中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2015年
7期
17-22
,共6页
奈达铂%紫杉醇%中晚期宫颈癌%系统评价%Meta 分析%随机对照试验
奈達鉑%紫杉醇%中晚期宮頸癌%繫統評價%Meta 分析%隨機對照試驗
내체박%자삼순%중만기궁경암%계통평개%Meta 분석%수궤대조시험
nedaplatin%paclitaxel%middle and advanced stage of cervical cancer%systematic review%meta - analysis%randomized controlled trial
目的:系统评价奈达铂联合紫杉醇治疗中晚期宫颈癌的疗效和安全性。方法计算机检索 MEDLINE,CENTRAL,EMbase,PubMed, CNKI,CBM,VIP 和 WanFang Data,查找有关奈达铂联合紫杉醇治疗中晚期宫颈癌的随机对照试验(RCT),检索时限截至2013年11月。由2名研究者根据纳入与排除标准独立筛选文献、提取资料并评价质量后,采用 RevMan 5.1软件进行 Meta 分析。结果共纳入12项RCT 计787例患者,根据干预措施的不同,分为两个亚组。Meta 分析结果显示,与单纯放疗相比,奈达铂联合紫杉醇放化疗可显著提高患者的近期疗效[ RR =1.58,95% CI(1.03,2.41),P ﹤0.00001]和远期生存率[ RR =1.27,95% CI(1.14,1.40),P ﹤0.00001],胃肠道不良反应差异无统计学意义[ RR =1.32,95% CI(0.99,1.74),P =0.05];与顺铂联合紫杉醇相比,奈达铂联合紫杉醇的近期疗效差异无统计学意义[ RR =1.08,95% CI(0.98,1.1)9,P =0.10],胃肠道不良反应显著降低[ RR =0.48,95% CI(0.37,0.62),P ﹤0.00001],血小板减少的差异无统计学意义[ RR =1.24,95% CI(0.90,1.70),P =0.18]。结论奈达铂联合紫杉醇治疗中晚期宫颈癌安全有效,可作为顺铂联合紫杉醇治疗的替代。但纳入文献数量较少、质量较低,故此结论仅供参考,尚需更多高质量临床研究进一步证实。
目的:繫統評價奈達鉑聯閤紫杉醇治療中晚期宮頸癌的療效和安全性。方法計算機檢索 MEDLINE,CENTRAL,EMbase,PubMed, CNKI,CBM,VIP 和 WanFang Data,查找有關奈達鉑聯閤紫杉醇治療中晚期宮頸癌的隨機對照試驗(RCT),檢索時限截至2013年11月。由2名研究者根據納入與排除標準獨立篩選文獻、提取資料併評價質量後,採用 RevMan 5.1軟件進行 Meta 分析。結果共納入12項RCT 計787例患者,根據榦預措施的不同,分為兩箇亞組。Meta 分析結果顯示,與單純放療相比,奈達鉑聯閤紫杉醇放化療可顯著提高患者的近期療效[ RR =1.58,95% CI(1.03,2.41),P ﹤0.00001]和遠期生存率[ RR =1.27,95% CI(1.14,1.40),P ﹤0.00001],胃腸道不良反應差異無統計學意義[ RR =1.32,95% CI(0.99,1.74),P =0.05];與順鉑聯閤紫杉醇相比,奈達鉑聯閤紫杉醇的近期療效差異無統計學意義[ RR =1.08,95% CI(0.98,1.1)9,P =0.10],胃腸道不良反應顯著降低[ RR =0.48,95% CI(0.37,0.62),P ﹤0.00001],血小闆減少的差異無統計學意義[ RR =1.24,95% CI(0.90,1.70),P =0.18]。結論奈達鉑聯閤紫杉醇治療中晚期宮頸癌安全有效,可作為順鉑聯閤紫杉醇治療的替代。但納入文獻數量較少、質量較低,故此結論僅供參攷,尚需更多高質量臨床研究進一步證實。
목적:계통평개내체박연합자삼순치료중만기궁경암적료효화안전성。방법계산궤검색 MEDLINE,CENTRAL,EMbase,PubMed, CNKI,CBM,VIP 화 WanFang Data,사조유관내체박연합자삼순치료중만기궁경암적수궤대조시험(RCT),검색시한절지2013년11월。유2명연구자근거납입여배제표준독립사선문헌、제취자료병평개질량후,채용 RevMan 5.1연건진행 Meta 분석。결과공납입12항RCT 계787례환자,근거간예조시적불동,분위량개아조。Meta 분석결과현시,여단순방료상비,내체박연합자삼순방화료가현저제고환자적근기료효[ RR =1.58,95% CI(1.03,2.41),P ﹤0.00001]화원기생존솔[ RR =1.27,95% CI(1.14,1.40),P ﹤0.00001],위장도불량반응차이무통계학의의[ RR =1.32,95% CI(0.99,1.74),P =0.05];여순박연합자삼순상비,내체박연합자삼순적근기료효차이무통계학의의[ RR =1.08,95% CI(0.98,1.1)9,P =0.10],위장도불량반응현저강저[ RR =0.48,95% CI(0.37,0.62),P ﹤0.00001],혈소판감소적차이무통계학의의[ RR =1.24,95% CI(0.90,1.70),P =0.18]。결론내체박연합자삼순치료중만기궁경암안전유효,가작위순박연합자삼순치료적체대。단납입문헌수량교소、질량교저,고차결론부공삼고,상수경다고질량림상연구진일보증실。
Objective To evaluate the clinical effect and safety of nedaplatin combined with paclitaxel for middle and advanced stage of cervical cancer. Methods The databases of MEDLINE, CENTRAL, EMbase, PubMed, CNKI, CBM,VIP and WanFang Data were retrieved by computer for searching out the randomized controlled trials (RCTs) on nedaplatin combined with paclitaxel for treating middle and advanced stage of cervical cancer, the retrieval time limit was up to November 2013. According to the inclusion and exclusion criteria, two reviewers independently screened the literature, extracted the data and evaluated the quality of the included RCTs, and then meta -analysis was performed by using RevMan 5. 1 software. Results A total of 12 RCTs were included,involving 787 patients. According to the different intervention measures, the two subgroups were divided. The results of meta - analysis showed that compared with the simple radiotherapy, nedaplatin combined with paclitaxel chemoradiotherapy could significantly improve the short term efficacy of the patients [ RR = 1. 58,95% CI(1. 03,2. 41),P ﹤ 0. 000 01 ] and long - term survival rate[ RR = 1. 27,95% CI(1. 14,1. 40),P ﹤ 0. 000 01], the gastrointestinal adverse reactions had no statistical difference[ RR = 1. 32,95% CI(0. 99,1. 74),P = 0. 05]; the short term efficacy had no statistical difference between nedaplatin plus paclitaxel and cisplatin plus paclitaxel, relative in patients with advanced cervical cancer was not statistically significant[ RR = 1. 08,95% CI(0. 98,1. 1)9,P = 0. 10]; the gastrointestinal adverse reactions were significantly re-duced[ RR = 0. 48,95% CI(0. 37,0. 62),P ﹤ 0. 000 01], thrombocytopenia had no statistical difference [ RR = 1. 24,95% CI(0. 90, 1. 70),P = 0. 18] . Conclusion Nedaplatin plus paclitaxel in treating middle and advanced stage of cervical cancer is safe and effec-tive, can be used as an alternative to the cisplatin plus paclitaxel therapy. However, the included documents are smaller in number and lower in quality, therefore the conclusion of this systematic review only provides reference for clinical practice and research and needs more high - quality clinical studies to confirm.