CAJ | 학술논문

背景痴呆的疾病负担不断增加,而且缺乏有效的治疗方法,因此有些国家就推荐使用银杏叶提取物(ginkgo biloba extract, GbE)来治疗痴呆,虽然有关GbE疗效的研究结果尚不一致.目的就银杏叶提取物对痴呆患者认知功能和日常生活能力改善作用的研究进行meta分析.方法检索国内外数据库,找出1982年1月—2012年9月发表的关于银杏叶提取物治疗(不少于22周)痴呆患者的随机安慰剂对照研究的文献报告.根据 GRADE系统推荐的方法进行文献质量评估并提取资料.采用 RevMan 5.1软件进行异质性检验、敏感性分析并评估发表偏倚.对连续性变量的合并效应值采用标准均差(Standardized mean differences, SMD)表示,对分类变量则采用相对危险度(relative risk, RR)表示, meta分析的合并结果采用森林图显示.结果有9项研究共计2578例患者符合入组和排除标准.其中6项研究共计1917例患者纳入meta分析,结果发现仅在样本年龄相对较低(平均年龄75岁以下)的研究中GbE在延缓认知功能衰退和防止日常活动能力下降方面优于安慰剂.组间脱落率以及治疗中总的不良事件发生率均无显著差异.然而,不同研究结果间存在明显的异质性(主要是因为研究对象的年龄差异),文献存在可能的发表性偏倚(大多数是医药公司资助的),因此总体证据强度属于“低”.结论这一meta分析表明,现有对此重要问题的研究证据依然极其薄弱.GbE对75岁以下存在痴呆的人群可能有效.需要大样本、安慰剂对照的随机研究来验证上述结果,今后的研究应当聚焦于程度较轻的痴呆(包括轻度认知功能障碍),比较不同剂量GbE的效果,并且随访更长的时间(至少1年).
배경치태적질병부담불단증가,이차결핍유효적치료방법,인차유사국가취추천사용은행협제취물(ginkgo biloba extract, GbE)래치료치태,수연유관GbE료효적연구결과상불일치.목적취은행협제취물대치태환자인지공능화일상생활능력개선작용적연구진행meta분석.방법검색국내외수거고,조출1982년1월—2012년9월발표적관우은행협제취물치료(불소우22주)치태환자적수궤안위제대조연구적문헌보고.근거 GRADE계통추천적방법진행문헌질량평고병제취자료.채용 RevMan 5.1연건진행이질성검험、민감성분석병평고발표편의.대련속성변량적합병효응치채용표준균차(Standardized mean differences, SMD)표시,대분류변량칙채용상대위험도(relative risk, RR)표시, meta분석적합병결과채용삼림도현시.결과유9항연구공계2578례환자부합입조화배제표준.기중6항연구공계1917례환자납입meta분석,결과발현부재양본년령상대교저(평균년령75세이하)적연구중GbE재연완인지공능쇠퇴화방지일상활동능력하강방면우우안위제.조간탈락솔이급치료중총적불량사건발생솔균무현저차이.연이,불동연구결과간존재명현적이질성(주요시인위연구대상적년령차이),문헌존재가능적발표성편의(대다수시의약공사자조적),인차총체증거강도속우“저”.결론저일meta분석표명,현유대차중요문제적연구증거의연겁기박약.GbE대75세이하존재치태적인군가능유효.수요대양본、안위제대조적수궤연구래험증상술결과,금후적연구응당취초우정도교경적치태(포괄경도인지공능장애),비교불동제량GbE적효과,병차수방경장적시간(지소1년).
Background:Given the increasing burden of dementia internationally and the lack of effective treatments, several countries are already recommending the use of ginkgo biloba extract (GbE) in the treatment of dementia, despite the inconsistent research results about its effectiveness. Aim:Conduct a meta-analysis of studies about the effect of GbE on cognition and daily functioning in persons with dementia. Methods:Searches of various English and Chinese databases identified reports of placebo controlled, randomized trials of ginkgo biloba treatment (lasting a minimum of 22 weeks) for dementia that were published from January 1982 to September 2012. Data extraction and critical appraisal of studies were conducted using the GRADE system. Heterogeneity, sensitivity and potential publication bias of the studies were evaluated using RevMan 5.1. Pooled results of the meta-analysis were presented as forest plots using standardized mean differences (SMD) in scores for continuous variables and relative risk (RR) for categorical variables. Results:Nine studies with a total of 2578 patients met the inclusion and exclusion criteria. Pooled results from the six studies that were included in the meta-analysis (total n=1917) found that GbE was superior to placebo in preventing deterioration in cognitive functioning and in activities of daily living, but these results were only valid for studies with younger subjects (with a mean age below 75). There were no significant differences in the dropout rates between groups or in the overall rates of adverse events during treatment. However, there was considerable heterogeneity in the results between the studies (primarily based on the age of the subjects) and there were several potential biases in the reports (most of which were supported by pharmaceutical firms), so the overall evidence was considered of‘low quality’. Conclusion:This meta-analysis highlights serious weaknesses in the available studies about this important problem. GbE may be effective in persons under 75 years of age with dementia, but large, placebo controlled, randomized trials focused on milder forms of dementia (including mild cognitive impairment) that compare different doses of GbE and that follow subjects for prolonged periods (at least one year) are needed to confirm this result.