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.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.
4.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.
5.Preparation of Patchouli Oil Enteric-coated Dropping Pills and Its Efficacy Evaluation on Ulcerative Colitis Rats
Xiaofeng LI ; Weidong CHEN ; Huayuan CHEN ; Weihua XU ; Ergang LIU ; Huan SHEN ; Bing WANG ; Yongzhuo HUANG
Chinese Journal of Modern Applied Pharmacy 2024;41(12):1621-1630
OBJECTIVE
To prepare patchouli oil enteric-coated dropping pills, evaluate its colon-targeted release behaviors and therapeutic potency against rat ulcerative colitis(UC).
METHODS
The single factor combined with response surface optimization method was used to screen matrix types and optimize preparation process parameters. Formula and thickness of Eudragit coating was selected based on dissolution tendency toward simulated intestinal fluids. Finally, colon targeting release behavior and the therapeutic effect of the preparation were assessed on the rat UC model induced by 2,4,6-trinitrobenzene sulfonic acid(TNBS).
RESULTS
The optimal prescription of patchouli oil dropping pills was patchouli oil∶PEG6000∶PEG8000 ratio of 1∶1∶1; and the optimal condition for preparing patchouli oil pills was keeping nozzle temperature at 9 ℃, and dropping pills at the speed of 33 drops·min−1, with dropping distance set at 6 cm; the optimal ratio of Eudragit L100∶Eudragit S100 was 3∶7 for preferential release in simulate intestinal fluid over simulated gastric fluid. Compared with free patchouli oil, patchouli oil enteric-coated dropping pills significantly alleviated the pathological symptoms such as weight loss, hematochezia and colon shortening in rats; the expression of pro-inflammatory cytokines IL-6, IL-1β, and IL-23 in serum was significantly down-regulated and the expression of anti-inflammatory cytokines IL-10 and TGF-β1 was significantly up-regulated. The mRNA expression of Mucin-1 and Mucin-2 in colon tissue was significantly up-regulated and the mRNA expression of inflammatory cytokines IL-6, IL-1β, and TNF-α was significantly down-regulated.
CONCLUSION
The patchouli oil enteric-coated dropping pills have colon-targeted release ability and improve the anti-inflammatory effect of drugs.
6.Postoperative Patient-controlled Analgesia: Thirty Years of Clinical Experience in Peking Union Medical College Hospital
Lin ZHAO ; Liying REN ; Weihua NIE ; Yaqi CHEN ; Jie ZHANG ; Shengjie ZHANG ; Yingli WANG ; Cuicui DIAO ; Huiying MA ; Zheng ZHANG ; Li ZHOU ; Le SHEN ; Huizhen WANG ; Yuguang HUANG
Medical Journal of Peking Union Medical College Hospital 2024;15(2):239-245
Postoperative pain seriously affects the recovery process of patients, resulting in prolonged hospital stay and increased care costs. Appropriate application of patient-controlled analgesia devices can effectively relieve perioperative acute pain. In 1994 patient-controlled analgesia began to be used in Peking Union Medical College Hospital, and the Acute Pain Service Working Group was established in 2004. With the cooperation of anesthesiologists and specialist nurses, the group jointly has implemented the whole process and standardized management based on patient-controlled analgesia, and constantly improved and innovated working methods, laying a solid foundation for the development of postoperative pain management. This paper systematically reviews and summarizes the work from the aspects of clinical focus, nursing management experience, promotion and dissemination of pain treatment concepts, and development of acute pain service model under the new situation, with the hope of providing valuable reference for comprehensively strengthening pain management in the process of diagnosis and treatment, and enhancing patients' satisfaction with perioperative analgesia services.
7.Identification of Pharmacodynamic Material Basis of Ruyi Zhenbaowan by Multidimensional Correlation Model of "Pharmacodynamic-target-component-pharmacokinetic"
Mingzhu XU ; Huaiping LI ; Zhaochen MA ; Tao LI ; Yudong LIU ; Ziqing XIAO ; Chu ZHANG ; Kedian CHEN ; Weihua MA ; Feng HUANG ; Na LIN ; Yanqiong ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):68-77
ObjectiveTo identify the pharmacodynamic material basis of Ruyi Zhenbaowan in relieving neuropathic pain by integrating the calculation of biological network proximity and pharmacokinetic characterization. MethodThe interaction network of "drug candidate target-related gene of disease" was constructed by Cytoscape 3.8.2, and the average shortest path value of each drug putative target acting on neuropathic pain-related genes in this network was calculated by Pesca 3.8.0 tool so as to evaluate the network proximity between them, and screen prescription candidate targets with strong intervention efficiency and their corresponding potential effect components. After that, plasma and cerebrospinal fluid samples were collected from rats after administration of Ruyi Zhenbaowan at set time points, and the contents of potential effect components in samples was quantified by ultra performance liquid chromatography-quadrupole-ion trap mass spectrometry(UPLC-Q-TRAP/MS), and drug concentration-time curves were plotted, then the pharmacokinetic parameters were calculated by DAS 2.1.1. ResultBy evaluating the network proximity between candidate targets and neuropathic pain-related genes in the interaction network, a total of 40 putative targets of Ruyi Zhenbaowan with strong intervention effects on neuropathic pain-related genes, such as estrogen receptor 1(ESR1), cyclic adenosine monophosphate(cAMP)-dependent protein kinase catalytic subunit alpha(PRKACA) and protein kinase B1 (Akt1), and 10 corresponding potential effect components, such as glycyrrhizic acid and betulinic acid, were obtained. Pharmacokinetic characterization showed that among the 10 potential effect components, gallic acid, apigenin-7-O-glucuronide, glycyrrhizic acid and apigenin were well absorbed and metabolized in plasma and cerebrospinal fluid, with long onset time and good bioavailability. ConclusionFrom the perspective of efficacy-target-constituent-pharmacokinetic, this study analyzes the main effective materials of Ruyi Zhenbaowan, such as glycyrrhizic acid, gallic acid, apigenin-7-O-glucuronide and apigenin, which have a high exposure in plasma or cerebrospinal fluid and have a strong intervention effect on neuropathic pain. The related results provide reliable experimental evidences for clarifying the material basis and developing quality standards of Ruyi Zhenbaowan.
8.The safety and feasibility of peripheral vascular intervention via the ipsilateral transulnar access due to failure of transradial artery puncture
Weilin TIAN ; Xiaoxi MENG ; Huaqiang LIAO ; Hongchao LIU ; Yafeng GU ; Liyu HUANG ; Weihua DONG ; Hailin JIANG
Journal of Interventional Radiology 2024;33(7):723-727
Objective To investigate the safety and feasibility of peripheral vascular intervention via the ipsilateral transulnar access(TUA)due to failure of transradial access(TRA)puncture.Methods The clinical data of 2546 peripheral vascular interventions via TRA,which were performed at authors'hospital between January 2019 and December 2021,were retrospectively analyzed.Among the 2546 interventions,TRA puncture failed in 37 procedures,and in 27 of these patients the ipsilateral TUA puncture had to be adopted.The puncture success rate,surgical success rate and puncture approach-related complications of TUA of the 27 patients receiving ipsilateral TUA puncture were analyzed.Results The success rate of ipsilateral TUA puncture after TRA puncture failed was 96.3%(26/27),and in one patient transfemoral access(TFA)puncture had to be substituted because of the ulnar artery spasm.The total success rate of interventional procedures was 96.3%(26/27).No serious complications occurred,and the incidence of minor complications was 19.2%(5/26).Conclusion Preliminary results indicate that for the experienced TRA operators,using ipsilateral TUA puncture due to failure of TRA puncture is a safe and feasible strategy choice.
9.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.
10.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.


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