[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.
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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()
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《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.

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更新日期/Last Update: 1900-01-01