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基于China-PAR模型评估极低碳水化合物饮食对代谢相关脂肪性肝病患者心血管风险的影响

张珺洁 皮珊珊 邓金燕 吴子彧 李悦 王倩 杜宏波

引用本文:
Citation:

基于China-PAR模型评估极低碳水化合物饮食对代谢相关脂肪性肝病患者心血管风险的影响

DOI: 10.12449/JCH251214
基金项目: 

首都卫生发展科研专项 (2024-2-4195);

第五批全国中医临床优秀人才研修项目 ([2022]-1)

伦理学声明:本研究方案于2022年3月25日经由北京中医药大学东直门医院伦理委员会审批,批号:2022DZMEC-057-05,患者均签署知情同意书。
利益冲突声明:本文不存在任何利益冲突。
作者贡献声明:张珺洁负责文章撰写;皮珊珊、邓金燕、吴子彧、王倩、李悦负责数据整理及分析;杜宏波负责指导研究及论文审阅。
详细信息
    通信作者:

    杜宏波, duhongbotcm@126.com (ORCID: 0000-0002-5797-1399)

Impact of very-low-carbohydrate diet on cardiovascular risk in patients with metabolic associated fatty liver disease based on the China-PAR model

Research funding: 

Capital’s Funds for Health Improvement and Research (2024-2-4195);

The National Administration of Traditional Chinese Medicine Letter ([2022]-1)

More Information
  • 摘要:   目的  通过观察极低碳水化合物饮食(VLCD)对代谢相关脂肪性肝病(MAFLD)患者各项指标的影响,分析其干预该病的有效性与安全性,为临床治疗提供依据。  方法  本研究为单中心、回顾性、单臂试验队列观察,选取2021年9月—2024年5月于北京中医药大学东直门医院确诊为MAFLD的103例患者为研究对象。所有患者均接受VLCD干预方案,干预时长为2~6周。对患者干预前后的体重、体重指数(BMI)、肝脏受控衰减参数(CAP)、空腹血糖(FPG)、空腹血清C肽(C-P)、空腹血清胰岛素(FINS)、稳态模型评估胰岛素抵抗指数(HOMA-IR)、总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)进行比较。最后运用中国心血管风险预测模型China-PAR计算干预前后的心血管事件风险,以评估该饮食干预方式对心血管的影响。计量资料的比较采用配对t检验或Wilcoxon符号秩检验。  结果  经VLCD干预后,患者的体重、BMI、CAP较干预前下降,差异均具有统计学意义(Z值分别为-8.515、-8.495、-8.204,P值均<0.001);经VLCD干预后,患者的FPG、FINS、C-P及HOMA-IR均较干预前改善(Z值分别为-4.215、-5.310、-4.482、-5.422,P值均<0.001)。经干预后患者TG水平下降(Z=-5.373,P<0.001)。采用China-PAR模型计算后显示,103例患者的心血管疾病10年风险和终身风险评估指数下降,差异均具有统计学意义(Z值分别为-5.406、-5.383,P值均<0.001)。性别亚组分析结果显示,男性亚组干预前后体重、BMI、CAP、FPG、FINS、C-P、HOMA-IR、TG、血压、腰围、心血管疾病风险评估比较差异均具有统计学意义(P值均<0.05)。女性亚组干预前后体重、BMI、CAP、FPG、FINS、C-P、HOMA-IR、TC、TG、LDL-C、血压、腰围、心血管疾病风险评估比较差异均具有统计学意义(P值均<0.05)。年龄亚组方面,青年组干预后其体重、BMI、CAP、FPG、FINS、C-P、HOMA-IR、TG、收缩压、腰围、心血管疾病风险评估均明显下降,差异均具有统计学意义(P值均<0.05)。中年组其体重、BMI、CAP、FPG、FINS、C-P、HOMA-IR、TG、收缩压、舒张压、腰围、心血管疾病风险评估均明显下降,差异均具有统计学意义(P值均<0.05)。老年干预组在体重、BMI、CAP、收缩压、腰围、心血管疾病风险评估水平均有明显下降,差异均具有统计学意义(P值均<0.05)。经干预后TC、TG、LDL-C升高患者分别有43例(41.7%)、24例(23.3%)、43例(41.7%);HDL-C降低患者有53例(51.5%);CAP升高9例(8.7%);HOMA-IR 升高26例(25.2%)。  结论  VLCD在干预MAFLD过程中,可有效改善患者MAFLD程度、降低胰岛素抵抗,且未观察到心血管疾病风险上升。

     

  • 表  1  体重、BMI及CAP干预前后差异

    Table  1.   Difference inbody weight, body mass index and controlled attenuation parameter values before and after treatment

    指标 干预前(n=103) 干预后(n=103) Z P
    BMI(kg/m2 28.88(26.56~31.80) 27.34(25.20~30.09) -8.495 <0.001
    体重(kg) 83.00(73.00~95.00) 78.00(69.50~90.50) -8.515 <0.001
    CAP(dB/m) 318.00(291.00~345.00) 277.00(253.00~303.00) -8.204 <0.001

    注: BMI,体重指数;CAP,肝脏受控衰减参数值。

    下载: 导出CSV

    表  2  血糖、血脂代谢指标干预前后差异

    Table  2.   Differences in glucose metabolism indicators and blood lipid before and after treatment

    指标 干预前(n=103) 干预后(n=103) Z P
    FPG(mmol/L) 5.64(5.20~6.56) 5.36(4.86~5.86) -4.215 <0.001
    FINS(μIU/mL) 16.33(11.92~20.77) 11.47(8.77~16.12) -5.310 <0.001
    C-P(ng/mL) 3.21(2.63~4.32) 2.78(2.20~3.32) -4.482 <0.001
    HOMA-IR 4.15(3.07~6.10) 2.80(1.92~3.93) -5.422 <0.001
    TC(mmol/L) 5.35(4.42~6.09) 5.23(4.31~5.79) -1.689 0.091
    TG(mmol/L) 1.80(1.27~2.69) 1.35(0.98~2.07) -5.373 <0.001
    HDL-C(mmol/L) 1.18(1.00~1.35) 1.19(0.98~1.36) -0.389 0.697
    LDL-C(mmol/L) 3.39(2.58~3.95) 3.31(2.59~3.87) -1.145 0.252

    注:FPG,空腹血糖;FINS,空腹血清胰岛素;C-P,空腹血清C肽;HOMA-IR,稳态模型评估胰岛素抵抗指数;TC,总胆固醇;TG,甘油三酯;HDL-C,高密度脂蛋白胆固醇;LDL-C,低密度脂蛋白胆固醇。

    下载: 导出CSV

    表  3  心血管疾病基本风险评估因素及风险预测值

    Table  3.   Basic risk assessment factors and risk predictors for cardiovascular disease

    指标 干预前(n=103) 干预后(n=103) Z P
    收缩压(mmHg) 120.00(115.00~125.00) 116.00(112.00~120.00) -6.085 <0.001
    舒张压(mmHg) 82.00(78.00~87.00) 80.00(75.00~84.00) -3.407 <0.001
    腰围(cm) 98.00(94.50~100.00) 88.50(85.50~90.00) -8.769 <0.001
    心血管疾病10年风险评估(%)1) 1.80(0.70~5.10) 1.50(0.60~4.60) -5.406 <0.001
    心血管疾病终身风险评估(%)1) 21.50(17.80~22.40) 19.20(16.50~22.40) -5.383 <0.001

    注:1)China-PAR风险评估等级:10年风险:低危(<5%)、中危(5%~9.9%)、高危(≥10%);终身风险:低危(<32.8%)、高危(≥32.8%)。终身风险评估只在60岁以下人群计算11

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    表  4  性别亚组干预前后各指标分析

    Table  4.   Analysis of indicators in the gender subgroups before and after treatment

    指标 例数 干预前 干预后 统计值 P
    男性亚组 57
    体重(kg) 90.00(83.00~102.00) 86.00(77.45~96.75) Z=-6.571 <0.001
    BMI(kg/m2 29.32(27.45~32.98) 28.20(25.50~30.99) Z=-6.567 <0.001
    CAP(dB/m) 325.68±39.71 282.07±5.68 t=9.115 <0.001
    FPG(mmol/L) 6.00(5.33~6.95) 5.41(4.87~6.25) Z=-3.496 <0.001
    FINS(μIU/mL) 17.13(12.07~20.27) 11.11(8.04~15.94) Z=-4.096 <0.001
    C-P(ng/mL) 3.70±0.19 3.00±1.21 t=3.692 <0.001
    HOMA-IR 4.42(3.46~6.60) 2.93(1.91~3.97) Z=-4.422 <0.001
    TC(mmol/L) 5.29(4.25~5.97) 5.42(4.33~5.76) Z=-0.012 0.990
    TG(mmol/L) 1.98(1.16~3.15) 1.56(0.98~2.27) Z=-3.619 <0.001
    HDL-C(mmol/L) 1.15(0.98~1.31) 1.13(0.91~1.26) Z=-1.667 0.096
    LDL-C(mmol/L) 3.24±1.01 3.28±0.99 t=-0.515 0.608
    收缩压(mmHg) 118.00(114.00~123.00) 115.00(110.00~119.00) Z=-4.685 <0.001
    舒张压(mmHg) 83.00(79.00~87.00) 80.00(75.00~85.00) Z=-2.024 0.043
    腰围(cm) 100.00(96.20~104.30) 89.00(86.50~90.00) Z=-6.568 <0.001
    心血管疾病10年风险评估(%) 1.40(0.50~4.20) 1.20(0.40~4.10) Z=-2.136 0.033
    心血管疾病终身风险评估(%) 19.00(15.80~22.60) 18.20(15.50~21.30) Z=-1.994 0.046
    女性亚组 46
    体重(kg) 75.13±11.35 71.83±11.54 t=8.884 <0.001
    BMI(kg/m2 28.48±3.57 27.23±3.66 t=9.154 <0.001
    CAP(dB/m) 303.00(287.00~329.00) 270.00(247.00~300.00) Z=-5.518 <0.001
    FPG(mmol/L) 5.52(5.08~5.99) 5.34(4.84~5.66) Z=-2.500 0.012
    FINS(μIU/mL) 14.86(10.75~20.91) 12.32(8.98~16.20) Z=-3.436 <0.001
    C-P(ng/mL) 3.09(2.52~4.03) 2.60(2.24~3.31) Z=-3.799 <0.001
    HOMA-IR 3.78(2.79~5.62) 2.77(1.90~3.97) Z=-3.381 <0.001
    TC(mmol/L) 5.40(4.64~6.31) 5.14(4.07~5.89) Z=-2.409 0.016
    TG(mmol/L) 1.71(1.31~2.04) 1.15(0.98~1.71) Z=-4.059 <0.001
    HDL-C(mmol/L) 1.25(1.10~1.37) 1.31(1.10~1.46) Z=-1.276 0.202
    LDL-C(mmol/L) 3.37(2.68~4.18) 3.17(2.45~3.91) Z=-2.156 0.031
    收缩压(mmHg) 120.00(115.00~127.00) 117.00(113.00~121.00) Z=-3.912 <0.001
    舒张压(mmHg) 82.00(78.00~87.00) 77.00(73.00~82.00) Z=-2.817 0.005
    腰围(cm) 95.70±5.43 87.31±6.09 t=15.705 <0.001
    心血管疾病10年风险评估(%) 2.40(1.20~7.60) 1.80(0.80~5.90) Z=-5.351 <0.001
    心血管疾病终身风险评估(%) 23.50(19.60~28.10) 20.20(17.60~23.60) Z=-5.450 <0.001

    注:BMI,体重指数;CAP,肝脏受控衰减参数;FPG,空腹血糖;FINS,空腹血清胰岛素;C-P,空腹血清C肽;HOMA-IR,稳态模型评估胰岛素抵抗指数;TC,总胆固醇;TG,甘油三酯;HDL-C,高密度脂蛋白胆固醇;LDL-C,低密度脂蛋白胆固醇。

    下载: 导出CSV

    表  5  年龄亚组干预前后各指标分析

    Table  5.   Analysis of indicators in the age subgroups before and after treatment

    指标 例数 干预前 干预后 统计值 P
    青年组 57
    体重(kg) 88.00(78.00~104.00) 83.00(73.30~98.30) Z=-6.249 <0.001
    BMI(kg/m2 29.39(27.39~32.98) 28.50(25.75~31.40) Z=-6.208 <0.001
    CAP(dB/m) 322.67±37.76 281.32±41.67 t=9.278 <0.001
    FPG(mmol/L) 5.54(5.13~6.22) 5.23(4.82~5.71) Z=-3.619 <0.001
    FINS(μIU/mL) 16.95(12.07~23.35) 11.73(9.19~16.21) Z=-4.159 <0.001
    C-P(ng/mL) 3.19(2.70~4.58) 2.88(2.24~3.31) Z=-3.402 <0.001
    HOMA-IR 4.07(3.14~6.61) 2.80(2.15~3.96) Z=-4.382 <0.001
    TC(mmol/L) 5.19±1.12 5.14±1.23 t=0.481 0.632
    TG(mmol/L) 1.89(1.33~2.96) 1.43(1.02~2.20) Z=-4.164 <0.001
    HDL-C(mmol/L) 1.17(1.00~1.30) 1.19(1.00~1.35) Z=-0.801 0.423
    LDL-C(mmol/L) 3.31±0.98 3.31±1.00 t=0.047 0.963
    收缩压(mmHg) 117.00(112.00~120.00) 115.00(110.00~118.00) Z=-3.463 <0.001
    舒张压(mmHg) 80.00(75.00~85.00) 80.00(75.00~84.00) Z=-1.538 0.124
    腰围(cm) 98.00(94.60~103.10) 87.90(85.50~90.00) Z=-6.510 <0.001
    心血管疾病10年风险评估(%) 0.90(0.30~1.50) 0.70(0.30~1.20) Z=-3.402 <0.001
    心血管疾病终身风险评估(%) 19.50(16.30~23.60) 18.20(16.00~20.60) Z=-3.276 0.001
    中年组 34
    体重(kg) 80.40±13.19 76.05±13.26 t=9.275 <0.001
    BMI(kg/m2 28.22±3.64 26.68±3.72 t=9.415 <0.001
    CAP(dB/m) 302.00(287.00~334.00) 268.00(244.00~300.00) Z=-4.557 <0.001
    FPG(mmol/L) 6.14±1.25 5.58±0.83 t=3.036 0.005
    FINS(μIU/mL) 16.23(10.56~18.64) 10.42(8.04~15.89) Z=-3.052 0.002
    C-P(ng/mL) 3.53±1.36 2.83±0.81 t=3.118 0.004
    HOMA-IR 4.65±2.67 3.14±1.77 t=3.413 0.002
    TC(mmol/L) 5.57(4.83~6.14) 5.37(4.57~5.80) Z=-1.770 0.077
    TG(mmol/L) 1.87(1.31~2.92) 1.24(1.14~1.83) Z=-3.240 0.001
    HDL-C(mmol/L) 1.26(1.05~1.41) 1.19(1.00~1.38) Z=-1.179 0.238
    LDL-C(mmol/L) 3.53(2.87~4.18) 3.48(2.63~3.84) Z=-1.483 0.138
    收缩压(mmHg) 122.00(119.00~127.00) 119.00(114.00~121.00) Z=-4.164 <0.001
    舒张压(mmHg) 82.00(79.00~89.00) 80.00(75.00~84.00) Z=-2.680 0.007
    腰围(cm) 97.81±5.71 88.67±5.91 t=12.531 <0.001
    心血管疾病10年风险评估(%) 3.90(2.90~6.10) 3.70(2.40~6.00) Z=-3.246 <0.001
    心血管疾病终身风险评估(%) 22.20(18.30~25.80) 19.10(16.90~24.20) Z=-3.950 <0.001
    老年组 12
    体重(kg) 73.71±7.54 70.63±7.47 t=6.281 <0.001
    BMI(kg/m2) 27.98±2.14 26.83±2.41 t=6.323 <0.001
    CAP(dB/m) 318.58±33.42 275.92±32.82 t=3.763 0.003
    FPG(mmol/L) 5.59(5.30~7.73) 5.76(5.01~6.10) Z=-0.118 0.906
    FINS(μIU/mL) 14.69±6.38 12.58±7.18 t=0.944 0.366
    C-P(ng/mL) 3.18(1.91~3.55) 2.52(1.41~3.15) Z=-1.295 0.195
    HOMA-IR 3.78(2.03~6.40) 3.14(1.33~4.99) Z=-1.255 0.209
    TC(mmol/L) 1.45(0.72~2.06) 0.96(0.66~1.59) Z=-1.805 0.071
    TG(mmol/L) 1.45±0.69 1.28±0.90 t=0.952 0.362
    HDL-C(mmol/L) 1.24±0.27 1.21±0.33 t=0.685 0.508
    LDL-C(mmol/L) 2.80±1.03 2.75±1.09 t=0.532 0.605
    收缩压(mmHg) 126.00(124.00~130.00) 118.00(113.00~124.00) Z=-2.983 0.003
    舒张压(mmHg) 87.00(82.00~90.00) 80.00(77.00~85.00) Z=-1.930 0.054
    腰围(cm) 96.62±7.14 87.20±8.25 t=10.252 <0.001
    心血管疾病10年风险评估(%) 9.00(7.80~13.70) 6.90(6.10~9.40) Z=-2.847 0.004

    注:BMI,体重指数;CAP,肝脏受控衰减参数值;FPG,空腹血糖;FINS,空腹血清胰岛素;C-P,空腹血清C肽;HOMA-IR,稳态模型评估胰岛素抵抗指数;TC,总胆固醇;TG,甘油三酯;HDL-C,高密度脂蛋白胆固醇;LDL-C,低密度脂蛋白胆固醇。

    下载: 导出CSV

    表  6  经干预后代谢相关的不良反应事件分析

    Table  6.   Analysis of metabolism-related adverse events after treatment

    项目 例(%) 干预前后指标差值范围
    TC升高 43(41.7) 0.03~2.65 mmol/L
    TG升高 24(23.3) 0.01~2.16 mmol/L
    HDL-C降低 53(51.5) 0.01~1.17 mmol/L
    LDL-C升高 43(41.7) 0.02~2.33 mmol/L
    CAP升高 9(8.7) 3.00~26.00 dB/m
    体重升高 2(1.9) 1.00~4.50 kg/m2
    HOMA-IR升高 26(25.2) 0.03~10.49

    注:此表中提及的升高以及下降是以指标前后的绝对值进行定义。TC,总胆固醇;TG,甘油三酯;HDL-C,高密度脂蛋白胆固醇;LDL-C,低密度脂蛋白胆固醇;CAP,肝脏受控衰减参数;HOMA-IR,稳态模型评估胰岛素抵抗指数。

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  • 收稿日期:  2025-06-26
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