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1. 厅市共建中枢神经系统药物四川省重点实验室,泸州,646000
2. 四川科瑞德制药股份有限公司,泸州,646000
3. 成都大学附属医院 麻醉科,成都,610081
纸质出版日期:2022,
网络出版日期:2022-7-20,
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雷奇林, 游正华, 黄振原, 等. 枸橼酸坦度螺酮治疗功能性消化不良有效性与安全性的Meta分析[J]. 西南医科大学学报, 2022,45(4):315-321.
Meta-analysis of the effectiveness and safety of tandospirone citrate in the treatment of functional dyspepsia[J]. Journal of Southwest Medical University, 2022,45(4):315-321.
雷奇林, 游正华, 黄振原, 等. 枸橼酸坦度螺酮治疗功能性消化不良有效性与安全性的Meta分析[J]. 西南医科大学学报, 2022,45(4):315-321. DOI: 10.3969/j.issn.2096-3351.2022.04.007.
Meta-analysis of the effectiveness and safety of tandospirone citrate in the treatment of functional dyspepsia[J]. Journal of Southwest Medical University, 2022,45(4):315-321. DOI: 10.3969/j.issn.2096-3351.2022.04.007.
目的 评价枸橼酸坦度螺酮治疗功能性消化不良的有效性及安全性。 方法 检索中国知网(CNKI)、万方(WanFang)、维普(VIP)、PubMed、Web of Science、谷歌学术(Google Scholar)、Clinical Trials等数据库,对建库至2020年8月国内外公开发表的有关于枸橼酸坦度螺酮治疗功能性消化不良的临床随机对照试验(RCT)进行搜集。采用Cochrance协作网“偏倚风险”评价工具对纳入的研究进行方法学质量评价。采用RevMan 5.3软件进行Meta分析。 结果 根据入选标准,本研究共纳入8项RCT,总共包含746例功能性消化不良病人。其中试验组(单用坦度螺酮或坦度螺酮联用其它药物)380例,对照组(使用安慰剂或除坦度螺酮外的其它药物)366例。6项RCT采用了随机序列方法,2项研究按入院顺序或就诊序列生成。部分RCT中存在脱落情况,但由于脱落病人数量很少,未对结果产生显著影响。所有研究中均报告了功能性消化不良的重要结局指标,选择性报告风险偏倚较小。Meta分析结果显示:试验组的总体有效率明显高于对照组(OR:5.25,95% CI:3.65~7.56
P < 0.00001),不良反应发生率无显著性差异(OR:1.58,95% CI:0.52~4.77
P = 0.42),但当坦度螺酮与其它5-HT受体激动剂(如莫沙必利)联用时,可能增加不良反应的发生率。 结论 相较于常规治疗方式,枸橼酸坦度螺酮在功能性消化不良,特别是伴有焦虑状态的功能性消化不良的治疗中疗效好,不良反应率低。同时建议临床上在坦度螺酮与其它5-HT受体激动剂药物联用时进行评估,以减少不良反应的发生。
Objective To evaluate the efficacy and safety of tandospirone citrate in the treatment of functional dyspepsia. Method Randomized controlled trials (RCT) of tandospirone citrate in the treatment of functional dyspepsia were searched in databases including CNKI,Wan Fang,VIP,PubMed,Web of Science,Google Scholar and Clinical Trials,from the inception of these databases to August 2020. The methodological quality of the included RCTs was evaluated via the Cochrane Risk of Bias tool,and the RevMan 5.3 software was used for Meta-analysis. Result 8 RCTs were included,involving 746 patients with FD. The experimental group included 380 patients (using tandospirone alone or tandospirone in combination with other drugs),and the control group included 366 patients (using placebo or other drugs except tandospirone). The random sequence method was utilized in 6 RCTs,and the sequence were generated according to admission or visit order in other 2 studies. There were cases of lost to follow-up or drop-outs in some RCTs,which did not significantly affect the results due to the small number of these cases. All RCTs reported key outcomes of FD,which made selective reporting bias in a low risk. Meta-analysis results indicated that the overall effective rate in experimental group was significantly higher than the control group (OR:5.25
95%CI:3.65 ~ 7.56,P<0.00001),and the incident of adverse reaction has no significant difference between experiment group and control group (OR:1.58
95%CI:0.52 ~ 4.77,P = 0.42). Whereas,more adverse reactions could happen when tandospirone combined with other 5-HT receptor agonists (e.g. Mosapride). Conclusion Compared with conventional treatment,tandospirone citrate is effective in the treatment of functional dyspepsia,especially functional dyspepsia with anxiety,and the rate of adverse reactions is lower. Meanwhile,it is recommended to evaluate tandospirone in combination with other 5-HT agonists to reduce the incidence of adverse reactions.
枸橼酸坦度螺酮功能性消化不良FD症状分数焦虑分数系统评价
Tandospirone citrateFunctional dyspepsiaFD symptom scoreAnxiety scoreSystem evaluation
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