1.Preliminary study on an improved method for constructing internal quality control framework of ELISA
Youbin DUAN ; Rui WANG ; Le CHANG ; Changwen QIU ; Zhiqiang LI ; Gengrui CHEN ; Jingjuan YANG ; Qing HE ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(1):103-108
Objective: To propose an improved method for constructing the internal quality control (IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods: 1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example. 2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage, number of batches used, days of use, number of QC points, batch-specific means, and coefficients of variation (CV) across all nine centers. 4) Using the improved construction method for IQC framework, provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9, followed by outlier determination. Results: 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1 (P<0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously. 2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used, the number of QC runs per batch, and the QC values for identical lots. Therefore, individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting, using the pre-experimental mean and cumulative coefficient of variation (CV) from the preceding batch. For batches used >20 days with >20 QC points, permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers, 10 were classified as normal by the provisional frames, while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion: Based on the statistical analysis of IQC practices across blood centers of varying scales, combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials, it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.
2.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
3.Tumor cells targetable graphene oxide doped microneedle for synergistic photothermal-chemotherapy treatment of melanoma.
Zhiqiang ZHANG ; Junfang KE ; Yuxin DAI ; Chenxi FANG ; Yunfeng DAI ; Chen WANG ; Meitao DUAN ; Jungang REN ; Ming CHEN ; Chen WANG
Journal of Pharmaceutical Analysis 2025;15(10):101270-101270
Melanoma is characterized by high malignancy, ranking the third among skin malignancies, and is associated with lack of specific treatment options and poor prognosis. Therefore, the development of effective therapies for melanoma is imperative. A critical challenge in addressing subcutaneous disease lies in overcoming the skin barrier. In this study, we engineered a microneedle (MN) system that integrates chemotherapy, photothermal therapy (PTT), and targeted therapy to enhance anti-tumor efficacy while effectively penetrating the skin barrier. In vitro studies have demonstrated that the MN drug delivery system (DDS) can effectively penetrate the stratum corneum of the skin, deliver therapeutics to subcutaneous tumor sites, and establish a drug reservoir at these locations to exert anti-tumor effects. Cellular experiments indicated that the engineered PTT chemotherapy-targeted MNs can be internalized by tumor cells, exhibiting enhanced cytotoxicity against them. In vivo pharmacological investigations revealed that the combination of PTT and chemotherapy delivered via this MN DDS produced synergistic anti-tumor effects, achieving a tumor inhibition rate of up to 98.15%. This in situ DDS minimizes involvement with other organs, significantly reducing chemotherapy-related side effects. In summary, the PTT chemotherapy-targeted MNs developed in this study demonstrate promising application potential by enhancing anti-tumor efficacy while minimizing adverse effects.
4.Correlations of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio with arteriovenous fistula stenosis in hemodialysis patients
Jiali LIU ; Heping ZHANG ; Zhiqiang DUAN ; Dong LI ; Kun YANG
Journal of Chongqing Medical University 2025;50(3):416-420
Objective:To study the correlations of neutrophil-lymphocyte ratio(NLR)and platelet-lymphocyte ratio(PLR)with arte-riovenous fistula(AVF)stenosis in hemodialysis(HD)patients.Methods:Data were collected from 625 patients who underwent arterio-venous fistula hemodialysis at the Department of Nephrology,Affiliated Hospital of North Sichuan Medical College between January 2021 and June 2022.Of these,395 eligible patients with complete information were selected as subjects of study.The 245 patients with AVF stenosis were designated as group 1 and the 150 patients with-out AVF stenosis were designated as group 2.The routine biochemi-cal parameters and complete blood count were recorded for all pa-tients.Results:①Compared with patients in group 2,those in group 1 showed significantly higher NLR(5.07(4.00,6.66)vs.3.46(2.63,4.15),P<0.001),PLR(169.52(127.56,227.11)vs.125.66(89.31,165.31),P<0.001),and C-reactive protein(Hs-CRP)(1.90(0.80,2.99)vs.0.82(0.42,1.27),P<0.001).②Multivariate logistic regression analysis,which was corrected for age,sex,body mass index,AVF anastomosis,puncture method,and diabetes,showed that NLR(OR=2.195,95%CI=1.674~2.878,P<0.001),PLR(OR=1.008,95%CI=1.002~1.012,P=0.007),and Hs-CRP(OR=2.170,95%CI=1.607~2.751,P<0.001)were independent risk factors for AVF ste-nosis in HD patients.③Receiver operating characteristic curve analysis showed that the area under the NLR curve(0.799,95%CI=0.756~0.838,P<0.001),PLR(0.694,95%CI=0.646~0.740,P<0.001),and Hs-CRP(0.717,95%CI=0.670~0.761,P<0.001)could be used to predict AVF stenosis.Their optimal critical values for prediction were 4.08,122.49,and 1.62,respectively.Their combina-tion showed improved prediction effect(AUC 0.870,95%CI=0.833~0.901,P<0.001),high sensitivity(79.18%),and high specificity(81.33%).Conclusion:NLR,PLR,and Hs-CRP were independent risk factors and predictors of AVF stenosis,and their combination has higher predictive value.
5.Treatment of Pulmonary Nodules based on the Theory of "Two Colds Interacting,and Disturbance of Pivots"
Jingrui WANG ; Kexin DUAN ; Junjie HUANG ; Shujing WANG ; Zhiqiang CHEN ; Ying WANG ; Yanlong LI ; Xiangjun QI ; Lizhu LIN
Journal of Traditional Chinese Medicine 2024;65(23):2487-2491
Based on the discussions in the The Inner Canon of Yellow Emperor (《黄帝内经》), it is proposed that in the course of the disease, "bind" represents the initial stage of pulmonary nodules, while "accumulation" represents the final form. In terms of the pathogenesis, "two colds interacting" represented by "body cold" and "cold fluid retention" are the prerequisites for the formation of pulmonary nodules, while "disorder of qi" represented by "fainting" is the core of the formation. The specific manifestation is the disturbance of pivot of shaoyang (少阳) or shaoyin (少阴), resulting in a complex of cold and heat, and then phlegm and stasis are suddenly generated and further formed into nodules. Therefore, the treatment principle should be to regulate the cardinal mechanism, dissolve phlegm and blood stasis. Depending on the complex degree of cold and heat, it is suggested to use Chaihu Guizhi Decoction (柴胡桂枝汤), Chaihu Guizhi Ganjiang Decoction (柴胡桂枝干姜汤), or Chaihu Xianxiong Decoction (柴胡陷胸汤) for disturbance of shaoyang pivot, while for shaoyin pivot dysfunction, modified Mahuang Fuzi Xixin Decoction (麻黄附子细辛汤) or Shengjiang Powder (升降散) can be used.
6.Research hotspots and trends of tigecycline drug resistance: A study based on CiteSpace
Xinjing JIA ; Yanding WANG ; Chunyuan DUAN ; Lisha LIU ; Di WU ; Xinran GONG ; Zhiqiang LI ; Meitao YANG ; Dayang ZOU ; Yong WANG
Journal of Public Health and Preventive Medicine 2024;35(1):16-19
Objective To explore the research progress, research hotspot and development trend of tigecycline resistance based on the quantitative analysis and visualization function of CiteSpace. Methods The data were collected from 4,263 Chinese and English articles on tigecycline resistance in CNKI, Wanfang, VIP and Web of Science (WOS) databases from 2012 to 2022. CiteSpace 5.8.R3 software was used to analyze the cooperative network of authors, the cooperative network of countries and institutions, the total citation times of journals, and keywords included in the literature, to reveal the hotspots and trends of tigecycline resistance research. Results The number of articles published in English literature was higher than that in Chinese literature. China had the largest number of published documents, showing a significant international academic influence in this research field. Countries all over the world were concerned about the resistance of tigecycline, but Chinese literatures focused more on the clinical infection and prevention of tigecycline resistance, while English literatures placed special emphasis on the research about the drug resistance mechanism of tigecycline. Conclusion The research direction at home and abroad is basically the same, but the research focus has gradually shifted from the clinical treatment and monitoring of tigecycline to the molecular level of drug resistance mechanism.
7.Analysis of clinical application of laparoscopic right posterior sectionectomy with the left side lying at 60° run-hug position
Changyan ZHU ; Yuqiu HU ; Deqing LI ; Jinxin DUAN ; Hongcao LIN ; Guangyao CHEN ; Quanbo ZHOU ; Zhiqiang FU
Chinese Journal of Hepatobiliary Surgery 2024;30(7):489-493
Objective:To explore the safety and efficacy of laparoscopic right posterior sectionectomy (LRPS) in the left side lying at 60° run-hug position.Methods:The clinical data of 12 cases underwent LRPS at the Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University from August 2022 to June 2023 were analyzed. There were 9 males and 3 females, ranging in age from 26 to 76 years old. To evaluate the safety and effectiveness of the operation, operation time, intraoperative blood loss, the number and time of intraoperative hilar occlusion, postoperative drainage time, postoperative hospitalization time and postoperative complications were summarized.Results:Twelve operations were successfully completed under laparoscopy, and no patient was converted to laparotomy due to the difficulty in controlling intraoperative bleeding. 12 patients included 1 case of intrahepatic bile duct stones, 5 cases of primary liver cancer, 2 cases of hepatic hemangioma, 2 cases of focal nodular hyperplasia of the liver, 1 case of metastatic liver cancer, and 1 case of liver abscess. Operation time was (246.2±90.4) min, and the intraoperative blood loss was 125(22, 275) ml. The number of intraoperative hilar occlusion was 2.00(0.25, 2.75), and intraoperative hilar occlusion time was (27±22) min. Postoperative drainage time was (5.0±2.6) d, and the length of postoperative hospital stay was 6.0(4.3, 8.0) d. Intraoperative blood transfusion occurred in 1 patient, and postoperative abdominal effusion occurred in 1 patient. There was no postoperative death. All patients were recovered and discharged successfully.Conclusion:LRPS is safe and effective for the lesions in the right posterior hepatic region with the left side lying at 60° run-hug position.
8.Risk Factors Analysis for Obstructive Sleep Apnea Combined with Metabolic Associated Fatty Liver Disease and Construction of Prediction Model
Ying PU ; Zhiqiang ZHANG ; Peng DUAN
Journal of Medical Research 2024;53(7):94-99,162
Objective To investigate clinical features and risk factors of obstructive sleep apnea(OSA)complicated with metabolic associated fatty liver disease(MAFLD),and to construct a prediction model,so as to provide reference for clinical diagnosis and treat-ment.Methods A total of 228 OSA patients admitted to Xiangyang No.1 People's Hospital Affiliate to Hubei University of Medicine from January 2020 to December 2022 were selected.According to whether complicated with MAFLD,the patients were divided into OSA+MAFLD group(n=94)and OSA group(n=134).According to the liver/spleen CT values,OSA+MAFLD group was further di-vided into OSA+mild MAFLD group(n=56)and OSA+moderate-severe MAFLD group(n=38).General clinical data,polysomnog-raphy(PSG),serological examination and other related indicators and parameters of all patients were collected for statistical analysis.Results Univariate analysis showed that there were significant differences between the OSA group and the OSA+MAFLD group in age,hypertension,diabetes,hyperlipidemia,body mass index(BMI),apnea hypopnea index(AHI),oxygen reduction index(ODI),lon-gest apnea time(LAT),snore frequency,lowest saturation oxygen(LSpO2),mean oxygen saturation(MSpO2),CT90%,fasting plasma glucose(FPG),alanine aminotransferase(ALT),aspartate aminotransferase(AST),γ-glutamyltransferase(GGT)(P<0.05);and there were significant differences between the OSA+mild MAFLD group and the OSA+moderate-severe MAFLD group in age,hyperlip-idemia,BMI,AHI,ODI,LAT,snore frequency,LSpO2,MSpO2,CT90%and ALT(P<0.05).Multivariate Logistic regression analy-sis showed that age,BMI,AHI,snore frequency were independent risk factors for OSA and MAFLD(P<0.05);Age,BMI,AHI and ALT were independent risk factors for OSA with moderate-severe MAFLD(P<0.05).The Logistic regression model was established:Y1=-13.183+0.083age+0.205BMI+0.039AHI+0.002snore frequency,the area under the receiver operating characteristic curve was 0.915,and the sensitivity and specificity of the regression model were 87.2%and 82.8%.Y2=-44.956+0.146age+0.510BMI+0.056AHI+0.022ALT,the area under the receiver operating characteristic curve was 0.924,and the sensitivity and specificity of the regression model were 78.9%and 91.1%.Conclusion In clinical work,the occurrence of MAFLD should be considered for OSA pa-tients with older age,higher BMI,higher AHI,and more snoring frequency.OSA patients with MAFLD with older age,higher BMI,higher AHI,and higher ALT are more serious.Moreover,the combined prediction model constructed in this study has better diagnostic value,and can provide reference for early diagnosis of OSA complicated with MAFLD.
9.Current progress in role of circular RNA in stroke
Di LÜ ; Hengqian DUAN ; Zhujun ZHUANG ; Peng CHEN ; Renhua YANG ; Zhiqiang SHEN ; Bo HE
Chinese Journal of Pathophysiology 2024;40(6):1114-1121
Stroke is a cerebrovascular disease characterized by high rates of disability,recurrence and mortal-ity.It results primarily from cerebrovascular rupture or transient/permanent occlusion.Due to the complex pathological mechanism of stroke and the lack of early-stage biomarkers,effective treatment options remain limited.Circular RNAs(circRNAs)are stable and conserved endogenous long noncoding RNA that regulate the pathological process of stroke,in-cluding oxidative stress,inflammation,apoptosis and autophagy.In addition,the regulatory roles of circRNAs in stroke include ceRNA,DNA methylation and histone modification.This review provides a comprehensive overview of circRNA biogenesis,major functions and characteristics.Furthermore,it presents the latest research findings on circRNAs in the context of stroke pathology,with the aim of providing new insights and potential approaches for unraveling the underlying mechanism,diagnosis and treatment of such diseases.
10.Clinical treatment guideline for pulmonary blast injury (version 2023)
Zhiming SONG ; Junhua GUO ; Jianming CHEN ; Jing ZHONG ; Yan DOU ; Jiarong MENG ; Guomin ZHANG ; Guodong LIU ; Huaping LIANG ; Hezhong CHEN ; Shuogui XU ; Yufeng ZHANG ; Zhinong WANG ; Daixing ZHONG ; Tao JIANG ; Zhiqiang XUE ; Feihu ZHOU ; Zhixin LIANG ; Yang LIU ; Xu WU ; Kaican CAI ; Yi SHEN ; Yong SONG ; Xiaoli YUAN ; Enwu XU ; Yifeng ZHENG ; Shumin WANG ; Erping XI ; Shengsheng YANG ; Wenke CAI ; Yu CHEN ; Qingxin LI ; Zhiqiang ZOU ; Chang SU ; Hongwei SHANG ; Jiangxing XU ; Yongjing LIU ; Qianjin WANG ; Xiaodong WEI ; Guoan XU ; Gaofeng LIU ; Junhui LUO ; Qinghua LI ; Bin SONG ; Ming GUO ; Chen HUANG ; Xunyu XU ; Yuanrong TU ; Liling ZHENG ; Mingke DUAN ; Renping WAN ; Tengbo YU ; Hai YU ; Yanmei ZHAO ; Yuping WEI ; Jin ZHANG ; Hua GUO ; Jianxin JIANG ; Lianyang ZHANG ; Yunfeng YI
Chinese Journal of Trauma 2023;39(12):1057-1069
Pulmonary blast injury has become the main type of trauma in modern warfare, characterized by externally mild injuries but internally severe injuries, rapid disease progression, and a high rate of early death. The injury is complicated in clinical practice, often with multiple and compound injuries. Currently, there is a lack of effective protective materials, accurate injury detection instrument and portable monitoring and transportation equipment, standardized clinical treatment guidelines in various medical centers, and evidence-based guidelines at home and abroad, resulting in a high mortality in clinlcal practice. Therefore, the Trauma Branch of Chinese Medical Association and the Editorial Committee of Chinese Journal of Trauma organized military and civilian experts in related fields such as thoracic surgery and traumatic surgery to jointly develop the Clinical treatment guideline for pulmonary blast injury ( version 2023) by combining evidence for effectiveness and clinical first-line treatment experience. This guideline provided 16 recommended opinions surrounding definition, characteristics, pre-hospital diagnosis and treatment, and in-hospital treatment of pulmonary blast injury, hoping to provide a basis for the clinical treatment in hospitals at different levels.


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