枸橼酸坦度螺酮治疗广泛性焦虑症有效性和安全性的系统评价

Efficacy and Safety of Citric Acid Tandospirone Citrate in the Treatment of Generalized Anxiety Disorder:A Systematic Review

目的系统评价枸橼酸坦度螺酮治疗广泛性焦虑症(GAD)的有效性和安全性,为临床提供循证参考。方法计算机检索Pub Med、EMbase、the Cochrane Library、中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普中文期刊数据库(VIP)和万方数据库(Wanfang Data),搜集枸橼酸坦度螺酮治疗GAD的相关随机对照试验(RCT),时间为建库至2016年11月,提取资料并进行质量评估后,采用Rev Man 5.3版软件进行Meta分析。结果共纳入5个RCT,受试者500例。Meta分析结果显示,试验组汉密尔顿焦虑量表(HAMA)评分和对照组比较差异无统计学意义[MD=0.47,95%CI(-0.51,1.45),P=0.34];试验组总有效率和对照组比较差异无统计学意义[OR=1.03,95%CI(0.64,1.67),P=0.90]。试验组不良反应发生率明显低于对照组,差异有统计学意义[OR=0.65,95%CI(0.44,0.95),P=0.03]。结论枸橼酸坦度螺酮治疗GAD临床疗效确切,不良反应轻微,安全性较好。

Objective To systematically review the efficacy and safety of tandospirone in the treatment of generalized anxiety disorder( GAD) and to provide evidence-based references for clinic. Methods Databases include Pub Med,EMbase,The Cochrane Library,CBM,CNKI,VIP and Wanfang Data were electronically searched from the inception to November 2016,to collect randomized controlled trials( RCTs) about the tandospirone citrate in the treatment of generalized anxiety disorder.Meta-analysis was performed by Rev Man5.3 software after data extraction and quality evaluation. Results A total of 5 RCTs involving 500 patients were included.The results of Meta-analysis showed no significant differences in the Hamilton Anxiety Scale( HAMA) score between experimental group and control group[MD = 0.47,95%CI(-0.51,1.45),P = 0.34]; and there was no significant differences of total effective rate between experimental group and control group [OR = 1.03,95% CI( 0.64,1.67),P = 0.90]. The incidence of adverse reactions in experimental group was significantly lower than that of control group,the difference was statistically significant[OR = 0.65,95%CI( 0.44,0.95),P = 0.03]. Conclusion Tandospirone citrate,as a new type of non-BZDs of antianxiety drug,shows exact clinical curative effect in the treatment of generalized anxiety disorder with mild adverse reaction and good safety.