| Background: Cancer is a major public health problem and has emerged as a leading cause of death globally.Research on cancer treatment has never stopped.Clinical research has paid increasing attention to quality of life(QoL)in recent years,but the assessment of QoL is difficult,hampered by the subjectivity,complexity,and adherence of patients and physicians.According to previous studies,QoL in cancer patients is related to performance status(PS)and influenced by chemotherapy-related toxicity.Aidi injection is an anti-cancer traditional Chinese medicine injection mainly composed of ginseng,cantharidin,Astragalus membranaceus and acanthopanax senticosus.It has the effect of clearing away heat and detoxification,eliminating blood stasis and dispersing blood stasis.In clinical,Aidi injection is mainly used as adjuvant medicine to treat lung cancer,liver cancer and breast cancer,and is used to enhance the curative effect of chemotherapy.The purpose of this study was to investigate whether Aidi injection could improve the quality of life by improving PS and reducing the toxicity of chemotherapy.Methods: A population-based retrospective cohort study was conducted in the First Affiliated Hospital of Anhui Medical University.Retrieval of hospitalization information of cancer patients diagnosed from January 2014 to January 2018 from Electronic Medical Record(EMR): name,sex,age,height,weight,tumor type,stage,lymphatic metastasis,distant metastasis,chemotherapy history,radiotherapy history,baseline ECOG score,combined diseases,chemotherapy regimen and chemotherapy cycle,clinical examination Information: CR,creatinine,glomerular filtration rate(GFR),alanine aminotransferase(ALT),aspartate aminotransferase(AST),white blood count(WBC),platelet count(PC)and neutrophil count(NC)? After the exclusion criteria were screened out,the patients were matched by 1:1 propensity score match.According to the treatment methods adopted,the patients were divided into two groups,Aidi injection combined with chemotherapy group(exposure group)and patients only receiving chemotherapy(control group).The information of chemotherapy patients was recorded and the database was established.The association rule model was established by Apriori algorithm to understand the combined medication information of the two groups.In addition,the differences of PS and chemotherapy-related toxicity between the two groups were compared.Finally,the exposed patients were further divided into routine dose group(50-100ml)and low dose group(20-50ml),to explore the effect of different doses of Aidi injection on QoL of patients.Results: Firstly,5 072 cancer patients were enrolled in this study.After screening by inclusion exclusion criteria and 1:1 propensity score matching,3200 cancer patients were enrolled in the study,including 1 600 in the exposed group and 1 600 in the control group.After propensity score matching,the baseline data of the two groups reached a balance,and the standard mean difference(SMD)was controlled within 10%.It can be considered that the matching was successful.In addition,we found that there was no significant difference in the number of users of other drugs in the associationrule model of combined medication information.The incidence rate of liver function damage,kidney function damage,nausea,vomiting and diarrhea in the exposed group was significantly lower than that in the control group.Aidi injection can significantly reduce the incidence of leucopenia,neutropenia and thrombocytopenia caused by cancer chemotherapy.In terms of the number of PS improvements,the exposure group showed obvious advantages(137 vs 48,P < 0.01).After adjusting the covariates affecting PS(sex,age,height,weight,type of tumor,stage of tumor,lymphatic metastasis,distant metastasis,chemotherapy history,radiotherapy history,baseline ECOG score,combined diseases,chemotherapy regimen,chemotherapy cycle and combined use of other traditional Chinese medicines)by logistic regression model,Aidi injection combined with chemotherapy has significant benefits in improving PS in cancer patients [P < 0.001,Odds ratio(OR)3.4,95% confidence interval(CI)2.4-4.8] than the control group.In stratified analysis,the improvement rate of PS in most subgroups except hepatocellular carcinoma group,hypertension group,renal insufficiency group,hepatic insufficiency group and diabetes mellitus group was significantly higher than that in the control group.At the same time,we found that the conventional dose of Aidi injection(50-100ml)has obvious advantages in improving the PS improvement rate and reducing the toxicity of chemotherapy compared with the low dose group(20-50ml)and the control group.Conclusion: This retrospective cohort study showed that Aidi injection as adjuvant to chemotherapy might improve the QoL in cancer patients by improving PS and reducing incident rate of chemotherapy-related toxicity.In addition,because of excellent effect of Aidi injection on patients with different types of cancer,it should be recommended to apply in clinical work. |
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