1.Analysis of the dilemmas of the simplified ethical review procedure in practice
Benze HU ; Yuhong HUANG ; Xufang GU ; Weihua GUO ; Siyuan HU ; Yaqing YANG
Chinese Medical Ethics 2025;38(1):46-51
In September 2023, the Measures for Scientific and Technological Ethics Review (Trial Implementation) was issued, revising the provisions related to the simplified procedure for ethical review in Chapter 3, Section 3. This revision of these provisions provides systematic guarantees for further optimizing ethical review work, ensuring that ethical review procedure is well-regulated, and improving scientific research efficiency. The “simplified procedure” does not mean reducing the quality and requirements of the review. Instead, based on always following internationally recognized ethical standards and emphasizing not violating national laws and regulations, improving the efficiency of ethical review and subsequent research work, and promoting the development of life sciences and medical research involving humans. In practical work, it introduces numerous new opportunities and challenges for the improvement of ethics review ability, such as new tests on the judgment and decision-making power of ethics committees, how to ensure the reliability and controllability of the conditions related to the simplified review procedure, and how to determine the basic conditions for adopting the simplified review procedure for review. Therefore, to actively respond to the challenges and possible risks brought by the simplified procedure review, efforts should be made to achieve three “unifications”, including the unification of researchers’ moral autonomy and the heteronomy of supervision implemented by relevant departments; the unification of the standard formulation of the simplified procedure review and the review work in practice; and the unification of ethical responsibility and legal responsibility.
2.Comparative analysis of characteristics and functions of exosomes from human induced pluripotent stem cell-derived platelets and apheresis platelets
Weihua HUANG ; Yan ZANG ; Aihua QIN ; Ziyang FENG ; Heshan TANG ; Fei GUO ; Chuyan WU ; Qiu SHEN ; Baohua QIAN ; Haihui GU ; Zhanshan CHA
Chinese Journal of Blood Transfusion 2025;38(9):1154-1161
Objective: To compare the biological characteristics of human induced pluripotent stem cell-derived platelet exosomes (hiPSC-Plt-Exos) with those of conventional apheresis platelet exosomes (Plt-Exos), specifically focusing on their differential abilities to enhance the proliferation and migration of human umbilical cord mesenchymal stem cells (hUC-MSCs). Methods: Exosomes were isolated from hiPSC-derived Plt and apheresis Plt concentrate using size exclusion chromatography. These exosomes were then characterized through nanoparticle tracking analysis (NTA), transmission electron microscopy (TEM), and Western blotting. Co-culture experiments into hUC-MSCs were conducted with hiPSC-Plt-Exos and apheresis Plt-Exos, respectively. Their effects on the proliferation and migration of hUC-MSCs were assessed via cell proliferation assays and scratch tests. Results: hiPSC-Plt-Exos and apheresis Plt-Exos exhibited comparable particle sizes, morphological features (such as the characteristic cup-shaped structure), and surface markers (including CD9 and HSP70). Notably, hiPSC-Plt-Exos demonstrated a significantly greater ability to enhance the proliferation and migration of hUC-MSCs compared to apheresis Plt-Exos (P<0.05). These differences provide critical comparative data for their application in various clinical contexts. Conclusion: This study establishes a theoretical foundation for developing precise therapeutic strategies based on hiPSC-Plt-Exos. Furthermore, it underscores the necessity of selecting the appropriate type of exosomes according to the specific disease microenvironment to achieve optimal therapeutic outcomes.
3.Meta-synthesis of qualitative researches on cardiac telerehabilitation experience in patients with cardiovascular disease
Shujuan WEN ; Haohua HUANG ; Yanhong XU ; Lili HOU ; Yuqin CHENG ; Weihua WU ; Siqi LI
Chinese Journal of Modern Nursing 2024;30(5):576-583
Objective:To systematically evaluate the qualitative researches on cardiac telerehabilitation experience of patients with cardiovascular disease (CVD), so as to provide reference for clinical development and improvement of cardiac telerehabilitation services.Methods:Qualitative studies on cardiac telerehabilitation experience of CVD patients in PubMed, Web of Science, Embase, CINAHL, Cochrane Library, Scopus, China National Knowledge Infrastructure, China Biology Medicine disc, Wanfang Database and VIP were searched by computer. The search period was from establishment of the databases to August 2023. The quality of the literature was evaluated according to the quality evaluation criteria of the Evidence-Based Health Care Center of the Joanna Briggs Institute in Australia, and the results were integrated by aggregative integration method.Results:A total of 13 articles were included, 52 research results were extracted and classified into 11 categories. Four integrated results were formed, including the benefits, promoting factors, obstacle, expectations and suggestions for cardiac telerehabilitation experience in CVD patients.Conclusions:CVD patients benefit significantly from participating in cardiac telerehabilitation. In the future, it is supposed to pay more attention to the factors that affect patients' participation in cardiac telerehabilitation, actively develop domestic cardiac telerehabilitation tools and optimize the cardiac telerehabilitation model according to the needs and suggestions of patients.
4.Efficacy and learning curve of Thulium laser enucleation of the prostate by laser controller anchored at six o'clock position of bladder neck in the treatment of BPH with large gland
Jiling WEN ; Guosheng YANG ; Rongbing LI ; Weihua CHEN ; Dongyang LI ; Hao WANG ; Liqun HUANG
Chinese Journal of Urology 2024;45(7):521-526
Objective:To analyze the efficacy, safety and learning curve of Thulium laser enucleation of the prostate by laser controller(LC-THuLEP) anchored at six o'clock position of the bladder neck in the treatment of benign prostatic hyperplasia(BPH) with large gland.Methods:The clinical data of the 1st to 45th BPH cases with large gland(prostate volume> 80 ml) treated by a doctor with LC-THuLEP anchored at six o'clock position of bladder neck in Shanghai East Hospital from January to October 2022 were retrospectively analyzed. The patients were divided into groups A, B and C according to the order of operation time, with 15 cases in each group. There were no significant differences among the three groups( P>0.05) in age[(71.8±9.4)years old vs. (73.5±8.2) years old vs.(71.4±5.5)years old], prostate volume[88.3(84.8, 100.6)ml vs.91.5(86.1, 118.4)ml vs. 94.5(84.7, 101.8)ml], prostate specific antigen(PSA)[4.8(2.9, 8.5)ng/ml vs. 7.2(3.2, 11.2)ng/ml vs. 7.8(4.5, 12.7)ng/ml], postvoid residual volume[44.0(34.0, 67.0)ml vs. 60.0(40.0, 76.0)ml vs. 39.0(0, 59.0)ml], maximum urine flow rate(Q max)[8.4(7.6, 11.1)ml/s vs. 8.6(6.5, 10.6)ml/s vs. 10.4(7.8, 13.2)ml/s], international prostate symptom score(IPSS)[20(18, 21) vs. 20(20, 22) vs. 20(20, 25)]and quality of life(QOL)[4(4, 5) vs. 4(4, 4) vs. 4(3, 5)].The doctor had more than 100 cases of TURP surgery experience. LC-THuLEP anchored at six o'clock position of bladder neck was described as follows. The bladder neck at six o'clock position is reserved 0.5-1.0 cm as an "anchor" to fix the prostatic bladder neck when the gland was pushed directly by the laser controller, preventing the detached prostate gland from turning. Finally the bladder neck was cut off at six o'clock position, and the prostate was en-bloc removed. The effect of surgery and postoperative complications were compared. The enucleation efficiency was equal to the weight of prostate tissue removed divided by the time of enucleation. Results:The differences among the three groups in operation time [100.0(90.0, 110.0)min vs. 80.0(70.0, 90.0)min vs. 75.0(70.0, 90.0)min], enucleation time[89.0(72.0, 97.0)min vs. 67.0(64.0, 77.0)min vs. 64.0(60.0, 77.0)min] and the efficiency of enucleation [0.65(0.62, 0.68)g/min vs. 0.84(0.83, 0.94)g/min vs. 0.93(0.82, 1.00)g/min] were statistically significant( P<0.05). The operation time and enucleation time in groups B and C were significantly lower than those in group A, and the enucleation efficiency was significantly higher than that in group A( P<0.05), while there was no significant difference between group B and C. However, the difference of three groups in hemoglobin decrease [8.0(5.0, 11.0)g/L vs. 7.0(2.0, 10.0)g/L vs. 11.0(4.0, 16.0)g/L] and catheter indwelling duration[4.0(2.0, 6.0)d vs. 6.0(3.0, 7.0)d vs. 4.0(3.0, 6.0)d] were not statistically different( P>0.05). All patients were followed up for 6 months after surgery. In three groups, postoperative Q max were 23.2(21.0, 25.1)ml/s, 22.7(21.1, 26.1)ml/s and 22.9(21.5, 25.7)ml/s, IPSS were 6(5, 8), 7(6, 8) and 7(7, 8), QOL were 2(1, 2), 2(1, 2) and 2(1, 2), postvoid residual volume were 20.0(10.0, 25.0)ml, 22.0(15.0, 25.0)ml and 5.0(0, 25.0)ml, respectively, which were all significantly different from that of pre-operation( P<0.05).However, there were no statistically significant differences in the postoperative indicators among the three groups ( P>0.05). No statistical difference was found in postoperative complications among the three groups[26.7%(4/15) vs. 20.0%(3/15) vs. 20.0%(3/15), P>0.05]. Conclusions:LC-THuLEP anchored at six o'clock position of bladder neck was an effective operation in the treatment of BPH with large gland, and the learning curve could be reached after 15 cases.
5.Microsurgical efficacy of large primary intracranial solitary fibrous tumor and influencing factors for prognoses
Lidong CHENG ; Qihang PAN ; Weihua LIU ; Wei HUANG ; Hongtao ZHU ; Yixuan MA ; Jun LI
Chinese Journal of Neuromedicine 2024;23(7):698-704
Objective:To investigate the microsurgical efficacy of large primary intracranial solitary fibrous tumor and influencing factors for its prognoses.Methods:From January 2010 to December 2022, 47 patients with large primary intracranial solitary fibrous tumor admitted to and accepted microsurgery in Department of Neurosurgery, Wuhan Central Hospital and Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, were enrolled. The clinical data, microsurgical efficacy and follow-up results of these patients were retrospectively analyzed, and influencing factors for total resection and prognoses were determined.Results:Thirty-two patients had tumor within the supratentorial region and 15 in the mandibular region, including 24 with sinus involved tumor. According to 2021 WHO Classification of Tumors of the Central Nervous System, 5 patients (10.6%) had grading 1, 32 (68.1%) grading 2, and 10 (21.3%) grading 3. Total resection was achieved in 31 patients (66.0%) and subtotal resection in 16 patients (34.0%). Postoperative complications, such as intraoperative hemorrhage, distant epidural hematoma and subcutaneous effusion, occurred in 7 patients (14.9%) and they were cured after secondary hematoma removal or conservative treatment; residual limb mobility disorder occurred in 3 patients, visual impairment in 3, and postoperative seizures in 2. Adjuvant radiotherapy was performed in 13 patients (27.7%). Follow-up was performed for (69.1±29.6) months and 29 patients (61.7%) had recurrent tumors (6 with intracranial and extracranial metastases and 4 deaths). Mean progression-free survival was (57.5±25.1) months; the 1-, 3-, and 5-year progression-free survival rates were 95.7%, 87.2%, and 59.6%, respectively. Sinus involvement was the independent influencing factor for total tumor resection; and total resection was an independent protective factor for progression-free survival for large primary intracranial solitary fibrous tumor ( HR=4.291, 95% CI: 1.555-11.838, P=0.005). Conclusion:Patients with large primary intracranial solitary fibrous tumor have a high recurrent risk after surgery; and gross-total resection should be strived to prevent tumor recurrence.
6.Child with sitosterolemia initially presenting with hemolytic anemia and thrombocytopenia: a case repore and literrature review
Ziyue ZHAO ; Jinying LI ; Weihua HUANG ; Liling QIU ; Baohua QIAN ; Zhanshan ZHA
Chinese Journal of Hematology 2024;45(1):90-93
This article focuses on a case study of sitosterolemia in a child who initially presented with hemolytic anemia and thrombocytopenia. Sitosterolemia is a rare autosomal recessive lipid metabolism disorder, difficult to diagnose due to its non-typical clinical manifestations. The 8-year-old patient was initially misdiagnosed with pyruvate kinase deficiency. Comprehensive biochemical and molecular biology analyses, including gene sequencing, eventually led to the correct diagnosis of sitosterolemia. This case highlights the complexity and diagnostic challenges of sitosterolemia, emphasizing the need for increased awareness and accurate diagnosis in patients presenting with similar symptoms.
7.Treatment status of tyrosine kinase inhibitor for newly-diagnosed chronic myeloid leukemia: a domestic multi-centre retrospective real-world study
Xiaoshuai ZHANG ; Bingcheng LIU ; Xin DU ; Yanli ZHANG ; Na XU ; Xiaoli LIU ; Weiming LI ; Hai LIN ; Rong LIANG ; Chunyan CHEN ; Jian HUANG ; Yunfan YANG ; Huanling ZHU ; Ling PAN ; Xiaodong WANG ; Guohui LI ; Zhuogang LIU ; Yanqing ZHANG ; Zhenfang LIU ; Jianda HU ; Chunshui LIU ; Fei LI ; Wei YANG ; Li MENG ; Yanqiu HAN ; Li'e LIN ; Zhenyu ZHAO ; Chuanqing TU ; Caifeng ZHENG ; Yanliang BAI ; Zeping ZHOU ; Suning CHEN ; Huiying QIU ; Lijie YANG ; Xiuli SUN ; Hui SUN ; Li ZHOU ; Zelin LIU ; Danyu WANG ; Jianxin GUO ; Liping PANG ; Qingshu ZENG ; Xiaohui SUO ; Weihua ZHANG ; Yuanjun ZHENG ; Qian JIANG
Chinese Journal of Hematology 2024;45(3):215-224
Objective:To retrospectively analyze the treatment status of tyrosine kinase inhibitors (TKI) in newly diagnosed patients with chronic myeloid leukemia (CML) in China.Methods:Data of chronic phase (CP) and accelerated phase (AP) CML patients diagnosed from January 2006 to December 2022 from 77 centers, ≥18 years old, and receiving initial imatinib, nilotinib, dasatinib or flumatinib-therapy within 6 months after diagnosis in China with complete data were retrospectively interrogated. The choice of initial TKI, current TKI medications, treatment switch and reasons, treatment responses and outcomes as well as the variables associated with them were analyzed.Results:6 893 patients in CP ( n=6 453, 93.6%) or AP ( n=440, 6.4%) receiving initial imatinib ( n=4 906, 71.2%), nilotinib ( n=1 157, 16.8%), dasatinib ( n=298, 4.3%) or flumatinib ( n=532, 7.2%) -therapy. With the median follow-up of 43 ( IQR 22-75) months, 1 581 (22.9%) patients switched TKI due to resistance ( n=1 055, 15.3%), intolerance ( n=248, 3.6%), pursuit of better efficacy ( n=168, 2.4%), economic or other reasons ( n=110, 1.6%). The frequency of switching TKI in AP patients was significantly-higher than that in CP patients (44.1% vs 21.5%, P<0.001), and more AP patients switched TKI due to resistance than CP patients (75.3% vs 66.1%, P=0.011). Multi-variable analyses showed that male, lower HGB concentration and ELTS intermediate/high-risk cohort were associated with lower cytogenetic and molecular responses rate and poor outcomes in CP patients; higher WBC count and initial the second-generation TKI treatment, the higher response rates; Ph + ACA at diagnosis, poor PFS. However, Sokal intermediate/high-risk cohort was only significantly-associated with lower CCyR and MMR rates and the poor PFS. Lower HGB concentration and larger spleen size were significantly-associated with the lower cytogenetic and molecular response rates in AP patients; initial the second-generation TKI treatment, the higher treatment response rates; lower PLT count, higher blasts and Ph + ACA, poorer TFS; Ph + ACA, poorer OS. Conclusion:At present, the vast majority of newly-diagnosed CML-CP or AP patients could benefit from TKI treatment in the long term with the good treatment responses and survival outcomes.
8.Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fracture with kyphotic deformity in the elderly (version 2024)
Jian CHEN ; Qingqing LI ; Jun GU ; Zhiyi HU ; Shujie ZHAO ; Zhenfei HUANG ; Tao JIANG ; Wei ZHOU ; Xiaojian CAO ; Yongxin REN ; Weihua CAI ; Lipeng YU ; Tao SUI ; Qian WANG ; Pengyu TANG ; Mengyuan WU ; Weihu MA ; Xuhua LU ; Hongjian LIU ; Zhongmin ZHANG ; Xiaozhong ZHOU ; Baorong HE ; Kainan LI ; Tengbo YU ; Xiaodong GUO ; Yongxiang WANG ; Yong HAI ; Jiangang SHI ; Baoshan XU ; Weishi LI ; Jinglong YAN ; Guangzhi NING ; Yongfei GUO ; Zhijun QIAO ; Feng ZHANG ; Fubing WANG ; Fuyang CHEN ; Yan JIA ; Xiaohua ZHOU ; Yuhui PENG ; Jin FAN ; Guoyong YIN
Chinese Journal of Trauma 2024;40(11):961-973
The incidence of osteoporotic thoracolumbar vertebral fracture (OTLVF) in the elderly is gradually increasing. The kyphotic deformity caused by various factors has become an important characteristic of OTLVF and has received increasing attention. Its clinical manifestations include pain, delayed nerve damage, sagittal imbalance, etc. Currently, the definition and diagnosis of OTLVF with kyphotic deformity in the elderly are still unclear. Although there are many treatment options, they are controversial. Existing guidelines or consensuses pay little attention to this type of fracture with kyphotic deformity. To this end, the Lumbar Education Working Group of the Spine Branch of the Chinese Medicine Education Association and Editorial Committee of Chinese Journal of Trauma organized the experts in the relevant fields to jointly develop Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fractures with kyphotic deformity in the elderly ( version 2024), based on evidence-based medical advancements and the principles of scientificity, practicality, and advanced nature, which provided 18 recommendations to standardize the clinical diagnosis and treatment.
9.Hereditary pheochromocytoma/paraganglioma and associated syndromes:a clinical and genetic study
Peng TANG ; Weihua LAN ; Yao ZHANG ; Jun ZHANG ; Zehua SHU ; Ke LI ; Zaoming HUANG ; Yiqiang HUANG ; Qiuli LIU ; Jun JIANG
Journal of Army Medical University 2024;46(4):377-383
Objective To summarize and analyze the clinical phenotypes,hereditary features and treatment and follow-up strategies of different hereditary pheochromocytoma/paragangliomas(PCC/PGL)and related syndromes.Methods Forty-four clinically diagnosed PCC/PGL patients admitted in our hospital from January 2000 to August 2022 were enrolled,and the clinical data of them and their family members were collected.Second-generation sequencing was performed on 43 patients for genetic detection,and Sanger sequencing was applied to verify the mutation of the probands and family members.Results There were 15 patients diagnosed with hereditary PCC/PGL,including 7 cases of von Hippel-Lindau(VHL)syndrome,3 cases of multiple endocrine neoplasia type 2(MEN2),and 5 cases of familial paraganglioma syndrome.Seven VHL syndrome families were diagnosed as VHL2A(c.500G>A),VHL2B(c.239G>T and c.444_457del),and VHL2C(c.293A>G)according to their clinical manifestations.All probands received surgical treatment,and 2 cases of recurrent PCC and the patients with multiple renal cancer also received targeted therapy with sunitinib.Three MEN2 families carried c.1901G>C,c.1832G>A,and c.1901G>A missense mutations,respectively,and were diagnosed with MEN2A clinically.All of them underwent adrenalectomy and thyroidectomy,including one for preventive thyroidectomy.Among the 5 familial paraganglioma syndrome families,4 patients carried SDHB mutations(SDHB:c.343C>T,c.541-2A>G,c.575G>A,c.268C>T)and 1 patient carried an SDHD mutation(SDHD:c.337_340del).Sporadic retroperitoneal PGL were most common.Conclusion More than 1/3 of PCC/PGL patients carry germline gene mutations,showing obvious genotype-phenotype correlation.Genetic diagnosis technology plays an important guidance role for clinical precision treatment and follow-up,and genetic counseling.
10.Effects and mechanism of AMPP2 on mesangial cell proliferation induced by TGF-β1
Linlin ZHANG ; Tangming ZHAO ; Chan HUANG ; Shanwen LI ; Weihua GAN
Tianjin Medical Journal 2024;52(1):50-55
Objective To explore the effect and mechanism of anti-mesangial cell-proliferation-peptide 2(AMPP2)on mesangial cell proliferation induced by transforming growth factor β1(TGF-β1).Methods Mesangial cells were cultured in vitro and treated with TGF-β1(10 μg/L)and AMPP2(10 ng/L).According to different intervention factors,mesangial cells were divided into four groups:the control group,the AMPP2 group,the TGF-β1 group and the TGF-β1+AMPP2 group.The proliferation activity of mesangial cells was detected by CCK-8.The relative protein expression of cyclin dependent kinase 4(CDK-4),cyclin dependent kinase 6(CDK-6),proliferating cell nuclear antigen(PCNA),α-smooth muscle actin(α-SMA),collagen-Ⅰ(COL-Ⅰ)and fibronectin(FN)were examined by Western blot assay.The relative mRNA expression of α-SMA,COL-Ⅰ and FN were detected by qPCR.Results Compared with the control group,proliferation activity of mesangial cells was significantly increased in the TGF-β1 group(P<0.05).The proliferation activity of mesangial cells was markedly decreased in the TGF-β1+AMPP2 group compared with that of the TGF-β1 group(P<0.05).Compared with the control group,protein levels of CDK-4,CDK-6,PCNA,α-SMA,COL-Ⅰand FN in cells were significantly increased in the TGF-β1 group(P<0.05),as well as the mRNA levels of α-SMA,COL-Ⅰand FN(P<0.05).In the TGF-β1+AMPP2 group,the protein and mRNA levels of α-SMA,COL-Ⅰand FN and the protein levels of CDK-4,CDK-6 and PCNA were markedly decreased compared with those of the TGF-β1 group(P<0.05).Compared with the control group,levels of p-SMAD3/SMAD3 was remarkably upregulated in the TGF-β1 group(P<0.05),while levels of p-SMAD3/SMAD3 was remarkably downregulated in the TGF-β1+AMPP2 group compared with those of the TGF-β1 group(P<0.05).Conclusion AMPP2 may inhibit mesangial cell proliferation by regulating TGF-β1/SMAD3 pathway.

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