氨磺必利与阿立哌唑治疗以阴性症状为主精神分裂症安全性及有效性对比的Meta分析

Efficacy and Safety of Aminosulpirim and Aripiprazole for Schizophrenia with Mainly Negative Symptoms:a Meta-analysis

目的:系统评价氨磺必利和阿立哌唑治疗以阴性症状为主精神分裂症的安全性及有效性。方法:计算机检索CNKI、WanFang Data、VIP、SinoMed、Embase、the Cochrane Library、PubMed和PsyclNFO数据库,搜集有关氨磺必利与阿立哌唑治疗以阴性症状为主的精神分裂症的随机对照试验(RCT),检索时限均为从建库至2021年1月8日。由两位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入14个RCT,包括1050例患者。Meta分析结果显示,氨磺必利与阿立哌唑治疗以阴性症状为主精神分裂症的PANSS和SANS评分临床有效率差异均无统计学意义[OR_(PANSS≥30%)=1.18,95%CI(0.63,2.21),P=0.61;OR_(PANSS≥50%)=1.81,95%CI(0.68,4.81),P=0.23;OR_(SANS)=1.21,95%CI(0.63,2.33),P=0.56]。氨磺必利在治疗4周后PANSS评分差值明显高于阿立哌唑[SMD=0.61,95%CI(0.30,0.93),P=0.0002],其余的PANSS阴性因子评分或SANS评分差值的差异均无统计学意义(P>0.05)。安全性方面,氨磺必利组月经紊乱[OR=2.59,95%CI(1.09,6.13),P=0.03]、体重增加[OR=4.32,95%CI(1.52,12.26),P=0.006]的发生率均高于阿立哌唑组,震颤[OR=0.28,95%CI(0.11,0.74),P=0.01]、静坐不能[OR=0.48,95%CI(0.25,0.93),P=0.03]的发生率均低于阿立哌唑组;而在嗜睡、失眠、便秘、视物模糊、口干、心电图异常和兴奋激越方面比较,两组差异无统计学意义(P>0.05)。结论:现有证据表明,氨磺必利与阿立哌唑治疗以阴性症状为主精神分裂症疗效总体相当,但药物相关不良反应有所不同。

Objective:To systematically review the safety and efficacy of aminosulpirim and aripiprazole in the treatment of schizophrenia with mainly negative symptoms.Methods:CNKI,VIP,WanFang Data,SinoMed,Embase,the Cochrane Library,PubMed and PsyclNFO databases were electronically searched to collect randomized controlled trials(RCTs)about aminosulpirim and aripiprazole treating schizophrenia with mainly negative symptoms from inception to January 8,2021.Two reviewers indepently screened literatures,extracted data and assessed the risk of bias of included studies.Then,Meta-analysis was performed using RevMan 5.3 software.Results:A total of 14 RCTs involving 1050 participants were included.The results of Meta-analysis showed:there was no statistically significant in clinical effectiveness of amisulpride and aripiprazole of PANSS and SANS scores in the treatment for schizophrenia with negative symptoms(OR_(PANSS≥30%)=1.18,95%CI 0.63 to 2.21,P=0.61;OR_(PANSS≥50%)=1.81,95%CI 0.68 to 4.81,P=0.23;OR_(SANS)=1.21,95%CI 0.63 to 2.33,P=0.56).The difference of PANSS score of aminosulpiriol after 4 weeks of treatment was significantly higher than that of aripiprazole(SMD=0.61,95%CI 0.30 to 0.93,P=0.0002),and there were no significant differences in PANSS negative factor score or SANS score(P>0.05).Adverse drug reactions in the two groups,menstrual disorders(OR=2.59,95%CI 1.09 to 6.13,P=0.03),weight gain(OR=4.32,95%CI 1.52 to 12.26,P=0.006),akathisia(OR=0.28,95%CI 0.11 to 0.74,P=0.01)and parkinsonism(OR=0.48,95%CI 0.25 to 0.93,P=0.03)had statistical significance,and other adverse reactions showed no statistical significance(P>0.05).Conclusion:The current evidence shows that,aminosulpirim is equivalent to aripiprazole in the treatment of schizophrenia with mainly negative symptoms,but there are differences in drug-related adverse reactions.