摘要
目的:评价中药联合吉非替尼治疗中晚期非小细胞肺癌(NSCLC)的临床疗效和安全性。方法:检索中国知网数据库、中国生物医学文献数据库、维普全文期刊数据库、万方数据库,纳入中药联合吉非替尼或与单用吉非替尼治疗的随机对照试验为研究对象,根据Cochrane协作网质量评价标准提取资料,采用Renman 5.0软件进行资料分析,结局的效应指标,为疾病控制率、生存质量、皮疹、腹泻、肝功能损害和恶心呕吐等毒副反应。结果:最终纳入20个RCTs共1235患者,中药联合吉非替尼组624例,吉非替尼组611例。20项试验显示中药联合吉非替尼组疾病控制率、9项试验显示生活质量改善、10项试验显示皮疹发生、8项试验显示腹泻出现均好于吉非替尼对照组(P<0.01);5项试验显示中药联合吉非替尼组肝功能损害、4项试验显示恶心呕吐出现与吉非替尼对照组无明显差异(P>0.05)。进行敏感性分析,结果稳定。漏斗图显示对称,提示纳入评价的文献不存在发表性偏倚。结论:中药联合吉非替尼治疗中晚期NSCLC较单纯吉非替尼治疗显示出疗效更优的趋势,可提高疾病控制率、改善生存质量,并能减少皮疹、腹泻不良反应,但对于肝功能损害和恶心呕吐改善不明显。由于本系统评价纳入研究的方法学质量较低,尚需开展更多设计合理、执行严格的多中心大样本且随访时间足够长的随机对照试验验证其疗效及安全性。
Objective： To evaluate the efficacy and safety of traditional Chinese medicine（ TCM） combined with gefitinib on treating non- small cell lung cancer. Methods： The randomized controlled trials（ RCTs） of integrative medicine combined with gefitinib and gefitinib alone were searched in China National Knowledge Internet,Chinese Biomedical Literature Database,Vl P database and Wanfang database. The Cochrane Handbook Scale was used to extract the data. The Rev Man5. 0 Software was used to analyze the data. The outcome was evaluated according to disease control rates,quality of life,adverse reactions such as skin rash,diarrhea,liver function damage and nausea and vomiting. Results： A total of 20 RCTs were included,1235 cases of NSCLC in which 624 cases in TCM combined with gefitinib,and 611 cases in gefitinib control group included. The disease control rates in 20 RCTs,quality of life in 9 RCTs,skin rash in 10 RCTs,diarrhea in8 RCTs were significantly higher than those in gefitinib alone control group（ P〈 0. 01）. The function damage and nausea and vomiting were not obvious（ P〈 0. 05）. Sensitivity analysis showed the result was stable. Funnel plot was symmetric,indicating publication was not bias. Conclusion： The efficacy of TCM combined with gefitinib for NSCLC is superior to gefitinib alone in enhancing disease control rates,improving quality of life and fewer adverse reactions such as skin rash,diarrhea. But it is not obvious in liver function damage and nausea and vomiting. As the quality of studies is low,more rigorously designed,large sample and multi- center trials are needed.
出处
《中华中医药学刊》
CAS
北大核心
2015年第3期700-704,共5页
Chinese Archives of Traditional Chinese Medicine
基金
宁波市医学科技计划项目(2013A20)
关键词
中西医结合
非小细胞肺癌
吉非替尼
随机对照试验
Meta分析
combination of Chinese traditional and Western medicine
non-small cell lung cancer
gefitinib
randomized controlled trials
Meta-analysis
