Meta-analysis of the effectiveness and safety of tandospirone citrate in the treatment of functional dyspepsia. [J]. Journal of Southwest Medical University 45(4):315-321(2022)
DOI:
Meta-analysis of the effectiveness and safety of tandospirone citrate in the treatment of functional dyspepsia. [J]. Journal of Southwest Medical University 45(4):315-321(2022) 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
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。
Abstract
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.