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目的系统评价长春瑞滨联合顺铂(vinorelbine combined cisplatin,NP方案)加复方苦参(岩舒)注射液治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的临床疗效及安全性。方法计算机检索中国期刊全文数据库、中文科技期刊全文数据库、中国生物医学文献光盘数据库、万方数据库、PubMed及the Cochrane Library等,辅助手工检索相关期刊杂志,收集岩舒注射液联合NP方案治疗NSCLC的随机对照试验(randomized controlledtrials,RCTs);由两名研究员独立按照纳入排除标准选择RCTs,进行质量评价后提取数据并采用Cochrane系统评价软件RevMan5.0进行Meta分析。结果共纳入10项研究,包括726例晚期NSCLC患者,所有研究均报道采用了随机对照的研究方法,但未详细报道是否采用分配隐藏及双盲。Meta分析结果显示,与单纯NP方案化疗比较,岩舒注射液联合NP方案对晚期NSCLC患者进行治疗,可以提高化疗有效率(RR=1.33,95%CI=1.10~1.59,P<0.01)、改善患者生活质量(RR=1.69,95%CI=1.39~2.05,P<0.01)、减少骨髓抑制的发生(RR=0.08,95%CI=0.72~0.88,P<0.01)、降低胃肠不良反应(RR=0.75,95%CI=0.68~0.84,P<0.01)以及有效缓解癌痛(RR=1.97,95%CI=1.54~2.51,P<0.01)。结论岩舒注射液联合NP方案可以提高NSCLC治疗的有效率、改善患者生活质量、减少骨髓抑制和胃肠反应等化疗造成的不良反应及有效缓解癌痛,更易为晚期NSCLC患者所接受,值得进一步研究及临床推广。但由于纳入研究方法学质量不高,势必影响结果的论证程度,故此结论有待更多高质量及大样本的随机双盲对照试验提供高质量的证据。
Objective To evaluate the clinical efficacy and safety of vinorelbine combined cisplatin (NP) and Fufang Kushen (Yan Shu) injection in the treatment of advanced non-small cell lung cancer (NSCLC). Methods The Chinese Journal Full-text Database, Chinese Science and Technology Periodicals Full Text Database, Chinese Biomedical Literature CD-ROM Database, Wanfang Database, PubMed and the Cochrane Library were searched by computer, and related manuals and journals were searched manually to collect Yan Shu Injection and NP regimen for NSCLC Randomized controlled trials (RCTs) were performed; two researchers independently selected RCTs according to inclusion criteria, and the data were extracted after quality evaluation and analyzed by Meta-analysis using Cochrane systematic review software RevMan5.0. Results A total of 10 studies were included, including 726 patients with advanced NSCLC. All studies reported a randomized, controlled study but did not report in detail whether to use concealment and double blindness. Meta-analysis showed that Yan-shu injection combined with NP regimen could improve the efficiency of chemotherapy (RR = 1.33, 95% CI = 1.10-1.59, P <0.01), improve The quality of life (RR = 1.69, 95% CI = 1.39-2.05, P <0.01) decreased the incidence of myelosuppression (RR = 0.08, 95% CI = 0.72-0.88, P <0.01) RR = 0.75, 95% CI = 0.68-0.84, P <0.01) and effective relief of cancer pain (RR = 1.97,95% CI = 1.54-2.51, P <0.01). Conclusion Yanshu injection combined with NP regimen can improve the efficiency of treatment of NSCLC, improve the quality of life of patients, reduce adverse reactions caused by chemotherapy such as myelosuppression and gastrointestinal reaction and effectively relieve cancer pain, which is more acceptable for patients with advanced NSCLC and worth further Research and clinical promotion. However, due to the low quality of research methodology, it is bound to affect the degree of argument of the results. Therefore, the conclusion needs more high-quality evidence from more high-quality and large-scale randomized double-blind controlled trials.