中国医学创新
中國醫學創新
중국의학창신
MEDICAL INNOVATION OF CHINA
2014年
30期
104-106,107
,共4页
中药注射液%晚期乳腺癌%随机对照%文献质量评价
中藥註射液%晚期乳腺癌%隨機對照%文獻質量評價
중약주사액%만기유선암%수궤대조%문헌질량평개
Chinese traditional medicine injection%Advanced breast cancer%Randomized controlled trials%Quality evaluation of literature
目的:对中药注射液治疗晚期乳腺癌的文献进行质量评价,明确中药注射液治疗晚期乳腺癌的疗效及存在的问题。方法:选择“万方数据库”(1989-2013)及“中国知网”(1979-2013),以“晚期乳腺癌”、“转移性乳腺癌”、“随机”、“对照”为检索词,对1979年1月-2013年12月期刊发表的随机对照临床试验文献进行检索。对纳入文献的随机方法、分配隐藏、诊断标准、疗效判定标准、组间均衡性、盲法、随访、依从性及统计方法等方面进行评价。结果:符合纳入标准的文献共20篇。缺乏多中心临床研究,有明确诊断标准2篇(10%);有明确疗效判定标准的16篇(80%);做组间均衡性比较11篇(55%);正确使用随机分配方法的6篇(30%);所有文献均未描述对受试对象的依从性检测;有随访记录的2篇(10%);正确使用统计方法15篇(70%),确切给出检验值的5篇(20%);所有文献均报道了不良反应。结论:中药注射液治疗晚期乳腺癌的研究中,40%及60%的文献分别指出中药注射液联合化疗在总有效率及生活质量评分方面优于单纯化疗组,但缺乏多中心研究,诊断标准不明确,随机、分配隐藏和随访、依从性等有关研究方案质量的评价较低。
目的:對中藥註射液治療晚期乳腺癌的文獻進行質量評價,明確中藥註射液治療晚期乳腺癌的療效及存在的問題。方法:選擇“萬方數據庫”(1989-2013)及“中國知網”(1979-2013),以“晚期乳腺癌”、“轉移性乳腺癌”、“隨機”、“對照”為檢索詞,對1979年1月-2013年12月期刊髮錶的隨機對照臨床試驗文獻進行檢索。對納入文獻的隨機方法、分配隱藏、診斷標準、療效判定標準、組間均衡性、盲法、隨訪、依從性及統計方法等方麵進行評價。結果:符閤納入標準的文獻共20篇。缺乏多中心臨床研究,有明確診斷標準2篇(10%);有明確療效判定標準的16篇(80%);做組間均衡性比較11篇(55%);正確使用隨機分配方法的6篇(30%);所有文獻均未描述對受試對象的依從性檢測;有隨訪記錄的2篇(10%);正確使用統計方法15篇(70%),確切給齣檢驗值的5篇(20%);所有文獻均報道瞭不良反應。結論:中藥註射液治療晚期乳腺癌的研究中,40%及60%的文獻分彆指齣中藥註射液聯閤化療在總有效率及生活質量評分方麵優于單純化療組,但缺乏多中心研究,診斷標準不明確,隨機、分配隱藏和隨訪、依從性等有關研究方案質量的評價較低。
목적:대중약주사액치료만기유선암적문헌진행질량평개,명학중약주사액치료만기유선암적료효급존재적문제。방법:선택“만방수거고”(1989-2013)급“중국지망”(1979-2013),이“만기유선암”、“전이성유선암”、“수궤”、“대조”위검색사,대1979년1월-2013년12월기간발표적수궤대조림상시험문헌진행검색。대납입문헌적수궤방법、분배은장、진단표준、료효판정표준、조간균형성、맹법、수방、의종성급통계방법등방면진행평개。결과:부합납입표준적문헌공20편。결핍다중심림상연구,유명학진단표준2편(10%);유명학료효판정표준적16편(80%);주조간균형성비교11편(55%);정학사용수궤분배방법적6편(30%);소유문헌균미묘술대수시대상적의종성검측;유수방기록적2편(10%);정학사용통계방법15편(70%),학절급출검험치적5편(20%);소유문헌균보도료불량반응。결론:중약주사액치료만기유선암적연구중,40%급60%적문헌분별지출중약주사액연합화료재총유효솔급생활질량평분방면우우단순화료조,단결핍다중심연구,진단표준불명학,수궤、분배은장화수방、의종성등유관연구방안질량적평개교저。
Objective:To observe the efficacy and analyze the problem of Chinese traditional medicine injection (CMI)therapy for advanced breast cancer by quality evaluation of literature.Method:The randomized controlled clinical trials published in the journals from January 1998 to December 2013 were searched by using"advanced breast cancer "," metastatic breast cancer "," random " and " control " as the search words from" WANFANG data"(1989-2013)and"CNKI.NET"(1979-2013)database. The collected literature were analyzed and evaluated according to randomization,allocation concealment,diagnostic criteria,efficacy criteria,baseline comparability,follow-up,compliance and statistical methods.Result:There were 20 articles met the inclusion criteria,2 articles(10%)with clear diagnostic criteria;16 articles(80%)with efficacy criteria;11 articles(55%)with balanced comparison between groups,6 articles(30%)with proper randomized controlled method;none of the articles described the compliance;2 articles(10%)with follow-up record;15 articles(70%)with clear statistical methods but only 5 articles(20%)showed exact test value. All the literature reported adverse reactions.Conclusion:40%and 60%of the literatures,respectively, pointed out CMI combined with chemotherapy was superior to chemotherapy alone group in total effective rates and quality of life. CMI therapy for advanced breast cancer is lack of multi-center study with efficacy assessment and low quality of research program.