骨疏康颗粒对阿仑膦酸钠治疗骨质疏松症的增效减毒作用研究
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摘要
目的:探讨骨疏康颗粒对阿仑膦酸钠治疗骨质疏松症的增效减毒作用。方法:选取2013年7月至2016年12月中国人民解放军联勤保障部队第903医院治疗的老年性骨质疏松症患者200例,按随机数字表法分对照组和观察组,每组100例。对照组患者给予阿仑膦酸钠、碳酸钙D_3,观察组患者在对照组基础上加用骨疏康颗粒;均连续服用12个月。比较两组患者的临床疗效、疼痛视觉模拟评分(visual analog score,VAS)、生活质量Oswestry功能障碍指数问卷表(oswestry dability index,ODI)评分、骨密度(BMD)、骨代谢生化指标水平及不良反应发生情况。结果:共194例患者完成研究,其中观察组患者98例,对照组患者96例。观察组患者的总有效率(91.84%,90/98)明显高于对照组(82.29%,79/96),差异有统计学意义(P<0.05)。治疗后,观察组患者的VAS评分、ODI评分明显优于对照组,差异有极显著统计学意义(P<0.01);观察组患者的股骨颈BMD、腰椎BMD优于对照组,但差异无统计学意义(P>0.05);观察组患者的血清碱性磷酸酶、N端中段骨钙素、总Ⅰ型胶原蛋白氨基端延长肽及Ⅰ型胶原降解产物等骨代谢指标水平改善情况均明显优于对照组,差异均有统计学意义(P<0.05);观察组患者血清钙、骨钙素、25羟基维生素D_3及甲状旁腺激素水平有所改善,但与对照组的差异无统计学意义(P>0.05)。两组患者均无严重不良反应发生,观察组患者不良反应发生率明显低于对照组,差异有统计学意义(P<0.05)。结论:骨疏康颗粒对阿仑膦酸钠治疗老年骨质疏松症具有显著的增效减毒作用。
OBJECTIVE: To probe into the synergistic and attenuation effects of Gushukang granules on alendronate in treatment of osteoporosis. METHODS: Totally 200 elderly patients with osteoporosis admitted into the 903 Hospital of the Chinese People's Liberation Army Joint Logistics Support Force from Jul. 2013 to Dec. 2016 were extracted to be divided into the conreol group and the observation group via the random number table, with 100 cases in each group. The control group was given alendronate sodium and calcium carbonate D_3, while the observation group was treated with Gushukang granules on the basis of the control group, both groups were continuously administered for 12 months. The clinical efficacy, visual analog score(VAS), quality of life Oswestry disability index(ODI) score, BMD, BMD and the occurrence of adverse drug reactions were compared between two groups. RESULTS: A total of 194 patients completed the study, including 98 patients in the observation group and 96 patients in the control group. The total effective rate of the observation group(91.84%, 90/98) was significantly higher than that of the control group(82.29%, 79/96), and the difference was statistically significant(P<0.05). After treatment, the VAS score and ODI score of the observation group were significantly better than those of the control group, the difference was statistically significant(P<0.01). The BMD of the femoral neck and the BMD of the lumbar spine of the observation group were better than those of the control group, yet the difference was not statistically significant(P>0.05). The serum alkaline phosphatase, N-terminal middle osteocalcin, total type Ⅰ collagen amino terminal prolongation peptide and type Ⅰ collagen degradation products in the observation group were significantly better than those of the control group, and the differences were statistically significant(P<0.05). The serum calcium, osteocalcin, 25-hydroxyvitamin D_3 and parathyroid hormone levels were improved in the observation group, but there was no significant difference between two groups(P>0.05). There were no severe adverse drug reactions in two groups, and the incidence of adverse drug reactions in the observation group was significantly lower than that in the control group, with statistically significant difference(P<0.05). CONCLUSIONS: Gushukang granules have significant synergistic and attenuation effects in treatment of elderly osteoporosis.
OBJECTIVE: To probe into the synergistic and attenuation effects of Gushukang granules on alendronate in treatment of osteoporosis. METHODS: Totally 200 elderly patients with osteoporosis admitted into the 903 Hospital of the Chinese People's Liberation Army Joint Logistics Support Force from Jul. 2013 to Dec. 2016 were extracted to be divided into the conreol group and the observation group via the random number table, with 100 cases in each group. The control group was given alendronate sodium and calcium carbonate D_3, while the observation group was treated with Gushukang granules on the basis of the control group, both groups were continuously administered for 12 months. The clinical efficacy, visual analog score(VAS), quality of life Oswestry disability index(ODI) score, BMD, BMD and the occurrence of adverse drug reactions were compared between two groups. RESULTS: A total of 194 patients completed the study, including 98 patients in the observation group and 96 patients in the control group. The total effective rate of the observation group(91.84%, 90/98) was significantly higher than that of the control group(82.29%, 79/96), and the difference was statistically significant(P<0.05). After treatment, the VAS score and ODI score of the observation group were significantly better than those of the control group, the difference was statistically significant(P<0.01). The BMD of the femoral neck and the BMD of the lumbar spine of the observation group were better than those of the control group, yet the difference was not statistically significant(P>0.05). The serum alkaline phosphatase, N-terminal middle osteocalcin, total type Ⅰ collagen amino terminal prolongation peptide and type Ⅰ collagen degradation products in the observation group were significantly better than those of the control group, and the differences were statistically significant(P<0.05). The serum calcium, osteocalcin, 25-hydroxyvitamin D_3 and parathyroid hormone levels were improved in the observation group, but there was no significant difference between two groups(P>0.05). There were no severe adverse drug reactions in two groups, and the incidence of adverse drug reactions in the observation group was significantly lower than that in the control group, with statistically significant difference(P<0.05). CONCLUSIONS: Gushukang granules have significant synergistic and attenuation effects in treatment of elderly osteoporosis.
引文
[1] 张智海,刘忠厚,李娜,等.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.
[2] 唐永亮,张静怡,杨寅.阿仑膦酸钠联合钙尔奇D对骨质疏松症患者疼痛和骨密度的影响[J].临床药物治疗杂志,2017,15(6):39-43.
[3] 陈昌博.骨疏康胶囊联合骨化三醇和阿仑膦酸钠治疗骨质疏松的临床疗效[J].药品评价,2017,14(7):41-43,63.
[4] 王弢,冯世庆.老年骨质疏松性骨折患者血清生化指标检测及风险评估[J].中国实验诊断学,2016,20(4):618-620.
[5] 王海燕.骨化三醇联合钙尔奇D对绝经后骨质疏松症患者骨代谢指标及疗效的影响[J].实用临床医药杂志,2016,20(3):152-153.
[6] 陈文秀.阿仑膦酸钠片不良反应26例分析[J].福建医药杂志,2008,30(5):119-120.
[7] 仲影.中西医结合治疗原发性骨质疏松症临床观察[J].世界最新医学信息文摘,2015,15(60):171.
[8] Hofstetter B,Gamsjaeger S,Varga F,et al.Bone quality of the newest bone formed after two years of teriparatide therapy in patients who were previously treatment-na?ve or on long-term alendronate therapy[J].Osteoporos Int,2014,25(12):2709-2719.
[9] Borromeo GL,Brand C,Clement JG,et al.A large case control study reveals a positive association between bisphosphonate use and delayed dental healing and osteonecrosis of the jaw[J].J Bone Miner Res,2014,29(6):1363-1368.
[10] 林广珍,蒋云霞,莫文秋,等.中药活性成分防治骨质疏松机理研究概况[J].亚太传统医药,2016,12(3):47-48.
[11] 王明熹,蔡慧颜.骨疏康颗粒联合玉龙散外敷治疗原发性骨质疏松症的临床疗效分析[J].海峡药学,2016,28(10):136-138.
[12] 王和鸣,葛继荣,石关桐,等.骨疏康胶囊治疗骨质疏松症临床试验总结[J].中国中医骨伤科杂志,2006,14(6):10-15.
[13] 余兴华.骨疏康颗粒含药血清对成骨细胞增殖及细胞周期的影响[J].北京中医药,2010,29(12):953-955.
[14] Yoon BK,Lee DY,Park MC,et al.Effects of Combination Therapy of Alendronate and Hormonal Therapy on Bone Mineral Density in Post-menopausal Korean Women:Multicenter,Randomized Cont-rolled Clinical Trial[J].J Korean Med Sci,2017,32(6):992-998.
[15] Krüger TB,Herlofson BB,Landin MA,et al.Alendronate alters osteoblast activities[J].Acta Odontol Scand,2016,74(7):550-557.
[16] Hauser M,Siegrist M,Keller I,et al.Healing of fractures in osteoporotic bones in mice treated with bisphosphonates—A transcri-ptome analysis[J].Bone,2018,112:107-119.
[17] Kan SL,Yuan ZF,Li Y,et al.Alendronate prevents glucocorticoid-induced osteoporosis in patients with rheumatic diseases:A meta-analysis[J].Medicine(Baltimore),2016,95(25):e3990.
[18] 徐海清,黄美琴,袁引芳.骨疏康颗粒联合钙尔奇D片治疗老年性骨质疏松症效果观察[J].中国乡村医药,2016,23(12):58-59.
[19] 徐志强,陈发胜,罗国亮,等.骨疏康颗粒对糖尿病并骨质疏松症的疗效研究[J].中国医药指南,2013,11(15):667-668.
[2] 唐永亮,张静怡,杨寅.阿仑膦酸钠联合钙尔奇D对骨质疏松症患者疼痛和骨密度的影响[J].临床药物治疗杂志,2017,15(6):39-43.
[3] 陈昌博.骨疏康胶囊联合骨化三醇和阿仑膦酸钠治疗骨质疏松的临床疗效[J].药品评价,2017,14(7):41-43,63.
[4] 王弢,冯世庆.老年骨质疏松性骨折患者血清生化指标检测及风险评估[J].中国实验诊断学,2016,20(4):618-620.
[5] 王海燕.骨化三醇联合钙尔奇D对绝经后骨质疏松症患者骨代谢指标及疗效的影响[J].实用临床医药杂志,2016,20(3):152-153.
[6] 陈文秀.阿仑膦酸钠片不良反应26例分析[J].福建医药杂志,2008,30(5):119-120.
[7] 仲影.中西医结合治疗原发性骨质疏松症临床观察[J].世界最新医学信息文摘,2015,15(60):171.
[8] Hofstetter B,Gamsjaeger S,Varga F,et al.Bone quality of the newest bone formed after two years of teriparatide therapy in patients who were previously treatment-na?ve or on long-term alendronate therapy[J].Osteoporos Int,2014,25(12):2709-2719.
[9] Borromeo GL,Brand C,Clement JG,et al.A large case control study reveals a positive association between bisphosphonate use and delayed dental healing and osteonecrosis of the jaw[J].J Bone Miner Res,2014,29(6):1363-1368.
[10] 林广珍,蒋云霞,莫文秋,等.中药活性成分防治骨质疏松机理研究概况[J].亚太传统医药,2016,12(3):47-48.
[11] 王明熹,蔡慧颜.骨疏康颗粒联合玉龙散外敷治疗原发性骨质疏松症的临床疗效分析[J].海峡药学,2016,28(10):136-138.
[12] 王和鸣,葛继荣,石关桐,等.骨疏康胶囊治疗骨质疏松症临床试验总结[J].中国中医骨伤科杂志,2006,14(6):10-15.
[13] 余兴华.骨疏康颗粒含药血清对成骨细胞增殖及细胞周期的影响[J].北京中医药,2010,29(12):953-955.
[14] Yoon BK,Lee DY,Park MC,et al.Effects of Combination Therapy of Alendronate and Hormonal Therapy on Bone Mineral Density in Post-menopausal Korean Women:Multicenter,Randomized Cont-rolled Clinical Trial[J].J Korean Med Sci,2017,32(6):992-998.
[15] Krüger TB,Herlofson BB,Landin MA,et al.Alendronate alters osteoblast activities[J].Acta Odontol Scand,2016,74(7):550-557.
[16] Hauser M,Siegrist M,Keller I,et al.Healing of fractures in osteoporotic bones in mice treated with bisphosphonates—A transcri-ptome analysis[J].Bone,2018,112:107-119.
[17] Kan SL,Yuan ZF,Li Y,et al.Alendronate prevents glucocorticoid-induced osteoporosis in patients with rheumatic diseases:A meta-analysis[J].Medicine(Baltimore),2016,95(25):e3990.
[18] 徐海清,黄美琴,袁引芳.骨疏康颗粒联合钙尔奇D片治疗老年性骨质疏松症效果观察[J].中国乡村医药,2016,23(12):58-59.
[19] 徐志强,陈发胜,罗国亮,等.骨疏康颗粒对糖尿病并骨质疏松症的疗效研究[J].中国医药指南,2013,11(15):667-668.
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