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目的:系统评价托伐普坦治疗低钠血症患者的疗效与安全性。方法:计算机检索中国期刊全文数据库(CNKI)、万方数据知识服务平台、中文科技期刊数据库(VIP)、Pub Med、Web of Science、Springer等数据库,检索时间为2000至2015年6月,纳入关于托伐普坦治疗低钠血症患者疗效及安全性的随机对照试验(randomized controlled trials,RCTs),由2名评价者按照纳入与排除标准,独立筛选文献,提取资料并用Jadad量表评价纳入研究的方法学质量,采用R3.1.3软件进行Meta分析。结果:纳入14篇RCTs,包含低钠血症患者1 324例(托伐普坦组678例,对照组646例)。Meta分析结果显示:1疗效:托伐普坦组治疗前后血清钠浓度差值大于对照组,WMD=3.33 mmol/L(90%CI=2.90~3.75,Z=12.95,P=0.000);血清钠浓度恢复正常率高于对照组,RR=2.61(90%CI=2.13~3.21,Z=7.70,P=0.000);24 h尿量多于对照组,WMD=812.82 ml(90%CI=534.90~1 090.75,Z=4.81,P=0.000);净液体平衡变化(尿量与液体摄入量差值)多于对照组,WMD=750.54 ml(90%CI=464.44~1 036.63,Z=4.32,P=0.000);2安全性:托伐普坦组与对照组的不良反应发生率和死亡率无统计学差异,RR分别为0.99(90%CI=0.86~1.13,Z=-0.184,P=0.854)和1.15(90%CI=0.78~1.69,Z=0.582,P=0.561)。结论:托伐普坦可显著提高血清钠浓度、血清钠恢复正常率,增加24 h尿量、净液体平衡变化,且不增加不良反应发生率及死亡率。
Objective: To systematically evaluate the efficacy and safety of tolvaptan in the treatment of patients with hyponatremia. Methods: The databases of Chinese Journal Full-text Database (CNKI), Wanfang Data Knowledge Service Platform, Chinese Science and Technology Periodical Database (VIP), Pub Med, Web of Science and Springer were searched by computer. The search time was from 2000 to June 2015, Randomized controlled trials (RCTs) of tolvaptan in the treatment of patients with hyponatremia were randomized controlled trials (RCTs). Two reviewers independently screened the literature according to inclusion and exclusion criteria. Data were extracted and included in the study using the Jadad scale The methodological quality, using R3.1.3 software for meta-analysis. Results: A total of 14 RCTs were included, including 1 324 cases of hyponatremia (678 cases in tolvaptan group and 646 cases in control group). The result of Meta analysis showed that: 1 Effect: The difference of serum sodium concentration before and after treatment in tolvaptan group was higher than that in the control group (WMD = 3.33 mmol / L, 90% CI = 2.90-3.75, Z = 12.95, P = 0.000) (90% CI = 2.13 ~ 3.21, Z = 7.70, P = 0.000); 24 h urine output was higher than that of the control group (WMD = 812.82 ml, 90% CI = 534.90 ~ (90% CI = 464.44 ~ 1 036.63, Z = 4.32, P = 0.000); The change of net fluid balance (difference between urine output and fluid intake) was more than that of the control group P = 0.000); 2 Safety: There was no significant difference in adverse reactions and death rates between tolvaptan group and control group, with RRs of 0.99 (90% CI = 0.86-1.13, Z = -0.184, P = 0.854) and 1.15 (90% CI = 0.78-1.69, Z = 0.582, P = 0.561). CONCLUSION: Tolvaptan can significantly increase the concentration of serum sodium, the normal rate of serum sodium recovery, the increase of 24-hour urine output and the net fluid balance without increasing the incidence of adverse reactions and mortality.