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| 青娥丸治疗绝经后骨质疏松症的系统评价及Meta分析 |
| The Meta-analysis and systematic evaluation of Qing’e Pill in the treatment of postmenopausal osteoporosis |
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| DOI：10.3969/j.issn.1006-7108.2021.02.005 |
| 中文关键词: 青娥丸 绝经后骨质疏松症 随机对照试验 系统评价 Meta分析 |
| 英文关键词:Qing’e Pill postmenopausal osteoporosis clinical trials system evaluation |
| 基金项目:中华中医药学会青年人才托举工程项目（CACM-2017-QNRC2-A03）；中国中医科学院循证能力提升建设项目（ZZ13-024-7）；中国中医科学院“十三五”重点领域科研项目（ZZ10-015） |
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| 中文摘要: |
| 目的 系统评价青娥丸（包括古方青娥丸、加味青娥丸）治疗绝经后骨质疏松症（postmenopausal osteoporosis,PMOP）的有效性及安全性。方法 计算机检索PubMed、the Cochrane Library、Embase、中国知网、中国生物医学数据库、万方、维普等中英文数据库。收集随机对照试验，依据Cochrane风险评估工具评估文献质量，改良Jadad量表量化评分。使用StataSE 15、RevMan 5.3软件进行Meta分析。结果 共纳入15项研究，总计915位患者。Meta分析显示，较之常规治疗，青娥丸+常规治疗在临床疗效方面[RR=1.90,95% CI (1.20,3.01),P=0.006] 可能具有优势，可以缓解患者的骨质疏松性疼痛[WMD= –1.05,95% CI (–1.32,–0.78),P<0.000 1]，明显改善患者股骨Word三角骨密度[WMD=0.08,95% CI (0.05,0.11),P<0.000 1]、股骨颈骨密度[WMD=0.06,95% CI (0.00,0.11), P=0.038]和肾虚血瘀证患者股骨大粗隆骨密度[WMD=0.07,95% CI (0.04,0.11),P<0.000 1]，但对不区分证候的患者股骨大粗隆骨密度无明显影响。相对常规治疗，青娥丸+常规治疗对Ⅰ型原胶原氨基端延长肽（PINP）、25-羟维生素D、雌二醇的影响无明显差异，可能下调PMOP患者β-CTX水平 [WMD= –0.03,95% CI (–0.05,–0.01),P=0.004]。Egger法检验显示本文无发表偏倚。结论 青娥丸治疗PMOP患者能够提高临床治疗效果，在改善患者疼痛、骨密度方面具有一定优势，可能改善β-CTX水平，但尚未有证据表明其能有效改善PINP、25-羟维生素D、雌二醇等指标水平。青娥丸不良事件较少报道，该治疗方法相对安全。 |
| 英文摘要: |
| Objective To evaluate the efficacy and safety of Qing’e Pill (including Gufang Qing’e Pill and Jiawei Qing’e Pill) in the treatment of postmenopausal osteoporosis (PMOP). Methods PubMed, the Cochrane Library, Embase, CNKI, Chinese Biomedical Database, Wanfang, VIP and other Chinese and English databases were searched by computer. Randomized controlled trials were collected, literature quality was evaluated according to the Cochrane risk assessment tool, and quantitative scores of the modified Jadad scale were improved. Meta analysis was performed with the software StataSE 15 and RevMan 5.3. Results a total of 15 studies with 915 patients were included. The meta analysis shows that: Compared with the conventional treatment, Qing’e Pill + conventional treatment may have an advantage in clinical efficacy [RR=1.90,95% CI (1.20,3.01),P=0.006], which can relieve patients' osteoporosis pain[WMD= –1.05,95% CI (–1.32,–0.78),P<0.000 1].The femoral word bone mineral density[WMD=0.08,95% CI (0.05,0.11),P<0.000 1], femoral neck bone mineral density [WMD=0.06,95% CI (0.00,0.11),P=0.038]and femoral greater trochanteric bone mineral density [WMD= –0.03,95% CI (–0.05,–0.01),P=0.004]and kidney deficiency and blood stasis syndrome patients were significantly improved, but there was no significant effect on the femoral greater trochanteric bone mineral density in patients without syndrome differentiation. Relative to conventional treatment, Qing’e Pill + conventional treatment of tropocollagen Ⅰ type amino terminal extension of the peptide (PINP), 25 - hydroxyl vitamin D, the influence of estradiol has no obvious difference, the possible downgrade PMOP beta CTX levels in patients with [WMD = 0.03, 95% CI (0.05, 0.01), P = 0.004).The Egger's test showed that there was no publication bias. Conclusion Qing’e Pill can improve the clinical therapeutic effect of PMOP patients, and has certain advantages in improving the pain and bone density of patients, which may improve the level of PINP, 25-hydroxyvitamin D, estradiol and other indicators.The adverse events of qinge pill are rarely reported, and the treatment is relatively safe. |
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