【摘要】 目的 探讨晚期卵巢癌患者应用参芪扶正注射液联合贝伐珠单抗治疗的效果。方法 前瞻性选取2019-06-03-2021-08-15河南大学第一附属医院收治的晚期卵巢癌患者126例作为研究对象，采用随机数字表法将患者分为参照组(n=63,给予贝伐珠单抗治疗，于化疗第1 d静脉滴注贝伐珠单抗注射液，7.5 mg/kg, 21 d为1个治疗周期，连续治疗6个周期),研究组(n=63,给予参芪扶正注射液联合贝伐珠单抗治疗，贝伐珠单抗注射液用法、用量同参照组，化疗第1～3 d,静脉滴注参芪扶正注射液，250 mL/次，1次/d,连续治疗6个周期)。比较2组临床疗效，采用流式细胞分析仪检测细胞免疫功能指标，酶联免疫吸附法(ELISA)检测血清人附睾分泌蛋白4(HE4)、人激肽释放酶10(HK10)水平，实时荧光定量聚合酶链式反应(qRT-PCR)检测血清微小RNA-203(miR-203)、微小RNA-92(miR-92)水平，采用癌症患者生活质量核心问卷(EORTCQLQ-C30)评估患者生活质量，统计2组生存率、毒副作用发生率。结果 与参照组临床总有效率33/63(52.38%)相比，研究组45/63(71.43%)较高，χ~2=4.846,P=0.028;治疗3个周期后研究组CD3~+、CD4~+、CD4~+/CD8~+水平分别为(56.67±2.43)%、(27.94±2.65)%、0.97±0.10,均高于参照组(53.25±2.32)%、(22.69±3.03)%、0.73±0.11,差异有统计学意义，t值分别为8.080、10.352、12.814,均P<0.001;治疗3个周期后研究组CD8~+、HE4、HK10、miR-203、miR-92水平分别为(28.93±2.42)%、(408.63±29.77) pmol/L、(17.79±3.18) ng/mL、2.19±0.22、3.08±0.25,均低于参照组(31.15±2.14)%、(485.25±30.42) pmol/L、(20.51±2.76) ng/mL、2.64±0.28、3.84±0.29,差异有统计学意义，t值分别为5.455、14.288、5.127、10.031、15.755,均P<0.001;治疗6个周期后研究组CD3~+、CD4~+、CD4~+/CD8~+、躯体功能、认知功能、社会功能、情感功能、角色功能评分分别为(60.81±2.28)%、(37.48±2.86)%、1.60±0.12、(78.53±6.11)分、(80.15±5.13)分、(77.52±4.49)分、(75.63±6.35)分、(71.63±3.08)分，均高于参照组(55.12±2.52)%、(29.17±2.71)%、1.12±0.13、(70.14±5.31)分、(72.46±5.42)分、(69.83±4.34)分、(67.66±5.31)分、(63.18±4.42),差异有统计学意义，t值分别为13.290、16.741、21.535、8.227、8.179、9.774、7.642、12.450,均P<0.001;治疗6个周期后研究组CD8~+、HE4、HK10、miR-203、miR-92水平分别为(23.46±2.52)%、(276.18±24.63) pmol/L、(11.65±2.08) ng/mL、1.36±0.12、1.59±0.07,均低于参照组(26.02±2.17)%、(317.34±25.54) pmol/L、(15.48±2.37) ng/mL、1.65±0.14、2.14±0.17,差异有统计学意义，t值分别为6.110、9.208、9.641、12.483、23.745,均P<0.001;研究组1、2、3年生存率分别为88.14%(52/59)、77.97%(49/59)、54.24%(32/59),均高于参照组71.93%(41/57)、59.65%(34/57)、35.09%(20/57),差异有统计学意义，χ~2值分别为4.790、4.545、4.299,均P<0.05;研究组骨髓抑制、恶心/呕吐、白细胞降低、肝肾功能异常、脱发、尿蛋白、胃肠道穿孔/出血、高血压发生率分别为25.40%(16/63)、30.16%(19/63)、17.46%(1163)、9.52%(6/63)、28.57%(18/63)、15.87%(10/63)、11.11%(7/63)、11.11%(7/63),均低于参照组42.86%(27/63)、50.79%(32/63)、36.51%(23/63)、26.98%(17/63)、53.97%(34/63)、33.33%(21/63)、28.57%(18/63)、25.40%(16/63),差异有统计学意义，χ~2值分别为4.272、5.567、5.801、6.436、8.383、5.177、6.038、4.308,均P<0.05。结论 参芪扶正注射液联合贝伐珠单抗可在一定程度上提高晚期卵巢癌患者的治疗效果，且对患者细胞免疫功能、生活质量、血清肿瘤标志物水平、毒副作用发生率及生存率具有一定的改善作用。更多还原

【Abstract】 Objective To investigate the efficacy of Shenqi Fuzheng injection combined with bevacizumab in the treatment of patients with advanced ovarian cancer. Methods A total of 126 patients with advanced ovarian cancer admitted to the First Affiliated Hospital of Henan University from June 3, 2019 to August 15, 2021 were prospectively selected as the research objects. Using random number table method, the patients were divided into the reference group(n=63, treated with bevacizumab, intravenous infusion of bevacizumab injection on the first day of chemotherapy, 7.5 mg/kg, 21 days as a treatment cycle, continuous treatment for 6 cycles) and the study group(n=63, treated with Shenqi Fuzheng injection combined with bevacizumab, the usage and dosage of bevacizumab injection were the same as those of the reference group, on the 1 st to 3 rd day of chemotherapy, Shenqi Fuzheng injection was intravenously dripped, 250 ml/time, once a day, for 6 consecutive cycles). The clinical efficacy of the two groups was compared. The cellular immune function indexes were detected by flow cytometry. The levels of serum human epididymis secretory protein 4(HE4) and human kallikrein 10(HK10) were detected by enzyme-linked immunosorbent assay(ELISA). The levels of serum microRNA-203(miR-203) and microRNA-92(miR-92) were detected by real-time fluorescence quantitative polymerase chain reaction(qRT-PCR). The quality of life of patients was evaluated by the European organization for research and treatment of cancer quality of life questionnaire(EORTCQLQ-C30). The survival rate and incidence of toxic and side effects of the two groups were counted. Results Compared with the total clinical effective rate of the reference group 33/63(52.38%), the study group 45/63(71.43%) was higher(χ~2=4.846, P=0.028). After three cycles of treatment, the levels of CD3~+, CD4~+ and CD4~+/CD8~+ in the study group were(56.67±2.43)%,(27.94±2.65)% and 0.97±0.10, respectively, which were higher than those in the reference group [(53.25±2.32)%,(22.69±3.03)% and 0.73±0.11], the differences were statistically significant, t values were 8.080, 10.352 and 12.814, respectively, all P<0.001; after three cycles of treatment, the levels of CD8~+, HE4, HK10, miR-203 and miR-92 in the study group were(28.93±2.42)%,(408.63±29.77) pmol/L,(17.79±3.18) ng/ml, 2.19±0.22 and 3.08±0.25, respectively, which were lower than those in the reference group [(31.15±2.14)%,(485.25±30.42) pmol/L,(20.51±2.76) ng/ml, 2.64±0.28 and 3.84±0.29], the differences were statistically significant, t values were 5.455, 14.288, 5.127, 10.031, 15.755, respectively, all P<0.001. After 6 cycles of treatment, the scores of CD3~+, CD4~+, CD4~+/CD8~+, physical function, cognitive function, social function, emotional function and role function in the study group were(60.81±2.28)%,(37.48±2.86)%, 1.60±0.12,(78.53±6.11) scores,(80.15±5.13) scores,(77.52±4.49) scores,(75.63±6.35) scores and(71.63±3.08) scores, respectively, which were higher than the reference group [(55.12±2.52)%,(29.17±2.71)%, 1.12±0.13,(70.14±5.31) scores,(72.46±5.42) scores,(69.83±4.34) scores,(67.66±5.31) scores,(63.18±4.42) scores], the differences were statistically significant, t values were 13.290, 16.741, 21.535, 8.227, 8.179, 9.774, 7.642, 12.450, all P<0.001; after 6 cycles of treatment, the levels of CD8~+, HE4, HK10, miR-203 and miR-92 in the study group were(23.46±2.52)%,(276.18±24.63) pmol/L,(11.65±2.08) ng/ml, 1.36±0.12 and 1.59±0.07, respectively, which were lower than those in the reference group [(26.02±2.17)%,(317.34±25.54) pmol/L,(15.48±2.37) ng/ml, 1.65±0.14 and 2.14±0.17], the differences were statistically significant, t values were 6.110, 9.208, 9.641, 12.483, 23.745, all P<0.001. The 1-year, 2-year and 3-year survival rates of the study group were 88.14%(52/59), 77.97%(49/59) and 54.24%(32/59), respectively, which were higher than those of the reference group [71.93%(41/57), 59.65%(34/57) and 35.09%(20/57)], the differences were statistically significant, χ~2 values were 4.790, 4.545 and 4.299, respectively, all P<0.05; the incidence of bone marrow suppression, nausea/vomiting, leukopenia, liver and kidney dysfunction, alopecia, urinary protein, gastrointestinal perforation/hemorrhage, and hypertension in the study group were 25.40%(16/63), 30.16%(19/63), 17.46%(11/63), 9.52%(6/63), 28.57%(18/63), 15.87%(10/63), 11.11%(7/63), and 11.11%(7/63), respectively, which were lower than the reference group [42.86%(27/63), 50.79%(32/63), 36.51%(23/63), 26.98%(17/63), 53.97%(34/63), 33.33%(21/63), 28.57%(18/63), 25.40%(16/63)], the differences were statistically significant, χ~2 values were 4.272, 5.567, 5.801, 6.436, 8.383, 5.177, 6.038, 4.308, all P<0.05. Conclusion The combination of Shenqi Fuzheng injection and bevacizumab can improve the therapeutic effect of patients with advanced ovarian cancer to a certain extent, and also has certain improvements on patients’ cellular immune function, quality of life, serum tumor marker levels, incidence of toxic side effects, and survival rate.更多还原