信迪利单抗联合重组人血管内皮抑制素治疗晚期非小细胞肺癌的临床研究

doi:10.3760/cma.j.issn.1007-1245.2024.24.015

摘要/Abstract

摘要：

目的　研究信迪利单抗联合重组人血管内皮抑制素治疗晚期非小细胞肺癌（NSCLC）的疗效。方法　本研究为随机对照试验。将2019年6月至2022年6月在咸阳市第一人民医院就诊的62例NSCLC患者按照随机数字表法分为观察组和参照组各31例。参照组男20例，女11例，年龄（66.64±9.59）岁，ⅢB期16例、Ⅳ期15例。观察组男19例，女12例，年龄（65.55±9.16）岁，ⅢB期14例、Ⅳ期17例。两组均接受白蛋白紫杉醇+卡铂化疗：化疗周期第1天、第8天给予白蛋白紫杉醇100 mg/m²静脉滴注，滴注时间30 min；化疗周期第1天静脉滴注卡铂，每次给药曲线下面积（AUC）为5 mg/（ml·min）；21 d为1个周期。参照组在此基础上接受重组人血管内皮抑制素治疗，15 mg/m²，加入500 ml生理盐水中，静脉滴注3～4 h，1次/d，连续给药14 d后停药7 d。观察组在参照组基础上接受信迪利单抗治疗，200 mg/次，以100 ml生理盐水稀释，静脉滴注30～90 min，每个周期第1天使用。两组均连续治疗3个周期。对比两组临床疗效、肿瘤标志物水平［细胞角蛋白19片段（CYFRA21-1）、癌胚抗原（CEA）、神经元特异性烯醇化酶（NSE）］、安全性，随访1年记录两组患者生存情况。采用t检验、χ²检验、Log-rank检验进行统计学分析。结果　观察组客观缓解率、临床控制率均高于参照组［45.16%（14/31）比19.35%（6/31）、77.42%（24/31）比48.39%（15/31）］（均P<0.05）。治疗后，观察组CEA、CYFRA21-1、NSE水平均低于治疗前和参照组（均P<0.05）。观察组与参照组总不良反应发生率比较差异无统计学意义［19.35%（5/31）比22.58%（7/31）］（P>0.05）。随访1年，观察组和参照组分别失访1、2例，存活16、10例，两组总生存曲线经Log-rank检验，观察组优于参照组（χ²=6.987，P=0.010）。结论　信迪利单抗联合重组人血管内皮抑制素治疗NSCLC效果确切，可降低患者肿瘤标志物水平，安全性良好，且可延长患者近期生存。

关键词:

晚期非小细胞肺癌, 信迪利单抗, 重组人血管内皮抑制素, 生存率, 不良反应

Abstract:

Objective　To study the efficacy of Sintilimab combined with recombinant human endostatin in the treatment of advanced non-small cell lung cancer (NSCLC). Methods　This study was a randomized controlled trial. A total of 62 patients with NSCLC admitted to Xianyang First People's Hospital from June 2019 to June 2022 were divided into an observation group and a reference group according to the random number table method, with 31 cases in each group. In the reference group, there were 20 males and 11 females, aged (66.64±9.59) years, 16 cases of stage ⅢB and 15 cases of stage Ⅳ. In the observation group, there were 19 males and 12 females, aged (65.55±9.16) years, 14 cases of stage ⅢB and 17 cases of stage Ⅳ. Both groups were given albumin-paclitaxel + carboplatin chemotherapy: intravenous infusion with 100 mg/m² of albumin-paclitaxel was given on day 1 and day 8 of the chemotherapy cycle for 30 min; carboplatin was given intravenously on day 1 of the chemotherapy cycle, with the area under the curve (AUC) of 5 mg/(ml·min) each time, with 21 days as a cycle. The reference group was given 15 mg/m² of recombinant human endostatin on the basis, added into 500 ml of normal saline, injected intravenously for 3-4 h, once a day, continuous administration for 14 days and then stopped for 7 days. The observation group was given Sintilimab on the basis of the reference group, 200 mg/time, diluted with 100 ml of normal saline, intravenous infusion for 30-90 min, and used on day 1 of the chemotherapy cycle. Both groups were treated for 3 consecutive cycles. The clinical efficacy, levels of tumor markers [cytokeratin 19 fragment (CYFRA21-1), carcinoembryonic antigen (CEA), and neuron-specific enolase (NSE)], and safety of the two groups were compared, and the survival of the two groups was recorded during 1-year of follow-up. t test, χ² test, and Log-rank test were used for statistical analysis. Results　The objective remission rate and clinical control rate of the observation group were higher than those of the reference group [45.16% (14/31) vs. 19.35% (6/31), 77.42% (24/31) vs. 48.39% (15/31)] (both P<0.05). After treatment, the levels of CEA, CYFRA21-1, and NSE in the observation group were lower than those before treatment and in the reference group (all P<0.05). There was no statistically significant difference in the incidence of adverse reactions between the observation group and the reference group [19.35% (5/31) vs. 22.58% (7/31)] (P>0.05). At 1 year of follow-up, 1 and 2 cases were lost and 16 and 10 cases survived in the observation and reference groups, respectively, and the total survival curve of the observation group was better than that of the reference group by Log-rank test (χ²=6.987, P=0.010). Conclusion　Sintilimab combined with recombinant human endostatin in the treatment of NSCLC is effective, can reduce the levels of tumor markers, has good safety, and can prolong the patients' short-term survival.

Key words:

Advanced non-small cell lung cancer, Sintilimab, Recombinant human endostatin, Survival rate, Adverse reactions

张田赵丹.

信迪利单抗联合重组人血管内皮抑制素治疗晚期非小细胞肺癌的临床研究 [J]. 国际医药卫生导报, 2024, 30(24): 4137-4140.

Zhang Tian, Zhao Dan.

Clinical study on Sintilimab combined with recombinant human endostatin in the treatment of advanced non-small cell lung cancer [J]. International Medicine and Health Guidance News, 2024, 30(24): 4137-4140.

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