摘要
目的比较紫杉醇联合顺铂方案(TP方案)与联合卡铂方案(TC方案)2种铂类辅助化疗方案治疗卵巢癌的临床疗效、安全性及药物经济学优势。方法将实施卵巢肿瘤细胞减灭术后首次接受化疗的卵巢癌患者147例随机分为TP组72例和TC组75例。以无进展生存期为主要研究终点,疗效分级、客观有效率和疾病控制率为次要研究终点,住院日为探索性研究终点,考察2组的临床疗效。根据不良反应发生情况分级考察2组的安全性。在临床疗效和安全性的基础上进一步考察2组的药物经济学优势,综合确定TP方案和TC方案治疗卵巢癌的优越性。结果TP组和TC组分别有13例和12例出现肿瘤进展,中位无进展生存期(14个月vs 23个月)、客观有效率(61.11%vs 65.33%)、疾病控制率(91.94%vs 84.00%)和疗效分级比较,差异均无统计学意义(P>0.05)。2组住院日比较,TP组较TC组显著延长(13.6dvs8.4d,P<0.05)。2组不良反应均以骨髓抑制和胃肠道反应为主,1~2级不良反应发生情况比较,差异无统计学意义(P>0.05);3~4级不良反应发生情况比较,TP组高于TC组(P<0.05)。TP组较TC组人均每疗程的治疗成本(10997.09元vs 7511.38元)、成本-客观有效率比(179.96元vs 114.89元)与成本-疾病控制率比(119.61元vs 89.42元)均较高。结论TP、TC 2种铂类辅助化疗方案治疗卵巢癌临床疗效相似,但TC方案安全性高,药物经济学优势明显。
AIM To compare the clinical efficacy,safety and pharmacoeconomic advantages of two platinumbased adjuvant chemotherapy regimens of taxol plus cisplatin(TP regimen)and plus carboplatin(TC regimen)in the treatment of ovarian cancer.METHODS A total of 147 patients with ovarian cancer who received chemotherapy for the first time after ovarian tumor cytoreductive surgery were randomly divided into TP group(n=72)and TC group(n=75).Progression-free survival was the primary study endpoint,efficacy grade and objective response rate and disease control rate were the secondary study endpoints,and length of stay was the exploratory study endpoint.The clinical efficacy of 2 groups were investigated according to the occurrence of adverse drug reactions.On the basis of clinical efficacy and safety,the pharmacoeconomic advantages of 2 groups were further investigated to comprehensively determine the superiority of TP regimen and TC regimen in the treatment of ovarian cancer.RESULTS There were 13 and 12 patients of tumor progressions in TP and TC groups,respectively.Difference of progression-free survival(14 months vs 23 months),objective response rate(61.11%vs 65.33%),disease control rate(91.94%vs 84.00%)and efficacy grade between TP and TC groups were not statistically different(P>0.05).Compared with the TC group,the TP group had significantly longer length of stay(13.6 d vs 8.4 d,P<0.05).Bone marrow suppression and gastrointestinal reactions were the main adverse reactions in 2 groups.Similar occurrence of 1-2 grade adverse drug reactions between 2 groups but higher occurrence of 3-4 grade adverse reactions in TP group were observed.Compared with the TC group,the TP group had an increased mean cost of per treatment course(10997.09 yuan vs 7511.38 yuan),ratio of cost-to-objective response rate(179.96 yuan vs 114.89 yuan)and ratio of cost-to-disease control rate(119.61 yuan vs 89.42 yuan).CONCLUSION TP and TC regimens have similar clinical efficacy,but TC regimen has high safety and obvious advantages of pharmacoeconomics in the treatment of ovarian cancer.
作者
谭志美
郑春茂
王安发
周西滢
成浩
TAN Zhimei;ZHENG Chunmao;WANG Anfa;ZHOU Xiying;CHENG Hao(Department of Pharmacy,Chenzhou No.1 People′s Hospital,Chenzhou 423000,China;Department of Reproductive Oncology,Chenzhou No.1 People′s Hospital,Chenzhou 423000,China;Department of Medical Oncology,Chenzhou No.1 People′s Hospital,Chenzhou 423000,China)
出处
《中国临床药学杂志》
CAS
2022年第7期505-512,共8页
Chinese Journal of Clinical Pharmacy
基金
湖南省郴州市第一人民医院院内科研基金
关键词
顺铂
卡铂
紫杉醇
卵巢癌
药物经济学
cisplatin
carboplatin
paclitaxel
ovarian cancer
pharmacoeconomics
作者简介
第一作者:谭志美,副主任药师。主要从事临床药学研究。E-mail:tzmscholar@163.com
