心脉隆注射液治疗心力衰竭安全性的Meta分析
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篇名: 心脉隆注射液治疗心力衰竭安全性的Meta分析
TITLE:
摘要: 目的:系统评价心脉隆注射液治疗心力衰竭的安全性。方法:计算机检索PubMed、Cochrane图书馆、万方数据库、中国知网数据库和维普数据库,并人工检索相关会议论文集,收集心脉隆注射液联合常规治疗(试验组)对比常规治疗(对照组)用于心力衰竭的随机对照试验(RCT)和观察性研究,提取相关资料并按照改良Jadad量表(RCT)及纽卡斯尔-渥太华量表(NOS)(观察性研究)评价文献质量后,采用Rev Man 5.3统计软件进行Meta分析。结果:共纳入25项研究,其中18项为RCT,7项为观察性研究;共计2 778例患者,其中试验组1 421例,对照组1 357例。试验组有106例患者发生不良反应(7.46%),对照组有68例患者发生不良反应(5.01%)。Meta分析结果显示,试验组患者不良反应总发生率[RR=1.45,95%CI(1.09,1.91),P=0.01]、皮肤不良反应发生率[RR=2.04,95%CI(1.05,3.96),P=0.03]均显著高于对照组;两组患者神经系统、循环系统、消化系统、全身性损害及其他不良反应发生率比较,差异均无统计学意义(P>0.05)。结论:心脉隆注射液治疗心力衰竭的不良反应发生率相对较高,临床应警惕皮肤不良反应的发生。
ABSTRACT: OBJECTIVE: To conduct a systematic review on the safety of Xinmailong injection in the treatment of heart failure. METHODS: PubMed, Cochrane library, Wanfang database, CNKI and VIP were retrieved, and meanwhile related meeting reports were retrieved manually. RCTs and observational study about Xinmailong injection combined with routine treatment (trial group) vs. routine treatment (control group) in the treatment of heart failure were collected. After extracting data and evaluating literature quality according to Jadad scale (RCTs) and NOS score (observational trials); Meta-analysis was carried out using the Rev Man 5.3 statistical software. RESULTS: A total of 25 studies were included, involving 18 RCTs and 7 observational trials. There were 2 778 patients in totally, including 1 421 cases in trial group and 1 357 cases in control group. Totally 106 patients had ADR in trial group (7.46%) while 68 patients in control group (5.01%) had ADR. Results of Meta-analysis showed that the incidence of overall ADR [RR=1.45,95%CI(1.09,1.91),P=0.01] and the incidence of skin ADR [RR=2.04,95%CI(1.05,3.96),P=0.03] in trial group were significantly higher than control group. There was no statistical significance in the incidence of ADR in nervous system, circulatory system, digestive system or systemic injury and other between 2 groups (P>0.05). CONCLUSIONS: For heart failure, Xinmailong injection has a high incidence of ADR. The occurrence of skin ADR should be paid attention in clinic.
期刊: 2018年第29卷第22期
作者: 刘志强,刘和波,王博龙
AUTHORS: LIU Zhiqiang,LIU Hebo,WANG Bolong
关键字: 心脉隆注射液;心力衰竭;安全性;Meta分析
KEYWORDS: Xinmailong injection; Heart failure; Safety; Meta-analysis
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