1.Application value of soluble C5b-9 in the diagnosis of delayed graft function after kidney transplantation
Lihong SHANG ; Zhihua WANG ; Wenyan ZHANG ; Jiaoxia LIANG ; Mingjun WANG ; Ning LI ; Shaohua SHI ; Linru ZHU
Organ Transplantation 2026;17(5):757-764
Objective To explore the diagnostic value of soluble C5b-9 (sC5b-9) for delayed graft function (DGF) following kidney transplantation. Methods Clinical data of 49 kidney transplant recipients who underwent sC5b-9 detection at the Second People’s Hospital of Shanxi Province between January 2024 and December 2025 were retrospectively analyzed. Recipients were divided into the DGF group (n=25) and the non-DGF group (n=24) according to the occurrence of DGF. Baseline characteristics and serum sC5b-9 levels were compared between the two groups. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the diagnostic efficacy of sC5b-9 for DGF. A restricted cubic spline model was adopted to investigate the association between sC5b-9 and DGF. Results Among the 49 recipients, DGF occurred in 25 patients. Compared with the non-DGF group, the DGF group presented a higher proportion of male patients, a higher incidence of adverse transplant outcomes, and elevated final serum creatinine levels (all P<0.05). Within 30 days after transplantation, sC5b-9 concentrations were significantly higher in the DGF group than those in the non-DGF group (P<0.001). ROC analysis revealed that the area under the curve (AUC) of sC5b-9 for diagnosing DGF was 0.81, with a 95% confidence interval (CI) of 0.68-0.92, and the optimal cutoff value was 265.7 ng/mL. Recipients with elevated sC5b-9 (≥265.7 ng/mL) had a significantly higher incidence of DGF than those with low sC5b-9 levels (<265.7 ng/mL) (P<0.001). Recipients with adverse outcomes exhibited significantly higher sC5b-9 levels than those without adverse outcomes (P<0.001), and the AUC of sC5b-9 for identifying adverse outcomes was 0.82 (95%CI 0.63-0.95). A significant nonlinear correlation was observed between sC5b-9 and final serum creatinine (P<0.001). Conclusions Elevated sC5b-9 is correlated with the development of DGF after kidney transplantation and exhibits favorable diagnostic performance. It may serve as a potential biomarker for predicting early allograft dysfunction and adverse outcomes in kidney transplant recipients.
2.Development and application of an auxiliary device based on embedded microcontroller system for venipuncture
Jing YANG ; Jun JI ; Xiujun CHEN ; Zhihan SHANG ; Wenhui ZHAI ; Ning WANG ; Xiao ZHANG ; Rong ZHANG
China Medical Equipment 2025;22(10):159-162
Objective:To design an auxiliary device based on embedded microcontroller system for venipuncture,which can adjust posture,so as to resolve the problem that occurs failure in puncture due to insufficient exposure of the puncture site in various scenarios.Methods:The device consisted of a support component,an air ring,a component with lifting and angle adjustment,and a pedestal.By advanced embedded microcontroller technique,it can precisely regulate the posture of the support structure of patient's limbs,and fully expose the targeted puncture site,and create more favorable conditions for nurses in performing punctures.A total of 2,482 patients who underwent blood collection at emergency department of the 305th Hospital of the People's Liberation Army from September to October 2024 were selected.The 1,204 patients were enrolled in September were divided into control group(without using the auxiliary device for venipuncture),and the 1,278 patients were enrolled in October were divided into observation group(using the auxiliary device for venipuncture).The puncture's one-time success rates of junior nurses(experience≤3 years)for both groups were compared.Each group respectively selected 150 patients by using the random number table method to conduct investigate,and satisfaction scores for success rate of puncture,and comfort degree of puncture for position,as well as the pain,process and efficiency,were investigated Results:The puncture's one-time success rates of junior nurses for the patients of control and observation groups were respectively 85.05%and 89.36%,with a statistically significant difference(x2=10.35,P<0.05).The satisfaction scores of patients in the observation group were significantly higher than those in the control group,with a statistically significant difference(t=-5.529,P<0.05).Conclusion:This device is simple and convenient in operation,and has favorable stability.It is beneficial to adjust position and exposure puncture site for patients who undergo peripheral venipuncture.It can improve puncture's success rate and patients'satisfaction.
3.Multi-center clinical study on the efficacy and safety of combined lienal polypeptide injection therapy in children with Mycoplasma pneumoniae pneumonia
Qi CHENG ; Yunxiao SHANG ; Han ZHANG ; Jiujun LI ; Ning CHEN ; Lishen SHAN ; Nan YANG ; Lihua NING ; Xuemei BAI ; Jianhua LIU ; Yuling HAN ; Jichun WANG ; Jing LI ; Yong FENG ; Liyun LIU ; Li CHEN ; Si LIU ; Qinzhen ZHANG ; Jia ZHENG ; Fengchao LI ; Sukun LU ; Yun ZHANG ; Xiaoyi CHAI
International Journal of Pediatrics 2025;52(3):204-210
Objective:To observe the efficacy and safety of combined lienal polypeptide injection therapy in the treatment of Mycoplasma pneumoniae pneumonia(MPP)in children aged 3 to 14 years old in multiple clinical centers.Methods:A randomized,controlled,multi-center clinical study design was adopted.A total of 240 hospitalized children aged 3 to 14 years old with MPP from 7 hospitals from September 1,2023 to January 31,2024 were included.According to the severity of pneumonia,they were divided into the mild MPP group with 80 cases and the severe MPP/refractory MPP(SMPP/RMPP)group with 160 cases,and then randomly divided into the control group and the experimental group at a ratio of 1 ∶1,using the random number table method.After screening,subjects entered a treatment period of 5 to 7 days.The control group was treated with azithromycin,while the experimental group was treated with azithromycin plus lienal polypeptide injection .The recovery of lung CT,length of hospital stay,duration of fever,cough score,whether mild cases developed into severe or refractory cases,duration of hormone use,use of intravenous immunoglobulin(IVIG),bronchoscopy treatment,and immune function were observed between the two groups to evaluate the efficacy of lienal polypeptide injection.Adverse events after medication,vital signs,blood routine,urine routine,liver function,myocardial enzymes,renal function,and electrocardiogram were observed to evaluate the safety. Results:A total of 231 subjects have completed the trial in the 7 hospitals,including 118 cases in the experimental group and 113 cases in the control group.Main observation index:the rate of lung CT aggravation in the experimental group was lower than that in the control group(2.6% vs 15.3%, P<0.01),and the difference was statistically significant.Secondary indexes:there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).However,the rate of cases of plastic bronchitis(PB)found under bronchoscopy in the experimental group was lower than that in the control group(0 vs 18.8%, P=0.03),and the difference was statistically significant.Among the mild MPP(72 cases),there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and the improvement rate of lung CT between the two groups(all P>0.05).However,compared with the control group,the rate of cases developing into SMPP/RMPP in the experimental group was less(24.3% vs 48.6%, P=0.03),and the difference in IgG before and after treatment was small[0.53(-0.04,1.18)g/L vs 1.33(0.48,2.25)g/L, P=0.01].Among the SMPP/RMPP cases(159 cases),the rate of cases of PB found under bronchoscopy in the experimental group was less than that in the control group(0 vs 20%, P=0.04),and the rate of cases with aggravated lung CT in the experimental group was less than that in the control group(1.3% vs 19.5%, P<0.01),and the improvement rate of lung CT in the experimental group was higher than that in the control group(88.8% vs 75.3%, P=0.03),with statistically significant differences.There were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).Two cases in the experimental group developed rashes,which improved after the drug was discontinued.There were no serious adverse reactions such as abnormal vital signs like dyspnea and cyanosis due to the use of lienal polypeptide injection.There were no obvious changes in blood routine,liver function,myocardial enzymes,renal function,electrocardiogram,and urine routine values before and after medication compared with the baseline. Conclusion:The combined use of lienal polypeptide injection in the treatment of MPP in children can reduce the probability of the transformation from mild cases to SMPP/RMPP,reduce the rate of aggravation of the image findings,promote the absorption of lung inflammation,reduce the rate of PB found under bronchoscopy,and has good safety.
4.Development and application of an auxiliary device based on embedded microcontroller system for venipuncture
Jing YANG ; Jun JI ; Xiujun CHEN ; Zhihan SHANG ; Wenhui ZHAI ; Ning WANG ; Xiao ZHANG ; Rong ZHANG
China Medical Equipment 2025;22(10):159-162
Objective:To design an auxiliary device based on embedded microcontroller system for venipuncture,which can adjust posture,so as to resolve the problem that occurs failure in puncture due to insufficient exposure of the puncture site in various scenarios.Methods:The device consisted of a support component,an air ring,a component with lifting and angle adjustment,and a pedestal.By advanced embedded microcontroller technique,it can precisely regulate the posture of the support structure of patient's limbs,and fully expose the targeted puncture site,and create more favorable conditions for nurses in performing punctures.A total of 2,482 patients who underwent blood collection at emergency department of the 305th Hospital of the People's Liberation Army from September to October 2024 were selected.The 1,204 patients were enrolled in September were divided into control group(without using the auxiliary device for venipuncture),and the 1,278 patients were enrolled in October were divided into observation group(using the auxiliary device for venipuncture).The puncture's one-time success rates of junior nurses(experience≤3 years)for both groups were compared.Each group respectively selected 150 patients by using the random number table method to conduct investigate,and satisfaction scores for success rate of puncture,and comfort degree of puncture for position,as well as the pain,process and efficiency,were investigated Results:The puncture's one-time success rates of junior nurses for the patients of control and observation groups were respectively 85.05%and 89.36%,with a statistically significant difference(x2=10.35,P<0.05).The satisfaction scores of patients in the observation group were significantly higher than those in the control group,with a statistically significant difference(t=-5.529,P<0.05).Conclusion:This device is simple and convenient in operation,and has favorable stability.It is beneficial to adjust position and exposure puncture site for patients who undergo peripheral venipuncture.It can improve puncture's success rate and patients'satisfaction.
5.The efficacy and safety of nebulized inhalation of recombinant human interferon α1b in the treatment of pediatric respiratory syncytial viral associated lower respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ clinical study
Xiaohui LIU ; Baoping XU ; Yunxiao SHANG ; Han ZHANG ; Zhenkun ZHANG ; Guangyu LIN ; Ju YIN ; Aihua CUI ; Guocheng ZHANG ; Zhaoling SHI ; Liwei GAO ; Chunming JIANG ; Junmei BIAN ; Yongjian HUANG ; Rongfang ZHANG ; Xiaomei LIU ; Xiaoqing YANG ; Yu TANG ; Lili ZHONG ; Hongmei QIAO ; Chuangli HAO ; Yuqing WANG ; Qubei LI ; Ling CAO ; Yungang YANG ; Ling LU ; Rongjun LIN ; Xingzhen SUN ; Wei ZHOU ; Qiang CHEN ; Jikui DENG ; Yuejie ZHENG ; Lin ZHAO ; Tao AI ; Xiaohong LIU ; Xiaoxia LU ; Ning JIANG ; Ming LI
Chinese Journal of Applied Clinical Pediatrics 2025;40(3):180-186
Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.
6.Novel Structural Features of Isoflavone Synthase from Medicago truncatula Shed Light on Its Unique Enzymatic Mechanism
Chao SHI ; Zhao-Yang YE ; Fei XU ; Xiang-Ning DU ; Zhang-Xin CHEN ; Ming-Yue GU ; Jie DENG ; Wei WANG ; Liang-Yu LIU ; Mei-Ying WANG ; Xiao-Dong SU ; He-Li LIU ; Ming-Ying SHANG ; Li-Xin HUANG ; Zhen-Zhan CHANG
Chinese Journal of Biochemistry and Molecular Biology 2025;41(8):1204-1213,中插1-中插6
Isoflavones which mainly distributed in leguminous plants have plenty of health benefits.Isoflavone synthase(IFS)is a membrane-associated cytochrome P450 enzyme(CYP450)which carries out the unique aryl-ring migration and hydroxylation.So far,few crystal structures of plant P450s have been obtained.We determined the crystal structure of IFS from Medicago truncatula at 1.9 ? by MAD method using a selenomethionine substituted crystal and conducted molecular docking and mutagenesis study.The structure of IFS complexed with imidazole exhibits the helix Ⅰa-loop-helix Ⅰβ motif which cor-responds to helix Ⅰ of other P450s.Compared with structures of common P450s,IFS/imidazole structure contains an extra domain,i.e.,the γ-domain.The structure reveals a homodimer in which the γ-domain of one molecule interacts with the β-domain of another.The plane of heme group makes an angle of ap-proximately 40° with the helix Ⅰa-loop-helix Ⅰβ motif.Molecular docking combined with mutagenesis study suggested that Trp-128 and Asp-300 might play important roles in substrate binding and recogni-tion.Phe-301,Ser-303 and Gly-305 from the helix Ⅰa-loop-helix Ⅰβ motif may play important roles in the aryl-ring migration.These novel structural features reveal insights into the unique reaction mechanism of IFS and provide a basis for engineering IFS in leguminous crops for health purpose.
7.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
8.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
Jun ZHANG ; Baoming NING ; Shifeng WEI ; Haoyu SHEN ; Yue SHANG ; Ran ZHU ; Xinyi XU ; Lei CHEN ; Tingting LIU ; Shuangcheng MA
Drug Standards of China 2025;26(1):34-44
To introduce the general thinking,guidelines,work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition,and to summarize and figure out the main characteristics on dosage forms,physico-chemical testing,microbial and biological testing,ref-erence standards and guidelines.The newly revised general chapters of pharmacopoeia give full play to the norma-tive and guiding role of the Chinese Pharmacopoeia standard,track the frontier dynamics of international drug regu-latory science and the elaboration of monographs,expand the application of state-of-the-art technologies,and stead-ily promote the harmonization and unification with the ICH guidelines;further enhance the overall capacity of TCM quality control,actively implement the 3 R principles on animal experiments,and practice the concept of environ-mental-friendly;replace and/orreduce the use of toxic and hazardousreagents,strengthen the requirementsofdrug safety control.This paper aims to provide a full-view perspective for the comprehensive,correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
9.FLZ attenuates Parkinson's disease pathological damage by increasing glycoursodeoxycholic acid production via down-regulating Clostridium innocuu m.
Meiyu SHANG ; Jingwen NING ; Caixia ZANG ; Jingwei MA ; Yang YANG ; Yueqi JIANG ; Qiuzhu CHEN ; Yirong DONG ; Jinrong WANG ; Fangfang LI ; Xiuqi BAO ; Dan ZHANG
Acta Pharmaceutica Sinica B 2025;15(2):973-990
Increasing evidence shows that the early lesions of Parkinson's disease (PD) originate from gut, and correction of microbiota dysbiosis is a promising therapy for PD. FLZ is a neuroprotective agent on PD, which has been validated capable of alleviating microbiota dysbiosis in PD mice. However, the detailed mechanisms still need elucidated. Through metabolomics and 16S rRNA analysis, we identified glycoursodeoxycholic acid (GUDCA) was the most affected differential microbial metabolite by FLZ treatment, which was specially and negatively regulated by Clostridium innocuum, a differential microbiota with the strongest correlation to GUDCA production, through inhibiting bile salt hydrolase (BSH) enzyme. The protection of GUDCA on colon and brain were also clarified in PD models, showing that it could activate Nrf2 pathway, further validating that FLZ protected dopaminergic neurons through promoting GUDCA production. Our study uncovered that FLZ improved PD through microbiota-gut-brain axis, and also gave insights into modulation of microbial metabolites may serve as an important strategy for treating PD.
10.Microbial metabolite 3-indolepropionic acid alleviated PD pathologies by decreasing enteric glia cell gliosis via suppressing IL-13Rα1 related signaling pathways.
Meiyu SHANG ; Jingwen NING ; Caixia ZANG ; Jingwei MA ; Yang YANG ; Zhirong WAN ; Jing ZHAO ; Yueqi JIANG ; Qiuzhu CHEN ; Yirong DONG ; Jinrong WANG ; Fangfang LI ; Xiuqi BAO ; Dan ZHANG
Acta Pharmaceutica Sinica B 2025;15(4):2024-2038
Although enteric glial cell (EGC) abnormal activation is reported to be involved in the pathogenesis of Parkinson's disease (PD), and inhibition of EGC gliosis alleviated gut and dopaminergic neuronal dysfunction was verified in our previous study, the potential role of gut microbiota on EGC function in PD still need to be addressed. In the present study, fecal microbiota transplantation revealed that EGC function was regulated by gut microbiota. By employing 16S rRNA and metabolomic analysis, we identified that 3-indolepropionic acid (IPA) was the most affected differential microbial metabolite that regulated EGC gliosis. The protective effects of IPA on PD were validated in rotenone-stimulated EGCs and rotenone (30 mg/kg i.g. for 4 weeks)-induced PD mice, as indicated by decreased inflammation, improved intestinal and brain barrier as well as dopaminergic neuronal function. Mechanistic study showed that IPA targeted pregnane X receptor (PXR) in EGCs, and inhibition of IL-13Rα1 involved cytokine-cytokine receptor interaction pathway, leading to inactivation of downstream JAK1-STAT6 pathway. Our data not only provided evidence that EGC gliosis was critical in spreading intestinal damage to brain, but also highlighted the potential role of microbial metabolite IPA in alleviating PD pathological damages through gut-brain axis.

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