奥氮平联合托烷司琼、地塞米松防治肝癌TACE术后恶心呕吐的临床观察

发布时间：2019-02-11 21:36

【摘要】：引言原发性肝癌(primary hepatic carcinoma,PHC),是世界范围内发病率较高恶性肿瘤之一,该病早期临床症状无特异性,多数病人发现时已不能行手术治疗。经导管肝动脉化疗栓塞术(transhepatic arterial chemotherapy and embolization,TACE)是中、晚期原发性肝癌患者的首选治疗方案之一,减慢肿瘤生长速度,使病人生存年限延长。但其术后导致的恶心呕吐是临床面临的主要问题之一,恶心呕吐严重者容易诱发食管-胃底曲张静脉破裂出血,可直接导致死亡。目前5-HT3受体阻滞剂(5-HT3RA)结合地塞米松显著降低了恶心、呕吐发生率,但仍有一部分病人症状非常顽固,达不到理想效果。近年来,NCCN指南提出奥氮平可用于恶心呕吐的辅助治疗,其中,奥氮平可以与多种神经递质受体结合发挥作用。目前已有多项研究表明其结合5-HT3RA(如托烷司琼、帕若诺司琼等)、地塞米松对化疗相关CINV有效,而在肝癌介入术后恶习呕吐的研究中,未见相关文献报道。本文旨在探讨奥氮平联合托烷司琼、地塞米松对于原发性肝癌TACE术后恶心呕吐治疗效果的临床评价。目的研究评价奥氮平结合托烷司琼、地塞米松三联方案在防治原发性肝癌TACE术后恶心呕吐的临床效果及毒副作用。方法经过严格的纳入和排除标准,本研究纳入2016年10月-2017年1月山东大学附属省立医院感染性疾病科收治的30例原发性肝癌患者。采用自身前后对照方法,30例患者先后经历两次TACE术,纳入后首次接受TACE(包括初治和经治TACE患者)治疗时止吐药物采取A方案:托烷司琼4mg、地塞米松5mg于TACE术前30分钟静脉滴注,纳入后第二次接受TACE治疗时止吐药物采用B方案:托烷司琼4mg、地塞米松5mg于TACE术前30分钟静脉滴注,同时于TACE术前口服奥氮平5mg,其中,奥氮平使用1天的12例,连续使用2天的6例,3天的6例,4天的4例,5天的2例。主要研究终点:1、A方案、B方案患者0-24h、25-120h、0-120h三个时段恶心呕吐症状评分。2、A方案、B方案患者0-24h、25-120h、0-120h三个时段恶心的控制率;3、A方案、B方案患者0-24h、25-120h、0-120h三个时段的完全应答率(complete response rate,CR 率)。次要研究终点:奥氮平应用的主要副反应及安全性评价。结果主要研究终点:1、A方案、B方案0-24h、25-120h、0-120h三个时段恶心呕吐症状评分分别为:5.3±2.8 分 vs.7.3±2.4 分、6.0±6.0 vs.13.9±5.5、11.3±8.0 vs.21.1±6.9,P 值均小于 0.05,差异有统计学意义。2、A方案、B方案0-24h、25-120h、0-120h三个时段恶心的控制率分别为:46.7%vs.26.7%、53.3%vs.26.7%、33.3%vs.6.7%,P 值均小于 0.05,差异有统计学意义。3、A方案、B方案0-24h、25-120h、0-120h三个时段的完全应答率分别为:53.3%vs.26.7%、86.7%vs.40%、53.3%vs.16.7%,P 值均小于 0.05,差异有统计学意义。次要研究终点:A方案、B方案相比,B方案部分病人在口服奥氮平后第二天出现困倦,无其他明显毒性反应。结论奥氮平结合托烷司琼、地塞米松防治原发性肝癌TACE术后恶心呕吐安全有效。
[Abstract]:Introduction of primary liver cancer (primary hepatic carcinoma,PHC) is one of the highest incidence of malignant tumors in the world, the early clinical symptoms of the disease is not specific, most patients can not be treated by surgery. Transcatheter hepatic arterial chemoembolization (transhepatic arterial chemotherapy and embolization,TACE) is one of the first choice for patients with advanced primary liver cancer. It slows down tumor growth and prolongs the survival time of patients. However, nausea and vomiting after operation is one of the main clinical problems. Severe nausea and vomiting can easily induce esophageal-gastric variceal bleeding, which can lead to death directly. At present, 5-HT3 receptor blocker (5-HT3RA) combined with dexamethasone has significantly reduced the incidence of nausea and vomiting, but some patients are still very stubborn symptoms and do not achieve the desired results. In recent years, the NCCN guidelines suggest that olanzapine can be used as an adjuvant therapy for nausea and vomiting, in which olanzapine can bind to a variety of neurotransmitter receptors. Several studies have shown that dexamethasone combined with 5-HT3RA (tropisetron, paronosetron, etc.) is effective for chemotherapy-related CINV. The purpose of this study was to evaluate the efficacy of olanzapine combined with tropisetron and dexamethasone in the treatment of nausea and vomiting after TACE for primary liver cancer. Objective to evaluate the clinical effects and side effects of olanzapine combined with tropisetron and dexamethasone in the prevention and treatment of nausea and vomiting after TACE for primary liver cancer. Methods after strict inclusion and exclusion criteria, this study included 30 patients with primary liver cancer admitted to the Department of Infectious Diseases of the Provincial Hospital affiliated to Shandong University from October 2016 to January 2017. 30 patients underwent two TACE procedures before and after treatment, and the first time they were treated with TACE (including newly treated and treated TACE patients) was treated with regimen A: tropisetron 4 mg, tropisetron 4 mg. Dexamethasone 5mg was intravenously infused 30 minutes before TACE, followed by intravenous infusion of tropisetron 4 mg, dexamethasone 5mg 30 minutes before TACE and olanzapine 5 mg before TACE. Among them, 12 cases were treated with olanzapine for 1 day, 6 cases for 2 days, 6 cases for 3 days, 4 cases for 4 days and 2 cases for 5 days. The main endpoints of the study were as follows: (1) regimen A, the score of nausea and vomiting symptoms in patients with regimen B: 0-24 h, 25-120 h, 0-120 h, and the control rate of nausea in patients with regimen B (0-24 h, 25-120 h, 0-120 h); The complete response rate (complete response rate,CR) of the patients with regimen A and regimen B was 0-24 h, 25-120 h and 0-120 h). Secondary study endpoint: major side effects and safety evaluation of olanzapine. Results the main endpoints were as follows: (1) the scores of nausea and vomiting were 5.3 卤2.8 (vs.7.3 卤2.4) and 5.3 卤2.8 (vs.7.3 卤2.4), respectively. 6. 0 卤6. 0 vs.13.9 卤5. 5 卤11. 3 卤8. 0 vs.21.1 卤6. 9 P < 0. 05. The difference was statistically significant. The control rates of nausea in the three periods of 0-120 h were 46.7vs.26.7and 53.3and 53.3and 53.3v / 26.7and 33.3vs.6.7respectively, and the P values were all less than 0.05.The difference was statistically significant. The complete response rates of 0-24hu 25-120h / 0-120h were 53.3% and 86.7vs.40, respectively. The difference was significant (P < 0.05). The end point of the study was as follows: compared with regimen A and regimen B, some patients of regimen B developed sleepiness on the second day after oral olanzapine and had no other obvious toxic reactions. Conclusion olanzapine combined with tropisetron and dexamethasone is safe and effective in the treatment of nausea and vomiting after TACE.
【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】：R735.7

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