中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2015年
1期
11-14,15
,共5页
高靓%郑晓辉%赵振营%史桂玲%张惠娟
高靚%鄭曉輝%趙振營%史桂玲%張惠娟
고정%정효휘%조진영%사계령%장혜연
卡培他滨%多西他赛%表柔比星%转移性乳腺癌%Meta分析
卡培他濱%多西他賽%錶柔比星%轉移性乳腺癌%Meta分析
잡배타빈%다서타새%표유비성%전이성유선암%Meta분석
capecitabine%docetaxel%epirubicin%metastatic breast cancer%meta-analysis
目的：系统评价卡培他滨或表柔比星联合多西他赛对蒽环类药物治疗失败的转移性乳腺癌患者的疗效和安全性。方法计算机检索Medline，Embase，PubMed，Cochrane Library等英文数据库及中国期刊全文数据库（CNKI）、中文科技期刊全文数据库( VIP )、万方数字化期刊全文库等中文数据库，纳入卡培他滨或表柔比星联合多西他赛对比治疗蒽环类药物治疗失败的转移性乳腺癌的随机对照试验（RCT），检索日期截至2013年12月，语种限定为中文和英文。按Cochrane系统评价方法评价纳人研究的方法学质量，提取有效数据后使用RevMan 5.0软件对客观缓解、疾病稳定、疾病进展、不良反应进行Meta分析。结果共纳入4个RCT ，包括419例患者。Meta分析结果显示，卡培他滨或表柔比星联合多西他赛对治疗蒽环类药物治疗失败的转移性乳腺癌在客观缓解率[ RR=1.17，95% CI（0.98，1.39），P=0.08]、疾病稳定率[ RR=0.79，95% CI（0.58，1.08），P=0.14]和疾病进展率[ RR=1.11，95% CI（0.92，1.33），P<0.28]方面均无明显差异，证明两组疗效相当。卡培他滨治疗乳腺癌的不良反应Meta分析结果显示，手足综合征、贫血、恶心呕吐和肌痛具有统计学意义( P<0.01)，其中 RR值显示手足综合征卡培他滨组较非卡培他滨组的发生率更大，而贫血、恶心呕吐和肌痛的 RR <1，显示表柔比星组的发生率更大。结论卡培他滨或表柔比星联合多西他赛对蒽环类药物治疗失败的转移性乳腺癌患者的疗效相当。卡培他滨不良反应中手足综合征发生率较大，而贫血、恶心呕吐和肌痛等方面的发生率相对较低。
目的：繫統評價卡培他濱或錶柔比星聯閤多西他賽對蒽環類藥物治療失敗的轉移性乳腺癌患者的療效和安全性。方法計算機檢索Medline，Embase，PubMed，Cochrane Library等英文數據庫及中國期刊全文數據庫（CNKI）、中文科技期刊全文數據庫( VIP )、萬方數字化期刊全文庫等中文數據庫，納入卡培他濱或錶柔比星聯閤多西他賽對比治療蒽環類藥物治療失敗的轉移性乳腺癌的隨機對照試驗（RCT），檢索日期截至2013年12月，語種限定為中文和英文。按Cochrane繫統評價方法評價納人研究的方法學質量，提取有效數據後使用RevMan 5.0軟件對客觀緩解、疾病穩定、疾病進展、不良反應進行Meta分析。結果共納入4箇RCT ，包括419例患者。Meta分析結果顯示，卡培他濱或錶柔比星聯閤多西他賽對治療蒽環類藥物治療失敗的轉移性乳腺癌在客觀緩解率[ RR=1.17，95% CI（0.98，1.39），P=0.08]、疾病穩定率[ RR=0.79，95% CI（0.58，1.08），P=0.14]和疾病進展率[ RR=1.11，95% CI（0.92，1.33），P<0.28]方麵均無明顯差異，證明兩組療效相噹。卡培他濱治療乳腺癌的不良反應Meta分析結果顯示，手足綜閤徵、貧血、噁心嘔吐和肌痛具有統計學意義( P<0.01)，其中 RR值顯示手足綜閤徵卡培他濱組較非卡培他濱組的髮生率更大，而貧血、噁心嘔吐和肌痛的 RR <1，顯示錶柔比星組的髮生率更大。結論卡培他濱或錶柔比星聯閤多西他賽對蒽環類藥物治療失敗的轉移性乳腺癌患者的療效相噹。卡培他濱不良反應中手足綜閤徵髮生率較大，而貧血、噁心嘔吐和肌痛等方麵的髮生率相對較低。
목적：계통평개잡배타빈혹표유비성연합다서타새대은배류약물치료실패적전이성유선암환자적료효화안전성。방법계산궤검색Medline，Embase，PubMed，Cochrane Library등영문수거고급중국기간전문수거고（CNKI）、중문과기기간전문수거고( VIP )、만방수자화기간전문고등중문수거고，납입잡배타빈혹표유비성연합다서타새대비치료은배류약물치료실패적전이성유선암적수궤대조시험（RCT），검색일기절지2013년12월，어충한정위중문화영문。안Cochrane계통평개방법평개납인연구적방법학질량，제취유효수거후사용RevMan 5.0연건대객관완해、질병은정、질병진전、불량반응진행Meta분석。결과공납입4개RCT ，포괄419례환자。Meta분석결과현시，잡배타빈혹표유비성연합다서타새대치료은배류약물치료실패적전이성유선암재객관완해솔[ RR=1.17，95% CI（0.98，1.39），P=0.08]、질병은정솔[ RR=0.79，95% CI（0.58，1.08），P=0.14]화질병진전솔[ RR=1.11，95% CI（0.92，1.33），P<0.28]방면균무명현차이，증명량조료효상당。잡배타빈치료유선암적불량반응Meta분석결과현시，수족종합정、빈혈、악심구토화기통구유통계학의의( P<0.01)，기중 RR치현시수족종합정잡배타빈조교비잡배타빈조적발생솔경대，이빈혈、악심구토화기통적 RR <1，현시표유비성조적발생솔경대。결론잡배타빈혹표유비성연합다서타새대은배류약물치료실패적전이성유선암환자적료효상당。잡배타빈불량반응중수족종합정발생솔교대，이빈혈、악심구토화기통등방면적발생솔상대교저。
Objective To systematically evaluate the clinical effect and safety of capecitabine plus docetaxel in the treatment of the pa-tients with anthracycline-failed metastatic breast cancer. Methods The English databases of Medline, Embase, Pubmed, Cochrane library and the Chinese databases of CNKI, VIP, Wanfang were retrieved by computer. The randomized controlled trials ( RCTs ) on the combina-tion therapy of capecitabine plus docetaxel in the anthracycline-failed patients with metastatic breast cancer were included. The retrieval cut-off date was up to December 2013. The retrieval was limited to English and Chinese languages. The methodological quality of the included RCTs was evaluated by the Cochrane system evaluation method. After extracting the effective data, the RevMan 5. 0 software was applied for conducting the meta-analysis on the objective response rate ( ORR ) , stable disease ( SD ) , time to progression ( TTP ) and adverse events. Results 4 RCTs involving 419 patients were included. The meta-analysis results showed that capecitabine plus docetaxel and epirubicin plus docetaxel for treating anthracycline-failed metastatic breast cancer had no obvious differences in ORR [ RR=1. 17, 95% CI(0. 98, 1. 39),P=0. 08], SD[ RR=0. 79,95% CI(0. 58,1. 08),P=0. 14] and TTP[ RR=1. 11,95% CI(0. 92, 1. 33),P<0. 28], indicating that the efficacy of the two regimens was similar. The meta-analysis showed that the adverse reactions of capecitabine were hand-foot syndrome, anemia, nausea, vomiting as well as myalgia with statistical significance ( P<0. 01 );in which the RR value revealed that the occurrence rate of the hand-foot syndrome in the capecitabine group was greater than that in the non-capecitabine group, but the RR< 1 in anemia, vomiting, nausea and myalgia, which revealing that their occurrence rates in the epirubicin group were greater;other adverse reactions had no statistical significance. Conclusion Capecitabine plus docetaxel and epirubicin plus docetaxel have the equal efficacy in treating anthracycline-failed metastatic breast cancer. Among the adverse reactions of capecitabine, the hand-foot syn-drome has the higher incidence rate, while anemia, nausea, vomiting and myalgia have the lower incidence rate. These results need more high-quality RCTs to be further verified.
