Objective To explore the impact of gender factors in participant selection during bioequivalence studies,and to provide insights for improving the screening success rate in subsequent trials.Methods A retrospective study was con-ducted to summarize the screening information of healthy subjects in the bioequivalence study conducted in the Phase Ⅰ Clinical Trial Laboratory of the Affiliated Hospital of Xiangnan University from July 2021 to July 2023.The number of failed screening ca-ses in different stages of screening for each project was counted,and the influence of gender factors on subject screening was ana-lyzed.Results A total of 32 bioequivalence studies involving 2 794 subjects,including 1 816 males and 978 females,were in-cluded in the study.The proportion of males was higher in vital signs and BMI abnormalities,and the proportion of females was higher in ECG abnormalities and active withdrawal,and the pass rate was lower in males than in females(40.0％ vs.45.8％),and the existence of the two was statistically significant(P＜0.05).The results of PC A showed that the distribution of data in males was more dispersed,and the distribution of data in females was centralized,and the two could be clearly differentiated.Binary lo-gistic regression analysis showed significant differences between males and females in laboratory test screening failures and BMI(P＜0.05).Further analysis showed that the screening failure rates of blood biochemistry,urine routine,coagulation function and blood transfusion were higher in males than in females,but the screening failure rates of blood routine were lower than those of fe-males.Conclusions Gender is an important influencing factor in the screening process of bioequivalence studies.Including subjects with appropriate gender ratios can help improve enrollment speed and reduce clinical trial costs.

Objective To compare the effects of quadratus lumborum block at the lateral supra-arcuate ligament(QLB-LSAL)versus subcostal transversus abdominis plane block(STAPB)on perioperative analgesia and postoperative inflammation in patients undergoing laparoscopic radical resection of colorectal cancer.Methods In this prospective randomized study,we recruited 102 patients undergoing laparoscopic colorectal cancer surgery between October 2022 and October 2024 under general anesthesia and randomly assigned them to two groups:QLB-LSAL(Group Q,n=51)and STAPB(Group S,n=51).Mean arterial pressure(MAP)and heart rate(HR)were recorded before anesthesia induction(T0),before surgical incision(T1),start of surgery(T2),during pneumoperitoneum establishment(T3),during peritoneal lavage(T4),at the end of surgery(T5),and upon leaving the operating room(T6).Intraoperative remifentanil consumption,time to first patient-controlled analgesia demand,and frequency of effective compression and rescue analgesia were recorded.Visual Analog Scale(VAS)scores at rest and during coughing were assessed at 24,48,and 72 hours postoperatively.Interleukin-6(IL-6)and systemic immune-inflammatory index(SII)at 1 day preoperatively,1,and 3 days postoperatively were recorded.Postoperative recovery indicators and adverse events were also recorded.Results Group Q demonstrated significantly lower MAP and HR compared with Group S from T3 to T6(P<0.05).Group Q had significantly lower intraoperative remifentanil consumption,significantly longer time to first analgesic pump demand,fewer effective pump compres-sion,and lower frequency for rescue analgesia requests(all P<0.05).VAS scores at rest and during coughing in Group Q were significantly lower at 24 h and 48 h postoperatively(P<0.05).As compared with preoperative levels,both IL-6 and SII increased at 1 and 3 days postoperatively,but magnitude of increase in Group Q was smaller than in Group S(P<0.05).In comparison to Group S,Group Q demonstrated significantly earlier ambulation,shorter hospital stay,and fewer adverse events(P<0.05).Conclusion QLB-LSAL is superior to STAPB in enhancing perioperative analgesia,attenuating inflammatory response,and accelerating postoperative rehabilitation in patients undergoing laparoscopic colorectal cancer resection.

Objective To compare the effects of quadratus lumborum block at the lateral supra-arcuate ligament(QLB-LSAL)versus subcostal transversus abdominis plane block(STAPB)on perioperative analgesia and postoperative inflammation in patients undergoing laparoscopic radical resection of colorectal cancer.Methods In this prospective randomized study,we recruited 102 patients undergoing laparoscopic colorectal cancer surgery between October 2022 and October 2024 under general anesthesia and randomly assigned them to two groups:QLB-LSAL(Group Q,n=51)and STAPB(Group S,n=51).Mean arterial pressure(MAP)and heart rate(HR)were recorded before anesthesia induction(T0),before surgical incision(T1),start of surgery(T2),during pneumoperitoneum establishment(T3),during peritoneal lavage(T4),at the end of surgery(T5),and upon leaving the operating room(T6).Intraoperative remifentanil consumption,time to first patient-controlled analgesia demand,and frequency of effective compression and rescue analgesia were recorded.Visual Analog Scale(VAS)scores at rest and during coughing were assessed at 24,48,and 72 hours postoperatively.Interleukin-6(IL-6)and systemic immune-inflammatory index(SII)at 1 day preoperatively,1,and 3 days postoperatively were recorded.Postoperative recovery indicators and adverse events were also recorded.Results Group Q demonstrated significantly lower MAP and HR compared with Group S from T3 to T6(P<0.05).Group Q had significantly lower intraoperative remifentanil consumption,significantly longer time to first analgesic pump demand,fewer effective pump compres-sion,and lower frequency for rescue analgesia requests(all P<0.05).VAS scores at rest and during coughing in Group Q were significantly lower at 24 h and 48 h postoperatively(P<0.05).As compared with preoperative levels,both IL-6 and SII increased at 1 and 3 days postoperatively,but magnitude of increase in Group Q was smaller than in Group S(P<0.05).In comparison to Group S,Group Q demonstrated significantly earlier ambulation,shorter hospital stay,and fewer adverse events(P<0.05).Conclusion QLB-LSAL is superior to STAPB in enhancing perioperative analgesia,attenuating inflammatory response,and accelerating postoperative rehabilitation in patients undergoing laparoscopic colorectal cancer resection.

Objective To explore the impact of gender factors in participant selection during bioequivalence studies,and to provide insights for improving the screening success rate in subsequent trials.Methods A retrospective study was con-ducted to summarize the screening information of healthy subjects in the bioequivalence study conducted in the Phase Ⅰ Clinical Trial Laboratory of the Affiliated Hospital of Xiangnan University from July 2021 to July 2023.The number of failed screening ca-ses in different stages of screening for each project was counted,and the influence of gender factors on subject screening was ana-lyzed.Results A total of 32 bioequivalence studies involving 2 794 subjects,including 1 816 males and 978 females,were in-cluded in the study.The proportion of males was higher in vital signs and BMI abnormalities,and the proportion of females was higher in ECG abnormalities and active withdrawal,and the pass rate was lower in males than in females(40.0％ vs.45.8％),and the existence of the two was statistically significant(P＜0.05).The results of PC A showed that the distribution of data in males was more dispersed,and the distribution of data in females was centralized,and the two could be clearly differentiated.Binary lo-gistic regression analysis showed significant differences between males and females in laboratory test screening failures and BMI(P＜0.05).Further analysis showed that the screening failure rates of blood biochemistry,urine routine,coagulation function and blood transfusion were higher in males than in females,but the screening failure rates of blood routine were lower than those of fe-males.Conclusions Gender is an important influencing factor in the screening process of bioequivalence studies.Including subjects with appropriate gender ratios can help improve enrollment speed and reduce clinical trial costs.

Extensive penile ulcer secondary to granulomatosis with polyangiitis（GPA）is clinically rare. This study reports a 20-year-old male patient with pathologically confirmed GPA-induced penile ulcers. Following control of GPA progression and wound infection management，reconstruction using a scrotal pedicled flap was performed to address the penile skin defect. The follow-up of 1 year results demonstrated favorable flap survival and significant improvement in penile appearance.

Extensive penile ulcer secondary to granulomatosis with polyangiitis（GPA）is clinically rare. This study reports a 20-year-old male patient with pathologically confirmed GPA-induced penile ulcers. Following control of GPA progression and wound infection management，reconstruction using a scrotal pedicled flap was performed to address the penile skin defect. The follow-up of 1 year results demonstrated favorable flap survival and significant improvement in penile appearance.

Objective To investigate the effect of ultrasound-guided anterior quadratus lumborum block at lateral supra-arcuate ligament on postoperative analgesia and inflammation response in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy.Methods A total of 60 elderly patients who had undergone robot-assisted laparoscopic radical prostatectomy from June 2022 to June 2023 were randomly divided into a group of ultra-sound-guided anterior quadratus lumborum block at lateral supra-arcuate ligament combined with general anesthesia(observation group,n = 30)and a general anesthesia group(control group,n = 30).Both groups received patient-controlled intravenous analgesia after surgery.The first compression time of an analgesic pump and the numbers of effective compression and remedial analgesia were recorded.The VAS scores at postsurgical hours 2,12,24,and 48 during rest and coughing were recorded.Interleukin-6(IL-6)and systemic immunoinflammatory index(SII)at one day before surgery and two hours,one day and three days after surgery were recorded.Anal exhaust time,length of postoperative hospital stay and occurrence of adverse reactions were recorded.Results The observation group,as compared with the control group,had significantly longer first compression time of an analgesic pump and had fewer numbers of effective compressions and remedial analgesic administrations(P<0.05).The VAS scores during rest and coughing in the observation group were lower than those in the control group at postsurgical hours 2,12,24,and 48(P<0.05).As compared with one day before surgery,both IL-6 and SII in the two groups increased at 2 hours,1,and 3 days after surgery,but the changes in the observation group were lower than those in the control group(P<0.05).As compared with the control group,the observation group had shorter anal exhaust time and length of postoperative hospital stay,and a lower incidence of adverse reactions(P<0.05).Conclusions Ultrasound-guided anterior quadratus lumborum block at lateral supra-arcuate ligament can provide better postoperative analgesia,reduce inflammatory response and accelerate postoperative recovery in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy.

Objective:To evaluate the effect of anterior quadratus lumborum block at the lateral supra-arcuate ligament on the postoperative pulmonary function in patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia.Methods:Seventy-two American Society of Anesthesiologists Physical Status classification Ⅰ-Ⅲ patients, aged 50-80 yr, with body mass index of 18.5-27.9 kg/m 2, scheduled for elective robot-assisted laparoscopic radical prostatectomy under general anesthesia, were divided into 2 groups ( n=36 each) using a random number table method: control group and observation group. After induction of general anesthesia, observation group underwent anterior quadratus lumborum block at the lateral supra-arcuate ligament under ultrasound guidance, with 20 ml of 0.375% ropivacaine administered on each side. Control group only received total intravenous anesthesia. Postoperative analgesia was provided by patient-controlled intravenous analgesia until 48 h after operation, and intravenous dezocine was administered as rescue analgesic when the visual analogue scale score at rest≥4. Pulmonary function was assessed at 1 day before surgery and 1-7 days after surgery. Forced vital capacity (FVC), forced expiratory volume in 1 s (FEV 1), maximal mid-expiratory flow rate (FEF 25%-75%), and time to recovery of 80% predicted pulmonary function were recorded. Arterial blood gas analysis was performed at 1 day before surgery and 1-3 days after surgery, and SpO 2, PaO 2 and PaCO 2 were recorded. The consumption of intraoperative remifentanil, effective pressing times of patient-controlled analgesia, and the number of patients required rescue analgesia were recorded. Postoperative pulmonary complications within 7 days after operation and re-hospitalization within 30 days were recorded. The time to first flatus, postoperative length of hospital stay and occurrence of adverse reactions (dizziness, nausea, vomiting) within 3 days after surgery were also recorded. Results:Compared with control group, FVC, FEV 1 and FEF 25%-75% were significantly increased postoperatively, the time to recovery of 80% FVC, FEV 1 and FEF 25%-75% was shortened, postoperative SpO 2 and PaO 2 were increased, postoperative PaCO 2 was decreased, the consumption of intraoperative remifentanil, effective pressing times of patient-controlled analgesia, and the number of patients required rescue analgesia were reduced, the postoperative time to first flatus and length of hospital stay were shortened, and the incidence of adverse reactions and pulmonary complications was decreased ( P<0.05). Conclusions:Anterior quadratus lumborum block at the lateral supra-arcuate ligament can improve postoperative pulmonary function, reduce adverse reactions, and promote early recovery for the patients undergoing robot-assisted laparoscopic radical prostatectomy under general anesthesia.

Objective:To establish an antibody expression system to reduce the antibody-dependent enhancement (ADE) effect of target antibody.Methods:Site-directed mutagenesis was used to mutate the 234 and 235 sites of the Fc region of the mammalian cell antibody expression vector-L234A and L235A to establish the antibody expression vector pFRT-IgG1κ-FcM. An antibody Wt-WNV with significant ADE effect obtained in previous work was selected and expressed by the pFRT-IgG1κ-FcM system to obtain mutant antibody FcM-WNV. The binding ability of FcM-WNV to target antigen West Nile virus envelope protein-DⅢ (WNV E-DⅢ) was detected by ELISA, and the its binding ability to human high-affinity IgG Fc receptor hFcγRⅠ (hCD64 ) was analyzed by flow cytometry. The neutralizing activity of FcM-WNV in vitro was detected by pseudovirus infection of host cells (BHK21 and K562). Results:The expression levels of FcM-WNV and Wt-WNV were comparable, and FcM-WNV could recognize and bind to WNVE-DIII in a concentration-dependent manner. Compared with Wt-WNV, the binding ability of FcM-WNV to hCD64 was significantly weakened, showing a significant decrease in fluorescence intensity. Consistent with the previous experimental results, Wt-WNV at a concentration of 5 μg/ml significantly enhanced the infection of K562 by WNV pseudovirus, while FcM-WNV at a concentration of 5 μg/ml could effectively block pseudovirus infection in both K562 and BHK21 cells.Conclusions:The established antibody expression system can effectively reduce the ADE effect of the target antibody.

Streptococcus parasuis(S.parasuis)is a close relative of S.suis and can cause meningi-tis,pneumonia or systemic symptoms in affected animals.In this paper,the dominant strain was i-solated from diseased pigs with pneumonia in Jilin,China,and the isolated strain was identified as S.parasuis by 16S rRNA,it was named WYF-8B.Resistance was tested by the susceptibility tablet diffusion method,and WYF-8B was resistant to bacitracin,sulfamethoxoprim,lincomycin,erythro-mycin,fosfamycin,azithromycin,penicillin,doxycycline,cotrimotrixazole,sulfamisoxazole,cipro-floxacin,enrofloxacin,tetracycline,benzoxacillin,gentamicin,efazolin,and ampicillin.It was highly sensitive to florfenicol,chloramphenicol.Iochemical identification revealed that WYF-8B could fer-ment salicylic acid,maltose,lactose,sucrose,oxaesin,and glucose;nonfermentable mannitol,urea,raffinose,xylose,arabinose,and sorbitol.Using the second-generation whole-genome sequencing technology to study the WYF-8B resistant genotype,it was found that it carried the macrolide anti-biotic resistance genes Mef(E)and ErmB;resistance genes pbp2b,pbp1a,and pbp2x to β-lactam antibiotics;resistance genes gyrA,parC,and grlB to fluoroquinolones;resistance genes ANT(6)-Ia,AAC(6')-Ie-APH(2')-Ia,ANT(9)-Ia,APH(3')-Ⅲa to aminoglycoside antibiotics;re-sistance groups lnuB,lmrC,lmrD against lincomide antibiotics;resistance gene tetM to tetracy-cline antibiotics;the resistance gene of bacitracin,bcrA.The results found that the resistance phe-notype matches the resistance genotype of the sequencing results.The study of WYF-8B virulence factors found that WYF-8B carried 13 virulence factors(pavA,fbp 54,clpP,cps 4,cps 4 I,wbtB,cps,sI,tufA,galE,hasC,groEL,wrbtL,wbbtF),which mainly acted to promote bacterial diffu-sion,transfer,settlement,antiphagocytosis and immune evasion.The results of drug sensitivity test provide a reference for the study of clinical medication of S.parasuis,and drug resistance pheno-type and virulence factors lay the foundation for the research and development of new drugs and vaccines.