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: o develop an onset risk prediction nomogram for patients with homocysteine-type (H-type) hypertension (HTH) based on pulse diagram parameters to assist early clinical prediction and diagnosis of HTH. Methods: Patients diagnosed with essential hypertension and admitted to Shanghai Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai Hospital of Traditional Chinese Medicine, and Shanghai Hospital of Integrated Traditional Chinese and Western Medicine from July 6th 2020 to June 16th 2021, and from August 11th 2023 to January 22nd 2024, were enrolled in this retrospective research. The baselines and clinical biochemical indicators of patients were collected. The SMART-I TCM pulse instrument was applied to gather pulse diagram parameters. Multivariate logistic regression was adopted to analyze the risk factors for HTH. RStudio was employed to construct the nomogram model, receiver operating characteristic (ROC) curve, and calibration curve (bootstrap self-sampling 200 times), and clinical decision curve were drawn to evaluate the model’s discrimination and clinical effectiveness. Results: A total of 168 hospitalized patients with essential hypertension were selected and divided into non-HTH group (n = 29) and HTH group (n = 139). Compared with non-HTH group, HTH group had a lower body mass index (BMI), and higher proportions of male patients and drinkers (P < 0.05). The ventricular wall thickening (VWT) could not be determined. The proportions of left common carotid intima-media wall thickness (LCCIMWT) and serum creatinine (SCR) were higher in HTH group (P < 0.05). The pulse diagram parameter As was significantly higher, and H4/H1 and T1/T were lower in HTH group (P < 0.05). Gender, alcohol consumption, serum creatinine, and the pulse diagram parameter H4/H1 were identified as independent risk factors for HTH (P < 0.05). The nomogram’s area under the ROC curve (AUC) was 0.795 [95% confidence interval (CI): (0.706 6, 0.882 8)], with a specificity of 0.724 and sensitivity of 0.799. After 200 times repeated bootstrap self-samplings, the calibration curve showed that the simulated curve fits well with the actual curve (x2 = 9.5002, P = 0.301 9). The clinical decision curve indicated that the nomogram’s applicability was optimal when the threshold for predicting HTH was between 0.38 and 1.00. Conclusion The nomogram model could be valuable for predicting the onset risk of HTH and pulse diagram parameters can facilitate early screening and prevention of HTH.

Objective: To explore the association between parental education level and time spent outdoors among children, so as to provide the scientific evidence for formulating policies of myopia prevention and control among children. Methods: The study was based on secondary analysis of data from outdoor intervention studies in Shanghai. The follow up period was from March to December 2018. It included control group children ( n =1 117) with complete questionnaire surveys, ocular examinations, and time spent outdoors. Generalized linear regression models and trend tests were used to analyze the effect of parental education level on time spent outdoors among children. Results: The median time spent outdoors was 76.4(59.7, 94.6) minutes. After adjusting for covariates including children s sex and age, generalized linear regression model suggested that there was no statistical significance between father s education level and outdoor activity time ( P >0.05). Compared with children whose mothers had a junior high school education or below, children whose mothers had high school/vocational high school education, college or above had shorter time spent outdoors ( β=-6.64, -8.84 , P <0.05). Trend tests revealed that time spent outdoors among children decreased with the increase of parental education level ( P trend <0.01). Conclusions The higher the education level of fathers or mothers, the shorter time spent outdoors of children. In addition to highlight outdoor activities at school, myopia prevention and control efforts should be focused on the role of parents in increasing children s outdoor activities.

AIM:To investigate the effect of vaccarin(VAC)on endothelial dysfunction in type 2 diabetes mellitus(T2DM),and to uncover the underlying mechanisms.METHODS:(1)C57BL/6 mice received intraperitoneal injection of streptozotocin and were fed with a high-fat diet(21.8 kJ/kg,60%of the energy source was fat)to construct a T2DM mouse model.Thirty mice were randomly divided into control,T2DM and T2DM+VAC groups,with 10 mice in each group.The mice in T2DM+VAC group were given 1 mg/kg VAC via oral gavage for 6 weeks,while those in control and T2DM groups were given the same volume of PBS.The mRNA and protein expression levels of BCL2-interacting pro-tein 3(BNIP3),PTEN-induced kinase 1(PINK1)and parkin in the thoracic aorta were detected by RT-qPCR and West-ern blot.(2)Human umbilical vein endothelial cells(HUVECs)were stimulated by high glucose(HG;35 mmol/L glu-cose).Mitochondrial membrane potential,autophagy and mitochondrial superoxide levels were detected using JC-1,acri-dine orange(AO)and MitoSOX staining,respectively.RESULTS:Compared with control group,the mRNA and protein levels of BNIP3,PINK1 and parkin were significantly increased in the thoracic aorta of T2DM mice(P<0.05).Compared with T2DM group,the mRNA and protein levels of BNIP3,PINK1 and parkin in the thoracic aorta were significantly re-duced in T2DM+VAC group(P<0.05).The results of JC-1,AO and MitoSOX staining showed that VAC attenuated the decrease in mitochondrial membrane potential and the increase in autophagy and mitochondrial superoxide levels in HG-in-duced HUVECs.Treatment with VAC also inhibited HG-mediated mitochondrial damage in HUVECs after BNIP3 overex-pression.The effect of miR-570-3p mimic on mitochondrial damage was similar to VAC.RT-qPCR and Western blot showed that both miR-570-3p mimic and VAC significantly reduced the mRNA and protein levels of BNIP3,PINK1 and parkin.In contrast,inhibition of miR-570-3p exhibited the opposite effects.CONCLUSION:Treatment with VAC alle-viated endothelial dysfunction in T2DM by inhibiting HG-induced mitochondrial dysfunction through miR-570-3p/BNIP3.

ObjectiveThis study aims to investigate the changes in fungal community diversity and volatile components during the aging process of Aquilariae Lignum Resinatum and explore the internal relationship between them. MethodAquilariae Lignum Resinatum samples with different aging years were collected. High-throughput sequencing was employed to analyze the fungal diversity and abundance， and α and β diversity indicators were calculated to reveal the composition and dynamic changes of the fungal community. In addition， the essential oils of Aquilariae Lignum Resinatum with different aging years were extracted， separated， and identified by two-dimensional gas chromatography-high resolution time-of-flight mass spectrometry. ResultA total of 61 compounds were identified from the volatile components of five groups of Aquilariae Lignum Resinatum samples， including 2 monoterpenes， 24 sesquiterpenoids， 1 diterpene， 13 aromatic hydrocarbons， 9 alkanes， and 12 other compounds. Among them， the volatile compounds isolated from the sample aged for 1 year had the largest number， and those from the sample aged for 2 years accounted for the largest proportion of the total components. The internal transcribed spacer（ITS） amplicon sequencing revealed that the fungi in the five groups of samples belonged to 162 genera. Kirschsteiniothelia， Aspergillus， Lasiodiplodia， Phaeoacremonium， and Trichoderma were the dominant fungal genera. The fungal diversity in the Aquilariae Lignum Resinatum sample aged for 4 years was significantly higher than that in the samples aged for 0 to 3 years. ConclusionThe volatile component content and composition of Aquilariae Lignum Resinatum altered dramatically during aging. The aging of Aquilariae Lignum Resinatum was accompanied by the increasing fungal diversity， decreasing relative content of aromatic hydrocarbons， and increasing relative content of sesquiterpenoids. In general， aging was beneficial to the transformation of sesquiterpenoids and the enrichment of fungi.

Objective:To study the risk factors of postoperative permanent hypoparathyroidism after total thyroidectomy.Methods:In this retrospective study ,the receiver operating characteristic (ROC) curve of postoperative 24 h parathyroid hormone(PTH) values was used to predict the risk of permanent hypoparathyroidism.The clinical and pathological features that related to postoperative permanent hypoparathyroidism were studied by χ2 test and multivariate Logistic regression analysis. Results:Eight hundred and eighty-nine patients were enrolled, the incidence of postoperative transient and permanent hypoparathyroidism was 33.3% and 4.0%, respectively. When 24 h PTH levels less than or equal to 5.84 pg/ml were used as cut off value, the sensitivity of the prediction of permanent hypoparathyroidism was 100%, the specificity was 72%, and the positive predictive value was 22.5%. The presence of parathyroid gland in the pathologic specimen, parathyroid autotransplantation and PTH≤5.84 pg/ml at 24 h after operation were statistically significant risk factor for permanent hypoparathyroidism in multivariate analysis( χ2=10.900, P=0.001; χ2=4.415, P=0.044; χ2=13.576, P=0.000). Group analysis found that the lower 24 h PTH the higher incidence of permanent hypoparathyroidism. Conclusions:For patients undergoing total thyroidectomy, when parathyroid gland is involved and/or the PTH value is low at 24 h after surgery, the occurrence of permanent hypoparathyroidism is high.

Objective To analyze the changes in morphology of intervertebral foramina in patients with cervical spondylotic radiculopathy (CSR) treated with fixedpoint lateral flexion and rotation manipulation based on three-dimensional (3D) reconstruction technology, so as to provide references for the effectiveness of manipulation treatment. MethodsForty patients with CSR were treated with fixed point lateral flexion and rotation manipulation once every other day for a total of 7 times and 2 weeks as a course of treatment. CT data of the patients before and after treatment were analyzed by using multifunctional CT, Mimics 21.0, Geomagic and SolidWorks 2017. The area of the intervertebral foramen, anterior and posterior diameter of the intervertebral foramen, upper and lower diameter of the intervertebral foramen were measured before and after treatment, as well as the infrared thermal imaging temperature differences of the bilateral neck and shoulder, front and back of the upper limb, and the VAS scores of the patients were observed before treatment, 7 d after treatment, 14 d after treatment and 1 month follow-up. Results Foraminal area, anterior and posterior diameters, upper and lower diameters of 40 patients were improved after treatment, and the temperature differences of infrared thermal imaging of patients before and after treatment were statistically significant. The VAS score of the patients decreased progressively. Conclusions Fixed point lateral flexion manipulation can significantly improve the shape of the intervertebral foramen in patients with CSR, so as to achieve the treatment purpose of relieving nerve compression.

Objective:To investigate the pathogenesis, selection of endovascular treatment (EVT) strategies, and efficacies of acute vertebrobasilar artery occlusion (AVBAO) of different lesion sites.Methods:One hundred and five patients with AVBAO, admitted to and accepted EVT in our hospital from February 2017 to September 2019, were chosen in our study. The data of disease onset, imaging findings, EVT status, perioperative complications, and prognoses of these patients were collected. According to DSA results, the involved lesions were divided into 4 sites: the upper segment of basilar artery (BA), the middle segment of BA, the lower segment of BA, and the intracranial segment of vertebral artery (V4 segment), and patients with tandem lesions would be recorded as distal lesions. The risk factors, EVT strategies, and prognoses 90 d after follow-up (modified Rankin scale [mRS] scores≤3: good prognosis) were compared in patients with 4 different lesion sites.Results:There were significant differences in etiological classifications and percentage of patients combined with atrial fibrillation among patients with 4 different lesion sites ( P<0.05). There was significant difference in proportion of patients accepted emergency stent implantation among patients with 4 different lesion sites ( P<0.05): those with lesions at the V4 segment had the highest proportion of patients accepted emergency stent implantation (79.55%), followed by those with lesions at the lower segment of BA (50.00%). There was significant difference in EVT time (the time from arterial puncture to successful recanalization of occluded vessels) among patients with 4 different lesion sites ( P<0.05): the EVT time in patients with lesions at the middle segment of BA was the shortest (87.5 [58.5, 130.8] min), and the EVT time in patients with lesions at the lower segment of BA was the longest (115.0 [81.0, 163.0] min). There was no statistical difference among patients with different lesion sites in good prognosis rate 90 d after follow-up ( P>0.05). Conclusion:The pathogenesis of patients with different AVBAO lesion sites is different, so different EVT strategies should be adopted.

Objective:To explore the relationship between neutrophil to lymphocyte ratio(NLR) and first pass effect (FPE) during mechanical thrombectomy in patients with acute anterior circulation large vessel occlusive stroke.Methods:Four hundred and six patients with acute anterior circulation large vessel occlusive stroke, admitted to and received mechanical thrombectomy in our hospital from January 2018 to June 2021, were chosen in our study. They were divided into FPE group ( n=186) and non-FPE group ( n=220) according to whether the occluded vessels were successfully or completely re-canalized after the first mechanical thrombectomy. The baseline data, clinical characteristics and operation related data were recorded and compared. The factors with P<0.05 in univariate analysis were included in multivariate Logistic regression analysis to identify the independent factors for FPE. The receiver operating characteristic (ROC) curve was plotted to compare the effectiveness of various factors in predicting FPE. Results:Univariate analysis showed that there were significant differences in gender, proportion of different collateral circulation grading, neutrophil count, lymphocyte count, platelet to lymphocyte ratio (PLR), and NLR between the two groups ( P<0.05). As compared with non-FPE group, FPE group had significantly higher ASPECTS scores at admission, significantly shorter time from femoral artery puncture to recanalization, significantly higher proportion of vascular recanalization, statistically higher proportion of patients using balloon guiding catheter, significantly lower ratio of contrast extravasation, significantly lower incidences of spontaneous intracerebral hemorrhage and mortality, and statistically higher rate of good prognosis 90 d after surgery ( P<0.05). The results of multivariate Logistics regression analysis showed that gender ( OR=0.686, 95%CI: 1.131-3.491, P=0.017), ASPECTS scores ( OR=0.143, 95%CI: 0.094-0.220, P<0.001), NLR ( OR=1.722, 95%CI: 1.413-2.098, P<0.001), and PLR ( OR=1.007, 95%CI: 1.003-1.014, P<0.001) were independent factors for FPE. ROC curve results showed that the areas under the curve predicted by gender, ASPECTS scores, PLR, NLR and combination of multiple factors (gender+ASPECTS scores+PLR+NLR) were 0.60, 0.17, 0.71, 0.77 and 0.91, respectively; among them, NLR had the highest efficacy in single-factor prediction for FPE, with cut-off value of 5.86, specificity of 83.3%, and sensitivity of 62.3%. Conclusion:High NLR at admission in patients with acute anterior circulation large vessel occlusive stroke is likely to have FPE failure during mechanical thrombectomy.

Objective:To investigate the safety and effectiveness of Willis covered stent in patients having carotid artery rupture during transnasal endoscopic pituitary tumor resection.Methods:A retrospective analysis was performed. Six patients having carotid artery rupture during transnasal endoscopic pituitary tumor resection admitted to the 3 hospitals from May 2016 to December 2019 were chosen; their clinical data were collected. The surgical processes and complications were concluded, and the prognoses were evaluated by modified Rankin scale (mRS).Results:One patient was treated with intraoperative simple tamponade compression for hemostasis, and died for massive intracranial hemorrhage 2 weeks after surgery. Five patients were occluded by Willis covered stents; the occluded success rate was 100% but ophthalmic arteries were blocked in all. During the perioperative period, diabetes insipidus occurred in one patient and incomplete oculomotor paralysis occurred in one patient; 5 patients were followed up for 3-12 months: MRI indicated subtotal resection of tumor in 4 patients and total resection in one patient, no new bleeding or ischemic stroke events occurred in these 5 patients, and the prognosis was good.Conclusion:Willis covered stent is safe and effective in patients having carotid artery rupture during transnasal endoscopic pituitary tumor resection.