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中药方剂二仙汤治疗骨质疏松症的效果:一项系统评价

Effects of Chinese herbal formula Erxian decoction for treating osteoporosis: a systematic review.

作者信息

Li Jin-Yu, Jia Yu-Song, Chai Li-Min, Mu Xiao-Hong, Ma Sheng, Xu Lin, Wei Xu

机构信息

Department of Orthopaedics, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China.

Department of Scientific Research, Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, People's Republic of China.

出版信息

Clin Interv Aging. 2017 Jan 4;12:45-53. doi: 10.2147/CIA.S117597. eCollection 2017.

Abstract

PURPOSE

The aim is to systematically assess the effectiveness and safety of Chinese herbal formula Erxian decoction (EXD) for treating osteoporosis.

MATERIALS AND METHODS

Six databases were searched from inception through September 17, 2016, without language restriction. All randomized controlled trials of EXD for osteoporosis were included. One or more outcome measures including fracture, change in bone mineral density (BMD), pain symptom improvement, bone biochemical markers, quality of life, adverse event or adverse drug reaction were evaluated. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards.

RESULTS

Eight trials including 644 patients investigated the effects of EXD in the treatment of osteoporosis. The methodological quality of the included trials was generally low. The meta-analysis from two trials showed favorable effects of EXD in improving BMD of lumbar spine (mean difference [MD]: 0.05 [0.03, 0.06]; =0%; <0.00001) and BMD of femoral great trochanter (MD: 0.06 [0.02, 0.10]; =59%; =0.005) compared with caltrate tablets. The other meta-analysis from two trials showed beneficial effects of EXD plus caltrate tablets and calcitriol in improving BMD of femoral neck (MD: 0.04 [0.00, 0.09]; =56%; =0.04), the level of calcium (MD: 0.20 [0.15, 0.24]; =0%; <0.00001), and phosphorus (MD: -0.28 [-0.39, -0.17]; =68%; <0.00001) compared with caltrate tablets and calcitriol alone. The adverse drug reactions of EXD were mainly slight gastrointestinal symptoms.

CONCLUSION

The study provides suggestive evidence of the superiority of EXD monotherapy or combination therapy over basic supplements for treating osteoporosis. However, the evidence remains weak. More rigorously designed and measured, randomized double-blind, placebo-controlled trials with larger sample size are needed to verify the current conclusions.

摘要

目的

旨在系统评估中药方剂二仙汤(EXD)治疗骨质疏松症的有效性和安全性。

材料与方法

检索了6个数据库,检索时间从建库至2016年9月17日,无语言限制。纳入所有关于EXD治疗骨质疏松症的随机对照试验。评估一项或多项结局指标,包括骨折、骨密度(BMD)变化、疼痛症状改善、骨生化标志物、生活质量、不良事件或药物不良反应。根据Cochrane标准进行研究选择、数据提取、质量评估和数据分析。

结果

8项试验共644例患者研究了EXD治疗骨质疏松症的效果。纳入试验的方法学质量普遍较低。两项试验的荟萃分析显示,与钙尔奇片相比,EXD在改善腰椎骨密度(平均差[MD]:0.05[0.03,0.06];I² = 0%;P < 0.00001)和股骨大转子骨密度(MD:0.06[0.02,0.10];I² = 59%;P = 0.005)方面有良好效果。另外两项试验的荟萃分析显示,与单独使用钙尔奇片和骨化三醇相比,EXD联合钙尔奇片和骨化三醇在改善股骨颈骨密度(MD:0.04[0.00,0.09];I² = 56%;P = 0.04)、血钙水平(MD:0.20[0.15,0.24];I² = 0%;P < 0.00001)和血磷水平(MD:-0.28[-0.39,-0.17];I² = 68%;P < 0.00001)方面有有益作用。EXD的药物不良反应主要为轻微胃肠道症状。

结论

该研究提供了提示性证据,表明EXD单药治疗或联合治疗在治疗骨质疏松症方面优于基础补充剂。然而,证据仍然薄弱。需要更严格设计和测量的、样本量更大的随机双盲安慰剂对照试验来验证当前结论。

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