复方苦参注射液联合FOLFOX4化疗方案治疗结直肠癌Meta分析和试验序贯分析

Meta-Analysis and Trial Sequential Analysis of Compound Kushen Injection Combined withFOLFOX4 Chemotherapy Regimen in the Treatment of Colorectal Cancer

目的:系统评价复方苦参注射液(CKI)联合FOLFOX4化疗方案治疗结直肠癌的有效性和安全性。方法:检索公开发表的CKI联合FOLFOX4化疗方案治疗结直肠癌的临床试验,时间范围为建库至2022年11月,对符合纳入标准的文献进行Meta分析及试验序贯分析(TSA)。结果:Meta分析显示,在疗效终点上,相较于FOLFOX4,CKI联合FOLFOX4能有效提高结直肠癌的临床总有效率[RR=1.32,95%CI=(1.18,1.47),P<0.00001],提高CD3^(+)[MD=8.03,95%CI=(6.00,10.7),P<0.00001]、CD4^(+)[MD=12.82,95%CI=(9.40,16.24),P<0.00001]和NK细胞水平[MD=4.35,95%CI=(3.65,5.04),P<0.00001],降低CD8^(+)T淋巴细胞[MD=-5.15,95%CI=(-8.46,-1.84),P=0.002],改善CD4^(+)/CD8^(+)比值水平[MD=0.44,95%CI=(0.10,0.79),P=0.01]。在安全性终点上,CKI联合FOLFOX4能减少胃肠道不良事件、血小板死亡、白细胞死亡和减轻神经系统损害。TSA显示,当前信息量观察到的临床总有效率结果具有结论性。Harbord检验显示,不存在显著的发表偏倚(P=0.204)。结论:CKI联合FOLFOX4化疗方案治疗结直肠癌的有效性和安全性均优于单用FOLFOX4化疗方案,具有一定临床应用价值。

Objective:To evaluate the efficacy and safety of compound Kushen injection(CKI)combined with FOLFOX4 chemotherapy in the treatment of colorectal cancer.Methods:To search the published clinical trials of CKI combined with FOLFOX4 chemotherapy regimen in the treatment of colorectal cancer.The time range is from the establishment of the database to November 2022.Meta-analysis and trial sequential analysis(TSA)were conducted on the collected studies.Results:Meta-analysis showed that compared with FOLFOX4,CKI combined with FOLFOX4 could effectively increase the total clinical effective rate of colorectal cancer[RR=1.32,95%CI=(1.18,1.47),P<0.00001],and CD3^(+)[MD=8.03,95%CI=(6.00,10.7),P<0.00001],CD4^(+)[MD=12.82,95%CI=(9.40,16.24),P<0.00001]and NK cell levels[MD=4.35,95%CI=(3.65,5.04),P<0.00001],decreased CD8^(+)T lymphocytes[MD=-5.15,95%CI=(-8.46,-1.84),P=0.002],regulating CD4^(+)/CD8^(+)ratio levels[MD=0.44,95%CI=(0.10,0.79),P=0.01].At the end point of safety,CKI combined with FOLFOX4 can reduce gastrointestinal adverse events,platelet death,leukocyte death and reduce nervous system damage.TSA shows that the clinical total effective rate observed by the current information amount is conclusive.Harbord test showed that there was no significant publication bias(P=0.204).Conclusion:The efficacy and safety of CKI combine with FOLFOX4 chemotherapy in the treatment of colorectal cancer are bet than that of FOLFOX4 chemotherapy alone,which has certain clinical application value and is worthy of promotion.The efficacy and safety of CKI combined with FOLFOX4 chemotherapy in the treatment of colorectal cancer are superior to those of FOLFOX4 chemotherapy alone,which has certain clinical application value.