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.Efficacy and safety of intrasaccular flow disruptor in wide-necked intracranial aneurysms: a multicenter retrospective study
Xiaowen ZHANG ; Jing LI ; Xifeng LI ; Chuanzhi DUAN ; Aihua LIU ; Huaizhang SHI ; Haowen XU ; Nan MA ; Zhiqiang YAO ; Feng FAN ; Chao LIU ; Jinyi LI ; Hailong ZHONG ; Mengyan FAN ; Jiaxin WAN ; Rijin LIN ; Huixiang LIU ; Jiamei ZHANG ; Xin ZHANG ; Sheng GUAN
Chinese Journal of Neuromedicine 2025;24(1):16-22
Objective:To evaluate the efficacy and safety of intrasaccular flow disruptor in wide-necked intracranial aneurysms.Methods:One hundred and seventeen patients with wide-necked intracranial aneurysms treated with intrasaccular flow disruptor were collected from Department of Neurointervention (First Affiliated Hospital of Zhengzhou University), Department of Neurosurgery (Beijing Tiantan Hospital, Capital Medical University), Department of Cerebrovascular Surgery, Neurosurgery Center (Zhujiang Hospital, Southern Medical University), and Department of Neurosurgery (First Affiliated Hospital of Harbin Medical University) from August 2022 to March 2024. Raymond-Roy Occlusion Classification (RROC) was employed to evaluate aneurysm embolization immediately after procedure; cranial CT or MRI within 48 hours of embolization were performed to identify any new intracranial hemorrhage, subarachnoid hemorrhage, or new symptomatic cerebral infarction related to the intracranial aneurysms. Modified Rankin Scale (mRS) was used to assess the neurological function at discharge. Imaging follow-up and outpatient follow-up were performed at 6 months after embolization to evaluate the aneurysm occlusion degree and complications.Results:A total of 117 intrasaccular flow disruptors were implanted in 117 patients, with a technical success rate of 100%; 115 patients (98.3%) enjoyed successful one-time release of their disruptors, and 2 patients (1.7%) required retrieval and redirection of the disruptors before second successful attempt. Flow disruptor plus stent was performed in 13 patients (11.1%). Immediately after procedure, RROC grading I was noted in 3 patients, grading II in 51 patients and grading III in 63 patients. Cranial CT or MRI within 48 hours of embolization indicated no new intracranial hemorrhage, subarachnoid hemorrhage, or symptomatic cerebral infarction related to the intracranial aneurysms. All patients had mRS score of 0 at discharge. Eighty-three patients completed a 6-month follow-up (RROC grading I in 41 patients, grading II in 33 patients and grading III in 9 patients), without ischemic or hemorrhagic adverse events.Conclusion:The results of this study preliminarily suggest that intrasaccular flow disruptor is effective and safe in wide-necked intracranial aneurysms.
5.Neuroform Atlas stent-assisted coil embolization for middle cerebral artery bifurcation aneurysms: a multicenter retrospective study
Mengyan FAN ; Jing LI ; Chuanzhi DUAN ; Huaizhang SHI ; Aihua LIU ; Xiaochuan SUN ; Feng FAN ; Jinyi LI ; Chao LIU ; Haowen XU ; Linyu WANG ; Zhiqiang YAO ; Hailong ZHONG ; Xiaowen ZHANG ; Rijin LIN ; Jiaxin WAN ; Nan ZHANG ; Huixiang LIU ; Jiamei ZHANG ; Sheng GUAN
Chinese Journal of Neuromedicine 2025;24(2):141-146
Objective:To evaluate the efficacy and safety of Neuroform Atlas stent-assisted coil embolization in patients with middle cerebral artery bifurcation aneurysms.Methods:A retrospective analysis was performed; the clinical data of 46 patients with middle cerebral artery bifurcation aneurysms accepted Neuroform Atlas stent-assisted coil embolization in First Affiliated Hospital of Zhengzhou University, Beijing Tiantan Hospital Affiliated to Capital Medical University, First Affiliated Hospital of Harbin Medical University, Zhujiang Hospital of Southern Medical University and First Affiliated Hospital of Chongqing Medical University from January 2022 to March 2024 were collected. There were 28 ruptured aneurysms (60.87%) and 18 unruptured aneurysms (39.13%). Follow-up was performed for more than 3 months; Raymond-Roy grading was used to evaluate the aneurysm embolization immediately after embolization and during follow-up; perioperative hemorrhagic or ischemic complications were recorded; modified Rankin Scale (mRS) was used to evaluate the prognosis of the patients at discharge and during follow-up (mRS score≤2: good prognosis, and mRS score>2: poor prognosis).Results:Coil embolization was successful in all 46 patients. DSA immediately after embolization showed that 41 patients (89.13%) had completely occluded aneurysms (Raymond-Roy grading I), 2 patients (4.35%) had residual aneurysm neck (Raymond-Roy grading Ⅱ) and 3 patients (6.52%) had partially occluded aneurysms (Raymond-Roy grading Ⅲ). Perioperative complications occurred in 5 patients, including 2 with postoperative cerebral infarction, 1 with hydrocephalus, 1 with postoperative pneumonia leading to respiratory failure, and 1 with stent thrombosis during embolization. Both at discharge and 3 months after embolization, 43 patients (93.48%) had good prognosis and 3 patients (6.52%) had poor prognosis. No obvious ischemic complications (such as stent restenosis) or hemorrhagic complications (such as re-rupture of the aneurysms) were found in all patients. Thirty patients (65.22%) had imaging follow-up for 6-12 months: 26 (86.67%) had Raymond-Roy grading I, 3 (10.00%) had Raymond-Roy grading II, and 1 (3.33%) had Raymond-Roy grading III.Conclusion:Neuroform Atlas stent-assisted coil embolization has good short-term efficacy and high safety in middle cerebral artery bifurcation aneurysms, but long-term follow-up observation is still needed to verify its efficacy.
6.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.
7.Efficacy and safety of intrasaccular flow disruptor in wide-necked intracranial aneurysms: a multicenter retrospective study
Xiaowen ZHANG ; Jing LI ; Xifeng LI ; Chuanzhi DUAN ; Aihua LIU ; Huaizhang SHI ; Haowen XU ; Nan MA ; Zhiqiang YAO ; Feng FAN ; Chao LIU ; Jinyi LI ; Hailong ZHONG ; Mengyan FAN ; Jiaxin WAN ; Rijin LIN ; Huixiang LIU ; Jiamei ZHANG ; Xin ZHANG ; Sheng GUAN
Chinese Journal of Neuromedicine 2025;24(1):16-22
Objective:To evaluate the efficacy and safety of intrasaccular flow disruptor in wide-necked intracranial aneurysms.Methods:One hundred and seventeen patients with wide-necked intracranial aneurysms treated with intrasaccular flow disruptor were collected from Department of Neurointervention (First Affiliated Hospital of Zhengzhou University), Department of Neurosurgery (Beijing Tiantan Hospital, Capital Medical University), Department of Cerebrovascular Surgery, Neurosurgery Center (Zhujiang Hospital, Southern Medical University), and Department of Neurosurgery (First Affiliated Hospital of Harbin Medical University) from August 2022 to March 2024. Raymond-Roy Occlusion Classification (RROC) was employed to evaluate aneurysm embolization immediately after procedure; cranial CT or MRI within 48 hours of embolization were performed to identify any new intracranial hemorrhage, subarachnoid hemorrhage, or new symptomatic cerebral infarction related to the intracranial aneurysms. Modified Rankin Scale (mRS) was used to assess the neurological function at discharge. Imaging follow-up and outpatient follow-up were performed at 6 months after embolization to evaluate the aneurysm occlusion degree and complications.Results:A total of 117 intrasaccular flow disruptors were implanted in 117 patients, with a technical success rate of 100%; 115 patients (98.3%) enjoyed successful one-time release of their disruptors, and 2 patients (1.7%) required retrieval and redirection of the disruptors before second successful attempt. Flow disruptor plus stent was performed in 13 patients (11.1%). Immediately after procedure, RROC grading I was noted in 3 patients, grading II in 51 patients and grading III in 63 patients. Cranial CT or MRI within 48 hours of embolization indicated no new intracranial hemorrhage, subarachnoid hemorrhage, or symptomatic cerebral infarction related to the intracranial aneurysms. All patients had mRS score of 0 at discharge. Eighty-three patients completed a 6-month follow-up (RROC grading I in 41 patients, grading II in 33 patients and grading III in 9 patients), without ischemic or hemorrhagic adverse events.Conclusion:The results of this study preliminarily suggest that intrasaccular flow disruptor is effective and safe in wide-necked intracranial aneurysms.
8.Neuroform Atlas stent-assisted coil embolization for middle cerebral artery bifurcation aneurysms: a multicenter retrospective study
Mengyan FAN ; Jing LI ; Chuanzhi DUAN ; Huaizhang SHI ; Aihua LIU ; Xiaochuan SUN ; Feng FAN ; Jinyi LI ; Chao LIU ; Haowen XU ; Linyu WANG ; Zhiqiang YAO ; Hailong ZHONG ; Xiaowen ZHANG ; Rijin LIN ; Jiaxin WAN ; Nan ZHANG ; Huixiang LIU ; Jiamei ZHANG ; Sheng GUAN
Chinese Journal of Neuromedicine 2025;24(2):141-146
Objective:To evaluate the efficacy and safety of Neuroform Atlas stent-assisted coil embolization in patients with middle cerebral artery bifurcation aneurysms.Methods:A retrospective analysis was performed; the clinical data of 46 patients with middle cerebral artery bifurcation aneurysms accepted Neuroform Atlas stent-assisted coil embolization in First Affiliated Hospital of Zhengzhou University, Beijing Tiantan Hospital Affiliated to Capital Medical University, First Affiliated Hospital of Harbin Medical University, Zhujiang Hospital of Southern Medical University and First Affiliated Hospital of Chongqing Medical University from January 2022 to March 2024 were collected. There were 28 ruptured aneurysms (60.87%) and 18 unruptured aneurysms (39.13%). Follow-up was performed for more than 3 months; Raymond-Roy grading was used to evaluate the aneurysm embolization immediately after embolization and during follow-up; perioperative hemorrhagic or ischemic complications were recorded; modified Rankin Scale (mRS) was used to evaluate the prognosis of the patients at discharge and during follow-up (mRS score≤2: good prognosis, and mRS score>2: poor prognosis).Results:Coil embolization was successful in all 46 patients. DSA immediately after embolization showed that 41 patients (89.13%) had completely occluded aneurysms (Raymond-Roy grading I), 2 patients (4.35%) had residual aneurysm neck (Raymond-Roy grading Ⅱ) and 3 patients (6.52%) had partially occluded aneurysms (Raymond-Roy grading Ⅲ). Perioperative complications occurred in 5 patients, including 2 with postoperative cerebral infarction, 1 with hydrocephalus, 1 with postoperative pneumonia leading to respiratory failure, and 1 with stent thrombosis during embolization. Both at discharge and 3 months after embolization, 43 patients (93.48%) had good prognosis and 3 patients (6.52%) had poor prognosis. No obvious ischemic complications (such as stent restenosis) or hemorrhagic complications (such as re-rupture of the aneurysms) were found in all patients. Thirty patients (65.22%) had imaging follow-up for 6-12 months: 26 (86.67%) had Raymond-Roy grading I, 3 (10.00%) had Raymond-Roy grading II, and 1 (3.33%) had Raymond-Roy grading III.Conclusion:Neuroform Atlas stent-assisted coil embolization has good short-term efficacy and high safety in middle cerebral artery bifurcation aneurysms, but long-term follow-up observation is still needed to verify its efficacy.
9.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.
10.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.

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