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丙戊酸镁缓释片治疗躁狂发作的药品临床综合评价

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目的:对丙戊酸镁缓释片治疗躁狂发作的临床综合价值进行评价,为临床合理用药和相关用药决策提供证据支持。方法:系统检索PubMed、the Cochrane Library、中国知网、万方数据库等中英文数据库(检索时限均为建库至2023年7月11日),筛选丙戊酸镁缓释片治疗躁狂发作的随机对照试验(研究组为丙戊酸镁缓释片或在其基础上联合常规抗躁狂药物治疗,对照组为常规抗躁狂药物治疗)。采用文献研究的方法,基于当前可获得的证据,围绕丙戊酸镁缓释片治疗躁狂发作的有效性、安全性、经济性、创新性、适宜性和可及性6个维度,开展临床综合评价。结果:共纳入20篇随机对照试验研究进行Meta分析。有效性方面,丙戊酸镁缓释片改善躁狂症状的总有效率与喹硫平、碳酸锂等一线药物相似(OR=1。19,95%CI=0。94~1。49,P=0。14);安全性方面,使用丙戊酸镁缓释片的患者出现头晕头痛、乏力等不良反应的发生率(OR=0。57,95%CI=0。37~0。89,P=0。01)及严重程度(MD=-1。23,95%CI=-1。70~-0。75,P<0。000 01)均低于对照药物;经济学方面,最小成本分析结果显示,丙戊酸镁缓释片治疗躁狂发作的经济性优于喹硫平;创新性方面,丙戊酸镁缓释片由我国湖南省湘中制药有限公司生产,其可通过多途径提高脑内抑制性递质的含量,是目前全球唯一的丙戊酸镁制剂,该药制备工艺及外观均获得专利保护;适宜性方面,丙戊酸镁具有良好的技术特点适宜性,使用方便且便于存储;可及性方面,丙戊酸镁缓释片已被纳入国家医保目录,覆盖范围广,且可负担性较高。结论:丙戊酸镁缓释片作为我国自主生产研发的药物,在有效性、安全性和经济性方面具有显著优势,药品作用机制具有创新性,适宜性、可获得性及可负担性均较好。
Clinical Comprehensive Evaluation of Magnesium Valproate Sustained-Release Tablets in the Treatment of Manic Episodes
OBJECTIVE:To evaluate the comprehensive clinical value of Magnesium valproate sustained-release tablets in the treatment of manic episodes,so as provide evidence support for clinical rational medicationand relevant medication decisions.METHODS:PubMed,the Cochrane Library,CNKI,Wanfang Data,and other Chinese and English databases were systematically retrieved(the retrieval time was from database establishment to Jul.1ist,2023)to collect the randomized controlled trial of Magnesium valproate sustained-release tablets in the treatment of manic episodes(the study group was treated with Magnesium valproate sustained-release tablets or combined with conventional antimanic drugs,while the control group received conventional antimanic drugs).The method of literature research was adopted,based on the current available evidence,a clinical comprehensive Evaluation of Magnesium valproate sustained-release tablets in the treatment of manic episodes was carried out around six dimensions of effectiveness,safety,economy,innovation,suitability,and accessibility.RESULTS:A total of 20 randomized controlled trials were included in the Meta-analysis.In terms of effectiveness,the total effective rate of Magnesium valproate sustained-release tablets in improving manic symptoms was similar to quetiapine and lithium carbonate(OR=1.19,95%CI=0.94-1.49,P=0.14).In terms of safety,the incidence(OR=0.57,95%CI=0.37-0.89,P=0.01)and severity(MD=-1.23,95%CI=-1.70--0.75,P<0.000 01)of adverse drug reactions such as dizziness,headache and fatigue in patients using Magnesium valproate sustained-release tablets were lower than those of control drugs.In terms of economy,the minimum-cost analysis showed that Magnesium valproate sustained-release tablets were more economical than quetiapine.In terms of innovation,Magnesium valproate sustained-release tablets,produced by Hunan Xiangzhong Pharmaceutical Co.,LTD.,could increase the content of inhibitory transmitter in the brain through multiple ways.As the only magnesium valproate preparation in the world at present,the preparation process and appearance of Magnesium valproate sustained-release tablets are protected by patents.In terms of suitability,Magnesium valproate sustained-release tablets had good technical characteristics and suitability,easy to use and store.In terms of accessibility,Magnesium valproate sustained-release tablets was also included in the National Reimbursement Drug List with wide hospital coverage and high affordability.CONCLUSIONS:As the drug independently produced and developed in China,Magnesium valproate sustained-release tablets has good advantages in safety,effectiveness and economy,with innovative mechanism of action,good suitability,availability and affordability.

Magnesium valproate sustained-release tabletsManic episodesClinical comprehensive evaluation of drugs

李晓曦、邢晓璇、冯英楠、庄伟、王之舟、王可、张蔷、张兰、董宪喆

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首都医科大学宣武医院药学部,国家老年疾病临床医学研究中心,北京 100053

首都医科大学药学院,北京 100069

丙戊酸镁缓释片 躁狂发作 药品临床综合评价

北京市医院管理中心"登峰"人才培养计划项目

DFL20190803

2024

中国医院用药评价与分析
中国医药生物技术协会,中国药房杂志社

中国医院用药评价与分析

CSTPCD
影响因子:1.142
ISSN:1672-2124
年,卷(期):2024.24(8)