复方丹参滴丸改善阿司匹林抵抗有效性和安全性的Meta分析
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篇名: 复方丹参滴丸改善阿司匹林抵抗有效性和安全性的Meta分析
TITLE: Meta-analysis of the Effectiveness and Safety of Compound Danshen Dripping Pills in Improving Aspirin Resistance
摘要: 目的:系统评价复方丹参滴丸改善阿司匹林抵抗的有效性与安全性,为临床用药提供循证参考。方法:计算机检索中国知网、维普网、万方数据、中国生物医学文献数据库、PubMed、Embase、Cochrane图书馆等数据库,收集复方丹参滴丸(试验组)对比阿司匹林(对照组)的随机对照研究(RCT),检索时限均为各数据库建库起至2020年9月。筛选文献、提取数据后,采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具对纳入文献质量进行评价,采用RevMan5.3软件进行Meta分析、发表偏倚分析。结果:共纳入10项RCT,共计800例患者。Meta分析结果显示,试验组患者二磷酸腺苷(ADP)诱导的血小板聚集率(PAR)显著低于对照组[SMD=-2.63,95%CI(-3.56,-1.70),P<0.00001];按治疗周期进行的亚组分析结果显示,治疗2周[SMD=-2.11,95%CI(-2.75,-1.46),P<0.00001]、治疗4周[SMD=-2.84,95%CI(-4.26,-1.41),P<0.0001]、治疗8周[SMD=-2.63,95%CI(-3.21,-2.04),P<0.00001]时试验组患者ADP诱导的PAR均显著低于对照组。试验组患者花生四烯酸(AA)诱导的PAR显著低于对照组[SMD=-2.44,95%CI(-3.64,-1.24),P<0.0001];按治疗周期进行的亚组分析结果显示,治疗2周[SMD=-2.56,95%CI(-3.26,-1.85),P<0.00001]、治疗4周[SMD=-2.45,95%CI(-4.79,-0.10),P=0.04]、治疗8周[SMD=-2.38,95%CI(-2.94,-1.82),P<0.00001]时试验组患者AA诱导的PAR均显著低于对照组。试验组患者治疗后ADP诱导的PAR下降值[SMD=2.24,95%CI(1.36,3.13),P<0.00001]、AA诱导的PAR下降值[SMD=2.42,95%CI(1.94,2.89),P<0.00001]、有效率[RR=8.56,95%CI(4.38,16.74),P<0.00001]均显著高于对照组,试验组患者普通不良反应发生率[RR=0.30,95%CI(0.15,0.60),P=0.0006]、缺血事件发生率[RR=0.13,95%CI(0.07,0.27),P<0.00001]和治疗后CR、PF(P<0.05)均显著低于对照组;两组患者出血事件发生率比较,差异无统计学意义[RR=0.78,95%CI(0.34,1.78),P=0.55]。发表偏倚结果显示,本研究存在发表偏倚的可能性较小。结论:复方丹参滴丸可有效改善患者阿司匹林抵抗,且安全性较好。
ABSTRACT: OBJECTIVE:To systematically evaluate the effectiveness and safety of Compound danshen dripping pills in improving aspirin resistance ,and to provide evidence-based evidence for clinical drug use. METHODS :Retrieved from CNKI , VIP,Wanfang database ,CBM,PubMed,Embase,the Cochrane L ibrary,randomized controlled trials (RCTs)about Compound danshen dripping pills (trial group )versus aspirin (control group )were collected during the inception to Jun. 2020. After literature screening and data extraction ,bias risk assessment tool recommended by the Cochrane evaluation manual handbook 5.1.0 was used to evaluate the quality of the included literatures ,and Rev Man 5.3 software was used for Meta-analysis and publication bias analysis. RESULTS :A total of 10 RCTs were included ,with a total of 800 patients. Meta-analysis showed that the platelet aggregation rate (PAR)induced by adenosine diphosphate (ADP)in trial group was significantly lower than that of control group [SMD =-2.63,95%CI(-3.56,-1.70),P<0.000 01]. Results of sub-group analysis by treatment cycle showed that PAR induced by ADP in trial group after 2 weeks of treatment [SMD =-2.11,95%CI(-2.75,-1.46),P<0.000 01],4 weeks of treatment [SMD =-2.84,95%CI(-4.26,-1.41),P<0.000 1] Δ 基金项目 :国家重点研发计划中医药现代化研究重点专项 and 8 weeks of treatment [SMD =-2.63,95%CI(-3.21, (No.2019YFC1710000,No.2019YFC1710003);国家中医药管理局中 - 2.04),P<0.000 01] was significantly lower than control 医药循证能力建设项目(No.2019XZZX-XXG003);河南省创新型科技 团队项目 group. PAR induced by arachidonic acid (AA)of trial group *硕士研究生 。研究方向:中西医结合心血管疾病的预防和治 was significantly lower than that of control group [SMD = 疗。E-mail:guohongxin1214@163.com -2.44,95%CI(-3.64,-1.24),P<0.000 1]. Results of # 通信作者:主任医师,教授,硕士生导师,博士。研究方向:中医 sub-group analysis by treatment cycle showed that PAR 药防治心血管疾病的临床和基础 。电话:0371-66233478。E-mail: induced by AA in trial group after 2 weeks of tre atment [SMD = zhumingjun317@163.com -2.56,95%CI(-3.26,-1.85),P<0.000 01],4 weeks of 中国药房 2021年第32卷第6期 China Pharmacy 2021Vol. 32 No. 6 ·743· treatment of [SMD =-2.45,95%CI(-4.79,-0.10),P=0.04],8 weeks of treatment [SMD =-2.38,95%CI(-2.94,-1.82),P< 0.000 01] was significantly lower than control group. The decrease of ADP-induced PAR [SMD =2.24,95%CI(1.36,3.13),P< 0.000 01],AA-induced PAR [SMD =2.42,95%CI(1.94,2.89),P<0.000 01] and response rate [RR =8.56,95%CI(4.38,16.74), P<0.000 01] in trial group were significantly higher than control group ,while the incidence of ADR [RR =0.30,95%CI(0.15, 0.60),P=0.000 6],the incidence of ischemic events [RR =0.13,95%CI(0.07,0.27),P<0.000 01],CR and RF after treatment (P<0.05)were significantly lower than control group. There was no statistical significant difference in the incidence of bleeding events between 2 groups [RR =0.78,95% CI(0.34,1.78),P=0.55]. The results of publication bias showed that there was less possibility of publication bias in this study. CONCLUSIONS :Compound danshen dripping pills can effectively improve aspirin resistance and has good safety.
期刊: 2021年第32卷第06期
作者: 郭红鑫,乔利杰,卫靖靖,于瑞,李彬,彭广操,王永霞,朱明军
AUTHORS: GUO Hongxin ,QIAO Lijie,WEI Jingjing ,YU Rui,LI Bin,PENG Guangcao ,WANG Yongxia ,ZHU Mingjun
关键字: 复方丹参滴丸;阿司匹林抵抗;Meta分析;有效性;安全性
KEYWORDS: Compound danshen dripping pills ;Aspirin resistance ;Meta-analysis;Efficacy;Safety
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