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1.北京中医药大学深圳医院,广东 深圳 518172
2.北京中医药大学,北京 100029
Published:15 July 2024,
Received:08 November 2023,
Revised:02 April 2024,
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卢芬萍,邢光艳,胡世平.益生菌治疗非酒精性脂肪性肝病有效性及安全性的Meta分析 Δ[J].中国药房,2024,35(13):1643-1650.
LU Fenping,XING Guangyan,HU Shiping.Efficacy and safety of probiotics in the treatment of nonalcoholic fatty liver disease: a meta-analysis[J].ZHONGGUO YAOFANG,2024,35(13):1643-1650.
卢芬萍,邢光艳,胡世平.益生菌治疗非酒精性脂肪性肝病有效性及安全性的Meta分析 Δ[J].中国药房,2024,35(13):1643-1650. DOI: 10.6039/j.issn.1001-0408.2024.13.17.
LU Fenping,XING Guangyan,HU Shiping.Efficacy and safety of probiotics in the treatment of nonalcoholic fatty liver disease: a meta-analysis[J].ZHONGGUO YAOFANG,2024,35(13):1643-1650. DOI: 10.6039/j.issn.1001-0408.2024.13.17.
目的
2
系统评价益生菌制剂治疗非酒精性脂肪性肝病(NAFLD)的有效性及安全性。
方法
2
计算机检索中国知网、万方数据、维普网、SinoMed、PubMed、Embase、Web of Science、Cochrane图书馆数据库,收集已发表的使用益生菌制剂(治疗组)对比安慰剂或健康生活方式(对照组)治疗NAFLD的随机对照试验(RCT),检索时限为建库起至2023年10月10日。采用Cochrane系统评价员手册5.1.0、GRADE工具对纳入文献进行质量评价和评级,RevMan 5.4、Stata 17.0软件进行Meta分析、Egger’s检验。
结果
2
共纳入24项RCT(1 391例NAFLD患者)。Meta分析结果显示,与对照组相比,治疗组患者丙氨酸转氨酶[MD=-6.29,95%CI(-9.35,-3.22),
P
<0.000 1
]
、天冬氨酸转氨酶[MD=-4.89,95%CI(-7.55,-2.23),
P
=0.000 3
]
、
γ
-谷氨酰转移酶[MD=-4.87,95%CI(-6.54,-3.20),
P
<0.000 01
]
水平,肝脏硬度值[MD=-0.36,95%CI(-0.48,-0.24),
P
<0.000 01
]
,甘油三酯[MD=-0.22,95%CI(-0.27,-0.16),
P
<0.000 01
]
、总胆固醇[MD=-0.34,95%CI(-0.44,-0.25),
P
<0.000 01
]
和稳态模型评估的胰岛素抵抗[MD=-0.38,95%CI(-0.63,-0.13),
P
=0.003
]
水平均显著降低;但肿瘤坏死因子α[MD=-0.41,95%CI(-1.29,0.48),
P
=0.37
]
、白细胞介素6[MD=0.39,95%CI(-0.10,0.88),
P
=0.12
]
、超敏C反应白蛋白[MD=-0.30,95%CI(-0.85,0.25),
P
=0.28
]
、高密度脂蛋白胆固醇[MD=0.03,95%CI(-0.01,0.06),
P
=0.10
]
、低密度脂蛋白胆固醇[MD=-0.10,95%CI(-0.27,0.07),
P
=0.23
]
水平和身体质量指数[MD=0.07,95%CI(-0.26,0.40),
P
=0.68
]
的差异无统计学意义。按照干预措施不同进行亚组分析,合生元组
γ
-谷氨酰转移酶水平、肝脏硬度值、稳态模型评估的胰岛素抵抗水平与对照组相比无明显改善,其余结果与上述一致。Egger’s检验结果显示均无发表偏倚的存在。
结论
2
使用益生菌疗法对NAFLD患者的肝功能指标、肝脏硬度值、血脂水平、胰岛素抵抗水平具有良好的调节作用。
OBJECTIVE
2
To systematically evaluate the efficacy and safety of probiotics in the treatment of nonalcoholic fatty liver disease (NAFLD).
METHODS
2
Retrieved from CNKI, Wanfang data, VIP, SinoMed, PubMed, Embase, Web of Science, Cochrane library databases, the published randomized controlled trials (RCTs) about probiotics(treatment group) versus placebo or healthy lifestyle(control group) in the treatment of NAFLD were collected from the inception to Oct. 10th, 2023. The quality of the included literature was evaluated and rated by Cochrane system evaluator manual 5.1.0 and GRADE tools. Meta-analysis and Egger’s test were carried out by using RevMan 5.4 and Stata 17.0 software.
RESULTS
2
Overall 24 RCTs were included in this study, involving 1 391 patients with NAFLD. Meta-analysis showed that compared with control group, the levels of alanine aminotransferase [MD=-6.29, 95%CI (-9.35, -3.22),
P
<0.000 1
]
, aspartate aminotransferase [MD=-4.89, 95%CI (-7.55, -2.23),
P
=0.000 3
]
and
γ
-glutamyl transferase [MD=-4.87, 95%CI (-6.54, -3.20),
P
<0.000 01
]
, the liver stiffness measurement [MD=-0.36, 95%CI (-0.48, -0.24),
P
<0.000 01
]
, the levels of triglycerides [MD=-0.22, 95%CI (-0.27, -0.16),
P
<0.000 01
]
, total cholesterol [MD=-0.34, 95%CI (-0.44, -0.25),
P
<0.000 01
]
and insulin resistance assessed by homeostasis model [MD=-0.38, 95%CI (-0.63, -0.13),
P
=0.003
]
were all significantly decreased in the treatment group. However, there was no statistically
significant difference of probiotics therapy in the levels of tumor necrosis factor-α [MD=-0.41, 95%CI (-1.29, 0.48),
P
=0.37
]
, interleukin-6 [MD=0.39, 95%CI (-0.10, 0.88),
P
=0.12
]
, high-sensitivity C-reactive protein [MD=-0.30, 95%CI (-0.85, 0.25),
P
=0.28
]
, high-density lipoprotein cholesterol [MD=0.03, 95%CI (-0.01, 0.06),
P
=0.10
]
and low-density lipoprotein cholesterol [MD=-0.10, 95%CI (-0.27, 0.07),
P
=0.23
]
and body mass index [MD=0.07, 95%CI (-0.26, 0.40),
P
=0.68
]
. Subgroup analysis based on different intervention measures showed that the levels of
γ
-glutamyl transferase, liver stiffness measurement, and homeostatic model assessment of insulin resistance in the synbiotic group were not significantly improved compared to the control group, with consistent results for the remaining outcomes. Egger’s test results showed no publication bias.
CONCLUSIONS
2
The probiotic therapy can regulate liver function indexes, liver stiffness measurement and insulin resistance levels in patients with NAFLD well.
益生菌非酒精性脂肪性肝病安全性有效性Meta分析
nonalcoholic fatty liver diseasesafetyefficacymeta-analysis
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