左归丸与佑归丸治疗骨质疏松症的随机对照研究

IF 2 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Journal of Traditional Chinese Medicine Pub Date : 2018-02-01 DOI:10.1016/j.jtcm.2018.01.005
Li Wenxiong , Zhang Kuaiqiang , Liu Zhu , Liu Li , Cheng Yan , Yin Jichao , Sun Yindi , Yang Feng
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引用次数: 17

摘要

目的评价经典阴阳补方左归丸和右归丸治疗骨质疏松症的疗效和安全性,并探讨其作用机制。方法将55 ~ 75岁骨质疏松合并中医肾虚患者随机分为治疗组和对照组。治疗组给予左归丸或右归丸中药配方颗粒治疗,对照组给予安慰剂治疗。主要结果是腰椎骨密度(BMD) (L1-4)和股骨骨密度。次要结局包括疼痛强度、健康相关生活质量(HRQoL)、骨转换标志物和安全性。结果2014年12月至2016年4月共入组4家医院患者200例。两组在基线时无统计学差异(P >0.05),具有良好的可比性。两组患者6个月和12个月时腰椎骨密度(L1-4)、疼痛VAS评分和HRQoL以及12个月时股骨骨密度(P <0.05),但6个月时股骨骨密度和骨转换指标差异无统计学意义(P >0.05)。治疗前后不同时间腰椎(L1-4)骨密度、股骨骨密度、疼痛VAS评分及健康相关生活质量差异均有统计学意义,且治疗前后时间、组间存在交叉效应。治疗组8例失访,3例发生不良事件(ae);对照组10例失访,2例发生ae。两组在ae、损失率和安全性方面无显著差异(P >0.05)。结论左归丸或游归丸可改善骨质疏松症患者的骨密度,缓解疼痛,缓解肾虚证,改善患者的生活质量,抑制骨转化,调节骨形成与骨吸收的耦合平衡,但其长期疗效有待于长期随访和大样本临床随机对照试验的证实。
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Effect of Zuogui pill and Yougui pill on osteoporosis: a randomized controlled trial

OBJECTIVE

To evaluate the effect and safety of Zuogui pill and Yougui pill, classic Yin and Yang tonic formula (CYYTF), in the treatment of osteoporosis and the underlying mechanism.

METHODS

Participants aged 55 to 75 with osteoporosis and Kidney deficiency in Traditional Chinese Medicine (TCM) will be included and randomly allocated into two groups: treatment group and control group. Participants in the treatment group were treated with Zuogui pill or Yougui pill TCM formula granule, while the control group received placebo. Primary outcomes are the lumbar spine on bone mineral density (BMD) (L1-4) and femoral BMD. Secondary outcomes include pain intensity, health-related quality of life (HRQoL), bone turnover markers and safety.

RESULTS

Totally 200 patients were enrolled from December 2014 to April 2016 from four hospitals. There were no statistically significant differences between the two groups at baseline (P > 0.05) and it was good to comparability. Statistically significant differences between the two groups were observed for the lumbar BMD (L1-4), pain VAS scores and HRQoL at six months and twelve months and femoral BMD at twelve months (P < 0.05), but no significant differences for femoral BMD and bone turnover markers at six months (P > 0.05). Moreover, significant difference was observed at different time before and after treatment in terms of lumbar spine (L1-4) BMD, femoral BMD, pain VAS scores and health-related quality of life, and there was an crossover effect between the time and groups before and after treatment. In additional, in the treatment group, 8 patients lost to follow-up and 3 patients had adverse events (AEs) and in the control group, 10 patients lost to follow-up and 2 patients had AEs. No remarkable differences were observed between the two groups with regard to AEs, lost rate and safety (P > 0.05).

CONCLUSION

Zuogui pill or Yougui pill could improve BMD, ease pain, relieve Kidney deficiency syndrome, improve the quality of life osteoporosis patients, inhibit bone conversion and regulate the coupling balance of bone formation and bone resorption, but long-term efficacy should be confirmed by a longer term follow-up and larger of samples clinical randomized controlled trials.

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来源期刊
Journal of Traditional Chinese Medicine
Journal of Traditional Chinese Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
2.40
自引率
3.80%
发文量
32269
审稿时长
2 months
期刊介绍: Journal of Traditional Chinese Medicine(JTCM) is devoted to clinical and theortical research on the use of acupuncture and Oriental medicine. The main columns include Clinical Observations, Basic Investigations, Reviews, Questions and Answers, an Expert''s Forum, and Discussions of Clinical Cases. Its key topics include acupuncture and electro-acupuncture, herbal medicine, homeopathy, masseotherapy, mind-body therapies, palliative care, and other CAM therapies.
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