[1]李超,张贤,马勇,等.补髓丹治疗骨质疏松症肾阳虚证的随机对照临床试验[J].中医正骨,2024,36(12):24-31,54.
　LI Chao,ZHANG Xian,MA Yong,et al.Busui Dan(补髓丹)in the treatment of osteoporosis with syndrome of kidney-yang deficiency:a randomized controlled trial[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2024,36(12):24-31,54.
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补髓丹治疗骨质疏松症肾阳虚证的随机对照临床试验()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第36卷
期数:
2024年12期
页码:
24-31,54
栏目:
临床研究
出版日期:
2024-12-20

文章信息/Info

Title:
Busui Dan(补髓丹)in the treatment of osteoporosis with syndrome of kidney-yang deficiency:a randomized controlled trial
作者:
李超1; 张贤1; 马勇2; 肖清明1; 廖翼涛2; 刘小峰2; 范志鸿2; 李文杰2
1.无锡市中医医院,江苏 无锡 214071; 2.南京中医药大学,江苏 南京 210023
Author(s):
LI Chao1; ZHANG Xian1; MA Yong2; XIAO Qingming1; LIAO Yitao2; LIU Xiaofeng2; FAN Zhihong2; LI Wenjie2
1.Wuxi Hospital of Traditional Chinese Medicine,Wuxi 214071,Jiangsu,China 2.Nanjing University of Chinese Medicine,Nanjing 210023,Jiangsu,China
关键词:
骨质疏松;  肾阳虚;  补髓丹;  随机对照试验专题
Keywords:
osteoporosis;  syndrome of deficiency of kidney yang;  Busui Dan;  randomized controlled trials as topic
摘要:
目的:观察补髓丹治疗骨质疏松症(osteoporosis,OP)肾阳虚证的临床疗效。方法:将符合要求的123例OP肾阳虚证患者随机分为基础治疗组、阿仑膦酸钠治疗组、补髓丹治疗组,每组41例。基础治疗组采用口服碳酸钙D3片和骨化三醇软胶囊治疗,阿仑膦酸钠治疗组在基础治疗的基础上增加口服阿仑膦酸钠片,补髓丹治疗组在基础治疗的基础上增加口服补髓丹,各组患者均连续服药3个月。记录并比较3组患者治疗前、治疗结束时、治疗结束后3个月、治疗结束后9个月腰背部疼痛视觉模拟量表(visual analogue scale,VAS)评分、血清骨代谢标志物Ⅰ型前胶原氨基端前肽(N-terminal propeptide of typeⅠprecollagen,PⅠNP)和Ⅰ型胶原羧基末端交联肽(C-terminal cross-linked telopeptide of typeⅠcollagen,CTX-Ⅰ)水平、临床症状评分、中国人骨质疏松症生存质量简明量表(Chinese osteoporosis targeted quality of life short questionnaire,COQOL)评分、肌少症SARCF评分,以及治疗前和治疗结束后9个月骨密度T值、治疗结束后9个月临床综合疗效。结果:①腰背部疼痛VAS评分。3组患者腰背部疼痛VAS评分随时间变化均呈下降趋势(F=3.618,P=0.015; F=24.958,P=0.000; F=51.780,P=0.000)。治疗结束时、治疗结束后3个月、治疗结束后9个月,补髓丹治疗组患者腰背部疼痛VAS评分均低于阿仑膦酸钠治疗组和基础治疗组(P=0.000,P=0.006,P=0.000; P=0.001,P=0.000,P=0.000)。②血清骨代谢标志物水平。阿仑膦酸钠治疗组和补髓丹治疗组患者血清PⅠNP水平随时间变化呈先下降后上升的趋势(F=5.879,P=0.001; F=15.626,P=0.000)。治疗结束时、治疗结束后3个月、治疗结束后9个月,补髓丹治疗组患者血清PⅠNP水平均低于阿仑膦酸钠治疗组和基础治疗组(P=0.000,P=0.010,P=0.000; P=0.000,P=0.000,P=0.000)。阿仑膦酸钠治疗组和补髓丹治疗组患者血清CTX-Ⅰ水平随时间变化均呈先下降再上升又下降的趋势(F=13.529,P=0.000; F=20.900,P=0.000)。治疗结束时、治疗结束后3个月、治疗结束后9个月,补髓丹治疗组患者血清CTX-Ⅰ水平均低于基础治疗组(P=0.000,P=0.000,P=0.000),和阿仑膦酸钠治疗组比较,差异无统计学意义(P=0.322,P=0.109,P=0.130)。③骨密度T值。治疗结束后9个月,3组患者L1～L4椎体骨密度T值均大于治疗前(t=7.433,P=0.000; t=4.132,P=0.000; t=7.334,P=0.000),补髓丹治疗组患者L1～L4椎体骨密度T值大于阿仑膦酸钠治疗组和基础治疗组(P=0.028,P=0.022)。④临床症状评分。3组患者临床症状评分随时间变化均呈下降趋势(F=24.518,P=0.000; F=0.560,P=0.000; F=0.615,P=0.000)。治疗结束时、治疗结束后9个月,补髓丹治疗组患者临床症状评分均低于阿仑膦酸钠治疗组和基础治疗组(P=0.000,P=0.009; P=0.001,P=0.001)。⑤COQOL评分。3组患者COQOL评分随时间变化均呈下降趋势(F=35.470,P=0.000; F=59.423,P=0.000; F=100.845,P=0.000)。治疗结束时、治疗结束后3个月、治疗结束后9个月,补髓丹治疗组患者COQOL评分均低于阿仑膦酸钠治疗组和基础治疗组(P=0.000,P=0.002,P=0.000; P=0.000,P=0.000,P=0.018)。⑥肌少症SARCF评分。3组患者肌少症SARCF评分随时间变化均呈下降趋势(F=30.036,P=0.000; F=30.714,P=0.000; F=34.190,P=0.000)。治疗结束时,补髓丹治疗组患者肌少症SARCF评分低于基础治疗组(P=0.010),和阿仑膦酸钠治疗组比较,差异无统计学意义(P=0.601)。⑦临床综合疗效。治疗结束后9个月,补髓丹治疗组患者临床综合疗效优于基础治疗组(R^-=52.060,P=0.018),和阿仑膦酸钠治疗组比较,差异无统计学意义(R^-=57.690,P=0.432)。结论:补髓丹治疗OP肾阳虚证,在改善骨代谢、增加骨密度、缓解腰背部疼痛等临床症状、提高生活质量、改善肌肉功能及提升临床综合疗效等方面,优于阿仑膦酸钠或与其相当。
Abstract:
Objective:To observe the clinical outcomes of Busui Dan(补髓丹,BSD)in the treatment of osteoporosis(OP)with kidney-yang deficiency syndrome(KYDS).Methods:One hundred and twenty-three eligible KYDS-type OP patients were enrolled in the study and were randomized into basic treatment group,alendronate sodium(ALS)treatment group,and BSD treatment group,with 41 cases in each group.All patients in the 3 groups were treated with oral application of calcium carbonate and Vitamin D3 tablets,as well as calcitriol softgel capsules; moreover,the ones in ALS treatment group were further treated with oral application of ALS tablets,and the ones in BSD treatment group with oral application of BSD.All patients were treated for consecutive 3 months.The low back pain visual analogue scale(VAS)score,serum levels of bone metabolism markers including N-terminal propeptide of type I procollagen(PⅠNP)and C-terminal cross-linked telopeptide of typeⅠcollagen(CTX-Ⅰ),clinical symptom score,Chinese osteoporosis targeted quality of life short questionnaire(COQOL)score,and sarcopenia SARCF score evaluated before the treatment,at the end of treatment,at 3 and 9 months after the end of treatment,respectively,the bone mineral density(BMD)T-score detected before the treatment and at 9 months after the end of treatment,respectively,as well as the total clinical outcome evaluated at 9 months after the end of treatment were recorded and compared among the 3 groups.Results:①The low back pain VAS score.The low back pain VAS score presented a downward trend over time in the 3 groups(F=3.618,P=0.015; F=24.958,P=0.000; F=51.780,P=0.000),and it was lower in BSD treatment group compared to ALS treatment group and basic treatment group at the end of treatment,at 3 and 9 months after the end of treatment,respectively(P=0.000,P=0.006,P=0.000; P=0.001,P=0.000,P=0.000).②The serum levels of bone metabolism markers.The serum level of PⅠNP displayed a trend of going downward firstly and upward subsequently over time in ALS treatment group and BSD treatment group(F=5.879,P=0.001; F=15.626,P=0.000),and it was lower in BSD treatment group compared to ALS treatment group and basic treatment group at the end of treatment,at 3 and 9 months after the end of treatment,respectively(P=0.000,P=0.010,P=0.000; P=0.000,P=0.000,P=0.000).The serum level of CTX-Ⅰdisplayed a trend of going downward firstly,upward subsequently,and downward finally over time in ALS treatment group and BSD treatment group(F=13.529,P=0.000; F=20.900,P=0.000).At the end of treatment,at 3 and 9 months after the end of treatment,the serum level of CTX-Ⅰwas lower in BSD treatment group compared to basic treatment group(P=0.000,P=0.000,P=0.000),with no significant differences between BSD treatment group and ALS treatment group(P=0.322,P=0.109,P=0.130).③The BMD T-score.The BMD T-score of lumbar vertebrae from L1 to L4 increased in the 3 groups at 9 months after the end of treatment compared to pretreatment(t=7.433,P=0.000; t=4.132,P=0.000; t=7.334,P=0.000),and it was greater in BSD treatment group compared to ALS treatment group and basic treatment group(P=0.028,P=0.022).④The clinical symptom score.The clinical symptom score presented a downward trend over time in the 3 groups(F=24.518,P=0.000; F=0.560,P=0.000; F=0.615,P=0.000),and it was lower in BSD treatment group compared to ALS treatment group and basic treatment group at the end of treatment and at 9 months after the end of treatment,respectively(P=0.000,P=0.009; P=0.001,P=0.001).⑤The COQOL score.The COQOL score presented a downward trend over time in the 3 groups(F=35.470,P=0.000; F=59.423,P=0.000; F=100.845,P=0.000),and it was lower in BSD treatment group compared to ALS treatment group and basic treatment group at the end of treatment,at 3 and 9 months after the end of treatment,respectively(P=0.000,P=0.002,P=0.000; P=0.000,P=0.000,P=0.018).⑥The sarcopenia SARCF score.The sarcopenia SARCF score presented a downward trend over time in the 3 groups(F=30.036,P=0.000; F=30.714,P=0.000; F=34.190,P=0.000).At the end of treatment,the sarcopenia SARCF score was lower in BSD treatment group compared to basic treatment group(P=0.010),with no significant differences between BSD treatment group and ALS treatment group(P=0.601).⑦The total clinical outcome.At 9 months after the end of treatment,the total clinical outcome was better in BSD treatment group compared to basic treatment group(R^-=52.060,P=0.018),with no significant differences between BSD treatment group and ALS treatment group(R^-=57.690,P=0.432).Conclusion:BSD is superior to or comparable to ALS in improving the bone metabolism and muscle function,increasing the BMD,alleviating the clinical symptoms such as low back pain,enhancing the quality of life and total clinical outcome in the treatment of OP with KYDS.

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备注/Memo

备注/Memo:
基金项目:江苏省科技计划专项基金(基础研究计划自然科学基金)项目(BK20231147); 江苏省中医药科技发展计划项目(MS2021044)
通讯作者:张贤 E-mail:zhangxian0772@sina.com
更新日期/Last Update: 1900-01-01