论著

PD-1合CTLA-4双免疫疗法对改善晚期乳腺癌近期疗效及远期预后的影响

Effect of PD-1 combined with CTLA-4 dual immunotherapy on short-term efficacy and long-term prognosis of advanced breast cancer

:66-71
 
目的 观察程序性死亡受体1(PD-1)联合细胞毒性T淋巴细胞相关蛋白4(CTLA-4)双免疫疗法对改善晚期乳腺癌近期疗效及远期预后的影响。方法 选择2020年5月—2022年5月商丘市第一人民医院收治的124例晚期乳腺癌患者为研究对象,经随机数字表法将其分为对照组(60例)和观察组(64例),对照组予以常规PD-1单抗免疫疗法治疗,观察组采用PD-1联合CTLA-4双免疫疗法治疗,比较2组患者治疗前后肿瘤标志物水平、治疗后病灶缓解情况,对所有患者开展为期1年随访,统计并对比2组的不良反应发生情况及远期生存情况。结果 治疗前,2组患者的肿瘤标志物水平比较差异均无统计学意义(均P>0.05);治疗后,观察组的癌胚抗原为(3.36±0.17)ng/mL,糖类抗原15-3为(25.33±5.28)U/mL,糖类抗原19-9为(38.77±5.62)U/mL,均低于对照组[(5.27±1.36)ng/mL、(28.44±5.18)U/mL、(41.25±5.46)U/mL,均P<0.05]。治疗后,观察组的完全缓解率为21.88%(14/64),部分缓解率为31.25%(20/64),病情稳定率为37.50%(24/64),均高于对照组[8.33%(5/60)、13.33%(8/60)、23.33%(14/60)],肿瘤生长率为(30.27±5.18)%,肿瘤超进展率为6.25%(4/64),均低于对照组[(33.49±5.32)%、18.33%(11/60),均P<0.05]。治疗后,观察组的不良反应发生率为34.38%(22/64),略高于对照组33.33%(20/60),组间比较差异无统计学意义(P>0.05);观察组的中位无进展生存期为(9.33±2.25)月,中位总生存期为(10.76±3.32)月,均高于对照组[(7.25±2.31)月、(7.41±1.62)月,均P<0.05]。结论 PD-1联合CTLA-4双免疫疗法能有效改善晚期乳腺癌的近期疗效及远期预后,此疗法未明显增加不良反应发生风险,安全性高。
Objective To observe the effect of programmed cell death protein-1(PD-1)combined with cytotoxic T lymphocyte-associated antigen-4(CTLA-4)dual immunotherapy on the short-term efficacy and long-term prognosis of advanced breast cancer.Methods A total of 124 patients with advanced breast cancer who were admitted to the First People's Hospital of Shangqiu City from May 2020 to May 2022 were selected as the research objects.They were randomly divided into the control group(60 cases)and the observation group(64 cases)by the method of random number table.The control group was treated with conventional PD-1 monoclonal antibody immunotherapy,and the observation group was treated with PD-1 combined with CTLA-4 double immunotherapy.The levels of tumor markers before and after treatment and the focal remission after treatment were compared between the two groups.All patients were followed up for one year,the incidence of adverse reactions and long-term survival between the two groups were compared.Results Before treatment,there was no statistically significant difference in the levels of tumor markers between two groups(all P>0.05).After treatment,the carcino-embryonic antigen content of the observation group was(3.36±0.17)ng/mL,CA153 was(25.33±5.28)U/mL,and CA199 was(38.77±5.62)U/mL,which were lower than those of the control group [(5.27±1.36)ng/mL,(28.44±5.18)U/mL,(41.25±5.46)U/mL,all P<0.05].After treatment,the complete remission rate of the observation group was 21.88%(14/64),partial remission rate was 31.25%(20/64),and stable disease rate was 37.50%(24/64),all higher than those of the control group [8.33%(5/60),13.33%(8/60),23.33%(14/60)];tumor growth rate of the observation group was(30.27±5.18)%,hyper progressive disease rate was 6.25%(4/64),both lower than those of the control group [(33.49±5.32)%,18.33%(11/60),both P<0.05].After treatment,the incidence of adverse reactions in the observation group was 34.38%(22/64),slightly higher than that in the control group 33.33%(20/60)(P>0.05).The median progression free survival of the observation group was(9.33±2.25)months,and the median overall survival was(10.76±3.32)months,both higher than those of the control group [(7.25±2.31)months and(7.41±1.62)months](P<0.05).Conclusions PD-1 combined with CTLA-4 dual immunotherapy can effectively improve the short-term efficacy and long-term prognosis of advanced breast cancer.This therapy does not significantly increase the risk of side effects,which is safe.
论著

团体认知行为干预联合揿针全程护理对胃癌晚期癌痛患者心理状态的影响

Effect of group cognitive behavior intervention combined with whole-process nursing of pressing needle on mental state of patients with advanced gastric cancer pain

:114-117
 
目的 分析团体认知行为干预联合揿针全程护理对胃癌晚期癌痛患者心理状态的影响。方法 选取我院115例胃癌晚期癌痛患者(2018年3月—2021年1月),依照干预方案不同分为3组。对照1组(37例)接受团体认知行为干预,对照2组(38例)接受揿针全程护理干预,观察组(40例)接受团体认知行为干预联合揿针全程护理干预,比较3组干预效果。结果 疼痛爆发时疼痛缓解情况:观察组疼痛爆发时疼痛缓解率均较对照1组、对照2组高(P<0.05);心理状态:干预1个月后,3组心理状态均得到改善,且观察组汉密尔顿抑郁量表(HAMD)、汉密尔顿焦虑量表(HAMA)评分均较对照1组、对照2组低(P<0.05);护理满意度:与对照1组、对照2组对比,观察组护理满意度较高(P<0.05)。结论 团体认知行为干预联合揿针全程护理应用于胃癌晚期癌痛患者,能有效缓解疼痛,改善心理状态,且护理满意度高。
Objective To analyze the effect of group cognitive behavior intervention combined with whole-process nursing of pressing needle on the psychological state of patients with advanced gastric cancer pain. Methods A total of 115 patients with advanced gastric cancer pain in our hospital (from March 2018 to January 2021) were selected and divided into 3 groups according to different intervention methods. Control group 1 (37 cases) received group cognitive behavioral intervention, control group 2 (38 cases) received whole-course nursing intervention of pressing needle, and observation group (40 cases) received whole-process nursing intervention of group cognitive behavioral intervention combined with pressing needle. The intervention effects of the three groups were compared. Results Pain relief when pain burst: the pain relief rate of observation group was higher than control group 1 and control group 2 (P<0.05). Mental state: after 1 month of intervention, the mental state of the 3 groups was improved, and the scores of Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA) in the observation group were lower than those in control group 1 and control group 2 (P<0.05). Nursing satisfaction: compared with control group 1 and control group 2, nursing satisfaction of observation group was higher (P<0.05). Conclusions Group cognitive behavior intervention combined with whole-process nursing of pressing needle applied to patients with advanced gastric cancer pain could effectively relieve pain, improve psychological state, and nursing satisfaction.
论著

自适应调强放疗同步铂类化疗治疗局部晚期宫颈癌患者的可行性分析

Feasibility analysis of adaptive intensity modulated radiotherapy combined with platinum-based chemotherapy in the treatment of local advanced cervical cancer

:93-96
 
目的 研究自适应调强放疗(ART)同步铂类化疗治疗局部晚期宫颈癌患者的可行性。方法 选取我院诊治的92例局部晚期宫颈癌患者,随机分为研究组与对照组各46例,其中对照组行调强放疗(IMRT)同步铂类化疗,研究组行ART同步铂类化疗。治疗8周后,比较2组患者临床疗效;于治疗前后比较2组患者肿瘤标志物[癌胚抗原(CEA)、鳞状细胞癌抗原(SCC-Ag)]水平;以急性放射损伤分级标准(RTOG)和常见不良反应事件评价标准(CTCAE)比较2组患者不良反应发生情况。结果 治疗8周后,研究组客观缓解率高于对照组(P<0.05);2组患者CEA、SCC-Ag水平均较治疗前降低,且研究组低于对照组 (P<0.05);研究组基于RTOG的消化道反应等级与泌尿系统反应等级均低于对照组(P<0.05);2组患者基于CTCAE的肝功能损害与皮疹评级相比,差异无统计学意义(P>0.05)。结论 ART同步铂类化疗治疗局部晚期宫颈癌患者疗效较好,使患者病情好转,同时安全性突出,切实可行。
Objective To study the feasibility of adaptive radiotherapy (ART) combined with platinum chemotherapy in the treatment of locally advanced cervical cancer. Methods A total of 92 patients with locally advanced cervical cancer treated in our hospital were randomly divided into study group and control group, with 46 cases in each group. The control group received intensity-modulated radiation therapy (IMRT) combined with platinum chemotherapy and the study group received ART combined with platinum chemotherapy. After 8 weeks of treatment, the clinical effects of the two groups were compared. The levels of tumor markers [carcinoembryonic antigen (CEA) and squamous cell carcinoma associated antigen (SCC-Ag)] were compared between the two groups before and after treatment. The incidence of adverse reactions in the two groups was compared with the grading standard of Acute Radiation Injury Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE). Results After 8 weeks of treatment, the Objective remission rate in the study group was higher than that in the control group (P<0.05). The levels of CEA and SCC-Ag in the study group were significantly lower than those in the control group (P<0.05). The reaction grades of digestive tract and urinary system based on RTOG in the study group were significantly lower than those in the control group (P<0.05). There was no significant difference in CTCAE based liver function impairment and rash rating between the two groups (P> 0.05). Conclusions ART combined with platinum chemotherapy is effective and safe in the treatment of locally advanced cervical cancer.
论著

SEER数据库中晚期三阴性乳腺癌的危险因素及预后分析

Analysis of risk factors and prognosis of advanced triple negative breast cancer based on SEER database

:26-34
 
目的 分析晚期三阴性乳腺癌(TNBC)的危险因素并建立有效的预后列线图。方法 通过检索美国SEER(surveillance, epidemiology, and end results)数据库筛选晚期TNBC患者,采用单因素和多因素分析来确定晚期TNBC的独立预后因素,并以此构建了列线图,通过校准曲线检验和C指数(C-index)评估已建立的列线图。结果 共纳入4 687例晚期TNBC患者,与同期其他分子分型的乳腺癌相比较,TNBC的预后最差。单因素分析发现,年龄、性别、分期、手术、化疗、放疗、转移与更好的预后相关(P<0.05)。多因素分析发现年龄、性别、种族、分期、手术、化疗、放疗、各器官转移是患者预后的独立影响因素(P<0.05),并以此构建了列线图,其C-index为0.75(95%CI,0.71~0.79),校准图显示了预测的总生存期(OS)与观察到的OS之间的最佳一致性。结论 我们分析了晚期TNBC的临床特征,为TNBC患者的OS提供了一些预后因素,并根据这些预后因素制定了列线图,帮助临床医生进行风险管理并选择TNBC患者的长期生存策略。
Objective To analyze the risk factors of advanced triple-negative breast cancer (TNBC) and establish an effective prognostic nomogram. Methods Screening patients with advanced TNBC by searching the SEER (surveillance, epidemiology, and end results) database, using univariate and multivariate analysis to determine the independent prognostic factors of advanced TNBC, and constructing a nomogram based on it. Results A total of 4 687 patients with advanced TNBC were included. Compared with other types of breast cancer over the same period, TNBC had the worst prognosis. Univariate analysis found that age, gender, stage, surgery, chemotherapy, radiotherapy, and metastasis were associated with a better prognosis (P<0.05). Multivariate analysis found that age, gender, race, stage, surgery, chemotherapy, radiotherapy, and metastasis of the organs were independent factors affecting the prognosis of patients (P<0.05), and constructed a nomogram with a C-index of 0.75 ( 95% CI, 0.71~0.79). The calibration chart showed the best agreement between the predicted overall survival (OS) and the observed OS. Conclusion We analyzed the clinical features of advanced TNBC, provided some prognostic factors for the OS of TNBC patients, and developed a nomogram based on these prognostic factors to help clinicians manage risk and choose long-term survival strategies for TNBC patients.
临床诊疗

妊娠中晚期服用奥司他韦对罹患甲型H1N1流感孕妇症状及母婴结局的影响

:131-134
 
目的 探讨妊娠中晚期服用奥司他韦对罹患甲流孕妇症状及母婴结局的影响。方法 选择2018年1月—2019年12月在某三甲医院进行就诊且罹患甲型H1N1的20名孕妇作为研究组对象;同时随机选择同一孕期在该医院产检和分娩,妊娠期间未患甲流H1N1的80名正常孕妇作为对照组对象。在给予口服奥司他韦后,记录研究对组对象流感症状的缓解时间。在妊娠结束后,记录两组研究对象的母婴结局,并进行比较。结果 两组孕妇的年龄≥30岁(65.0% vs 56.3%)、孕周≥32周(60.0% vs 52.5%)、汉族(100.0% vs 95.0%)、中学及以下(40.0% vs 45.0%)、月收入≥3500元(70.0% vs 65.0%)比较,差异均无统计学意义(P>0.05)。服药时间<48 h和服药时间≥48h研究对象的发热缓解时间[(2.9±0.3)d vs(3.4±0.4)d]、肌肉和关节酸痛的缓解时间[(3.3±0.4)d vs(3.8±0.5)d]、流涕的缓解时间[(5.6±0.5)d vs(6.8±0.7)d]、咽痛的缓解时间[(2.7±0.3)d vs(3.4±0.5)d]、咳嗽的缓解时间[(8.1±0.6)d vs(9.6±0.8)d]、体力恢复时间[(7.8±0.9)d vs(9.2±0.7)d]比较,服药时间<48 h者低于服药时间≥48 h者,差异均有统计学意义(P<0.05)。两组孕妇的自然流产(5.0% vs 2.5%)、死胎(0.0 vs 1.3%)、胎膜早破(10.5% vs 13.8%)、顺产(79.0%vs 81.8%)、低出生体重(15.8%vs 19.5%)比较,差异均无统计学意义(P>0.05)。结论 奥司他韦对于缓解善中晚期孕妇的甲型H1N1流感症状和预防甲型H1N1带来的不良母婴结局具有良好作用,具有良好的临床推广意义。
论著

中性粒细胞与淋巴细胞比值在晚期不可切除结直肠癌患者化疗疗效及预后的意义

Significance of neutrophil-lymphocyte ratio in chemotherapy curative effect and prognosis in patients with advanced unresectable colorectal cancer

:59-65
 
目的 评估中性粒细胞与淋巴细胞比值(NLR)在晚期结直肠癌(CRC)患者化疗疗效及预后的意义。方法 回顾性收集2016年1月—2019年4月期间接受以奥沙利铂为基础的标准一线化疗的晚期不可切除结直肠癌患者50例临床病历资料,并在2个化疗周期后评估化疗疗效;根据入组患者化疗前血液学数据计算中性粒细胞与淋巴细胞比值(NLR),运用受试者工作特征曲线确定的NLR最佳截断值,将患者分为高NLR(≥3.785) 组和低NLR(<3.785) 组,比较高、低NLR与临床病理特征、化疗疗效及无进展生存期(PFS)、总生存期(OS)差异;采用COX回归分析模型分析影响晚期结直肠癌患者PFS、OS的因素。结果 高、低NLR两组肿瘤分化程度(P=0.030)、ECOG评分(P=0.003)、CEA(P=0.011)、CA19-9(P=0.047)比较,差异有统计学意义;高低NLR两组间化疗疗效比较,差异有统计学意义(P<0.001),高NLR组化疗疗效较差;两组中位PFS分别为3.44个月和12.84个月,差异有统计学意义(χ2=39.730,P<0.001),两组中位OS分别为7.59个月和22.32个月,差异有统计学意义(χ2=40.505,P<0.001);Cox回归分析提示NLR高低、CEA水平是PFS、OS的独立预后因素(P<0.05)。结论 高水平NLR与晚期结直肠癌患者化疗疗效不佳和预后不良相关,可作为其化疗疗效及预后监测的指标。
Objective To evaluate the value of neutrophil-lymphocyte ratio (NLR) in the chemotherapy curative effect and prognosis of patients with advanced colorectal cancer (CRC). Methods Retrospective collection of clinical data from 50 patients with advanced unresectable colorectal cancer who received oxaliplatin-based standard first-line chemotherapy between January 2016 and April 2019. Chemotherapy curative effect was evaluated following 2 chemotherapy cycles. Calculation of neutrophil to lymphocyte ratio (NLR) based on pre-chemotherapy hematology data. The receiver operating characteristic curve was used to determine the optimal cutoff value of NLR,according to patients who were divided into groups of high NLR(NLR≥3.785)and low NLR(NLR≥3.785).The differences between high and low NLR and clinicopathological features, efficacy of chemotherapy, progression-free survival (PFS), and total survival (OS) were compared. COX regression analysis mode was used to analysis of factors affecting PFS and OS in patients with advanced colorectal cancer. Results The differences in tumor differentiation (P=0.030), ECOG score (P=0.003), CEA (P=0.011), CA19-9 (P=0.047) in the high and low NLR groups were statistically significant. The differences in chemotherapy between the two groups was statistically significant (P<0.001), and the high NLR group was less effective. The median PFS of the high and low NLR groups were 3.44 months and 12.84 months, respectively, and the difference was statistically significant (χ2=39.730, P<0.001). The median OS of the high and low NLR groups was 7.59 months and 22.32 months, respectively, and the difference was statistically significant (χ2=40.505, P<0.001). Cox regression analysis suggested that NLR levels and CEA levels were independent prognostic factors for PFS and OS(P<0.05). Conclusion High-level NLR is associated with poor chemotherapy response and poor prognosis in patients with advanced colorectal cancer, and was used as an indicator of chemotherapy efficacy and prognosis.
论著

影响孕晚期死胎延迟就诊的临床因素分析

Analysis of clinical factors influencing delayed consultation of stillbirth after decreased fetal movement in late pregnancy

:77-81
 
目的 探讨影响孕晚期死胎伴胎动减少延迟就诊的临床因素,加强围产期宣教。方法 回顾性分析2017年1月—2019年10月广州市妇女儿童医疗中心住院分娩的孕晚期(孕周≥28周)单胎死胎病例的相关临床资料。结果 在79例死胎中,有59例(74.68%)孕妇感知胎动减少,但只有27人(45.76%)在感知胎动减少后24小时内就诊。妊娠未合并胎儿生长受限可能会导致延迟就诊(P=0.03<0.1)。结论 胎动减少和死胎发生密切相关,但大部分孕妇可能会出现延迟就诊。加强孕期产检,规范孕期宣教,尤其是合并胎儿生长受限等高危妊娠时的孕期严密监测,强调胎动的重要性,在感知胎动减少后强调早期就诊,有助于减少孕晚期死胎风险。
Objective To explore the clinical factors that affect the consultation time of stillbirth after perceptive reduction of fetal movement in the third trimester of pregnancy, and to strengthen the perinatal education. Methods A retrospective analysis of single stillbirth in late pregnancy (gestational weeks≥ 28 weeks) in Guangzhou Women and Children's Medical Center from January 2017 to October 2019 was taken, and the relevant clinical data were summarized and evaluated. Results Out of 79 stillbirth cases, 59 (74.68%) cases had decreased fetal motility. Only 27 pregnant women (45.76%) visited the doctor in 24 hours after they perceived the reduction of fetal movement. Pregnancy without fetal growth restriction may lead to delayed consultation (P=0.03<0.1). Conclusion Perception of decreased fetal movement is closely related to the occurrence of stillbirth, but most pregnant women may have delayed visits. To strengthen the prenatal examination, standardize the propaganda and education during pregnancy, especially the close monitoring of high-risk pregnancy such as fetal growth restriction, emphasize the importance of fetal movement, and emphasize the early consultation after perceiving the reduction of fetal movement, are helpful to reduce the risk of stillbirth in late pregnancy.
临床诊疗

早、晚期关节镜下前交叉韧带重建术治疗ACL损伤的临床对照研究

:120-124
 
目的 研究早、晚期关节镜下前交叉韧带重建术治疗前交叉韧带损伤(ACL)的临床效果。方法 选取我院2017年12月—2019年12月收治的100例ACL损伤患者,根据不同手术治疗时间分为早期重建组(≤3周,54例)和晚期重建组(4~12周,46例)。比较两组术前及术后14周膝关节功能Lysholm及国际膝关节文献委员会(IKDC)评分,分析两组术前及术后14周膝关节活动度及肌力情况,对比两组术后2、4、8周的患膝屈曲角度,比较两组围术期临床指标。结果 两组患者术后均无早期并发症发生,手术切口均Ⅰ期愈合。两组术后14周Lysholm及IKDC评分较治疗前升高(P<0.05);早期重建组术后14周Lysholm及IKDC评分与晚期重建组比较差异无统计学意义(P>0.05)。两组术后14周屈曲受限角度、伸膝受限角度及萎缩指数较治疗前降低(P<0.05);早期重建组术后14周屈曲受限角度、伸膝受限角度及萎缩指数与晚期重建组比较差异无统计学意义(P>0.05)。早期重建组术前及术后2、4、8周的患膝屈曲角度与晚期重建组比较差异无统计学意义(P>0.05)。早期重建组疼痛消除时间、肿胀消除时间及关节恢复正常时间显著长于晚期重建组(P<0.05)。结论 行早、晚期关节镜下前交叉韧带重建术治疗ACL损伤患者的疗效相近,但晚期重建患者术后恢复效果显著,利于改善预后。
论著

晚期胰腺癌超级伽玛刀治疗的临床研究

Clinical study of super gamma knife in the treatment of advanced pancreatic cancer

:62-65
 
目的 探讨晚期胰腺癌超级伽玛刀治疗的临床效果。方法 选取2015年1月—2019年1月我院收治的晚期胰腺癌患者46例,随机分为对照组(23例)与观察组(23例),对照组接受单纯化疗治疗,观察组患者接受超级伽玛刀方案治疗。收集两组患者的治疗有效率、生存时间的临床受益反应(CBR)等指标,进行对比分析。结果 接受不同治疗措施干预1个月后,对两组患者治疗总有效率进行比较。观察组患者治疗总有效率为60.87%,高于对照组患者治疗总有效率13.04%(P<0.01)。观察组患者中疼痛程度改善阳性人数比例、KPS体力改善阳性人数比例和体质量改善阳性人数比例均高于对照组患者(P<0.05),但两组患者镇痛药物消耗量改善阳性人数比例差异并无统计学意义(P>0.05)。观察组患者无进展生存期中位时间为4个月(95%CI,2.124±5.274),对照组患者无进展生存期中位时间为3个月(95%CI,1.804±4.851)。观察组患者无进展生存期中位时间长于对照组患者(P=0.042<0.05)。结论 基于立体定向伽马射线全身治疗系统的超级伽玛刀采用中等剂量分割方法治疗晚期胰腺癌,其临床效果切实,副作用相对较低,对患者生存治疗有明显提升效果,值得临床推广。
Objective To explore the clinical effect of super gamma knife in the treatment of advanced pancreatic cancer. Methods 46 patients with advanced pancreatic cancer admitted to our hospital from January 2015 to January 2019 were randomly divided into control group (23 cases)and observation group (23 cases). The control group received chemotherapy only; the observation group received super gamma knife treatment. We collected the clinical benefit response (CBR)and other indicators of treatment efficiency and survival time of the two groups for comparative analysis. Results One month after the intervention of different treatment measures, the total effective rate of the two groups was compared. The total effective rate of the observation group was 60.87%, which was higher than that of the control group (13.04%)(P<0.01). The positive rate of pain degree improvement, KPS physical strength improvement, body weight improvement in the observation group were all higher than those in the control group (P<0.05), but there was no statistical significance between the two groups in the positive rate of analgesic consumption improvement (P>0.05). The median time of progression free survival was 4 months (95% CI, 2.124±5.274)in the observation group and 3 months (95% CI, 1.804±4.851)in the control group. The median time of progression free survival in the observation group was longer than that in the control group (P = 0.042<0.05). Conclusion The super gamma knife based on the stereotactic gamma ray systemic therapy system uses the medium dose segmentation method to treat the advanced pancreatic cancer. Its clinical effect is practical, the side effects are relatively low, and the survival treatment of patients has a significant improvement effect, which is worthy of clinical promotion.
论著

重组人血管内皮抑素联合化疗治疗晚期非小细胞肺癌的效果

Curative effect of recombinant human vascular endostatin combined with chemotherapy on advanced nonsmall cell lung cancer

:72-75
 
目的 观察重组人血管内皮抑素注射液(恩度) 联合化疗治非小细胞肺癌(NSCLC)的近期疗效和安全性。方法 对2015年3月—2017年10月经病理组织学或细胞学检查确诊的Ⅲ-Ⅳ期NSCLC74例患者,采用随机数字法把受试者随机分为联合治疗组(n=35)和对照组(n=39),联合治疗组接受恩度联合化疗的方案治疗;对照组单纯行常规化疗治疗。近期疗效评价采用RECIST标准,生活质量(QOL)采用Karnofsky评分(KPS),抗癌药物急性与亚急性毒性反应分度标准分0~Ⅳ度。比较两组患者的近期疗效指标(疾病完全缓解(CR)、疾病稳定( SD)、疾病进展( PD)、客观有效率(RR)、疾病控制率(DCR );QOL评分及毒副反应情况。结果 联合治疗组近期疗效指标RR及DCR高于对照组(P < 0.05);联合治疗组KPS评分高于对照组(P < 0.05);两组间的毒副作用包括恶心/呕吐、腹泻、疲乏、脱发、血小板下降及白细胞下降等,两组间毒副反应出现数量比较,差异无统计学意义(P > 0.05)。结论 恩度与化疗药物联合使用可以提高NSCLC疗效和改善患者生活质量,未增加患者不良反应发生率。
Objective To observe the curative effect and the side effects of recombinant human vascular endostatin (Endostar) combined with the chemotherapy on nonsmall cell lung cancer(NSCLC). Methods Seventy-four NSCLC patients confirmed by histopathology or cytopathology were randomly distributed to combined therapy group (n=35, with Endostar combined with chemotherapy) and control group (n=39, with conventional chemotherapy). The recent efficacy of drug was evaluated according to the RECIST criteria. The quality of life (QOL) was assessed by usingto the Karnofsky scores, and the safety of drug was evaluated according to WHO side effects criteria. Results The therapeutic effectiveness was better in the combined therapy group than that in the control group(P<0.01). The KPS was better in co-therapy group than that in the control group(P<0.05). The common adverse reactions in both groups included neutropenia, thrombocytopenia, nausea/vomiting, diarrhea, lassitude, alopecia, thrombocytopenia and leukocytopenia. However, the incidence rates of adverse reactions between the two group was not significant (P>0.05). Conclusion Endostar combined with the related chemotherapy may improve the curative effect and QOL of NSCLC.
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