力尔凡联合铂类药物胸腔内置管灌注化疗治疗恶性胸水的Meta分析

Meta Analysis of Lifein Combined with Cisplatin in Chest Catheterization Perfusion Chemotheapy for Malignant Pleural Effusion

目的:评价力尔凡联合铂类与单纯铂类药物胸腔内置管化疗治疗恶性胸腔积液的疗效和安全性。方法:计算机检索万方、CNKI、维普、Cochrane图书馆等电子资料库,查找应用力尔凡联合铂类药物与单纯铂类药物比较治疗恶性胸水的随机对照研究。对符合条件的随机对照试验(RCT),由两位研究者独立进行资料提取和质量评价后,采用RevMan 5.1软件进行Meta分析,并采用GRADE系统对证据质量和等级推荐进行分级。结果:共纳入15个RCT,合计799例满足条件的恶性胸水患者。Meta分析结果显示:与单纯铂类药物化疗相比,力尔凡联合铂类化疗能提高总有效率(CR+PR)[RR=1.43,95%CI(1.30,1.58),P<0.000 01]、Krnofsky生活质量评分改善率[RR=1.88,95%CI(1.52,2.33),P=0.000 01]和增加发热发生率[RR=4.45,95%CI(1.78,11.13),P=0.001];但能降低白细胞减少风险[RR=0.46,95%CI(0.34,0.61),P<0.000 01]、胸痛发生风险[RR=0.66,95%CI(0.45,0.95),P=0.02]及胃肠道反应发生风险[RR=0.45,95%CI(0.26,0.80),P=0.006]。GRADE系统评价结果显示,证据水平均为C级,推荐等级为弱推荐。结论:目前的临床实验结果表明,力尔凡联合铂类药物化疗治疗恶性胸腔积液疗效确切,不仅能显著提高生存质量,而且可有效降低毒副反应。鉴于系统评价为二次研究,受纳入分析的原始文献质量影响较大,且评价过程可能存在偏倚等局限性,上述结论尚需开展大规模、高质量的基础和临床研究进一步论证。

Objective： To evaluate the efficacy and safety of lifein combined with Cisplatin vs Cisplatin alone in chest catheterization perfusion chemotheapy for malignant pleural effusion. Methods： Randomized controlled trials （RCTs） on lifein combined with Cisplatin chest catheterization per- fusion chemotherapy for malignant pleural effusion were searched in the electronic data of Chi- nalnfo, Cochrane library, CNKI, MEDLINE, and VIP. The quality of RCTs meeting inclusion criteria was evaluated and the data were extracted by two independent researchers; meta-analyses were performed with ReMan 5.1 software, and then the GRADE system was used to rate the lev- el of evidence and strength of recommendation. Results： Fifteen studies involving 799 patients met the inclusion criteria of malignant pleural effusion cases. The results of meta-analysesshowed that, as compared with the Cisplatin alone, lifein combined with Cisplatin could increase total effective rate （CR＋PR） （RR=I. 43, 95%CI1-1.30,1. 587, P%0. 000 01）, the Karnofsky quality of life score improved rate （RR=I. 88,95%CI[-1.52,2. 331, 〈0. 000 01） and the inci- dence risk of fever, but decrease the incidence risk of leucopenia （RR = 0.46, 950/00 CI EO. 34, 0.61）, P%0. 000 1）, incidence risk of chest pain （RR=0.66, 95%CI[-0.45,0. 951, P=0.02）, and the incidence risk of gastrointestinal reaction （RR=0.06, 95 %CIEO. 26,0. 801, P= 0. 006）. Based on GRADE, the level of evidence was Grade C, and the strength of recommendation was weak. Conclusion： The present result of clinical trials show that Lifein combined with Cisplatin chemotherapy for malignant pleural effusion is effective, and it could significantly improve the quality of life, meanwhile, decrease the toxic reaction. Based on GRADE, the level of evidence was Grade C. In view of the secondary research which was greatly influenced by the original liter ature quality, there may be limitations of bias in the evaluation process, so it is suggested that large scale and high quality basic and clinical studies should be performed to verify the above con- clusion by critical outcome indicators.