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作 者:由婷婷 谷俊杰[1] 白春梅[1] 马水清[2] YOU Ting-ting;GU Jun-jie;BAI Chun-mei;MA Shui-qing(Peking Union Medical College Hospital,Chinese Academy of Medical ScienceDepartment of Medical Oncology,Beijing 100032,China;Peking Union Medical College Hospital,Chinese Academy of Medical Science Department of Obstetrics and Gynecology,Beijing 100032,China)
机构地区:[1]中国医学科学院北京协和医学院北京协和医院肿瘤内科,北京100730 [2]中国医学科学院北京协和医学院北京协和医院妇产科,北京100730
出 处:《中国新药杂志》2020年第17期2027-2033,共7页Chinese Journal of New Drugs
摘 要:目的:通过Meta分析探讨白蛋白结合型紫杉醇在卵巢癌治疗中的有效性与安全性。方法:根据指定纳入及排除标准,检索PubMed、EMBASE、Medline、CochraneLibrary、CNKI、万方数据资源库、维普数据库中关于白蛋白结合型紫杉醇治疗卵巢癌的临床研究。筛选文献后提取相关数据,并应用Minors(methodological index for non-randomized studies)量表和改良Jadad量表分别对非随机试验和随机对照试验进行质量评价。结果:共纳入13篇临床研究(样本量488例)。汇总分析白蛋白结合型紫杉醇单药二线治疗卵巢癌的疾病缓解率(ORR)为47.3%(95%CI:25.5%,69.1%),疾病控制率(DCR)为75.9%(95%CI:57.7%,94.1%);联合铂类晚期一线或复发二线治疗ORR和DCR分别为48.7%(95%CI:26.5%,71.0%)与70.0%(95%CI:50.3%,89.7%);联合贝伐珠单抗二线治疗ORR和DCR分别为60.1%(95%CI:39.7%,80.5%)与86.1%(95%CI:80.4%,91.7%)。3~4级不良反应方面,单药白蛋白结合型紫杉醇白细胞减少发生率为8.4%(95%CI:-0.4%,17.3%),恶心呕吐等消化道反应发生率为3.4%(95%CI:0.2%,6.5%),周围神经病变发生率为2.7%(95%CI:-0.1%,5.5%);联合铂类时白细胞减少发生率为9.9%(95%CI:-2.2%,21.9%),恶心呕吐等消化道反应发生率为7.7%(95%CI:2.0%,13.3%),周围神经病变发生率为5.9%(95%CI:0.9%,10.9%)。结论:白蛋白结合型紫杉醇在卵巢癌二线或晚期一线的治疗中具有一定的有效性与安全性,仍需大型临床试验进一步验证。Objective: To systematically assess the effectiveness and safety of albumin-bound(nab) paclitaxel in ovarian cancer. Methods: Based on the inclusion and exclusion criteria, clinical trials about albumin-bound(nab) paclitaxel and ovarian cancer in the databases of PubMed, EMBASE, Medline, Cochrane Library, CNKI, Wanfang and CQVIP were collected. Methodological index for non-randomized studies and modified Jadad checklists were used to assess trials. Results: A total of 13 clinical trials involving 488 patients were included in this study. The results of Meta-analysis showed the single agent of albumin-bound(nab) paclitaxel as the second-line treatment achieved ORR was 47.3%(95%CI: 25.5%, 69.1%) and DCR was 75.9%(95%CI: 57.7%, 94.1%). When combined with platinum as the first-line treatment in advanced or the second-line treatment in recurrent ovarian cancer, ORR was 48.7%(95%CI: 26.5%, 71.0%) and DCR was 70.0%(95%CI: 50.3%, 89.7%). When combined with bevacizumab as the second-line treatment, ORR was 60.1%(95%CI: 39.7%, 80.5%) and DCR was 86.1%(95%CI: 80.4%, 91.7%). For grade 3 or 4 side effects, the incidence of leukopenia, nausea and vomiting, as well as neuropathy, were 8.4%(95%CI:-0.4%, 17.3%), 3.4%(95%CI: 0.2%, 6.5%) and 2.7%(95%CI:-0.1%, 5.5%) when treated by the single agent of albumin-bound(nab) paclitaxel. Besides, the incidence of leukopenia, nausea and vomiting, as well as neuropathy, were 9.9%(95%CI:-2.2%,21.9%), 7.7%(95%CI:2.0%,13.3%) and 5.9%(95%CI:0.9%,10.9%) when combined with platinum. Conclusion: Albumin-bound(nab) paclitaxel shows effectiveness and safety in the second-line or first-line on advanced ovarian cancer in some degree and needs to be evaluated in more clinical trials.
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