[1]王灵芝,范丽丽,吴向辉,等.氟唑帕利治疗铂敏感型复发性上皮性卵巢癌的疗效及安全性[J].新乡医学院学报,2023,40(12):1156-1160.[doi:10.7683/xxyxyxb.2023.12.011]
　WANG Lingzhi,FAN Lili,WU Xianghui,et al.Efficacy and safety of fluzopril in the treatment of platinum-sensitive recurrent epithelial ovarian cancer[J].Journal of Xinxiang Medical University,2023,40(12):1156-1160.[doi:10.7683/xxyxyxb.2023.12.011]
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氟唑帕利治疗铂敏感型复发性上皮性卵巢癌的疗效及安全性
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《新乡医学院学报》[ISSN:1004-7239/CN:41-1186/R]

卷:
40卷
期数:
2023年12
页码:
1156-1160
栏目:
临床研究
出版日期:
2023-12-05

文章信息/Info

Title:
Efficacy and safety of fluzopril in the treatment of platinum-sensitive recurrent epithelial ovarian cancer
作者:
王灵芝; 范丽丽; 吴向辉; 薛秀珍
（河南科技大学第一附属医院妇产科，河南　洛阳　471000）
Author(s):
WANG Lingzhi; FAN Lili; WU Xianghui; XUE Xiuzhen
（Department of Obstetrics and Gynecology,the First Affiliated Hospital of Henan University of Science and Technology,Luoyang 417000,Henan Province,China）
关键词:
铂敏感型; 复发性上皮性卵巢癌; 氟唑帕利; 疗效; 安全性
Keywords:
platinum-sensitive; recurrent epithelial ovarian cancer; fluzopril; efficacy; safety
分类号:
R737.31
DOI:
10.7683/xxyxyxb.2023.12.011
文献标志码:
A
摘要:
目的　探讨氟唑帕利治疗铂敏感型复发性上皮性卵巢癌的疗效及安全性。
方法　选择2019年1月至2020年12月河南科技大学第一附属医院收治的107例铂敏感型复发性上皮性卵巢癌患者为研究对象，根据治疗方式将患者分为对照组（n=50）和观察组（n=57）。对照组患者采用紫杉醇联合铂类一线化学治疗方案，第1 天，静脉滴注紫杉醇注射液135 mg·m-2；第1~3天，静脉滴注顺铂50~60 mg·m-2；21 d为1个化学治疗周期。观察组患者在对照组基础上给予氟唑帕利胶囊口服，每次150 mg，每日2次，连续治疗至疾病进展或出现不可接受的毒性反应；21 d为1个化学治疗周期。2组患者均连续接受3个化学治疗周期。比较2组患者化学治疗3个周期后的临床疗效、治疗后2 a内预后情况、化学治疗前后卡氏（KPS）评分及化学治疗期间不良反应发生情况。
结果　化学治疗3个周期后，观察组患者的疾病控制率和客观缓解率显著高于对照组（χ2=5.420、4.220，P<0.05）。随访至24个月，观察组患者的无进展生存期显著长于对照组（t=6.702，P<0.05）；2组患者的1 a生存率比较差异无统计学意义（χ2= 0.415，P>0.05）；观察组患者的2 a生存率显著高于对照组（χ2= 5.420，P<0.05）。化学治疗前，2组患者KPS评分比较差异无统计学意义（t=0.537，P>0.05）；2组患者化学治疗3个周期后的KPS评分显著高于化学治疗前（t=5.604、9.378，P<0.05）；化学治疗3个周期后，观察组患者的KPS评分显著高于对照组（t=2.608，P<0.05）。2组患者在化学治疗期间均出现有血液系统和非血液系统不良反应，其中血液系统不良反应主要为骨髓抑制，多为Ⅲ°及Ⅳ°不良反应；非血液系统不良反应有脱发、胃肠道反应和肝肾功能异常等，多为Ⅰ°和Ⅱ°不良反应；2组患者均未出现化学治疗相关性死亡病例。对照组患者化学治疗期间贫血、血小板减少症、中性粒细胞减少症、白细胞减少症、淋巴细胞减少症、恶心、呕吐、乏力、食欲减退、脱发、血肌酐升高、丙氨酸转氨酶(ALT)升高发生率分别为68.00%（34/50）、72.00%（36/50）、58.00%（29/50）、68.00%（34/50）、22.00%（11/50）、26.00%（13/50）、24.00%（12/50）、46.00%（23/50）、30.00%（15/50）、50.00%（25/50）、20.00%（10/50）、10.00%（5/50），观察组患者化学治疗期间贫血、血小板减少症、中性粒细胞减少症、白细胞减少症、淋巴细胞减少症、恶心、呕吐、乏力、食欲减退、脱发、血肌酐升高、ALT升高发生率分别为61.40%（35/57）、63.16%（36/57）、49.12%（28/57）、52.63%（30/57）、21.05%（12/57）、22.81%（13/57）、24.56%（14/57）、42.11%（24/57）、29.82%（17/57）、47.37%（27/57）、21.05%（12/57）、10.53%（6/57）；对照组与观察组患者化学治疗期间贫血、血小板减少症、中性粒细胞减少症、白细胞减少症、淋巴细胞减少症、恶心、呕吐、乏力、食欲减退、脱发、血肌酐升高、ALT升高发生率比较差异均无统计学意义（χ2=0.047、0.000、0.041、0.694、0.056、0.000、0.208、0.041、0.184、0.160、0.233、0.102，P>0.05）。
结论　对于铂敏感型复发性卵巢癌患者，在紫杉醇联合铂类化学治疗的基础上联合氟唑帕利可有效地提高抗肿瘤效果，延长患者无进展生存期，提高生存率，改善生存质量，且不良反应可控。
Abstract:
Objective　To investigate the efficacy and safety of fluzopril in the treatment of platinum-sensitive recurrent epithelial ovarian cancer.
Methods　A total of 107 patients with platinum-sensitive recurrent epithelial ovarian cancer admitted to the First Affiliated Hospital of Henan University of Science and Technology from January 2019 to December 2020 were selected as the subjects.According to treatment methods,the patients were divided into control group (n=50) and observation group (n=57).The patients in the control group received a first-line chemotherapy regimen of paclitaxel combined with platinum:on the first day,intravenous infusion with paclitaxel injection 135 mg·m-2 was administered;on day 1-3,intravenous drip with cisplatin 50-60 mg·m-2 was administered;21 days was one chemotherapy cycle.On the basis of the treatment in the control group,the patients in the observation group were given fluzoparide capsules orally,150 mg each time,twice a day,and the treatment continued until disease progression or unacceptable toxic reactions occurred;21 days was one chemotherapy cycle.The patients in both groups received three consecutive chemotherapy cycles.The clinical efficacy,prognosis within 2 years after chemotherapy,Karnofsky Performance Status（KPS） score before and after chemotherapy,and incidence of adverse reactions during chemotherapy of patients between the two groups were compared.
Results　After 3 cycles of chemotherapy,the disease control rate and objective remission rate of patients in the observation group were significantly higher than those in the control group（χ2=5.420,4.220;P<0.05).Following up to 24 months,the progression free survival of patients in the observation group was significantly longer than that in the control group (t=6.702,P<0.05);there was no statistically significant difference in 1-year survival rate of patients between the two groups（χ2= 0.415,P>0.05);the 2-year survival rate of patients in the observation group was significantly higher than that in the control group（χ2= 5.420,P<0.05).Before chemotherapy,there was no statistically significant difference in KPS scores of patients between the two groups (t=0.537,P>0.05);the KPS scores of patients in the two groups after three cycles of chemotherapy were significantly higher than those before chemotherapy (t=5.604,9.378;P<0.05);after three cycles of chemotherapy,the KPS score of patients in the observation group was significantly higher than that in the control group (t=2.608,P<0.05).The patients in both groups experienced hematological and non-hematological adverse reactions during chemotherapy;the main hematological adverse reactions was bone marrow suppression,most of which were Ⅲ° and Ⅳ° adverse reactions;the non-hematological adverse reactions included alopecia,gastrointestinal reactions,and liver and kidney dysfunction,most of which were Ⅰ°and Ⅱ°adverse reactions.There were no chemotherapy related deaths of patients in both groups.The incidence rates of anemia,thrombocytopenia,neutropenia,leukopenia,lymphopenia,nausea,vomiting,fatigue,loss of appetite,hair loss,elevated serum creatinine,and elevated alanine amino-transferase (ALT) of patients during chemotherapy in the control group were 68.00% (34/50),72.00% (36/50),58.00% (29/50),68.00% (34/50),22.00% (11/50),26.00% (13/50),24.00% (12/50),46.00% (23/50),30.00% (15/50),50.00% (25/50),20.00% (10/50),10.00% (5/50),respectively;the incidence rates of anemia,thrombocytopenia,neutropenia,leukopenia,lymphopenia,nausea,vomiting,fatigue,loss of appetite,hair loss,elevated serum creatinine,and elevated ALT of patients during chemotherapy in the observation group were 61.40% (35/57),63.16% (36/57),49.12% (28/57),52.63% (30/57),21.05% (12/57),22.81% (13/57),24.56% (14/57),42.11% (24/57),29.82% (17/57),47.37% (27/57),21.05% (12/57),10.53% (6/57),respectively.There was no statistically significant difference in the incidences of anemia,thrombocytopenia,neutropenia,leukopenia,lymphopenia,nausea,vomiting,fatigue,loss of appetite,hair loss,elevated serum creatinine,and elevated ALT of patients during chemotherapy between the control group and the observation group（χ2=0.047,0.000,0.041,0.694,0.056,0.000,0.208,0.041,0.184,0.160,0.233,0.102;P>0.05).
Conclusion　For patients with platinum-sensitive recurrent ovarian cancer,the combination of paclitaxel and platinum chemotherapy combined with fluzopril can effectively improve the anti-tumor effect,prolong the progression-free survival,improve survival rate and quality of life,and the adverse reactions are controllable.

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更新日期/Last Update: 2023-12-05