[1]曹俊青,郑剑南,张麟.右归丸联合阿仑膦酸钠口服治疗绝经后骨质疏松症肾阳虚证的临床研究[J].中医正骨,2018,30(05):20-23.
 CAO Junqing,ZHENG Jiannan,ZHANG Lin.A clinical study of oral application of Yougui Wan(右归丸)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.
点击复制

右归丸联合阿仑膦酸钠口服治疗绝经后骨质疏松症肾阳虚证的临床研究()
分享到:

《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第30卷
期数:
2018年05期
页码:
20-23
栏目:
临床研究
出版日期:
2018-05-20

文章信息/Info

Title:
A clinical study of oral application of Yougui Wan(右归丸)and alendronate sodium for treatment of postmenopausal osteoporosis with kidney-yang deficiency syndrome
作者:
曹俊青1郑剑南2张麟1
1.湖北省武汉市第一医院,湖北 武汉 430022; 2.湖北省疾病预防控制中心,湖北 武汉 430079
Author(s):
CAO Junqing1ZHENG Jiannan2ZHANG Lin1
1.The First Hospital of Wuhan,Wuhan 430022,Hubei,China 2.Hubei Center for Disease Control and Prevention,Wuhan 430079,Hubei,China
关键词:
骨质疏松绝经后 肾阳虚 右归丸 腰痛 骨密度 疲劳 阿仑膦酸钠 临床试验
Keywords:
osteoporosispostmenopausal kidney-yang deficiency Yougui pill low back painbone density fatigue alendronate sodium clinical trial
文献标志码:
A
摘要:
目的:观察右归丸联合阿仑膦酸钠口服治疗绝经后骨质疏松症肾阳虚证的临床疗效。方法:将64例绝经后骨质疏松症肾阳虚证患者随机分为2组,每组32例,分别采用右归丸联合阿仑膦酸钠口服和单纯阿仑膦酸钠口服治疗。阿仑膦酸钠口服,每周1片,连续服用1年; 右归丸口服,每次9 g,每日3次,连续服用1年。分别于治疗前和治疗开始后1年记录并比较2组患者腰背部疼痛视觉模拟量表(visual analogue scale,VAS)评分、腰椎骨密度T值及总疲劳评分; 并于治疗开始后1年,参照《中药新药临床研究指导原则》中骨质疏松症的评定标准评价综合疗效。结果:①腰背部疼痛VAS评分。治疗前和治疗开始后1年,2组患者腰背部疼痛VAS评分比较,组间差异均无统计学意义[(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]; 治疗开始后1年,2组患者腰背部疼痛VAS评分均低于治疗前(t=16.161,P=0.000; t=17.399,P=0.000)。②腰椎骨密度T值。治疗前和治疗开始后1年,2组患者腰椎骨密度T值比较,组间差异均无统计学意义(-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); 治疗开始后1年,2组患者腰椎骨密度T值均高于治疗前(t=19.738,P=0.000; t=17.550,P=0.000)。③总疲劳评分。治疗前2组患者总疲劳评分比较,差异无统计学意义[(7.68±2.26)分,(8.18±2.42)分,t=1.944,P=0.056]; 治疗开始后1年,右归丸联合阿仑膦酸钠组总疲劳评分低于阿仑膦酸钠组[(4.31±1.15)分,(6.82±1.54)分,t=7.518,P=0.000],2组患者总疲劳评分均低于治疗前(t=7.518,P=0.000; t=3.940,P=0.000)。④综合疗效。治疗开始后1年,右归丸联合阿仑膦酸钠组显效9例、有效21、无效2例,单纯阿仑膦酸钠组显效3例、有效20例、无效9例; 右归丸联合阿仑膦酸钠组的综合疗效优于单纯阿仑膦酸钠组(Z=-2.688,P=0.007)。结论:右归丸联合阿仑膦酸钠口服与单纯阿仑膦酸钠口服治疗绝经后骨质疏松症肾阳虚证,均能在一定程度上缓解腰背部疼痛、改善骨密度,但前者在缓解疲劳和综合疗效方面优于后者,值得临床推广应用。
Abstract:
Objective:To observe the clinical curative effects of oral application of Yougui Wan(右归丸,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.

参考文献/References:

[1] ZHANG L,YIN X,WANG JC,et al.Associations between VDR gene polymorphisms and osteoporosis risk and bone mineral density in postmenopausal women:A systematic review and meta-analysis[J].Sci Rep,2018,8(1):981.
[2] HIRSCH C.In postmenopausal women with osteoporosis,romosozumab followed by alendronate reduced fractures vs alendronate alone[J].Ann Intern Med,2018,168(2):3.
[3] 吴海洋,索欢,王平.绝经后骨质疏松症的临床中药治疗进展[J].中国骨质疏松杂志,2015,21(2):241-244.
[4] 中国老年学学会骨质疏松委员会骨质疏松症诊断标准学科组.中国人骨质疏松症诊断标准专家共识(第三稿·2014版)[J].中国骨质疏松杂志,2014,20(9):1007-1010.
[5] 葛继荣,郑洪新,万小明,等.中医药防治原发性骨质疏松症专家共识(2015)[J].中国骨质疏松杂志,2015,21(9):1023-1028.
[6] 蒋协远,王大伟.骨科临床疗效评价标准[M].北京:人民卫生出版社,2005:123.
[7] 郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:356-361.
[8] CHALDER T,BERELOWITZ G,PAWLIKOWSKA T,et al.Development of a tigue scale[J].J Payehosom Res,1993,37(2):147-153.
[9] 许正发,代玉金.右归丸治疗骨质疏松症96例[J].国医论坛,2002,17(2):50.
[10] 赵丽颖,夏天,宋文嘉.右归丸的现代研究进展[J].吉林中医药,2012,32(4):425-427.
[11] 符惠果,诸毅晖,谭丽君,等.针灸治疗慢性疲劳综合征用穴规律探讨[J].针灸临床杂志,2009,25(10):29-30.
[12] 欧国峰,刘鑫,董博,等.绝经后骨质疏松症的免疫学研究进展[J].中医正骨,2016,28(8):70-72.
[13] 黄建武,黄建华,林爱菊.补肾健骨汤合阿伦磷酸钠对绝经后骨质疏松症患者骨密度和性激素水平的影响[J].中医正骨,2013,25(8):30-31.
[14] 周黎,戴燚,李浩,等.绝经后妇女基质金属蛋白酶-3和骨桥蛋白水平与骨密度和骨保护蛋白及其配体的相关性研究[J].湖北中医药大学学报,2012,14(2):60-62.
[15] 黄建武,陈金春,黄建华,等.二仙养骨汤合福善美对绝经后骨质疏松症骨密度及细胞因子的影响[J].中医正骨,2008,20(3):12-13.

相似文献/References:

[1]李林军.应用膨胀式椎弓根螺钉内固定治疗合并骨质疏松的 胸腰椎退行性疾病[J].中医正骨,2015,27(08):49.
[2]李学朋,朱立国.骨疏康胶囊对去卵巢大鼠骨小梁的影响[J].中医正骨,2015,27(12):12.
 LI Xuepeng,ZHU Liguo.Effect of Gushukang Jiaonang(骨疏康胶囊)on bone trabecula in the ovariectomized rats[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(05):12.
[3]陈冠军,陈扬,庄汝杰.可灌注骨水泥椎弓根螺钉系统 在老年腰椎疾患手术中的应用[J].中医正骨,2015,27(02):40.
[4]王丹辉,贲越,韩梅.林蛙油治疗绝经后骨质疏松症的临床研究[J].中医正骨,2014,26(01):27.
 Wang Danhui*,Ben Yue,Han Mei..Clinical study of Rana temporaria oil in the treatment of postmenopausal osteoporosis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2014,26(05):27.
[5]黄建华,黄建武,李慧辉,等.加味左归丸对绝经后骨质疏松症肝肾不足证 患者骨密度的影响[J].中医正骨,2013,25(11):19.
 Huang Jianhua*,Huang Jianwu,Li Huihui,et al.Effect of JIAWEI ZUOGUI pill on bone mineral density in postmenopausal osteoporosis patients with deficiency of liver and kidney[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2013,25(05):19.
[6]项旻,杨虹,林爱菊,等.绝经后2型糖尿病患者骨质疏松与血微量元素的关系研究[J].中医正骨,2013,25(12):20.
 Xiang Min*,Yang Hong,Lin Aiju,et al.Clinical study on the relationship between osteoporosis and serum trace elements levels in postmenopausal women with type 2 diabetes[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2013,25(05):20.
[7]史晓林,李春雯,张志强.弱阳离子磁珠分离技术和基质辅助激光解吸电离飞行时间质谱技术在原发性Ⅰ型骨质疏松症血清标志蛋白筛选中的应用[J].中医正骨,2014,26(03):5.
 Shi Xiaolin*,Li Chunwen,Zhang Zhiqiang..Application of magnetic beads based weak cation exchange separation technology and matrix-assisted laser desorption-ionization time of flight mass spectrometry technology in screening serum protein markers of primary type-Ⅰ osteoporosis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2014,26(05):5.
[8]李明,徐明雄,冯左基,等.自拟壮骨方治疗绝经后骨质疏松症的疗效及作用机制研究[J].中医正骨,2014,26(09):21.
 Li Ming*,Xu Mingxiong,Feng Zuoji,et al.Study on the curative effect and mechanism of action of self-made ZHUANGGU decoction in treatment of postmenopausal osteoporosis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2014,26(05):21.
[9]陈俊杰,李晴晴,夏瑢.脂代谢及血清内脂素水平与绝经后骨质疏松症的 相关性研究[J].中医正骨,2012,24(04):16.
 CHEN Jun-jie*,LI Qing-qing,XIA Rong.*.Study on the correlations between the levels of lipid metabolism and serum visfatin and postmenopausal osteoporosis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2012,24(05):16.
[10]许超,肖鲁伟,吴承亮.绝经后女性骨质疏松症辨证分型与抑郁焦虑的关系研究[J].中医正骨,2011,23(12):3.
 XU Chao*,XIAO Lu-wei,WU Cheng-liang.*.Study on the relationship between the syndrome differ classification and the depression and anxiety for the postmenopausal women with osteoporosis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2011,23(05):3.
[11]韩艳,温利平,刘娜,等.补肾活血方对去卵巢大鼠骨代谢及骨密度的影响[J].中医正骨,2015,27(12):7.
 HAN Yan,WEN Liping,LIU Na,et al.Effect of Bushen Huoxue Fang(补肾活血方)on bone metabolism and bone mineral density in the ovariectomized rats[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(05):7.
[12]欧国峰,刘鑫,董博,等.绝经后骨质疏松症的免疫学研究进展[J].中医正骨,2016,28(08):70.
[13]施振宇,刘钟,陈文亮,等.中医综合疗法防治绝经后骨量减少的多中心临床研究[J].中医正骨,2017,29(04):1.
 SHI Zhenyu,LIU Zhong,CHEN Wenliang,et al.A multicenter clinical study of complex therapy of traditional Chinese medicine for prevention and treatment of postmenopausal osteopenia[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2017,29(05):1.
[14]梁文娜,李西海,李灿东.血清microRNA与绝经后骨质疏松症肾虚证的关系[J].中医正骨,2017,29(10):53.
[15]梁文娜,李西海,胡柳,等.二至丸抑制绝经后骨质疏松大鼠骨代谢紊乱的作用机制研究[J].中医正骨,2017,29(11):1.
 LIANG Wenna,LI Xihai,HU Liu,et al.Study on mechanism of action of Erzhi Wan(二至丸)in inhibiting bone metabolism disorder in rats with postmenopausal osteoporosis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2017,29(05):1.
[16]刘晨,李兴勇,姚兴璋,等.绝经后骨质疏松症的流行病学概况及发病机制研究进展[J].中医正骨,2018,30(03):52.
[17]杨依然,刘钟,毛一凡,等.酪蛋白激酶-2相互作用蛋白1基于磷脂酰肌醇3-激酶/蛋白激酶B/哺乳动物雷帕霉素靶蛋白通路参与绝经后骨质疏松症发生发展过程中细胞自噬的机制[J].中医正骨,2018,30(04):59.

更新日期/Last Update: 1900-01-01