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[1]李超,張賢,馬勇,等.補(bǔ)髓丹治療骨質(zhì)疏松癥腎陽(yáng)虛證的隨機(jī)對(duì)照臨床試驗(yàn)[J].中醫(yī)正骨,2024,36(12):24-31,54.
　LI Chao,ZHANG Xian,MA Yong,et al.Busui Dan(補(bǔ)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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補(bǔ)髓丹治療骨質(zhì)疏松癥腎陽(yáng)虛證的隨機(jī)對(duì)照臨床試驗(yàn)()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第36卷
期數(shù):
2024年12期
頁(yè)碼:
24-31,54
欄目:
臨床研究
出版日期:
2024-12-20

文章信息/Info

Title:
Busui Dan(補(bǔ)髓丹)in the treatment of osteoporosis with syndrome of kidney-yang deficiency:a randomized controlled trial
作者:
李超1; 張賢1; 馬勇2; 肖清明1; 廖翼濤2; 劉小峰2; 范志鴻2; 李文杰2
1.無(wú)錫市中醫(yī)醫(yī)院,江蘇 無(wú)錫 214071; 2.南京中醫(yī)藥大學(xué),江蘇 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
關(guān)鍵詞:
骨質(zhì)疏松;  腎陽(yáng)虛;  補(bǔ)髓丹;  隨機(jī)對(duì)照試驗(yàn)專(zhuān)題
Keywords:
osteoporosis;  syndrome of deficiency of kidney yang;  Busui Dan;  randomized controlled trials as topic
摘要:
目的:觀察補(bǔ)髓丹治療骨質(zhì)疏松癥(osteoporosis,OP)腎陽(yáng)虛證的臨床療效。方法:將符合要求的123例OP腎陽(yáng)虛證患者隨機(jī)分為基礎(chǔ)治療組、阿侖膦酸鈉治療組、補(bǔ)髓丹治療組,每組41例。基礎(chǔ)治療組采用口服碳酸鈣D3片和骨化三醇軟膠囊治療,阿侖膦酸鈉治療組在基礎(chǔ)治療的基礎(chǔ)上增加口服阿侖膦酸鈉片,補(bǔ)髓丹治療組在基礎(chǔ)治療的基礎(chǔ)上增加口服補(bǔ)髓丹,各組患者均連續(xù)服藥3個(gè)月。記錄并比較3組患者治療前、治療結(jié)束時(shí)、治療結(jié)束后3個(gè)月、治療結(jié)束后9個(gè)月腰背部疼痛視覺(jué)模擬量表(visual analogue scale,VAS)評(píng)分、血清骨代謝標(biāo)志物Ⅰ型前膠原氨基端前肽(N-terminal propeptide of typeⅠprecollagen,PⅠNP)和Ⅰ型膠原羧基末端交聯(lián)肽(C-terminal cross-linked telopeptide of typeⅠcollagen,CTX-Ⅰ)水平、臨床癥狀評(píng)分、中國(guó)人骨質(zhì)疏松癥生存質(zhì)量簡(jiǎn)明量表(Chinese osteoporosis targeted quality of life short questionnaire,COQOL)評(píng)分、肌少癥SARCF評(píng)分,以及治療前和治療結(jié)束后9個(gè)月骨密度T值、治療結(jié)束后9個(gè)月臨床綜合療效。結(jié)果:①腰背部疼痛VAS評(píng)分。3組患者腰背部疼痛VAS評(píng)分隨時(shí)間變化均呈下降趨勢(shì)(F=3.618,P=0.015; F=24.958,P=0.000; F=51.780,P=0.000)。治療結(jié)束時(shí)、治療結(jié)束后3個(gè)月、治療結(jié)束后9個(gè)月,補(bǔ)髓丹治療組患者腰背部疼痛VAS評(píng)分均低于阿侖膦酸鈉治療組和基礎(chǔ)治療組(P=0.000,P=0.006,P=0.000; P=0.001,P=0.000,P=0.000)。②血清骨代謝標(biāo)志物水平。阿侖膦酸鈉治療組和補(bǔ)髓丹治療組患者血清PⅠNP水平隨時(shí)間變化呈先下降后上升的趨勢(shì)(F=5.879,P=0.001; F=15.626,P=0.000)。治療結(jié)束時(shí)、治療結(jié)束后3個(gè)月、治療結(jié)束后9個(gè)月,補(bǔ)髓丹治療組患者血清PⅠNP水平均低于阿侖膦酸鈉治療組和基礎(chǔ)治療組(P=0.000,P=0.010,P=0.000; P=0.000,P=0.000,P=0.000)。阿侖膦酸鈉治療組和補(bǔ)髓丹治療組患者血清CTX-Ⅰ水平隨時(shí)間變化均呈先下降再上升又下降的趨勢(shì)(F=13.529,P=0.000; F=20.900,P=0.000)。治療結(jié)束時(shí)、治療結(jié)束后3個(gè)月、治療結(jié)束后9個(gè)月,補(bǔ)髓丹治療組患者血清CTX-Ⅰ水平均低于基礎(chǔ)治療組(P=0.000,P=0.000,P=0.000),和阿侖膦酸鈉治療組比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(P=0.322,P=0.109,P=0.130)。③骨密度T值。治療結(jié)束后9個(gè)月,3組患者L1～L4椎體骨密度T值均大于治療前(t=7.433,P=0.000; t=4.132,P=0.000; t=7.334,P=0.000),補(bǔ)髓丹治療組患者L1～L4椎體骨密度T值大于阿侖膦酸鈉治療組和基礎(chǔ)治療組(P=0.028,P=0.022)。④臨床癥狀評(píng)分。3組患者臨床癥狀評(píng)分隨時(shí)間變化均呈下降趨勢(shì)(F=24.518,P=0.000; F=0.560,P=0.000; F=0.615,P=0.000)。治療結(jié)束時(shí)、治療結(jié)束后9個(gè)月,補(bǔ)髓丹治療組患者臨床癥狀評(píng)分均低于阿侖膦酸鈉治療組和基礎(chǔ)治療組(P=0.000,P=0.009; P=0.001,P=0.001)。⑤COQOL評(píng)分。3組患者COQOL評(píng)分隨時(shí)間變化均呈下降趨勢(shì)(F=35.470,P=0.000; F=59.423,P=0.000; F=100.845,P=0.000)。治療結(jié)束時(shí)、治療結(jié)束后3個(gè)月、治療結(jié)束后9個(gè)月,補(bǔ)髓丹治療組患者COQOL評(píng)分均低于阿侖膦酸鈉治療組和基礎(chǔ)治療組(P=0.000,P=0.002,P=0.000; P=0.000,P=0.000,P=0.018)。⑥肌少癥SARCF評(píng)分。3組患者肌少癥SARCF評(píng)分隨時(shí)間變化均呈下降趨勢(shì)(F=30.036,P=0.000; F=30.714,P=0.000; F=34.190,P=0.000)。治療結(jié)束時(shí),補(bǔ)髓丹治療組患者肌少癥SARCF評(píng)分低于基礎(chǔ)治療組(P=0.010),和阿侖膦酸鈉治療組比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(P=0.601)。⑦臨床綜合療效。治療結(jié)束后9個(gè)月,補(bǔ)髓丹治療組患者臨床綜合療效優(yōu)于基礎(chǔ)治療組(R^-=52.060,P=0.018),和阿侖膦酸鈉治療組比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(R^-=57.690,P=0.432)。結(jié)論:補(bǔ)髓丹治療OP腎陽(yáng)虛證,在改善骨代謝、增加骨密度、緩解腰背部疼痛等臨床癥狀、提高生活質(zhì)量、改善肌肉功能及提升臨床綜合療效等方面,優(yōu)于阿侖膦酸鈉或與其相當(dāng)。
Abstract:
Objective:To observe the clinical outcomes of Busui Dan(補(bǔ)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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備注/Memo

備注/Memo:
基金項(xiàng)目:江蘇省科技計(jì)劃專(zhuān)項(xiàng)基金(基礎(chǔ)研究計(jì)劃自然科學(xué)基金)項(xiàng)目(BK20231147); 江蘇省中醫(yī)藥科技發(fā)展計(jì)劃項(xiàng)目(MS2021044)
通訊作者:張賢 E-mail:[email protected]
更新日期/Last Update: 1900-01-01