首页|基于倾向评分匹配法的复方苦参注射液联合化疗治疗结直肠癌术后患者的有效性和安全性研究

基于倾向评分匹配法的复方苦参注射液联合化疗治疗结直肠癌术后患者的有效性和安全性研究

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目的:探讨复方苦参注射液(CKI)联合化疗治疗结直肠癌(CRC)术后患者的有效性和安全性.方法:选取 2016 年1月~2019 年 3 月于某院普通外科接受CRC术后化疗的 345 例患者作为研究对象,依据不同的治疗方案分为对照组(212 例)和观察组(133 例).对照组给予化疗,观察组在对照组的基础上给予CKI治疗.采用倾向评分匹配法(PSM)平衡两组基线资料不均衡的变量并获得匹配患者,比较两组患者临床疗效和不良反应.结果:两组患者行PSM后,共174例患者纳入本研究,每组87例.生存分析显示,CRC术后观察组患者5年生存率高于对照组(80.5%vs 69.0%,P=0.042);以肿瘤类型分组进行亚组分析,结果显示,直肠癌术后观察组患者5年生存率高于对照组(72.9%vs 58.5%,P=0.023).不良反应分析发现,前半周期化疗期间观察组患者恶心和呕吐的发生率均低于对照组(P<0.001);全周期化疗期间观察组患者恶心、呕吐、骨髓抑制、肝细胞损伤和神经毒性的发生率均低于对照组(P<0.05);观察组患者不良反应总发生率低于对照组(74.71%vs 88.51%,P=0.030).结论:CKI联合化疗治疗CRC术后患者可提高临床疗效,并减少不良反应的发生,值得临床推广应用.
Study on Efficacy and Safety of Compound Kushen Injection Combined with Chemotherapy in the Treatment of Postoperative Patients with Colorectal Cancer Based on Propensity Score Matching
Objective:To investigate the efficacy and safety of compound Kushen injection(CKI)combined with chemotherapy in the treatment of postoperative patients with colorectal cancer(CRC).Methods:A total of 345 patients with CRC who received postoperative chemotherapy in the general surgery of a hospital from January 2016 to March 2019 were selected and assigned to the control group(212 patients)and observation group(133 patients)according to different treatment regimens.The control group was treated with chemotherapy,and the observation group was treated with CKI in addition to the treatment given in the control group.The propensity score matching(PSM)was used to balance the unbalanced variables in the baseline data of the two groups and to obtain the matched patients.The clinical efficacy and adverse reactions were compared between the two groups.Results:After performing the PSM in both groups,a total of 174 patients were included in this study,with 87 patients in each group.Survival analysis showed that the 5-year survival rate of postoperative patients with CRC in the observation group was higher than that in the control group(80.5% vs 69.0%,P=0.042).Subgroup analysis by tumor type showed that the 5-year survival rate of postoperative patients with rectal cancer in the observation group was higher than that in the control group(72.9% vs 58.5%,P=0.023).Analysis of adverse reactions showed that during the first half of the chemotherapy cycle,the incidence of nausea and vomiting was lower in the observation group than in the control group(P<0.001).During the entire chemotherapy cycle,the incidence of nausea,vomiting,bone marrow suppression,liver cell damage,and neurotoxicity was lower in the observation group compared to the control group(P<0.05).Additionally,the overall incidence of adverse reactions was lower in the observation group than in the control group(74.71% vs 88.51%,P=0.030).Conclusion:CKI combined with chemotherapy in the treatment of postoperative patients with CRC can improve the clinical efficacy and reduce the incidence of adverse reactions,making it worthy of clinical promotion and application.

compound Kushen injectioncolorectal cancerchemotherapypropensity score matchingefficacysafety

周信方、盛书娟、王世超、宋锐强、陶有金

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河南大学肿瘤医院普通外科,郑州 450099

复方苦参注射液 结直肠癌 化疗 倾向评分匹配 有效性 安全性

2024

中国合理用药探索
中国执业药师协会

中国合理用药探索

影响因子:0.62
ISSN:2096-3327
年,卷(期):2024.21(12)