| BackgroundGastric cancer is one of the common malignant tumors of the digestive system and a disease that seriously threatens health.Traditional Chinese medicine has certain experience in the prevention and treatment of tumor-related complications and adverse reactions.Mylabris is one of them.It has the effects of removing blood stasis,dispersing accumulated pathogens to reslove the mass,counteracting toxic substances and eroding sores.At present,there are a variety of marketed drugs that are Mylabris extract preparations or contain Mylabris.These are widely used in clinical practice,especially for tumors,mainly including Disodium cantharidinate and vitamin B6 injection,Aidi injection,Fufang Banmao capsules and so on.Whether the preparations containing Mylabris combined with specific chemotherapy regimens for gastric cancer can improve the quality of life and survival of patients,as well as the adverse reactions caused by the toxic Mylabris,the focus of Mylabris of past generations,etc.,all need to be explored.This study is based on Meta-analysis to explore the efficacy and safety of traditional Chinese medicine preparations containing Mylabris compared with chemotherapy only to evaluate the efficacy and safety of gastric cancer,and to provide references for the clinically adjuvant treatment of gastric cancer.In the literature research part,through the induction and comparison methods,the medicinal books of the past dynasties of Mylabris were analyzed,and the evolution of the prescription and compatibility of Mylabris was obtained.Objective1.Meta-analysis was performed to evaluate the efficacy and safety of Mylabris combined with chemotherapy in the treatment of gastric cancer.2.Exploration on the evolution of properties and efficacy of Mylabris in past ages.Methods1.Meta-analysisThrough searching CNKI,Wanfang,VIP,CBM Database,the English database mainly searches Web of Science,Spring,PubMed,Embase,Cochrane,from January 1,2010 to December 31,2020.For Chinese medicine preparations containing Mylabris,combined with specific chemotherapy regimens,collect clinical randomized controlled trials for the treatment of gastric cancer,evaluate the quality of the literature,and extract the general situation,methodological content,intervention content,and outcome content,and use the Review Manager 5.4 software to conduct Meta-analysis2.Literature researchBy searching the Chinese Medical Dictionary and the books in the library of Beijing University of Chinese Medicine,I collected and sorted out some Chinese medical books containing Mylabris.In the literature research part,through the induction and comparison methods,the medicinal books of the past dynasties of Mylabris were analyzed,and the evolution of the prescription and compatibility of Mylabris was obtained.Results1 Clinical evaluation based on Meta-analysis1.1 Literature search resultsArticles that meet the criteria for inclusion and discharge are all published Chinese literature.The publication time is from 2010 to 2020.They are all Chinese patients.There are 15 articles in total,including 12 articles by Aidi Injection,2 articles on Fufangbanmao Capsules and 1 article on Disodium cantharidinate and vitamin B6 injection.According to the chemotherapy regimen,there are 5 articles in the FOLFOX regimen,2 articles in the SOX regimen,3 articles in the XELOX regimen,3 articles in the S-1 regimen and 2 articles in the capecitabine regimen.1.2 The basic characteristics of the included studiesThe name of the first author and the year of publication were defined as the study ID.There were a total of 987 patients in 15 studies,501 in the experimental group and 486 in the control group.There were 609 males and 378 females.1.3 Quality evaluation of included studiesThe Cochrane System Evaluation Manual Version 6.2 was used for quality evaluation.15 studies mentioned randomization,9 studies did not mention specific randomization methods.In terms of allocation concealment,9 studies showed unclear risk,and 6 studies showed high risk.None of the 15 studies mentioned blinding;1 study had incomplete data reports,3 studies existed selectively report research results;Other bias in 15 studies were unclear.1.4 Results of Meta-analysis1.4.1 Objective response and control of the diseaseIn terms of disease objective response rate,6 studies were evaluated based on RECIST and tested for heterogeneity.P=-0.74,I2=0%,using a fixed-effect model.Meta-analysis showed that response of the experimental group was higher than that of the control group,which was statistically significant(RR 1.56 95%CI 1.22 to 1.99,P=0.0004).7 studies were evaluated according to the WHO criteria and tested for heterogeneity,P=0.30,I2=17%,using a fixed-effect model.Meta-analysis showed that response of the experimental group was higher than that of the control group,which was statistically significant(RR 1.24,95%CI 1.03 to 1.49,P=0.02).In terms of disease control rate,6 studies were evaluated for efficacy based on RECIST and tested for heterogeneity,P=0.30,I2=17%,using a fixed-effect model,Meta-analysis showed that disease control of the experimental group was higher than that of the control group,which was statistically significant(RR 1.17,95%CI 1.05 to 1.31,P--0.005).7 studies were evaluated based on the WHO criteria and tested for heterogeneity,P=0.29,I2=18%,using a fixed-effect model.Meta-analysis showed that there was no significant difference in disease control rate between the experimental group and the control group.(RR 1.06,95%CI 0.98 to 1.14,P=0.14).1.4.2 Survival SituationTwo studies reported the 2-year survival rate,tested for heterogeneity,P=0.97,I2=0%,using a fixed-effect model,Meta analysis showed that there was no significant difference in 2-year survival rate between the experimental group and the control group.1.4.3 Quality of lifeA total of 6 studies were included in the study,reporting the quality of life of the patients.2 studies used KPS for quality of life scores,and 4 studies used KPS before and after treatment to increase by more than 10 points for improvement.KPS were tested for heterogeneity,P=0.73,I2=0%,using fixed-effects model,Meta-analysis showed that the KPSscore of the experimental group was higher than that of the control group,which was statistically significant(MD 5.85,95%CI 4.21 to 7.49,P<0.00001).KPS improvement,heterogeneity test was conducted,P=0.93,I2=0%.Fixed effect model was used.Meta-analysis showed that KPS improvement in the experimental group was higher than that in the control group,which was statistically significant(RR 2.51,95%CI 1.80 to 3.51,P<0.00001).1.4.4 Clinical side effectsLeucocyte reduction was tested for heterogeneity,P=0.007,I2=62%,using a random effect model,Meta-analysis showed that the reduction of leucocyte in the experimental group was lower than that in the control group,which was statistically significant(RR 0.52,95%CI 0.38 to 0.70,P<0.0001).Platelet reduction was tested for heterogeneity,P=0.57,I2=0%,using a fixed-effect model,Meta-analysis showed that platelet reduction in the experimental group was lower than that of the control group,which was statistically significant(RR 0.54,95%CI 0.41 to 0.70,P<0.00001).The hemoglobin decreased,and the heterogeneity test was performed,P=0.14,I2=45%,using a fixed-effect model,Meta-analysis showed that the hemoglobin decreased in the experimental group was lower than that in the control group,which was statistically significant(RR 0.69,95%CI 0.51 to 0.94,P=0.02).Nausea and vomiting were tested for heterogeneity,P=0.02,I2=60%,using a random effect model,Meta-analysis showed that the experimental group was lower than that of the control group,which was statistically significant(RR 0.69,95%CI 0.55 to 0.86,P=0.001).Hepatic function damage was tested for heterogeneity,P=0.96,I2=0%,using a fixed-effect model,Meta-analysis showed that liver function damage in the experimental group was lower than that in the control group,which was statistically significant(RR 0.32,95%CI 0.18 to 0.58,P=0.0001).Conclusions1.Compared with chemotherapy only,the preparation containing Mylabris combined with specific chemotherapy regimens can improve the objective remission rate of gastric cancer patients,improve quality of life,and reduce the occurrence of adverse reactions.However,the 2-year survival rate and disease control rate did not significantly improve.This may be related to the low quality of the included literature,which needs further study.2.In terms of literature research,it is believed that Mylabris is pungent,salty,and hot,belongs to the liver,kidney,stomach,and large and small intestine meridians.The effect is on the basis of eliminating blood stasis,dispelling stagnation,eliminating symptoms,and fighting poison and sore,and increase access to water channels.Mylabris has serious toxicity,and it is necessary to combine specific conditions in clinical practice,treat syndromes based on syndrome differentiation,and use drugs with caution. |
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