摘要
目的：运用Meta分析的方法评价重组人p53腺病毒（rAd-p53）注射液联合顺铂治疗恶性胸腔积液的疗效及安全性。方法应用Cochrane Library、Pubmed、Embase、中国生物医学文献数据库、中国期刊全文数据库、万方医药期刊全文数据库及维普中文科技期刊全文数据库，全面收集有关 rAd-p53联合顺铂与单药顺铂治疗恶性胸腔积液的随机对照研究（RCT）。用RevMan5.2软件对数据进行 Meta分析。结果本研究共纳入10篇 RCT，总计538例患者。Meta分析结果显示，rAd-p53联合顺铂组与单药顺铂组相比，胸腔积液总缓解率前者高于后者（RR =1.67，95% CI 为0.90～2.01；Z =5.51，P =0.00001）；Kamofsky 评分改善率前者高于后者（ RR =1.76，95% CI 为1.45～2.14；Z =5.69，P 〈0.00001）；发热发生率前者高于后者（RR =3.10，95% CI 为2.25～4.27；Z =6.94，P 〈0.00001）；两组胸痛发生率比较差异无统计学意义（RR =0.99，95% CI =0.5～1.96，Z =0.04，P =0.97）；消化道反应发生率比较差异无统计学意义（RR =1.16，95% CI =0.90～1.50；Z =1.13，P =0.26），骨髓抑制反应发生率比较差异无统计学意义（RR =1.09，95% CI =0.81～1.47；Z =0.59，P =0.55）。结论现有研究表明，rAd-p53联合顺铂治疗恶性胸腔积液的疗效优于单药顺铂，发热均为自限性，安全性好，值得晚期恶性肿瘤伴胸腔积液患者治疗的临床推广。
Objective To assess the efficacy and safety of recombinant human Ad-p53（ rAd-p53） injection combined with cisplatin in treating malignant pleural effusion by conducting a Meta-analysis. Methods A comprehensive collection of randomized controlled studies（RCTs）of rAd-p53 combined with cisplatin versus single cisplatin in the treatment of malignant pleural effusion was retrieved form Cochrane Library,Pubmed, EMBase,CBM,CNKI,Wanfang and VIP databases. Meta-analysis was conducted by RevMan 5. 2 software. Results Ten RCTs involving 538 patients were identified in the study. The Meta-analysis results showed that rAd-p53 combined with cisplatin group had a higher hydrothorax total remission rate than single cisplatin group （RR = 1. 67,95% CI：0. 90-2. 01;Z = 5. 51,P = 0. 000 01）. The PS score in rAd-p53 combined with cisplatin group was better than that in single cisplatin group（RR = 1. 76,95% CI：1. 45-2. 14;Z = 5. 69,P 〈0. 000 01）. The incidence rate of adverse reaction of heating in the former was higher than that in the latter （RR = 3. 10,95% CI：2. 25-4. 27;Z = 6. 94,P 〈 0. 000 01）. There were no significant differences in adverse reactions of chest pain（RR = 0. 99,95% CI：0. 50-1. 96;Z = 0. 04,P = 0. 97）,gastrointestinal reaction （RR = 1. 16,95% CI：0. 90-1. 50;Z = 1. 13,P = 0. 26）and marrow suppression（RR = 1. 09,95% CI：0. 81-1. 47;Z = 0. 59,P = 0. 55）between the two groups. Conclusion rAd-p53 combined with cisplatin therapy for the treatment of malignant pleural effusion is superior to single cisplatin therapy. Mean while,fever is self-limited,and the safety is identified. It is worthy for promotion of rAd-p53 injection combined with cisplatin inclinical treatment of advanced malignant pleural effusion.
出处
《国际肿瘤学杂志》
CAS
2015年第5期336-341,共6页
Journal of International Oncology
基金
国家自然科学基金（81272739）
