Page 97 - 《中国药房》2023年8期

·循证药学·

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
Δ

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梁笑笑 1， 2＊ ，吕淑贤 ，陈世贤 ，李 晓 ，李 羚 ，黄 欣 1， 2 # [1.山东中医药大学药学院，济南 250355；2.山东第
1
2
一医科大学第一附属医院（山东省千佛山医院）药学部，济南 250014；3.山东第一医科大学药学院，济南
250000]

中图分类号 R979.9 文献标志码 A 文章编号 1001-0408（2023）08-0983-06
DOI 10.6039/j.issn.1001-0408.2023.08.17

摘 要 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。
关键词 托伐普坦；低钠血症；有效性；安全性；系统评价；Meta分析；再评价

Efficacy and safety of tolvaptan for hyponatremia：an overview of systematic reviews/meta-analysis
LIANG Xiaoxiao ，LYU Shuxian ，CHEN Shixian ，LI Xiao ，LI Ling ，HUANG Xin [1. School of Pharmacy，
1
1， 2
3
2
1， 2
2
Shandong University of Traditional Chinese Medicine， Jinan 250355， China；2. Dept. of Pharmacy， the First
Affiliated Hospital of Shandong First Medical University（Shandong Provincial Qianfoshan Hospital）， Jinan
250014， China；3. School of Pharmacy， Shandong First Medical University， Jinan 250000， China]
ABSTRACT 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
Δ 基金项目 国家自然科学基金资助项目（No.82104222）
abdominal circumference， relieve edema， and reduce alanine
＊第一作者 硕士研究生。研究方向：临床药学。电话：0531-
89268352。E-mail：1695536538@qq.com transaminase level. In terms of safety， the incidence of total
# 通信作者 主任药师，硕士生导师。研究方向：临床药学。电话： adverse drug reaction induced by tolvaptan was controversial；
0531-89268352。E-mail：13791120711@126.com it may increase the risk of dry mouth， thirst， frequent

中国药房 2023年第34卷第8期 China Pharmacy 2023 Vol. 34 No. 8 · 983 ·