摘要
背景:女性更年期综合征是妇科常见病、多发病,现代医学大多采用激素替代疗法,长期服用易增加子宫内膜癌、乳腺癌的发病率。在古今医学文献中,记载和报导了中医药治疗女性更年期综合征确有疗效。目前已有许多关于女性更年期综合征的随机对照临床试验研究,但其结果存在争议。因此,对这些治疗的系统性评价是十分重要的,现今临床研究对方法学的重视仍不够,而影响了其研究结论的推广和国外医学的认可。随着循证医学及系统评价的方法和结果日益得到国际医学和卫生决策部门的认可和重视,故利用循证医学及系统评价的方法,对文献进行综合数据的Meta-分析,以了解其随机对照试验证据现状。
目的:采用Cochrane系统评价方法对国内中医药治疗女性更年期综合征的临床有效性、安全性进行评价,为合理选择及应用治疗措施提供临床研究证据。
方法:运用Cochrane系统评价方法,检索国内中医药治疗女性更年期综合征的临床随机对照试验。检索数据库:CBM—中国生物医学文献数据库(1978-2007年)、中国期刊全文数据库(CNKI Web)(1994-2007年)、中文科技期刊全文数据库(CQVIP)(1989-2007年)、手工检索收集结果未发表的文献及追踪检索相关的综述、论文的参考文献。纳入有关中医药治疗女性更年期综合征的、无混杂因素、临床随机对照试验(RCTs),由两名评价人员独立提取每个纳入试验关于研究质量、基线资料及结果等数据,并进行交叉核对。由同样两名评价人员对每个纳入试验进行质量评价,如有争议,则共同讨论,必要时由第3者仲裁。数据采用Cochrane协作网提供的Revman 4.3软件进行统计分析。
结果:本系统评价纳入的14个已完成的临床随机对照试验中仅有1个试验为前瞻、随机、双盲、双模拟平行对照临床、两中心研究,为高质量研究,其余13个试验均为低质量研究,均未说明具体随机方法及分配隐藏方法,其中仅1个试验提及使用单盲法,余均未提及使用盲法。排除干预措施为针药合用的1个试验,初步入选13个试验作Meta-分析。Meta-分析结果显示:数据的异质性检验:7个采用中药作为治疗组的临床随机对照试验的异质性检验:OR Q=5.82,df=6,P=0.44,I~2=0%;RR Q=4.58,df=6,P=0.60,I~2=0%。6个采用针灸作为治疗组的临床随机对照试验的异质性检验:OR Q=1.93,df=5,P=0.86,I~2=0%;RR Q=1.83,df=5,P=0.87,I~2=0%。因P＞0.10,I~2=0%,可认为无异质性,选择固定效应模型计算其合并统计量,进行Meta-分析。Meta-分析效应值合并的结果:7个采用中药作为治疗组的临床随机对照试验的疗效分析:OR为0.28,其95%可信区间为(CI)[0.17,0.45],统计学显著性检验Z=5.21,P＜0.00001,有统计学意义。RR为0.32,其95%可信区间为(CI)[0.21,0.50],统计学显著性检验Z=5.13,P＜0.00001,有统计学意义。6个采用针灸作为治疗组的临床随机对照试验的疗效分析:OR为0.13,其95%可信区间为(CI)[0.05,0.35],统计学显著性检验Z=4.02,P＜0.0001,有统计学意义。RR为0.15,其95%可信区间为(CI)[0.06,0.38],统计学显著性检验Z=4.01,P＜0.0001,有统计学意义。
结论:经过Meta-分析的结果,中医药治疗女性更年期综合征确有一定的疗效,然而由于所纳入试验的质量方法学上的诸多缺陷,所以支持这一结论的证据十分有限,期待有高质量的临床随机对照试验来进一步证实本研究结果。
The Background: The climacteric syndrome is a common and polidisease in the gynecology. Most of the foreign medical adopt the hormone replacement therapeusis, but long-term taking medicine can result to increase the incidence rate of the cancer of the membrane in the uterus, and the breast. In the ancient and modern literature, it has been regarded and reported that the Chinese traditional medicine treats can lead this kind of sickness to be effective. At present oneself has many the stochastic comparison clinical test research which drafts about the menopause synthesis, but its result has dispute. So the systematic evaluation of these treatments is very important. Now the clinical investigation does not think highly of the methodology that affects the extence of the investigative conclusion and the admittance of the western medical. The method and result of the Evidence Based Medicine and systematic analysis has been admitted and thought highly of by the international-medicine and the medical-decision department day by day. To utilize the Evidence-based medicine and the method of systematic analysis. The Meta-analysis of the multipdate of the literature can lead our to know that present the situation of the Randomized -Contorlled-Tirals of the Chinese traditional medicine.
Objectives: To assess the safety and efficacy of the Chinese traditional medicine that it helps the climacteric syndrome. To provide the current randomized evidence.
The Methods: The Cochrane systematic review method was used to evaluate the matched-control literatures are those published in the civil. To investigate the clinical effect of TCM that it helps the climacteric syndrome. Literature-retrieved data: CBM during 1978-2007 years.CNKI Web during 1994-2007 years. and CQVIP during 1989-2007 years. And manual retrieval collection result publication literature and tracing retrieval related summary, paper reference. In addition, we tracked down the reference lists of papers related to the climacteric syndrome. We included all completed uncompounded truly randomized trials (RCTs) about TCM for the climacteric syndrome. Two authors independently assessed the methodological quality of studies and extracted datas. Discussion or the third person when needed resolved the disagreement. Datas are analyzed with RevMan 4. 3 analysis software supplied by Cochrane centre.
Results:We identified 14 completed RCTs, one experiment gazes, stochastically, double blind, the double simulation parallel comparison for front clinical, two central research, is the high grade research, -odd 13 for low quality researches. The showing specifically stochastic method and assigns the hideaway method, In which only 1 mentions uses single blind method, Others have not used blind method. The elimination intervention measure one literature which uses for the injection,we rejected one research about the acupuncture and TCM of treatment groups. Is selected 13 researches to make the Meta- analysis initially. The Meta-analysis result showed that, Seven use the Chinese native medicine to take the treatment group compared with the Western medicine the research research non-uniformity examination:the OR Q=5.82,df=6,P=0.44,I~2=0%.the RR Q=4.58,df=6,P=0.60,I~2=0%.Six use the acupuncture and moxibustion to take the treatment group compared with the Western medicine the research non-uniformity examination:the OR Q=1.93,df=5,P=0.86, I~2=0%. the RR Q=1.83,df=5,P =0.87,I~2=0%.Because of P>0.10,I~2=0%, may think the not non-uniformity, Chooses the fixed effect model to calculate its merge statistics. The Meta-analysis effect size merge result showed that, Seven use the Chinese native medicine to take the treatment group compared with the Western medicine the resarch curative effect analysis:the OR was 0.28, 95% CI[0.17,0.45], Z=5.21, P<0.00001; the RR was 0.32, 95% CI[0.21,0.50], Z=5.13,P<0.00001.Six researches of the acupuncture and moxibustion of treatment groups compared with the Western medicine,the OR was 0.13, 95% CI[0.05, 0.35], Z=4.02, P<0.0004. the RR was 0.15, 95% CI[0.06, 0.38], Z=4.01,P<0.0001.
Conclusion: Via the Meta-analysis result, there are some effect of TCM treating climacteric syndrome. But if there were more high quality articles about TCM treating climacteric syndrome, the causality of this article will be more intense.
引文
[1]Hill K.The demography of menopause Maturitas[J].1996,23:113-127.
[2]曹泽毅.中华妇产科学[M].北京:人民卫生出版社,1999.6.
[3]王吉耀.循证医学与临床实践[M].北京:科学出版社,2002.1..
[4]张鸣明,李幼平.Cochrane协作网及Cochrane图书馆[M].北京:科学出版社,2002.1.
[5]Glass GV.Primary,secondary,and meta analysis of research[J].Education Research,1976,6
[6]Primary,secondary and meta analysis of research.Educ.Res.5:3-8(1976 ).
[7]方积乾,陆盈.Meta分析.现代医学统计学[M].北京:人民卫生出版社,2002,150-209.
[8]张鸣明,李幼平.Cochrane协作网及Cochrane图书馆[M].北京:科学出版社,2002,25-26.
[8]王家良,吴一龙.循证医学.北京:人民卫生出版社,2005,49-72.
[11]李强.循证医学:临床证据的产生、评价与利用.北京:科学出版社,2002,12-30.
[11]李幼平,刘鸣.循证医学-21世纪的临床医学.实用医学杂志,2000,16(7):517-518
[12]Roux PD,Elliot JP.Eskridge JM,et al.Risk and benefits of diagnostic angiography after aneurysm surgery:A retorspective analysis of 597studies.Neurosurgery,1998,42:1248.
[13]中华人民共和国卫生部.中药新药临床研究指导原则.1997.3.
[14]国家中医药管理局.中医病证诊断疗效标准.南京:南京大学出版社,1998.66.
[15]Cook,et al.Methodologic guidelines for systematic reviews of randomized control trials in health care from the Potsdam consultation on meta-analysis.J Clin Epidemiol 1994;45:167-171;
[16]Sloan MA,Butch CM,Wozniak MA et al.Stroke,1994,25(11):2187-2197.
[17]刘鸣.张世洪.临床试验中的意向处理分析.英国医学杂志中文版,2001.(4):223-224.
[18]杨建平.补肾更年汤治疗更年期综合征42例临床观察[J].湖南中医杂志,2006,22(3):34-35.
[19]康轶鑫,李乐敬.针刺与耳穴贴压并用治疗更年期综合征35例[J].中医外治杂志,2006,15(2):50-51.
[20]林菁.针刺治疗女性更年期综合征的临床观察[J].新疆医学,2006,36(6):77-79.
[21]陈蓉,林守清,杨欣,等.坤泰胶囊治疗妇女更年期综合征的临床研究[J].中国新药杂志.2005.14(12):1472-1476.
[22]陈大蓉,漆于邦.黄连阿胶胶囊对更年期综合征的治疗作用[J].中国实验方剂学杂志,1997,3(2):6-9.
[23]李芳莉.熏脐灸治疗女性更年期综合征疗效观察[J].针灸临床杂志,2004,20(8):41-42.
[24]邓毅,杨柳.加味甘麦大枣汤治疗更年期综合征疗效观察[J].现代中西医结合杂志,2004,13(10):1297-1298.
[25]赵宁明,纳顺达来.蒙药暖宫七味散治疗更年期综合征临床观察[J].中国民族医药杂志,2007,13(1):7-8.
[26]田华张,张春燕.针药合用治疗更年期综合征63例临床观察[J],四川中医.2006,24(6):101-102.
[27]沈晓明,杜元灏,阎莉,等.调神益肾针法治疗更年期综合征35例临床研究[J].中医杂志.2003,44(5):347-349.
[28]吴富东,马晓芃,单秋华.耳穴贴压结合拔罐治疗女性更年期综合征28例[J].国医论坛,2002.17(6):25-25.
[29]马晓芃.针刺治疗女性更年期综合征研究[J].山东中医药大学学报,1999,23(1):34-38.
[30]杨欣,李淑云.六味地黄丸合加味逍遥丸治疗更年期综合征44例临床观察[J].中华中西医学杂志,2007,5(7):50-51.
[31]王爱蓉,王秀芹,毕婉春,等.更年安治疗妇女更年期综合征疗效观察[J].中国中医药信息杂志,2002.9(9):47-47.
[32]Jadad AR,More A,Carrolld,et al.Assessing the quality of reports of randomized clinical trials:Is blingding necessary[J].Control Clinal Trials,1996,17(1):1-12.
[33]张宝屏,高晓坚,夏海晖,等.广州地区40-60岁女性社区卫生服务及需求状况的调查分析.中国妇幼保健,1997,12(6):356.
[34]Wuif HU.At last-A new and precise international Set of menopoause-related definitions.Menopause Management.2000,9(1):47.
[35]刘敏如,吴克明.世界传统医学妇科学.北京:科学技术出版社,1999.第1版:235.
[36]Lauritzen C.Clinical use of estrogens and progestogens.Maturitas,1990,12(3):199-214.
[37]Ettinger B,Friedman GD,Bush T,et al.Reduced mortality associated with long-term postmenopausal estrogen therapy.Obstet Gynecol,1996,87(1):6-12.
[38]Colditz GA,Hankinson SE,Hunter DJ,et al.The use of estrogens and progestins and the risk of breast cancer in postrnenopansal women.N Engl J Med,1995,332(24):1589-93.
[39]Voigt LF,Weiss NS,Chu J,et al.Progestagen supplementation of exogenous oestrogens and risk of endometrial cancer.Lancet,1991,338(8762):274-277.
[40]黄薇.卵巢功能衰竭及有关疾病.见王世阆主编卵巢疾病.北京:人民卫生出版社,2004. 115-147.
[1]张舒亚.辨证分型治疗更年期综合征68例疗效观察[J].新中医,2007.39(5):34-35.
[2]邱明英,舒广袖,卢玉珍.辨证治疗更年期综合征50例[J].辽宁中医杂志,2003,30(9):741-741.
[3]金忠玉,张桂芳.从胆辨治更年期综合征63例[J].浙江中医杂志,2003.38(4):155-155.
[4]杨晓红.补肾化瘀汤治疗更年期综合征60例[J].现代中西医结合杂志,2003,12(20):2218-2219.
[5]张庆福.从“痰”论治更年期综合症及辨证调护[J].中国社区医药2005,7(3):36-37,
[6]杨耀峰,霍振壮.从肝肾调治更年期综合征50例[J].陕西中医2007,28(7):817-818)
[7]孙淑慧.八珍汤加减治疗更年期综合征60例疗效观察[J].云南中医中药杂志,2005.26(3):28-28.
[8]冯雷.百合地黄汤加味治疗妇女更年期综合征82例报道[J].甘肃中医,2003,16(2):31-32.
[9]镁日斯.柏子养心丸加味治疗更年期综合征的疗效观察[J].广州中医药大学学报,2005,22(5):357-359.
[10]高允珊.左归饮加味治疗妇女更年期综合征58例临床观察[J].江西中医药,2005,36(5):49-50.
[11]韩桂华.二仙汤加减治疗更年期综合征60例[J].四川中医,2004,22(11):65-66.
[12]李秀忠.丹栀逍遥散加味治疗更年期综合征105例[J].河南中医,2004.24(12):62-62.
[13]何卫东.妇更汤治疗更年期综合征64例[J]江苏中医药,2005,26(12):22-22.
[14]白丽丹,陈国成.“更年舒安汤”治疗更年期综合征47例临床观察[J].江苏中医药,2004,25(7);32-33.
[15]刘臣 李青山 宫晓燕.“四甲安更汤”治疗更年期综合征81例[J].江苏中医药,2006,27(11):34-35.
[16]顾亚平.补肾活血法治疗更年期综合征临床观察[J].光明中医,2007,22(1):80-81.
[17]高亮,刘孝平.自制女贞丸治疗更年期综合征220例体会[J].基层医学论坛:B版,2007,11(4):321-322.
[18]骆晓金,李亚伟.耳穴埋针治疗更年期综合征12例[J].辽宁中医学院学报.2004,6(4):329-329.
[19]孙远征,崔淑子,郭淑颖,等.俞募配穴为主治疗更年期综合征[J].中国针灸,2004. 24(2):85-87.
[20]张义忠,赵少华,乔连明,等.子午流注法临床运用体会[J].实用中医药杂志,2003,19(12):658-658.
[21]肖菊层.按摩治疗更年期综合征38例临床体会[J].光明中医,2007,22(1):79-80.
[22]陈冠林,许仕杰,周福生(指导).周福生教授“三位一体”辨治更年期综合征[J].吉林中医药,2007,27(7):4-6.
[23]冯鑫.李赛美教授巧用乌梅丸验案二则[J].湖南中医药导报,2003,9(7):11-12.
[24]金亚蓓.裘笑梅治肝八法治疗更年期综合征的经验[J].中华中医药杂志,2006,21(9):542-544.
[25]丁凤,梁晓星,李萍,等.金水相生论治更年期综合征[J].中华中医釣杂志,2006,21(2):107-108.
[26]毕光安.罕见更年期综合征1例[J].疑难病杂志,2004,3(3):166-166.
[27]秦翠润,邢永成.半夏泻心汤临床应用举隅[J].中国民间疗法,2005,13(7):42-43.