补肾健脾通络汤联合伊班膦酸钠注射液治疗老年性骨质疏松症的临床研究
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摘要
目的观察补肾健脾通络汤联合伊班膦酸钠注射液治疗老年性骨质疏松症(SOP)的临床疗效。方法将120例SOP患者按照随机数字表法分为2组。2组均予碳酸钙D_3咀嚼片(Ⅱ)口服,对照组60例予伊班膦酸钠注射液联合仙灵骨葆胶囊治疗,治疗组60例予伊班膦酸钠注射液联合补肾健脾通络汤治疗。2组均治疗6个月。比较2组中医证候评分、疼痛视觉模拟评分法(VAS)评分及股骨颈、第2～4腰椎(L_(2～4))、髋部骨密度(BMD)和血清骨代谢标志物骨钙素(BGP)、Ⅰ型胶原羧基端肽β特殊序列(β-CTx)、Ⅰ型前胶原N端前肽(PⅠNP)水平变化情况及不良反应发生情况。结果治疗组总有效率93.33%,对照组总有效率75.00%,治疗组疗效优于对照组(P<0.05)。2组治疗后及治疗后6个月中医证候评分及总积分均低于本组治疗前(P<0.05),且治疗组治疗后及治疗后6个月中医证候评分及总积分均低于对照组同期(P<0.05)。2组治疗后及治疗后6个月疼痛VAS评分均低于本组治疗前(P<0.05),且治疗组治疗后及治疗后6个月疼痛VAS评分均低于对照组同期(P<0.05)。2组治疗后及治疗后6个月股骨颈、L_(2～4)、髋部BMD均高于本组治疗前(P<0.05),且治疗组治疗后及治疗后6个月股骨颈、L_(2～4)、髋部BMD均高于对照组同期(P<0.05)。2组治疗后及治疗后6个月BGP、PⅠNP较治疗前均升高(P<0.05),β-CTx较治疗前均降低(P<0.05);且治疗组治疗后及治疗后6个月BGP、PⅠNP均高于对照组同期(P<0.05),β-CTx均低于对照组同期(P<0.05)。结论补肾健脾通络汤联合伊班膦酸钠注射液治疗SOP疗效确切,能有效减轻临床症状,缓解疼痛,提高BMD,改善骨代谢生化指标水平,且副作用少,安全性高。
Objective To observe the clinical efficacy of Bushen Jianpi Tongluo decoction combined with ibandronate sodium injection in the treatment of senile osteoporosis(SOP). Methods 120 patients with SOP were divided into two groups according to random number table method. Both groups were treated by calcium carbonate D_3 chewable tablets(II). 60 cases in control group were treated by ibandronate sodium injection combined with xianling gubao capsule. 60 cases in treatment group were treated by ibandronate sodium injection combined with Bushen Jianpi Tongluo decoction. Both groups were treated for 6 months. The changes of TCM syndrome score, pain visual analogue scale(VAS) score were observed between two groups. The changes of bone mineral density(BMD) of femoral neck, 2 nd to 4 th lumbar vertebrae(L_(2-4)) and hip were observed between two groups. The changes of serum bone metabolic markers such as osteocalcin(BGP), collagen type I hydroxyterminus peptide β special sequence(β-CTx), procollagen type I N-terminal propeptide(PINP) levels and occurrence of adverse reactions were observed between two groups. Results The total effective rate was 93.33 % in treatment group and 75.00 % in control group. The clinical curative effect of the treatment group was better than that of the control group(P<0.05). The scores and total scores of TCM syndromes in the two groups after treatment and 6 months after treatment were lower than those in the group before treatment(P<0.05), and the treatment group were lower than the control group at the same time(P<0.05). The VAS scores in the two groups after treatment and 6 months after treatment were lower than those in the group before treatment(P<0.05), and the treatment group were lower than the control group at the same time(P<0.05). The BMD of femoral neck, L_(2-4) and hip in the two groups after treatment and 6 months after treatment were higher than those in the group before treatment(P<0.05), and the treatment group were higher than the control group at the same time(P<0.05). After treatment and 6 months after treatment, BGP and PINP in the two groups were higher than those in the group before treatment(P<0.05), and β-CTx was lower than those before treatment(P<0.05); BGP and PINP in the treatment group were higher than those in the control group(P<0.05), and β-CTx was lower than those in the control group(P<0.05). Conclusion Bushen Jianpi Tongluo decoction combined with ibandronate sodium injection is effective in treating SOP. It can effectively alleviate clinical symptoms, relieve pain, improve BMD, and improve biochemical indexes of bone metabolism, with fewer side effects and high safety.
Objective To observe the clinical efficacy of Bushen Jianpi Tongluo decoction combined with ibandronate sodium injection in the treatment of senile osteoporosis(SOP). Methods 120 patients with SOP were divided into two groups according to random number table method. Both groups were treated by calcium carbonate D_3 chewable tablets(II). 60 cases in control group were treated by ibandronate sodium injection combined with xianling gubao capsule. 60 cases in treatment group were treated by ibandronate sodium injection combined with Bushen Jianpi Tongluo decoction. Both groups were treated for 6 months. The changes of TCM syndrome score, pain visual analogue scale(VAS) score were observed between two groups. The changes of bone mineral density(BMD) of femoral neck, 2 nd to 4 th lumbar vertebrae(L_(2-4)) and hip were observed between two groups. The changes of serum bone metabolic markers such as osteocalcin(BGP), collagen type I hydroxyterminus peptide β special sequence(β-CTx), procollagen type I N-terminal propeptide(PINP) levels and occurrence of adverse reactions were observed between two groups. Results The total effective rate was 93.33 % in treatment group and 75.00 % in control group. The clinical curative effect of the treatment group was better than that of the control group(P<0.05). The scores and total scores of TCM syndromes in the two groups after treatment and 6 months after treatment were lower than those in the group before treatment(P<0.05), and the treatment group were lower than the control group at the same time(P<0.05). The VAS scores in the two groups after treatment and 6 months after treatment were lower than those in the group before treatment(P<0.05), and the treatment group were lower than the control group at the same time(P<0.05). The BMD of femoral neck, L_(2-4) and hip in the two groups after treatment and 6 months after treatment were higher than those in the group before treatment(P<0.05), and the treatment group were higher than the control group at the same time(P<0.05). After treatment and 6 months after treatment, BGP and PINP in the two groups were higher than those in the group before treatment(P<0.05), and β-CTx was lower than those before treatment(P<0.05); BGP and PINP in the treatment group were higher than those in the control group(P<0.05), and β-CTx was lower than those in the control group(P<0.05). Conclusion Bushen Jianpi Tongluo decoction combined with ibandronate sodium injection is effective in treating SOP. It can effectively alleviate clinical symptoms, relieve pain, improve BMD, and improve biochemical indexes of bone metabolism, with fewer side effects and high safety.
引文
[1] 秦集斌,宋洁富,薛旭红.原发性骨质疏松症的病因学研究进展[J].中国骨质疏松杂志,2016,22(4):511-514.
[2] Cosman F,de Beur SJ,LeBoff MS,et al.Clinician's Guide to Prevention and Treatment of Osteoporosis[J].Osteoporos Int,2014,25(10):2359-2381.
[3] 黄广灵,张道鹏.穴位注射骨肽治疗老年骨质疏松性腰背痛的疗效观察[J].中医药导报,2016,22(17):76-78.
[4] 郑莎.骨质疏松症的药物治疗研究进展[J].中国处方药,2017,15(8):26-28.
[5] 李军,王永胜,封挺,等.伊班膦酸钠输注液和阿仑膦酸钠片治疗老年性骨质疏松症的疗效-成本分析[J].北方药学,2015,12(7):166-167.
[6] 黄武维,杨琳.电针结合补肾健脾方对老年骨质疏松患者骨密度及血钙和血清OPN水平的影响[J].陕西中医,2016,37(4):481-483.
[7] 中国老年学学会骨质疏松委员会.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.
[8] 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,2002:356-360.
[9] Carlsson AM.Assessment of chronic pain.I.Aspects of the reliability and validity of the visual analogue scale[J].Pain,1983,16(1):87-101.
[10] 夏丽颖.中药治疗原发性骨质疏松作用机制研究进展[J].上海中医药大学学报,2017,31(2):95-98.
[11] 林霞,黎明,赵文.鲑鱼降钙素联合基础药物治疗老年骨质疏松的疗效分析[J].当代医学,2017,23(13):106-108.
[12] Kanis JA,Mc Closkey EV,Johansson H,et al.European guidance for the diagnosis and management of osteoporosis in postmenopausal women[J].Osteoporos Int,2013,24(1):23-57.
[13] 丁超.老年性骨质疏松症相关问题研究进展[J].中国骨质疏松杂志,2016,22(3):372-375.
[14] 邢帅,高延征,高坤,等.双膦酸盐类药物治疗原发性骨质疏松症研究进展[J].风湿病与关节炎,2016,5(3):70-73.
[15] 刘光勇,易泽洪,杨国奇,等.仙灵骨葆胶囊联合伊班膦酸钠注射液和碳酸钙D3治疗老年骨质疏松的临床研究[J].现代药物与临床,2016,31(7):1067-1070.
[16] 赵建根,马超.PVP结合仙灵骨葆胶囊治疗老年性骨质疏松症伴骨折临床疗效评价[J].中华中医药学刊,2016,34(11):2805-2807.
[17] 李鹏,李新颖,李正伟,等.仙灵骨葆胶囊干预老龄骨质疏松模型大鼠骨力学特性的变化[J].中国组织工程研究,2017,21(32):5170-5176.
[18] 潘永苗,袁临益,卢建华.补肾健脾通络汤对骨质疏松症患者的骨密度、疼痛及中医证候改善分析[J].中华中医药学刊,2017,35(3):655-657.
[19] 覃裕,邱冰,朱思刚,等.仙灵骨葆胶囊治疗骨质疏松症的疗效及其对骨代谢及骨转换指标的影响分析[J].中国骨质疏松杂志,2015,21(9):1056-1060.
[20] 孔西建,吴丹,叶进,等.唑来膦酸、降钙素对骨生化标志物BAP、N-MID、β-CTX的影响[J].中国骨质疏松杂志,2013,19(1):46-50.
[2] Cosman F,de Beur SJ,LeBoff MS,et al.Clinician's Guide to Prevention and Treatment of Osteoporosis[J].Osteoporos Int,2014,25(10):2359-2381.
[3] 黄广灵,张道鹏.穴位注射骨肽治疗老年骨质疏松性腰背痛的疗效观察[J].中医药导报,2016,22(17):76-78.
[4] 郑莎.骨质疏松症的药物治疗研究进展[J].中国处方药,2017,15(8):26-28.
[5] 李军,王永胜,封挺,等.伊班膦酸钠输注液和阿仑膦酸钠片治疗老年性骨质疏松症的疗效-成本分析[J].北方药学,2015,12(7):166-167.
[6] 黄武维,杨琳.电针结合补肾健脾方对老年骨质疏松患者骨密度及血钙和血清OPN水平的影响[J].陕西中医,2016,37(4):481-483.
[7] 中国老年学学会骨质疏松委员会.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.
[8] 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,2002:356-360.
[9] Carlsson AM.Assessment of chronic pain.I.Aspects of the reliability and validity of the visual analogue scale[J].Pain,1983,16(1):87-101.
[10] 夏丽颖.中药治疗原发性骨质疏松作用机制研究进展[J].上海中医药大学学报,2017,31(2):95-98.
[11] 林霞,黎明,赵文.鲑鱼降钙素联合基础药物治疗老年骨质疏松的疗效分析[J].当代医学,2017,23(13):106-108.
[12] Kanis JA,Mc Closkey EV,Johansson H,et al.European guidance for the diagnosis and management of osteoporosis in postmenopausal women[J].Osteoporos Int,2013,24(1):23-57.
[13] 丁超.老年性骨质疏松症相关问题研究进展[J].中国骨质疏松杂志,2016,22(3):372-375.
[14] 邢帅,高延征,高坤,等.双膦酸盐类药物治疗原发性骨质疏松症研究进展[J].风湿病与关节炎,2016,5(3):70-73.
[15] 刘光勇,易泽洪,杨国奇,等.仙灵骨葆胶囊联合伊班膦酸钠注射液和碳酸钙D3治疗老年骨质疏松的临床研究[J].现代药物与临床,2016,31(7):1067-1070.
[16] 赵建根,马超.PVP结合仙灵骨葆胶囊治疗老年性骨质疏松症伴骨折临床疗效评价[J].中华中医药学刊,2016,34(11):2805-2807.
[17] 李鹏,李新颖,李正伟,等.仙灵骨葆胶囊干预老龄骨质疏松模型大鼠骨力学特性的变化[J].中国组织工程研究,2017,21(32):5170-5176.
[18] 潘永苗,袁临益,卢建华.补肾健脾通络汤对骨质疏松症患者的骨密度、疼痛及中医证候改善分析[J].中华中医药学刊,2017,35(3):655-657.
[19] 覃裕,邱冰,朱思刚,等.仙灵骨葆胶囊治疗骨质疏松症的疗效及其对骨代谢及骨转换指标的影响分析[J].中国骨质疏松杂志,2015,21(9):1056-1060.
[20] 孔西建,吴丹,叶进,等.唑来膦酸、降钙素对骨生化标志物BAP、N-MID、β-CTX的影响[J].中国骨质疏松杂志,2013,19(1):46-50.