Objective: To establish a real-time quality control scheme based on the median (MD-IC) of internal control cycle threshold value in negative samples (NEG-IC-CT), so as to monitor anomalies such as progressive drift in nucleic acid testing system not covered by conventional internal quality control (IQC) in blood center nucleic acid laboratories, and to verify its feasibility. Methods: The internal control CT values of 54 426 negative samples were retrospectively collected. These samples were from four reagent batches of the two new and old equipment sets during the operation of the Wantai nucleic acid testing system in our blood center. The daily median of NEG-IC-CT values was used as the research indicator. Control limits were calculated using median absolute deviation (MAD) to construct the Median-MAD quality control chart. The monitoring performance of this scheme for the operation status of the testing system was simultaneously evaluated. Results: Statistical analysis showed significant differences in NEG-IC-CT value distribution between the new and old equipment sets, as well as between the two different reagent batches of the old equipment (P<0.000 1). The NEG-IC-CT value performance of the two different reagent batches of the new equipment was no significant difference in distribution (P>0.05). This scheme identified three typies of distinct anomalies. The out-of-control events observed with the old equipment in both the O1 and O2 reagent batches suggested potential performance decay due to equipment aging. The unreported change of reagent batch in time of Phase B with new equipment caused a stepwise drift on the quality control chart. In the later stage of Phase A with the new equipment, an alert was triggered, indicating potential quality risks associated with practices such as the mixed use of the remaining reagents and extremely long operator working hours. Conclusion: The realtime quality control scheme based on NEG-IC-CT value established in this study has been preliminarily validated for its monitoring effectiveness in nucleic acid testing in our blood center. This scheme performed well in detecting differences among testing systems and reagent batches, serving as an effective supplement to routine internal quality control. It can provide an intuitive and effective evaluation method for monitoring the performance of the nucleic acid testing process at blood center.

This consensus will introduce the characteristics of fillers used in the surgical cavities of domestic nasal surgery patients based on relevant literature and expert opinions. It will also provide recommendations for the selection of cavity fillers for different nasal diseases, with chronic sinusitis as a representative example.
Humans ; Nasal Cavity/surgery* ; Nasal Surgical Procedures ; China ; Consensus ; Sinusitis/surgery* ; Dermal Fillers

Objective:To explore the effects of Jianpi Mixture on the glucose receptor/glucagon like peptide-1 (GLP-1)/5-hydroxytryptamine (5-HT) signaling pathway and the mechanism of Jianpi Mixture in improving visceral hypersensitivity in diarrhea-predominant irritable bowel syndrome (IBS-D) rats.Methods:Totally 40 healthy male SPF rats were divided into blank group, model group, Jianpi Mixture low- and high-dosage groups according to the random number table method, with 10 rats in each group. Except for the blank group, the rest of the rats were prepared by the "senna gavage combined with restraint stress" method to replicate the IBS-D spleen deficiency model. The aqueous extract of Jianpi Mixture was 2.52 and 7.56 g/kg in the low- and high-dosage groups, and the same volume of normal saline was given to the blank group and the model group, once a day, for 14 days. On the 1st, 7th and 14th days of administration, the body weight of rats was recorded, the fecal traits of the rats were scored with Bristol score, the visceral sensitivity of IBS-D rats was evaluated by the abdominal wall retraction reflex score (AWR) under rectal dilation, the morphology of colonic mucosal tissues was observed by HE staining, and the protein expressions of T1R2, SLGT1, GLUT2, GLP-1 and 5-HT in colon tissues were detected by immunohistochemical staining.Results:On the 1st, 7th and 14th days of administration, compared with the model group, the weight of the rats in the Jianpi Mixture high-dosage group increased ( P<0.05); on the 14th day of administration, the fecal Bristol score decreased significantly ( P<0.05) and the AWR score increased ( P<0.05); HE staining showed that the mucosal epithelium of colon tissue in the model group was slightly damaged, and local edema was visible. The pathological condition of colonic mucosa in the Jianpi Mixture low- and high-dosage groups was effectively improved; compared with the model group, the expressions of T1R2 and GLP-1 in the Jianpi Mixture low- and high-dosage groups increased ( P<0.05), and the expression of 5-HT decreased ( P<0.05); the protein expressions of GLUT2 and SGLT1 in the Jianpi Mixture high-dosage group increased ( P<0.05). Conclusion:Jianpi Mixture can treat spleen-deficiency IBS-D by restoring the normal expression of intestinal glucose receptors, regulating the secretion of GLP-1/5-HT, improving intestinal motility and alleviating visceral hypersensitivity.

Objective: To investigate the effects of different doses of X ⁃rays irradiation combined with allogeneic lymphocyte infusion on the establishment of aplastic anemia in mice. Methods: Forty BALB/c mice were randomly divided into four groups : the 3 Gy group (n = 9) , the 4 Gy group (n = 9) , the 5 Gy group (n = 10) , and the con⁃trol group (n = 12) . In the 3 Gy , 4 Gy , and 5 Gy groups , the experimental mice were exposed to corresponding do⁃ses of X ⁃ray and then intravenously infused with 0. 2 mL mixed suspension of the thymus and spleen cells from DBA/2 mice , at a concentration of 1 × 107 cells/mL , within 4 hours after irradiation. The control group did not un⁃dergo X ⁃ray irradiation and infused with an equivalent volume of physiological saline instead. Blood samples were collected from the orbital venous plexus of BALB/c mice and analyzed using an animal automated hematology analy⁃zer to measure peripheral blood parameters , including red blood cells ( RBC) , white blood cells ( WBC) , and platelets (PLT) . The general condition of mice was monitored daily , and survival rates were recorded for each group. At the experimental endpoint , the tibias were harvested for hematoxylin and eosin (HE) staining , while the femurs were used to prepare bone marrow smears for morphological examination. For the 5 Gy group , T ⁃cell subsets(ELISA) at the endpoint. Results : In the 3 Gy group , pancytopenia was observed , but platelet recovery occured rapidly , returning to normal levels by day 17 post⁃modeling. No deaths occurred during the observation period. At myeloid⁃to⁃erythroid (M/E) ratio , and no significant morphological abnormalities were noted in cells at any devel⁃with hematopoietic cells. In the 4 Gy group , pancytopenia persisted throughout the observation period. The survival rate was 90% . Endpoint analysis showed hypocellular marrow by morphological examination. HE staining indicated minimal fatty infiltration in the bone marrow tissue. In the 5 Gy group , pancytopenia was observed , though erythro⁃cyte counts returned to normal levels by day 24. The survival rate during the observation period was 50% . Endoint analysis revealed vacuolization of marrow particles and reduced hematopoietic cells with predominantly non⁃hematopoietic cells in bone marrow morphology. HE staining demonstrated severe fatty infiltration in the bone mar⁃row tissue , with scarcity of immature cells and hematopoietic precursor cells. Flow cytometry analysis showed a de⁃creased proportion of CD4 + T cells (% ) and an increased proportion of CD8 + T cells (% ) . ELISA confirmed elevated secretion of negative hematopoietic regulators : interferon⁃gamma ( IFN⁃γ) and tumor necrosis factor⁃alpha (TNF⁃α ) . Conclusion Combined administration of varying radiation doses with allogeneic lymphocyte infusion consistently induced peripheral blood cytopenia in mice , characterized by reductions in RBC , WBC , and PLT counts. Integrated analysis of bone marrow morphology , histopathological assessment via HE staining , and immuno logical parameters confirmed that a mouse model of aplastic anemia can be successfully established using 5 Gy X ⁃ ray irradiation coupled with infusion of 2 × 106 allogeneic lymphocytes.

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 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 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.

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.

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.