1.A real-time process monitoring scheme for blood center NAT using the median of internal control CT value
Yuntao XU ; Jiaqiang ZHU ; Zuomei YIN ; Li MU ; Huiping ZHANG ; Xingfeng ZHANG ; Lijing QIAO
Chinese Journal of Blood Transfusion 2026;39(3):391-396
Objective: To establish a real-time quality control scheme based on the median (MD-IC) of internal control cycle threshold value in negative samples (NEG-IC-CT), so as to monitor anomalies such as progressive drift in nucleic acid testing system not covered by conventional internal quality control (IQC) in blood center nucleic acid laboratories, and to verify its feasibility. Methods: The internal control CT values of 54 426 negative samples were retrospectively collected. These samples were from four reagent batches of the two new and old equipment sets during the operation of the Wantai nucleic acid testing system in our blood center. The daily median of NEG-IC-CT values was used as the research indicator. Control limits were calculated using median absolute deviation (MAD) to construct the Median-MAD quality control chart. The monitoring performance of this scheme for the operation status of the testing system was simultaneously evaluated. Results: Statistical analysis showed significant differences in NEG-IC-CT value distribution between the new and old equipment sets, as well as between the two different reagent batches of the old equipment (P<0.000 1). The NEG-IC-CT value performance of the two different reagent batches of the new equipment was no significant difference in distribution (P>0.05). This scheme identified three typies of distinct anomalies. The out-of-control events observed with the old equipment in both the O1 and O2 reagent batches suggested potential performance decay due to equipment aging. The unreported change of reagent batch in time of Phase B with new equipment caused a stepwise drift on the quality control chart. In the later stage of Phase A with the new equipment, an alert was triggered, indicating potential quality risks associated with practices such as the mixed use of the remaining reagents and extremely long operator working hours. Conclusion: The realtime quality control scheme based on NEG-IC-CT value established in this study has been preliminarily validated for its monitoring effectiveness in nucleic acid testing in our blood center. This scheme performed well in detecting differences among testing systems and reagent batches, serving as an effective supplement to routine internal quality control. It can provide an intuitive and effective evaluation method for monitoring the performance of the nucleic acid testing process at blood center.
2.Prognostic significance of TRIM28 elevation in non-M3 acute myeloid leukemia
Siqi GONG ; Cong LI ; Mengmeng FAN ; Huiping WANG ; Wanqiu ZHANG ; Xue LIANG ; Qianshan TAO ; Qiang HONG ; Zhimin ZHAI
Acta Universitatis Medicinalis Anhui 2026;61(2):301-308
ObjectiveTo clarify the expression of TRIM28 in non-M3 acute myeloid leukemia (AML) and its correlation with clinical indicators and prognosis, and to further explore the effect of TRIM28 expression levels on the proliferation and apoptosis of AML cells using small interfering RNA. MethodsThe GSE34577 dataset was analyzed using R software to compare TRIM28 expression between healthy controls and non-M3 acute myeloid leukemia (AML) patients. Clinical samples from non-M3 AML patients were collected, with TRIM28 expression levels measured using real-time quantitative PCR (qPCR). The analysis focused on correlations between TRIM28 expression and various clinical indicators, treatment efficacy, and patient prognosis. Furthermore, small interfering RNA (siRNA) technology was employed to downregulate TRIM28 expression in human primary AML cells (HL60 cell line). The effects on cell proliferation and apoptosis were then assessed through CCK-8 assays and flow cytometry, respectively. ResultsThe results showed that TRIM28 was up-regulated in non-M3 AML of both online database GSE34577 and clinical samples (P<0.000 1), TRIM28 expression of new diagnosis group and relapsed refractory group was higher than iron deficiency anemia group (P<0.01), and there was no significance between different French-American-British classification systems subtype. TRIM28 expression was higher in non-M3 AML patients with a poor genetic prognosis stratified as moderate than in the good prognosis group, and TRIM28 expression was associated with NPM1 combined with the FLT3-ITD mutation, positively correlated with age, bone marrow blast, peripheral blood blast and white blood cell, negatively correlated with hemoglobin. In addition, interference TRIM28 greatly inhibited cell proliferation and promoted cell apoptosis. ConclusionThis study reveals that TRIM28 is highly expressed in non-M3 AML and associated with prognosis, and plays a key role in the proliferation and apoptosis of AML cells, suggesting that TRIM28 may serve as a novel therapeutic target for non-M3 AML.
3.Regulatory effect of Jiedu Huayu granules on liver injury in mice with acute liver failure and its mechanism
Chengyu YA ; Tingshuai WANG ; Huiping YAN ; Yi WANG ; Qingrui ZHAO ; Shenglan ZENG ; Weiyu CHEN ; Rongzhen ZHANG
Journal of Clinical Hepatology 2026;42(1):143-150
ObjectiveTo investigate the mechanism of action of Jiedu Huayu granules in improving liver injury in mice with acute liver failure (ALF) by observing its effect on a mouse model of ALF after prophylactic administration, and to provide a basis for clinical medication. MethodsA total of 60 specific pathogen-free male C57BL/6J mice were divided into normal group, model group, Jiedu Huayu granules group (JDHY group), and farnesoid X receptor (FXR) agonist (GW4064) group using a random number table, with 15 mice in each group. The model of ALF was induced by a single intraperitoneal injection of D-galactosamine combined with lipopolysaccharide. The mice in the JDHY group were given prophylactic administration of 0.3 g/mL drug solution of Jiedu Huayu granules by gavage for 3 days before modeling, those in the normal group and the model group were given 0.9% NaCl solution by gavage, and those in the GW4064 group were given intraperitoneal injection of GW4064 for 3 consecutive days before modeling. The mice were sacrificed after modeling, and serum and liver tissue samples were collected. A veterinary automatic biochemical analyzer was used to measure the serum levels of total bilirubin (TBil), total bile acids (TBA), gamma-glutamyl transferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) in mice from each group; HE staining was used to observe liver pathological changes; RT-PCR was used to measure the mRNA expression levels of FXR, fibroblast growth factor 15 (FGF15), fibroblast growth factor receptor 4 (FGFR4), small heterodimer partner (SHP), and bile salt export pump (BSEP) in mice, and Western blot was used to measure the protein expression levels of FXR, FGF15, FGFR4, SHP, and BSEP. A one-way analysis of variance was used for comparison between groups, and the Dunett method was used for further comparison between two groups. ResultsCompared with the normal group, the model group had significant increases in the serum levels of TBil, ALT, AST, TBA, and GGT (all P<0.01), and compared with the model group, the JDHY group and the GW4064 group had significant reductions in the serum levels of TBil, ALT, AST, TBA, and GGT (all P <0.01). HE staining showed that compared with the model group, the JDHY group and the GW4064 group had milder pathological injury, a reduction in the area of hepatocyte necrosis, and alleviation of cellular swelling and edema. Compared with the normal group, the model group had significant reductions in the mRNA and protein expression levels of FXR, FGF15, FGFR4, SHP, and BSEP in liver tissue (all P <0.01), and compared with the model group, the JDHY group and the GW4064 group had significant increases in the mRNA and protein expression levels of FXR, FGF15, FGFR4, SHP, and BSEP in liver tissue (all P <0.05). ConclusionJiedu Huayu granules may alleviate liver injury in mice with ALF through the FXR/SHP axis.
4.Quality evaluation of Abri Mollis Herba
Xingmei LIN ; Huiping LI ; Ting WANG ; Chengzhong ZHANG ; Baokang HUANG
Journal of Pharmaceutical Practice and Service 2025;43(5):251-258
Objective To establish a quality evaluation method for Abri Mollis Herba based on its morphological characteristics, microscopic features, and the determination of principal component contents. Methods The morphological characteristics of Abri Mollis Herba were identified by morphological authentication methods. Microscopic techniques were employed to observe the microscopic features of both the powdered form and cross-sectional tissue of Abri Mollis Herba. Additionally, a high-performance liquid chromatography (HPLC) method was developed to establish the quantify the main components, abrine and soyasaponin Bb, in Abri Mollis Herba. Results The morphological characteristics of Abri Mollis Herba were defined by numerous long pubescence on both the upper and lower surfaces of the leaflets, with indistinct veins and vein islands. The microscopic features mainly included non-glandular hairs, prismatic crystals, and crystal-sheathed fibers in the powdered form. In the root cross-section, xylem bundles, rays, vessels, and stone cells were visible. The stem cross-section displayed rays, vessels, and a hollow pith, while the leaf cross-section revealed collateral vascular bundles, vessels, and prismatic crystals. Conclusion The quality of Abri Mollis Herba could be effectively evaluated by the combination of morphological identification, microscopic authentication, and the quantification of main components abrine and soyasaponin Bb .
5.Relationship of Serum IL-27,CysC,GAPDH Antibodies with Disease Severity and Prognosis in Children with Neuromyelitis Optica Spectrum Disorder
Zuohua WANG ; Rongfeng WU ; Xiaoyan ZHANG ; Huiping WANG
Journal of Kunming Medical University 2025;46(7):146-154
Objective To explore the relationship between serum Interleukin-27(IL-27),Cystatin C(CysC),and Glyceraldehyde-3-phosphate dehydrogenase(GAPDH)antibodies and the severity of disease in children with Neuromyelitis optica spectrum disorder(NMOSD),as well as their impact on prognosis.Methods A total of 102 children with NMOSD admitted to Kunming Children's Hospital from July 2019 to July 2023 were selected,along with 102 healthy during the same period.Serum levels of IL-27,CysC,and GAPDH antibodies were compared between children with NMOSD and healthy children.The levels of serum IL-27,CysC,and GAPDH antibodies were compared among children with varying disease severity.The correlations between serum IL-27,CysC,GAPDH antibodies and disease condition,cerebrospinal fluid markers were analyzed.And 102 children with NMOSD received individualized treatment and were followed up for 1 year.The prognosis was evaluated based on disease relapse,and patients were divided into recurrence group and non-recurrence group.The clinical data,serum IL-27,CysC,and GAPDH antibody levels were compared between the two groups.the impact of serum IL-27,CysC,and GAPDH antibodies on disease recurrence was analyzed,and the predictive value of serum IL-27,CysC,and GAPDH antibodies for disease recurrence was evaluated.Results Children with NMOSD had lower levels of serum IL-27 and CysC and higher levels of GAPDH antibodies than healthy children(P<0.05).Serum IL-27 and CysC levels were negatively correlated with Aquaporin 4(AQP4)-IgG antibody positivity,the number of spinal cord-involved segments,Expanded disability status scale(EDSS)scores,cerebrospinal fluid protein content,and white blood cell count.In contrast GAPDH antibodies were positively correlated with these parameters(P<0.05).After 1-year follow-up,2 cases were lost to follow-up,21 cases relapsed,and 79 cases did not,which were included in the relapse group and non-relapse group,respectively.There were significant differences in the number of spinal cord-involved segments,EDSS scores,and cerebrospinal fluid protein content between the relapse group and non-relapse group(P<0.05).The levels of serum IL-27 and CysC were lower and the levels of GAPDH antibodies were higher in the relapse group than the non-relapse group(P<0.05).Serum IL-27,CysC,and GAPDH antibodies were significantly associated with disease relapse(P<0.05).The Area under the curve(AUC)values for predicting disease recurrence in children with NMOSD based on serum IL-27,CysC,and GAPDH antibodies were 0.748,0.791,and 0.747,respectively,with optimal cutoff values of 38.77 pg/mL,0.79 mg/L,and 55.81 pg/mL,respectively.The combined prediction of disease relapse using these three markers had an AUC of 0.900,which was superior to individual prediction values(Z=2.215,2.137,2.220,P=0.024,0.033,0.023).Conclusion The levels of serum IL-27,CysC,and GAPDH antibodies are significantly correlated with the disease severity and prognosis in children with NMOSD,and can effectively predict the risk of disease recurrence.Combined detection provides more reliable predictive value.
6.The parallel mediating effects of anxiety and depression states between life events and behavior problems in adolescents
Zihao YANG ; Qingqing ZHANG ; Dan WANG ; Lei ZHANG ; Hua ZHENG ; Lijing SHI ; Nana WANG ; Yihan ZHANG ; Zhenyi LI ; Min SUN ; Huimin CHEN ; Huiping CHENG ; Ruiling ZHANG ; Chuansheng WANG
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(3):259-265
Objective:To explore the relationship between life events, anxiety, depression, and behavior problems in adolescents.Methods:From September to October 2022, the cluster sampling method was used to select 5 341 adolescents from 4 middle schools in Xinxiang urban area.The subjects and their parents were investigated by the adolescent self-rating life events check list (ASLEC), generalized anxiety disorder scale (GAD-7), patient health questionnaire (PHQ-9), and child behavior checklist (CBCL). SPSS 27.0 software was used for Spearman correlation analysis, and AMOS 28.0 software was used to construct the structural equation model.Results:The scores of anxiety, depression, and behavioral problems were 1 (0, 4), 1 (0, 4), and 3 (0, 10). The total score of life events was 5 (1, 13), and the dimensions scored as follows: interpersonal conflict 1 (0, 4), academic pressure 2 (0, 5), punishment 0 (0, 2), loss 0 (0, 0), health and adaptation problem 0 (0, 1), and others 0 (0, 2). There were positive correlations between life events and its dimensions, depression, anxiety and behavioral problems ( r=0.28-0.69, all P<0.01). In the overall population, anxiety and depression played parallel mediating roles in the impact of life events on behavior problems. Life events could positively predict anxiety ( β=0.68, P<0.01), and anxiety could positively predict behavior problems ( β=0.04, P=0.02). Life events could positively predict depression ( β=0.77, P<0.01), and depression could positively predict behavior problems ( β=0.18, P<0.01). The standardized total effect size of the impact of life events on behavioral problems was 0.622 (95% CI=0.564-0.675). The standardized direct effect size and indirect effect size were 0.460 (95% CI=0.374-0.539) and 0.162 (95% CI=0.108-0.218), accounting for 74.0% and 26.0%of the total effect, respectively. After stratification by gender, the results for male adolescents were consistent with the overall population, while the mediating effect of anxiety was not significant in the female adolescents. Conclusion:Life events can lead to anxiety and depression in adolescents, thereby increasing the risk of behavior problems.
7.Characteristics of first-time callers with suicidal ideation to psychological assistance hotline in Henan Province
Kunya LIU ; Xiaoniu LI ; Qingqing ZHANG ; Lei ZHANG ; Huiping CHENG ; Shiyun WANG ; Yunsheng HOU ; Ying XU ; Ruiling ZHANG
Chinese Mental Health Journal 2025;39(5):398-404
Objective:To examine the spatial and temporal distribution characteristics of first-time callers with suicidal ideation and risk factors related to suicidal ideation in a psychological assistance hotline in Henan Province.Methods:The computerised counselling operating system of the Henan Provincial Psychological Assis-tance Hotline was used to extract data from 31 401 callers who called the hotline between January 2020 and October 2023.A circular distribution and kernel density analysis were employed to investigate the spatial and temporal distri-bution of first-time callers with suicidal ideation.Binary logistic regression analysis was employed to investigate the risk factors for suicidal ideation.Results:A total of 5 494 first-time callers were included in the study,of whom 1 697(30.9%)reported suicidal ideation in the previous two weeks.The temporal distribution of suicidal ideation calls indicated a peak between 12:36 and 01:08.The weekly distribution further revealed that the majority of calls occurred on Fridays.In terms of spatial distribution,the primary hotspots for callers with suicidal ideation were clus-tered around Zhengzhou and Xinxiang.Meanwhile,the secondary hotspots exhibited a dispersed distribution across multiple centers within the province.Logistic regression analysis revealed that being under 20 years old(OR=11.85),being unemployed(OR=1.78),having psychological issues(OR=5.03),experiencing family relation-ship problems(OR=3.67),and facing economic hardships(OR=7.08)were risk factors for suicidal ideation.Conclusion:The time distribution of calls from individuals with suicidal ideation to the psychological as-sistance hotline in Henan Province exhibits a centralized trend,while the spatial distribution of calls demonstrates an imbalance.When receiving initial calls from individuals with suicidal ideation,particular attention should be paid to those aged 20 years old or younger,those who are unemployed,and those experiencing psychiatric,psychological,familial,and economic difficulties.
8.Validation of the atopic dermatitis control tool in assessing disease control
Yani LIU ; Qian ZHAO ; Yuan LIU ; Junyan ZHANG ; Huiping WANG
Chinese Journal of Dermatology 2025;58(2):154-160
Objective:To verify the validity of the atopic dermatitis control tool (ADCT) in assessing disease control in patients with atopic dermatitis (AD) .Methods:Based on a cross - sectional study, demographic data, comorbidities and information on disease assessment - related scales such as the ADCT, the pruritus numerical rating scale (NRS), the patient-oriented eczema measure (POEM), and the dermatological life quality index (DLQI) were collected from patients with AD at Tianjin Medical University General Hospital from June 2021 to March 2023. The reliability and validity of the ADCT were assessed using these data. The discrimination power of the ADCT total score was evaluated by comparing the differences in the mean ADCT total scores among adjacent POEM/DLQI subgroups based on POEM/DLQI response classifications (POEM: clear or almost absent, mild, moderate, severe, very severe; DLQI: no effect, mild effect, moderate effect, serious effect, very serious effect). According to the ADCT scores, the AD patients were divided into an uncontrolled AD group (ADCT scores ≥ 7 points) and a controlled AD group (ADCT scores < 7 points). Differences between the above two groups were analyzed in terms of ADCT item scores, mean pruritus NRS scores, POEM total scores, DLQI total scores, and DLQI dimension scores to evaluate the validity of the ADCT in assessing AD disease control.Results:A total of 338 patients with AD were included, comprising 170 (50.30%) males and 168 (49.70%) females, and they were aged 17 to 89 (41.36 ± 17.63) years. Reliability analysis showed that the Cronbach′s α coefficient and split-half reliability coefficient of the ADCT were 0.886 and 0.878 respectively (both > 0.70), and the test- retest reliability coefficient was 0.977 (> 0.70, P < 0.001). Content validity analysis showed that the Pearson correlation coefficients between the ADCT item scores and the ADCT total score ranged from 0.753 to 0.852 (all P < 0.001) ; confirmatory factor analysis revealed that the Chi-square to degree of freedom ratio ( χ2/df) was 2.896 (< 5), the Tucker-Lewis index was 0.976 (> 0.9), the comparative fit index was 0.991 (> 0.9), the standardized root mean square residual was 0.026 (< 0.08), and the root-mean-square error of approximation was 0.075 (< 0.08) ; convergent validity analysis showed that the standardized factor loadings of all observed variables ranged from 0.689 to 0.905 (all > 0.500), combined reliability coefficient was 0.896 (> 0.700), and the average extracted variance value was 0.591 (> 0.500) ; criterion validity analysis showed that the correlation coefficients of the ADCT total score with other patient - reported outcome measures (the mean pruritus NRS scores, peak pruritus NRS scores, POEM total scores, and DLQI total scores) and DLQI dimension scores ranged from 0.649 to 0.730 and from 0.303 to 0.647, respectively (all P < 0.001). Analysis of the discrimination power of the ADCT total score showed significant differences in the mean ADCT total scores among adjacent POEM/DLQI subgroups (all P ≤ 0.001). The uncontrolled AD group (287 cases) showed significantly increased ADCT item scores, mean pruritus NRS score, POEM total score, DLQI total score, and DLQI dimension scores compared with the controlled AD group (51 cases, all P<0.001) . Conclusion:The ADCT exhibited good reliability, validity and discriminability based on the cross-sectional study, and can efficiently and reliably assess disease control in AD patients.
9.Disease burden in patients with chronic spontaneous urticaria: a single-center retrospective analysis
Meng XIAO ; Meiru ZHAO ; Xinmei ZHANG ; Junyan ZHANG ; Yuqing QI ; Huiping WANG
Chinese Journal of Dermatology 2025;58(6):530-535
Objective:To analyze clinical data from patients with chronic spontaneous urticaria (CSU) , and to explore their disease burden.Methods:Clinical data were retrospectively collected from CSU outpatients who visited the Tianjin Medical University General Hospital from November 2021 to October 2023. The primary evaluation indicators included the 7-day urticaria activity score (UAS7) , chronic urticaria quality of life questionnaire (CU-Q2oL) , urticaria control test (UCT) , medication use in the past 6 months, number of outpatient visits and medical expenses, CSU disease duration, and the presence of comorbid atopic diseases and autoimmune diseases. For quantitative data, results were expressed as mean ± standard deviation when normally distributed, or as median (lower quartile, upper quartile) when not normally distributed. Correlation analysis was performed using Pearson correlation coefficients, false discovery rate (FDR) correction, multivariate linear regression, and collinearity diagnostics.Results:A total of 489 CSU patients were included, comprising 303 females (62.0%) and 186 males (38.0%) , with the ages being 39.3 ± 15.0 years and disease duration being 0.75 (0.17, 3) years. The number of outpatient visits was 5.1 ± 1.9, and the medical costs were 396.4 ± 116.0 yuan. Baseline UAS7, UCT, and CU-Q2oL scores were 16.9 ± 11.0 points, 7.0 ± 3.8 points, and 51.9 ± 16.3 points, respectively. Seventy-two patients (14.7%) had a family history of atopic diseases, and 144 patients (29.4%) had comorbid atopic conditions, including atopic dermatitis ( n = 29) , allergic rhinitis ( n = 89) , allergic conjunctivitis ( n = 13) , allergic asthma ( n = 7) , and allergic sinusitis ( n = 6) . Forty-one patients (8.4%) had comorbid autoimmune diseases, including connective tissue diseases ( n = 2) and autoimmune thyroid diseases ( n = 39) . In the past 6 months, 419 patients (85.7%) received first-line or second-line therapies (antihistamines alone or in combination) , while 70 patients (14.3%) received third-line therapies, including omalizumab ( n = 35, 7.1%) , glucocorticoids ( n = 22, 4.5%) , cyclosporine ( n = 7, 1.4%) , and Tripterygium wilfordii preparations ( n = 7, 1.4%) . According to the UAS7 scores, 98 patients (20.0%) were in good control, 153 (31.3%) exhibited mild disease activity, 138 (28.2%) showed moderate activity, and 100 (20.5%) exhibited severe activity; outpatient visits and medical costs increased with disease activity (both P < 0.05) . The CU-Q2oL scores were positively correlated with the UAS7 scores ( r = 0.520, P < 0.001, FDR < 0.001) , and negatively correlated with the UCT scores ( r = -0.597, P < 0.001, FDR < 0.001) . Disease duration was positively associated with the UAS7 scores ( β = 0.223, P = 0.023) . The patients with autoimmune diseases had significantly longer disease duration ( P = 0.049) , but there was no significant difference in the UAS7 score between the patients with and without autoimmune diseases ( P = 0.340) ; there were no significant differences in disease duration or UAS7 scores between patients with and without atopic diseases (both P > 0.05) . Conclusion:Higher disease activity in CSU patients was significantly correlated with worse quality of life, increased outpatient visits, and greater economic burden.
10.Omalizumab for the treatment of eight patients with chronic spontaneous urticaria during pregnancy and lactation
Meiru ZHAO ; Meng XIAO ; Xinmei ZHANG ; Junyan ZHANG ; Yuqing QI ; Huiping WANG
Chinese Journal of Dermatology 2025;58(6):536-539
Objective:To investigate the efficacy and safety of omalizumab in the treatment of chronic spontaneous urticaria (CSU) during pregnancy and lactation.Methods:A single-center retrospective study was conducted. From February 2022 to December 2024, 8 pregnant or lactating patients with CSU who received omalizumab treatment were collected from the Departments of Dermatovenereology and Allergy, Tianjin Medical University General Hospital, including 3 pregnant and 5 lactating patients. Clinical data were analyzed, including the patients' ages, disease duration of CSU, timing of omalizumab initiation, dosage and treatment intervals of omalizumab. During the treatment and follow-up, the 7-day urticaria activity score (UAS7) was used to evaluate disease activity of CSU patients, and adverse events were recorded.Results:The ages of the 8 patients ranged from 29 to 40 (33.25 ± 3.81) years, and the disease duration of CSU ( M[ Q1, Q3]) was 2.8 (1.6, 5.2) years. Three patients began omalizumab treatment before conception, with a dose of 300 mg every 3 - 4 weeks; after 3 - 8 sessions of treatment, pregnancy was confirmed, followed finally by successful deliveries. Five patients started omalizumab treatment at doses of 150 - 300 mg/4 weeks during lactation. All the 8 patients received omalizumab injections for 3 - 24 sessions, with an average of 10.38 sessions. Before omalizumab treatment, the UAS7 scores were 6.0 (2.8, 23.5) points; during the treatment, UAS7 scores decreased to 0 - 6 points, and CSU symptoms were completely controlled or well controlled. None of the 3 pregnant patients reported maternal adverse events, small-for-gestational-age or low-birth-weight infant outcomes, premature delivery (< 37 weeks) , spontaneous abortion (< 28 weeks) , congenital malformations in infants, or infant adverse events. One lactating patient developed a mild fever and fatigue 6 hours after the first omalizumab injection, which resolved spontaneously within 48 hours; the other 4 lactating patients did not experience any maternal or infant adverse events. Conclusion:Omalizumab may be an effective and safe treatment option for CSU patients during pregnancy and lactation.

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