CAJ | 학술논문

目的：系统评价中医药干预对老年痴呆症患者认知功能症状的改善与安全。方法全面搜集单纯中医药与中西医结合对比西药治疗老年痴呆症的相关随机对照试验（ RCT）文献，采用计算机综合检索维普数据库、万方数据库、中国知网及中国生物医学文献数据库、Cochrane Li－brary、EMbase与PubMed，相关文献检索时间止于2014年8月1日；同时在大学图书馆以手工方式检索期刊资料库，对纳入研究的试验则依据 Co－chrane Handbook 5．1评估偏倚性风险及文献质量；采用软件RevMan5．2．6进行相关数据分析，结合软件 GRADE profiler对本研究的证据质量进行标化测评。结果本研究共纳入31个RCT临床干预文献，受试者2583例；Meta分析提示：在有效率评测层面，中西医结合（中医药结合西药）疗效优于单纯西药治疗〔OR＝3．35，95％CI（2．17，5．17）〕，单纯中医药与西药的有效率比较差异无统计学意义〔OR＝1．20，95％CI（0．95，1．51）〕；在痊愈率评测层面，中西医结合（中医药结合西药）效应优于单纯西药治疗〔OR＝1．86，95％CI（1．31，2．63）〕，单纯中医药和西药的痊愈率（临床控制率）比较差异无统计学意义〔OR＝1．17，95％CI（0．94，1．46）〕；在 MMSE 评分层面对单纯中医药与西药进行亚组分析，即干预4 w〔WMD＝0．31，95％CI（－0．38，0．99）〕、6 w〔WMD＝0．18，95％CI（－0．52，0．89）〕、8 w〔WMD＝0．75，95％CI（－0．32，1．83）〕及12 w〔WMD＝0．06，95％CI （－0．76，0．88）〕组间评分皆无统计学差异（P＞0．05）。中医药（中医药结合西药）治疗老年痴呆患者不良事件的发生率（1．18％）显著低于西药干预（9．61％）。结论中医药作为一种有效的干预措施，相对安全可靠，不良反应较少，与西药干预效应相当。
목적：계통평개중의약간예대노년치태증환자인지공능증상적개선여안전。방법전면수집단순중의약여중서의결합대비서약치료노년치태증적상관수궤대조시험（ RCT）문헌，채용계산궤종합검색유보수거고、만방수거고、중국지망급중국생물의학문헌수거고、Cochrane Li－brary、EMbase여PubMed，상관문헌검색시간지우2014년8월1일；동시재대학도서관이수공방식검색기간자료고，대납입연구적시험칙의거 Co－chrane Handbook 5．1평고편의성풍험급문헌질량；채용연건RevMan5．2．6진행상관수거분석，결합연건 GRADE profiler대본연구적증거질량진행표화측평。결과본연구공납입31개RCT림상간예문헌，수시자2583례；Meta분석제시：재유효솔평측층면，중서의결합（중의약결합서약）료효우우단순서약치료〔OR＝3．35，95％CI（2．17，5．17）〕，단순중의약여서약적유효솔비교차이무통계학의의〔OR＝1．20，95％CI（0．95，1．51）〕；재전유솔평측층면，중서의결합（중의약결합서약）효응우우단순서약치료〔OR＝1．86，95％CI（1．31，2．63）〕，단순중의약화서약적전유솔（림상공제솔）비교차이무통계학의의〔OR＝1．17，95％CI（0．94，1．46）〕；재 MMSE 평분층면대단순중의약여서약진행아조분석，즉간예4 w〔WMD＝0．31，95％CI（－0．38，0．99）〕、6 w〔WMD＝0．18，95％CI（－0．52，0．89）〕、8 w〔WMD＝0．75，95％CI（－0．32，1．83）〕급12 w〔WMD＝0．06，95％CI （－0．76，0．88）〕조간평분개무통계학차이（P＞0．05）。중의약（중의약결합서약）치료노년치태환자불량사건적발생솔（1．18％）현저저우서약간예（9．61％）。결론중의약작위일충유효적간예조시，상대안전가고，불량반응교소，여서약간예효응상당。
Objective To systematically evaluate efficacy and adverse events of Chinese herbal medicine( CHM) for the treatment of Alzheimer's Disease(AD).Methods Randomized controlled trial(RCTs) involving CHM or integrative medicine comparing with routine pharmacotherapy for AD were retrieved and collected from database of VIP,WANFANG,CNKI,CBM,PubMed,EMbase,and the Cochrane Li-brary.The journals related to the research were also manually searched from college library.The quality of literature was conducted by the risk of bias and quality evaluation based on the Cochrane Handbook 5.1,while the data analysis was handled by the software RevMan 5.2.6 of Cochrane Collaboration.The evidence quality grading evaluation for the system review was operated by the software of 'GRADE profiler'. Results Thirty-one studies involving 2 583 participants were contained in the meta-analysis.The main meta-analysis results indicated rela-tive benefits for the effective rate in six studies( odds ratio〔 OR〕3.35,95%CI 2.17,5.17) and the cure(control) rate in six studies(OR 1.86,95%CI 1.31,2.63) in favor of the CHM plus routine pharmacotherapy group.For CHM compared with routine pharmacotherapy,no significant difference was revealed in effective rate(OR 1.20,95%CI 0.95,1.51),cure rate(OR 1.17,95%CI 0.94,1.46) and the detailed sub-group of MMSE score at the timing-point of week-4〔weighted mean difference(WMD) 0.31,95%CI -0.38,0.99〕,week-6(WMD 0.18,95%CI-0.52,0.89),week-8(WMD 0.75,95%CI-0.32,1.83),week-12(WMD 0.06,95%CI-0.76,0.88).The GRADE quality level of this systematic review indicated"very low".Compared to the routine pharmacotherapy group(9.61%) ,the incidence of adverse e-vents of CHM(1.18%) was much lower.Conclusions As a relative safe intervention method for AD,CHM shows benefits with few adverse reactions and relative better effect of improving cognitive function incorporated with the routine pharmacotherapy;CHM reveales no statistical difference while in contrast with routine pharmacotherapy.Further study of rigorous design is required to conducted and provided reference for the decision-making of clinical practice.