OBJECTIVE To optimize the management model of drugs used in investigator-initiated trial （IIT）. METHODS With benchmarking analysis， based on the practical work experience of a tertiary specialized hospital in the field of IIT drug management in Shanghai， a thorough review was conducted， involving relevant laws， regulations， and academic literature to establish benchmark criteria and the evaluation standards. Starting from the initiation of IIT projects， a detailed comparative analysis of key processes was carried out， such as the receipt， storage， distribution， use and recycling of drugs for trial. The deficiencies in the current management of IIT drugs were reviewed in detail and a series of optimization suggestions were put forward. RESULTS It was found that the authorized records of drug management were missing， the training before project implementation was insufficient， and the records of receipt and acceptance of IIT drugs were incomplete. In light of these existing problems， improvement measures were put forward， including strengthening the training of drug administrators and stipulating that only drug administrators with pharmacist qualifications be eligible to inspect and accept drugs， etc. The related systems were improved， and 17 key points of quality control for the management of IIT drugs were developed. CONCLUSIONS A preliminary IIT drug management system for medical institutions has been established， which helps to improve the institutional X2023076） framework of medical institutions in this field.

Objective: To investigate the distribution of IgM anti-A/B titers among group O whole blood donors in Jiangsu, establish a low-titer threshold, and analyze the demographic characteristics of low-titer donors, so as to provide data for recruiting low-titer group O whole blood (LTOWB) donors. Methods: Plasma samples from 1 009 group O whole blood donors were tested for IgM anti-A and anti-B titers using the microplate technique. The distribution of antibody titers was analyzed to establish a low-titer threshold. The distribution trends of titers across different demographic groups were also analyzed. Results: The peak titer for anti-A, anti-B were 64 (31.5%), 4 (23.8%), respectively, The proportion of donors with both anti-A and anti-B titers below 64 was 97.3% (982/1 009). The mean anti-A titer was higher than anti-B titer. Anti-A titers were higher in female donors than in male donors (P<0.05). The anti-A titers differed significantly among different age groups (P<0.05). However, no significant difference in titers was observed based on the number of donations (P>0.05). Conclusion: A titer of 64 can be used as the reference threshold of LTOWB in Jiangsu. Male donors of appropriate age are more suitable than female donors for establishing an emergency panel of LTOWB mobile donors.

Objective To monitor the antifungal resistance of clinical isolates of Candida spp.in the East China region.Methods MALDI-TOF MS or molecular methods were used to re-identify the strains collected from January 2018 to December 2022.Antifungal susceptibility testing was performed using the broth microdilution method.The susceptibility test results were interpreted according to the breakpoints of 2022 Clinical and Laboratory Standards Institute(CLSI)documents M27 M44s-Ed3 and M57s-Ed4.Results A total of 3 026 strains of Candida were collected,65.33％of which were isolated from sterile body sites,mainly from blood(38.86％)and pleural effusion/ascites(10.21％).The predominant species of Candida were Candida albicans(44.51％),followed by Candida parapsilosis complex(19.46％),Candida tropicalis(13.98％),Candida glabrata(10.34％),and other Candida species(0.79％).Candida albicans showed overall high susceptibility rates to the 10 antifungal drugs tested(the lowest rate being 93.62％).Only 2.97％of the strains showed dose-dependent susceptibility(SDD)to fluconazole.Candida parapsilosis complex had a SDD rate of 2.61％and a resistance rate of 9.42％to fluconazole,and susceptibility rates above 90％to other drugs.Candida glabrata had a SDD rate of 92.01％and a resistance rate of 7.99％to fluconazole,resistance rates of 32.27％and 48.24％to posaconazole and voriconazole non-wild-type strains(NWT),respectively,and susceptibility rates above 90％to other drugs.Candida tropicalis had resistance rates of 29.55％and 26.24％to fluconazole and voriconazole,respectively,resistance rates of 76.60％and 21.99％to posaconazole and echinocandins non-wild-type strains(NWT),and a resistance rate of 2.36％to echinocandins.Conclusions The prevalence and species distribution of Candida spp.in the East China region are consistent with previous domestic and international reports.Candida glabrata exhibits certain degree of resistance to fluconazole,while Candida tropicalis demonstrates higher resistance to triazole drugs.Additionally,echinocandins resistance has emerged in Candida albicans,Candida glabrata,Candida tropicalis,and Candida parapsilosis.

Objective:To assess the efficacy of endoscopic transmural drainage, transpapillary drainage and their combination in reducing cyst recurrence in patients with disconnected pancreatic duct syndrome (DPDS).Methods:A retrospective study was conducted involving 22 patients diagnosed as having DPDS in Peking Union Medical College Hospital from January 2018 to December 2022. Patient data including clinical information, imaging characteristics, drainage technique, complications, and outcomes were extracted from the medical records and telephone follow-up.Results:There were 27 endoscopic treatments in 22 patients, which were categorized into 3 groups based on the procedural approach: transmural in 11 cases, transpapillary in 8, and the combination of both in 8. The combined drainage group exhibited a significantly higher drainage success rate (100.0%, 8/8) compared with the transpapillary group (50.0%, 4/8, P=0.012), with no significant difference compared with the transmural group [90.9% (10/11), P=0.621]. The one-year recurrence rate was significantly lower in the combined drainage group [0.0% (0/8)] than that in the transmural drainage group [55.6% (5/9), P=0.018], and transpapillary drainage alone [42.9% (3/7)] though it did not reach significance ( P=0.085). No significant differences were observed in treatment success rate [45.5% (5/11), 75.0% (6/8) and 87.5% (7/8), H=3.890, P=0.143], or complication incidence [54.5% (6/11), 75.0% (6/8) and 25.0% (2/8), H=3.909, P=0.142]. Conclusion:Transmural drainage combined with pancreatic duct stent placement results in satisfactory drainage of cystic fluid in the short term and significantly reduces one-year recurrence among patients with DPDS.

Objective:To explore the risk factors for atrial fibrillation in adult patients with critically severe burns after the first surgery.Methods:This study was a retrospective case series study. From January 1, 2018 to March 31, 2023, 211 adult patients with critically severe burns were admitted to the Department of Burns of Tongren Hospital of Wuhan University & Wuhan Third Hospital and met the inclusion criteria, including 158 males and 53 females, aged 24-81 years. According to whether atrial fibrillation occurred after the first surgery, the patients were divided into postoperative atrial fibrillation (POAF) group (23 cases) and non-POAF group (188 cases). The following indexes of patients in POAF group were collected, including the onset time, duration, treatment method, and number of patients with more than once of atrial fibrillation after the first surgery. The following data of the two groups of patients were collected, including general data, such as gender, age, burn type, total burn area, full-thickness burn area, inhalation injury, underlying diseases, mechanical ventilation, and sepsis; electrolyte imbalance and blood index level before the first surgery; the first surgery-related information such as surgical length and surgical method; volume changes and vital signs during the first surgery, such as total volume of fluid infusion, total volume of blood transfusion, volume of blood loss, hypotension, and hypothermia; postoperative hypothermia; inflammatory index levels before the first surgery and on the first day after the first surgery, such as procalcitonin levels, white blood cell count, neutrophil count, lymphocyte count, platelet count, neutrophil to lymphocyte ratio (NLR), platelet count to lymphocyte ratio (PLR); mortality within 30 days of admission. The independent risk factors for occurrence of atrial fibrillation in adult patients with critically severe burns after the first surgery were screened.Results:The onset time of atrial fibrillation of patients in POAF group was 2 (2, 4) hours after the first surgery, and the duration of atrial fibrillation was 16 (6, 26) hours. Twenty-one patients were treated with intravenous injection of amiodarone, two patients were treated with cardiac electrical cardioversion, and atrial fibrillation of all patients converted to sinus rhythm after treatment. Three patients experienced atrial fibrillation more than once. The age was 59 (42, 70) years and the total burn area was 90% (70%, 94%) total body surface area (TBSA) in patients in POAF group, which were significantly higher than 48 (38, 56) years and 70% (60%, 83%) TBSA in non-POAF group (with Z values of -2.64 and -3.56, respectively, P<0.05). Compared with those in non-POAF group, the incidence rate of inhalation injury of patients in POAF group was significantly higher ( χ2=4.45, P<0.05), the total volumes of fluid infusion and blood transfusion during the first surgery were significantly increased (with Z values of -3.98 and -3.75, respectively, P<0.05), the incidence rates of hypothermia during the first surgery and hypothermia after the first surgery were significantly increased (with χ2 values of 8.24 and 18.72, respectively, P<0.05), the levels of procalcitonin before the first surgery and on the first day after the first surgery, as well as the NLR on the first day after the first surgery were significantly increased (with Z values of -3.03, -2.19, and -2.18, respectively, P<0.05), the lymphocyte count (with Z values of -2.07 and -2.60, respectively, P<0.05) and platelet count (with Z values of -3.35 and -3.58, respectively, P<0.05) were significantly reduced before the first surgery and on the first day after the first surgery, and the mortality rate within 30 days of admission was significantly higher ( χ2=4.03, P<0.05). There were no statistically significant differences in other indexes between the two groups of patients ( P>0.05). Multivariate logistic regression analysis showed that age, total burn area, and intraoperative hypothermia were independent risk factors for the occurrence of atrial fibrillation in adult patients with critically severe burns after the first surgery (with odds ratios of 1.08, 1.07, and 4.18, 95% confidence intervals of 1.03-1.12, 1.03-1.11, and 1.48-11.80, respectively, P<0.05). Conclusions:Age, total burn area, and intraoperative hypothermia are independent risk factors for the occurrence of atrial fibrillation in adult patients with critically severe burns after the first surgery. Patients with atrial fibrillation have an increased risk of death.

Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75％(27/36);boys accounted for 64％(23/36).Among the 36 neonates,31(86％)had disease onset within 3 days after birth,and 19(53％)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61％)had left cerebral infarction and 13(36％)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75％)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72％)and seizures in 10 neonates(34％).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33％,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44％(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

Sulforaphane is a naturally occurring active substance derived from cruciferous vegetables with potent antioxidant and anticancer properties. Researches have shown that sulforaphane has good bioavailability and can be absorbed by the small intestine through passive transport, followed by excretion in the form of urine via the hydrophobic acid pathway. In addition, since sulforaphane is easy to be absorbed and metabolized, wrapping sulforaphane with nanomaterials can improve its bioavailability and stability, prolong its action time in human body, and better utilize its therapeutic effect. In terms of mechanism of action, sulforaphane can activate Nrf2 and HSF1 signaling pathways, induce the expression of phase II detoxification enzymes HO-1, NADPH, GST and HSP, thus regulating the concentration of oxidative stress ROS in vivo; inhibit NF-κB signaling pathway, thus suppressing the expression of inflammatory factors TNF-α, IL-1 and IL-6; regulate epigenetic modifications, thus inhibiting HDAC and DNMT, and increasing the concentration of histone H3 and H4. By regulating the expression levels of the above factors, sulforaphane can affect the occurrence and development of cancer, neurodegenerative diseases and other diseases. In recent years, several phase I/II clinical trials have shown that sulforaphane has good drug-generating properties. For example, researchers have found that patients with skin cancer have not shown any health problems and their corresponding functional problems have improved greatly after long-term use of sulforaphane. This suggests that in the future sulforaphane has a very high medicinal potential for the treatment of cancer and neurodegenerative diseases. In this paper, we review the pharmacokinetics, target of action and safety of sulforaphane and its research progress in tumor and neurodegenerative diseases to provide a reference for the future application of sulforaphane in the treatment of tumor and neurodegenerative diseases.

To explore the application value of endoscopic ultrasound fine-needle aspiration (EUS-FNA) and endoscopic retrograde cholangiopancreatography (ERCP) in the diagnosis and treatment ofpatients with pancreatic cancer combined with obstructive jaundice.

Objective China is among the 30 countries with a high burden of tuberculosis(TB)worldwide,and TB remains a public health concern.Kashgar Prefecture in the southern Xinjiang Autonomous Region is considered as one of the highest TB burden regions in China.However,molecular epidemiological studies of Kashgar are lacking. Methods A population-based retrospective study was conducted using whole-genome sequencing(WGS)to determine the characteristics of drug resistance and the transmission patterns. Results A total of 1,668 isolates collected in 2020 were classified into lineages 2(46.0%),3(27.5%),and 4(26.5%).The drug resistance rates revealed by WGS showed that the top three drugs in terms of the resistance rate were isoniazid(7.4%,124/1,668),streptomycin(6.0%,100/1,668),and rifampicin(3.3%,55/1,668).The rate of rifampicin resistance was 1.8%(23/1,290)in the new cases and 9.4%(32/340)in the previously treated cases.Known resistance mutations were detected more frequently in lineage 2 strains than in lineage 3 or 4 strains,respectively:18.6%vs.8.7 or 9%,P<0.001.The estimated proportion of recent transmissions was 25.9%(432/1,668).Multivariate logistic analyses indicated that sex,age,occupation,lineage,and drug resistance were the risk factors for recent transmission.Despite the low rate of drug resistance,drug-resistant strains had a higher risk of recent transmission than the susceptible strains(adjusted odds ratio,1.414;95%CI,1.023-1.954;P = 0.036).Among all patients with drug-resistant tuberculosis(DR-TB),78.4%(171/218)were attributed to the transmission of DR-TB strains. Conclusion Our results suggest that drug-resistant strains are more transmissible than susceptible strains and that transmission is the major driving force of the current DR-TB epidemic in Kashgar.