膀胱热灌注化疗和灌注化疗临床疗效和安全性的系统评价

发布时间：2018-03-03 16:27

本文选题：膀胱热灌注化疗　切入点：灌注化疗　出处：《新乡医学院》2016年硕士论文　论文类型：学位论文

【摘要】：目的比较膀胱热灌注化疗和灌注化疗治疗非肌层浸润性膀胱癌(Non-muscle-invasive Bladder Cancer,NMIBC)术后的优缺点,全面系统的评价两种化疗方式的临床疗效及安全性,为非肌层浸润性膀胱癌的临床诊疗提供高质量的证据。方法通过电子计算机检索Cochrane图书馆、MEDLINE(通过PubMed检索平台)、EMBASE(通过ovidsp检索平台)、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方数据库(WanFang),收集膀胱热灌注化疗和膀胱灌注化疗治疗膀胱癌的临床试验文献研究,检索时限至2015年10月15日。手工检索1993年1月-2015年10月与膀胱肿瘤相关的几种中文杂志:《现代泌尿生殖肿瘤杂志》、《国际泌尿系统杂志》、《中华泌尿外科杂志》、《临床泌尿外科杂志》等。由2位独立的评价者参照Cochrane协作网推荐采用的新的偏倚风险评估‖工具来评价文献质量,采用最新的RevMan 5.3.0软件进行Meta分析。结果本研究共纳入16篇文献,进一步排除数据后纳入8篇文献进行分析。纳入文献2篇为病例对照试验,属于回顾性试验,其余6篇为随机对照试验(RCT),属于前瞻性试验,其中英文6篇,中文2篇,共包括455例患者。其中MMC热灌注治疗组共171例患者,MMC单独应用组共170例患者;治疗剂量组38例患者,预防剂量组46例患者。Meta分析结果显示:热灌注MMC治疗组和单独MMC治疗组的化疗疗效相比,整体风险比为0.17(95%CI,0.10,0.28);治疗剂量组与预防剂量组的复发对比整体风险比为0.66(95%CI,0.22,2.02);热灌注MMC治疗组和单独MMC治疗组化疗后疾病进展率,整体风险比为0.62(95%CI 0.13,3.03),无统计学意义;膀胱痉挛在病人中发生率为11.8%,膀胱疼痛发生率为12.9%;膀胱痉挛更容易出现在预防性治疗中(17.8%vs 10.7%;p=0.398),而疼痛的出现在预防性计划和治疗性计划中基本相同,但是,更常见于治疗性计划中(17.0%vs 15.6%;p=0.366)。而疼痛的出现在预防性计划和治疗性计划中的概率基本相同,相比之下更常见于治疗性计划中(17.0%vs15.6%;p=0.366)。该meta分析结果的风险偏倚程度较小,结果较为可信。结论我们的系统综述表明,膀胱热灌注化疗和灌注化疗治疗非肌层浸润性膀胱癌(NMIBC)术后的疗效相比,膀胱热灌注后病人复发的几率与单纯灌注化疗相比降低83.0%,经过热灌注化疗后膀胱的整体保存率达到87.6%。膀胱保全率与药物剂量无明显相关性。然而,由于数量有限的随机试验和不同的研究设计,还不能对其复发和进展得出明确的结论。膀胱热灌注化疗较单纯灌注化疗通常有更多的不良反应,但是这种差异没有统计学意义。由于纳入系统评价文献的数量较少,存在一定的选择及发表的偏倚,缺乏大样本的临床随机对照试验的支持,因此上述结论仍需今后更多的大样本、多中心、高质量的临床随机对照研究的进一步验证。
[Abstract]:Objective to compare the advantages and disadvantages of bladder hyperthermic infusion chemotherapy and infusion chemotherapy in the treatment of non-muscle-invasive Bladder carcinoma of bladder after operation, and to evaluate the clinical efficacy and safety of the two chemotherapy methods. Methods Cochrane library MEDLINE (via PubMed search platform) was searched by computer. According to CBMU and WanFangang, a literature study on the clinical trial of bladder hyperthermic chemotherapy and bladder infusion chemotherapy for bladder cancer was made. Search time is up to October 15th 2015. Manually search several Chinese magazines related to bladder neoplasms from January 1993 to October 2015: Journal of Modern urogenital tumors, International Journal of Urology, Chinese Journal of Urology, and Clinical. Journal of Urology et al. The quality of the literature was evaluated by two independent reviewers using a new risk assessment tool recommended by Cochrane. Meta analysis was carried out with the latest software RevMan 5.3.0.Results 16 articles were included in this study, 8 articles were further excluded from the data, and 2 articles were included as case-control trials, which were classified as retrospective trials. The other 6 were randomized controlled trials, including 6 in Chinese and 6 in Chinese, and 2 in Chinese, including 455 patients, including 171 patients in MMC hyperthermic perfusion group, 170 patients in MMC alone group, 38 patients in treatment dose group, 38 patients in treatment dose group, 3 patients in Chinese group, 3 patients in Chinese group, 3 patients in Chinese group, 3 patients in Chinese group, 3 patients in Chinese group and 38 patients in dosage group. The results of meta analysis of 46 patients in prophylaxis dose group showed that the therapeutic effect of hyperthermic infusion of MMC was compared with that of MMC alone. The overall risk ratio was 0.17 ~ 95 ~ 0.10 ~ 0.28%, the overall risk ratio was 0.66 ~ 95 ~ 0.222.02 ~ 0.22 ~ 2.02 ~ 0.66 ~ 95%, the disease progression rate and the overall risk ratio were 0.62n ~ 95 ~ (95) CI 0.133.03 ~ 0. 62% in the MMC treatment group and MMC alone group respectively, and there was no significant difference in the overall risk ratio between the treatment group and the prophylaxis dose group (P < 0.05). The incidence of bladder spasm in patients was 11.8% and the incidence of bladder pain was 12.9%. Bladder spasm was more likely to occur in preventive treatment than 10.7% 0.398%, and pain occurred in both prophylactic and therapeutic plans, but, The incidence of pain in prophylactic and therapeutic plans was almost the same, compared with 17.0vs15.6g in therapeutic plans. The risk bias of the results of the meta analysis was lower. Conclusion our systematic review shows that the efficacy of intravesical hyperthermic chemotherapy and infusion chemotherapy in the treatment of non-myometrial invasive bladder cancer is more effective than that of NMIBC+. The rate of recurrence was 83.0% lower than that of chemotherapy alone. The overall survival rate of bladder was 87.6% after hyperthermic chemotherapy. There was no significant correlation between bladder preservation rate and drug dosage. Due to a limited number of randomized trials and different research designs, it is not possible to draw a definite conclusion on the recurrence and progression of bladder hyperthermia chemotherapy. However, the difference was not statistically significant. Due to the small number of papers included in the systematic evaluation, the existence of certain selection and publication bias, and the lack of support from large clinical randomized controlled trials, Therefore, more large, multicenter, and high quality randomized controlled clinical trials are needed in the future.
【学位授予单位】：新乡医学院
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R737.14

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