康莱特在肺癌辅助化疗应用研究的Meta分析

发布时间：2018-03-08 08:45

本文选题：康莱特　切入点：肺癌　出处：《遵义医学院》2017年硕士论文　论文类型：学位论文

【摘要】：目的:通过系统性评价康莱特辅助化疗肺癌的疗效及安全性,系统分析康莱特注射液分别辅助联合长春瑞滨加铂类、吉西他滨加铂类、紫杉醇加铂类化疗治疗肺癌的疗效和安全性,评估增效、减毒作用,为合理制订治疗肺癌的策略提供临床依据。方法:分别检索万方(WANGFANG)、维普(VIP)、中国知网(CNKI)、中国生物医学文献数据库(CBM)、Pubmed、Cochrane Library、EMBASE和SCI、中国临床试验注册中心数据库、美国临床试验注册中心数据库,采用Cochrane RCT质量评价标准评价纳入研究质量,Meta分析提取数据。结果:1)康莱特联合NP方案:共纳入35个RCT,2634例肺癌患者,研究质量一般;与NP方案比较:ORR、DCR、1年远期疗效、生活质量、白细胞减低、血小板减低、骨髓抑制、消化道反应、恶心及呕吐、静脉炎、脱发的Meta分析合并R D值为0.13(0.09~0.16)、0.08(0.05~0.11)、0.37(0.21~0.52)、0.20(0.16~0.25)、-0.22(-0.28~-0.17)、-0.21(-0.27~-0.16)、-0.37(-0.47~-0.28)、-0.29(-0.36~-0.22)、-0.11(-0.16~-0.05)、0.11(0.06~0.16)、-0.16(-0.26~-0.07),均具有统计学差异;免疫指标CD3+细胞、CD4+细胞、CD8+细胞的Meta分析合并SMD值为-1.02(-1.67~-0.37)、2.07(1.45~2.69)、3.03(2.39~3.67),均具有统计学意义;CD4+/CD8+细胞的Meta分析合并SMD值为0.00(-0.06~0.06),无统计学意义;贫血、肝功损伤、肾功损伤、心功损伤、神经毒性Meta分析合并RD值为-0.03(-0.09~0.03)、-0.03(-0.09~0.03)、-0.02(-0.06~0.01)、-0.03(-0.06~-0.01)、-0.06(-0.15~-0.04),均无统计学差异;ORR、DCR、白细胞降低、生活质量、恶心及呕吐、血小板降低的发表偏倚不大。2)康莱特联合GP方案:共纳入的30个RCT,2150例肺癌患者,研究质量一般;与GP方案比较:ORR、DCR、1年远期疗效、生活质量、白细胞降低、贫血、骨髓抑制、消化道反应、恶心及呕吐、肝功损伤、脱发、皮肤瘙痒的Meta分析合并RD值为0.17(0.13~0.21)、0.13(0.09~0.17)、0.12(0.01~0.22)、0.23(0.18~0.28)、-0.19(-0.24~-0.13)、-0.09(-0.15~-0.02)、-0.10(-0.17~-0.03)、-0.29(-0.39~-0.19)、-0.15(-0.23~-0.08)、-0.10(-0.15~-0.04)、-0.11(-0.17~-0.04)、-0.27(-0.38~-0.16),均具有统计学意义;免疫指标CD3+细胞、CD4+细胞、CD8+细胞、CD4+/CD8+细胞的Meta分析合并SMD值为1.59(1.31~1.70)、1.36(1.17~1.55)、0.65(0.48~0.83)、0.69(0.50~0.88),均具有统计学意义;2年远期疗效、肾功损伤、心功损伤、神经毒性、皮肤瘙痒的Meta分析合并RD值为0.12(-0.09~0.33)、-0.03(-0.08~0.03)、0.04(-0.02~0.09)、-0.02(-0.13~0.10)、-0.08(-0.19~0.03),均无统计学意义;ORR、DCR、生活质量、白细胞降低、恶心及呕吐的发表偏倚均不大。3)康莱特联合TP方案:纳入的22个RCT,1681例肺癌患者,研究质量一般;与TP方案比较:ORR、DCR、生活质量、白细胞降低、贫血、骨髓抑制、恶心及呕吐反应的Meta分析合并RD值为0.13(0.08~0.17)、0.15(0.11~0.19)、0.27(0.22~0.33)、-0.24(-0.32~-0.17)、-0.26(-0.39~-0.13)、-0.34(-0.50~-0.17)、-0.24(-0.32~-0.16);免疫指标CD3+细胞、CD4+细胞、CD4+/CD8+细胞、NK细胞的Meta分析合并SDM值为0.59(0.38~0.79)、1.04(0.83~1.25)、0.56(0.36~0.76)、0.85(0.63~1.07),均具有统计学意义,CD8+细胞的Meta分析合并SDM值为-0.06(-0.37~0.25),无统计学意义;1年远期疗效、血小板降低、消化道反应、肝功损伤、肾功损伤、心功损伤、脱发、静脉炎、发热的Meta分析合并RD值为-0.04(-0.16~0.09)、0.81(0.55~1.18)、0.80(0.40~1.20)、-0.02(-0.13~0.08)、-0.02(-0.10~0.05)、-0.03(-0.09~0.03)、-0.08(-0.20~0.05)、-0.03(-0.15~0.09)、0.04(-0.06~0.14)、-0.04(-0.13~0.04),无统计学意义;ORR、DCR、生活质量的发表偏倚均不大。结论:1.康莱特作为一种辅助化疗药物,联合NP方案治疗肺癌有增效及减毒作用,且疗效显著,安全性好,临床可推广;2.康莱特联合GP方案治疗肺癌,可减轻其不良反应及增加患者疗效,安全性好,值得应用;3.康莱特与TP方案联合治疗肺癌,应用有效指标评价后,其安全性及疗效性好,具有增效减毒作用。
[Abstract]:Objective: the efficacy and safety of systematic evaluation of Kanglaite adjuvant chemotherapy of lung cancer, combined with analysis of Kanglaite Injection were assisted Changchun Platinum system, gemcitabine plus platinum and paclitaxel plus platinum chemotherapy in the treatment of lung cancer efficacy and safety evaluation of efficiency, reducing toxicity, to provide clinical basis for the reasonable treatment of lung cancer. Methods: Wanfang, VIP (WANGFANG) (VIP), Chinese HowNet (CNKI), Chinese biomedical literature database (CBM), Pubmed, Cochrane, Library, EMBASE and SCI, China clinical trials registry database, the clinical trials registry database, using the standard Cochrane RCT quality evaluation to evaluate the quality of included studies, Meta extraction and analysis of data. Results: 1) Kanglaite combined with NP regimen: a total of 35 RCT, 2634 cases of lung cancer, a study on quality; a comparison with the NP: ORR, DCR, the 1 year long term effect, The quality of life, leukopenia, thrombocytopenia, bone marrow suppression, gastrointestinal reactions, nausea and vomiting, phlebitis, alopecia Meta analysis with R D 0.13 (0.09~0.16), 0.08 (0.05~0.11), 0.37 (0.21~0.52), 0.20 (0.16~0.25), -0.22 (-0.28~-0.17), -0.21 (-0.27~-0.16), -0.37 (-0.47~-0.28), -0.29 (-0.36~-0.22), -0.11 (-0.16~-0.05), 0.11 (0.06~0.16), -0.16 (-0.26~-0.07), the differences were all statistically significant; immune index of CD3+ cells, CD4+ cells, CD8+ cells and SMD Meta analysis of the value of -1.02 (-1.67~-0.37), 2.07 (1.45~2.69), 3.03 (2.39~3.67), were statistically meaning; CD4+/CD8+ cell Meta analysis combined with SMD value of 0 (-0.06~0.06), no statistical significance; anemia, liver damage, kidney damage, heart function damage, neurotoxicity Meta analysis combined RD = -0.03 (-0.09~0.03), -0.03 (-0.09~0.03), -0.02 (-0.06~0.01), -0.03 (-0.06~-0.01), -0.06 (-0.15~-0 .04), there was no significant difference; ORR, DCR, leukopenia, nausea and vomiting, quality of life, reduce platelet publicationbias little.2) Kanglaite combined with GP regimen: a total of 30 RCT, 2150 cases of lung cancer patients, study the general quality; a comparison with the GP: ORR, DCR, quality of life 1 in the long-term effect, leukopenia, anemia, bone marrow suppression, gastrointestinal reactions, nausea and vomiting, liver damage, hair loss, skin itching and Meta analysis of the value of RD was 0.17 (0.13~0.21), 0.13 (0.09~0.17), 0.12 (0.01~0.22), 0.23 (0.18~0.28), -0.19 (-0.24~-0.13), -0.09 (-0.15~-0.02), -0.10 (-0.17~-0.03), -0.29 (-0.39~-0.19), -0.15 (-0.23~-0.08), -0.10 (-0.15~-0.04), -0.11 (-0.17~-0.04), -0.27 (-0.38~-0.16), were statistically significant; immune index of CD3+ cells, CD4+ cells, CD8+ cells, CD4+/CD8+ cells and Meta analysis of the value of SMD was 1.59 (1.31~1.70), 1.36 (1.17~1.55, 0.) 65 (0.48~0.83), 0.69 (0.50~0.88), were statistically significant; 2 years long-term efficacy, renal damage, heart function damage, neurotoxicity, pruritus Meta analysis with an RD of 0.12 (-0.09~0.33), -0.03 (-0.08~0.03), 0.04 (-0.02~0.09), -0.02 (-0.13 ~0.10), -0.08 (-0.19~0.03) and had no statistical significance; ORR, DCR, quality of life, leukopenia, nausea and vomiting were not publicationbias.3) Kanglaite combine TP 22 RCT into the 1681 cases of lung cancer patients, study the general quality; a comparison with the TP: ORR, DCR, quality of life, leukopenia, anemia, myelosuppression, nausea and vomiting reaction Meta analysis combined with RD value of 0.13 (0.08~0.17), 0.15 (0.11~0.19), 0.27 (0.22~0.33), -0.24 (-0.32~-0.17), -0.26 (-0.39~-0.13), -0.34 (-0.50~-0.17), -0.24 (-0.32~-0.16); immune index of CD3+ cells, CD4+ cells, CD4+/CD8+ cells, NK cells Meta analysis with SDM A value of 0.59 (0.38~0.79), 1.04 (0.83~1.25), 0.56 (0.36~0.76), 0.85 (0.63~1.07), were statistically significant, CD8+ cell Meta analysis combined with SDM value of -0.06 (-0.37~0.25), no statistical significance; platelet 1 years long-term curative effect, reduce gastrointestinal reaction, liver damage, kidney damage and heart function damage, alopecia, phlebitis, fever Meta analysis combined with RD value of -0.04 (-0.16~0.09), 0.81 (0.55~1.18), 0.80 (0.40~1.20), -0.02 (-0.13~0.08), -0.02 (-0.10~0.05), -0.03 (-0.09~0.03), -0.08 (-0.20~0.05), -0.03 (-0.15~0.09), 0.04 (-0.06~0.14), -0.04 (-0.13~0.04), no statistical significance; ORR, DCR, quality of life are not the publication bias. Conclusion: 1. Kanglaite as an adjunct to chemotherapy drugs have synergy and attenuation combined with NP regimen in treatment of lung cancer, and has obvious curative effect, good safety, clinical promotion; 2. Kanglaite injection combined with GP regimen in the treatment of lung cancer, can to alleviate the adverse The reaction and increase the curative effect, good safety, it is worthy of application; 3. of Kanglaite combined with TP regimen for lung cancer, application of effective evaluation index, its safety and efficacy, a synergistic effect.

【学位授予单位】：遵义医学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R734.2

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