In September 2023， the Measures for Scientific and Technological Ethics Review （Trial Implementation） was issued， revising the provisions related to the simplified procedure for ethical review in Chapter 3， Section 3. This revision of these provisions provides systematic guarantees for further optimizing ethical review work， ensuring that ethical review procedure is well-regulated， and improving scientific research efficiency. The “simplified procedure” does not mean reducing the quality and requirements of the review. Instead， based on always following internationally recognized ethical standards and emphasizing not violating national laws and regulations， improving the efficiency of ethical review and subsequent research work， and promoting the development of life sciences and medical research involving humans. In practical work， it introduces numerous new opportunities and challenges for the improvement of ethics review ability， such as new tests on the judgment and decision-making power of ethics committees， how to ensure the reliability and controllability of the conditions related to the simplified review procedure， and how to determine the basic conditions for adopting the simplified review procedure for review. Therefore， to actively respond to the challenges and possible risks brought by the simplified procedure review， efforts should be made to achieve three “unifications”， including the unification of researchers’ moral autonomy and the heteronomy of supervision implemented by relevant departments； the unification of the standard formulation of the simplified procedure review and the review work in practice； and the unification of ethical responsibility and legal responsibility.

Objective To investigate the effect of intravenous lidocaine on postoperative fatigue syndrome(POFS)in patients undergoing laparoscopic resection for gastric carcinoma.Methods A total of 80 patients who underwent elective laparoscopic resection for gastric carcinoma at Xuzhou Central Hospital between September 2023 and June 2024 were enrolled.Inclusion criteria included age 18～75 years,ASA physical status classificationⅠ～Ⅲ,body mass index(BMI)of 18.5～27.9 kg/m2,preoperative Christensen score≤4,and estimated operation time≤4 hours.Patients were randomly allocated into either the lidocaine group(Group L)or the saline group(Group C)using a random number table,with 40 patients in each group.Group L received an intravenous infusion of lidocaine at a dose of 1.5 mg·kg?1 over 15 minutes,initiated 30 minutes before anesthesia induction.If no adverse reactions occurred,lidocaine was maintained at a rate of 1.5 mg/(kg·h)throughout the surgery until its conclusion.Group C received an equivalent volume of normal saline administered in the same manner.The Christensen score and Visual Analogue Scale(VAS)scores were recorded on postoperative days 1,3,5,and 7,and the time-weighted average(TWA)of the Christensen score was calculated.Postoperative inflammatory markers were measured,and additional outcomes including extubation time,post-anesthesia care unit(PACU)stay duration,postoperative nausea and vomiting(PONV),consumption of rescue analgesics,time to first flatus and defecation,and length of hospital stay were also documented.Results Compared with Group C,the TWA of the Christensen score in Group L decreased by 0.44 points(95％CI:0.11～0.76;P<0.05).The VAS scores were significantly lower in Group L on postoperative days 1 and 3(P<0.05).Levels of IL-6 and TNF-α at the end of surgery and 24 hours after surgery were also lower in Group L(P<0.05).The time to first flatus and defecation was significantly shorter in Group L(P<0.05).There were no significant differences between the two groups regarding extubation time,PACU stay duration,incidence of PONV,postoperative consumption of remedial analgesic drugs,or length of hospital stay(P>0.05).Conclusion Intravenous lidocaine may improve POFS in patients following laparo-scopic resection for gastric carcinoma by attenuating inflammatory responses,alleviating pain,and facilitating gastrointestinal function recovery,while maintaining a favorable safety profile.

There has been an increase in research interest and application of treated dentin matrix (TDM) in vital pulp therapy (VPT) in recent years. TDM has excellent biocompatibility and contains transforming growth factor-β, bone morphogenetic protein 2, and other odontogenesis/osteogenesis-related proteins and factors that promote odontogenic differentiation of dental stem cells. TDM-based products, ranging from powders and pastes to injectable composite gels and gel scaffolds, have gained increasing consensus for their ability to induce dentin-like tissue regeneration. Animal and clinical studies found that TDM has significant advantages over traditional pulp capping materials, as it can form well-organized layers of odontoblast-like cells and uniform dentinal tubule structures. Future challenges of TDM in VPT application are primarily focused on improving mechanical properties and addressing potential immune rejection issues with heterologous material use. Additionally, further studies should be conducted on the odontogenetic pathway mechanism of TDM and the immune regulatory capabilities of xenogeneic dentin matrix materials. Utilizing TDM to construct tissue engineering scaffolds for VPT presents a promising strategy. This article reviews the structure and biological properties of TDM and related materials, thoroughly examines their progresses in the field of VPT, and discusses their current challenges as well as future research directions.

Objective:Using bacterial culture as the gold standard, to evaluate the agreement of rapid antigen detection test (RADT) and rapid nucleic acid test (RNAT) in diagnosing group A Streptococcus (GAS) pharyngitis in pediatric outpatients, and assess their potential clinical utility. Methods:This cross-sectional study prospectively collected throat swab specimens and clinical data of 338 children diagnosed with acute pharyngitis at the Department of Outpatient Beijing Children′s Hospital, Capital Medical University, between July 2023 and February 2024. The specimens were tested for GAS bacterial culture, RADT and RNAT. Using bacterial culture results as the reference standard, Kappa consistency analysis was performed to assess the diagnostic concordance between RADT and RNAT. Chi-square test was used to compare clinical characteristics between cases diagnosed by different methods.Results:In the 338 children diagnosed with pharyngitis, 195 were male and 143 were female, with an age at the visit of 7.4 (5.9, 7.4) years. The positivive rates for GAS detection were 25.7% (87/338) by bacterial culture, 20.7% (70/338) by RADT, and 41.7% (141/338) by RNAT. In terms of diagnostic performance, RADT exhibited a higher specificity (96.8% (243/251)) and better agreement with bacterial culture results ( κ=0.73), whereas RNAT showed greater sensitivity (95.4% (83/87)) but lower specificity (76.9% (193/251)) and moderate agreement ( κ=0.61). Among the 87 children with positive bacterial culture for GAS, 56 were male and 31 were female, with an age at visit of 7.3 (6.2, 8.8) years. Clinically, body temperature predominantly ranged from 38.1 to 39.0 ℃ in 48 cases (55.2%), and common accompanying symptoms included sore throat 62 cases (71.3%), cough 33 cases (37.9%), and cervical lymphadenopathy or tenderness 16 cases (18.4%). On physical examination, tonsillar enlargement was present in 73 cases (83.9%) and exudate in 37 cases (42.5%). The McIsaac score was most frequently 4 points, observed in 37 cases (42.5%). Laboratory tests showed a peripheral white blood cell (WBC) count of 14.5 (12.3, 18.7)×10?/L and C-reactive protein (CRP) concentration of 22.0 (10.1, 41.4) mg/L. There were no statistically significant differences in the proportion of fever, sore throat, cough, tender cervical lymphadenopathy, tonsillar exudates, or tonsillar enlargement, nor in WBC count or CRP, among children who tested positive by RADT, RNAT, or bacterial culture (all P>0.05). Conclusions:Compared with bacterial culture,the RADT demonstrates higher specificity, while the RNAT exhibits greater sensitivity. Both methods show good concordance with culture results and may serve as effective adjunctive tools for the early screening of GAS pharyngitis.

Objective To investigate the effect of intravenous lidocaine on postoperative fatigue syndrome(POFS)in patients undergoing laparoscopic resection for gastric carcinoma.Methods A total of 80 patients who underwent elective laparoscopic resection for gastric carcinoma at Xuzhou Central Hospital between September 2023 and June 2024 were enrolled.Inclusion criteria included age 18～75 years,ASA physical status classificationⅠ～Ⅲ,body mass index(BMI)of 18.5～27.9 kg/m2,preoperative Christensen score≤4,and estimated operation time≤4 hours.Patients were randomly allocated into either the lidocaine group(Group L)or the saline group(Group C)using a random number table,with 40 patients in each group.Group L received an intravenous infusion of lidocaine at a dose of 1.5 mg·kg?1 over 15 minutes,initiated 30 minutes before anesthesia induction.If no adverse reactions occurred,lidocaine was maintained at a rate of 1.5 mg/(kg·h)throughout the surgery until its conclusion.Group C received an equivalent volume of normal saline administered in the same manner.The Christensen score and Visual Analogue Scale(VAS)scores were recorded on postoperative days 1,3,5,and 7,and the time-weighted average(TWA)of the Christensen score was calculated.Postoperative inflammatory markers were measured,and additional outcomes including extubation time,post-anesthesia care unit(PACU)stay duration,postoperative nausea and vomiting(PONV),consumption of rescue analgesics,time to first flatus and defecation,and length of hospital stay were also documented.Results Compared with Group C,the TWA of the Christensen score in Group L decreased by 0.44 points(95％CI:0.11～0.76;P<0.05).The VAS scores were significantly lower in Group L on postoperative days 1 and 3(P<0.05).Levels of IL-6 and TNF-α at the end of surgery and 24 hours after surgery were also lower in Group L(P<0.05).The time to first flatus and defecation was significantly shorter in Group L(P<0.05).There were no significant differences between the two groups regarding extubation time,PACU stay duration,incidence of PONV,postoperative consumption of remedial analgesic drugs,or length of hospital stay(P>0.05).Conclusion Intravenous lidocaine may improve POFS in patients following laparo-scopic resection for gastric carcinoma by attenuating inflammatory responses,alleviating pain,and facilitating gastrointestinal function recovery,while maintaining a favorable safety profile.

Acute large vessel occlusion stroke(ALVOS)of anterior circulation is associated with severe clinical manifestations and high rates of disability and mortality.Mechanical thrombectomy has emerged as the primary therapeutic intervention.However,post-procedural outcomes remain highly variable,and patients continue to face elevated risks of poor prognosis.Machine learning,a transformative tool in medical research,enables comprehensive analysis of multimodal data to identify specific biomarkers and improve the accuracy of predictions for clinical outcomes and adverse events.This review summarized the latest developments in machine learning applications aim at predicting post-thrombectomy prognosis and risk of adverse event,including futile recanalization,hemorrhagic transformation,and malignant cerebral edema in patients with anterior circulation ALVOS in order to provide a basis for developing personalized treatment plan and improve their clinical prognosis.

OBJECTIVE: To explore the methods, fixation points, and effectiveness of staged therapy using external fixation frame in treatment of infectious nonunion near knee joint. METHODS: A retrospective analysis was conducted on the clinical data of 60 patients with infectious nonunion near knee joint, who underwent staged therapy using external fixation frame between June 2021 and June 2024 and were followed up. There were 48 males and 12 females with an average age of 47.9 years (range, 16-70 years). The disease duration ranged from 9 months to 20 years, with a median of 14 months. Among them, 21 cases of infectious nonunion located in the distal femur, 36 cases in the proximal tibia, and 3 cases in the patella; 12 cases exhibited segmental bone defects (≥4 cm), while 48 cases presented with localized bone defects (<4 cm). Osteomyelitis was classified using the Cierny-Mader system, with 3 cases classified as type Ⅰ, 6 cases as type Ⅱ, 35 cases as type Ⅲ, and 16 cases as type Ⅳ. Preoperative C-reactive protein levels ranged from 15.1 to 55.8 mg/L (mean, 36.4 mg/L). The erythrocyte sedimentation rate was 35-80 mm/1 h (mean, 56.9 mm/1 h). The Hospital for Special Surgery (HSS) score for knee joint was 69.3±17.7 and the range of motion was (70.61±40.60)°. After debridement and placement of antibiotic carriers at the first-stage operation, unilateral orbital frames ( n=14), combined frames ( n=27), or Ilizarov frames ( n=19) were used for cross joint fixation ( n=9) or joint preservation fixation ( n=51). After 6-8 weeks of infection control, the bone grafting or bone transport was performed at the second-stage operation based on the type of bone defect, with internal fixation employed as an adjunct if necessary. After operation, the infection control and fracture healing were observed and the bone healing time was recorded. The knee joint function was assessed using the HSS score, and the knee joint range of motion was measured as well as the angle of motion loss. Patients were grouped according to the site of nonunion, type of external fixation frame, and fixation method. The bone healing time, change value of HSS score, and knee joint range of motion loss (difference between pre- and post-operation) were compared between groups. RESULTS: All infection markers returned to the normal range within 6 weeks after the first-stage operation. All patients were followed up 12-48 months (mean, 22.0 months) after the second-stage operation. There were 5 cases of needle tract infection during the external fixation period, and 3 cases of infection recurrence after the second-stage operation, all of which were cured after symptomatic treatment. The bone healing time was 6-18 months (mean, 11.0 months). At last follow-up, the HSS score was 88.5±7.9 and the range of motion was (61.84±40.59)°, with significant differences compared to preoperative values ( P<0.05); the knee joint range of motion loss was (8.77±11.07)°. The bone healing time was significantly longer in the distal femur group than in the proximal tibia group ( P<0.05), and in the unilateral orbital frames group than in the Ilizarov frames group and the combined frames group ( P<0.05). The angle of motion loss was significantly larger in the Ilizarov frames group than in the unilateral orbital frames group and the combined frames group ( P<0.05). The change value of HSS score was significantly higher in the cross joint fixation group than in the joint preservation fixation group ( P<0.05). CONCLUSION During the first-stage operation, debridement is performed and antibiotic carriers are placed to control infection. External fixation frames are then precisely positioned based on the distance between the lesion and the joint surface, avoiding the infected wound while ensuring mechanical balance. During the second-stage operation, bone grafting options are selected according to the extent of bone defects to enhance the bone union. Postoperative early functional exercises of the knee joint are permitted to improve joint function.
Humans ; Male ; Female ; Middle Aged ; Adult ; Fractures, Ununited/surgery* ; Retrospective Studies ; External Fixators ; Aged ; Knee Joint/surgery* ; Adolescent ; Young Adult ; Treatment Outcome ; Osteomyelitis/surgery* ; Fracture Fixation/instrumentation* ; Bone Transplantation ; Tibial Fractures/surgery*

OBJECTIVE: To explore the effectiveness of primary interventional revascularization combined with secondary perforator composite flap in the treatment of peripheral arterial disease (PAD) accompanied by soft tissue defects around the ankle. METHODS: Between January 2022 and January 2025, 12 patients with PAD and soft tissue defects around the ankle were admitted. Among them, there were 9 males and 3 females; their ages ranged from 52 to 82 years, with an average of 68.9 years. The causes of injury included 4 cases of traffic accident, 5 cases of falls, 1 case of falling from height, 1 case of foreign body puncture injury, and 1 case of electric shock injury. The infection duration ranged from 1 month to 35 years, with a median duration of 3.5 months. The wound size ranged from 5.5 cm×3.0 cm to 15.0 cm×9.0 cm. The ankle-brachial index (ABI) was 0.32±0.12. The visual analogue scale (VAS) score for pain was 3.3±0.5. Preoperative vascular stenosis assessment was performed in all patients, with primary intervention to dredge large and medium-sized arteries, followed by secondary repair of the wound using a perforator composite flap. The flap size ranged from 6.5 cm×4.0 cm to 16.0 cm×10.0 cm. The donor sites were sutured directly or repaired with skin grafts. After two stages of treatment, the effectiveness was evaluated by measuring ABI, observing flap survival and wound healing, assessing VAS scores, and American Orthopedic Foot and Ankle Society (AOFAS) scores. RESULTS: All 12 cases completed two stages of treatment; all patients were followed up after the second-stage treatment, with a follow-up period ranging from 7 to 28 months, with an average of 16.8 months. After the first-stage treatment, the skin temperature around the ankle was significantly higher than that before treatment, and the ABI increased to 0.71±0.07, with a significant difference ( t=9.918, P<0.001). After the second-stage treatment, the blisters on the distal end of the skin flap occurred in 3 cases. The flaps survived and the wounds healed, with a healing time ranging from 10 to 14 days (mean, 11.8 days). The incisions at the donor site healed by first intention, and the skin grafts survived. The VAS score was 0.5±0.5 at 3 weeks, which was significantly lower than that before treatment ( t=13.675, P<0.001). No infection recurrence occurred during follow-up. At 6 months after the second-stage treatment, the AOFAS score of the ankle joint ranged from 92 to 97, with an average of 94.7, all reaching excellent. CONCLUSION Interventional revascularization combined with perforator composite flap for staged treatment of PAD with ankle soft tissue defects can obtain good effectiveness, by unclogging the main blood vessels, improving lower limb blood supply, and improving the survival rate of the skin flap.
Humans ; Male ; Female ; Middle Aged ; Aged ; Peripheral Arterial Disease/surgery* ; Soft Tissue Injuries/surgery* ; Perforator Flap/blood supply* ; Plastic Surgery Procedures/methods* ; Aged, 80 and over ; Ankle/blood supply* ; Treatment Outcome ; Ankle Brachial Index ; Skin Transplantation/methods*

OBJECTIVE: To assess the osteogenesis height in maxillary sinus segment one year after zygomatic implantation by imaging methods, and evaluate the influence of patient factors, maxillary sinus anatomical factors and surgical factors on postoperative osteogenesis height. METHODS: This study is a retrospective study, including patients who underwent zygomatic implantation and whose zygomatic implants passed through the maxillary sinus at the Department of Implantology, Peking University School and Hospital of Stomatology from July 2017 to January 2022. Preoperative and postoperative cone beam CT (CBCT)was taken to measure and calculate the average osteogenesis height (AOH) in maxillary sinus segment of the zygomatic implants, then the residual bone height, the width and morphology of the maxillary sinus floor in the buccal and palatal directions were measured. Besides, the integrity of Schneiderian membrane during implant surgery, and the general information of the patients and zygomatic implants were recorded. By comparing anatomical situations and surgical characteristics, the differences of AOH under different conditions were analyzed. Then AOH was divided into two groups (obvious osteogenesis group and non-obvious osteogenesis group) using the median as the threshold, and the influencing factors of osteogenesis were evaluated using mixed effect generalized linear model univariable and multivariable analysis. RESULTS: A total of 47 zygomatic implants were implanted in 24 patients. During the average follow-up period of 12.1 months, there was no implant failure, and the implant survival rate was 100%. Postoperative CBCT showed that 43 zygomatic implants had osteogenic images in the maxillary sinus segment, most of which originated from the floor of the maxillary sinus, and the median AOH was 3.1 mm [interquartile range (IQR): 4.0 mm]. In terms of maxillary sinus width, there were 31 cases (66.0%) of wide type and 16 cases (34.0%) of narrow type. In the aspect of buccal and palatal morphology, 17 cases were taper (36.2%), 20 cases were round (42.6%), and 10 cases were flat (21.3%). The median of residual bone height was 2.8 mm (IQR: 2.2 mm) before operation. Univa-riate analysis of mixed effect generalized linear model showed that postoperative obvious osteogenic rate was related to the residual bone height (OR=2.09, P=0.006). Multivariate analysis showed that the resi-dual bone height (OR=2.55, P=0.022) and the shape of a taper maxillary sinus (OR=11.44, P=0.040) had a significant impact on the postoperative obvious osteogenic rate. CONCLUSION The maxillary sinus floor showed osteogenic images 1 year after the zygomatic implantation surgery. Larger residual bone height and the shape of a taper maxillary sinus may be favorable factors for osteogenesis.
Humans ; Maxillary Sinus/surgery* ; Cone-Beam Computed Tomography ; Retrospective Studies ; Zygoma/diagnostic imaging* ; Male ; Female ; Osteogenesis/physiology* ; Middle Aged ; Adult ; Dental Implants ; Aged ; Dental Implantation, Endosseous/methods*

Objective: To compare the biological characteristics of human induced pluripotent stem cell-derived platelet exosomes (hiPSC-Plt-Exos) with those of conventional apheresis platelet exosomes (Plt-Exos), specifically focusing on their differential abilities to enhance the proliferation and migration of human umbilical cord mesenchymal stem cells (hUC-MSCs). Methods: Exosomes were isolated from hiPSC-derived Plt and apheresis Plt concentrate using size exclusion chromatography. These exosomes were then characterized through nanoparticle tracking analysis (NTA), transmission electron microscopy (TEM), and Western blotting. Co-culture experiments into hUC-MSCs were conducted with hiPSC-Plt-Exos and apheresis Plt-Exos, respectively. Their effects on the proliferation and migration of hUC-MSCs were assessed via cell proliferation assays and scratch tests. Results: hiPSC-Plt-Exos and apheresis Plt-Exos exhibited comparable particle sizes, morphological features (such as the characteristic cup-shaped structure), and surface markers (including CD9 and HSP70). Notably, hiPSC-Plt-Exos demonstrated a significantly greater ability to enhance the proliferation and migration of hUC-MSCs compared to apheresis Plt-Exos (P<0.05). These differences provide critical comparative data for their application in various clinical contexts. Conclusion: This study establishes a theoretical foundation for developing precise therapeutic strategies based on hiPSC-Plt-Exos. Furthermore, it underscores the necessity of selecting the appropriate type of exosomes according to the specific disease microenvironment to achieve optimal therapeutic outcomes.