OBJECTIVE To provide a reference for standardizing the conduct of positron-emitting radiopharmaceuticals’ phase 0 clinical trials （hereinafter referred to as “phase 0 clinical trials”） and advancing the development of innovative drug by medical institutions. METHODS Initiated by the First Affiliated Hospital of Jinan University， a panel of experts consisting of pharmacy， clinical medicine and medical ethics from multiple institutions was established to investigate the current landscape， and discuss the necessary conditions， procedures， and other aspects for conducting phase 0 clinical trials in medical institutions by integrating relevant national policies， regulations and expert consensus. Finally， an agreement was reached to formulate this consensus. RESULTS & CONCLUSIONS Currently， most medical institutions have deficiencies in pharmaceutical care during the management of radiopharmaceuticals and the phase 0 clinical trials. In conjunction with the Expert Consensus on the Establishment of Nuclear Pharmacist Positions， this consensus explicitly defines the responsibilities of nuclear pharmacists in the phase 0 clinical trials on the basis of the Expert Consensus for the Application of Positron Emission Tomography Radioligands for Translational Study in the Phase 0 Clinical Trials （2020 edition）， providing a guidance for high-quality participation of nuclear pharmacists from medical institutions in China in phase 0 clinical research. Additionally， in consideration of some constraints imposed by current relevant regulations， this consensus also proposes strategic recommendations， such as encouraging medical institutions to form a consortium， leading to the establishment of dedicated bases or industrial parks， holding significant implications to strengthen institutional capacity for advancing radiopharmaceutical innovation through phase 0 clinical trials.

Fragile X syndrome(FXS)is caused by abnormal duplication and amplification of the FMR1 gene CGG.This article reports a pair of brothers diagnosed with FXS by genetic testing.Two patients,aged 15 and 14 years old respectively,both had clinical manifestations such as language disorders,intellectual disabilities,attention deficit disorder,autism spectrum disorder,and FXS's characteristic facial features.The proband had a rare late-onset epileptic seizure,which was well treated with levetiracetam,while his younger brother had no electroencephalogram abnormalities after repeated follow-up.This pair of cases suggests that the clinical phenotype of FXS has diversity and heterogeneity.

Objective To investigate the correlation of serum calmodulin(CaM)level with the con-dition and prognosis of patients with severe traumatic brain injury(sTBI).Methods A total of 208 elderly sTBI patients admitted to the Geriatric Hospital and Puren Hospital Affiliated to Wuhan University of Science and Technology from January 2021 to June 2023 were enrolled,and after 3 months'follow-up,192 cases were finally included in this study.According to their progno-sis,they were divided into poor prognosis group(n=56)and good prognosis group(n=136).Their general data were collected,and serum CaM level was measured by ELISA.Pearson correla-tion analysis was used to study the correlation between the level and the disease condition.Multi-variate logistic regression model was employed to screen the prognosis related factors of sTBI pa-tients,and restricted cubic spline was applied to fit the relationship between serum CaM level and prognosis of sTBI patients.Results Midline shift,significantly lower CaM level and acute physi-ology and chronic health evaluation Ⅱ(APACHE Ⅱ)score,and obviously higher Glasgow Coma Scale(GCS)score and albumin level were observed in the good prognosis group than the poor prognosis group(P＜0.05,P＜0.01).Pearson correlation analysis showed that serum CaM level was negatively correlated with condition of sTBI(r=-0.804,P＜0.05).Multivariate logistic analysis indicated that APACHE Ⅱ score(OR=1.248,95％CI:1.076-1.447,P=0.003)and ser-um CaM level(OR=1.030,95％CI:1.017-1.044,P=0.001)were risk factors for prognosis,while,GCS score(OR=0.730,95％CI:0.536-0.994,P=0.045)and serum albumin level(OR=0.730,95％CI:0.649-0.822,P=0.001)were protective factors for poor prognosis in sTBI pa-tients.Restricted cubic spline revealed that there was a linear dose-response relationship between serum CaM level and prognosis of sTBI patients(X2=27.080,P＜0.01).Conclusion Serum CaM level is correlated with sTBI disease and prognosis.

Objective To analyze the hip joint biomechanies of the acetabular anatomical reconstruction and nonanatomi-cal reconstruction in total hip arthroplasty(THA)for Crowe type Ⅲ developmental dysplasia of the hip(DDH)by finite ele-ment method,which provided theoretical foundation and experimental basis for the anatomical acetabular reconstruction dur-ing THA in clinical practice.Methods One patient with left end-stage hip arthritis secondary to Crowe type Ⅲ DDH was se-lected in this study,who underwent total hip arthroplasty in the orthopedic department of the First Affiliated Hospital of Bengbu Medical College in April 2020.This patient was female,57 years old.The preoperative and postoperative three dimentional CT scan of the patient's pelvis were performed.Fourteen acetabular cup models with different anteversion,inclination and rotation center height were established in Mimics and 3-Matic software.The boundary and load conditions were set in Abaqus software.The Von Mises and stress distribution of the hip joint were calculated and observed.Results In the Crowe type Ⅲ DDH THA,if the hip rotation center was restored anatomically and the acetabular cup's inclination was set as 40°,the cup's anteversion var-ied from 5° to 25°,the lowest Von Mises value of acetabular cup and polyethylene liner occured in 20°anteversioin;if the hip rotation center was restored anatomically and the acetabular cup's anteversion was set as 15°,the cup's inclination varied from 35° to 55°,the lowest Von Mises value of acetabular cup and polyethylene liner occured in 35° inclination;if the acetabular cup's anteversion and inclination were set as 15°and 40°respectively,the up migration of hip rotaion center varied from 0 mm to 20 mm,the lowest Von Mises value of acetabular cup and polyethylene liner occured in 10 mm up migration.In all fourteen models,the Von Mises value of the acetabulum,acetabulum cup and polyethylene liner were lowest when the acetabular cup's anteversion and inlcination were 15°,35° respectively,as well as the rotation center was restored anatomically.Conclusion In total hip arthroplasty for Crowe type Ⅲ DDH,the anatomical restoration of hip rotation center with 15° anteversion and 35° in-clination of the acetabular cup are suggested,bone graft above the acetabular cup and additional screws are recommended si-multaneously to further reduce the Von Mises of hip joint.

Aim To observe the role of salvianolic acid B(Sal B)in enhancing the survival of random skin flaps and to preliminarily explore its potential mecha-nisms.Methods The appearance,degree of edema,color and hair condition of the skin flap were evaluated seven days after operation.The vascular network and blood flow of random flaps were measured by laser Doppler flow measurement.HE staining was used to detect the growth of microvessels in random flaps.The expressions of VEGF and CD34 were detected by im-munohistochemistry,the expressions of RIPK1,2 and LC3 Ⅱ were detected by immunofluorescence,and the effects of autophagy related proteins and signaling path-ways were detected by Western blot.Results The ex-perimental results showed that Sal B induced autophagy in the random skin flaps,promoted angiogenesis,and reduced oxidative stress and necrotic apoptosis,signifi-cantly increasing the survival rate of the flaps.Immu-nohistochemistry,immunofluorescence staining,and Western blot confirmed that Sal B induced autophagy in the random skin flaps by activating TFE3 protein.Conclusion Sal B can promote autophagy in cells of random skin flaps and reduce their necrotic apoptosis by activating TFE3 protein.

Background: and Purpose Syncope is characterized by the temporary loss of consciousness and is commonly associated with migraine. However, the genetic factors that contribute to this association are not well understood. This study investigated the specific genetic loci that make patients with migraine more susceptible to syncope as well as the genetic factors contributing to syncope and migraine comorbidity in a Han Chinese population in Taiwan. Methods: A genome-wide association study was applied to 1,724 patients with migraine who visited a tertiary hospital in Taiwan. The patients were genotyped using the Affymetrix Axiom Genome-Wide TWB 2.0 array and categorized into the following subgroups based on migraine type: episodic migraine, chronic migraine, migraine with aura, and migraine without aura. Multivariate regression analyses were used to assess the relationships between specific single-nucleotide polymorphisms (SNPs) and the clinical characteristics in patients with syncope and migraine comorbidity. Results: In patients with migraine, SNPs were observed to be associated with syncope. In particular, the rs797384 SNP located in the intron region of LOC102724945 was associated with syncope in all patients with migraine. Additionally, four SNPs associated with syncope susceptibility were detected in the nonmigraine control group, and these SNPs differed from those in the migraine group, suggesting distinct underlying mechanisms. Furthermore, the rs797384 variant in the intron region of LOC102724945 was associated with the score on the Beck Depression Inventory. Conclusions The novel genetic loci identified in this study will improve our understanding of the genetic basis of syncope and migraine comorbidity.

Objective: This study compared the outcomes of laparotomic radical hysterectomy (LRH) and minimally invasive radical hysterectomy (MISRH) in patients with early-stage cervical cancer. Methods: The clinical data of patients with early-stage cervical cancer who underwent LRH or MISRH (laparoscopic/robotic) at Chang Gung Memorial Hospital, Linkou Branch, from 2002 to 2017 were retrospectively reviewed. The surgical safety (operation time, blood loss, blood transfusion rate, length of postoperative stay, and perioperative complications), overall survival (OS), disease-free survival (DFS), and recurrence pattern were analyzed. Propensity score matching (PSM) at a 3:1 ratio was performed to balance prognostic variables. Results: Of the 760 patients (entire cohort), 614 underwent LRH and 146 underwent MISRH.After PSM, 394 and 140 patients were included in the LRH and MISRH groups, respectively.The 5-year OS rate was significantly lower in the MISRH group than in the LRH group (85.6% vs. 93.2%, p=0.043), and the 5-year DFS rate (p=0.21) did not differ significantly. After PSM, the 5-year OS rates did not differ significantly between the MISRH and LRH groups (87.1% vs. 92.1%, p=0.393). The MISRH group had a significantly shorter operation time (p<0.001), lower intraoperative blood loss (p<0.001), lower blood transfusion rate (p<0.001), and shorter postoperative stay (p<0.001) but a significantly higher rate of intraoperative bladder injury (p<0.001) than the LRH group. Conclusion After PSM, MISRH is associated with nonsignificantly lower OS but a significantly higher risk of intraoperative urological complications than LRH.

Background: and Purpose Syncope is characterized by the temporary loss of consciousness and is commonly associated with migraine. However, the genetic factors that contribute to this association are not well understood. This study investigated the specific genetic loci that make patients with migraine more susceptible to syncope as well as the genetic factors contributing to syncope and migraine comorbidity in a Han Chinese population in Taiwan. Methods: A genome-wide association study was applied to 1,724 patients with migraine who visited a tertiary hospital in Taiwan. The patients were genotyped using the Affymetrix Axiom Genome-Wide TWB 2.0 array and categorized into the following subgroups based on migraine type: episodic migraine, chronic migraine, migraine with aura, and migraine without aura. Multivariate regression analyses were used to assess the relationships between specific single-nucleotide polymorphisms (SNPs) and the clinical characteristics in patients with syncope and migraine comorbidity. Results: In patients with migraine, SNPs were observed to be associated with syncope. In particular, the rs797384 SNP located in the intron region of LOC102724945 was associated with syncope in all patients with migraine. Additionally, four SNPs associated with syncope susceptibility were detected in the nonmigraine control group, and these SNPs differed from those in the migraine group, suggesting distinct underlying mechanisms. Furthermore, the rs797384 variant in the intron region of LOC102724945 was associated with the score on the Beck Depression Inventory. Conclusions The novel genetic loci identified in this study will improve our understanding of the genetic basis of syncope and migraine comorbidity.

Objective: This study compared the outcomes of laparotomic radical hysterectomy (LRH) and minimally invasive radical hysterectomy (MISRH) in patients with early-stage cervical cancer. Methods: The clinical data of patients with early-stage cervical cancer who underwent LRH or MISRH (laparoscopic/robotic) at Chang Gung Memorial Hospital, Linkou Branch, from 2002 to 2017 were retrospectively reviewed. The surgical safety (operation time, blood loss, blood transfusion rate, length of postoperative stay, and perioperative complications), overall survival (OS), disease-free survival (DFS), and recurrence pattern were analyzed. Propensity score matching (PSM) at a 3:1 ratio was performed to balance prognostic variables. Results: Of the 760 patients (entire cohort), 614 underwent LRH and 146 underwent MISRH.After PSM, 394 and 140 patients were included in the LRH and MISRH groups, respectively.The 5-year OS rate was significantly lower in the MISRH group than in the LRH group (85.6% vs. 93.2%, p=0.043), and the 5-year DFS rate (p=0.21) did not differ significantly. After PSM, the 5-year OS rates did not differ significantly between the MISRH and LRH groups (87.1% vs. 92.1%, p=0.393). The MISRH group had a significantly shorter operation time (p<0.001), lower intraoperative blood loss (p<0.001), lower blood transfusion rate (p<0.001), and shorter postoperative stay (p<0.001) but a significantly higher rate of intraoperative bladder injury (p<0.001) than the LRH group. Conclusion After PSM, MISRH is associated with nonsignificantly lower OS but a significantly higher risk of intraoperative urological complications than LRH.

Background: and Purpose Syncope is characterized by the temporary loss of consciousness and is commonly associated with migraine. However, the genetic factors that contribute to this association are not well understood. This study investigated the specific genetic loci that make patients with migraine more susceptible to syncope as well as the genetic factors contributing to syncope and migraine comorbidity in a Han Chinese population in Taiwan. Methods: A genome-wide association study was applied to 1,724 patients with migraine who visited a tertiary hospital in Taiwan. The patients were genotyped using the Affymetrix Axiom Genome-Wide TWB 2.0 array and categorized into the following subgroups based on migraine type: episodic migraine, chronic migraine, migraine with aura, and migraine without aura. Multivariate regression analyses were used to assess the relationships between specific single-nucleotide polymorphisms (SNPs) and the clinical characteristics in patients with syncope and migraine comorbidity. Results: In patients with migraine, SNPs were observed to be associated with syncope. In particular, the rs797384 SNP located in the intron region of LOC102724945 was associated with syncope in all patients with migraine. Additionally, four SNPs associated with syncope susceptibility were detected in the nonmigraine control group, and these SNPs differed from those in the migraine group, suggesting distinct underlying mechanisms. Furthermore, the rs797384 variant in the intron region of LOC102724945 was associated with the score on the Beck Depression Inventory. Conclusions The novel genetic loci identified in this study will improve our understanding of the genetic basis of syncope and migraine comorbidity.