补肾活血类中药复方制剂治疗绝经后骨质疏松症有效性和安全性的Meta分析
|
摘要
目的:系统评价补肾活血类中药复方制剂治疗绝经后骨质疏松症的有效性与安全性,为临床合理用药提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国生物医学文献数据库、中国知网、维普数据库和万方数据库,收集补肾活血类中药复方制剂(试验组)对比钙剂或非钙剂(对照组)治疗绝经后骨质疏松症的随机对照试验(RCT)。筛选文献、提取资料并采用Cochrane系统评价员手册5.1.0提供的偏倚风险评价工具和Jadad量表评价文献质量后,采用Stata 12.0软件进行Meta分析,采用TSA 0.9软件进行试验序贯分析。结果:共纳入18项RCT,共计1 408例患者。Meta分析结果显示,试验组患者总有效率[RR=1.35,95%CI(1.17,1.54),P<0.000 1]、骨密度[SMD=0.24,95%CI(0.16,0.32),P<0.000 1]均显著高于对照组,血钙水平[SMD=-0.05,95%CI(-0.09,0.00),P=0.033]显著低于对照组。两组患者尿肌酐[SMD=-1.60,95%CI(-5.94,2.74),P=0.470]、尿钙/尿肌酐比值[SMD=-0.05,95%CI(-0.14,0.04),P=0.295]、尿羟脯氨酸/尿肌酐比值[SMD=-0.16,95%CI(-1.04,0.72),P=0.726]、丙氨酸转氨酶[SMD=0.51,95%CI(-3.26,4.28),P=0.790]、天冬氨酸转氨酶[SMD=0.23,95%CI(-5.22,4.77),P=0.929]、碱性磷酸酶[SMD=-0.22,95%CI(-0.68,0.25),P=0.361]、血磷[SMD=-0.02,95%CI(-0.11,0.07),P=0.639]、尿素氮[SMD=-0.19,95%CI(-0.70,0.31),P=0.453]、雌二醇[SMD=0.62,95%CI(-0.28,1.52),P=0.177]、白细胞介素6[SMD=-1.78,95%CI(-4.86,1.30),P=0.258]、视觉模拟评分[SMD=0.55,95%CI(-1.03,2.13),P=0.496]比较,差异均无统计学意义。两组患者均未见严重不良反应发生。序贯分析结果显示,补肾活血类中药复方制剂治疗绝经后骨质疏松症总有效率证据确切。结论:补肾活血类中药复方制剂治疗绝经后骨质疏松症的疗效显著,可改善患者血钙和骨密度,且安全性较好。
OBJECTIVE:To systematically evaluate the efficacy and safety of TCM compound preparation for tonifying kidney and activating blood circulation,and to provide evidence-based reference for rational drug use in the clinic. METHODS:By retrieving Cochrane library,PubMed,Embase,CBM,CNKI,VIP and Wanfang database,randomized controlled trials(RCTs)about TCM compound preparation for tonifying kidney and activating blood circulation(trial group)versus calcium or non-calcium agents(control group) in the treatment of postmenopausal osteoporosis were included. After literature screening,data extraction and quality evaluation with bias risk evaluation tool and Jadad scale of Cochrane system evaluator manual 5.1.0,Meta-analysis was conducted by using Stata 12.0 software,and trial sequential analysis(TSA)was conducted by using TSA 0.9 software. RESULTS:Totally 18 RCTs were included,involving 1 408 patients. The results of Meta-analysis showed that total response rate [RR=1.35,95%CI(1.17,1.54),P<0.000 1] and bone density[SMD=0.24,95%CI(0.16,0.32),P<0.000 1] of trial group were significantly higher than those of control group;blood calcium [SMD=-0.05,95%CI(-0.09,0.00),P=0.033] of trial group was significantly lower than that of control group. There was no statistical significance in the levels of urine creatinine [SMD=-1.60,95%CI(-5.94,2.74),P=0.470],urinary calcium/urine creatinine ratio [SMD=-0.05,95%CI(-0.14,0.04),P=0.295],urinary hydroxyproline/urine creatinine ratio [SMD=-0.16,95%CI(-1.04,0.72),P=0.726],ALT [SMD=0.51,95%CI(-3.26,4.28),P=0.790],AST[SMD=0.23,95% CI(-5.22,4.77),P=0.929],serum alkaline phosphatase [SMD=-0.22,95% CI(-0.68,0.25),P=0.361],serum phosphate [SMD=-0.02,95% CI(-0.11,0.07),P=0.639],urea nitrogen [SMD=-0.19,95% CI(-0.70,0.31),P=0.453],estradiol [SMD=0.62,95%CI(-0.28,1.52),P=0.177],IL-6 [SMD=-1.78,95%CI(-4.86,1.30),P=0.258] or VAS[SMD=0.55,95%CI(-1.03,2.13),P=0.496] between 2 groups. No server ADR was found in 2 groups. TSA showed that there were extract evidences for total response rate of TCM compound preparation in the treatment postmenopausal osteoporosis.CONCLUSIONS:TCM compound preparation for tonifying kidney and activating blood circulation shows significant therapeutic efficacy for postmenopausal osteoporosis,and can improve serum calcium and bone density with good safety.
OBJECTIVE:To systematically evaluate the efficacy and safety of TCM compound preparation for tonifying kidney and activating blood circulation,and to provide evidence-based reference for rational drug use in the clinic. METHODS:By retrieving Cochrane library,PubMed,Embase,CBM,CNKI,VIP and Wanfang database,randomized controlled trials(RCTs)about TCM compound preparation for tonifying kidney and activating blood circulation(trial group)versus calcium or non-calcium agents(control group) in the treatment of postmenopausal osteoporosis were included. After literature screening,data extraction and quality evaluation with bias risk evaluation tool and Jadad scale of Cochrane system evaluator manual 5.1.0,Meta-analysis was conducted by using Stata 12.0 software,and trial sequential analysis(TSA)was conducted by using TSA 0.9 software. RESULTS:Totally 18 RCTs were included,involving 1 408 patients. The results of Meta-analysis showed that total response rate [RR=1.35,95%CI(1.17,1.54),P<0.000 1] and bone density[SMD=0.24,95%CI(0.16,0.32),P<0.000 1] of trial group were significantly higher than those of control group;blood calcium [SMD=-0.05,95%CI(-0.09,0.00),P=0.033] of trial group was significantly lower than that of control group. There was no statistical significance in the levels of urine creatinine [SMD=-1.60,95%CI(-5.94,2.74),P=0.470],urinary calcium/urine creatinine ratio [SMD=-0.05,95%CI(-0.14,0.04),P=0.295],urinary hydroxyproline/urine creatinine ratio [SMD=-0.16,95%CI(-1.04,0.72),P=0.726],ALT [SMD=0.51,95%CI(-3.26,4.28),P=0.790],AST[SMD=0.23,95% CI(-5.22,4.77),P=0.929],serum alkaline phosphatase [SMD=-0.22,95% CI(-0.68,0.25),P=0.361],serum phosphate [SMD=-0.02,95% CI(-0.11,0.07),P=0.639],urea nitrogen [SMD=-0.19,95% CI(-0.70,0.31),P=0.453],estradiol [SMD=0.62,95%CI(-0.28,1.52),P=0.177],IL-6 [SMD=-1.78,95%CI(-4.86,1.30),P=0.258] or VAS[SMD=0.55,95%CI(-1.03,2.13),P=0.496] between 2 groups. No server ADR was found in 2 groups. TSA showed that there were extract evidences for total response rate of TCM compound preparation in the treatment postmenopausal osteoporosis.CONCLUSIONS:TCM compound preparation for tonifying kidney and activating blood circulation shows significant therapeutic efficacy for postmenopausal osteoporosis,and can improve serum calcium and bone density with good safety.
引文
[1]CHEN B,LO GF,SHEN Y,et al.Reducing iro accumulation:a potential approach for the prevention and treatment of postmenopausal osteoporosis[J].Exp Ther Med,2015,10(1):7-11.
[2]张亚军,刘忠厚,张鹏.绝经后骨质疏松症流行病学研究进展[J].中国骨质疏松杂志,2010,16(3):229-233.
[3]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治指南:2011年[J].中华骨质疏松和骨矿盐疾病杂志,2011,4(1):2-15.
[4]黄琪仁.钙、维生素D与原发性骨质疏松症[J].中国实用妇科与产科杂志,2014,30(5):336-340.
[5]崔莹,冯正平.抗骨质疏松药物的研究进展[J].中国骨质疏松杂志,2015,21(3):367-371.
[6]万雯馨.绝经后骨质疏松症中医证型分布特点及其发病因素探讨[D].北京:北京中医药大学,2013.
[7]董万涛,泽斌,宋敏,等.“骨肉不相亲”理论发微:从脾肾论治原发性骨质疏松症的科学涵义[J].中国骨质疏松杂志,2014,20(6):714-717.
[8]梁文娜,李亚婵,李西海,等.绝经后骨质疏松症肾阳虚证素变化与熵变的内在关系[J].中华中医药杂志,2014,29(6):1791-1793.
[9]曾昭洋,胡文斌,魏学玲,等.中老年人群原发性骨质疏松中医体质及辨证分型分布[J].中国老年学杂志,2018,38(2):435-438.
[10]GAO Z,LU Y,HALMURAT UPUR,et al.Study of osteoporosis treatment principles used historically by ancient physicians in Chinese medicine[J].Chin J Integr Med,2013,19(11):862-868.
[11]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.
[12]卫生部.中药新药临床研究指导原则[S].1997.
[13]Higgins JPT,Green S.Cochrane handbook for systematic reviews of interventions version 5.1.0[EB/OL].(2011-03-12)[2018-08-18].http://www.cochranehand-book.org.
[14]JADAD AR,MOORE RA,CARROLL D,et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary[J].Control Clin Trials,1996,17(1):1-12.
[15]翁鸿,李胜,曾宪涛,等.试验序贯分析软件在Meta分析中的应用[J].中国循证医学杂志,2016,16(5):604-611.
[16]向科明,赖洪华,庄琼,等.补肾活血法治疗绝经后妇女骨质疏松症98例临床观察[J].临床和实验医学杂志,2011,10(13):1044-1045.
[17]石昊.补肾活血法治疗绝经后骨质疏松症的临床研究[D].恩施:湖北民族学院,2014.
[18]宋献文,沈培芝,陈百先.补肾活血方药治疗绝经后骨质疏松症[J].中国骨伤,2001,14(8):476.
[19]刘莹,刘艳,周晶.补肾活血方治疗绝经后骨质疏松疗效观察[J].陕西中医,2017,38(5):612-613.
[20]王彬,刘会玲,罗艳华.补肾活血复方治疗绝经后骨质疏松症疗效观察[J].中国地方病防治杂志,2009,24(3):232-233.
[21]曾武雄,盛璞义,舒友元,等.补肾活血复方中药与激素替代治疗绝经后骨质疏松患者血清细胞因子水平的变化[J].中国组织工程研究与临床康复,2007,11(27):5421-5423.
[22]李煜明.补肾活血剂治疗绝经后骨质疏松症60例[J].南京中医药大学学报,2005,21(1):56-57.
[23]李建鹏.补肾活血颗粒治疗绝经后骨质疏松症随机、双盲、安慰剂对照临床研究[D].北京:中国中医科学院中医临床基础医学研究所,2012.
[24]黄永明,许少健,石宇雄,等.骨松安胶囊治疗绝经后骨质疏松症34例[J].陕西中医,2006,27(8):954-955.
[25]许峰,章光华,李欢华.蠲偻丸治疗绝经后骨质疏松症37例[J].中医杂志,2010,51(3):243-244.
[26]黄剑美.补肾健脾活血法治疗绝经后骨质疏松症疗效观察[J].中国老年保健医学杂志,2008,6(4):21-22.
[27]何铭涛,梁细妹,梁祖建,等.补肾健脾活血方治疗绝经后骨质疏松症临床研究[J].山东中医杂志,2007,26(7):447-449.
[28]刘维嘉,麦敏军,刘永坤,等.补肾健脾活血汤治疗绝经后骨质疏松症33例[J].安徽中医学院学报,2009,28(4):33-34.
[29]刘维嘉,麦敏军,刘永坤,等.补肾健脾活血汤治疗绝经后骨质疏松症疗效观察[J].浙江中西医结合杂志,2009,19(9):558-559.
[30]王丽丽.补肾生骨颗粒对肾虚血瘀型绝经后骨质疏松症BMD、血清E2、BALP、N-MID的影响[D].济南:山东中医药大学,2015.
[31]邹来勇,汤群珍,朱玉辉.健脾活血补肾方治疗绝经后骨质疏松症38例[J].中国中医药现代远程教育,2016,14(16):93-94.
[32]李仲平,靳国印,贺金,等.抗骨松胶囊治疗绝经后骨质疏松症30例[J].陕西中医,2008,29(4):444-445.
[33]杨林芝.益肾强督活血法治疗绝经后骨质疏松症38例临床疗效观察[J].中国现代药物应用,2011,5(14):78-79.
[34]王冰.重广补注黄帝内经素问[M].北京:学苑出版社,2004:7-8.
[35]陈易,王明三,徐琬梨.绝经后骨质疏松症证型探讨[J].辽宁中医杂志,2017,44(2):273-275.
[2]张亚军,刘忠厚,张鹏.绝经后骨质疏松症流行病学研究进展[J].中国骨质疏松杂志,2010,16(3):229-233.
[3]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治指南:2011年[J].中华骨质疏松和骨矿盐疾病杂志,2011,4(1):2-15.
[4]黄琪仁.钙、维生素D与原发性骨质疏松症[J].中国实用妇科与产科杂志,2014,30(5):336-340.
[5]崔莹,冯正平.抗骨质疏松药物的研究进展[J].中国骨质疏松杂志,2015,21(3):367-371.
[6]万雯馨.绝经后骨质疏松症中医证型分布特点及其发病因素探讨[D].北京:北京中医药大学,2013.
[7]董万涛,泽斌,宋敏,等.“骨肉不相亲”理论发微:从脾肾论治原发性骨质疏松症的科学涵义[J].中国骨质疏松杂志,2014,20(6):714-717.
[8]梁文娜,李亚婵,李西海,等.绝经后骨质疏松症肾阳虚证素变化与熵变的内在关系[J].中华中医药杂志,2014,29(6):1791-1793.
[9]曾昭洋,胡文斌,魏学玲,等.中老年人群原发性骨质疏松中医体质及辨证分型分布[J].中国老年学杂志,2018,38(2):435-438.
[10]GAO Z,LU Y,HALMURAT UPUR,et al.Study of osteoporosis treatment principles used historically by ancient physicians in Chinese medicine[J].Chin J Integr Med,2013,19(11):862-868.
[11]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.
[12]卫生部.中药新药临床研究指导原则[S].1997.
[13]Higgins JPT,Green S.Cochrane handbook for systematic reviews of interventions version 5.1.0[EB/OL].(2011-03-12)[2018-08-18].http://www.cochranehand-book.org.
[14]JADAD AR,MOORE RA,CARROLL D,et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary[J].Control Clin Trials,1996,17(1):1-12.
[15]翁鸿,李胜,曾宪涛,等.试验序贯分析软件在Meta分析中的应用[J].中国循证医学杂志,2016,16(5):604-611.
[16]向科明,赖洪华,庄琼,等.补肾活血法治疗绝经后妇女骨质疏松症98例临床观察[J].临床和实验医学杂志,2011,10(13):1044-1045.
[17]石昊.补肾活血法治疗绝经后骨质疏松症的临床研究[D].恩施:湖北民族学院,2014.
[18]宋献文,沈培芝,陈百先.补肾活血方药治疗绝经后骨质疏松症[J].中国骨伤,2001,14(8):476.
[19]刘莹,刘艳,周晶.补肾活血方治疗绝经后骨质疏松疗效观察[J].陕西中医,2017,38(5):612-613.
[20]王彬,刘会玲,罗艳华.补肾活血复方治疗绝经后骨质疏松症疗效观察[J].中国地方病防治杂志,2009,24(3):232-233.
[21]曾武雄,盛璞义,舒友元,等.补肾活血复方中药与激素替代治疗绝经后骨质疏松患者血清细胞因子水平的变化[J].中国组织工程研究与临床康复,2007,11(27):5421-5423.
[22]李煜明.补肾活血剂治疗绝经后骨质疏松症60例[J].南京中医药大学学报,2005,21(1):56-57.
[23]李建鹏.补肾活血颗粒治疗绝经后骨质疏松症随机、双盲、安慰剂对照临床研究[D].北京:中国中医科学院中医临床基础医学研究所,2012.
[24]黄永明,许少健,石宇雄,等.骨松安胶囊治疗绝经后骨质疏松症34例[J].陕西中医,2006,27(8):954-955.
[25]许峰,章光华,李欢华.蠲偻丸治疗绝经后骨质疏松症37例[J].中医杂志,2010,51(3):243-244.
[26]黄剑美.补肾健脾活血法治疗绝经后骨质疏松症疗效观察[J].中国老年保健医学杂志,2008,6(4):21-22.
[27]何铭涛,梁细妹,梁祖建,等.补肾健脾活血方治疗绝经后骨质疏松症临床研究[J].山东中医杂志,2007,26(7):447-449.
[28]刘维嘉,麦敏军,刘永坤,等.补肾健脾活血汤治疗绝经后骨质疏松症33例[J].安徽中医学院学报,2009,28(4):33-34.
[29]刘维嘉,麦敏军,刘永坤,等.补肾健脾活血汤治疗绝经后骨质疏松症疗效观察[J].浙江中西医结合杂志,2009,19(9):558-559.
[30]王丽丽.补肾生骨颗粒对肾虚血瘀型绝经后骨质疏松症BMD、血清E2、BALP、N-MID的影响[D].济南:山东中医药大学,2015.
[31]邹来勇,汤群珍,朱玉辉.健脾活血补肾方治疗绝经后骨质疏松症38例[J].中国中医药现代远程教育,2016,14(16):93-94.
[32]李仲平,靳国印,贺金,等.抗骨松胶囊治疗绝经后骨质疏松症30例[J].陕西中医,2008,29(4):444-445.
[33]杨林芝.益肾强督活血法治疗绝经后骨质疏松症38例临床疗效观察[J].中国现代药物应用,2011,5(14):78-79.
[34]王冰.重广补注黄帝内经素问[M].北京:学苑出版社,2004:7-8.
[35]陈易,王明三,徐琬梨.绝经后骨质疏松症证型探讨[J].辽宁中医杂志,2017,44(2):273-275.
© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号 地址：北京市海淀区学院路29号 邮编：100083 电话：办公室：(+86 10)66554848；文献借阅、咨询服务、科技查新：66554700 |