仙灵骨葆胶囊治疗绝经后骨质疏松症有效性的系统评价和Meta分析
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摘要
目的评价仙灵骨葆胶囊治疗绝经后骨质疏松症的有效性和安全性。方法电子检索中、英文数据库共7个(自建库时间至2017年11月),按照纳入标准和排除标准筛选文献,依据Cochrane Handbook for Systematic Reviews of Interventions(version 5.35)质量评估,并用RevMan 5.3软件进行Meta分析。结果检索到文献共1 779篇,筛选后纳入文献16篇(19项原始研究),总样本量1 492例。Meta分析得出单用仙灵骨葆胶囊对于提高腰椎骨密度疗效优于常规治疗[MD=0.08,95%CI(0.03,0.14),P=0.002];仙灵骨葆胶囊加常规干预对于提高临床有效率[OR=3.35,95%CI(1.86,6.05),P<0.000 1]、改善疼痛[MD=-1.71,95%CI(-2.39,-1.03),P<0.000 01]疗效优于常规治疗;在改善腰椎骨密度方面,仙灵骨葆胶囊+单一常规干预疗效明显优于单一常规干预[MD=0.06,95%CI(0.04,0.07),P<0.000 01];仙灵骨葆胶囊联合常规干预在提高髋部骨密度疗效上可能优于常规干预[MD=0.08,95%CI(0.03,0.14),P=0.001]。结论仙灵骨葆胶囊在改善腰椎骨密度、提高临床有效率及改善疼痛方面疗效确切;但在改善髋部骨密度方面证据不足,总疗程可能是其重要影响因素;仙灵骨葆胶囊联合单一抗骨质疏松药物具有增效作用,与两种或以上抗骨质疏松药物联用叠加增效作用尚待研究。
Objective To evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of postmenopausal osteoporosis. Methods Seven electronic databases(from the date of establishment to November 2017) were retrieved. The literatures were screened according to the inclusion criteria and exclusion criteria. All the trials were assessed according to the Cochrane Handbook 5. 1 for Systematic Reviews of Intervention and the analyses was performed using RevMan5. 3 Software. Results A total of 1 779 articles were retrieved, 16 papers were selected, and 19 original studies were included, with a total sample size of 1 492 cases. Meta-analysis showed that the efficacy of Xianling Gubao capsule alone in improving bone mineral density of the lumbar vertebrae was superior to that of routine treatment(MD 0.08, 95% CI 0.03 to 0.14). Xianling Gubao capsule combined with routine intervention was better than routine treatment in terms of improving effective ratio(OR 3.35, 95%CI 1.86 to 6.05) and pain(MD-1.71, 95%CI-2.39 to-1.03). The curative effect of single routine intervention plus Xianling Gubao capsule was better than that of single routine intervention in bone mineral density of the lumbar vertebrae(MD 0.06, 95%CI 0.04 to 0.07). Xianling Gubao capsule combined with routine intervention was superior to routine interventions in improving hip bone mineral density(MD 0.08, 95%CI 0.03 to 0.14). Conclusion Xianling Gubao capsule is effective in improving bone mineral density of the lumbar vertebrae, increasing clinical effective rate, and improving pain. However, the advantage in improving hip bone density is not obvious. The total treatment course may be an important influencing factor. Xianling Gubao capsule combined with single anti-osteoporosis drug has synergistic effect, but the synergistic effect is not obvious when combined with two or more anti-osteoporosis drugs.
Objective To evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of postmenopausal osteoporosis. Methods Seven electronic databases(from the date of establishment to November 2017) were retrieved. The literatures were screened according to the inclusion criteria and exclusion criteria. All the trials were assessed according to the Cochrane Handbook 5. 1 for Systematic Reviews of Intervention and the analyses was performed using RevMan5. 3 Software. Results A total of 1 779 articles were retrieved, 16 papers were selected, and 19 original studies were included, with a total sample size of 1 492 cases. Meta-analysis showed that the efficacy of Xianling Gubao capsule alone in improving bone mineral density of the lumbar vertebrae was superior to that of routine treatment(MD 0.08, 95% CI 0.03 to 0.14). Xianling Gubao capsule combined with routine intervention was better than routine treatment in terms of improving effective ratio(OR 3.35, 95%CI 1.86 to 6.05) and pain(MD-1.71, 95%CI-2.39 to-1.03). The curative effect of single routine intervention plus Xianling Gubao capsule was better than that of single routine intervention in bone mineral density of the lumbar vertebrae(MD 0.06, 95%CI 0.04 to 0.07). Xianling Gubao capsule combined with routine intervention was superior to routine interventions in improving hip bone mineral density(MD 0.08, 95%CI 0.03 to 0.14). Conclusion Xianling Gubao capsule is effective in improving bone mineral density of the lumbar vertebrae, increasing clinical effective rate, and improving pain. However, the advantage in improving hip bone density is not obvious. The total treatment course may be an important influencing factor. Xianling Gubao capsule combined with single anti-osteoporosis drug has synergistic effect, but the synergistic effect is not obvious when combined with two or more anti-osteoporosis drugs.
引文
[1] Consensus development conference: diagnosis, prophylaxis, and treatment of osteoporosis[J]. Am J Med, 1993,94(6):646-650.
[2] Wright N C, Looker A C, Saag K G, et al. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine[J]. J Bone Miner Res, 2014,29(11):2520-2526.
[3] Hernlund E, Svedbom A, Ivergard M, et al. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA)[J]. Arch Osteoporos, 2013,8:136.
[4] 中国健康促进基金会骨质疏松防治中国白皮书编委会. 骨质疏松症中国白皮书[J]. 中华健康管理学杂志, 2009,3(3):148-154.Editorial Board Of Osteoporosis Prevention And Treatment China White Paper, China Health Promotion Foundation. White paper on osteoporosis[J]. Chinese Journal of Health Management, 2009,3(3):148-154. (in Chinese)
[5] 中华医学会骨质疏松和骨矿盐疾病分会. 原发性骨质疏松症诊疗指南(2017)[J].中国全科医学,2017,20(32):3963-3982.Chinese Society of Osteoporosis and Bone Mineral Research. Guidelines for the diagnosis and treatment of primary osteoporosis (2017)[J]. Chin Gen Pract,2017,20(32): 3963 -3982. (in Chinese)
[6] Eastell R, O'Neill T W, Hofbauer L C, et al. Postmenopausal osteoporosis[J]. Nat Rev Dis Primers, 2016,2:16069.
[7] 李微,张博,张雨薇,等.雌激素调节骨代谢作用的研究进展[J].中国骨质疏松杂志,2017,23(02):262-266.Li W,Zhang B,Zhang YW, et al. Review on the research of estrogen in regulating bone metabolism[J]. Chin J Osteoporosis,2017,23(02):262-266. (in Chinese)
[8] Garnero P, Sornay-Rendu E, Chapuy M C, et al. Increased bone turnover in late postmenopausal women is a major determinant of osteoporosis[J]. J Bone Miner Res, 1996,11(3):337-349.
[9] Lindsay R. Estrogens in prevention and treatment of osteoporosis[J]. Schweiz Med Wochenschr, 1989,119(50):1806-1810.
[10] Camacho P M, Petak S M, Binkley N, et al. American association of clinical endocrinologists and american college of endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis[J]. Endocr Pract, 2016,22(Suppl 4):1-42.
[11] 谢雁鸣, 宇文亚, 董福慧, 等. 原发性骨质疏松症中医临床实践指南(摘录)[J]. 中华中医药杂志, 2012,27(07):1886-1890.Xie YM, Yu WY, Dong FH, et al. Clinical practice guideline of traditional Chinese medicine for primary osteoporosis(extract)[J]. Chin J Tradit Chin Med Pharm, 2012,27(07):1886-1890. (in Chinese)
[12] Ding Y, Zeng J C, Yin F, et al. Multicenter Study on Observation of Acute-phase Responses After Infusion of Zoledronic Acid 5 mg in Chinese Women with Postmenopausal Osteoporosis[J]. Orthop Surg, 2017,9(3):284-289.
[13] 邢燕, 毕宏焱, 张倩楠, 等. 骨质疏松常用中成药介绍[J]. 中国骨质疏松杂志, 2013,19(01):83-85+96.Xing Y, Bi HY, Zhang QN, et al.Introduction of common Chinese patent medicines for the treatment of osteoporosis[J]. Chin J Osteoporosis, 2013,19(01):83-85+96. (in Chinese)
[14] 倪力刚, 王伟, 李春雯, 等. 仙灵骨葆胶囊对骨质疏松性髋部骨折的研究近况[J]. 中国骨质疏松杂志, 2011,17(11):1014-1018.Ni LG,Wang W,Li CW,et al. Current research status of Xianlinggubao for the treatment of osteoporotic hip fracture[J]. Chin J Osteoporosis, 2011,17(11):1014-1018. (in Chinese)
[15] Wang X, He Y, Guo B, et al. In Vivo Screening for Anti-Osteoporotic Fraction from Extract of Herbal Formula Xianlinggubao in Ovariectomized Mice[J]. PLoS One, 2015,10(2):e0118184.
[16] Ge Zhang, Ling Qin PhD, Shi Y. Epimedium-derived phytoestrogen flavonoids exert beneficial effect on preventing bone loss in late postmenopausal women: a 24-month randomized, double-blind and placebo-controlled trial[J]. Journal of Bone and Mineral Research, 2007(No.7):1072-1079.
[17] Zhu H M, Qin L, Garnero P, et al. The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis[J]. Osteoporos Int, 2012,23(4):1317-1327.
[18] 王桂倩, 廖星, 章轶立, 等. 仙灵骨葆胶囊治疗原发性骨质疏松症随机对照试验的系统评价及Meta分析[J]. 中国中药杂志, 2017,42(15):2829-2844.Wang GQ, Liao X, Zhang YL, et al. Systemic evaluation and Meta-analysis of Xianling Gubao capsule in treatment of primary osteoporosis in randomized controlled trials[J].Chin J Chin Mater Med, 2017,42(15):2829-2844. (in Chinese)
[19] 章轶立, 廖星, 刘福梅, 等. 仙灵骨葆胶囊上市后用药安全性系统评价[J]. 中国中药杂志, 2017,42(15):2845-2856Zhang YL, Liao X, Liu FM, et al. Systematic review on safety of Xianling Gubao capsule[J].Chin J Chin Mater Med, 2017,42(15):2845-2856 (in Chinese)
[20] 杜倩, 王哲, 运乃茹, 等. 仙灵骨葆胶囊安全性系统评价[J]. 中国药业, 2017,26(19):37-43.Du Q, Wang Z, Yun NR, et al. Safety of Xianling Gubao Capsules: a System Evaluation[J]. China Pharmaceuticals, 2017(19):37-43. (in Chinese)
[21] 孙丽, 唐汉武. 仙灵骨葆胶囊辅助治疗骨质疏松性疼痛疗效与安全性的meta分析[J]. 中国药物警戒, 2016,13(07):422-425.Sun L, Tang HW, Meta-analysis of Efficacy and Safety of Xianlinggubao Capsule in Adjuvant Treatment of Osteoporosis Pain[J]. Chinese Journal of Pharmacovigilance, 2016,13(07):422-425. (in Chinese)
[22] 黄冬, 官堂明, 马晓鹂. 仙灵骨葆胶囊对骨质疏松性骨折预后的Meta分析[J]. 今日药学, 2015,25(10):694-696.Huang D, Guan TM, Ma XL. Efficacy of Xianlinggubao Capsule in Patients of Osteoporotic Fractures: A Meta-analysis[J].Pharmacy Today, 2015,25(10):694-696. (in Chinese)
[23] 闫乾, 陈锋, 孙海林, 等. 仙灵骨葆胶囊治疗膝骨性关节炎的有效性和安全性系统评价[J]. 中国药房, 2014,25(35):3333-3338.Yan Q, Chen F, Sun HL, et al.Therapeutic Efficacy and Safe of Xianling Gubao Capsule for Knee Osteoarthritis: A Systematic Review[J]. China Pharmacy, 2014,25(35):3333-3338.(in Chinese)
[24] 赵宜军, 胡晶, 陈静, 等. 仙灵骨葆胶囊治疗绝经后骨质疏松的系统评价[J]. 天津中医药, 2010,27(04):279-282.Zhao YJ, Hu J, Chen J, et al. Systemic evaluation of Xianling Gubao capsule in treatment of postmenopausal osteoporosis[J].Tianjin Journal of Traditional Chinese Medicine, 2010,27(04):279-282. (in Chinese)
[25] 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(09):1007-1010.Zhang ZH, Liu ZH, Li N, et al.Expert consensus on the diagnosis of osteoporosis in Chinese Population[J].Chin J Osteoporosis, 2014,20(09):1007-1010. (in Chinese)
[26] 原发性骨质疏松症诊治指南(2011年)[J]. 中华骨质疏松和骨矿盐疾病杂志, 2011,4(01):2-17.Guidelines for the diagnosis and treatment of primary osteoporosis (2011)[J].Chinese Journal of Osteoporosis and Bone Mineral Research, 2011,4(01):2-17. (in Chinese)
[27] 刘忠厚, 杨定焯, 朱汉民. 中国人骨质疏松症建议诊断标准(第二稿)[C] 全国骨矿研究年会会议. 2002:1-3.Liu ZH, Yang DZ, Zhu HM, et al,Diagnostic criteria for Osteoporosis in Chinese (second draft)[C] National Conference on Bone Mineral Research. 2002:1-3. (in Chinese)
[28] 刘忠厚. 中国人原发性骨质疏松症诊断标准(试行)[J]. 中国骨质疏松杂志, 1999, 19(1):1-3.Liu ZH. Diagnostic criteria for Primary Osteoporosis in Chinese (trial)[J]. Chin J Osteoporosis,1999, 19(1):1-3. (in Chinese)
[29] 宋小梅. 仙灵骨葆胶囊治疗绝经期骨质疏松症临床研究[J]. 河南中医, 2017, 37(4):686-688.Song XM. The Clinical Research into menopausal osteoporosis Treated with Xianlinggubao Capsules[J]. Henan Traditional Chinese Medicine, 2017, 37(4):686-688. (in Chinese)
[30] 陈鑫, 朱雄白, 林文军, 等. 仙灵骨葆胶囊治疗绝经后骨质疏松的疗效及其机制研究[J]. 中国临床药理学杂志, 2015,31(10):827-829+854.Chen X, Zhu XB, Lin WJ, et al. Effect of Xianling Gubao capsule on Postmenopausal Osteoporosis and its Mechanism [J].The Chinese Journal of Clinical Pharmacology, 2015,31(10):827-829+854. (in Chinese)
[31] 钟银燕, 章源, 包斐丰. 中西药结合治疗绝经后骨质疏松症临床观察[J]. 新中医, 2015,47(1):145-147.Zhong YY, Zhang Y, Bao FF. Clinical observation on treatment of Postmenopausal Osteoporosis with combination of Chinese and Western Medicine[J]. Journal of New Chinese Medicine, 2015,47(1):145-147.
[32] 王锦兰. 仙灵骨堡胶囊联合牡蛎碳酸钙咀嚼片治疗女性更年期后骨质疏松症[J]. 医学信息, 2015,28(33):317-318.Wang JL. Treatment of Osteoporosis after menopause with Xianling Gubao capsule combined with Oyster calcium Carbonate chewable tablet[J].Medical Information, 2015,28(33):317-318. (in Chinese)
[33] 徐瑞丛. 仙灵骨葆治疗绝经后妇女骨质疏松症40例临床观察[J]. 浙江中医杂志, 2014,49(02):155.Xu RC. Clinical observation on 40 cases of Postmenopausal Osteoporosis treated with Xianling Gubao[J]. Zhejiang Journal of Traditional Chinese Medicine, 2014,49(02):155. (in Chinese)
[34] 庄凌峰. 仙灵骨葆联合福善美治疗绝经后骨质疏松症疗效观察[J]. 浙江中西医结合杂志, 2013,23(7):558-560.Zhuang LF. Observation on curative effect of Xianling Gubao combined with Fushan Mei in treating Postmenopausal Osteoporosis[J]. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2013,23(7):558-560. (in Chinese)
[35] 巴哈德尔, 陶剑, 崔永刚. 仙灵骨葆联合钙尔奇-D 治疗绝经后骨质疏松症的临床研究[J]. 世界最新医学信息文摘(电子版), 2012,12(9):46-47.BaHa DE, Tao J, Cui YG, Clinical study on treatment of Postmenopausal Osteoporosis with Xianling Gubao and Calcichi-d[J]. World Latest Medicine Information, 2012,12(9):46-47. (in Chinese)
[36] 吴中琴. 仙灵骨葆胶囊合用钙尔奇D治疗女性绝经后骨质疏松症的疗效观察[J]. 海峡药学, 2010,22(12):159-160.Wu ZQ. Therapeutic effect of Xianling Gubao capsule combined with Calcichid on female Postmenopausal Osteoporosis[J]. Strait Pharmaceutical Journal, 2010,22(12):159-160. (in Chinese)
[37] 董艳, 陆英, 华丽霞. 鲑降钙素联合仙灵骨葆治疗绝经后妇女骨质疏松症所致骨痛疗效观察[J]. 中国药房, 2010,21(2):154-156.Dong Y, Lu Y, Hua LX. Efficacy of Salmon Calcitonin plus Xianling Gubao for Osteoporosis and Ostealgia in Postmenopausal Women:A Clinical Observation[J]. China Pharmacy, 2010,21(2):154-156. (in Chinese)
[38] 聂达荣, 彭美玉, 林增如, 等. 仙灵骨葆胶囊合罗钙全治疗绝经后骨质疏松性疼痛35例临床观察[J]. 福建中医学院学报, 2009,19(3):37-38.Nie DR, Peng MY, Lin ZR, et al. Clinical Research on Xianling Gubao Capsule and Rocalirol Tablet in Treating 35 Cases of Postmenopausai Osteoporosis Related Pain[J]. Journal of Fujian college of traditional Chinese medicine, 2009,19(3):37-38. (in Chinese)
[39] 徐敏, 刘保新, 黄承军, 等. 仙灵骨葆合阿仑磷酸钠治疗绝经后骨质疏松症的临床观察[J]. 辽宁中医药大学学报, 2009,11(1):94-95.Xu M, Liu BX, Huang CJ, et al. Clinical observation on treatment of Postmenopausal Osteoporosis with Xianling Gubao and Alendronate[J]. Journal of Liaoning university of traditional Chinese Medicine, 2009,11(1):94-95 (in Chinese)
[40] 王旭凯,王英,杨有庚.仙灵骨葆胶囊治疗绝经后妇女骨质疏松症的临床疗效观察[J].中国妇幼保健,2009,24(12):1707-1708.Wang XK, Wang Y, Yang YG. Clinical observation of Xianling Gubao capsule in treating Postmenopausal Women with Osteoporosis[J]. Maternal and Child Health Care of China, 2009,24(12):1707-1708. (in Chinese)
[41] 尚玉敏, 刘艳艳, 李惠萍. 仙灵骨葆胶囊治疗绝经后骨质疏松症的临床观察[J]. 中国中西医结合急救杂志, 2007,14(1):55.Shang YM, Liu YY, Li HP. Clinical observation of Xianling Gubao capsule in treating Postmenopausal Osteoporosis[J]. Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care, 2007,14(1):55. (in Chinese)
[42] 吴文, 李东风, 智喜梅, 等. 仙灵骨葆对绝经后妇女骨质疏松的防治作用[J]. 广州中医药大学学报, 2005,22(3):191-193.Wu W, Li DF, Zhi XM, et al. Prevention and treatment of osteoporosis in postmenopausal women by Xianling Gubao[J]. Journal of Guangzhou University of Traditional Chinese Medicine, 2005,22(3):191-193. (in Chinese)
[43] 张秀珍, 韩峻峰, 钱国峰, 等. 仙灵骨葆对PMO骨密度及IL-6、TNF-α、IGF-Ⅰ的影响[J]. 中国骨质疏松杂志, 2004,10(1):90-93.Zhang XZ, Han JF, Qian GF,et al. Effect of Xianling Gubao on bone mineral density and cytokines in postmenopausal osteaporoflc Paflen. Chin J Osteoporosis,2004, 10(1):90-93. (in Chinese)
[44] 马克昌. 骨生理学[M]. 郑州:河南医科大学出版社, 2000:252-254.Ma KC.Bone physiology[M]. Zhengzhou:Henan Medical University Press, 2000:252-254. (in Chinese)
[45] 郑明节, 周耘, 吕小琴. 仙灵骨葆胶囊与双氯芬酸钠缓释胶囊合用致肝衰竭1例[J]. 中国药物警戒, 2014,11(8):507-508.Zheng MJ, Zhou y, Lv XQ. A case of liver failure caused by combination of Xianling Gubao capsule and diclofenac sodium sustained-release capsule[J]. Chinese Journal of Pharmacovigilance, 2014,11(8):507-508. (in Chinese)
[46] 赵晓卫,徐灿丽.仙灵骨葆胶囊与奥美拉唑联用致肝损害及乙型肝炎再活动[J].药物不良反应杂志,2012,14(1):60-61.Zhao XD, Xu CL. Hepatic injury and hepatitis B virus reactivation due to concomitant use of Xianlinggubao capsules and omeprazole[J] Adverse Drug Reactions Journal,2012,14(1):60-61. (in Chinese)
[47] 杨毅恒, 周艳莉. 仙灵骨葆胶囊致肝功能异常2例[J]. 药物不良反应杂志, 2007,9(3):214-215.Yang YH, Zhou YL. Liver dysfunction resulting from Xianlinggubao capsules in 2 cases[J]. Adverse Drug Reactions Journal,2007,9(3):214-215. (in Chinese)
[48] D M, KF S, D A, et al. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001.[J]. Explore, 2005(1):40-45.
[49] YM C, SC H, SS L, et al. Beneficial effect of soy isoflavones on bone mineral content was modified by years since menopause, body weight, and calcium intake: a double-blind, randomized, controlled trial.[J]. Menopause, 2004(3):246-254.
[50] KD S, E. L. Dietary phytoestrogens and their effect on bone: evidence from in vitro and in vivo, human observational, and dietary intervention studies[J]. The American Journal of Clinical Nutrition, 2003(No.3Suppl):593S-609S.
[51] Compston J. The use of combination therapy in the treatment of postmenopausal osteoporosis[J]. Endocrine, 2012,41(1):11-18.
[52] Rittmaster R S, Bolognese M, Ettinger M P, et al. Enhancement of bone mass in osteoporotic women with parathyroid hormone followed by alendronate[J]. J Clin Endocrinol Metab, 2000,85(6):2129-2134.
[2] Wright N C, Looker A C, Saag K G, et al. The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine[J]. J Bone Miner Res, 2014,29(11):2520-2526.
[3] Hernlund E, Svedbom A, Ivergard M, et al. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA)[J]. Arch Osteoporos, 2013,8:136.
[4] 中国健康促进基金会骨质疏松防治中国白皮书编委会. 骨质疏松症中国白皮书[J]. 中华健康管理学杂志, 2009,3(3):148-154.Editorial Board Of Osteoporosis Prevention And Treatment China White Paper, China Health Promotion Foundation. White paper on osteoporosis[J]. Chinese Journal of Health Management, 2009,3(3):148-154. (in Chinese)
[5] 中华医学会骨质疏松和骨矿盐疾病分会. 原发性骨质疏松症诊疗指南(2017)[J].中国全科医学,2017,20(32):3963-3982.Chinese Society of Osteoporosis and Bone Mineral Research. Guidelines for the diagnosis and treatment of primary osteoporosis (2017)[J]. Chin Gen Pract,2017,20(32): 3963 -3982. (in Chinese)
[6] Eastell R, O'Neill T W, Hofbauer L C, et al. Postmenopausal osteoporosis[J]. Nat Rev Dis Primers, 2016,2:16069.
[7] 李微,张博,张雨薇,等.雌激素调节骨代谢作用的研究进展[J].中国骨质疏松杂志,2017,23(02):262-266.Li W,Zhang B,Zhang YW, et al. Review on the research of estrogen in regulating bone metabolism[J]. Chin J Osteoporosis,2017,23(02):262-266. (in Chinese)
[8] Garnero P, Sornay-Rendu E, Chapuy M C, et al. Increased bone turnover in late postmenopausal women is a major determinant of osteoporosis[J]. J Bone Miner Res, 1996,11(3):337-349.
[9] Lindsay R. Estrogens in prevention and treatment of osteoporosis[J]. Schweiz Med Wochenschr, 1989,119(50):1806-1810.
[10] Camacho P M, Petak S M, Binkley N, et al. American association of clinical endocrinologists and american college of endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis[J]. Endocr Pract, 2016,22(Suppl 4):1-42.
[11] 谢雁鸣, 宇文亚, 董福慧, 等. 原发性骨质疏松症中医临床实践指南(摘录)[J]. 中华中医药杂志, 2012,27(07):1886-1890.Xie YM, Yu WY, Dong FH, et al. Clinical practice guideline of traditional Chinese medicine for primary osteoporosis(extract)[J]. Chin J Tradit Chin Med Pharm, 2012,27(07):1886-1890. (in Chinese)
[12] Ding Y, Zeng J C, Yin F, et al. Multicenter Study on Observation of Acute-phase Responses After Infusion of Zoledronic Acid 5 mg in Chinese Women with Postmenopausal Osteoporosis[J]. Orthop Surg, 2017,9(3):284-289.
[13] 邢燕, 毕宏焱, 张倩楠, 等. 骨质疏松常用中成药介绍[J]. 中国骨质疏松杂志, 2013,19(01):83-85+96.Xing Y, Bi HY, Zhang QN, et al.Introduction of common Chinese patent medicines for the treatment of osteoporosis[J]. Chin J Osteoporosis, 2013,19(01):83-85+96. (in Chinese)
[14] 倪力刚, 王伟, 李春雯, 等. 仙灵骨葆胶囊对骨质疏松性髋部骨折的研究近况[J]. 中国骨质疏松杂志, 2011,17(11):1014-1018.Ni LG,Wang W,Li CW,et al. Current research status of Xianlinggubao for the treatment of osteoporotic hip fracture[J]. Chin J Osteoporosis, 2011,17(11):1014-1018. (in Chinese)
[15] Wang X, He Y, Guo B, et al. In Vivo Screening for Anti-Osteoporotic Fraction from Extract of Herbal Formula Xianlinggubao in Ovariectomized Mice[J]. PLoS One, 2015,10(2):e0118184.
[16] Ge Zhang, Ling Qin PhD, Shi Y. Epimedium-derived phytoestrogen flavonoids exert beneficial effect on preventing bone loss in late postmenopausal women: a 24-month randomized, double-blind and placebo-controlled trial[J]. Journal of Bone and Mineral Research, 2007(No.7):1072-1079.
[17] Zhu H M, Qin L, Garnero P, et al. The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis[J]. Osteoporos Int, 2012,23(4):1317-1327.
[18] 王桂倩, 廖星, 章轶立, 等. 仙灵骨葆胶囊治疗原发性骨质疏松症随机对照试验的系统评价及Meta分析[J]. 中国中药杂志, 2017,42(15):2829-2844.Wang GQ, Liao X, Zhang YL, et al. Systemic evaluation and Meta-analysis of Xianling Gubao capsule in treatment of primary osteoporosis in randomized controlled trials[J].Chin J Chin Mater Med, 2017,42(15):2829-2844. (in Chinese)
[19] 章轶立, 廖星, 刘福梅, 等. 仙灵骨葆胶囊上市后用药安全性系统评价[J]. 中国中药杂志, 2017,42(15):2845-2856Zhang YL, Liao X, Liu FM, et al. Systematic review on safety of Xianling Gubao capsule[J].Chin J Chin Mater Med, 2017,42(15):2845-2856 (in Chinese)
[20] 杜倩, 王哲, 运乃茹, 等. 仙灵骨葆胶囊安全性系统评价[J]. 中国药业, 2017,26(19):37-43.Du Q, Wang Z, Yun NR, et al. Safety of Xianling Gubao Capsules: a System Evaluation[J]. China Pharmaceuticals, 2017(19):37-43. (in Chinese)
[21] 孙丽, 唐汉武. 仙灵骨葆胶囊辅助治疗骨质疏松性疼痛疗效与安全性的meta分析[J]. 中国药物警戒, 2016,13(07):422-425.Sun L, Tang HW, Meta-analysis of Efficacy and Safety of Xianlinggubao Capsule in Adjuvant Treatment of Osteoporosis Pain[J]. Chinese Journal of Pharmacovigilance, 2016,13(07):422-425. (in Chinese)
[22] 黄冬, 官堂明, 马晓鹂. 仙灵骨葆胶囊对骨质疏松性骨折预后的Meta分析[J]. 今日药学, 2015,25(10):694-696.Huang D, Guan TM, Ma XL. Efficacy of Xianlinggubao Capsule in Patients of Osteoporotic Fractures: A Meta-analysis[J].Pharmacy Today, 2015,25(10):694-696. (in Chinese)
[23] 闫乾, 陈锋, 孙海林, 等. 仙灵骨葆胶囊治疗膝骨性关节炎的有效性和安全性系统评价[J]. 中国药房, 2014,25(35):3333-3338.Yan Q, Chen F, Sun HL, et al.Therapeutic Efficacy and Safe of Xianling Gubao Capsule for Knee Osteoarthritis: A Systematic Review[J]. China Pharmacy, 2014,25(35):3333-3338.(in Chinese)
[24] 赵宜军, 胡晶, 陈静, 等. 仙灵骨葆胶囊治疗绝经后骨质疏松的系统评价[J]. 天津中医药, 2010,27(04):279-282.Zhao YJ, Hu J, Chen J, et al. Systemic evaluation of Xianling Gubao capsule in treatment of postmenopausal osteoporosis[J].Tianjin Journal of Traditional Chinese Medicine, 2010,27(04):279-282. (in Chinese)
[25] 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(09):1007-1010.Zhang ZH, Liu ZH, Li N, et al.Expert consensus on the diagnosis of osteoporosis in Chinese Population[J].Chin J Osteoporosis, 2014,20(09):1007-1010. (in Chinese)
[26] 原发性骨质疏松症诊治指南(2011年)[J]. 中华骨质疏松和骨矿盐疾病杂志, 2011,4(01):2-17.Guidelines for the diagnosis and treatment of primary osteoporosis (2011)[J].Chinese Journal of Osteoporosis and Bone Mineral Research, 2011,4(01):2-17. (in Chinese)
[27] 刘忠厚, 杨定焯, 朱汉民. 中国人骨质疏松症建议诊断标准(第二稿)[C] 全国骨矿研究年会会议. 2002:1-3.Liu ZH, Yang DZ, Zhu HM, et al,Diagnostic criteria for Osteoporosis in Chinese (second draft)[C] National Conference on Bone Mineral Research. 2002:1-3. (in Chinese)
[28] 刘忠厚. 中国人原发性骨质疏松症诊断标准(试行)[J]. 中国骨质疏松杂志, 1999, 19(1):1-3.Liu ZH. Diagnostic criteria for Primary Osteoporosis in Chinese (trial)[J]. Chin J Osteoporosis,1999, 19(1):1-3. (in Chinese)
[29] 宋小梅. 仙灵骨葆胶囊治疗绝经期骨质疏松症临床研究[J]. 河南中医, 2017, 37(4):686-688.Song XM. The Clinical Research into menopausal osteoporosis Treated with Xianlinggubao Capsules[J]. Henan Traditional Chinese Medicine, 2017, 37(4):686-688. (in Chinese)
[30] 陈鑫, 朱雄白, 林文军, 等. 仙灵骨葆胶囊治疗绝经后骨质疏松的疗效及其机制研究[J]. 中国临床药理学杂志, 2015,31(10):827-829+854.Chen X, Zhu XB, Lin WJ, et al. Effect of Xianling Gubao capsule on Postmenopausal Osteoporosis and its Mechanism [J].The Chinese Journal of Clinical Pharmacology, 2015,31(10):827-829+854. (in Chinese)
[31] 钟银燕, 章源, 包斐丰. 中西药结合治疗绝经后骨质疏松症临床观察[J]. 新中医, 2015,47(1):145-147.Zhong YY, Zhang Y, Bao FF. Clinical observation on treatment of Postmenopausal Osteoporosis with combination of Chinese and Western Medicine[J]. Journal of New Chinese Medicine, 2015,47(1):145-147.
[32] 王锦兰. 仙灵骨堡胶囊联合牡蛎碳酸钙咀嚼片治疗女性更年期后骨质疏松症[J]. 医学信息, 2015,28(33):317-318.Wang JL. Treatment of Osteoporosis after menopause with Xianling Gubao capsule combined with Oyster calcium Carbonate chewable tablet[J].Medical Information, 2015,28(33):317-318. (in Chinese)
[33] 徐瑞丛. 仙灵骨葆治疗绝经后妇女骨质疏松症40例临床观察[J]. 浙江中医杂志, 2014,49(02):155.Xu RC. Clinical observation on 40 cases of Postmenopausal Osteoporosis treated with Xianling Gubao[J]. Zhejiang Journal of Traditional Chinese Medicine, 2014,49(02):155. (in Chinese)
[34] 庄凌峰. 仙灵骨葆联合福善美治疗绝经后骨质疏松症疗效观察[J]. 浙江中西医结合杂志, 2013,23(7):558-560.Zhuang LF. Observation on curative effect of Xianling Gubao combined with Fushan Mei in treating Postmenopausal Osteoporosis[J]. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2013,23(7):558-560. (in Chinese)
[35] 巴哈德尔, 陶剑, 崔永刚. 仙灵骨葆联合钙尔奇-D 治疗绝经后骨质疏松症的临床研究[J]. 世界最新医学信息文摘(电子版), 2012,12(9):46-47.BaHa DE, Tao J, Cui YG, Clinical study on treatment of Postmenopausal Osteoporosis with Xianling Gubao and Calcichi-d[J]. World Latest Medicine Information, 2012,12(9):46-47. (in Chinese)
[36] 吴中琴. 仙灵骨葆胶囊合用钙尔奇D治疗女性绝经后骨质疏松症的疗效观察[J]. 海峡药学, 2010,22(12):159-160.Wu ZQ. Therapeutic effect of Xianling Gubao capsule combined with Calcichid on female Postmenopausal Osteoporosis[J]. Strait Pharmaceutical Journal, 2010,22(12):159-160. (in Chinese)
[37] 董艳, 陆英, 华丽霞. 鲑降钙素联合仙灵骨葆治疗绝经后妇女骨质疏松症所致骨痛疗效观察[J]. 中国药房, 2010,21(2):154-156.Dong Y, Lu Y, Hua LX. Efficacy of Salmon Calcitonin plus Xianling Gubao for Osteoporosis and Ostealgia in Postmenopausal Women:A Clinical Observation[J]. China Pharmacy, 2010,21(2):154-156. (in Chinese)
[38] 聂达荣, 彭美玉, 林增如, 等. 仙灵骨葆胶囊合罗钙全治疗绝经后骨质疏松性疼痛35例临床观察[J]. 福建中医学院学报, 2009,19(3):37-38.Nie DR, Peng MY, Lin ZR, et al. Clinical Research on Xianling Gubao Capsule and Rocalirol Tablet in Treating 35 Cases of Postmenopausai Osteoporosis Related Pain[J]. Journal of Fujian college of traditional Chinese medicine, 2009,19(3):37-38. (in Chinese)
[39] 徐敏, 刘保新, 黄承军, 等. 仙灵骨葆合阿仑磷酸钠治疗绝经后骨质疏松症的临床观察[J]. 辽宁中医药大学学报, 2009,11(1):94-95.Xu M, Liu BX, Huang CJ, et al. Clinical observation on treatment of Postmenopausal Osteoporosis with Xianling Gubao and Alendronate[J]. Journal of Liaoning university of traditional Chinese Medicine, 2009,11(1):94-95 (in Chinese)
[40] 王旭凯,王英,杨有庚.仙灵骨葆胶囊治疗绝经后妇女骨质疏松症的临床疗效观察[J].中国妇幼保健,2009,24(12):1707-1708.Wang XK, Wang Y, Yang YG. Clinical observation of Xianling Gubao capsule in treating Postmenopausal Women with Osteoporosis[J]. Maternal and Child Health Care of China, 2009,24(12):1707-1708. (in Chinese)
[41] 尚玉敏, 刘艳艳, 李惠萍. 仙灵骨葆胶囊治疗绝经后骨质疏松症的临床观察[J]. 中国中西医结合急救杂志, 2007,14(1):55.Shang YM, Liu YY, Li HP. Clinical observation of Xianling Gubao capsule in treating Postmenopausal Osteoporosis[J]. Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care, 2007,14(1):55. (in Chinese)
[42] 吴文, 李东风, 智喜梅, 等. 仙灵骨葆对绝经后妇女骨质疏松的防治作用[J]. 广州中医药大学学报, 2005,22(3):191-193.Wu W, Li DF, Zhi XM, et al. Prevention and treatment of osteoporosis in postmenopausal women by Xianling Gubao[J]. Journal of Guangzhou University of Traditional Chinese Medicine, 2005,22(3):191-193. (in Chinese)
[43] 张秀珍, 韩峻峰, 钱国峰, 等. 仙灵骨葆对PMO骨密度及IL-6、TNF-α、IGF-Ⅰ的影响[J]. 中国骨质疏松杂志, 2004,10(1):90-93.Zhang XZ, Han JF, Qian GF,et al. Effect of Xianling Gubao on bone mineral density and cytokines in postmenopausal osteaporoflc Paflen. Chin J Osteoporosis,2004, 10(1):90-93. (in Chinese)
[44] 马克昌. 骨生理学[M]. 郑州:河南医科大学出版社, 2000:252-254.Ma KC.Bone physiology[M]. Zhengzhou:Henan Medical University Press, 2000:252-254. (in Chinese)
[45] 郑明节, 周耘, 吕小琴. 仙灵骨葆胶囊与双氯芬酸钠缓释胶囊合用致肝衰竭1例[J]. 中国药物警戒, 2014,11(8):507-508.Zheng MJ, Zhou y, Lv XQ. A case of liver failure caused by combination of Xianling Gubao capsule and diclofenac sodium sustained-release capsule[J]. Chinese Journal of Pharmacovigilance, 2014,11(8):507-508. (in Chinese)
[46] 赵晓卫,徐灿丽.仙灵骨葆胶囊与奥美拉唑联用致肝损害及乙型肝炎再活动[J].药物不良反应杂志,2012,14(1):60-61.Zhao XD, Xu CL. Hepatic injury and hepatitis B virus reactivation due to concomitant use of Xianlinggubao capsules and omeprazole[J] Adverse Drug Reactions Journal,2012,14(1):60-61. (in Chinese)
[47] 杨毅恒, 周艳莉. 仙灵骨葆胶囊致肝功能异常2例[J]. 药物不良反应杂志, 2007,9(3):214-215.Yang YH, Zhou YL. Liver dysfunction resulting from Xianlinggubao capsules in 2 cases[J]. Adverse Drug Reactions Journal,2007,9(3):214-215. (in Chinese)
[48] D M, KF S, D A, et al. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001.[J]. Explore, 2005(1):40-45.
[49] YM C, SC H, SS L, et al. Beneficial effect of soy isoflavones on bone mineral content was modified by years since menopause, body weight, and calcium intake: a double-blind, randomized, controlled trial.[J]. Menopause, 2004(3):246-254.
[50] KD S, E. L. Dietary phytoestrogens and their effect on bone: evidence from in vitro and in vivo, human observational, and dietary intervention studies[J]. The American Journal of Clinical Nutrition, 2003(No.3Suppl):593S-609S.
[51] Compston J. The use of combination therapy in the treatment of postmenopausal osteoporosis[J]. Endocrine, 2012,41(1):11-18.
[52] Rittmaster R S, Bolognese M, Ettinger M P, et al. Enhancement of bone mass in osteoporotic women with parathyroid hormone followed by alendronate[J]. J Clin Endocrinol Metab, 2000,85(6):2129-2134.