| Part oneObjective and SignificanceAcute mastitis is an acute purulent infectious disease.The non-abscess period of acute mastitis is a critical period for the treatment.Antibiotics is the mainly medicine.Ho wever,overuse antibiotics can lead to antibiotic resistance and destruction of bacterial diversity,the research about new treatments has become a hot topic.It is found that t raditional Chinese medicine has a good effect in the treatment of non-abscess acute m astitis.Dandelion Granules are widely used in the clinical treatment of non-abscess ac ute mastitis.However,there is a lack of high-quality clinical research to observe its e fficacy.Therefore,this study aims to carry out a randomized controlled clinical study of Dandelion Granules in the treatment of non-abscess acute mastitis,and to provide objective data support for reducing the application of antibiotics in the treatment of no n-abscess acute mastitis in Chinese medicine.MethodsThe study was conducted in Beijing University of chinese medicine third affiliated hos pital and Maternal and Child Health Hospital of Tongzhou District,Beijing.A total of 306 patients with non-abscess acute mastitis were enrolled.The subjects were random ly divided into 3 groups at a ratio of 1:1:1,Dandelion Granules group(PGY group),Cefdinir group(TB group),and Dandelion Granule combined with Cefdinir group(LH group).The treatment period is 3 days.After the treatment,the telephone follow-up will be conducted on the 3rd day.A comprehensive evaluation was included the aspec ts of body temperature,breast pain,blood routine index,breast mass area,number of abscesses,TCM syndromes,and security.This clinical study is supported by the Cap ital Health Development Research Special Project,has passed the review of the Resear ch Ethics Committee of the Third Affiliated Hospital of Beijing University of Traditio nal Chinese Medicine(ethics review batch number:BZYSY-SFKTPJ-1),and is on the clinical trial website of the National Institutes of Health(www.clinicaltrials.gov)to re gister,the registration number is NCT03756324.ResultsThe results showed that the number of hours of antipyretics in the PGY group was less than that of the TB group(P=0.046),suggesting that there may be differences in the number of hours of antipyretics between the PGY group and the TB group.The number of people with fever in the three groups was compared every 4 hours.The results showed that although the number of people with fever in the PGY group was significantly more than that in the TB group within 8 hours(P<0.05),but there was no significant difference between the LH group and the TB group.The body temperature was analyzed every 4 hours after taking the medicine,and the results showed that the body temperature of the three groups changed significantly with time,and the difference in body temperature between the groups was not statistically significant(P>0.05).There was no statistically significant difference in the number of body temperature rises after treatment in the PGY group,TB group,LH group and the follow-up body temperature group(P>0.05).Based on the above results,we can concluded that the antipyretic effect betwee Dandelion Granules and Cefdinir is comparable.In terms of pain,before treatment,3 days after treatment,and follow-up VAS scores were statistically different within each group(P<0.001),suggesting that the three groups of treatments can relieve the pain,and there is still a downward trend in pain after treatment.There was no statistically significant difference in VAS scores between the three groups after 3 days of treatment and follow-up(P>0.05),but the difference in pain relief in the LH group was significantly greater than that in the TB group(P<0.05),suggesting that Dandelion Granules combined with Cefdinir may have better pain relief effects than Cefdinir.WBC,NEUT%and CRP index were statistically different before and after treatment in each group(P<0.001).There was no statistical difference in WBC,NEUT%and CRP index after treatment(P>0.05).The number of abnormal CRP counts after treatment in the TB group was significantly higher than that in the PGY group after treatment,but there was no statistical difference between the TB group and the LH group(P>0.017).In summary,both Dandelion Granules and Cefdinir have the effect of restoring WBC count,NEUT%and CRP index levels in routine blood,and the efficacy are comparable.Regarding breast lumps,all three groups can reduce breast lumps.There was no significant difference in the number of tumors before and after treatment in the TB group(P>0.05),while the number of tumors before and after treatment in the PGY group and the LH group had a significant difference(P<0.05),The tumor area after treatment in the LH group was significantly smaller than that in the TB group(P<0.01).From the above,it can be found that the effect of Dandelion Granules in reducing tumor mass may be better than that of Cefdinir.One case in each of the PGY group and the LH group had breast suppuration during the treatment(P>0.05).In the TCM syndrome score,there was no statistically significant difference in the yellow and greasy tongue coating score between each group before and after treatment(P>0.05),and the other groups had statistical differences before and after treatment(P<0.05).After treatment,the TCM syndrome There was no statistically significant difference between the various groups in the scores(P>0.05);there were no serious adverse events in the three groups.Conclusions1.Dandelion Granules,Cefdinir and Dandelion Granules combined with Cefdinir have alleviated fever,relieved breast pain,restored blood inflammatory indexes,reduced breast lumps and relieved TCM syndromes after 3 days of treatment of non-abscess acute mastitis.The clinical curative effect is comparable.Single use Dandelion Granules and Dandelion Granules combined with Cefdinir(the dosage of Cefdinir Capsules is reduced to 2 days)for the treatment of non-abscess acute mastitis may not affect the clinical efficacy;2.Dandelion Granules combined with Cefdinir may have better pain relief effects than cefdinir used alone;Dandelion Granules may be better than Cefdinir in reducing tumor mass,and Dandelion Granules combined with Cefdinir may be more effective in reducing tumor mass.Therefore,when patients have painful lumps,it is recommended to give Dandelion Granules combined with Cefdinir;3.No serious adverse test occurred in this clinical trial.Dandelion granules are safer in the treatment of non-abscess acute mastitis.Part twoObjective and SignificanceAcute mastitis in the non-abscess period is a "mammary carbuncle" in traditional Chinese medicine.It is often due to the stagnation of heat in the spleen and stomach,block the qi,the organs are not smooth,and the tongue coating is yellow and greasy.Modern studies have confirmed that the tongue coating microbiota can affect the thickness of the tongue coating and is associated with a variety of diseases.Therefore,this study aims to explore the reasons for the formation of yellow greasy fur in non-abscess acute mastitis and whether the occurrence of this disease is related to changes in the tongue fur flora.MethodsAll subjects were from lactating women who attended the Hospital from August 2019 to December 2019.A total of 24 samples were taken from women diagnosed with ac ute mastitis,accompanied by fever and yellow greasy coating.A total of 17 samples were taken from healthy lactating women with thin white coating.Firly,by utilizing MiSeq high-throughput sequencing technology,DNA fragment sequences has been abta ined,then we used RDP classifier Bayesian algorithm to analyze the flora composition of two sets of tongue coating samples based on the representative sequence of taxa.Secondly,we conducted analysis about the Alpha diversity and β diversity of the two tongue coating samples.Finally,We analyzed the differences of environmental factors.ResultsFirstly,the species composition was evaluated,and it was found that the shannoneven index and shannon index of the yellow greasy coating group were higher than those of the thin white fur group,and the difference was statistically significant(P<0.05).The results of distance matrix quantitative analysis and PCoA analysis showed that there was a difference in the structure of the tongue fur group in the yellow greasy fur group and the thin white fur group,but the difference was not statistically significant(P>0.05).In order to further compare the differences in the structure of the two groups of flora and the size of the differences within the groups,the PLA-DA analysis results showed that compared with the differences between the groups,the differences in the structure of the flora of the two groups of sample species were smaller.Secondly,the difference in richness between the species groups was detected,and it was found that the richness of Bacteroides and Verrucomicrobiae in the yellow greasy moss group was significantly higher than that in the thin white moss group.The abundance of Prevotella and Alloprevotella under the classification level of Bacteroides phylum was significantly higher in the yellow greasy fur group than in the thin white fur group(P<0.05).Significant analysis of the differences between LEFSe multi-level species groups found that anaerobic bacteria such as Prevotella,Veillonella,Alloprevotella,etc.were significantly enriched in the yellow greasy tongue coating group(P<0.05).Finally,in order to explore the correlation between blood routine inflammatory indicators and the abundance and diversity of tongue fur,two sets of tongue fur samples were analyzed by RDA.The results showed that WBC count,NEUT%and CRP were significantly correlated with the flora structure of the two groups of tongue coating samples(P<0.05).Correlation Heatmap analysis was further used to calculate the correlation coefficients between blood routine indicators and bacterial genera in the two groups.The results showed that Alloprevotella was significantly positively correlated with WBC count and NEUT%(P<0.05).Conclusions:Non-abscess acute mastitis patients with yellow greasy fur have a higher tongue fur m icrobiota diversity than healthy thin white fur lactating women;non-abscess acute mast itis with yellow greasy fur patients and healthy thin white fur lactating women have s ignificant differences in the composition of the tongue fur microbial community.The r ichness of Prevotella and Alloprevotella in the yellow greasy moss flora was significan tly increased.Among them,Alloprevotella is positively correlated with blood routine in flammatory indicators,which may be an opportunistic pathogen causing acute mastitis in patients with yellow greasy fur during lactation;in addition,the accumulation of an aerobic bacteria in yellow greasy fur and aerobic bacteria Microbial disorders caused b y consumption may cause inflammatory reactions in the body.Therefore,yellow greas y coating in breastfeeding women may be a potential warning for the occurrence of mastitis. |
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