传统中药与激素治疗绝经后骨质疏松症的有效性和安全性比较

Comparative Efficacy and Safety of Traditional Chinese Medicine and Menopausal Hormone Therapy for Postmenopausal Osteoporosis

目的 比较传统中药(TCM)与绝经激素治疗(MHT)对绝经后骨质疏松症(PMOP)的治疗效果,评价在PMOP治疗中的有效性和安全性。方法 系统检索中国知网(CNKI)、万方、维普、中国生物医学(CBM)和PubMed(建库至2021年12月)5个中英文数据库中TCM与MHT治疗PMOP的随机对照试验(RCT)文献,依据改良JADAD评分对纳入文献进行质量评价;采用RevMan5.4.1和Stata12.0对纳入文献进行统计学分析。结果 共纳入17篇文献、1016例患者(TCM:579例,MHT:437例)。其中,临床有效率[RR=0.08,95%CI(0.01-0.15), Z=2.10, P=0.04]和肾虚症状积分[MD=1.40, 95%CI(0.14-2.66), Z=2.17, P=0.03],TCM组优于MHT组;不良反应发生率TCM组低于MHT组[RR=0.24, 95%CI(0.14-0.41), Z=5.15, P<0.05]。骨密度(BMD)[MD=-0.00, 95%CI(-0.01-0.01), Z=0.29, P=0.77]、雌二醇(E2)[MD=-5.10, 95%CI(-10.30-0.11), Z=1.92, P=0.06]、促卵泡生成激素(FSH)[MD=-18.33, 95%CI(-47.69-11.03), Z=1.22, P=0.22]和促黄体生成激素(LH)[MD=-9.96, 95%CI(-25.64-5.72), Z=1.24, P=0.21]4个指标两组间无显著差异;Begg’s(z=0.81,P=0.417)和Egger’s(t=0.32,P=0.750)检验结果显示无发表偏倚;敏感性分析表明研究结果稳定、可靠。结论 TCM提高PMOP引起的骨密度和雌激素减少与MHT一致,而临床有效率高于MHT组,不良反应发生率低,故PMOP长期治疗中建议将TCM与MHT两种疗法结合,保证疗效的同时,可减少不良事件的发生。但还需大样本、高质量的随机对照试验提供更加可靠的证据。

Objective To compare the efficacy and safety of traditional Chinese medicine(TCM) and menopausal hormone therapy(MHT) in treating the postmenopausal osteoporosis(PMOP).Methods Screened systematically literatures from five databases(Pub Med,CNKI,Wanfang,VIP and CBM) according to the strategy and evaluated the quality through the JADAD score;Rev Man 5.4.1 and Stata 12.0 softwares were used to analysis the included literatures.Results 17 articles were included in the study with 1016 patients(579 cases in TCM group and 437 cases in MHT group).The results showed that TCM was better than MHT in improving clinical effective rate [RR=0.08,95%CI(0.01-0.15),Z=2.10,P=0.04],reducing kidney deficiency symptom scores [MD=1.40,95%CI(0.14-2.66),Z=2.17,P=0.03] and the incidence of side-effect rate [RR=0.24,95%CI(0.14-0.41),Z=5.15,P0.05];TCM and MHT have similar efficacy in increasing bone mineral density(BMD) [MD=-0.00,95%CI(-0.01-0.01),Z=0.29,P=0.77],estradiol(E2) [MD=-5.10,95%CI(-10.30-0.11),Z=1.92,P=0.06],follicle stimulating hormone(FSH) [MD=-18.33,95%CI(-47.69-11.03),Z=1.22,P=0.22] and luteinizing hormone(LH) [MD=-9.96,95%CI(-25.64-5.72),Z=1.24,P=0.21].The Begg's(z=0.81,P=0.417) and Egger's(t=0.32,P=0.750) tests indicated that there was no publication bias in this study.Sensitivity analysis indicated that the conclusions were reliable.Conclusions TCM and MHT have the same efficacy in treatment of PMOP,and TCM has lower adverse effects and better clinical effective rate.Combination of TCM and MHT should be considered in long-term PMOP treatment.Meanwhile,high-quality and large samples of RCTs are needed to verify the efficacy and safety of TCM in PMOP treatment.