强骨饮对骨质疏松症患者预防跌倒作用的临床研究
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摘要
目的观察口服自拟中药益气温经方强骨饮对骨质疏松症患者预防跌倒作用的临床疗效。方法将入选的186例原发性骨质疏松症患者随机分成2组:治疗组(强骨饮+阿法迪三+钙尔奇),对照组(阿法迪三+钙尔奇),各93例,均维持治疗6个月,对比2组患者治疗前后的定量CT(quantitative computed tomography,QCT)腰椎骨密度、骨转换指标和腰背疼痛、腰膝酸软、下肢痿弱及步履艰难等中医症状评分情况。结果 2组各有90例患者完成本次试验。治疗组在改善骨质疏松症患者腰背疼痛、腰膝酸软、下肢痿弱及步履艰难等中医症状方面疗效显著,治疗前后比较以及与对照组相比较,差异均有统计学意义(P<0.05);在改善QCT腰椎骨密度及骨转换指标方面亦有良好效果,治疗前后差异有统计学意义(P<0.05);与对照组相比较,QCT腰椎骨密度、血清Ⅰ型前胶原氨基端前肽差异无统计学意义,血清Ⅰ型胶原交联C末端肽差异有统计学意义(P<0.05)。结论强骨饮联合维生素D与钙剂对骨质疏松症患者预防跌倒作用显著,值得临床推广和深入研究。
OBJECTIVE To observe the clinical efficacy of oral Chinese herbal medicine Yiqiwenjingfang Qiangguyin in preventing falls in patients with osteoporosis. METHODS A total of 186 patients with primary osteoporosis were randomly divided into 2 groups: the treatment group(Qianguyin+Afadi Ⅲ+Calcium), and the control group(Afadi Ⅲ+ Calcium), each in 93 cases, the 2 groups of patients were treated for 6 months. The scores of quantitative computed tomography(QCT) lumbar spine bone mineral, bone turnover index and low back pain, weak waist and knees, weak lower limbs and difficult walking were compared between the 2 groups. RESULTS Ninety patients in each group completed the trial. The treatment group was effective in improving the symptoms of low back pain, weak waist and knees, weak limbs and difficulty in walking. Compared with the control group, the difference was statistically significant(P<0.05). It also had good effect in improving the bone mineral density and bone turnover index of QCT. The difference before and after treatment was statistically significant(P<0.05).Compared with the control group, there was no significant difference in QCT lumbar spine bone mineral density and N-terminal propeptide of typeⅠprecollagen, and the difference of C-terminal telopeptides of serum typeⅠcollagen was statistically significant(P<0.05). CONCLUSION Qianguyin combined with vitamin D and calcium has a significant effect on preventing falls in patients with osteoporosis, which is worthy of clinical promotion and in-depth study.
OBJECTIVE To observe the clinical efficacy of oral Chinese herbal medicine Yiqiwenjingfang Qiangguyin in preventing falls in patients with osteoporosis. METHODS A total of 186 patients with primary osteoporosis were randomly divided into 2 groups: the treatment group(Qianguyin+Afadi Ⅲ+Calcium), and the control group(Afadi Ⅲ+ Calcium), each in 93 cases, the 2 groups of patients were treated for 6 months. The scores of quantitative computed tomography(QCT) lumbar spine bone mineral, bone turnover index and low back pain, weak waist and knees, weak lower limbs and difficult walking were compared between the 2 groups. RESULTS Ninety patients in each group completed the trial. The treatment group was effective in improving the symptoms of low back pain, weak waist and knees, weak limbs and difficulty in walking. Compared with the control group, the difference was statistically significant(P<0.05). It also had good effect in improving the bone mineral density and bone turnover index of QCT. The difference before and after treatment was statistically significant(P<0.05).Compared with the control group, there was no significant difference in QCT lumbar spine bone mineral density and N-terminal propeptide of typeⅠprecollagen, and the difference of C-terminal telopeptides of serum typeⅠcollagen was statistically significant(P<0.05). CONCLUSION Qianguyin combined with vitamin D and calcium has a significant effect on preventing falls in patients with osteoporosis, which is worthy of clinical promotion and in-depth study.
引文
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[8]SHI Z Y,LIU Z,CHEN W L,et al.A multicenter clinical study of complex therapy of traditional Chinese medicine for prevention and treatment of postmenopausal osteopenia[J].JTradit Chin Orthop Traumatol(中医正骨),2017,29(4):1-7.
[9]CHEN W L,MAO Y F,ZHANG J F,et al.Clinical efficacy of classic formula,tonifying Qi and warming meridian,combined with modified 5-bird exercise on postmenopausal osteopenia patients[J].Chin J Osteoporos(中国骨质疏松杂志),2018,24(7):954-958.
[10]ZHANG J,WU L S,SUN S C,et al.Clinical study on effect of JINTIANGE capsules for treatment of primary osteoporosis[J].Chin J Osteoporos(中国骨质疏松杂志),2005,11(4):490-495.
[11]LI N,CHENG X G.Introduction of“american college of radiology practice guideline for the performance of quantitative computed tomography bone densitometry(2013)”[J].Chin J Bone Jo(中国骨与关节杂志),2014,3(11):835-837.
[12]LIN H.Risk factors of osteoporotic fracture[J].Inter JEndocrinol Metabol(国际内分泌代谢杂志),2006(26):236-238.
[13]GIBSON M J.The prevention of Falls in later life.A report of the Kellogg International Work Group on the prevention of Falls by the elderly[J].Dan Med Bull,1987,34(Suppl 4):1-24.
[14]HUANG H X,WU Q,LI Y H,et al.Expert consensus on muscle,bone and osteoporosis[J].Chin J Osteoporos(中国骨质疏松杂志),2016,22(10):1221-1229,1236.
[15]LI C W,SHI X L.Clinical study of yiqi wenjing recipe in preventing and treating primary type I osteoporotic hip fractures with BMD and SF-36 quality of life score[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(5):592-595.
[16]SHI X L,LIANG B C,LI C W,et al.Pathomechanism of primary osteoporosis based on the theory of stasis caused by deficiency[J/OL].Chin J Integr West Med(中国中西医结合杂志):1-3[2018-09-19].
[17]YAO J L,WANG B,WU P,et al.The effect of strengthening-bone receipt on the change of trabecular bone of fracture healing under micro-CT in rat osteoporotic model[J].Chin J Osteoporos(中国骨质疏松杂志),2016,22(11):1395-1398,1403.
[18]WU L G,LIU K,HUANG J J,et al.Effect of QiangGu Drink on peri-prosthetic bone density after artificial femoral head replacement in patients with femoral neck fractures[J].J Tradit Chin Orthop Traumatol(中医正骨),2014,26(4):15-18.
[19]JIAN Z F,SUN W,CAO H.Qiangguyin strengthens periprosthetic bone density after hip arthroplasty:a randomized controlled half-year evaluation[J].Chin J Tissue Eng Res(中国组织工程研究),2015,19(39):6286-6290.
[20]ZHU Y Z.The clinical research of the impact on the bone metabolism index in Qiangguyin treatment primary osteoporosis[D].Zhejiang University of Traditional Chinese Medicine(浙江中医药大学),2008.
[21]GUI C Z.The empirical study progression of the treatment mechanism of the flavone of rhizome drynania on osteoporosis[J].Chin Arch Tradi Chin Med(中华中医药学刊),2010(6):1272-1274.
[2]COSMAN F,DE BEUR S J,LEBOFF M S,et al.Clinician’s guide to prevention and treatment of osteoporosis[J].Osteoporos Int,2014,25(10):2359-2381.
[3]J?RVINEN T L,SIEV?NEN H,KHAN K M,et al.Shifting the focus in fracture prevention from osteoporosis to falls[J].BMJ,2008,336(7636):124-126.
[4]NAKAMURA K,UENO K,NISHIWAKI T,et al.Nutrition,mild hyperparathyroidism,and bone mineral density in young Japanese women[J].Am J Clin Nutr,2005,82(5):1127-1133.
[5]BISCHOFF H A,ST?HELIN H B,DICK W,et al.Effects of vitamin D and calcium supplementation on falls:Arandomized controlled trial[J].J Bone Miner Res,2003,18(2):343-351.
[6]ZHANG Z H,LIU Z H,LI N,et al.Expert consensus on the diagnosis of osteoporosis in Chinese population[J].Chin JOsteoporos(中国骨质疏松杂志),2014,20(9):1007-1010.
[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.
[8]SHI Z Y,LIU Z,CHEN W L,et al.A multicenter clinical study of complex therapy of traditional Chinese medicine for prevention and treatment of postmenopausal osteopenia[J].JTradit Chin Orthop Traumatol(中医正骨),2017,29(4):1-7.
[9]CHEN W L,MAO Y F,ZHANG J F,et al.Clinical efficacy of classic formula,tonifying Qi and warming meridian,combined with modified 5-bird exercise on postmenopausal osteopenia patients[J].Chin J Osteoporos(中国骨质疏松杂志),2018,24(7):954-958.
[10]ZHANG J,WU L S,SUN S C,et al.Clinical study on effect of JINTIANGE capsules for treatment of primary osteoporosis[J].Chin J Osteoporos(中国骨质疏松杂志),2005,11(4):490-495.
[11]LI N,CHENG X G.Introduction of“american college of radiology practice guideline for the performance of quantitative computed tomography bone densitometry(2013)”[J].Chin J Bone Jo(中国骨与关节杂志),2014,3(11):835-837.
[12]LIN H.Risk factors of osteoporotic fracture[J].Inter JEndocrinol Metabol(国际内分泌代谢杂志),2006(26):236-238.
[13]GIBSON M J.The prevention of Falls in later life.A report of the Kellogg International Work Group on the prevention of Falls by the elderly[J].Dan Med Bull,1987,34(Suppl 4):1-24.
[14]HUANG H X,WU Q,LI Y H,et al.Expert consensus on muscle,bone and osteoporosis[J].Chin J Osteoporos(中国骨质疏松杂志),2016,22(10):1221-1229,1236.
[15]LI C W,SHI X L.Clinical study of yiqi wenjing recipe in preventing and treating primary type I osteoporotic hip fractures with BMD and SF-36 quality of life score[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(5):592-595.
[16]SHI X L,LIANG B C,LI C W,et al.Pathomechanism of primary osteoporosis based on the theory of stasis caused by deficiency[J/OL].Chin J Integr West Med(中国中西医结合杂志):1-3[2018-09-19].
[17]YAO J L,WANG B,WU P,et al.The effect of strengthening-bone receipt on the change of trabecular bone of fracture healing under micro-CT in rat osteoporotic model[J].Chin J Osteoporos(中国骨质疏松杂志),2016,22(11):1395-1398,1403.
[18]WU L G,LIU K,HUANG J J,et al.Effect of QiangGu Drink on peri-prosthetic bone density after artificial femoral head replacement in patients with femoral neck fractures[J].J Tradit Chin Orthop Traumatol(中医正骨),2014,26(4):15-18.
[19]JIAN Z F,SUN W,CAO H.Qiangguyin strengthens periprosthetic bone density after hip arthroplasty:a randomized controlled half-year evaluation[J].Chin J Tissue Eng Res(中国组织工程研究),2015,19(39):6286-6290.
[20]ZHU Y Z.The clinical research of the impact on the bone metabolism index in Qiangguyin treatment primary osteoporosis[D].Zhejiang University of Traditional Chinese Medicine(浙江中医药大学),2008.
[21]GUI C Z.The empirical study progression of the treatment mechanism of the flavone of rhizome drynania on osteoporosis[J].Chin Arch Tradi Chin Med(中华中医药学刊),2010(6):1272-1274.