托伐普坦治疗低钠血症有效性与安全性的系统评价/Meta分析再评价

Efficacy and safety of tolvaptan for hyponatremia:an overview of systematic reviews/meta-analysis

目的 对托伐普坦治疗低钠血症有效性和安全性的系统评价/Meta分析进行再评价。方法 计算机检索中国知网、万方数据、维普网、中国生物医学文献服务系统、PubMed、Embase、the Cochrane Library,收集托伐普坦治疗低钠血症的系统评价/Meta分析,检索时限为建库起至2022年6月15日。筛选文献、提取资料后,采用PRISMA声明评价纳入文献的报告质量,采用AMSTAR2量表评价纳入文献的方法学质量,采用GRADE工具评价纳入文献结局指标的证据质量。结果 共纳入6篇文献,其中1篇为系统评价,5篇为Meta分析,共56个结局指标。PRISMA评分为15.0~20.5分,报告质量均为中等。AMSTAR2量表评价结果显示,5篇文献的方法学质量等级为极低质量,1篇文献为低质量。GRADE证据质量评价结果显示,中级指标6个,低级指标13个,极低级指标35个,无法评价指标2个,造成降级的主要因素为局限性、不一致性、不精确性及发表偏倚。在有效性方面,托伐普坦可有效升高患者的血清钠浓度、增加尿量、降低体质量、缩小腹围、缓解水肿、降低丙氨酸转氨酶水平。在安全性方面,托伐普坦引起的总不良反应发生率存在争议,可能会增加患者口干、口渴、尿频、血清钠过度校正的发生风险。结论 托伐普坦治疗低钠血症的有效性较好,安全性方面应避免血清钠过度校正的发生,但目前相关系统评价/Meta分析的报告质量、方法学质量和证据质量较低,可能会降低结果的可靠性,应谨慎解读。

OBJECTIVE To reevaluate systematic reviews/meta-analysis of efficacy and safety of tolvaptan for hyponatremia.METHODS Retrieved from CNKI,Wanfang Data,VIP,CBM,PubMed,Embase and the Cochrane Library database,systematic reviews/meta-analysis about tolvaptan for the treatment of hyponatremia were included from the inception to June 15,2022.After screening literature and extracting data,the PRISMA statement,AMSTAR 2 scale and GRADE method were used to evaluate the reporting quality,methodological quality and evidence quality of the included literature,respectively.RESULTS A total of 6 articles were included,of which 1 was systematic review and 5 were meta-analysis,including 56 outcome indicators.All of the 6 studies had PRISMA scores ranging from 15.0 to 20.5,and the quality of them was moderate.Results of the AMSTAR 2 scale showed that the methodological quality of 5 literatures were very low,and the quality of 1 literature was low.The quality of GRADE evidence showed that there were 6 moderate-quality indicators,13 low-quality indicators,35 very low-quality indicators,and 2 indicators that could not be assessed due to missing data.The main factors causing degradation were limitations,inconsistency,imprecision and publication bias.In terms of efficacy,tolvaptan could effectively increase the level of serum sodium,increase urine volume,reduce body weight,reduce abdominal circumference,relieve edema,and reduce alanine transaminase level.In terms of safety,the incidence of total adverse drug reaction induced by tolvaptan was controversial;it may increase the risk of dry mouth,thirst,frequent urination or excessive correction of serum sodium. CONCLUSIONS Tolvaptan has great efficacy in the treatment of hyponatremia,but serum sodium overcorrection should be avoided in terms of safety. Relevant systematic reviews/meta-analysis have shortcomingsof low reporting quality, methodological quality and evidence quality, which may reduce the reliability of the results, so the resultsshould be treated with caution.