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目的系统评价胸腔化疗联合热疗治疗癌性胸腔积液的有效性及安全性。方法 2015年8月—2016年1月,计算机检索Cochrane Library、PubMed、EMBase、Web of Science等外文数据库以及中国生物医学文献数据库、中国知网、维普网和万方数据知识服务平台等中文数据库,并辅以补充检索手段,收集比较胸腔化疗联合热疗(联合组)与单纯胸腔化疗(对照组)治疗癌性胸腔积液有效性及安全性的随机对照试验。提取纳入文献资料,包括第一作者、发表时间、样本量、年龄、卡氏评分、化疗方案及结局指标,并进行方法学质量评价。结果共纳入23篇文献,包括1 647例患者,其中联合组819例,对照组828例。5篇文献报道了随机方法,各纳入文献均未说明分配隐藏和盲法实施情况,各文献两组患者基本特征具有可比性,1篇文献有患者失访,各文献均无选择性报告结果偏倚。联合组治疗癌性胸腔积液总有效率[OR=3.72,95%CI(2.92,4.74)]、完全缓解率[OR=2.24,95%CI(1.18,2.78)]、生活质量改善率[OR=3.66,95%CI(2.64,5.07)]均高于对照组(P<0.05)。联合组与对照组恶心呕吐[OR=0.80,95%CI(0.60,1.06)]、白细胞计数下降[OR=0.81,95%CI(0.60,1.10)]、发热[OR=0.98,95%CI(0.69,1.40)]、肝脏损害[OR=0.45,95%CI(0.11,1.81)]、气胸[OR=0.41,95%CI(0.06,2.91)]、皮肤烫伤[OR=5.33,95%CI(0.91,31.14)]发生率比较,差异均无统计学意义(P>0.05);联合组胸痛[OR=0.34,95%CI(0.16,0.74)]发生率低于对照组,皮下脂肪硬结[OR=6.27,95%CI(1.08,36.27)]发生率高于对照组(P<0.05)。结论与单纯胸腔化疗相比,胸腔化疗联合热疗可提高癌性胸腔积液患者近期疗效,显著改善患者生活质量,并且临床安全性较好,但其长期疗效和安全性评价尚需大样本高质量的研究进一步验证。
Objective To evaluate the efficacy and safety of thoracic chemotherapy combined with hyperthermia in the treatment of malignant pleural effusion. Methods From August 2015 to January 2016, computerized Chinese databases such as Cochrane Library, PubMed, EMBase and Web of Science, as well as Chinese biomedical literature database, China Knowledge Network, VW Network and Wanfang Data Knowledge Service Platform, Supplemented with additional search means to collect randomized controlled trials comparing the effectiveness and safety of thoracic chemotherapy combined with hyperthermia (combination group) and simple thoracic chemotherapy (control group) in the treatment of cancerous pleural effusion. The data included in the first author, time of publication, sample size, age, Karnofsky score, chemotherapy regimen and outcome measures were extracted and the methodological quality was evaluated. Results A total of 23 articles were included, including 1 647 patients, of which 819 in the combined group and 828 in the control group. Five literatures reported a randomized method. All the included literatures did not describe the implementation of the distribution concealment and the blinded method. The basic characteristics of the two groups of patients in each literature were comparable. One patient lost the patient’s follow-up and none of the literatures reported biased results . The total effective rate of combined treatment of malignant pleural effusion [OR = 3.72,95% CI 2.92,4.74], complete remission rate [OR = 2.24,95% CI (1.18,2.78)], quality of life improvement rate [OR = 3.66, 95% CI (2.64,5.07)] were higher than the control group (P <0.05). The combined group and the control group had nausea and vomiting [OR = 0.80, 95% CI (0.60, 1.06)], leukocyte count decreased [OR = 0.81, 95% CI (OR = 0.45, 95% CI 0.11, 1.81), pneumothorax (OR 0.41, 95% CI 0.06, 2.91), scalded skin (OR 5.33, 95% CI 0.91, 31.14). There was no significant difference between the two groups in the incidence of chest pain (OR = 0.34, 95% CI 0.16, 0.74) = 6.27,95% CI (1.08,36.27)] higher than the control group (P <0.05). Conclusions Compared with the simple thoracic chemotherapy, thoracic chemotherapy combined with hyperthermia can improve the short-term curative effect of patients with cancerous pleural effusion, significantly improve the quality of life of patients, and the clinical safety is good, but the long-term efficacy and safety evaluation still need large sample height Quality studies further verify.