针刺疗法干预高脂血症有效性和安全性的Meta分析

Efficacy and Safety of Acupuncture Therapy in Treating Hyperlipidemia:a Systematic Review and Meta-analysis of Randomized Controlled Trials

背景调控血脂对预防心血管疾病的发生至关重要,国内外相关指南推荐的他汀类药物可降低低密度脂蛋白胆固醇(LDL-C)水平,但不良反应多有发生,阻碍了患者坚持按照推荐剂量用药。中医药在防治慢性病方面具有独特优势,临床研究发现针灸与他汀类药物调脂效果相仿,但不良反应少。目的系统评价针刺疗法干预高脂血症的有效性和安全性。方法计算机检索中国知网(CNKI)、万方数据知识服务平台(Wanfang Data)、中文科技期刊全文数据库(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、the Cochrane Library中关于比较针刺疗法与口服他汀类药物治疗高脂血症患者有效性和安全性的随机对照试验,其中试验组采用单一的针刺疗法,对照组以指南推荐的他汀类药物治疗为主。检索时限为建库至2019-12-31。根据Cochrane评价标准进行文献筛选、资料提取和质量评价,采用RevMan 5.4软件进行Meta分析。结果共纳入15篇文献,包含1347例患者。Meta分析结果显示,试验组与对照组总有效率及治疗后总胆固醇(TC)、LDL-C、三酰甘油(TG)、体质指数(BMI)比较,差异均无统计学意义〔OR=1.28,95%CI(0.77,2.15),P=0.34;MD=-0.06,95%CI(-0.13,0.02),P=0.13;MD=0.11,95%CI(-0.07,0.28),P=0.24;MD=0.01,95%CI(-0.09,0.12),P=0.84;MD=-0.81,95%CI(-2.75,1.13),P=0.41〕。试验组治疗后高密度脂蛋白胆固醇(HDL-C)高于对照组〔MD=0.16,95%CI(0.04,0.28),P=0.009〕,中医症状积分、不良反应发生率低于对照组〔MD=-3.19,95%CI(-4.52,-1.87),P<0.00001;OR=0.28,95%CI(0.14,0.59),P=0.0007〕。试验组中医临床疗效优于对照组〔OR=3.86,95%CI(1.97,7.56),P<0.0001〕。对报道总有效率的RCT进行漏斗图分析,结果显示漏斗图图形不对称,提示可能存在发表偏倚。结论基于当前临床证据,针刺疗法治疗高脂血症在升高HDL-C方面优于他汀类药物,并在降低中医症状积分、改善中医临床疗效方面具有优势且不良反应小;但纳入研究质量不高,仍需要更多高质量随机双盲对照试验增加其证据强度。

Background Lipid regulation is critical to preventing cardiovascular diseases.Statins recommended by domestic and international guidelines can bring down LDL-C levels.However,adverse reactions,which are observed frequently,affect patients’ compliance with the recommended dose.Chinese medicine has a unique advantage in the prevention and treatment of chronic diseases.Clinical studies have revealed that acupuncture therapy is similar to statins in regulating lipids with less adverse reactions.Objective To systematically evaluate the effectiveness and safety of acupuncture therapy in treating hyperlipidemia.Methods Databases of CNKI,Wanfang Data,VIP,SinoMed,PubMed,and the Cochrane Library were searched from inception to December 31,2019 for randomized controlled trials(RCTs) comparing efficacy and safety in hyperlipidemia patients treated with acupuncture therapy(experimental group) and oral statins recommended by guidelines(control group).Literature screening,data extraction and quality evaluation were performed according to Cochrane Reviewers’ Handbook.Meta-analysis was performed using RevMan 5.4.Results Fifteen RCTs with 1 347 patients were included.Meta-analysis results demonstrated that there were no statistically significant differences in overall response rate,mean post-treatment TC,LDL-C,TG and BMI between the two groups〔OR=1.28,95%CI(0.77,2.15),P=0.34;MD=-0.06,95%CI(-0.13,0.02),P=0.13;MD=0.11,95%CI(-0.07,0.28),P=0.24;MD=0.01,95%CI(-0.09,0.12),P=0.84;MD=-0.81,95%CI(-2.75,1.13),P=0.41〕.The mean HDL-C level in the experimental group was higher〔MD=0.16,95%CI(0.04,0.28),P=0.009〕.The post-treatment mean TCM symptom score and incidence of adverse reactions in the experimental group were lower〔MD=-3.19,95%CI(-4.52,-1.87),P<0.000 01;OR=0.28,95%CI(0.14,0.59),P=0.000 7〕.The clinical TCM efficacy in the experimental group outperformed that of the control group〔OR=3.86,95%CI(1.97,7.56),P<0.000 1〕.Analysis of the RCTs in terms of the overall response rate of participants presented an asymmetrical funnel graphic,indicating the presence of publication bias.Conclusion The available clinical evidence indicates that acupuncture therapy is superior to statins for hyperlipidemia in terms of improving HDL-C and clinical TCM efficacy,reducing TCM symptom score with fewer adverse reactions.However,since quality of the included research was not high,the conclusion still needs to be tested in more high-quality,double-blind RCTs.