1.Expert consensus on the phase 0 clinical trials of positron-emitting radiopharmaceuticals (2025 edition)
Lu WANG ; Jinghao WANG ; Kuan HU ; Dongning YAO ; Benzhi CAI ; Chen SHI ; Baofeng YANG ; Rui WANG
China Pharmacy 2025;36(15):1825-1831
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.
2.Effects of Total Knee Arthroplasty on Proprioception in Patients with Knee Osteoarthritis
Quan ZHANG ; Jingnan SHI ; Kuan ZHANG ; Haohua ZHANG ; Songhua YAN
Journal of Medical Biomechanics 2024;39(4):663-669
Objective To explore proprioceptive changes in patients with knee osteoarthritis(KOA)before and after total knee arthroplasty(TKA).Methods Thirty-four KOA patients were selected as the experimental group and divided into posterior-cruciate-retaining TKA(CR-TKA)and posterior-stabilized TKA(PS-TKA)groups according to the surgical method and followed up for three months after the surgery.Twenty healthy individuals were included as the control group.The proprioception(position sense,kinesthesia,and force sense)of healthy individuals and KOA patients before and after surgery was assessed using the Biodex system III isokinetic training system,self-designed force sense test equipment,and surface electromyography test system,and the data were processed and analyzed.Results Compared with healthy individuals,KOA patients had significantly worse position sense at 30°,45°,and 60°,kinesthesia,and semitendinosus force sense in the affected and unaffected knees(P<0.05).Three months after surgery,there were significant differences in the force sense of the affected biceps femoris and contralateral semitendinosus forces in the CR-TKA group compared with healthy individuals(P<0.05).There were no statistically significant differences in deviation for preoperative and 3-month preoperative position sense,kinesthetic sense,and force sense on the affected and contralateral knee joints between the CR-TKA and PS-TKA groups(P>0.05).Conclusions Knee proprioception in KOA patients was significantly impaired compared with that in healthy individuals.No significant improvement in proprioception was found three months after TKA in the CR-TKA and PS-TKA groups.There was no difference in proprioception among the different surgical methods.The results can provide data support for clinical diagnosis and treatment,as well as determine a direction for subsequent rehabilitation programs.
3.Correlation between femoral offset,rotation center and leg length discrepancy after total hip arthroplasty based on digital analysis
Mao-Yong LI ; Wei CAO ; Pei-Xin SHA ; Xu-Dong SUN ; Shi-Yuan HUANG ; Kuan-Xin LI ; Heng ZHANG
China Journal of Orthopaedics and Traumatology 2024;37(4):381-386
Objective CT scans combined with Mimics software were used to measure femoral offset(FO),rotation center height(RCH)and lower leg length discrepancy(LLD)following total hip arthroplasty(THA),and the relationship between FO,RCH and LLD after THA is discussed.Methods Retrospective analysis was performed on 40 patients with unilateral THA who met standard cases from October 2020 to June 2022.There were 21 males and 19 females,18 patients on the left side and 22 patients on the right side,aged range from 30 to 81 years old,with an average age of(58.90±14.13)years old,BMI ranged from 17.3 to 31.5 kg·m-2withan average of(25.3±3.4)kg·m-2.There were 30 cases of femoral head necrosis(Ficattype Ⅳ),2 cases of hip osteoarthritis(Tonnis type Ⅲ),2 cases of developmental hip dislocation combined with end-stage osteoarthritis(Crowe type Ⅲ),and 6 cases of femoral neck fracture(Garden type Ⅳ).Three-dimensional CT reconstruction of pelvis was taken preoperative and postoperative,and three-dimensional reconstruction model was established after processing by Mimics software.FO,RCH and LLD were measured on the model.The criteria for FO reconstruction were as follows:postoperative bi-lateral FO difference less than 5 mm;the standard for equal length of both lower limbs was as follows:postoperative LLD differ-ence less than 5 mm.Results Bilateral FO difference was positively correlated with LLD(r=0.744,P<0.00l).Chi-square test was performed between the FO reconstructed group and the non-reconstructed eccentricity group:The results showed that the i-sometric ratio of lower limbs in the FO reconstructed group was significantly higher than that in the FO reconstructed group(x2=6.320,P=0.012).The bilateral RCH difference was significantly negatively correlated with LLD(r=-0.877,P<0.001).There is a linear relationship between bilateral FO difference and bilateral RCH difference and postoperative LLD,and the lin-ear regression equation is satisfied:postoperative LLD=0.038x-0.099y+0.257(x:postoperative bilateral FO difference,y:post-operative bilateral RCH difference;Unit:cm),F=77.993,R2=0.808,P=0.009.Conclusion After THA,LLD increased with the increase of FO and decreased with the increase of RCH.The effect of lower limb isometric length can be obtained more easily by reconstruction of FO.There is a linear relationship between the bilateral FO difference and the bilateral RCH difference after THA and LLD,and the regression equation can provide a theoretical reference forjudging LLD.
4.Predictive value of spectral CTA parameters for infarct core in acute ischemic stroke
Yan GU ; Dai SHI ; Yeqing WANG ; Dandan XU ; Aoqi XIAO ; Dan JIN ; Kuan LU ; Wu CAI ; Guohua FAN ; Junkang SHEN ; Liang XU
Chinese Journal of Emergency Medicine 2024;33(11):1572-1579
Objective:To investigate the value of dual-detector spectral CTA in distinguishing infarct core from penumbra in patients with acute ischemic stroke(AIS), and to further explore the risk factors associated with infarct core and their predictive value.Methods:The imaging and clinical data of 163 patients with AIS who met the inclusion criteria admitted to the Second Affiliated Hospital of Soochow University from March 2022 to May 2023 were retrospectively analyzed. Patients from March 2022 to December 2022 were used as the training group, and patients from January 2023 to May 2023 were used as the validation group for internal validation. The head and neck spectral CTA and brain CT perfusion imaging with dual-layer detector spectral CT were all carried out on all patients. Using CTP as reference, the patients were divided into infarct core group and non-infarct core group according to whether an infarct core occurred in the hypoperfusion regions of brain tissue. Multivariate logistic regression analysis was used to screen predictors related to the infarct core. The receiver operating characteristic (ROC) curve was used to evaluate the predictive efficacy.Results:A total of 163 patients were included in the study, including 112 in the training group and 51 in the validation group. There were significant differences in iodine density, effective atomic number, hypertension, triglyceride and neutrophils between the two groups ( P< 0.05). The cutoff values for iodine density values and effective atomic number values were 0.215 mg/mL and 7.405, respectively. Multivariate logistic regression analysis showed that iodine density and hypertension were independent risk factors for infarct core in AIS, and triglyceride was an independent protective factor. The area under the ROC curve (AUC) of iodine density value was the largest (0.859), with a sensitivity of 70.27%, and a specificity of 90.67%, which had a good predictive value. The ROC curve analysis results for the validation group were consistent with the training group. Conclusions:Spectral CT parameters iodine density values and effective atomic number values have the potential to distinguish the infarct core area from the penumbra area in patients with AIS. Iodine density and hypertension were independent risk factors of infarct core in AIS, triglyceride was an independent protective factor, and iodine density values obtained by dual-layer spectral detector CT had a high predictive value.
5.Sjögren's syndrome combined with cold agglutinin disease: A case report.
Li Fang WANG ; Lian Jie SHI ; Wu NING ; Nai Shu GAO ; Kuan Ting WANG
Journal of Peking University(Health Sciences) 2023;55(6):1130-1134
Sjögren's syndrome(SS)is a chronic autoimmune disease that affects exocrine glands, especially salivary and lacrimal glands. The main clinical manifestations are dry mouth and dry eyes, but also multi-organ and multi-system can be involved. Cold agglutinin disease(CAD)is an autoimmune disease characterized by red blood cell agglutination in the blood vessels of extremities caused by cold agglutinin at low temperature, resulting in skin microcirculation disturbance, or hemolytic anemia. Cold agglutinin disease is divided into two categories, primary cold agglutinin disease and secondary cold agglutinin disease. Primary cold agglutinin disease is characterized with cold agglutinin titer of 1 ∶4 000 or more and positive Coomb's test. However, the Coomb's test is not necessarily positive and the cold agglutinin titer is between 1 ∶32 and 1 ∶4 000 in secondary cold agglutinin disease. Here, we reported an elderly patient admitted to hospital due to fever. He was diagnosed with respiratory infection, but he showed incompletely response to the anti-infection treatment. Further laboratory tests showed the patient with positive ANA and anti-SSA antibodies. Additionally, the patient complained that he had dry mouth and dry eyes for 1 year. Schirmer test and salivate gland imaging finally confirmed the diagnosis Sjogren's syndrome. During the hospital stay, the blood clots were found in the anticoagulant tubes. Hemolytic anemia was considered as the patient had anemia with elevated reticulocytes and indirect bilirubin. In addition, further examination showed positive cold agglutination test with a titer of 1 ∶1 024, and cold agglutinin disease was an important type of cold-resistant autoimmune hemolytic anemia. Furthermore, the patient developed cyanosis after ice incubating at the tip of the nose. Hence, the patient was diagnosed as CAD and he was successfully treated with glucocorticoids instead of anti-infection treatments. Hence, the patient was diagnosed with SS combined with secondary CAD. SS combined CAD are rarely reported, and they are both autoimmune diseases. The abnormal function of B lymphocytes and the production of autoantibodies might be the common pathogenesis of them. Cold agglutinin disease can lead to severe hemolytic anemia, even life-threatening. In clinical practice, timely recognizing and dealing with CAD might promote the prognosis of the patient.
Male
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Humans
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Aged
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Anemia, Hemolytic, Autoimmune/diagnosis*
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Sjogren's Syndrome/diagnosis*
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Anemia, Hemolytic/complications*
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Dry Eye Syndromes/complications*
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Autoantibodies
6.Characteristics of Proprioception in Patients with Knee Osteoarthritis
Jingnan SHI ; Yayue XUE ; Kuan ZHANG ; Haohua ZHANG ; Songhua YAN
Journal of Medical Biomechanics 2022;37(2):E356-E360
Objective To explore the proprioception characteristics of knee joints for knee osteoarthritis (KOA) patients before unicondylar knee arthroplasty (UKA) and total knee arthroplasty (TKA). Methods Twenty-nine single-compartment KOA patients were selected. Fifteen patients were treated with UKA (UKA group) and fourteen patients were treated with TKA (TKA group). The test was performed 1 to 3 days before the operation.The keen society scores (KSS) of KOA patients in UKA group and TKA group were compared, and their joint position sense and kinesthesia were compared with control group. Results Significant differences in KSS were found in TKA group and UKA group, and the knee joint position sense and kinesthesia showed no significant differences between TKA group and UKA group.There were no significant differences in the knee joint position sense and kinesthesia between the operated leg and unoperated leg in TKA group and UKA group, and between the left leg and right leg in control group. Compared with control group, there were significant differences between UKA group and TKA group in 60° position sense of the operated leg and unoperated leg.The kinesthesia of the operated leg and unoperated leg in UKA group and TKA group were also significantly different from that in control group. Conclusions Compared with control group, the proprioception of the knee joint in KOA patients was significantly reduced before the surgery, but the characteristics of proprioception in UKA group and TKA group were similar.
7.Practice of Palliative Care Consultation Proposed by the Emergency Department in Peking Union Medical College Hospital.
Xiao-Hong NING ; Jia-Yi LI ; Xiao-Yan DAI ; Qian LIU ; Di SHI ; Xiao-Xuan ZHAO ; Jie LI ; Lei WANG ; Nan GE ; Xuan QU ; Tie-Kuan DU ; Hua-Dong ZHU
Acta Academiae Medicinae Sinicae 2022;44(5):763-767
Objective To summarize the palliative care consultations proposed by the Emergency Department of Peking Union Medical College Hospital. Methods A retrospective study was conducted on 22 palliative care consultations in the Emergency Department of Peking Union Medical College Hospital from January 2017 to June 2020. Results A total of 18 patients (6 males and 12 females) received palliative care consultations in the Emergency Department,with the average age of (65±8) years (36-88 years).Specifically,10 and 6 patients received once and twice consultations,respectively,and 2 patients did not complete the consultation.Of the patients receiving palliative care consultations,15 had malignant tumors and 3 had non-neoplastic diseases.The reasons for palliative care consultations included communication (61.1%,11/18) and pain relief (61.1%,11/18).In terms of the place of death,8 patients died in the hospital and 6 patients in other medical institutions. Conclusion There is a clear demand for palliative care consultation in the Emergency Department of Peking Union Medical College Hospital,and the consultation can bring help to both emergency doctors and patients.
Male
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Female
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Humans
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Middle Aged
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Aged
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Palliative Care/methods*
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Retrospective Studies
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Referral and Consultation
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Hospitals
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Emergency Service, Hospital
8.Cognition and Ability of Emergency Physicians for Palliative Care in Tertiary Hospitals.
Tie-Kuan DU ; Xiao-Hong NING ; Hua-Dong ZHU ; Di SHI ; Jia-Yi LI
Acta Academiae Medicinae Sinicae 2021;43(4):563-570
Objective To understand the cognition and related abilities of emergency physicians for palliative care in China. Methods A total of 115 emergency physicians were selected by convenient sampling to conduct a questionnaire survey.The questionnaire included the physicians' basic information,feelings and attitudes towards end-stage patients and their families,cognition of palliative care,and personal ability for palliative care. Results 25.2%,59.1%,and 15.7% of the emergency physicians considered they had "no understanding","partial understanding",and "full understanding" of palliative care,respectively.32(27.8%)physicians participated in palliative care-related lectures and they showed higher self-rated cognition levels(
Cognition
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Humans
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Palliative Care
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Physicians
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Surveys and Questionnaires
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Tertiary Care Centers
9.Rauwolfia vomitoria extract suppresses benign prostatic hyperplasia by reducing expression of androgen receptor and 5α-reductase in a rat model.
Tian FANG ; Ze-Sheng XUE ; Jia-Xuan LI ; Jia-Kuan LIU ; Di WU ; Mei-Qian LI ; Yu-Ting SONG ; Shi-Feng YUN ; Jun YAN
Journal of Integrative Medicine 2021;19(3):258-264
OBJECTIVE:
Herbal medicine is an important therapeutic option for benign prostatic hyperplasia (BPH), a common disease in older men that can seriously affect their quality of life. Currently, it is crucial to develop agents with strong efficacy and few side effects. Herein we investigated the effects of the extract of Rauwolfia vomitoria, a shrub grown in West Africa, on BPH.
METHODS:
Rats with testosterone-induced BPH were treated with R. vomitoria. Prostates were histologically analyzed by Hematoxylin and eosin staining. Proliferation index and the expression levels of androgen receptor and its associated proteins were quantified through immunohistochemistry and immunoblotting. Androgen receptor target genes were examined by quantitative real-time polymerase chain reaction. The sperm count and body weight of rats were also measured.
RESULTS:
The oral administration of R. vomitoria extract significantly reduced the prostate weight and prostate weight index in BPH rats, supported by the decreased thickness of the prostate epithelial layer and increased lumen size. Similar effects were observed in the BPH rats treated with the reference drug, finasteride. R. vomitoria extract significantly reduced the testosterone-induced proliferation markers, including proliferating cell nuclear antigen and cyclin D1, in the prostate glands of BPH rats; it also reduced levels of androgen receptor, its associated protein steroid 5α-reductase 1 and its downstream target genes (FK506-binding protein 5 and matrix metalloproteinase 2). Notably, compared with the finasteride group, R. vomitoria extract did not significantly reduce sperm count.
CONCLUSION
R. vomitoria suppresses testosterone-induced BPH development. Due to its milder side effects, R. vomitoria could be a promising therapeutic agent for BPH.
10.Effect of Fushengong Prescription on Wnt/β-catenin Signaling Pathway in Kidney of Rats with Chronic Renal Failure
Yang ZHANG ; Xue-kuan HUANG ; Qing SHEN ; Pan TONG ; Ke XU ; Hong-yu LUO ; Jia-yu TIAN ; Bo ZOU ; Shi YIN
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(24):89-95
Objective:To observe the effects of Fushengong prescription on secretory glycoprotein (Wnt)/

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