消癌平注射液联合SOX方案用于治疗晚期胃癌的临床疗效观察

发布时间：2018-05-28 11:55

本文选题：晚期胃癌 + 消癌平注射液　；参考：《山东大学》2017年硕士论文

【摘要】：目的:观察并探讨消癌平注射液联合SOX方案用于治疗晚期胃癌的临床有效性、安全性。方法:选择2015年03月至2016年10月胃肠外科及肿瘤内科就诊的患者100例作为研究对象,年龄范围31~75岁,中位年龄56岁。所有病例均为术后复发或不能手术,经CT、MRI、消化内镜等检查证实并由病理学或细胞学确诊为晚期胃癌,临床分期按美国癌症联合委员会(AJCC)和国际抗癌联盟(UICC)2010年制定的肿瘤TNM分期标准均为Ⅲ～Ⅳ期,Karnofsky评分为60~100分。将所有研究对象按随机数字表法随机分为观察组和对照组。两组患者均接受SOX化疗方案:第1天至第14天应用替吉奥80mg/m2/d,分两次口服,连续用药2周后停药休息1周。并于第1天应用奥沙利铂130mg/m2连续静脉滴注3个小时,21天为1个化疗周期。观察组加用消癌平注射液60ml/d,静脉滴注14d。对照组仅单纯应用SOX方案进行化疗,至少完成2个周期化疗。本研究治疗终止时间为出现疾病进展(PD)、患者死亡或者不可耐受的毒性。主要观察指标是肿瘤客观缓解率(ORR)、不良反应发生率、患者化疗前后生活质量(KPS评分)变化情况以及疾病进展时间(TTP)等。根据RECIST1.1实体瘤评价标准和WHO制定的急性及亚急性毒副反应分度标准评价两组患者的近期临床疗效、不良反应发生率和生活质量(KPS评分)改善率,应用SPSS 20.0统计软件对两组之间差异进行统计学分析比较。结果:共有96例完成临床试验(观察组48例,对照组48例),另有4例(观察组2例,对照组2例)因不遵医嘱、依从性差、经济因素、严重不良反应等原因退出临床试验。观察组和对照组患者的性别、年龄、功能状态(KPS评分)、临床分期及病理类型等基线资料差异无统计学意义(P0.05),具有同质可比性。1、观察组和对照组患者肿瘤客观缓解率(ORR)分别为66.7%和62.5%,经统计学分析比较,两组之间差异无统计学意义(P=0.6700.05)。观察组患者和对照组患者疾病控制率(DCR)分别为95.8%和89.6%,经统计学分析,两组之间差异无统计学意义(P=0.4320.05)。2、观察组和对照组患者生活质量(KPS评分)改善率分别为62.5%和37.5%,经统计学分析,两组之间差异存在统计学意义(P=0.0220.05)。3、药物毒副反应发生率方面,观察组白细胞减少发生率为22.9%,中性粒细胞减少发生率为27.1%;对照组白细胞减少发生率为45.8%,中性粒细胞减少发生率为52.1%。观察组患者白细胞减少发生率和中性粒细胞减少发生率低于对照组,经统计学分析比较,两组患者之间白细胞减少和中性粒细胞减少差异具有统计学意义(P0.05)。其余不良反应如红细胞减少、血小板减少、恶心呕吐、纳差、腹泻便秘、周围神经毒性、肝肾毒性、口腔黏膜炎等,经统计学分析,两组之间其余不良反应发生率差异无统计学意义(P0.05)。4、观察组和对照组患者的中位疾病进展时间(TTP)分别为7.0(95%CI:5.913~8.087)个月和 6.5(95%CI:5.720~7.280)个月。经统计学分析,两组之间差异无统计学意义(P=0.7460.05)。结论:1、消癌平注射液联合SOX方案与单纯SOX方案用于治疗晚期胃癌疗效相当,临床有效率存在差异但并无明显提高。2、消癌平注射液联合SOX方案治疗晚期胃癌可使化疗所致白细胞减少、中性粒细胞减少发生率降低。3、消癌平注射液联合SOX方案治疗晚期胃癌并未增加化疗所致的血小板减少、恶心呕吐、腹泻便秘、周围神经毒性、肝肾毒性、口腔黏膜炎等毒副反应的发生。4、消癌平注射液联合SOX方案治疗晚期胃癌可改善患者生活质量,值得临床推广应用。
[Abstract]:Objective: To observe and explore the clinical efficacy and safety of XiaoNPing injection combined with SOX scheme in the treatment of advanced gastric cancer. Methods: 100 patients aged from 03 months to October 2016 2015 to October 2016 in the gastrointestinal surgery and oncology department were selected as the research subjects, the age range was 31~75 years old and the median age was 56 years old. All cases were recurrent or inoperable after operation. The CT, MRI, and digestive endoscopy confirmed and confirmed by the pathology or cytology as advanced gastric cancer. The clinical staging of the TNM staging of the cancer of the United States cancer Joint Commission (AJCC) and the international anticancer Union (UICC) in 2010 were all stage III to IV, and the Karnofsky score was 60~100. All the subjects were randomly divided according to the random number table method. For the observation group and the control group, the two groups were treated with SOX chemotherapy regimen: first to fourteenth days with teggio 80mg/m2/d, two times of oral administration and 1 weeks after 2 weeks of continuous medication, and first days with oxaliplatin 130mg/m2 continuous intravenous drip for 3 hours, and 1 chemotherapy weeks for 21 days. The observation group added the intravenous injection of cisparin injection 60ml/d, intravenous drip. 14D. control group only used SOX regimen only for chemotherapy, at least 2 cycles of chemotherapy. The termination time of this study was the occurrence of disease progression (PD), death or intolerance of toxicity. The main index was the tumor objective remission rate (ORR), the incidence of adverse reactions, and the changes of quality of life (KPS score) before and after chemotherapy. And the time of disease progression (TTP), and so on. According to the standard of RECIST1.1 solid tumor evaluation and the standard of acute and subacute toxicity of WHO formulated by WHO, the short-term clinical efficacy, the incidence of adverse reactions and the improvement rate of quality of life (KPS score) were evaluated, and the difference between the two groups was statistically analyzed with the SPSS 20 software. Results: there were 96 cases of clinical trials (48 cases in the observation group, 48 cases in the control group), and 4 cases (2 cases in the observation group and 2 cases in the control group) from clinical trials because of non compliance, poor compliance, economic factors and serious adverse reactions. The sex, age, functional status (KPS score), clinical staging and pathological types of the patients in the observation group and the control group were baselines. The difference of data was not statistically significant (P0.05), with homogeneity comparability.1. The objective remission rate (ORR) of the observation group and the control group was 66.7% and 62.5% respectively. The difference between the two groups was not statistically significant (P=0.6700.05). The rate of disease control (DCR) in the observation group and the group was 95.8% and 89.6%, respectively. The difference between the two groups was not statistically significant (P=0.4320.05).2. The improvement rate of the quality of life (KPS score) in the observation group and the control group was 62.5% and 37.5% respectively. The statistical analysis showed that there was a statistically significant difference between the two groups (P=0.0220.05).3, and the incidence of leukocyte reduction was 22.9% in the observation group. The incidence of granulocytic reduction was 27.1%, the incidence of leukocytic reduction in the control group was 45.8%, the incidence of neutrophils and neutrophils in the 52.1%. observation group was lower than that in the control group. The difference between the two groups of leukocytic and neutrophils was compared with the two groups. Statistical significance (P0.05). Other adverse reactions such as erythrocytopenia, thrombocytopenia, nausea and vomiting, nausea, diarrhea constipation, peripheral neurotoxicity, hepatorenal toxicity, oral mucositis, and so on. Statistically, the difference in the incidence of other adverse reactions between the two groups was not statistically significant (P0.05).4, and the median disease in the observation group and the control group was entered. The duration (TTP) was 7 (95%CI:5.913~8.087) months and 6.5 (95%CI:5.720~7.280) months respectively. Statistically, there was no significant difference between the two groups (P=0.7460.05). Conclusion: 1, the efficacy of the combined SOX scheme and the simple SOX scheme in the treatment of advanced gastric cancer was similar, and the clinical efficiency was different but not significantly improved. 2, the treatment of advanced gastric cancer by Xiaoping injection combined with SOX regimen could reduce leukocytopenia caused by chemotherapy and decrease the incidence of neutrophils, the incidence of neutrophils decreased by.3. The treatment of advanced gastric cancer with SOX regimen of Xiaoping injection combined with chemotherapy did not increase the thrombocytopenia, nausea and vomiting, diarrhea constipation, peripheral neurotoxicity, hepatorenal toxicity, oral mucositis and so on. The occurrence of side effects.4, Xiao AI Ping injection combined with SOX regimen in the treatment of advanced gastric cancer can improve the quality of life of patients, and is worthy of clinical application.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R735.2

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