利那洛肽治疗便秘型肠易激综合征的快速卫生技术评估

Rapid health technology assessment of linaclotide in the treatment of constipated irritable bowel syndrome

目的对利那洛肽治疗便秘型肠易激综合征(IBS-C)的有效性、安全性及经济性进行综合评价,为临床应用提供循证依据。方法采用快速卫生技术评估方法。计算机检索PubMed、Embase、the Cochrane Library、Web of Science、中国知网、万方数据、维普网、中国生物医学文献服务系统以及卫生技术评估相关网站,收集利那洛肽治疗IBS-C的系统评价/Meta分析、HTA报告及药物经济学研究。筛选文献、提取资料和评价质量后,采用描述性分析对研究结果进行分类总结。结果共纳入11篇文献,其中7篇为系统评价/Meta分析、4篇为药物经济学研究。有效性方面,与安慰剂比较,利那洛肽可使IBS-C患者更快达到美国FDA推荐的联合终点和欧洲药品管理局建议的终点,显著改善患者完全自发排便应答、腹痛和便秘症状,提高生活质量,缓解患者整体症状;与鲁比前列酮、普卡那肽和替纳帕诺进行的间接证据比较结果显示,利那洛肽在FDA推荐的联合终点、完全自发排便应答、腹痛缓解率以及整体症状缓解率等方面的疗效更优。安全性方面,利那洛肽的总体不良反应、腹泻和胀气发生率均高于安慰剂,但患者均可耐受。经济性方面,与传统治疗药物相比,利那洛肽具有经济学优势。结论利那洛肽治疗IBS-C的有效性、安全性、经济性均有一定优势,是治疗IBS-C的有效策略。

OBJECTIVE To comprehensively evaluate the effectiveness,safety and economics of linaclotide in the treatment of constipated irritable bowel syndrome(IBS-C),and to provide the evidence-based basis for clinical application.METHODS Rapid health technology assessment method was adopted;PubMed,Embase,the Cochrane Library,Web of Science,CNKI,Wanfang data,VIP database,SinoMed,and related HTA websites were searched.Systematic review/meta-analysis,HTA reports and pharmacoeconomic research about linaclotide were collected.After literature screening,data extraction and quality evaluation,descriptive analysis was used to classify and summarize the research results.RESULTS A total of 11 literature were included,involving 7 systematic reviews/meta-analyses and 4 pharmacoeconomic research.In terms of effectiveness,compared with placebo,linaclotide could achieve FDA specified endpoint and European Medicines Agency-recommended endpoint faster,significantly improved patients’complete spontaneous bowel movements(CSBM),abdominal pain,constipation and quality of life,and relieved patients’global symptoms;compared with the indirect evidence of lubiprostone,plecanatide and tenapanor,the efficacy of linaclotide at the FDA specified endpoint,CSBM,abdominal pain relief,and global relief response were the best.In terms of safety,the incidence of overall adverse drug reactions,diarrhea and flatulence caused by linaclotide were significantly higher than placebo,but patients can tolerate them.In terms of economics,compared with traditional therapeutic drugs,linaclotide showed an economic advantage.CONCLUSIONS Linaclotide has advantages in efficacy,safety and economics in the treatment of IBS-C.It is an effective strategy for the treatment of IBS-C.