CAJ | 학술논문

目的：系统评价以益气活血为主的方药联合化疗治疗原发性肝癌的疗效。方法：采用Cochrane系统评价方法，计算机检索电子检索Cochrane图书馆临床对照试验资料库、 MEDLINE、 EMBASE 、 PUBMED、万方数据库、中文科技期刊全文数据库（ CNKI）、中国期刊全文数据库（ VIP），检索时间均从建库至2014年1月，文种限于中、英文。按照纳入与排除标准选择文献，并根据Cochrane系统评价员手册5.1版推荐要求进行方法学质量的评估、数据的提取和Meta 分析。结果：共纳入9个RCT研究，合计686例患者。方法学质量评价9个RCT均存在高度“偏倚性”风险。 Meta分析显示：以益气活血为主的方药联合化疗治疗原发性肝癌在改善患者生活质量、提高近期疗效、减轻患者疼痛、减少白细胞下降发生率等方面具有疗效优势，优于单纯化疗组，差异有统计学意义[ RR＝1.84，95％CI （1.35，2.50）， P＝0.0001； RR＝1.51，95％CI （1.21，1.88）， P＝0.0003； RR＝1.62，95％CI （1.22，2.16）， P＝0.001； RR＝0.37，95％CI （0.25，0.54）， P＝0.00001]。在改善患者腹水程度及延缓生存期上，联合用药患者疗效与单纯化疗者相当，差异无统计学意义[RR＝1.31，95％CI （0.96，1.79）， P＝0.09； RR＝1.06，95％CI （0.88，1.29）， P＝0.52； RR＝1.31，95％CI （1.00，1.72）， P＝0.05]。结论：基于当前临床证据表明，以益气活血为主的方药联合化疗治疗原发性肝癌有助于减轻患者疼痛，提高其生活质量，降低不良反应发生率，近期疗效明显，优于单纯化疗法，值得临床借鉴，期待有高质量RCT研究进一步验证。
목적：계통평개이익기활혈위주적방약연합화료치료원발성간암적료효。방법：채용Cochrane계통평개방법，계산궤검색전자검색Cochrane도서관림상대조시험자료고、 MEDLINE、 EMBASE 、 PUBMED、만방수거고、중문과기기간전문수거고（ CNKI）、중국기간전문수거고（ VIP），검색시간균종건고지2014년1월，문충한우중、영문。안조납입여배제표준선택문헌，병근거Cochrane계통평개원수책5.1판추천요구진행방법학질량적평고、수거적제취화Meta 분석。결과：공납입9개RCT연구，합계686례환자。방법학질량평개9개RCT균존재고도“편의성”풍험。 Meta분석현시：이익기활혈위주적방약연합화료치료원발성간암재개선환자생활질량、제고근기료효、감경환자동통、감소백세포하강발생솔등방면구유료효우세，우우단순화료조，차이유통계학의의[ RR＝1.84，95％CI （1.35，2.50）， P＝0.0001； RR＝1.51，95％CI （1.21，1.88）， P＝0.0003； RR＝1.62，95％CI （1.22，2.16）， P＝0.001； RR＝0.37，95％CI （0.25，0.54）， P＝0.00001]。재개선환자복수정도급연완생존기상，연합용약환자료효여단순화료자상당，차이무통계학의의[RR＝1.31，95％CI （0.96，1.79）， P＝0.09； RR＝1.06，95％CI （0.88，1.29）， P＝0.52； RR＝1.31，95％CI （1.00，1.72）， P＝0.05]。결론：기우당전림상증거표명，이익기활혈위주적방약연합화료치료원발성간암유조우감경환자동통，제고기생활질량，강저불량반응발생솔，근기료효명현，우우단순화요법，치득림상차감，기대유고질량RCT연구진일보험증。
Objective: To evaluate the clinical effect of Yiqi Huoxue prescriptions dominated combined with chemotherapy to primary liver cancer ( PLC) .Methods: By cochrane systematic review methods , Cochrane Central Register of Controlled Trials , MEDLINE, EMBASE, PUBMED, Wanfang, CNKI, VIP were retrived by computer from building databases to January 2014.The text was confined to the Chinese and English.According to the inclusion and exclusion criteria to select literature , the methodologi-cal quality was assessed on the basis of the recommend requirement of Cochrane Handbook for Systematic Reviews 5.1 version, ex-tracted data and Meta-analysis.Results: Nine randomized trials were matched the selection criteria , including 686 patients.There were high bias on the 9 RCTs according to methodological quality assessment.Meta analysis showed that: combination therapy of Yiqi Huoxue prescriptions with chemotherapy group was better than the pure chemotherapy group , to PLC in improving quality of life, improving in the near future curative effect and relieve patients′pain, reducing the incidence of white blood cells decline had curative effect advantage, the differences were statistically significant [RR =1.84, 95%CI (1.35, 1.35), P=0.0001;RR =1.51, 95%CI (1.21, 1.21), P=0.0003;RR =1.62, 95%CI (1.22, 1.22), P=0.001;RR =0.37, 95%CI (0.25, 0.25), P=0.00001] .On the improvement of patients with ascites and delay the survival , curative effect and the pure chemo-therapy group, the differences were not statistical significance [ RR=1.31, 95%CI (0.96, 1.79), P=0.09; RR=1.06, 95%CI (0.88, 1.29), P=0.52; RR=1.31, 95%CI (1.00, 1.72), P=0.05] .Conclusion: Based on the current evi-dence from clinical , there are obvious advantages of combination therapy of Yiqi Huoxue prescriptions with chemotherapy group in the treatment of PLCin reducing pain , improving quality of life , improving the curative effect of recent chemotherapy and reducing the incidence of adverse reactions by comparing with chemotherapy alone.It is worth to reference for clinical and look forward to having higher quality RCTs for further verification.