[1]李子一,刘孟楠,曾奇虎,等.丹参饮治疗高脂血症随机对照试验的系统评价与Meta分析[J].西部中医药,2026,39(01):120-128.[doi:10.12174/j.issn.2096-9600.2026.01.20]
　LI Ziyi,LIU Mengnan,ZENG Qihu,et al.RCTs of Danshen Drink in the Treatment of Hyperlipemia: Systematic Evaluation and Meta-analysis[J].Western Journal of Traditional Chinese Medicine,2026,39(01):120-128.[doi:10.12174/j.issn.2096-9600.2026.01.20]
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丹参饮治疗高脂血症随机对照试验的系统评价与Meta分析()

《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
39
期数:
2026年01期
页码:
120-128
栏目:
二次研究
出版日期:
2026-01-15

文章信息/Info

Title:
RCTs of Danshen Drink in the Treatment of Hyperlipemia: Systematic Evaluation and Meta-analysis
作者:
李子一1, 刘孟楠2, 曾奇虎2, 韩梅2, 杨廷富2, 李亚琴2, 李文龙2
1.西南医科大学临床医学院，四川 泸州 646000
2.西南医科大学附属中医医院，四川 泸州 646000
Author(s):
LI Ziyi1, LIU Mengnan2, ZENG Qihu2, HAN Mei2, YANG Tingfu2, LI Yaqin2, LI Wenlong2
1.School of Clinical Medicine, Southwest Medical University, Luzhou 646000, China
2.The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou 646000, China
关键词:
高脂血症; 丹参饮; 降脂药; 有效性; 系统评价
Keywords:
hyperlipemia; drink; lipid-lowering drugs; effectiveness; systematic evaluation
分类号:
R289.5
DOI:
10.12174/j.issn.2096-9600.2026.01.20
文献标志码:
A
摘要:
目的评价使用丹参饮或加味丹参饮治疗高脂血症的有效性与安全性。 方法计算机检索Pubmed、Web of Science、Cochrane Library、CNKI、VIP、Wanfang数据库，检索时间为自数据库创立至2023年3月1日，按照纳入、排除标准检索关于丹参饮联合常规治疗方法治疗高脂血症的临床随机对照试验，由2名研究员独立进行纳入文献的筛选以及信息提取，根据Corchrane协作网提供的风险评估工具对文献进行质量评价，文献的方法学质量评估使用jadad偏倚风险评估量表，文献结局指标的质量评级使用GRADE量表评估，数据使用RevMan V.5.4软件进行统计分析。 结果共纳入14项临床随机对照试验，涉及1207名患者。Meta分析结果包括临床有效率：（MD=3.94，95%CI：2.81～5.53，Z=7.93，P＜0.000 01）；血清学血脂指标包括总胆固醇（total Cholesterol，TC）、甘油三酯（triglyceride，TG）、低密度脂蛋白胆固醇（low-Density lipoprotein cholesterol，LDL-C）和高密度脂蛋白胆固醇（high-density lipoprotein Cholesterol，HDL-C），TC：（MD=-0.48，95%CI：-0.56～-0.40，Z=11.60，P＜0.000 01），TG：（MD=-0.28，95%CI（：-0.34～-0.22，Z=9.12，P＜0.000 01），LDL-C：（MD=-0.41，95%CI：-0.55～-0.26，Z=5.47，P＜0.000 01），HDL-C：（MD=0.15，95%CI：0.13～0.18，Z=11.55，P＜0.000 01）。共有4篇文献报道，丹参饮或加味丹参饮治疗后，不良反应、过敏反应、不适感觉或异常症状、不耐受现象、毒副作用和药物耐受性相关内容以及治疗前后血、尿常规及肝肾功能指标有无明显异常变化；Jadad文献偏倚风险评估量表显示纳入研究的文献总体偏倚风险较小；根据GRADE评分量表，各项结局指标总体而言质量较高且不具有发表偏倚。 结论与常规治疗高脂血症比较，丹参饮或加味丹参饮作为补充治疗或辅助治疗，能够显著提高临床有效率，改善血清学血脂指标以及拥有良好的安全性。然而，由于研究的方法学质量不足，存在一些偏倚风险与临床数据报告不足，因此需要更严格、多中心、足够样本和双盲随机临床试验。
Abstract:
ObjectiveTo evaluate the effectiveness and safety of Danshen drink or modified Danshen drink in treating hyperlipemia. MethodsClinical randomized controlled trials (RCTs) of Danshen drinks combined with conventional therapy in treating hyperlipemia were searched according to the inclusion and exclusion criteria from Pubmed, Web of Science, Cochrane Library, CNKI, VIP and Wanfang databases between the time of database establishment to March 1st, 2023, two researchers independently screened the included literature and extracted the information, quality evaluation of the literature was performed according to the risk assessment tool provided by the Cochrane Collaboration, Jadad assessment of Bias Risk scale is employed for the methodological quality assessment of literature, the quality of evidence in the included literature was evaluated with the GRADE scale, and statistical analysis was performed with RevMan V.5.4. ResultsA total of 14 clinical RCTs were included, involving 1207 patients. Meta analysis revealed clinical effective rate: (MD=3.94, 95%CI:2.81-5.53, Z=7.93, P<0.000 01); Serological lipid markers covered TC, TG, LDL-C and HDL-C, TC:(MD=-0.48, 95% CI:-0.56--0.40), Z=11.60, P<0.000 01),TG:(MD=-0.28, 95%CI:-0.34--0.22, Z=9.12, P<0.000 01), LDL-C:(MD=-0.41, 95% CI:-0.55--0.26, Z=5.47, P<0.000 01), HDL-C:(MD=0.15, 95% CI:0.13-0.18, Z=11.55, P<0.000 01). Four articles have reported whether there were significant abnormal changes in adverse reactions, allergic reactions, discomforts or abnormal symptoms, intolerance, toxic side effects, drug tolerance-related content after treatment with Danshen drink or modified Danshen drink, blood and urine routine, the indexes of liver and kidney function before and after treatment; Jadad scale for assessing risk of bias indicated a low risk of bias for the included literature; according to GRADE scale, the overall quality of all outcome measures was high, with no indication of publication bias. ConclusionCompared with conventional therapy for hyperlipemia, Danshen drink or modified Danshen drink, as supplementary therapy or adjuvant therapy, could significantly boost clinical effective rate, improve lipid markers and possess good safety. However, more rigorous, multi-center, sufficient samples and double-blind randomized clinical trials are required due to the insufficient methodological quality of the study, some bias risks and insufficient clinical data reporting.

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备注/Memo

备注/Memo:
国家自然科学基金面上项目（82074378）；四川省科技厅项目（2026NSFSC1823）、四川省医学会青年创新项目（Q20250014）；西南医科大学项目（2023ZYYQ04，2024ZKZ007，2024ZXYZX39，2024ZKY073）。李子一（2001—），男，医师。研究方向：心血管疾病的中医药诊治及研究。△李文龙（1988—），男，硕士学位，副主任医师。研究方向：中西医结合防治心血管疾病。Email：644484420@qq.com。
更新日期/Last Update: 2026-01-15