Ethical review represents the core of the scientific and technological ethical governance， and its quality depends on the participation of ethics. The absence of ethics and ethical experts will compromise the quality of the review. According to the spirit of the Guidelines on Strengthening the Governance over Ethics in Science and Technology， this paper analyzed the process of separating scientific and technological ethics from the field of scientific research morality， clarified the ethical attributes of ethical review， and argued that scientific research and technological innovation activities originated from ethics. On this basis， the fundamental principle of “ethics first” was proposed， aiming to proactively embed ethical considerations throughout the entire process of scientific and technological activities. This principle was the primary requirement for ensuring governance effectiveness and can also eliminate the risk of ethics being obscured in ethical governance. In practice， “ethics first” manifested specifically in dimensions such as prioritizing academic systems， prioritizing publicity， education， and training， as well as further advancing ethical considerations.

OBJECTIVE To investigate the mechanism of pachymic acid on renal injury in pregnancy induced hypertension （PIH） rats by regulating the silent information regulator transcript 1/peroxisome proliferator-activated receptor γ coactivator-1α （Sirt1/PGC-1α） pathway. METHODS Pregnant SD rats were prepared by co-caging and PIH model was induced using N-nitro-L- arginine methyl ester （L-NAME） method. PIH rats were randomly divided into model group， L-pachymic acid （low-dose pachymic acid， 10 mg/kg） group， H-pachymic acid （high-dose pachymic acid， 20 mg/kg） group， and H-pachymic acid+EX527 （20 mg/kg pachymic acid+10 mg/kg EX527） group， with 6 rats in each group. Another 6 normal pregnant rats were selected as blank group. Each group was given relevant medicine or solvent intragastrically or intraperitoneally daily， once a day， for 28 consecutive days. After the last administration， 24 h urinary protein and tail artery systolic blood pressure （SBP） were measured in pregnant rats from each group， along with the levels of serum creatinine （Scr）， blood urea nitrogen （BUN），uric acid （UA）， and cystatin C （Cys-C）. The contents of superoxide dismutase （SOD）， malondialdehyde （MDA）， glutathione peroxidase （GSH-Px）， and 8-hydroxy-2′-deoxyguanosine （8-OHdG） in renal tissue， as well as the mRNA and protein expression levels of Sirt1 and PGC-1α， were also determined. Meanwhile， renal histopathological changes in rats from each group were evaluated using hematoxylin-eosin （HE） staining and periodic acid-Schiff （PAS） staining. RESULTS Compared with model group， L-pachymic acid group and H-pachymic acid group exhibited significant decreases in 24 h urine protein quantification， tail artery SBP， Scr， BUN， UA， Cys-C levels， glomerulosclerosis index score of renal tissue， renal tubular injury score， the percentage of PAS positive area， MDA and 8-OHdG （P＜0.05）. Conversely， the contents of SOD and GSH-Px， along with the mRNA and protein expression levels of Sirt1 and PGC-1α， were significantly increased （P＜0.05）. Moreover， these improvements were more pronounced in H-pachymic acid group （P＜0.05）. Compared with H-pachymic acid group， the aforementioned indicators in pregnant rats from the H-pachymic acid+EX527 group showed significant reversal （P＜0.05）. CONCLUSIONS Pachymic acid significantly ameliorates renal injury induced by PIH in rats， potentially through activation of the Sirt1/PGC-1α pathway.

Drug clinical trials constitute a critical link in new drug development and an essential means to verify the safety and efficacy of pharmaceuticals. The protection of participants’ rights and interests and the prevention of risks directly affect the scientific ethics and social credibility of the trials. Vulnerable groups， due to restricted autonomous decision-making capacities or special social status， are more susceptible to safety risks. Children are a typical representative of vulnerable groups. Their physiological particularities， cognitive limitations， and dependence collectively epitomize the universal protection demands of vulnerable research participants. Taking children as an instance， this paper analyzes the current weak links in the protection of pediatric research participants. Integrating advanced international experience with domestic practical demands， it comprehensively identified protection risk points at every stage and constructed a multi-stakeholder collaborative mechanism for the full-process protection of pediatric research participants. This mechanism incorporated seven main entities， including drug regulatory authorities， sponsors， researchers， and ethics committees， covering the pre-trial， intra-trial， and post-trial phases to meet the requirements of full-chain and multi-dimensional protection. It provided references for the subsequent establishment of a systematic protection mechanism for vulnerable populations.

Objective To evaluate the effectiveness of WeChat group integrating with BOPPPS instructional model in the standardized training of nurses in an orthopedics department.Methods A total of 56 nurses in orthopedical standardized training from a hospital were selected and divided into a control group(28 nurses from September 2022 to August 2023)and an interven-tion group(28 nurses trained via WeChat groups and the BOPPPS model from September 2023 to August 2024).The two groups were compared in terms of their final assessment scores,critical thinking,and self-directed learning capabilities.Results After training,the intervention group had significantly higher scores in the final assessment,all items of the California Critical Thinking Disposition Inventory,and all dimensions of the Learning Ability Assessment Scale compared to the control group(all P＜0.05).Conclusion WeChat groups combined with the BOPPPS teaching mode effectively improves the self-directed learning ability,critical thinking skills,and assessment results of orthopedic nurses.

Objective To investigate the effect of Scutellarin(Scu)regulating miR-26a-3p/Survivin molecular axis on myocardial ischemia/reperfusion injury(MIRI)in rats and its mechanism.Methods Fifty SD rats were randomly divided into sham group,model group,scutellarin group(Scu),miR-26a-3p agomir group(agomir)and scutellarin+miR-26a-3p agomir group(Scu+agomir)with 10 rats in each group.The animal model of MIRI was established by ligating the anterior descending coronary artery.The rats in each group were given 20 mg/kg Scu or 10 nmol agomir before and during operation,respectively,and the rats in sham group and model group were given the same amount of solvent.At 48 h after operation,the cardiac function of rats was examined by echocardiography.The pathological changes of myocardial tissue were detected by HE staining.The levels of myocardial injury markers creatine kinase isoenzyme MB(CK-MB),lactate dehydrogenase(LDH)and cardiac troponin I(cTnI)in serum and the contents of oxidative markers Malondialdehyde(MDA),superoxide dismutase(SOD)and glutathione peroxidase(GSH-Px)in myocardial tissue were detected by biochemical kit.The apoptosis of rat cardiomyocytes was detected by TUNEL staining.The mRNA expression levels of miR-26a-3p and Survivin in rat myocardium were detected by qRT-PCR.Expression levels of Survivin,cyclin-dependent kinase inhibitor(p21)and cleaved-caspase 3 were detected by Western blot.Results Compared with sham group,the pathological damage of myocardial tissue in the model group was serious,the levels of cardiac function LVEDP and serum CK-MB,LDH and cTnI significantly increased(P<0.01),and the levels of LVESP,LVEF and LVFS significantly decreased(P<0.01).The apoptosis level and MDA level of myocardial tissue significantly increased(P<0.01),while the SOD and GSH-Px levels significantly decreased(P<0.01).Meanwhile,the expression levels of miR-26a-3p and cleaved-caspase 3 protein significantly increased(P<0.01),the p21 protein and Survivin mRNA and protein expression levels significantly decreased(P<0.01).Compared with model group,the pathological injury of myocardium in Scu group was significantly improved,the levels of cardiac function LVEDP and serum CK-MB,LDH and cTnI significantly decreased(P<0.01),and the levels of LVESP,LVEF and LVFS significantly increased(P<0.01).The apoptosis level and MDA level of myocardial tissue significantly decreased(P<0.01),while the SOD and GSH-Px levels significantly increased(P<0.01).Meanwhile,the expression levels of miR-26a-3p and cleaved-caspase 3 protein significantly decreased(P<0.01),the p21 protein and Survivin mRNA and protein expression levels significantly increased(P<0.01).However,intervention with miR-26a-3p agomir could significantly reverse the improvement effect of Scu on MIRI in rats.Conclusion Scu can improve cardiac function and myocardial injury and inhibit myocardial cell apoptosis in MIRI rats,and its mechanism may be related to the regulation of miR-26a-3p/Survivin molecular axis.

Objective To explore the risk signals of niraparib and provide references for rational and safe clinical medication.Methods Niraparib-related adverse drug events(ADEs)reports from Q1 2017 to Q2 2023 were extracted from the US FDA Adverse Event Reporting System(FAERS)database.Risk signals were identified using the reporting odds ratio(ROR),proportional reporting ratio(PRR),Bayesian confidence propagation neural network(BCPNN),and multi-item gamma Poisson shrinker(MGPS)methods.The Risk signals were described and classified by preferred system organ classes(SOCs)and preferred terms(PTs)from the Medical Dictionary for Regulatory Activities(MedDRA)version 26.1,and the occurrence of niraparib-related ADEs was also analyzed.Results A total of 16,961 ADE reports with niraparib as the primary suspected drug were extracted.Through screening and analysis,32 PTs were identified involving 11 SOCs,which were largely consistent with the information in the drug label.However,suspicious signals not mentioned in the label,including neuropathy peripheral,decreased red blood cell count,reduced hematocrit,dehydration,and hot flashes,require further attention.The median occurrence time was 22 days(IQR 2-98 days),and the Weibull distribution test indicated an early failure-type curve.Conclusion When using niraparib,particularly in early stages of treatment,it is essential to monitor not only the ADEs mentioned in the drug instructions,such as decreased platelet count,nausea and fatigue,but also to pay close attention to the ADEs not included in the instructions,such as peripheral neuropathy and decreased red blood cell count,which exhibit strong signal values,to ensure patient medication safety.

Objective:To evaluate the safety and efficacy of digital technology-assisted debridement and bone and soft tissue reconstruction in the treatment of chronic osteomyelitis of the tibia.Methods:This retrospective study analyzed clinical data from 38 patients (26 males, 12 females; mean age 45.61±18.36 years, range 16-83 years) with chronic post-traumatic osteomyelitis complicated by soft tissue defects in the tibia, treated at the Department of Orthopaedics, Fourth Medical Center of PLA General Hospital between June 2021 and June 2023. There were 18 cases of traffic accidents, 6 cases of high-altitude falls, 6 cases of heavy objects and 6 cases of low-energy falls. Lesion sites: 12 cases in the upper segment of the tibia, 12 cases in the middle segment, and 14 cases in the lower segment. According to the Cierny-Mader classification, there were 24 cases of type III and 14 cases of type IV. Before the operation, the "3D point cloud technology" was used to plan the debridement range of bone and soft tissue. During the operation, the optical navigation system was used to monitor the debridement range in real time. The flap was designed by combining "Reading Tablet Treasure" with CT angiography, and the amount of bone graft was predicted by AI algorithm. The surgical method adopted is the Masquelet technique, namely thorough debridement, bone cement occupation and soft tissue repair in the first stage, and bone reconstruction in the second stage. Comparing the calculated bone defect amount and soft tissue defect area before the operation with the actual measured values after debridement. The cure rate of infection was evaluated by using the McKee bone infection treatment criteria after the operation. The visual analogue scale (VAS) for pain, lower extremity functional scale (LEFS), and self-rating anxiety scale (SAS) were used to evaluate the improvement of the quality of life of postoperative patients.Results:38 patients were followed up with a mean follow-up of 13.53±2.37 months. 37 patients' infections were effectively controlled, and 1 patient had a recurrence of infection, with an effectiveness rate of 97% for the treatment of McKee's infections. The preoperative calculated bone defect amount and soft tissue defect area were 51.05±26.31 cm 3 and 68.42±43.45 cm 2 respectively, and the actual measured values after debridement during the operation were 51.66±26.35 cm 3 and 68.82±43.76 cm 2 respectively. There was no statistically significant difference before and after the operation ( P>0.05). The interval between the first and second stage surgeries was 10.36±1.61 weeks, and all flaps survived after the first stage surgery. Two months after the operation, one case had recurrent osteomyelitis. After palliative treatment, sinus tracts were formed at the infection site. At the 12-month regular dressing change follow-up, there were still purulent secretions in the sinus tracts. There was no recurrence of infection after primary debridement in 37 cases, and the bone grafts healed. The bone healing time was 3.58±0.97 months. The postoperative VAS, LEFS, and SAS scores were 1.00±0.91, 66.68±7.91, and 34.30±4.29, respectively, which were significantly improved compared with the preoperative scores of 7.54±1.52, 21.22±4.29, and 52.70±6.74, respectively, and the difference was statistically significant ( P<0.05). Conclusions:The application of digital technology to precisely design the debridement range of bone and soft tissue, and the real-time holographic visualization monitoring of the debridement range during the operation can achieve precise debridement of bone and soft tissue and personalized and precise repair of soft tissue defects. It is a safe and effective technique for the treatment of chronic osteomyelitis of the tibia.

OBJECTIVE: To observe the clinical efficacy of acupuncture combined with bamboo-based medicinal moxibustion in the treatment of chronic insomnia complicated with mild depressive state. METHODS: A total of 60 patients with chronic insomnia complicated with mild depressive state were randomly divided into an observation group and a control group, 30 cases in each group. The control group was treated with acupuncture at bilateral Zhaohai (KI6), Shenmen (HT7), Sanyinjiao (SP6), Anmian (Extra) and Sishencong (EX-HN1), Baihui (GV20), etc. The observation group was treated with bamboo-based medicinal moxibustion based on the treatment in the control group, on the abdomen，Shenque (CV8), Guanyuan (CV4), Zhongwan (CV12) and bilateral Tianshu (ST25) were selected , on the back, the acupoints of governer vessel from Dazhui (GV14) to Yaoshu (GV2) were selected. Both groups were treated once every other day, 3 times a week for 4 weeks. The Pittsburgh sleep quality index (PSQI) score, Hamilton depression scale-17 (HAMD-17) score, insomnia severity index (ISI) score, fatigue assessment instrument (FAI) score before and after treatment and after 2 weeks of treatment completion (follow-up) were observed in the two groups, and the serum level of γ-aminobutyric acid (GABA) before and after treatment was detected in the two groups, and the clinical efficacy and safety were evaluated. RESULTS: After treatment and in the follow-up, the sub-item scores and total scores of PSQI in both groups were reduced compared with those before treatment (P<0.001); except for the score of daytime dysfunction in the follow-up, the scores of sleep quality, sleep duration, daytime dysfunction, and total scores of PSQI in the observation group were lower than those in the control group (P<0.05). After treatment and in the follow-up, the HAMD-17, ISI and FAI scores in both groups were reduced compared with those before treatment (P<0.001); the scores in the observation group were lower than those in the control group (P<0.05). After treatment，the serum levels of GABA in both groups were increased compared with those before treatment (P<0.05); the level in the observation group was higher than that in the control group (P<0.05). The total effective rate of treating chronic insomnia in the observation group was 96.7% (29/30), which was higher than 80.0% (24/30) in the control group (P<0.05); and the total effective rate of improving mild depressive state was 93.3% (28/30), which was higher than 66.7% (20/30) in the control group (P<0.001). During the treatment period, no serious adverse reactions occurred in both groups. CONCLUSION Acupuncture combined with bamboo-based medicinal moxibustion has definite efficacy in the treatment of chronic insomnia complicated with mild depressive state, and has synergistic efficacy in improving sleep quality, sleep duration, daytime dysfunction and depressive state, its action mechanism may be related to the increase of serum level of GABA.
Humans ; Moxibustion ; Sleep Initiation and Maintenance Disorders/therapy* ; Male ; Female ; Middle Aged ; Adult ; Depression/therapy* ; Acupuncture Therapy ; Combined Modality Therapy ; Treatment Outcome ; Aged ; Young Adult ; Acupuncture Points

Purpose To investigate the expression of chromogranin A(CgA)in gastroenteropancreatic neuroendo-crine neoplasms(GEP-NENs)and its relationship with clinicopathological features.Methods The clinicopathological data of GEP-NENs diagnosed in the Department of Pathology,Beijing Chao-yang Hospital,Capital Medical University from May 2011 to December 2024 were retrospectively analyzed.Immunohistochemical staining was applied to evaluate the expression of CgA,and the patients were divided into CgA(+)group and CgA(-)group.Differences in clinico-pathological features between the 2 groups were compared.Results The age of 229 patients ranged from 21 to 89 years,with an average age of 54.4 years.The most common primary site was the rectum(56.8％,130/229),fol-lowed by the stomach(16.6％,38/229),pancreas(14.4％,33/229),small intestine(6.1％,14/229),and colon(6.1％,14/229).There were 206 cases of single lesion and 23 cases of multiple lesions(number of tumors ≥2).There were 153 cases of G1(66.8％),29 cases of G2(12.7％),7 cases of G3(3.1％),and 40 cases of neuroendocrine carcinoma(NEC,17.5％).The positive rates of CgA in G1,G2,G3,and NEC groups were 37.2％,75.8％,71.4％,and 65.0％,respectively,with statistically significant differences(P＜0.001).The positive rates of CgA in T1,T2,T3,and T4 were 37.2％,83.3％,75.9％,and 57.7％,respectively,with statistically significant differences(P＜0.001).There were significant differences in age,vascular invasion,lymph node metasta-sis,and number of tumors between CgA(+)group and CgA(-)group(P＜0.001),but there was no significant difference in sex,tumor location,Syn,and CD56 expression between the two groups(P=0.595,P=0.098,P=0.173,P=0.557).Conclusion Immunohistochemical antibody CgA is a useful marker for GEP-NENs.CgA positiv-ity may be a poor prognostic factor for GEP-NENs patients.

Objective To observe the clinical and echocardiographic manifestations of Williams syndrome(WS).Methods Two children with WS were retrospectively enrolled,and 21 cases of WS in literature were reviewed,and clinical and echocardiographic manifestations of WS were observed.Results Clinical manifestations of 23 cases including 21 cases of"elf"face,8 cases of intellectual disability,7 cases of developmental delay,7 cases of inguinal hernia,6 cases of hypothyroidism,4 cases of hypercalcemia,3 cases of urinary system abnormalities(1 case of hydrocele,1 case of ureteral dilation and tortuosity,and 1 case of kidney stones),2 cases of behavioral abnormalities,2 cases of feeding difficulties,1 case of congenital hypertrophic pyloric stenosis,1 case of binocular esotropia,1 case of hyperbilirubinemia,and 1 case of corpus callosum dysplasia.Echocardiography showed cardiovascular malformations in all 23 cases,including 20 cases of supravalvular aortic stenosis(SVAS),18 cases of pulmonary artery stenosis(PAS)and 10 cases of other cardiovascular malformations.Conclusion WS presented multiple system abnormalities in clinic,and cardiovascular malformations,especially SVAS and PAS could often be detected with echocardiography.