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Compound Kushen injection plus platinum-based chemotherapy for stage IIIB/IV non-small cell lung cancer: A protocol for meta-analysis of randomized clinical trials following the PRISMA guidelines

机译:复方禁毒注射加上铂类化学疗法IIIB / IV非小细胞肺癌:普遍指南后随机临床试验的荟萃分析的方案

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Background: Compound Kushen injection (CKI) is a commonly used anti-tumor Chinese patent medicine, which is extracted from Kushen ( Radix Sophorae Flavescentis) and Baituling ( Rhizoma Smilacis Glabrae) and has been widely prescribed as an add-on therapy to platinum-based chemotherapy (PBC) for advanced non-small cell lung cancer (NSCLC). However, the efficacy and safety of this combination therapy remain controversial. Methods and analysis: A systematic review and meta-analysis will be performed following the PRISMA (Preferred Reported Items for Systematic Review and Meta-analysis ) guidelines. All randomized controlled trials (RCTs) comparing CKI in combination with PBC versus PBC alone will be retrieved and assessed for inclusion. Analyses will be performed using Review Manager 5.3, Comprehensive Meta-Analysis 3.0 and Trial Sequential Analysis software. The disease control rate (DCR) will be defined as the primary outcome, and the objective response rate (ORR), quality of life (QOL), survival rate, and toxicities will be the secondary outcomes. Results: This study will systematically evaluate the efficacy and safety of Compound Kushen injection combined with platinum-based chemotherapy in the treatment of stage III/IV NSCLC. The results of this study will be published in a peer-reviewed journal. Conclusions: This systematic review and meta-analysis of eligible randomized controlled trials will evaluate the effects of Compound Kushen injection as adjunctive therapy to platinum-based chemotherapy in patients with stage III/IV non-small cell lung cancer, thus providing evidence to the clinical use of this combination therapy for the specific subsets of patients.
机译:背景:复合武仁注射(CKI)是一种常用的抗肿瘤中药专利药物,其从武申(Radix Sophorae Flavescentis)和Baituling(Rhizoma Smilacis Glabrae)中提取,并且已被广泛被规定为铂 - 铂 - 基于化疗(PBC)用于高级非小细胞肺癌(NSCLC)。然而,这种联合治疗的疗效和安全性仍然存在争议。方法和分析:将在Prisma(首选报告的系统审查项目和Meta-Analysis)指南之后进行系统审查和荟萃分析。将CKI与PBC与PBC组合的所有随机对照试验(RCT)进行评估并评估夹杂物。分析将使用Review Manager 5.3,全面的Meta-Analysis 3.0和试用顺序分析软件进行。疾病控制率(DCR)将被定义为主要结果,目标反应率(ORR),寿命质量(QOL),生存率和毒性将是二次结果。结果:本研究将系统地评估复合武仁注射液联合铂类化疗治疗III / IV NSCLC的疗效和安全性。本研究的结果将在同行评审日期刊上发表。结论:这种系统审查和符合条件随机对照试验的荟萃分析将评估复合禁止注射作为临床III / IV非小细胞肺癌患者铂化疗的辅助治疗的影响,从而向临床提供证据使用这种组合治疗对患者的特定子集。

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