1.Effect of Shixiaosan on Neurological Function and Ferroptosis in Rats with Cerebral Ischemia-reperfusion Injury Based on Nrf2/SLC7A11/GPX4 Signaling Pathway
Ying WEI ; Lixia WANG ; Junjun YIN ; Xiaohong CHEN ; Lijuan SONG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):22-31
ObjectiveTo investigate whether Shixiaosan can improve neurological function and inhibit ferroptosis in rats with cerebral ischemia-reperfusion injury (CIRI) by regulating the nuclear factor E2-related factor 2 (Nrf2)/solute carrier family 7 member 11 (SLC7A11)/glutathione peroxidase 4 (GPX4) pathway. MethodsA rat model of CIRI was established using the intraluminal filament method. Briefly, cervical blood vessels were separated, branches of the external carotid artery were ligated, and the common carotid artery and internal carotid artery were clamped. A nylon filament was inserted through the opening of the external carotid artery to the origin of the middle cerebral artery to block blood flow and induce cerebral ischemia. After 60-120 min of ischemia, the filament was withdrawn to restore blood flow, and the external carotid artery incision was ligated. The rats were divided into a CIRI group, a Shixiaosan low-dose (-L) group (intragastric administration of 1.26 g·kg-1 Shixiaosan), a Shixiaosan high-dose (-H) group (intragastric administration of 2.52 g·kg-1 Shixiaosan), a donepezil hydrochloride tablet (DON) group (intragastric administration of 0.45 mg·kg-1 DON), and a Shixiaosan -H + Nrf2 inhibitor (ML385) group (intragastric administration of 2.52 g·kg-1 Shixiaosan combined with intraperitoneal injection of 30 mg·kg-1 ML385). An additional 12 rats underwent cervical artery separation followed by incision suturing and served as the control group. Equal volumes of double-distilled water were administered to the CIRI and control groups. Neurological function impairment was assessed using the modified Garcia JH score. Magnetic resonance imaging was used to determine the cerebral infarct volume ratio. Hematoxylin-eosin (HE) staining and Prussian blue staining were performed to observe neuronal injury and iron accumulation in the ischemic penumbra, respectively. Transmission electron microscopy was used to examine the ultrastructure of neuronal mitochondria in the ischemic penumbra. Commercial kits were used to measure ferrous iron (Fe2+), malondialdehyde (MDA), reduced glutathione (GSH) content, and reactive oxygen species (ROS) activity in the ischemic penumbra. The BODIPY (581/591) C11 fluorescent probe was used to detect intracellular lipid peroxidation levels. Western blot was performed to detect protein expression levels of Nrf2, SLC7A11, GPX4, transferrin receptor 1 (TFRC), ferritin heavy chain (FHC), and ferritin light chain (FLC) in the ischemic penumbra. ResultsCompared with the control group, the CIRI group exhibited neuronal injury in the ischemic penumbra, characterized by reduced neuron numbers, nucleolar shrinkage, and interstitial edema. Marked iron accumulation was observed in the tissue. Neuronal mitochondria showed atrophy and rupture, with reduced mitochondrial cristae and increased membrane density. The cerebral infarct volume ratio, Fe2+ content, MDA content, ROS activity, and lipid peroxidation levels were increased, whereas the modified Garcia JH score, GSH content, and protein expression levels of Nrf2, SLC7A11, GPX4, FHC, and FLC were decreased, and TFRC protein expression was increased (P<0.05). Compared with the CIRI group, the Shixiaosan -L group, Shixiaosan -H group, and DON group showed attenuated neuronal injury in the ischemic penumbra, reduced iron accumulation, alleviated mitochondrial damage, decreased cerebral infarct volume ratio, Fe2+ and MDA contents, ROS activity, and lipid peroxidation levels, as well as increased modified Garcia JH scores, GSH content, and protein expression levels of Nrf2, SLC7A11, GPX4, FHC, and FLC, while TFRC protein expression was decreased (P<0.05). The magnitude of changes in all indicators was greater in the Shixiaosan -H group than in the Shixiaosan -L group (P<0.05). Compared with the Shixiaosan -H group, all measured indicators in the Shixiaosan -H + ML385 group showed opposite trends (P<0.05). ConclusionShixiaosan may inhibit ferroptosis and restore neurological function in rats with CIRI by activating the Nrf2/SLC7A11/GPX4 pathway.
2.Exploring the nursing characteristics and management for patients with high levels of human leukocyte antigen (HLA) - antibodies undergoing different desensitization strategies before allogeneic hematopoietic stem cell transplantation (allo-HSCT)
Danping ZHOU ; Yanting GU ; Yin LU ; Cuiping ZHANG ; Shiyuan ZHOU ; Xiaohong ZHOU ; Xiaming ZHU
Chinese Journal of Blood Transfusion 2025;38(12):1687-1694
Objective: To investigate the efficacy, nursing characteristics, and management of different desensitization strategies before allogeneic hematopoietic stem cell transplantation (allo-HSCT) among patients with high level of human leukocyte antigen (HLA) antibodies. Methods: A retrospective analysis was conducted on 82 patients with high levels of HLA antibodies who underwent allo-HSCT at the First Affiliated Hospital of Soochow University and Suzhou Hopes Hematonosis Hospital between January 2020 to November 2023. Patients were divided into two groups based on the desensitization strategy they received: the anti-CD20 monoclonal antibody combined with therapeutic plasma exchange (TPE) group (n=50) and the anti-CD20 monoclonal antibody combined with Protein A immunoabsorption group (n=32). The differences of efficacy between the desensitization strategies were analyzed. The safety of both desensitization strategies were assessed by close monitoring of adverse events throughout the treatment. The nursing characteristics and interventions specific to these strategies were comprehensively summarized. Results: There were no significant differences in age, gender, and diagnosis between the two groups of patients receiving different desensitization strategies (P>0.05). Following desensitization in the immunoadsorption group, the mean fluorescence intensity (MFI) levels of anti-HLA Class I antibody decreased significantly compared to initial screening (P=0.048), while the decrease in MFI values of anti-HLA Class II antibody was not statistically significant (P=0.173). In the TPE group, the MFI levels for both anti-HLA Class I and II antibodies after desensitization decreased significantly compared to initial screening (P=0.025 and 0.028, respectively). Monitoring of adverse events during desensitization treatment, found that patients in the immunoadsorption group experienced mild decreases in blood pressure during the process, with two patients developing severe hypotension. No allergic reactions occurred, and no damage of liver or kidney function was observed after the immunoadsorption. In the immunoadsorption group, a total of 19 patients underwent sera immunoglobulin assays before and after immunoadsorption. Compared to the initial screening, the immunoglobulin G (IgG) levels significantly decreased after immunoadsorption (P<0.001). In TPE group, 12 patients experienced mild hypotension during the plasma exchange process, but no severe hypotension was observed. One patient developed an allergic reaction. After the TPE treatment, no damage of liver or kidney function was observed, nor any decrease of IgG levels. In terms of safety of intravenous access, neither group experienced severe complications such as catheter-related bloodstream infections or deep vein thrombosis. In the TPE group, catheter occlusion occurred during the process of plasma exchange in 2 patients, while no such incident was observed in the immunoadsorption group. Patients of both groups exhibited anxiety and depression before treatment. After psychological care, the scores for anxiety and depression significantly decreased (P<0.001). Conclusion: Both desensitization strategies significantly decreased the HLA antibodies in highly sensitized patients with high level of HLA antibodies undergoing allo-HSCT. For patients receiving immunoabsorption, nursing care should focus on preventing and managing hypotension and implementing infection-prevention measures due to IgG depletion. In contrast, for those undergoing TPE, vigilant monitoring and prompt management of potential allergic reactions are essential components of nursing practice.
3.Trends of Esophageal Cancer Epidemiologic Characteris-tics and Life Years Lost in Linzhou City of Henan Province from 2010 to 2019
Qiang WANG ; Fuqiang QIN ; Xiaohong WANG ; Zhicai LIU ; Kai HOU ; Xiaodong YU ; Li WANG ; Chang LIU ; Ziru HAO ; Shuzheng LIU ; Qiong CHEN ; Yin LIU
China Cancer 2025;34(5):341-347
[Purpose]To analyze the trends in incidence,mortality and potential life loss of esophageal cancer in Linzhou City of Henan Province from 2010 to 2019.[Methods]The data of esophageal cancer incidence and mortality from 2010 to 2019 were collected from Linzhou cancer registries.The crude incidence and mortality rates,age-standardized rates(ASR)by sex and age group,the potential years of life lost(PYLL),average potential years of life lost(APYLL),and potential years of life lost rate(PYLLR)were calculated.The average annual percentage change(AAPC)from 2010 to 2019 were analyzed with Joinpoint software.[Results]From 2010 to 2019,there were a total of 8 447 newly diagnosed cases and 6 475 deaths of esophageal cancer in Linzhou.The ASR incidence and ASR mortality of esophageal cancer in the total population,males,females all showed significant downward trends,with AAPCs of-3.97%,-4.35%,-3.29%and-3.78%,-2.68%,-4.95%,respectively(all P<0.05).The crude incidence and mortality rates in all age groups also showed significant downward trends.The AAPCs of incidence rate for the age groups of 0~49,50~59,60~69,and ≥70 years old were-9.92%,-8.27%,-1.41%,and-3.86%,respectively(all P<0.05),and the AAPCs of mortality rate were-950%,-12.36%,-2.61%,and-2.98%,respectively(all P<0.05).From 2010 to 2019,the total PYLL caused by esophageal cancer was 60 880 person years,APYLL was 13.73 person years,and PYLLR was 5.77‰.The PYLL,APYLL,and the PYLLR of the total population and those stratified by sex all showed a decreasing trend(all P<0.05).[Con-clusion]From 2010 to 2019,the incidence,mortality and potential life loss of esophageal cancer in Linzhou City all decreased,and the long-term effect and screening programs is significant.How-ever,the risk of esophageal cancer among men and the elderly is still relatively high,indicating that more targeted prevention and control strategies should be developed.
4.Trends of Incidence and Mortality of Malignant Tumors in Linzhou City of Henan Province from 2010 to 2019
Junwu JING ; Fuqiang QIN ; Qiang WANG ; Xiaohong WANG ; Zhicai LIU ; Kai HOU ; Xiaodong YU ; Li WANG ; Chang LIU ; Ziru HAO ; Shuzheng LIU ; Qiong CHEN ; Yin LIU
China Cancer 2025;34(5):348-354
[Purpose]To analyze the trends of incidence and mortality of malignant tumors in Linzhou City of Henan Province from 2010 to 2019.[Methods]The incidence and mortality data of malignant tumors of Linzhou cancer registration areas from 2010 to 2019 were collected and evaluated for data quality.The crude incidence/mortality rates and age-standardized incidence/mortality rates by Chinese standard population(ASIRC/ASMRC)were calculated by sex,age and can-cer type.Joinpoint software was used to calculate the average annual percentage change(AAPC)to analyze the trends from 2010 to 2019.[Results]From 2010 to 2019,the crude incidence of malig-nant tumors in Linzhou City showed an upward trend,with an AAPC of 2.09%(95%CI:0.58%~3.63%),while the ASIRC tended to be stable.The incidence of malignant tumors showed a signifi-cant upward trend in the 15~29 and 60~69 age groups,and a significant downward trend in the 70~79 age group.From 2010 to 2019,the ASIRC of esophageal cancer and stomach cancer in both men and women showed a significant downward trend,while that of lung cancer and prostate cancer increased in men,and the incidences of thyroid cancer,uterus cancer,cervical cancer,lung cancer and breast cancer increased significantly in women.From 2010 to 2019,the crude mortality of malignant tumors in Linzhou showed a significant upward trend,with an AAPC of 1.18%(95%CI:0.88%~1.48%),while ASMRC showed a significant downward trend,with an AAPC of-1.63%(95%CI:-1.86%~-1.40%).The mortality increased in the group aged 80 and above,while the other age groups remained in a downward or stable state.From 2010 to 2019,the ASMRC of stomach cancer and esophageal cancer in both men and women showed a down-ward trend,while those of prostate cancer,and malignant tumors of the lip,oral cavity and pha-ryngeal in men increased,and that of ovarian cancer in women increased significantly.[Conclu-sion]The disease burden of malignant tumors in Linzhou City is still heavy.The incidence of common cancer types such as thyroid cancer,prostate cancer and lung cancer shows a significant-ly increasing trends from 2010 to 2019.
5.Construction and application of an exercise intervention scheme for patients with colorectal cancer
Xiaohong QIN ; Lianjie ZHANG ; Qing YIN ; Meiling LIU ; Si CHEN
Chinese Journal of Nursing 2025;60(8):901-907
Objective To construct an exercise intervention scheme for postoperative colorectal cancer patients and evaluate its application.Methods The research team summarized the evidence on exercise recommendations for patients with colorectal cancer(CRC)and constructed an exercise intervention scheme through group discussion,expert consultation,semi-structured interviews,and onsite consultation.Patients with CRC admitted to the Department of Colorectal Surgery of a tertiary A hospital in Jilin province were selected as the study subjects by a convenience sampling method from October 2023 to March 2024.The test group and the control group included 35 patients in each group.The test group received basic nursing and exercise intervention,the control group received basic nursing and knowledge-based education.The 2 groups were compared in terms of physical activity,number of 30 s chair-stand test,and physical activity compliance score at 1 week post-intervention and 1 month post-intervention.Results There were 4 cases dropped in the test group and 3 cases dropped in the control group.The results of repeated measures ANOVA showed that there were between-group and time interaction effects for walking time,sedentary time,and the number of chair stands in 30 s in the 2 groups(P<0.05).The experimental group's walking time,sedentary time,the number of chair stands in 30 s,moderate physical activity time and the physical activity compliance scores were better than those of the control group after the intervention,and the differences were statistically significant(P<0.05).Conclusion This exercise intervention based on a multi-theory model significantly increased the moderate physical activity time and walking time,decreased the sedentary time and improved compliance with physical activity recommendations,which may improve lower limb muscle strength in postoperative colorectal cancer patients.
6.Preliminary exploration of the mode and timing of delivery for complex fetal congenital heart disease
Junshu XIE ; Manman HAN ; Xiuju YIN ; Tiantian HAN ; Qiuyan PEI ; Lin ZHANG ; Huili ZHANG ; Shoujun LI ; Xiaohong ZHANG
Chinese Journal of Obstetrics and Gynecology 2025;60(10):763-771
Objective:To investigate the mode and timing of delivery in pregnant women with complex fetal congenital heart disease (CHD) detected by prenatal ultrasound.Methods:The clinical data of 123 fetuses with complex CHD detected by prenatal ultrasound in Peking University People′s Hospital from January 2016 to December 2023 were retrospectively analyzed. Pregnant women with indications for prenatal diagnosis underwent G-banding karyotype analysis, single nucleotide polymorphism array (SNP arrry) or whole exome sequencing after informed consent. Integrated managements were provided for pregnant women with complex CHD during pregnancy and perinatal period, and to determine the mode and timing of delivery. Infants with complex CHD received timely treatment or referral after birth.Results:The gestational age at ultrasound diagnosis of the 123 fetuses with complex CHD was (23.7±3.4) weeks. There were 11 cases (8.9%) of total anomalous pulmonary venous connection (TAPVC), 14 cases (11.4%) of anomalous pulmonary valve (PVA), 7 cases (5.7%) of right ventricle double outlet (RVDO), 13 cases (10.6%) of anomalous aortic arch, 69 cases (56.1%) of transposition of the great arteries (TGA), 9 cases (7.3%) of other types. All cases were treated with fetal preservation after prenatal consultation. Among the 72 cases undergoing prenatal diagnosis, 9 cases (12.5%) had chromosomal variations. Fifty-five cases (44.7%, 55/123) underwent trial of labor, of which 46 cases (37.4%, 46/123) had successful vaginal delivery, including 6 cases of forceps delivery, and other 9 cases of failed trial of labor transferred to cesarean section. A total of 77 cases of pregnant women underwent cesarean section. Except for the 21 cases of pregnant women who asked for cesarean section, the cesarean section rate of pregnant women with complex CHD was 45.5% (56/123), which was not significantly different from the average cesarean section rate of the same period in our hospital (40.2%; χ2=7.34, P=0.270). The gestational age at delivery of the 123 fetuses with complex CHD was (37.9±1.4) weeks, the birth weight of the neonates was (3 099±480) g, and the umbilical artery blood pH value was 7.31±0.05. The oxygen saturation of 86 cases before and after alprostadil infusion were (72.8±6.0)% and (80.5±5.0)%, respectively, and the difference was statistically significant ( t=4.38, P<0.001). One hundred and fourteen children underwent surgical treatment, 112 of them (98.2%) had good postoperative reexamination. Only 2 cases (1.8%) died after surgery, and 14.0% (16/114) had the possibility of secondary surgery. Conclusions:Fetal complex CHD is not an indication for cesarean section, and the delivery mode could be selected according to the obstetric situation. If the mother and child are in stable condition, the delivery is planned after 39 weeks of gestation. For children with low oxygen saturation after birth, alprostadil could be pumped to maintain the open ductus arteriosus, and timely referral to the pediatric cardiac surgery for subsequent surgical treatment, which could achieve a good prognosis.
7.The correlation between serum osteopontin, annexin A2 and recurrence after partial laryngectomy in patients with early-stage glottic laryngeal cancer
Zhenxing PENG ; Juan BAI ; Wei JI ; Jinshu YIN ; Hong PENG ; Xiaohong CHEN
Chinese Journal of Postgraduates of Medicine 2025;48(7):584-590
Objective:To explore the relationship between serum osteopontin (OPN), annexin A2 (ANXA2) and recurrence after partial laryngectomy in patients with early-stage glottic laryngeal cancer (EGC).Methods:A retrospective study was conducted by collecting clinical data from EGC patients who underwent partial laryngectomy at Beijing Shijitan Hospital from June 2020 to May 2022. Serum levels of OPN and ANXA2 were measured at the time of admission. Clinical data during the perioperative period were also collected. The recurrence within 2 years after surgery was used as the endpoint event. Patients were divided into a recurrence group and a non-recurrence group based on the occurrence of recurrence. The data were compared between the groups, and Cox regression was used to analyze the correlation between recurrence after partial laryngectomy and key factors. Receiver operating characteristic (ROC) curve and decision curve were used to evaluate the predictive value of serum OPN and ANXA2 for recurrence within 2 years after surgery.Results:Among 167 EGC patients, 42 patients experienced recurrence within 2 years after surgery (recurrence group), with a median recurrence time of 16.00 (13.75, 19.25) months, and a recurrence rate of 25.15%; 125 patients did experience recurrence within 2 years after surgery (non-recurrence group). Compared to the non-recurrence group, the proportions of poorly differentiated tumors and anterior commissure invasion in the recurrence group were higher, the serum levels of OPN, ANXA2 and testosterone were higher: 52.38% (22/42) vs. 20.80% (26/125), 52.38% (22/42) vs. 20.00% (25/125), (24.26 ± 4.64) μg/L vs. (18.83 ± 4.17) μg/L, (37.62 ± 6.15) μg/L vs. (31.24 ± 5.56) μg/L, (27.26 ± 5.31) nmol/L vs. (22.85 ± 4.62) nmol/L, with significant differences ( P<0.05). Cox regression analysis result showed that recurrence after partial laryngectomy in EGC patients was potentially related to tumor differentiation, anterior commissure invasion, and abnormal serum expression of OPN, ANXA2 and testosterone ( P<0.05). ROC curve analysis revealed that serum OPN and ANXA2 had an area under the curve of 0.80 and 0.79, respectively, showing predictive value, with optimal cutoff values of 21.40 and 34.72 μg/L. Decision curve analysis indicated that serum OPN and ANXA2 had predictive significance for recurrence after partial laryngectomy in EGC patients, and the combined use of pathological grade, anterior commissure invasion, and testosterone improved the net benefit. Conclusions:Recurrence after partial laryngectomy in EGC patients may be associated with elevated serum OPN and ANXA2 levels, which could increase the risk of postoperative recurrence. Early detection of serum OPN and ANXA2 could be valuable for predicting recurrence after surgery in EGC patients.
8.Mechanism of Xiakucao Xiaoliu Mixture against non-small cell lung cancer by network pharmacology
Yue HU ; Yong YIN ; Liuhui SHI ; Xiaohong XU ; Jianyong ZHU ; Hua NIAN
Journal of Pharmaceutical Practice and Service 2025;43(12):591-598
Objective To explore the mechanism of Xiakucao Xiaoliu Mixture against non-small cell lung cancer (NSCLC). Methods The effective components of Xiakucao Xiaoliu Mixture were screened by TCMSP, BATMAN-TCM database and literature reviews. The targets of effective components were predicted. NSCLC related targets were collected by GeneCards, OMIM, PharmGKB, TTD and Drugbank, combined with the differential genes of Xiakucao Xiaoliu Mixture against Lewis lung cancer mice. The intersection targets of Xiakucao Xiaoliu Mixture against NSCLC were obtained. Cytoscape software was used to construct the network diagram of traditional Chinese medicine-active ingredients-core targets. STRING database was used to construct PPI network diagram. GO function enrichment analysis and KEGG pathway enrichment analysis of the intersection targets were performed by Metascape database to predict the key targets and active components of Xiakucao Xiaoliu Mixture against NSCLC, and Schrodinger software was used to perform molecular docking verification. Results The 32 active components and 24 intersection targets of Xiakucao Xiaoliu Mixture against NSCLC were obtained. 11 core targets such as ESR1, MAPK1 were found. The mechanism of action may be related to 30 signaling pathways such as cellular senescence, receptor activation, prolactin signaling pathway. Conclusion The active components of Xiakucao Xiaoliu Mixture act on multiple targets and signaling pathways to regulate complex biological processes. By regulating ESR1 agsinst NSCLC, it may play an important role in improving the survival rate and prognosis of female patients.
9.Correlation analysis between styloid process length and symptoms in patients with styloid process syndrome
Guoyuan MU ; Xiaohong LIU ; Yin QIANG ; Yao SHI ; Nan CAO ; Yewen SHI ; Yani FENG ; Xiaoyong REN ; Huanan LUO
Chinese Archives of Otolaryngology-Head and Neck Surgery 2025;32(9):565-569
OBJECTIVE To analyze the correlation between styloid process related parameters and symptoms in patients with styloid process syndrome.METHODS A retrospective study was conducted on the 3D reconstruction CT results of the styloid process in 68 patients diagnosed with styloid process syndrome who visited the Department of Otolaryngology Head and Neck Surgery,the Second Affiliated Hospital of Xi'an Jiaotong University from January 2010 to December 2024.The relationship between parameters such as styloid process length,angle,distance from styloid process tip to pharynx,and specific symptoms in patients with styloid process syndrome was analyzed.RESULTS Among 68 patients with styloid process syndrome,44 had unilateral symptoms and 24 had bilateral symptoms.The length of the styloid process on the symptomatic side of patients with unilateral symptoms(3.86±0.16)cm was significantly longer than that on the asymptomatic side(2.98±0.17)cm(Z=-2.191,P=0.028);The length of the styloid process on the side with severe symptoms in patients with bilateral symptoms(3.98±0.37)cm was also significantly longer than that in patients with mild symptoms(3.37±0.15)cm(t=2.448,P=0.024).Patients with styloid process syndrome mainly present with pharyngalgia(64.71%,44/68).There were no significant differences in the length,inclination angle,anteversion angle,and distance between the styloid process tip and the pharynx among those with unilateral pharyngalgia(n=29),bilateral pharyngalgia(n=15),and non pharyngalgia(n=24)(P>0.05).However,among the 68 patients with styloid syndrome,12 had calcification of the styloid hyoid ligament,while 56 did not.The incidence of unilateral pharyngalgia was significantly higher in patients with calcification of the styloid hyoid ligament than in patients without calcification(66.7%vs.35.7%,χ2=3.909,P=0.048).CONCLUSION The severity of symptoms in patients with styloid process syndrome is related to the length of the styloid process,and those with calcification of the styloid hyoid ligament are more likely to experience pharyngalgia.
10.The efficacy and safety of nebulized inhalation of recombinant human interferon α1b in the treatment of pediatric respiratory syncytial viral associated lower respiratory tract infections: a multicenter, randomized, double-blind, placebo-controlled phase Ⅲ clinical study
Xiaohui LIU ; Baoping XU ; Yunxiao SHANG ; Han ZHANG ; Zhenkun ZHANG ; Guangyu LIN ; Ju YIN ; Aihua CUI ; Guocheng ZHANG ; Zhaoling SHI ; Liwei GAO ; Chunming JIANG ; Junmei BIAN ; Yongjian HUANG ; Rongfang ZHANG ; Xiaomei LIU ; Xiaoqing YANG ; Yu TANG ; Lili ZHONG ; Hongmei QIAO ; Chuangli HAO ; Yuqing WANG ; Qubei LI ; Ling CAO ; Yungang YANG ; Ling LU ; Rongjun LIN ; Xingzhen SUN ; Wei ZHOU ; Qiang CHEN ; Jikui DENG ; Yuejie ZHENG ; Lin ZHAO ; Tao AI ; Xiaohong LIU ; Xiaoxia LU ; Ning JIANG ; Ming LI
Chinese Journal of Applied Clinical Pediatrics 2025;40(3):180-186
Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.

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