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中药对绝经后血脂轻度异常妇女血脂的影响:一项随机、安慰剂对照的临床试验。

Effect of Chinese herbal medicine on serum lipids in postmenopausal women with mild dyslipidemia: a randomized, placebo-controlled clinical trial.

机构信息

Department of Gynecology, Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.

出版信息

Menopause. 2020 Jul;27(7):801-807. doi: 10.1097/GME.0000000000001539.

DOI:10.1097/GME.0000000000001539
PMID:32301894
Abstract

OBJECTIVE

Previous studies have shown the association between menopause and dyslipidemia. This study was aimed to evaluate the effect of Chinese herbal medicine, tonifying kidney and descending turbidity (TKDT) granule, on serum lipid profiles in postmenopausal women with dyslipidemia.

METHODS

A double-blind randomized, placebo-controlled trial was conducted among 104 postmenopausal Chinese women with mild dyslipidemia. Participants were randomized into treatment group (n = 53) and control group (n = 51). The participants in the treatment group received TKDT granule once per day for 24 weeks, whereas the control group received placebo in the same manner. All participants were subjected to healthy lifestyle during the study. Serum lipid profiles, body weight, waist circumference, and safety indicators were measured both at baseline and 24 weeks after admission.

RESULTS

Compared with placebo, significant improvements in total cholesterol, low-density lipoprotein cholesterol, apolipoprotein-B (Apo-B), weight, and waist circumference in the TKDT group (P < 0.05) were observed after 24 weeks of treatment. Total cholesterol, low-density lipoprotein cholesterol, and Apo-B were decreased by 0.84 (0.77) mmol/L, 0.72 (0.77) mmol/L, and 0.12 (0.27) mmol/L, mean ± SD respectively. The weight, waist circumference, and body mass index were decreased by 4.07 (3.01) kg, 3.10 (2.95) cm, 1.60 (1.13), respectively. There were no significant differences in triglycerides, high-density lipoprotein cholesterol, and Apo-A between the two groups. Seven participants in the treatment group and six participants in the placebo group had mild or moderate adverse reactions.

CONCLUSION

TKDT granule improved the lipid profile and reduced the related metabolic abnormalities in postmenopausal women with mild dyslipidemia based on lifestyle changes.

摘要

目的

既往研究表明,绝经与血脂异常有关。本研究旨在评估补肾化痰中药颗粒(TKDT 颗粒)对血脂异常绝经后妇女血脂谱的影响。

方法

对 104 例血脂轻度异常的绝经后中国女性进行了一项双盲随机、安慰剂对照试验。参与者被随机分为治疗组(n = 53)和对照组(n = 51)。治疗组每天服用 TKDT 颗粒一次,共 24 周,而对照组以同样的方式服用安慰剂。所有参与者在研究期间均接受健康的生活方式。在基线和入院后 24 周时测量血清血脂谱、体重、腰围和安全指标。

结果

与安慰剂组相比,治疗 24 周后,TKDT 组总胆固醇、低密度脂蛋白胆固醇、载脂蛋白-B(Apo-B)、体重和腰围均显著改善(P < 0.05)。总胆固醇、低密度脂蛋白胆固醇和 Apo-B 分别降低 0.84(0.77)mmol/L、0.72(0.77)mmol/L 和 0.12(0.27)mmol/L,均值±标准差。体重、腰围和体重指数分别降低 4.07(3.01)kg、3.10(2.95)cm 和 1.60(1.13)。两组间甘油三酯、高密度脂蛋白胆固醇和 Apo-A 无显著差异。治疗组 7 例和安慰剂组 6 例患者出现轻度或中度不良反应。

结论

在改变生活方式的基础上,TKDT 颗粒改善了血脂异常绝经后女性的血脂谱,并降低了相关代谢异常。

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