腎細胞癌靶向治療藥物的有效性和安全性評價
發(fā)布時間：2018-08-30 09:49
【摘要】：目的:通過Cochrane協(xié)作網(wǎng)推薦的方法,系統(tǒng)評價靶向藥物治療腎細胞癌的有效性和安全性。方法:根據(jù)制定的納入、排除標準,計算機檢索Cochrane圖書館、Pub Med和EMBASE,并手工檢索相關領域雜志及會議論文。檢索年限定從建庫至2014年11月,語種限定為英語,納入相關靶向藥物治療腎細胞癌的隨機對照試驗、列隊研究和回顧性病例分析,評價納入文獻的質量,并通過Revman5.3軟件對研究結果進行Meta分析。結果:本次有效性評價共納入隨機對照試驗23個,安全性評價納入研究12個。有效性評價meta分析的結果顯示:貝伐單抗聯(lián)合α-干擾素的無疾病生存期優(yōu)于α-干擾素單藥,且差異具有統(tǒng)計學意義[HR=0.51,95%CI(0.26,0.99),P=0.05];貝伐單抗聯(lián)合α-干擾素與α-干擾素單藥比較中,聯(lián)合方案的總生存期高于α-干擾素單藥,且差異具有統(tǒng)計學意義[HR=0.51,95%CI(0.26,0.99),P=0.05];安全性評價meta分析結果顯示:阿西替尼發(fā)生嚴重高血壓的發(fā)生率高于索拉菲尼[OR=3.76,95%CI(0.37,38.58),P=0.26];阿西替尼發(fā)生嚴重手足綜合征的發(fā)生率低于索拉菲尼,差異具有統(tǒng)計學意義[OR=0.32,95%CI(0.21,0.49),P0.00001];阿西替尼發(fā)生嚴重腹瀉的發(fā)生率高于索拉菲尼[OR=1.58,95%CI(1.00,2.49),P=0.05];m TOR抑制劑發(fā)生嚴重腹瀉的發(fā)生率小于TKI抑制[OR=0.49,95%CI(0.23,1.02),P=0.06];阿西替尼發(fā)生嚴重疲勞的發(fā)生率高于索拉菲尼,且差異具有統(tǒng)計學意義[OR=2.98,95%CI(1.63,5.45),P=0.0004];帕唑帕尼出現(xiàn)疲勞的發(fā)生率小于舒尼替尼,且差異具有統(tǒng)計學意義[OR=0.76,95%CI(0.60,0.96),P=0.02];m TOR抑制劑出現(xiàn)疲勞的發(fā)生率與TKI抑制劑相比,兩者無顯著性差異[OR=0.98,95%CI(0.54,1.60),P=1.50];m TOR抑制劑與TKI抑制劑出現(xiàn)嘔吐的發(fā)生率無明顯差異[OR=0.95,95%CI(0.48,1.86),P=0.87];m TOR抑制劑發(fā)生高血壓不良反應事件的發(fā)生率低于TKI抑制劑,但差異無統(tǒng)計學意義[OR=0.46,95%CI(0.13,1.64),P=0.23];m TOR抑制劑出現(xiàn)手足綜合征的發(fā)生率小于TKI抑制劑,差異具有統(tǒng)計學意義[OR=0.07,95%CI(0.28,0.67),P0.0001];帕唑帕尼出現(xiàn)手足綜合征的發(fā)生率遠遠小于舒尼替尼,且差異具有統(tǒng)計學意義[OR=0.44,95%CI(0.35,0.55),P0.00001]。結論:根據(jù)現(xiàn)有研究結果,一線靶向藥物治療時,貝伐單抗聯(lián)合α-干擾素較單用α-干擾素具有良好有效性;阿西替尼在治療腎細胞癌時,具有良好的有效性,但其發(fā)生高血壓等不良反應事件的發(fā)生率相對較高;m TOR抑制劑較TKI抑制劑出現(xiàn)某些不良反應事件的發(fā)生率更低,如高血壓和手足綜合征,前者安全性相對較高。
[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 偽 was better than that of interferon 偽 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 鹵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 鹵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 鹵1.60) P 1.50] m TOR inhibitor and TKI inhibitor [OR=0.95,95%CI (0.48 鹵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 偽 is more effective than 偽 -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.
【學位授予單位】：四川醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R737.11
本文編號：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 偽 was better than that of interferon 偽 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 鹵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 鹵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 鹵1.60) P 1.50] m TOR inhibitor and TKI inhibitor [OR=0.95,95%CI (0.48 鹵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 偽 is more effective than 偽 -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.
【學位授予單位】：四川醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R737.11
【參考文獻】
相關期刊論文 前1條
1 張思維;陳萬青;孔靈芝;李連弟;魯鳳珠;李光琳;孟佳;趙平;;中國部分市縣1998～2002年惡性腫瘤的發(fā)病與死亡[J];中國腫瘤;2006年07期
，本文編號：2212713
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