索拉菲尼与免疫治疗在治疗晚期肾癌的疗效与安全性的META分析

发布时间：2018-01-12 09:23

本文关键词：索拉菲尼与免疫治疗在治疗晚期肾癌的疗效与安全性的META分析　出处：《兰州大学》2015年硕士论文　论文类型：学位论文

【摘要】：肾癌,又称肾细胞癌(renal cell carcinoma, RCC),肾癌的发病率居泌尿外科肿瘤的第二位,仅次于膀胱癌。肾癌的早期临床症状不明显,部分患者发现时已属晚期,失去了行肾癌根治术的时机,故肾癌患者的5年总生存率仅为20-25%。目前,肾癌最主要的治疗方法是外科手术根治,但对于晚期肾癌患者,手术并未明显改善患者的预后及生存质量,又因肾癌对放疗及化疗均不敏感,因此,以索拉菲尼为代表的分子靶向治疗及各种联合治疗方案在对晚期肾癌的治疗上有着重要的意义。目的：系统评价索拉菲尼与免疫治疗比较或索拉菲尼联合免疫治疗与单用索拉菲尼比较治疗晚期肾癌的疗效和安全性。方法：计算机检索The Cochrane Library、PubMed、Web of Science、CBM、 CNKI、VIP和WanFang Data,检索时限截止至2014年2月,收集索拉菲尼与免疫治疗比较及索拉菲尼联合免疫治疗与单独使用索拉菲尼治疗比较的临床随机对照试验(RCTs).由两位研究人员严格按照纳入与排除的标准,独立进行文献筛选、资料提取及质量评价后,应用RevMan5.0软件进行统计分析。结果：研究最终共纳入8个研究,共674例患者。Meta分析结果显示：1.与免疫治疗相比,疗效上除索拉菲尼在晚期肾癌患者的无进展生存期上有更好的临床效益[MD=1.46,95%CI (0.07,2.85), P=0.04]外,其余两组在总有效率、控制率的差异上均无统计学意义[总有效率：OR=1.53,95%CI (0.93,2.51),P=0.09；控制率：OR=1.42,95%CI (0.41,4.91), P=0.58]。在两种治疗常见的不良反应事件上(乏力,腹泻,恶心呕吐,手足皮肤反应),索拉菲尼除恶心呕吐的不良反应发生率低于免疫治疗外,在其余三项常见不良事件的发生率上,差异均无统计学意义。2.与单用索拉菲尼相比,索拉菲尼联合免疫治疗的在疾病的总有效率、控制率及不良反应发生率上,差异均无统计学意义[总有效率：OR=1.40,95%CI(0.75,2.61),P=0.29；控制率：OR=1.70,95%CI (0.99,2.94), P=0.06;不良事件发生率：OR=1.12,95% CI(0.32,3.92),P=0.85]。结论：基于当前的临床证据,与免疫治疗相比,索拉菲尼可延长晚期肾癌患者疾病的无进展生存期；索拉菲尼联合免疫治疗并不能增强对晚期肾癌患者的疗效。Effectiveness and safety of sorafenib and immunotherapy for Advanced Renal Cell Carcinoma:A
[Abstract]:Renal cell carcinoma (RCC) is also called renal cell carcinoma (RCC). The incidence of renal cell carcinoma (RCC) is the second most common in urological tumors. Second only to bladder cancer. The early clinical symptoms of renal cell carcinoma is not obvious, some patients were found to be late, lost the opportunity to perform radical nephrectomy, so the overall 5-year survival rate of patients with renal cell carcinoma is only 20-25. At present. The main treatment for renal cell carcinoma is radical surgery, but for advanced renal cell carcinoma, surgery has not significantly improved the prognosis and quality of life of patients, but also because renal cell carcinoma is not sensitive to radiotherapy and chemotherapy, so. Molecular targeted therapy and various combination therapy protocols, represented by Solafini, are of great significance in the treatment of advanced renal cell carcinoma. The efficacy and safety of Solafini in the treatment of advanced renal cell carcinoma were systematically evaluated by comparing the efficacy and safety of Solafini with immunotherapy or solafini combined immunotherapy with solafini alone. Methods: The Cochrane was searched by computer. Library. The search time of PubMedof Web of Science CBM, CNKI, VIP and WanFang data is up to February 2014. To collect the clinical randomized controlled trial (RCTs) of Solafini compared with immunotherapy and salafenil combined immunotherapy with solafenil alone. The inclusion and exclusion criteria were strictly followed by two researchers. After independent literature screening, data extraction and quality evaluation, RevMan5.0 software was used to carry out statistical analysis. Results: the study was included in 8 studies. A total of 674 patients. Meta-analysis showed that: 1.Compared with immunotherapy, the curative effect was better than solafenil in the progressive survival of patients with advanced renal cell carcinoma. [There was no significant difference in the total effective rate and control rate between the other two groups except MD1.46 / 95CI 0.07 / 2.85, P0.04. [The total effective rate was 1.53 / 95 / CI 0.93 / 2.51 / P0.09; The control rate was 1.42 ~ 95% CI 0.41 ~ 4.91, P _ (0.58). There were two common adverse events (fatigue, diarrhea, nausea and vomiting) in the treatment of two kinds of common adverse events (fatigue, diarrhea, nausea and vomiting). In addition to nausea and vomiting, the incidence of adverse reactions of solafini was lower than that of immunotherapy, and the incidence of the other three common adverse events was higher than that of immunotherapy. Compared with solafenil alone, the total effective rate, control rate and adverse reaction rate of combined immunotherapy with Solafini had no statistical significance. [The total effective rate is 1.4095 / 0.75 / 0.75 / 2.61 / 0.29; The control rate was 1.70 / 95, CI = 0.99 / 2.94, P = 0.06; The incidence of adverse events was 1.1295% CI 0.32 / 3.92P 0.85. Conclusion: based on the current clinical evidence, compared with immunotherapy. Solafinil can prolong the progression free survival of advanced renal cell carcinoma patients. Solafini combined immunotherapy does not enhance the efficacy of and safety of sorafenib and in patients with advanced renal cell carcinoma. Immunotherapy for Advanced Renal Cell Carcinoma:A
【学位授予单位】：兰州大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R737.11

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