肾细胞癌靶向治疗药物的有效性和安全性评价
发布时间：2018-08-30 09:49
【摘要】：目的:通过Cochrane协作网推荐的方法,系统评价靶向药物治疗肾细胞癌的有效性和安全性。方法:根据制定的纳入、排除标准,计算机检索Cochrane图书馆、Pub Med和EMBASE,并手工检索相关领域杂志及会议论文。检索年限定从建库至2014年11月,语种限定为英语,纳入相关靶向药物治疗肾细胞癌的随机对照试验、列队研究和回顾性病例分析,评价纳入文献的质量,并通过Revman5.3软件对研究结果进行Meta分析。结果:本次有效性评价共纳入随机对照试验23个,安全性评价纳入研究12个。有效性评价meta分析的结果显示:贝伐单抗联合α-干扰素的无疾病生存期优于α-干扰素单药,且差异具有统计学意义[HR=0.51,95%CI(0.26,0.99),P=0.05];贝伐单抗联合α-干扰素与α-干扰素单药比较中,联合方案的总生存期高于α-干扰素单药,且差异具有统计学意义[HR=0.51,95%CI(0.26,0.99),P=0.05];安全性评价meta分析结果显示:阿西替尼发生严重高血压的发生率高于索拉菲尼[OR=3.76,95%CI(0.37,38.58),P=0.26];阿西替尼发生严重手足综合征的发生率低于索拉菲尼,差异具有统计学意义[OR=0.32,95%CI(0.21,0.49),P0.00001];阿西替尼发生严重腹泻的发生率高于索拉菲尼[OR=1.58,95%CI(1.00,2.49),P=0.05];m TOR抑制剂发生严重腹泻的发生率小于TKI抑制[OR=0.49,95%CI(0.23,1.02),P=0.06];阿西替尼发生严重疲劳的发生率高于索拉菲尼,且差异具有统计学意义[OR=2.98,95%CI(1.63,5.45),P=0.0004];帕唑帕尼出现疲劳的发生率小于舒尼替尼,且差异具有统计学意义[OR=0.76,95%CI(0.60,0.96),P=0.02];m TOR抑制剂出现疲劳的发生率与TKI抑制剂相比,两者无显著性差异[OR=0.98,95%CI(0.54,1.60),P=1.50];m TOR抑制剂与TKI抑制剂出现呕吐的发生率无明显差异[OR=0.95,95%CI(0.48,1.86),P=0.87];m TOR抑制剂发生高血压不良反应事件的发生率低于TKI抑制剂,但差异无统计学意义[OR=0.46,95%CI(0.13,1.64),P=0.23];m TOR抑制剂出现手足综合征的发生率小于TKI抑制剂,差异具有统计学意义[OR=0.07,95%CI(0.28,0.67),P0.0001];帕唑帕尼出现手足综合征的发生率远远小于舒尼替尼,且差异具有统计学意义[OR=0.44,95%CI(0.35,0.55),P0.00001]。结论:根据现有研究结果,一线靶向药物治疗时,贝伐单抗联合α-干扰素较单用α-干扰素具有良好有效性;阿西替尼在治疗肾细胞癌时,具有良好的有效性,但其发生高血压等不良反应事件的发生率相对较高;m TOR抑制剂较TKI抑制剂出现某些不良反应事件的发生率更低,如高血压和手足综合征,前者安全性相对较高。
[Abstract]:Objective: to evaluate the efficacy and safety of targeted drugs in the treatment of renal cell carcinoma (RCC). Methods: according to the inclusion and exclusion criteria, the Cochrane library was searched by computer for Pub Med and EMBASE, and related journals and conference papers were searched manually. The year of retrieval was limited from the establishment of the bank to November 2014, and the language was limited to English, which included a randomized controlled trial of relevant targeted drugs for the treatment of renal cell carcinoma, a queue of studies and retrospective case analysis, and an evaluation of the quality of the literature included. The results are analyzed by Meta with Revman5.3 software. Results: the effectiveness evaluation included 23 randomized controlled trials and 12 safety evaluations. The results of meta analysis showed that the disease-free survival time of bevacizumab combined with interferon 伪 was better than that of interferon 伪 alone, and the difference was statistically significant [HR=0.51,95%CI (0.260.99) P0. 05]. The total survival time of the combined regimen was higher than that of interferon alpha alone. The results of meta analysis showed that the incidence of severe hypertension by acitinib was higher than that by Solafini [OR=3.76,95%CI (0.37 ~ 38.58)], and the incidence of severe hand and foot syndrome was lower than that of acitinib. The difference was statistically significant [OR=0.32,95%CI (0.21 / 0.49) P 0.00001], the incidence of severe diarrhea of azetinib was higher than that of Solafini [OR=1.58,95%CI (1.000.49) P0. 05] the incidence of severe diarrhea was lower than that of TKI inhibition (OR=0.49,95%CI (0.231.02) P0.06), the incidence of severe fatigue of azetinib was higher than that of Solafenib. The incidence of fatigue in pazopani was lower than that in sulnitinib, and the difference was statistically significant [OR=0.76,95%CI (0.60 卤0.96) P 0.02] m TOR inhibitor had a higher incidence of fatigue than that of TKI inhibitor, and the incidence of fatigue in pazopanil was lower than that in sulnitinib [OR=0.76,95%CI (0.60 卤0.96) P0.02] and the incidence of fatigue in pazopanil was significantly lower than that in TKI. There was no significant difference in the incidence of vomiting between [OR=0.98,95%CI (0.54 卤1.60) P 1.50] m TOR inhibitor and TKI inhibitor [OR=0.95,95%CI (0.48 卤1.86)] m TOR inhibitor had lower incidence of adverse events of hypertension than TKI inhibitor. However, there was no significant difference [OR=0.46,95%CI (0.131.64) Pu 0.23] the incidence of palsy with TOR inhibitor was lower than that with TKI inhibitor (OR=0.07,95%CI (0.280.67) P 0.0001), and the incidence of pazopani with hand and foot syndrome was significantly lower than that with sunitinib (OR=0.44,95%CI (0.35) 0.55) (P 0.00001), but the incidence of pazopanil was significantly lower than that of TKI inhibitor [OR=0.07,95%CI (0.28) 0.67] (P 0.0001), and the incidence of pazopani was significantly lower than that of sunitinib [OR=0.44,95%CI (0.35) 0.55]. Conclusion: according to the results of current studies, bevacizumab combined with interferon 伪 is more effective than 伪 -interferon alone in the treatment of renal cell carcinoma, and acitinib is effective in the treatment of renal cell carcinoma. However, the incidence of adverse events such as hypertension was higher than that of TKI inhibitors. For example, hypertension and hand and foot syndrome, the former had higher safety.
【学位授予单位】：四川医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R737.11
本文编号：2212713
[Abstract]:Objective: to evaluate the efficacy and safety of targeted drugs in the treatment of renal cell carcinoma (RCC). Methods: according to the inclusion and exclusion criteria, the Cochrane library was searched by computer for Pub Med and EMBASE, and related journals and conference papers were searched manually. The year of retrieval was limited from the establishment of the bank to November 2014, and the language was limited to English, which included a randomized controlled trial of relevant targeted drugs for the treatment of renal cell carcinoma, a queue of studies and retrospective case analysis, and an evaluation of the quality of the literature included. The results are analyzed by Meta with Revman5.3 software. Results: the effectiveness evaluation included 23 randomized controlled trials and 12 safety evaluations. The results of meta analysis showed that the disease-free survival time of bevacizumab combined with interferon 伪 was better than that of interferon 伪 alone, and the difference was statistically significant [HR=0.51,95%CI (0.260.99) P0. 05]. The total survival time of the combined regimen was higher than that of interferon alpha alone. The results of meta analysis showed that the incidence of severe hypertension by acitinib was higher than that by Solafini [OR=3.76,95%CI (0.37 ~ 38.58)], and the incidence of severe hand and foot syndrome was lower than that of acitinib. The difference was statistically significant [OR=0.32,95%CI (0.21 / 0.49) P 0.00001], the incidence of severe diarrhea of azetinib was higher than that of Solafini [OR=1.58,95%CI (1.000.49) P0. 05] the incidence of severe diarrhea was lower than that of TKI inhibition (OR=0.49,95%CI (0.231.02) P0.06), the incidence of severe fatigue of azetinib was higher than that of Solafenib. The incidence of fatigue in pazopani was lower than that in sulnitinib, and the difference was statistically significant [OR=0.76,95%CI (0.60 卤0.96) P 0.02] m TOR inhibitor had a higher incidence of fatigue than that of TKI inhibitor, and the incidence of fatigue in pazopanil was lower than that in sulnitinib [OR=0.76,95%CI (0.60 卤0.96) P0.02] and the incidence of fatigue in pazopanil was significantly lower than that in TKI. There was no significant difference in the incidence of vomiting between [OR=0.98,95%CI (0.54 卤1.60) P 1.50] m TOR inhibitor and TKI inhibitor [OR=0.95,95%CI (0.48 卤1.86)] m TOR inhibitor had lower incidence of adverse events of hypertension than TKI inhibitor. However, there was no significant difference [OR=0.46,95%CI (0.131.64) Pu 0.23] the incidence of palsy with TOR inhibitor was lower than that with TKI inhibitor (OR=0.07,95%CI (0.280.67) P 0.0001), and the incidence of pazopani with hand and foot syndrome was significantly lower than that with sunitinib (OR=0.44,95%CI (0.35) 0.55) (P 0.00001), but the incidence of pazopanil was significantly lower than that of TKI inhibitor [OR=0.07,95%CI (0.28) 0.67] (P 0.0001), and the incidence of pazopani was significantly lower than that of sunitinib [OR=0.44,95%CI (0.35) 0.55]. Conclusion: according to the results of current studies, bevacizumab combined with interferon 伪 is more effective than 伪 -interferon alone in the treatment of renal cell carcinoma, and acitinib is effective in the treatment of renal cell carcinoma. However, the incidence of adverse events such as hypertension was higher than that of TKI inhibitors. For example, hypertension and hand and foot syndrome, the former had higher safety.
【学位授予单位】：四川医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R737.11
【参考文献】
相关期刊论文 前1条
1 张思维;陈万青;孔灵芝;李连弟;鲁凤珠;李光琳;孟佳;赵平;;中国部分市县1998～2002年恶性肿瘤的发病与死亡[J];中国肿瘤;2006年07期
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