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含红曲米的市售中药复方制剂与他汀类药物联合治疗血脂异常的效果：一项系统评价和荟萃分析。

Effects of the combination of red yeast rice-containing commercial Chinese polyherbal preparation with statins for dyslipidemia: a systematic review and meta-analysis.

作者信息

Shi Menglong, Sun Tianye, Zhang Chenyao, Ma Yucong, Pang Bo, Cao Lujia, Ji Zhaochen, Yang Fengwen, Zhang Junhua

机构信息

Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.

出版信息

Front Pharmacol. 2024 Jul 23;15:1398934. doi: 10.3389/fphar.2024.1398934. eCollection 2024.

DOI:10.3389/fphar.2024.1398934
PMID:39108747
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11300347/
Abstract

BACKGROUND

Significant challenges are associated with the pharmacological management of dyslipidemia, an important risk factor for cardiovascular disease. Limited reliable evidence exists regarding the efficacy of red yeast rice (RYR)-containing commercial Chinese polyherbal preparation (CCPP), despite their widespread use in China.

PURPOSE

We aimed to investigate the efficacy of RYR-containing CCPPs combined with statins in treating dyslipidemia.

METHODS

Eight databases were searched for relevant randomized controlled trials (RCTs) from database inception date to November 2023. Outcome measures, including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglyceride (TG), clinical efficacy, and adverse reactions, were assessed. The Cochrane Handbook for Systematic Reviews of Interventions was used for quality evaluation, and the meta-analysis was conducted using RevMan 5.3 and Stata 15.1.

RESULTS

Thirty-three studies involving 4,098 participants were included. The combination of RYR-containing CCPP, such as Xuezhikang (XZK), Zhibitai (ZBTAI), or Zhibituo (ZBTUO) with statins had a significant effect on the increase in clinical efficacy [RR:1.16, 95%CI (1.13, 1.19), < 0.00001]. In addition, they also improved blood lipid profile parameters by increasing HDL-C levels [MD:0.21, 95%CI(0.17, 0.25), < 0.00001], and decreasing TC [MD: 0.60, 95%CI(-0.76, -0.45), < 0.00001], TG [MD: 0.33, 95%CI(-0.39, -0.26), < 0.00001] and LDL-C levels [MD: 0.45, 95%CI(-0.54, -0.36), < 0.00001]. No significant adverse reactions was observed in the RYR-containing CCPPs. Notably, ZBTAI and XZK significantly reduced the incidence of gastrointestinal disturbances and muscular adverse reactions. However, subgroup analyses suggested that the type of CCPPs, dose, and treatment duration might affect the efficacy of RYR-containing CCPPs.

CONCLUSION

RYR-containing CCPPs combined with statins appears to improve lipid profiles and clinical efficacy in patients with dyslipidemia. However, due to the poor quality of the included studies, and some studied showing negative findings was unpublished. The results should be interpreted with caution until further confirmation by well-designed RCTs.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=487402, identifier CRD42023487402.

摘要

背景

血脂异常是心血管疾病的重要危险因素，其药物治疗面临重大挑战。尽管含红曲米（RYR）的商用中药复方制剂（CCPP）在中国广泛使用，但关于其疗效的可靠证据有限。

目的

我们旨在研究含RYR的CCPP与他汀类药物联合治疗血脂异常的疗效。

方法

检索了8个数据库，以获取从数据库建立之日至2023年11月的相关随机对照试验（RCT）。评估了包括低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）、总胆固醇（TC）、甘油三酯（TG）、临床疗效和不良反应等结局指标。使用《Cochrane干预措施系统评价手册》进行质量评估，并使用RevMan 5.3和Stata 15.1进行荟萃分析。

结果

纳入了33项研究，共4098名参与者。含RYR的CCPP，如血脂康（XZK）、脂必泰（ZBTAI）或脂必妥（ZBTUO）与他汀类药物联合使用对提高临床疗效有显著效果[RR：1.16，95%CI（1.13，1.19），P<0.00001]。此外，它们还通过提高HDL-C水平[MD：0.21，95%CI（0.17，0.25），P<0.00001]、降低TC[MD：0.60，95%CI（-0.76，-0.45），P<0.00001]、TG[MD：0.33，95%CI（-0.39，-0.26），P<0.00001]和LDL-C水平[MD：0.45，95%CI（-0.54，-0.36），P<0.00001]来改善血脂谱参数。在含RYR的CCPP中未观察到显著的不良反应。值得注意的是，ZBTAI和XZK显著降低了胃肠道不适和肌肉不良反应的发生率。然而，亚组分析表明，CCPP的类型、剂量和治疗持续时间可能会影响含RYR的CCPP的疗效。

结论

含RYR的CCPP与他汀类药物联合使用似乎可以改善血脂异常患者的血脂谱和临床疗效。然而，由于纳入研究的质量较差，且一些显示阴性结果的研究未发表。在经过精心设计的RCT进一步证实之前，应对结果谨慎解读。

系统评价注册

https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=487402，标识符CRD42023487402。

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