尼妥珠联合放化疗治疗非小细胞肺癌的疗效和安全性的Meta分析

A Meta Analysis of the Efficacy and Safety of Nimotuzumab Combined with Radiotherapy or Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

摘要: 目的：系统评价尼妥珠联合放化疗对比单纯放化疗治疗非小细胞肺癌的疗效及安全性。方法：计算机检索中国期刊全文数据库(CNKI)、万方数据库、维普全文数据库(VIP)、PubMed、Medline、EMBase中关于尼妥珠联合放化疗对比单纯放化疗治疗非小细胞肺癌的随机对照试验(RCT)，检索时限均从建库至2023年6月。由2名研究者按照纳入排除标准独立筛选文献、提取资料和质量评价后，采用RevMan5.4软件进行Meta分析。主要结局指标包括疾病控制率、客观缓解率、骨髓抑制、腹泻、皮疹、肝肾损伤，使用固定效应模型或随机效应模型计算具有95%置信区间的风险比。结果：纳入9个RCT，共838例患者。Meta分析结果显示，与单纯放化疗治疗非小细胞肺癌相比，尼妥珠联合放化疗可以提高非小细胞肺癌患者的疾病控制率[RR = 1.11, 95% CI (1.02, 1.20), P = 0.01]和客观缓解率[RR = 1.30, 95% CI (1.14, 1.49), P = 0.0001]，在安全性方面，两组骨髓抑制、腹泻、皮疹、肝肾功能损伤，差异均无统计学意义(均P > 0.05)。结论：尼妥珠联合放化疗对非小细胞肺癌的治疗具有一定的优越性，可显著提高疾病控制率、客观缓解率，具有良好的安全性。由于纳入研究的质量和数量有限，降低了本系统评价的证据强度，故本系统评价的结论仅供临床实践和研究参考。

Abstract: Objective: To systematically evaluate the efficacy and safety of nimotuzumab combined with radio-therapy and chemotherapy compared to radiotherapy and chemotherapy alone in the treatment of non-small cell lung cancer. Methods: CNKI, Wanfang Database, VIP Database, PubMed, Medline and EMBase were searched by computer to collect randomized controlled studies on the comparing nimotuzumab combined with radiotherapy or chemotherapy to radiotherapy or chemotherapy alone in the treatment of non-small cell lung cancer. The search period was from the establishment of the databases to June 2023. Two researchers independently screened literature, extracted data, and evaluated quality based on inclusion and exclusion criteria, and conducted meta-analysis using RevMan5.4 software. The main outcome measures include disease control rate, objective response rate, bone marrow suppression, diarrhea, rash, liver and kidney injury, and the risk ratio with a 95% confidence interval was calculated using fixed or random effects models. Result: Nine RCTs were in-cluded, with a total of 838 patients. The meta-analysis results showed that compared with simple radiotherapy or chemotherapy for non-small cell lung cancer, the combination of nimotuzumab and radiotherapy or chemotherapy can improve the disease control rate [RR = 1.11, 95% CI (1.02, 1.20), P = 0.01] and objective response rate [RR = 1.30,95% CI (1.14, 1.49), P = 0.0001] in non-small cell lung cancer patients. In terms of safety, there was no statistically significant difference between the two groups in terms of bone marrow suppression, diarrhea, rash, and liver and kidney function damage (both P > 0.05). Conclusion: Nimotuzumab combined with radiotherapy or chemotherapy has certain advantages in the treatment of non-small cell lung cancer, which can significantly im-prove the disease control rate, objective response rate, and has good safety. Due to the limited qual-ity and quantity of included studies, the evidence strength of this system evaluation has been re-duced. Therefore, the conclusions of this system evaluation are only for clinical practice and re-search reference.