Background: Compared with chemotherapy, whether aidi injection can improve the patient's quality of life is not definite. The aim of this study is to evaluate the efficacy and safety of axotere plus eisplatin chemotherapy combining aidi injection for patients with non-small cell lung cancer (NSCLC).
Methods: We searched relevant randomized controlled trials (RCTs) from Cochrane library, Pubmed, EMBASE, CancerLit, VIP, CBM and CNKI etc. The search was finished in March 20, 2010. We traced the related references and experts in this field, besides we also communicated with other authors to obtain some certain information that has not been found. RCTs of aidi injection plus TP versus TP for advanced NSCLC were included. We evaluated the quality of these included studies and analyzed data by Cochrane Collaboration's RevMan 5.0 software.
Results: Eleven RCTs involving 800 patients were included. meta analysis results suggested that compared with TP chemotherapy alone, the combination had a statistically significant benefit in healing efficacy (RR=1.2, 95%CI: 1.10-1.47, P=0.001) and improving quality of life (QOL) (RR=1.85, 95%Cl: 1.54-2.21, P < 0.001). Besides, the combination also had a statistically significant benefit in myelosuppression, white blood cell (WBC)(RR=0.71, 95%CI: 0.57-0.87, P=0.001) and hematoblast (RR=0.59, 95%CI: 0.40-0.87, P=0.008) and in reducing the gastroenteric reaction (RR=0.75, 95%CI: 0.58-0.98, P=0.03). But the combination had no statistically significant benefit in prevention of reducing hemoglobin (Hb) (RR=0.97, 95%CI: 0.70-1.34, P=0.85), liver function (RR=0.63, 95%CI: 0.09-1.57, P=0.18), kidney function (RR=0.42, 95%CI: 0.14-1.24, P=0.12), peripheral neuritis (RR=0.86, 95%CI: 0.56-1.32, P=0.50), and baldness (RR=0.92, 95%CI: 0.63-1.34, P=0.66).
Conclusions: Compared with TP chemotherapy alone, the combination can significantly improve the efficiency, QOL and myelosuppression, and reduce adverse events.
背景与目的: 艾迪联合紫杉醇和顺铂（paclitaxel and cisplatin, TP）治疗晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）在临床疗效和安全性方面是否优于单用紫杉醇和顺铂存在着争议。本研究系统评价艾迪联合TP化疗方案治疗晚期NSCLC的临床疗效和安全性。
方法: 计算机检索Cochrane Library、Pubmed、EMBASE、CancerLit、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊全文数据库，检索时间从各数据库建库至2010年3月20日；同时辅助其它检索，纳入艾迪联合TP化疗方案治疗NSCLC的随机对照试验（randomized controlled trials, RCTs）。两名评价者独立评价纳入研究的质量并提取资料，并用RevMan 5.0软件进行统计分析。
结果: 共纳入11篇RCTs，meta分析结果显示：与单纯TP化疗方案相比，艾迪注射液联合TP化疗方案可以改善近期疗效（RR=1.27, 95%CI: 1.10-1.47, P=0.001）、提高生活质量（RR=1.85, 95%CI: 1.54-2.21, P < 0.001）、减少白细胞下降（RR=0.71, 95%CI: 0.57-0.87, P=0.001）和血小板下降（RR=0.59, 95%CI: 0.40-0.87, P=0.008），降低恶心呕吐等胃肠道反应（RR=0.75, 95%CI: 0.58-0.98, P=0.03），而在血红蛋白下降（RR=0.97, 95%CI: 0.70-1.34, P=0.85）、肝功能下降（RR=0.63, 95%CI: 0.09-1.57, P=0.18）、肾功能下降（RR=0.42, 95%CI: 0.14-1.24, P=0.12）、周围神经炎发生情况（RR=0.86, 95%CI: 0.56-1.32, P=0.50）和脱发（RR=0.92, 95%CI: 0.63-1.34, P=0.66）方面的差异无统计学意义。
结论: 艾迪注射液联合TP方案可提高NSCLC治疗的近期疗效和患者生活质量、改善骨髓抑制，并降低化疗所产生的不良反应，值得临床推广使用。