银杏叶提取物治疗阿尔茨海默病有效性、安全性和经济性的快速卫生技术评估

Rapid Health Technology Assessment for Effectiveness,Safety and Economics of Ginkgo biloba Extract in the Treatment of Alzheimer’s Disease

目的:快速评价银杏叶提取物(EGb)治疗阿尔茨海默病(AD)的有效性、安全性和经济性,为临床药物选择和决策提供循证依据。方法:系统检索PubMed、Embase、Cochrane图书馆、Web of Science、中国知网、中国生物医学数据库、万方数据等中英文数据库,同时检索国内外快速卫生技术评估(HTA)机构官方网站及相关数据库,检索时限均为建库起至2020年8月10日,收集EGb对比安慰剂治疗AD的HTA报告、系统评价/Meta分析和药物经济学研究。筛选文献、提取资料后,分别采用HTA核查清单、系统综述质量评价工具量表2、综合卫生经济评价报告标准量表评价纳入HTA报告、系统评价/Meta分析和药物经济学研究的质量,采用定性描述方法汇总纳入研究的结论。结果:共纳入9篇文献,其中8篇为系统评价、1篇为药物经济学研究。有效性方面,EGb组患者的简易智能状态检查评分、120 mg EGb组患者的阿尔茨海默氏病评估量表-认知分量表(ADAS-Cog)评分与安慰剂组比较,差异均无统计学意义(P>0.05);EGb组患者的痴呆生活质量量表评分显著高于安慰剂组,简短认知能力测试评分、神经精神科问卷(NPI)评分、NPI-照顾者版评分、160 mg EGb组和240 mg EGb组患者的ADAS-Cog评分均显著低于对照组(P<0.05)。患者的日常生活活动能力(ADL)评分结果不一致,EGb组患者的ADL评分显著低于安慰剂组(P<0.05)或两组比较差异无统计学意义(P>0.05);按剂量进行亚组分析结果显示,120 mg EGb组患者的ADL评分与安慰剂组比较,差异无统计学意义(P>0.05);而240 mg EGb组患者的ADL评分显著低于安慰剂组(P<0.05)。临床总体印象改变(CGIC)评分的亚组分析结果显示,小于200 mg EGb和治疗26周时EGb组患者的CGIC评分与安慰剂组比较,差异均无统计学意义(P>0.05);大于200 mg EGb和治疗24周时EGb组患者的CGIC评分均显著高于安慰剂组(P<0.05)。安全性方面,EGb组患者的不良反应发生率、严重不良反应发生率与安慰剂组比较,差异均无统计学意义(P>0.05);按剂量进行亚组分析结果显示,240 mg EGb组患者的不良反应发生率显著高于安慰剂组(P<0.05)。经济学方面,EGb治疗AD具有成本-效益,可间接节省AD患者的护理费用。结论:EGb治疗AD的有效性尚不确切,但安全性与经济性均较好。

OBJECTIVE:To rapidly evaluate the effectiveness,safety and economics of Ginkgo biloba extract(EGb)in the treatment of Alzheimer’s disease(AD)patients,and to provide evidence-based reference for clinical drug selection and decision.METHODS:Retrieved from PubMed,Embase,Cochrane Library,Web of Science,CNKI,CBM,Wanfang database,health technology assessment(HTA)organization websites and database during the inception to Aug.10,2020,HTA reports,systematic reviews/Meta-analysis,and pharmacoeconomic studies of EGb versus placebo in the treatment of AD were collected.After literature screening and data extration,HTA checklist,AMSTAR-2 scale and CHEERS scale were used respectively to evaluate the literature quality of the included HTA report,systematic review/Meta-analysis and pharmacoeconomics studies.The conclusion of the included studies were summarized by using qualitative description.RESULTS:A total of 9 literatures were included,involving 8 systematic reviews and 1 economic studies.In terms of effectiveness,there was no statistical significance in MMSE score of EGb group,ADAS-Cog score of 120 mg EGb group,compared with placebo group(P>0.05).Dementia Quality of Life(DQoL)score of EGb group was significantly higher than that of placebo group.The scores of short cognitive aptitude tests,neuropsychiatric inventory(NPI),NPI caregiver version score,ADAS-Cog score of 160 mg EGb group and 240 mg EGb group were significantly lower than those of control group(P<0.05).ADL scores of patients were inconsistent;ADL scores of EGb group were significantly lower than those of placebo group(P<0.05),or there was no significant difference between 2 groups(P>0.05);subgroup analysis by dose showed that there was no significant difference in ADL score between 120 mg EGb group and placebo group(P>0.05);ADL score of 240 mg EGb group were signicantly lower than that of placebo group(P<0.05).Subgroup analysis of clinical global impression change(CGIC)score showed that there was no significant difference in CGIC score between EGb group and placebo group after receiving<200 mg EGb and 26 weeks of treatment(P>0.05);CGIC score of EGb group was significantly higher than that of placebo group after receiving>200 mg EGb and 24 weeks of treatment(P<0.05).In terms of safety,there was no statistical significance in the incidence of ADR or the incidence of severe ADR between EGb group and placebo group(P>0.05).Subgroup analysis by dose showed that the incidence of ADR in 240 mg EGb group was significantly higher than placebo group(P<0.05).Economically,EGb treatment for AD is cost-effective,which could indirectly save the nursing costs of AD patients.CONCLUSIONS:The efficacy of EGb in the treatment of AD is uncertain,and the safety and economy are good.