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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
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| 篇名： | 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 |
| TITLE： | Rapid Health Technology Assessment for Effectiveness ，Safety and Economics of Ginkgo biloba Extract in the Treatment of Alzheimer ’s Disease |
| 摘要： | 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、WebofScience、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、120mgEGb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、160mgEGb组和240mgEGb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，120mgEGb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240mgEGb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200mgEGb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200mgEGb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，240mgEGb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。 |
| ABSTRACT： | 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 o f placebo group （P＜0.05），or there was no significant diff erence between 2 groups（P＞0.05）； . subgroup analysis by dose showed that there was no RDY2019-39） significant difference in ADL score between 120 mg EGb group and placebo group （P＞0.05）；ADL score of 240 mg E-mail：renxiaolei83@126.com EGb group were signicantly lower than that of placebo group （P＜0.05）. Subgroup analysis of clinical global impression 010-88325751。E-mail：lyi1267@126.com 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. |
| 期刊： | 2020年第31卷第22期 |
| 作者： | 任晓蕾，刘一，詹轶秋，张春燕，黄琳，封宇飞 |
| AUTHORS： | REN Xiaolei ，LIU Yi，ZHAN Yiqiu，ZHANG Chunyan ，HUANG Lin，FENG Yufei |
| 关键字： | 银杏叶提取物；阿尔茨海默病；快速卫生技术评估；有效性；安全性；经济性 |
| KEYWORDS： | Ginkgo biloba extract；Alzheimer’s disease ；Rapid health technology assessment ；Effectiveness；Safety； |
| 阅读数： | 328 次 |
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