Meta-analysis Of Yiqi Yangyin Chinese Medicine Injection Combined With GP Regimen In The Treatment Of Advanced Non-small Cell Lung Cancer

[Background]Lung cancer has become the most malignant tumor having the highest death rate in China and the whole world.In our country,about 733,000 new cases of Lung cancer were diagnosed during 2013,and the number of fatal cases reached 591,000.The latest data of cancer statistics of urban China in 2017 showed that nearly 10,000 people are diagnosed with cancer every day,Lung cancer is still the leading cause of cancer death with highest incidence in our country.Non-Small Cell Lung Cancer(NSCLC)occupies about 80%-85%of Lung cancer cases.75%patients with NSCLC are diagnosed at advanced stage,the five-year survival rate is low.At present,chemotherapy,radiotherapy,molecular targeted therapy are major means in comprehensive therapy for advanced NSCLC.A large number of clinical studies indicate that traditional Chinese medicine(TCM)can inhibit tumor growth,modulate immune responses,improve symptoms caused by chemotherapy or radiotherapy.Traditional Chinese Medicine Injection is based on integration of Chinese medicine theory and modern technique,it is characterized by convenience,rapid treatment effect and widely used in clinic.Besides,how to consummate productive management system and ensure the safety in drug use is a matter of great concern.Considering physiology of lung in TCM concepts and susceptible group to Lung cancer,people grows older with deficiency of both Qi and Yin,cancerous toxin exploits Qi,blood and body fluid to strengthen itself.Furthermore,operation,chemotherapy and radiotherapy may damage vital Qi.Although there is still no standard evaluation method for TCM syndrome differentiation of Lung cancer at present,many studies have reported that patients with deficiency of both Qi and Yin syndrome is the main TCM syndrome of advanced NSCLC,[Objective]Select TCM injections for supplementing Qi and nourishing Yin according to the Chinese Pharmacopoeia or other authoritative standards,and conducted a meta-analysis of studies on the chosen injections combined with GP chemotherapy for advanced NSCLC,to evaluate the efficacy and safety of TCM injections for supplementing Qi and nourishing Yin used for advanced NSCLC.[Methods]Searched the Wan Fang Data,VIP,SinoMed,CNKI,PubMed,the Cochrane Library and Embase on computer and retrieve from inception to July 1,2017.The Cochrane Risk of Bias tool was used to assess the quality of the included randomized controlled trials.Revman 5.3 software was used for date synthesis and analysis.[Results]28 randomized controlled trials(n=2119)were included.Comparing TCM injections for supplementing Qi and nourishing Yin plus GP chemotherapy with pure GP chemotherapy in the short-term effective rate,the evaluation criteria for both WHO and RECIST were increased(RR =1.35,95%CI 1.18 to 1.54,P<0.00001),(RR =1.35,95%CI 1.12 to 1.63,P=0.002),the experimental group was 1.35 times high as that of control group in response rate of the quality of life(RR =1.35,95%CI 1.25 to 1.46,P<0.00001),TCM injections also can reduce the side effects of chemotherapy,such as reduce the occurrence of WBC decrease(RR =0.60,95%CI 0.53 to 0.68,P<0.00001),platelet decrease(RR =0.72,95%CI 0.63 to 0.82,P<0.00001)or nausea and vomiting(RR =0.75,95%CI 0.68 to 0.82,P<0.00001).Furthermore,it can improve the immunity of human body by means of increasing peripheral blood levels of CD3+[MD=8.74,95%CI(5.83,11.65),P<0.00001],CD4+[MD =5.41,95%CI(1.73,9.09),P=0.004]、CD4+/CD8+[MD = 0.46,95%CI(0.21,0.71),P=0.0003].[Conclusion]1.TCM injections for supplementing Qi and nourishing Yin can increase objective efficacy,improve life quality,decrease side reactions induced by chemotherapy,maybe have a positive impact on the immune function,but most of the included studies had poor quality,the evidence was weak,so higher-level RCTs are required to further confirm this conclusion in future.2.Although there have been reports of the exsisting potential safety problems in using TCM injections,as Chinese original technology,they have obvious advantages in clinic use,We should consummate productive management system and security evaluation system,improve its quality,standardize the use of TCM injections,and use the TCM theory of syndrome differentiation as guidance,so that more tumor patients can benefit from this treatment.