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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.
绝经后骨质疏松症补肾活血类中药复方制剂疗效安全性Meta分析序贯分析
Postmenopausal osteoporosisTCM compound preparation for tonifying kidney and activating blood circulationTherapeutic efficacySafetyMeta-analysisTrial sequential analysis
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