首页|多烯磷脂酰胆碱注射液治疗酒精性肝病的系统评价与Meta分析

多烯磷脂酰胆碱注射液治疗酒精性肝病的系统评价与Meta分析

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目的 系统评价多烯磷脂酰胆碱注射液治疗酒精性肝病(ALD)的有效性和安全性。方法 计算机检索 PubMed、Embase、the Cochrane L ibrary、ClinicalTrial。gov、中国知网、SinoMed、维普和万方数据库,搜集有关多烯磷脂酰胆碱注射液治疗ALD的随机对照临床试验(RCT),检索时限均为建库至2022年12月31日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,使用Stata 17。0软件进行随机效应模型的Meta分析。结果 最终纳入10个RCT,包含809例患者。Meta分析结果显示,多烯磷脂酰胆碱注射液组的有效率高于对照组[RR=1。12,95%CI(1。04,1。20),P=0。003 8];与对照组相比,多烯磷脂酰胆碱注射液可以降低丙氨酸氨基转移酶(ALT)水平[MD=-18。92 U/L,95%CI(-27。75,-10。09),P<0。001]、天门冬氨酸氨基转移酶(AST)水平[MD=-31。19 U/L,95%CI(-46。27,-16。11),P=0。000 1]、总胆红素(TBiL)水平[MD=-7。31μmol/L,95%CI(-10。75,-3。88),P<0。001]和 γ-谷氨酰转肽酶(GGT)水平[MD=-48。93 U/L,95%CI(-54。64,-43。21),P<0。001]。仅1项研究报告了轻度的不良反应,6项研究均报告患者未出现明显不良反应。结论 当前证据显示,多烯磷脂酰胆碱注射液治疗ALD可以提高有效率,改善肝功能指标(ALT、AST、TBiL、GGT)的水平,不良反应较少。受纳入研究数量和质量的限制,上述结论尚需开展更多高质量研究予以验证。
Polyene phosphatidylcholine injection in the treatment of alcoholic liver disease:a systematic review and Meta-analysis
Objective To evaluate the efficacy and safety of polyene phosphatidylcholine injection in the treatment of liver disease.Methods Pubmed,Embase,The Cochrane Library,ClinicalTrial.gov,CNKI,SinoMed,VIP,and WanFang Data were electronically searched to collect randomized controlled trials(RCTs)of polyene phosphatidylcholine injection in the treatment of liver disease from inception to December 31st,2022.Two researchers independently screened literature,extracted data and assessed the risk of bias of the included studies.The Meta-analysis was performed using Stata 17.0 software.Results A total of 10 RCTs were included,including 809 patients.Meta-analysis showed that the effective rate in the polyene phosphatidylcholine injection group was higher than that in the control group(RR=1.12,95%CI 1.04 to 1.20,P=0.003 8).Compared with the control group,polyene phosphatidylcholine injection could decrease ALT level(MD=-18.92 U/L,95%CI-27.75 to-10.09,P<0.001),AST level(MD=-31.19 U/L,95%CI-46.27 to-16.11,P=0.000 1),TBiL level(MD=-7.31 μmol/L,95%CI-10.75 to-3.88,P<0.001),and GGT levels(MD=-48.93 U/L,95%CI-54.64 to-43.21,P<0.001).Only one study reported mild adverse events,and six studies reported no severe adverse events in patients.Conclusion Current evidence shows that polyene phosphatidylcholine injection in the treatment of alcoholic liver disease can increase the effective rate,improve the levels of liver function indicators(ALT,AST,TBiL,and GGT),and has less adverse events.Due to the limited number and quality of included studies,the above conclusions need to be verified by more high-quality studies.

Polyene phosphatidylcholineAlcoholic liver diseaseEfficacyMeta-analysisRandomized controlled trial

曾保起、章萌、刘晓智、盛凤、孙凤

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天津市第五中心医院(北京大学滨海医院)中心实验室(天津 300450)

北京大学公共卫生学院流行病与卫生统计学系(北京 100191)

重大疾病流行病学教育部重点实验室(北京大学)(北京 100191)

多烯磷脂酰胆碱 酒精性肝病 有效性 Meta分析 随机对照试验

中国中医药循证医学中心业务研究室主任专项中国药品监管科学行动计划第二批重点项目

2020YJSZX-2[2021]37-10

2024

中国药师
国家药品监督管理局高级研修学院,武汉医药(集团)股份有限公司

中国药师

CSTPCD
影响因子:0.944
ISSN:1008-049X
年,卷(期):2024.27(1)
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