| Objective:This study aims to systematically evaluate the efficacy and safety of Kang'ai injection combined with chemotherapy in the treatment of advanced NSCLC,and to observe the efficacy,adverse events,the influence on CEA and traditional Chinese medicine syndromes in the treatment of patients with advanced lung adenocarcinoma of lung-spleen qi deficiency type.This study is expected to provide evidence-based support for the application of Kang'ai injection in the clinical treatment of advanced NSCLC,and at the same time to strengthen the understanding of its application value through clinical research.Methods:RCTs of Kang'ai injection combined with chemotherapy for advanced NSCLC were collected by searching the Chinese databases Wan Fang Data,CNKI,VIP and Sinomed,and the English databases Embase,Pub Med and Cochrane.Two researchers independently screened the retrieved literature and extracted relevant data.Then,the risk of bias in the included literature was assessed.Meta-analysis was performed using Rev Man 5.3 software and STATA15.1 software.91 patients with advanced lung adenocarcinoma of lung-spleen qi deficiency type from the former Wuhan General Hospital of the PLA were collected and divided into the treatment group and control group.The treatment group was treated with Kang'ai injection combined with chemotherapy,the control group was treated with chemotherapy alone.Chemotherapy used the PP regimen(cisplatin/carboplatin+pemetrexed),with a cycle of 21 days.Patients received a total of 2-6 cycles of treatment.The short-term therapeutic effects were evaluated,the occurrence of adverse reactions were recorded,serum CEA levels before and after treatment were detected by chemiluminescence method,and the improvement of traditional Chinese medicine syndromes were observed.Results:A total of 16 RCTs and 1525 patients were included in the Meta-analysis.The results showed that compared with chemotherapy alone,Kang'ai injection combined with chemotherapy could improve the short-term efficacy of patients with advanced NSCLC,including ORR [RR=1.32,95% CI(1.16,1.50),P<0.0001] and DCR [RR=1.19,95%CI(1.12,1.26),P < 0.0001].The combined therapy also could decrease the rate of myelosuppression [RR=0.66,95% CI(0.66,0.87),P<0.0001],gastrointestinal reactions [RR=0.62,95% CI(0.53,0.74),P<0.00001] and alopecia [RR=0.63,95% CI(0.49,0.81),P=0.0003],and improve the functional status [RR =1.50,95% CI(1.27,1.77),P<0.00001].However,there was no statistic difference in abnormal liver function [RR=0.56,95% CI(0.26,1.19),P=0.13] and abnormal renal function [RR=0.60,95% CI(0.30,1.22),P=0.16]between the two groups.And Kang'ai injection combined with chemotherapy could increase the percentage of CD3+T cells [MD=17.64,95% CI(9.23,26.06),P<0.0001],the percentage of CD4+T cells[MD=8.67,95% CI(6.21,11.12),P<0.00001] and the percentage of CD4+/CD8+T cells [MD=0.43,95% CI(0.13,0.72),P=0.004],and reduce the percentage of CD8+T cells [MD=-5.88,95% CI(-10.04,-1.72),P=0.006].Kang'ai injection combined with PP chemotherapy for patients with advanced lung adenocarcinoma of lung-spleen qi deficiency type was more effective than the control group,but there was no statistical difference between ORR(42.86% Vs.30.95%,P>0.05)and DCR(85.71% Vs.83.33%,P>0.05).Compared with the control group,the incidence of bone marrow suppression(33.3% Vs.59.5%,P=0.006)and the incidence of nausea and vomiting(28.6% Vs.47.6%,P=0.046)were significantly reduced in treatment group,and there were statistical differences between the two groups.CEA in both groups decreased after treatment compared with before treatment,but there was no statistical difference between the two groups(P>0.05);the total effective rate of improvement of traditional Chinese medicine syndromes in the treatment group was significantly better than that in the control group(97.62% Vs.73.80%,P=0.000),of which the shortness of breath,fatigue,and anorexia were improved in the treatment group than in the control group(P<0.05),but there was no difference in the improvement of cough,sputum,hemoptysis and chest tightness(P>0.05).Conclusion:Kang'ai injection combined with chemotherapy for advanced NSCLC can significantly reduce the adverse effects of chemotherapy,including bone marrow suppression,nausea,vomiting and alopecia,without affecting the short-term efficacy of chemotherapy.The combined therapy can improve the functional status of patients,enhance immune function of patients,and significantly improve the traditional Chinese medicine syndromes of patients with advanced lung adenocarcinoma of spleen-lung qi deficiency type.Therefore,the combination of Chinese and Western medicine in chemotherapy is superior to Western medicine alone.Kang'ai injection combined with chemotherapy for advanced NSCLC is worthy of further clinical promotion. |
PDF Full Text Request