1.Research on multi antigen extended matching transfusion in RhCE alloantibody positive patients with blood diseases
Pin YI ; Mingming WANG ; Yi ZHU ; Xintang DANG ; Ziyu OU ; Fan WU ; Chaopeng SHAO ; Changlin WU
Chinese Journal of Blood Transfusion 2025;38(5):678-683
Objective: To analyze the changes in homologous immunity after RhCE-matched transfusion in positive patients with RhCE blood group antibodies, and to provide precise transfusion strategies for chronic anemia patients. Methods: Patients with chronic anemia in our hospital from January 2020 to March 2024 (continuously receiving blood transfusions for more than 6 months) were enrolled, and 63 cases of unexpected antibody screening positive and identified as RhCE blood group antibodies were selected as the research subjects. The changes in unexpected antibody yield rate after ABO and RhCcDEe isotype blood transfusion were observed. Patients with MNS, Kidd, or Lewis blood group antibodies were screened for corresponding negative donors using monoclonal antibodies for extended typing transfusion based on RhCcEe typing, and the changes in unexpected antibody yield rate after transfusion were observed. Blood group genotyping was performed when serological techniques failed to resolve discrepancies or detect abnormal antigen expression. Results: After RhCcDEe-matched transfusions, RhCE antibodies disappeared in 62 patients, while 1 patient developed anti-Ce. The latter did not develop blood type isotype immunity after receiving RhccEE donor blood. Among the 62 patients, 9 developed unexpected antibodies against other systems: anti-M (4 cases), anti-Mur (2), anti-S (1), anti-Jka (1), and anti-Lea (1). No additional alloimmunization occurred after extended antigen-matched transfusions. A patient with serologically weak e phenotype was genotyped as DCe/DcE, with gene sequencing revealing an 827C>A mutation in exon 6 of the RHCE gene, forming the RHCE
01.31 allele. Conclusion: Precise transfusion strategies incorporating RhCE, MNS, Kidd, and Lewis blood group antigen typing can reduce the probability of blood group homologous immunity. RhCE complex antibodies and RhCE variants pose difficulties for clinical RhCE typing transfusion, which can be addressed through cross-matching and genetic analysis.
2.Clinical application of exempting anti-D monitoring in pregnant women with Asian-type DEL
Pin YI ; Ziyu OU ; Xiaoxiao SUN ; Mingming WANG ; Changlin WU ; Chaopeng SHAO
Chinese Journal of Blood Transfusion 2025;38(6):766-771
Objective: To evaluate the feasibility of exempting Asian-type DEL pregnant women from anti-D monitoring and RhD immunoglobulin prophylaxis injections by comparing and analyzing the clinical incidence of anti-D alloimmunization between Asian-type DEL pregnant women and true RhD-negative pregnant women. Methods: A total of 165 pregnant women who were initially screened as RhD negative by the saline method and received medical treatment in our hospital from December 2022 to August 2024 were collected as the research subjects. Absorption and elution tests, DEL genotyping, and gene sequencing were used to divide the pregnant women into the Asian-type DEL group and the true negative group. After obtaining informed consent, the following clinical management plan was implemented for pregnant women with Asian-type DEL: exemption from routine anti-D antibody detection, exemption from RhD immunoglobulin prophylaxis, and transfusion of RhD-positive red blood cells. Blood samples of newborns were sent for examination of hemolytic disease of the fetus and newborn (HDFN). The routine management plan was implemented for true negative pregnant women. The incidence of alloimmunization and HDFN was comparatively analyzed between the two groups. Results: Among 165 initially screened RhD negative pregnant women, serological testing and genotyping confirmed 42 as Asian-type DEL, 9 as D variant, and 114 as true negative. Among 42 pregnant women with Asian-type DEL, 3 cases tested positive for HDFN due to receiving RhD immunoglobulin prophylaxis injection. The remaining 39 cases were exempted from anti-D testing after being fully informed of the risk, and did not receive RhD immunoglobulin prophylaxis. The HDFN tests were all negative. In the true negative group, anti-D antibodies were detected in 20 cases, of which 6 cases tested positive for HDFN. A pregnant woman with Asian -type DEL did not show RhD homologous immune response after receiving 2 units of RhD positive red blood cells. Statistical analysis revealed a significantly lower risk of anti-D alloimmunization in Asian-type DEL carriers compared to true D-negative pregnant women (P<0.05). Conclusion: Pregnant women with Asian-type DEL can be exempted from routine anti-D antibody testing and do not require routine RhD immunoglobulin prophylaxis injections.
3.Analysis of transmission dynamics and effectiveness of control of local epidemics caused by the Omicron BA.2 and BA.5.2 COVID-19 strains in Fujian Province
Wen-Jing YE ; Sheng-Gen WU ; Mei-Rong ZHAN ; Zheng-Qiang HUANG ; Shao-Jian CAI ; Wu CHEN ; Jian-Ming OU ; Jie-Feng HUANG ; Tian-Mu CHEN ; Yan-Qin DENG ; Kui-Cheng ZHENG
Chinese Journal of Zoonoses 2023;39(11):1065-1071
This study evaluated the scientific nature and effectiveness of iterative optimization of prevention and control measures for local outbreaks caused by the BA.2 and BA.5.2 COVID-19 strains in Fujian Province in 2022,to provide a scientif-ic basis for responding to future new or recurrent respiratory infectious diseases.According to the theory of infectious disease dynamics,relevant information regarding the local epidemic situation caused by the BA.2 sub-type Omicron virus strain in March 2022 and BA.5.2 sub-type Omicron virus strain in October 2022 in Fujian Province was collected.The susceptible exposed infectious removed(SEIAR)model of COVID-19 infection with a latent period and asymptomatic infected persons was used to analyze the transmission dynam-ics of two local epidemic situations,and evaluate the preven-tion and control effects.The incubation period of the BA.2 epidemic was 3 days(1~9 days),the intergenerational inter-val was 3 days(1~5 days),and the initial Rt was 3.0(95%CI:2.7~3.3).The incubation period of the BA.5.2 epidemic was 2 days(1~6 days),the intergenerational interval was 1 day(0~2 days),and the initial R,was 1.9(95%CI:1.7~2.1).The fittingresults for the BA.2 and BA.5.2 epidemics were good,and no statistical difference was observed between the predic-ted and actual numbers of cases(x2BA.2=31.53,x2BA.5.2=27.88,P>0.05).If an emergency response had not been initiated,the BA.2 epidemic would have continued to spread andpeak on April 7th,with an estimated 638 035 cases.The BA.5.2 epidemic would have rapidly spread,reaching a peak on November 14th,with an estimated 685 940 cases.If one incubation period were detected early,the scale of the BA.2 epidemic would have decreased by 25.73%;if two incubation periods were detected early,the scale would have decreased by 79.56%,and if one incubation period had been delayed,the scale would have expanded by 13.72%.If one incubation period had been detected early in the BA.5.2 epidemic,the scale would have decreased by 35.04%;if two incubation periods had been detected early,the scale would have decreased by 92.47%;and if one incubation period had been delayed,the scale would have increased by 19.75%.The guiding ideology,and the prevention and control measures for handling two local epidemics were optimized and iterated.Our study indicated that implementing the"four early"measures ef-fectively decreased the scale of the epidemic,and earlier detection was associated with more significant control effects.This study provides valuable information for the prevention and control of new or recurrent respiratory infectious diseases.
4.Incidence of extrauterine growth retardation and its risk factors in very preterm infants during hospitalization: a multicenter prospective study.
Wei SHEN ; Zhi ZHENG ; Xin-Zhu LIN ; Fan WU ; Qian-Xin TIAN ; Qi-Liang CUI ; Yuan YUAN ; Ling REN ; Jian MAO ; Bi-Zhen SHI ; Yu-Mei WANG ; Ling LIU ; Jing-Hui ZHANG ; Yan-Mei CHANG ; Xiao-Mei TONG ; Yan ZHU ; Rong ZHANG ; Xiu-Zhen YE ; Jing-Jing ZOU ; Huai-Yu LI ; Bao-Yin ZHAO ; Yin-Ping QIU ; Shu-Hua LIU ; Li MA ; Ying XU ; Rui CHENG ; Wen-Li ZHOU ; Hui WU ; Zhi-Yong LIU ; Dong-Mei CHEN ; Jin-Zhi GAO ; Jing LIU ; Ling CHEN ; Cong LI ; Chun-Yan YANG ; Ping XU ; Ya-Yu ZHANG ; Si-Le HU ; Hua MEI ; Zu-Ming YANG ; Zong-Tai FENG ; San-Nan WANG ; Er-Yan MENG ; Li-Hong SHANG ; Fa-Lin XU ; Shao-Ping OU ; Rong JU
Chinese Journal of Contemporary Pediatrics 2022;24(2):132-140
OBJECTIVES:
To investigate the incidence of extrauterine growth retardation (EUGR) and its risk factors in very preterm infants (VPIs) during hospitalization in China.
METHODS:
A prospective multicenter study was performed on the medical data of 2 514 VPIs who were hospitalized in the department of neonatology in 28 hospitals from 7 areas of China between September 2019 and December 2020. According to the presence or absence of EUGR based on the evaluation of body weight at the corrected gestational age of 36 weeks or at discharge, the VPIs were classified to two groups: EUGR group (n=1 189) and non-EUGR (n=1 325). The clinical features were compared between the two groups, and the incidence of EUGR and risk factors for EUGR were examined.
RESULTS:
The incidence of EUGR was 47.30% (1 189/2 514) evaluated by weight. The multivariate logistic regression analysis showed that higher weight growth velocity after regaining birth weight and higher cumulative calorie intake during the first week of hospitalization were protective factors against EUGR (P<0.05), while small-for-gestational-age birth, prolonged time to the initiation of total enteral feeding, prolonged cumulative fasting time, lower breast milk intake before starting human milk fortifiers, prolonged time to the initiation of full fortified feeding, and moderate-to-severe bronchopulmonary dysplasia were risk factors for EUGR (P<0.05).
CONCLUSIONS
It is crucial to reduce the incidence of EUGR by achieving total enteral feeding as early as possible, strengthening breastfeeding, increasing calorie intake in the first week after birth, improving the velocity of weight gain, and preventing moderate-severe bronchopulmonary dysplasia in VPIs.
Female
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Fetal Growth Retardation
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Gestational Age
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Hospitalization
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Humans
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Incidence
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Infant
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Infant, Newborn
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Infant, Premature
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Infant, Very Low Birth Weight
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Prospective Studies
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Risk Factors
5.Genomic Correlates of Unfavorable Outcome in Locally Advanced Cervical Cancer Treated with Neoadjuvant Chemoradiation
Yuchun WEI ; Chuqing WEI ; Liang CHEN ; Ning LIU ; Qiuxiang OU ; Jiani C. YIN ; Jiaohui PANG ; Zhenhao FANG ; Xue WU ; Xiaonan WANG ; Dianbin MU ; Yang SHAO ; Jinming YU ; Shuanghu YUAN
Cancer Research and Treatment 2022;54(4):1209-1218
Purpose:
Neoadjuvant therapy modality can increase the operability rate and mitigate pathological risks in locally advanced cervical cancer, but treatment response varies widely. It remains unclear whether genetic alterations correlate with the response to neoadjuvant therapy and disease-free survival (DFS) in locally advanced cervical cancer.
Materials and Methods:
A total of 62 locally advanced cervical cancer (stage IB-IIA) patients who received neoadjuvant chemoradiation plus radical hysterectomy were retrospectively analyzed. Patients’ tumor biopsy samples were comprehensively profiled using targeted next generation sequencing. Pathologic response to neoadjuvant treatment and DFS were evaluated against the association with genomic traits.
Results:
Genetic alterations of PIK3CA were most frequent (37%), comparable to that of Caucasian populations from The Cancer Genome Atlas. The mutation frequency of genes including TERT, POLD1, NOS2, and FGFR3 was significantly higher in Chinese patients whereas RPTOR, EGFR, and TP53 were underrepresented in comparison to Caucasians. Germline mutations were identified in 21% (13/62) of the cohort and more than half (57%) had mutations in DNA damage repair genes, including BRCA1/2, TP53 and PALB2. Importantly, high tumor mutation burden, TP53 polymorphism (rs1042522), and KEAP1 mutations were found to be associated with poor pathologic response to neoadjuvant chemoradiation treatment. KEAP1 mutations, PIK3CA-SOX2 co-amplification, TERC copy number gain, and TYMS polymorphism correlated with an increased risk of disease relapse.
Conclusion
We report the genomic profile of locally advanced cervical cancer patients and the distinction between Asian and Caucasian cohorts. Our findings highlight genomic traits associated with unfavorable neoadjuvant chemoradiation response and a higher risk of early disease recurrence.
6.Histological regression and clinical benefits in patients with liver cirrhosis after long-term anti-HBV treatment
Shuyan CHEN ; Yameng SUN ; Jialing ZHOU ; Xiaoning WU ; Tongtong MENG ; Bingqiong WANG ; Hui LIU ; Tailing WANG ; Chen SHAO ; Xinyu ZHAO ; Xiaoqian XU ; Yuanyuan KONG ; Xiaojuan OU ; Jidong JIA ; Hong YOU
Chinese Journal of Hepatology 2022;30(6):583-590
Objective:Our study aims to determine histological regression and clinical improvement after long-term antiviral therapy in hepatitis B virus-related cirrhosis patients.Methods:Treatment-na?ve chronic hepatitis B patients with histologically or clinically diagnosed liver cirrhosis were enrolled. Liver biopsies were performed after 5 years entecavir-based antiviral treatment. Patients were followed up every 6 months. Cirrhosis regression was evaluated based on Metavir system and P-I-R score. Clinical improvement was evaluated before and after the long-term treatment. Kruskal Wallis test and Wilcoxon signed-rank test were used for continuous variables, Fisher's exact test was used for categorical variables and multivariate analysis was performed using logistic regression analysis.Results:Totals of 73 patients with HBV-related liver cirrhosis were enrolled. Among them, 30 (41.1%) patients were biopsy proved liver cirrhosis and the remaining 43 (58.9%) cirrhotic patients were diagnosed by clinical features. Based on Metavir system and P-I-R score, 72.6% (53/73) patients attained histological regression. Furthermore, 30.1% (22/73) were defined as significant regression (Metavir decrease ≥2 stage), 42.5% (31/73) were mild regression (Metavir decrease 1 stage or predominantly regressive by P-I-R system if still cirrhosis after treatment) and 27.4% (20/73) were the non-regression. Compared to levels of clinical characteristics at baseline, HBV DNA, ALT, AST, liver stiffness(decreased from 12.7 to 6.4 kPa in significant regression, from 18.1 to 7.3 kPa in mild regression and from 21.4 to 11.2 kPa in non-regression)and Ishak-HAI score significantly decreased after 5 years of anti-HBV treatment, while serum levels of platelets and albumin improved remarkably ( P<0.05). In multivariate analysis, only the pre-treatment liver stiffness level was associated with significant regression ( OR=0.887, 95% CI: 0.802-0.981, P=0.020). Conclusions:After long-term antiviral therapy, patients with HBV-related cirrhosis are easily to attain improvements in clinical parameters, while a certain percentage of these patients still cannot achieve histological reversal.
7.Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial.
Ya-Jun SHU ; Jian-Feng HE ; Rong-Juan PEI ; Peng HE ; Zhu-Hang HUANG ; Shao-Min CHEN ; Zhi-Qiang OU ; Jing-Long DENG ; Pei-Yu ZENG ; Jian ZHOU ; Yuan-Qin MIN ; Fei DENG ; Hua PENG ; Zheng ZHANG ; Bo WANG ; Zhong-Hui XU ; Wu-Xiang GUAN ; Zhong-Yu HU ; Ji-Kai ZHANG
Chinese Medical Journal 2021;134(16):1967-1976
BACKGROUND:
Innovative coronavirus disease 2019 (COVID-19) vaccines, with elevated global manufacturing capacity, enhanced safety and efficacy, simplified dosing regimens, and distribution that is less cold chain-dependent, are still global imperatives for tackling the ongoing pandemic. A previous phase I trial indicated that the recombinant COVID-19 vaccine (V-01), which contains a fusion protein (IFN-PADRE-RBD-Fc dimer) as its antigen, is safe and well tolerated, capable of inducing rapid and robust immune responses, and warranted further testing in additional clinical trials. Herein, we aimed to assess the immunogenicity and safety of V-01, providing rationales of appropriate dose regimen for further efficacy study.
METHODS:
A randomized, double-blind, placebo-controlled phase II clinical trial was initiated at the Gaozhou Municipal Centre for Disease Control and Prevention (Guangdong, China) in March 2021. Both younger (n = 440; 18-59 years of age) and older (n = 440; ≥60 years of age) adult participants in this trial were sequentially recruited into two distinct groups: two-dose regimen group in which participants were randomized either to follow a 10 or 25 μg of V-01 or placebo given intramuscularly 21 days apart (allocation ratio, 3:3:1, n = 120, 120, 40 for each regimen, respectively), or one-dose regimen groups in which participants were randomized either to receive a single injection of 50 μg of V-01 or placebo (allocation ratio, 3:1, n = 120, 40, respectively). The primary immunogenicity endpoints were the geometric mean titers of neutralizing antibodies against live severe acute respiratory syndrome coronavirus 2, and specific binding antibodies to the receptor binding domain (RBD). The primary safety endpoint evaluation was the frequencies and percentages of overall adverse events (AEs) within 30 days after full immunization.
RESULTS:
V-01 provoked substantial immune responses in the two-dose group, achieving encouragingly high titers of neutralizing antibody and anti-RBD immunoglobulin, which peaked at day 35 (161.9 [95% confidence interval [CI]: 133.3-196.7] and 149.3 [95%CI: 123.9-179.9] in 10 and 25 μg V-01 group of younger adults, respectively; 111.6 [95%CI: 89.6-139.1] and 111.1 [95%CI: 89.2-138.4] in 10 and 25 μg V-01 group of older adults, respectively), and remained high at day 49 after a day-21 second dose; these levels significantly exceed those in convalescent serum from symptomatic COVID-19 patients (53.6, 95%CI: 31.3-91.7). Our preliminary data show that V-01 is safe and well tolerated, with reactogenicity predominantly being absent or mild in severity and only one vaccine-related grade 3 or worse AE being observed within 30 days. The older adult participants demonstrated a more favorable safety profile compared with those in the younger adult group: with AEs percentages of 19.2%, 25.8%, 17.5% in older adults vs. 34.2%, 23.3%, 26.7% in younger adults at the 10, 25 μg V-01 two-dose group, and 50 μg V-01 one-dose group, respectively.
CONCLUSIONS:
The vaccine candidate V-01 appears to be safe and immunogenic. The preliminary findings support the advancement of the two-dose, 10 μg V-01 regimen to a phase III trial for a large-scale population-based evaluation of safety and efficacy.
TRIAL REGISTRATION
http://www.chictr.org.cn/index.aspx (No. ChiCTR2100045107, http://www.chictr.org.cn/showproj.aspx?proj=124702).
Aged
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Antibodies, Viral
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COVID-19/therapy*
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COVID-19 Vaccines
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Double-Blind Method
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Humans
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Immunization, Passive
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Recombinant Fusion Proteins
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SARS-CoV-2
8.The Chinese guidelines for the diagnosis and treatment of pancreatic neuroendocrine neoplasms (2020)
Wenming WU ; Jie CHEN ; Chunmei BAI ; Yihebali CHI ; Yiqi DU ; Shiting FENG ; Li HUO ; Yuxin JIANG ; Jingnan LI ; Wenhui LOU ; Jie LUO ; Chenghao SHAO ; Lin SHEN ; Feng WANG ; Liwei WANG ; Ou WANG ; Yu WANG ; Huanwen WU ; Xiaoping XING ; Jianming XU ; Huadan XUE ; Ling XUE ; Yang YANG ; Xianjun YU ; Chunhui YUAN ; Hong ZHAO ; Xiongzeng ZHU ; Yupei ZHAO
Chinese Journal of Digestive Surgery 2021;20(6):579-599
Pancreatic neuroendocrine neoplasms (pNENs) are highly heterogeneous, and the management of pNENs patients can be intractable. To address this challenge, an expert committee was established on behalf of the Chinese Pancreatic Surgery Association, Chinese Society of Surgery, Chinese Medical Association, which consisted of surgical oncologists, gastroenterologists, medical oncologists, endocrinologists, radiologists, pathologists, and nuclear medicine specialists. By reviewing the important issues regarding the diagnosis and treatment of pNENs, the committee concluded evidence-based statements and recommendations in this article, in order to further improve the management of pNENs patients in China.
9.The Chinese guidelines for the diagnosis and treatment of pancreatic neuroendocrine neoplasms (2020)
Wenming WU ; Jie CHEN ; Chunmei BAI ; Yihebali CHI ; Yiqi DU ; Shiting FENG ; Li HUO ; Yuxin JIANG ; Jingnan LI ; Wenhui LOU ; Jie LUO ; Chenghao SHAO ; Lin SHEN ; Feng WANG ; Liwei WANG ; Ou WANG ; Yu WANG ; Huanwen WU ; Xiaoping XING ; Jianming XU ; Huadan XUE ; Ling XUE ; Yang YANG ; Xianjun YU ; Chunhui YUAN ; Hong ZHAO ; Xiongzeng ZHU ; Yupei ZHAO
Chinese Journal of Surgery 2021;59(6):401-421
Pancreatic neuroendocrine neoplasms (pNENs) are highly heterogeneous, and the management of pNENs patients can be intractable. To address this challenge, an expert committee was established on behalf of the Group of Pancreatic Surgery, Chinese Society of Surgery, Chinese Medical Association, which consisted of surgical oncologists, gastroenterologists, medical oncologists, endocrinologists, radiologists, pathologists, and nuclear medicine specialists. By reviewing the important issues regarding the diagnosis and treatment of pNENs, the committee concluded evidence-based statements and recommendations in this article, in order to further improve the management of pNENs patients in China.
10.The Chinese guidelines for the diagnosis and treatment of pancreatic neuroendocrine neoplasms (2020)
Wenming WU ; Jie CHEN ; Chunmei BAI ; Yihebali CHI ; Yiqi DU ; Shiting FENG ; Li HUO ; Yuxin JIANG ; Jingnan LI ; Wenhui LOU ; Jie LUO ; Chenghao SHAO ; Lin SHEN ; Feng WANG ; Liwei WANG ; Ou WANG ; Yu WANG ; Huanwen WU ; Xiaoping XING ; Jianming XU ; Huadan XUE ; Ling XUE ; Yang YANG ; Xianjun YU ; Chunhui YUAN ; Hong ZHAO ; Xiongzeng ZHU ; Yupei ZHAO
Chinese Journal of Surgery 2021;59(6):401-421
Pancreatic neuroendocrine neoplasms (pNENs) are highly heterogeneous, and the management of pNENs patients can be intractable. To address this challenge, an expert committee was established on behalf of the Group of Pancreatic Surgery, Chinese Society of Surgery, Chinese Medical Association, which consisted of surgical oncologists, gastroenterologists, medical oncologists, endocrinologists, radiologists, pathologists, and nuclear medicine specialists. By reviewing the important issues regarding the diagnosis and treatment of pNENs, the committee concluded evidence-based statements and recommendations in this article, in order to further improve the management of pNENs patients in China.

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