常规降脂治疗对 PCSK9 循环水平的影响：系统评价和随机对照试验荟萃分析方案。
Impact of conventional lipid-lowering therapy on circulating levels of PCSK9: protocol for a systematic review and meta-analysis of randomised controlled trials.
机构信息
China International Neuroscience Institute (China-INI), Beijing, China.
Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
出版信息
BMJ Open. 2022 Sep 8;12(9):e061884. doi: 10.1136/bmjopen-2022-061884.
INTRODUCTION
Conventional lipid-lowering agents, including statins, ezetimibe, fibrates, bile acid sequestrants, nicotinic acid, bempedoic acid and Omega-3, are essential to the management of dyslipidaemia. However, these agents have been shown to increase the level of plasma proprotein convertase subtilisin/kexin 9 (PCSK9), a serine protease associated with increased cardiovascular risk. This review aims to investigate the impact of commonly available conventional lipid-lowering agents on circulating PCSK9 levels and lipid profiles.
METHODS AND ANALYSIS
This protocol is conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. A systematic search will be conducted in the following databases: MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Web of Science, SCOPUS and ScienceDirect. Additional information will be retrieved from clinical trial registries or from reference list searches. Published and peer-reviewed randomised controlled trials with adults receiving statin, ezetimibe, fibrate, bile acid sequestrant, nicotinic acid, bempedoic acid or Omega-3 monotherapy or in combination for at least 2 weeks, with availability of plasma PCSK9 at the beginning and end of treatment or the net changes in values, will be included. Study selection, data extraction and assessment of the risk of bias will be independently conducted by two investigators. Continuous data will be presented as a standardised mean difference with 95% confidence interval (CI) and dichotomous data as risk ratios with 95% CI. Subgroup analysis and sensitivity analysis will be performed when sufficient studies are included. Publication bias will be assessed with a funnel plot and Egger's test.
ETHICS AND DISSEMINATION
Ethics approval is not required as this review will only include data from published sources. The results will be published in a peer-reviewed journal.
PATIENT AND PUBLIC INVOLVEMENT
No patient or members of the general public are involved.
PROSPERO REGISTRATION NUMBER
CRD42022297942.
简介
传统的降脂药物，包括他汀类药物、依折麦布、贝特类药物、胆汁酸螯合剂、烟酸、贝匹莫德酸和欧米伽-3，对于血脂异常的治疗至关重要。然而，这些药物已被证明会增加血浆前蛋白转化酶枯草溶菌素/克那霉 9（PCSK9）的水平，PCSK9 是一种与心血管风险增加相关的丝氨酸蛋白酶。本综述旨在探讨常用的传统降脂药物对循环 PCSK9 水平和血脂谱的影响。
方法和分析
本方案按照系统评价和荟萃分析方案的首选报告项目进行。将在以下数据库中进行系统搜索：MEDLINE、Cochrane 对照试验中心注册库（CENTRAL）、EMBASE、Web of Science、SCOPUS 和 ScienceDirect。还将从临床试验注册处或参考文献搜索中获取额外信息。纳入的研究为接受他汀类药物、依折麦布、贝特类药物、胆汁酸螯合剂、烟酸、贝匹莫德酸或欧米伽-3 单药或联合治疗至少 2 周的成年患者的已发表和同行评议的随机对照试验，且在治疗开始和结束时或在值的净变化时具有血浆 PCSK9 的可用数据。两名研究者将独立进行研究选择、数据提取和偏倚风险评估。连续数据将以标准化均数差（SMD）及其 95%置信区间（CI）表示，二分类数据将以风险比（RR）及其 95%CI 表示。如果纳入足够的研究，将进行亚组分析和敏感性分析。将使用漏斗图和 Egger 检验评估发表偏倚。
伦理和传播
由于本综述仅包括已发表来源的数据，因此不需要伦理批准。研究结果将发表在同行评议的期刊上。
患者和公众参与
没有患者或公众成员参与。
PROSPERO 注册号：CRD42022297942。
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