| In recent years,the relationship between intestinal flora and tumor has become a hotspot in the field of life medicine.More and more studies have shown that intestinal flora is not only related to the occurrence of tumor,but also plays an important role in the treatment of tumor.Breast cancer and Colorectal cancer are two types of cancer with high incidence in contemporary society.At present,surgery combined with chemotherapy is still the main treatment mode.Chemotherapy can lead to intestinal microflora disorder in BC and CRC patients,accompanied by nausea,fever,vomiting,diarrhea and loss of appetite and other adverse reactions,which have a bad impact on patients’ lives.Therefore,it is urgent to seek drugs and methods that can regulate the body’s response to chemotherapy drugs,improve the efficacy of chemotherapy,reduce the side effects of chemotherapy,and further improve the quality of life of cancer patients undergoing chemotherapy.In recent years,the scientific evidence that intestinal microbiotics can regulate the balance of intestinal flora and improve the diseases and adverse reactions caused by chemotherapy,such as diarrhea,enteritis,constipation and dyspepsia,has become increasingly solid,but there are few reports on its clinical application.Chemotherapy patients are usually accompanied by severe intestinal microflora disorder and diarrhea.PST001 is a high-tech product developed in this study to improve intestinal microecology by integrating bioactive ingredients such as drugs,probiotics and prebiotics.Its ingredients are mainly composed of pueraria,inulin,ginseng,turmeric root and lactobacillus(Lactobacillus bulgari,Lactobacillus casei,Lactobacillus ferment,Lactobacillus paracei,Lactobacillus plantarum,Lactobacillus reuteri,Lactobacillus rhamnosus,Lactobacillus salivary).Through years of clinical studies,this product has shown good regulating effect of intestinal flora,which is of great help to improve the quality of life of people with diarrhea,and has shown good effect in the clinical phase I study on improving diarrhea in CRC patients.For further research on PST001 applicability in the treatment of diarrhea,expand the scope of its application,this group and Department of Oncology,The First Bethune Hospital of Jilin University,was carried out for regulating intestinal microecologic health "PST001 to improve the BC and CRC patients after chemotherapy efficacy and safety of the adverse reactions,single-center,randomized,double-blind,parallel-group phase II clinical research",objective to explore the intervention effect of complex intestinal microecological preparation PST001 on the intestinal flora of BC and CRC chemotherapy patients.Based on the consent and informed consent of the patients,20 BC and CRC patients who meet the inclusion criteria and plan to receive chemotherapy intervention will be selected as the study objects.After randomization,they will be divided into PST001 treatment group(experimental group)or placebo group(control group)according to 1:1.Patients were also treated with PST001 or placebo during chemotherapy.Each chemotherapy cycle was 21 days,a total of 4 chemotherapy cycles.Feces of patients were collected for intestinal microflora analysis before and after each cycle of chemotherapy,while other secondary efficacy indicators were observed and tested.This study analyzed the intestinal flora of BC and CRC chemotherapy patients and found the following important results: Chemotherapy reduced the number of OTU and destroyed microbial diversity in BC and CRC chemotherapy patients.PST001 may alleviate the decreasing trend of OTU number in some patients.Species composition analysis showed that compared with healthy controls,BC and CRC chemotherapy patients had dysbiosis of intestinal flora.Chemotherapy further causes the imbalance of intestinal flora structure and increases the number of some pathogenic bacteria.PST001 may have a positive regulation effect on some bacterial disorders,which is manifested in the regulation of Escherichia Shigella and Faecalibacterium in BC chemotherapy patients.α diversity analysis showed that the intestinal microflora diversity in PST001 group was higher than that in placebo group and closer to the healthy control group.PST001 intervention had little effect on the total bacterial abundance of the intestinal flora in BC patients,but alleviated the trend of decreasing the diversity of the intestinal flora.β diversity analysis showed that compared with the placebo group,the composition of intestinal flora in the PST001 treatment group was more similar to that in the healthy control group.The intestinal flora of patients in the PST001 treatment group showed clustering characteristics,whereas the structure of the intestinal flora in the placebo group was significantly different.BC patients undergoing the same cycle of chemotherapy had similar intestinal flora.LEf Se analysis showed that the biomarkers of intestinal flora in BC chemotherapy patients treated with PST001 included Prevotella,Ruminococcus and Clostridium etc.The biomarkers of intestinal flora in CRC chemotherapy patients with PST001 intervention were AKK bacteria,Clostridium,Blautia and Ruminococcus etc.In conclusion,our study shows that complex intestinal microecological preparation PST001 showed a trend of decreasing intestinal microbiota diversity in patients receiving chemotherapy for remission of BC and CRC,possibly by increasing the beneficial bacteria abundance,to reduce the harmful bacteria to chemotherapy in patients with intestinal flora structure recovery and reconstruction effect,thus alleviate intestinal flora imbalance caused by chemotherapy,improve the quality of life of cancer patients undergoing chemotherapy.This study provides important clinical data for the application of probiotics in tumor adjuvant therapy. |
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