The intestinal flora and gut barrier function are of great significance for gut function and human health. When the intestinal flora is disrupted and the gut barrier structure is disrupted, it can lead to bacterial translocation, endotoxin influx into the bloodstream, and the production of pro-inflammatory factors, leading to various tissue damage in the body. Tongfu method in TCM can affect the intestinal environment by regulating intestinal permeability and immune response, restoring normal intestinal movement, and regulating the structure and metabolites of intestinal flora, thereby maintaining intestinal homeostasis and body health. The research on regulating intestinal flora and improving intestinal barrier function by Tongfu method can provide reference for further research on the relationship between TCM and intestinal microecology, and provide ideas for clinical treatment.

Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.

Objective To investigate the clinical effect of different magnetic stimulation pelvic floor modes in the treatment of perimenopausal myofascial pelvic pain syndrome(MPSS).Methods A total of 60 perimenopausal women who were clinically diagnosed with MPSS in the hospital from May 2022 to May 2023 were selected as the research objects.They were divided into groups A,B and C by random number table method,with 20 cases in each group.All patients in the three groups were treated with pelvic floor myofascial manual release.Group A was given pelvic floor magnetic stimulation(alternating 10 Hz and 50 Hz),group B was given sacral nerve root magnetic stimulation(50 Hz),and group C was given pelvic floor magnetic stimu-lation combined with sacral nerve root magnetic stimulation at the same time.The three groups were treated twice a week for eight weeks.Visual analogue scale(VAS)was used to evaluate the degree of pelvic floor myofascial tenderness before and after treatment,and Glazer pelvic floor surface electromyography was used to evaluate pelvic floor muscle function.Results Compared with before treatment,the VAS scores of subjec-tive pain and pelvic floor myofascial tenderness in the three groups were decreased after treatment,and the differences were statistically significant(P<0.05).Compared with group A and group B,the VAS score of subjective pain and the VAS score of pelvic floor myofascial tenderness in group C were significantly decreased after treatment,and the differences were statistically significant(P<0.05).Compared with before treatment,the average amplitude and coefficient of variation(CV)of pre-rest potential and post-rest potential in the three groups were decreased after treatment,and the differences were statistically significant(P<0.05).Compared with before treatment,only the maximum amplitude of rapid contraction,the average amplitude of 10 s sustained contraction and 60 s sustained contraction and CV in group C were improved,and the differ-ences were statistically significant(P<0.05).Compared with group A and group B,the average amplitude and CV of pre-resting potential and post-resting potential in group C were decreased after treatment,the maxi-mum amplitude of rapid contraction and the average amplitude and CV of 10 s continuous contraction and 60 s persistent contraction were improved,and the differences were statistically significant(P<0.05).Conclusion Dif-ferent magnetic stimulation pelvic floor modes can effectively relieve pain and improve pelvic floor muscle strength in the treatment of perimenopausal MPSS,and the effect of pelvic floor magnetic stimulation com-bined with sacral nerve root magnetic stimulation is the best.

Objective To explore the application of standardized teaching mode in clinical teaching for B-type ultrasound-guided peripherally inserted central catheters(PICC),and to discuss its influence on the teaching quality,comprehensive skills and student satisfaction.Methods A total of 74 nurses,who learned B-type ultrasound-guided PICC operation at the Department of Emergency of a certain grade Ⅲ-A hospital in Guangzhou City of China from September 2021 to September 2023,were randomly divided into the study group and the control group with 37 nurses in each group.The teaching content of both groups was B-type ultrasound-guided PICC operation.The conventional teaching method was adopted for the control group,while on the basis of the conventional teaching method,additional standardized teaching mode was carried out for the study group.Teaching and training lasted for 3 months.The management indicators,teaching quality,comprehensive skills and student satisfaction with teaching were compared between the two groups.Results Compared with the control group,in the study group the catheterization time was shorter,the pain score was lower,and the success rate of single puncturing was higher(all P＜0.05).The results of final theory examination,case analysis ability,and clinical actual operation score(including the indications,puncturing method,and puncturing technique of B-type ultrasound-guided PICC)in the study group were significantly better than those in the control group(all P＜0.05).The comprehensive skills were remarkably improved in both groups.The scores of doctor-patient communication,physical examination,medical ethics,operation process in the study group were obviously higher than those in the control group(all P＜0.05).Moreover,the expression ability,the sense of team cooperation,the ability to search and read literature,the ability of clinical practice,the degree of knowledge mastery,the ability to analyze and solve problems,and the learning initiative in the study group were prominently better than those in the control group(all P＜0.05).Conclusion In clinical teaching for B-type ultrasound-guided PICC operation,the implement of standardized teaching mode can help to improve the quality of teaching and improve the nurse s comprehensive skills of PICC operation with higher degree of satisfaction with teaching,therefore,this kind of teaching mode is worth popularizing and applying.

Objective:To evaluate the impact of self-crosslinked hyaluronic acid (SCH) gel on endometrium recovery after artificial abortion.Methods:A multicenter, prospective randomized controlled trial was conducted across 18 hospitals from December 2021 to February 2023, involving 382 women who underwent artificial abortion. Participants were randomly allocated to receive either treatment with SCH gel (SCH group) or no treatment (control group) in a 1∶1 ratio. The primary outcome was endometrium thickness in 14 to 18 days after the first postoperative menstruation. Secondary outcomes included changes in menstrual volume during the first postoperative menstruation, menstruation resumption within 6 postoperative weeks, time to menstruation resumption, duration of the first postoperative menstruation, and incidence of dysmenorrhea.Results:Baseline characteristics of participants were comparable between the two groups (all P>0.05), with 95.3% (182/191) in SCH group and 92.7% (177/191) in the control group completed the study. The postoperative endometrial thickness in SCH group was significantly greater than that in the control group [(9.78±3.15) vs (8.95±2.32) mm; P=0.005]. SCH group also had significantly fewer participants with reduced menstrual volume [23 cases (12.6%, 23/182) vs 31 cases (17.5%, 31/177); P=0.038]. Although SCH group experienced less dysmenorrhea during the first postoperative menstrual period, this difference was not statistically significant [28.5% (51/179) vs 37.1% (65/175); P=0.083]. Outcomes were similar between SCH group and the control group regarding the proportion of participants who resumed menstruation within 6 weeks postoperatively, time to menstruation resumption, and duration of the first postoperative menstruation ( P=0.792, 0.485, and 0.254, respectively). No serious adverse events were observed during the study period, and no adverse events were attributed to SCH gel treatment. Conclusion:The application of SCH gel after artificial abortion is safe and might aid in the recovery of the endometrium.

Objective:To investigate the current status and longitudinal development trajectory of postoperative cognitive dysfunction (POCD) in elderly patients undergoing hip replacement surgery and analyze the relationship between POCD and postoperative hip joint function recovery.Methods:Using the convenient sampling method, elderly patients who underwent hip replacement surgery in Department of Orthopedics in the First Affiliated Hospital of Zhengzhou University from January 2021 to March 2022 were selected as the research objects. The cognitive function at 1 week, 1 month, 2 months and 3 months after surgery was assessed using Mini-Mental State Examination (MMSE), and the longitudinal development trajectory of postoperative POCD was fitted using latent class growth model (LCGM). The differences between cognitive function categories and Oxford Hip Score (OHS) score at 3 months after surgery were compared by ANOVA.Results:A total of 307 elderly patients with hip replacement completed full follow-up and data collection. The incidence of POCD (MMSE<8 points) in patients at four postoperative time points was 30.29% (93/307), 29.97% (92/307), 28.66% (88/307) and 21.17% (65/307), respectively. The MMSE score was lowest at 1 week after surgery. Three potential categories of cognitive function longitudinal development tracks were identified by LCGM, including 208 cases (67.75%) with no cognitive dysfunction, 32 cases (10.42%) with improved cognitive dysfunction, and 67 cases (21.82%) with continuous cognitive dysfunction. Three months after surgery, patients with no cognitive impairment had the lowest OHS score, while patients with persistent cognitive impairment had the highest OHS score. There were statistically significant differences in OHS scores among patients with three longitudinal potential categories of cognitive function ( P<0.05) . Conclusions:The incidence of POCD in elderly patients with hip replacement varies at different postoperative times, with the most significant difference occurring at 1 week after surgery. Medical staff must dynamically evaluate the postoperative cognitive function of elderly patients and adopt targeted nursing strategies for different types of cognitive impairments, to promote the patient's recovery of hip function.

Objective:To investigate the effects of evidence-based precision nursing in patients with sarcopenia undergoing total knee arthroplasty (TKA) .Methods:By convenience sampling, totally 41 TKA patients with sarcopenia treated in the Department of Orthopedics at The First Affiliated Hospital of Zhengzhou University from August 2021 to February 2022 were selected as the control group, and 41 TKA patients with sarcopenia treated from March 2022 to March 2023 as the observation group. Patients in the control group received conventional nursing care, while patients in the observation group received an evidence-based precision nursing plan. The differences in muscle mass, grip strength, physical activity ability, knee joint function, and quality of life between the two groups before and after the intervention were compared.Results:After the intervention, the total muscle mass, affected limb skeletal muscle mass, limb skeletal muscle mass, limb skeletal muscle mass index, and grip strength in the observation group were significantly higher than those in the control group ( P< 0.05). The scores on the Short Physical Performance Battery, Lysholm Score, and Sarcopenia Quality of Life Scale in the observation group were also significantly higher than those in the control group ( P<0.05) . Conclusions:Evidence-based precision nursing can improve postoperative muscle mass and strength, enhance physical activity ability and joint function, and improve the quality of life in TKA patients with sarcopenia.

Critical care medicine-related treatment is an interdisciplinary and multi-professional process,often leading to secondary or concomitant mental disorders in clinical practice.Currently,there is no consensus on the pharmacological treatment of related mental illnesses in China.The Chinese Society of Psychosomatic Medicine collaborated with the Critical Care Medicine expert group to form a consensus writing expert group.After a systematic review of relevant literature,summarizing published domestic and foreign literature,and extensive discussions,the consensus was developed.The consensus elaborates on the principles and processes of the standardized use of psychotropic drugs in critical care medicine,as well as the clinical indications,precautions,and specific drug selection of various psychiatric medications,providing feasible suggestions and guidance for the clinical application of psychiatric medications in the intensive care unit.

Objective:To investigate the factors influencing fall risk scores in elderly individuals.Methods:A total of 4 419 individuals were randomly selected using the cluster sampling method from Beijing, Nanning(Guangxi), and Yinchuan(Ningxia).Data on demographic characteristics and fall-related incidents were gathered and analyzed for their correlation with fall risk scores.Results:The fall risk score showed significant associations with various factors, such as the history of falls within one year( β=-3.607, 95% CI: -3.881 to -3.332), care methods( β=2.442, 95% CI: 2.226 to 2.658), exercise( β=0.714, 95% CI: 0.443 to 0.986), retirement( β=-0.585, 95% CI: -0.819 to -0.351), age( β=0.173, 95% CI: 0.159 to 0.187), and use of walking aids( β=-3.737, 95% CI: -4.054 to -3.421). Conclusions:Fall risk scores in older adults are influenced by a variety of factors.Factors such as no history of falls within the past year, living independently, engaging in physical activity, and being employed may contribute to lower fall risk scores in older adults.

Recent studies on male infertility reveal a growing worry: more infertile men are dealing with inflammation in the testis. Analyzing testicular biopsies from infertile men highlights a significant presence of inflammation. This connection, supported by clinical and pathological evidence, emphasizes that testicular inflammation hampers sperm production, leading to lasting declines in sperm count and quality. However, the exact reasons behind male infertility due to orchitis, a type of testicular inflammation, are still uncertain. Understanding these fundamental aspects of molecular signals and cellular mechanisms in testicular inflammation is crucial. Our review delves into recent literature with a dual objective: elucidating potential mechanisms involving immune cells, non-immune cells, and cytokines that link orchitis to male infertility, while also paving the way for precise interventions and solutions to address the challenges of male infertility.