03±0.13)分,t=0.700,P=0.488]; 治療開始后1年,2組患者腰背部疼痛VAS評分均低于治療前(t=16.161,P=0.000; t=17.399,P=0.000)。②腰椎骨密度T值。治療前和治療開始后1年,2組患者腰椎骨密度T值比較,組間差異均無統(tǒng)計學(xué)意義(-2.452±1.023,-2.471±1.118,t=0.067,P=0.947; 1.560±0.614,1.361±0.525,t=1.380,P=0.172); 治療開始后1年,2組患者腰椎骨密度T值均高于治療前(t=19.738,P=0.000; t=17.550,P=0.000)。③總疲勞評分。治療前2組患者總疲勞評分比較,差異無統(tǒng)計學(xué)意義[(7.68±2.26)分,(8.18±2.42)分,t=1.944,P=0.056]; 治療開始后1年,右歸丸聯(lián)合阿侖膦酸鈉組總疲勞評分低于阿侖膦酸鈉組[(4.31±1.15)分,(6.82±1.54)分,t=7.518,P=0.000],2組患者總疲勞評分均低于治療前(t=7.518,P=0.000; t=3.940,P=0.000)。④綜合療效。治療開始后1年,右歸丸聯(lián)合阿侖膦酸鈉組顯效9例、有效21、無效2例,單純阿侖膦酸鈉組顯效3例、有效20例、無效9例; 右歸丸聯(lián)合阿侖膦酸鈉組的綜合療效優(yōu)于單純阿侖膦酸鈉組(Z=-2.688,P=0.007)。結(jié)論:右歸丸聯(lián)合阿侖膦酸鈉口服與單純阿侖膦酸鈉口服治療絕經(jīng)后骨質(zhì)疏松癥腎陽虛證,均能在一定程度上緩解腰背部疼痛、改善骨密度,但前者在緩解疲勞和綜合療效方面優(yōu)于后者,值得臨床推廣應(yīng)用。
Abstract:
Objective:To observe the clinical curative effects of oral application of Yougui Wan(右歸丸,YGW)and alendronate sodium for treatment of postmenopausal osteoporosis(PMOP)with kidney-yang deficiency syndrome.Methods:Sixty-four patients with kidney-yang deficiency type PMOP were randomly divided into 2 groups,32 cases in each group,and were treated with combination therapy of oral application of YGW and alendronate sodium(combination therapy group)and monotherapy of oral application of alendronate sodium(monotherapy group)respectively.The alendronate sodium was taken for consecutive one year,one tablet a week.The YGW was taken for consecutive one year,three times a day,9 g at a time.Low back pain visual analogue scale(VAS)scores,T-value of bone density of lumbar vertebra and total fatigue scores were recorded and compared between the 2 groups before treatment and after 1-year treatment respectively,and the total clinical curative effects were evaluated after 1-year treatment according to the evaluation standard of osteoporosis which was extracted from Guiding principles of clinical research on new Chinese medicine.Results:There was no statistical difference in the low back pain VAS scores between the 2 groups before treatment and after 1-year treatment(7.54+/-1.52 vs 7.81+/-1.48 points,t=0.723,P=0.473; 1.99+/-0.22 vs 2.03+/-0.13 points,t=0.700,P=0.488).The low back pain VAS scores of the 2 groups were lower after 1-year treatment compared to pre-treatment(t=16.161,P=0.000; t=17.399,P=0.000).There was no statistical difference in the T-values of bone density of lumbar vertebra between the 2 groups before treatment and after 1-year treatment(-2.452+/-1.023 vs -2.471+/-1.118,t=0.067,P=0.947; 1.560+/-0.614 vs 1.361+/-0.525,t=1.380,P=0.172).The T-values of bone density of lumbar vertebra of the 2 groups were higher after 1-year treatment compared to pre-treatment(t=19.738,P=0.000; t=17.550,P=0.000).There was no statistical difference in the total fatigue scores between the 2 groups before treatment(7.68+/-2.26 vs 8.18+/-2.42 points,t=1.944,P=0.056).The total fatigue scores decreased in the 2 groups(t=7.518,P=0.000; t=3.940,P=0.000P)and were lower in combination therapy group compared to monotherapy group(4.31+/-1.15 vs 6.82+/-1.54 points,t=7.518,P=0.000)after 1-year treatment.Nine patients got a good result,21 fair and 2 poor in combination therapy group; while 3 patients got a good result,20 fair and 9 poor in monotherapy group after 1-year treatment.The combination therapy group surpassed the monotherapy group in the total clinical curative effect(Z=-2.688,P=0.007).Conclusion:Both combination therapy of oral application of YGW and alendronate sodium and monotherapy of oral application of alendronate sodium can relieve the low back pain and improve the bone density to some extent in the treatment of PMOP with kidney-yang deficiency syndrome,while the former surpasses the latter in relieving fatigue and total clinical curative effects,so it is worthy of popularizing in clinic.

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更新日期/Last Update: 1900-01-01