1.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.
2.Analysis on differences of plantar pressure and pressure center in patients with unilateral and bilateral plantar fasciitis
Guangming BIAN ; Yuheng WU ; Yuqing ZHOU ; Liansheng SHAO ; Lu CHEN ; Wen MIN
Chongqing Medicine 2025;54(2):457-463
Objective To explore the differences in stress distribution and stability of the planta pedis in the patients with unilateral and bilateral plantar fasciitis(PF)through plantar stress and center of pressure(COP)analysis.Methods A total of 100 patients with PF visiting in this hospital were enrolled,among them 50 cases were unilateral heel pain(unilateral heel pain group)and 50 cases were bilateral heel pain(bilateral heel pain).Meanwhile,50 healthy subjects were included(healthy group).In the health group and bilateral heel pain groups,the average stress value of both planta pedis surfaces of each subject was taken and named as the J0 group and H2 group,respectively.In the unilateral heel pain group,the plantar stress in 50 healthy feet and 50 affected feet were named as the J1 group and H1 group,respectively.The plantar pedis was divided into 10 regions for analysis and comparison[the first foot toe(T1),T2-5,the first-fifth metatarsal bones(M1-M5),the mid foot(MF),heel medial side(MH),heel lateral side(LH)].The subjects in 3 groups conducted the static and dynamic tests respectively,and the differences in plantar stress distribution and COP parameters among the J1,H1,H2 and J0 groups were compared respectively.Results In the static tests,the maximum pressure of the LH regions in the group J1 was increased when compared with the group J0,the contact area of LH regions in the group H1 was reduced when compared with the group J0,the maximum pressure of the M2 and M3 regions in the H1 group was increased when compared with the group J0,the contact areas of the MH and LH regions in the H2 group were decreased when compared with the group J0,the maximum pressure of the M1 region was increased when compared with the group J0,and the differences were statistically significant(P<0.05).In the dynamic tests,the maximum pressure of the T2-5 regions in the J1 group was increased when compared with the J0 group,the maximum pressure of the M3 region in the group H1 was increased when compared with the group J0,the maximum pressure of the M3 and M4 region in the group H2 was in-creased when compared with the group J0,and the differences were statistically significant(P<0.05).The COP 95%confidence ellipse area in the health group was the smallest,followed by the bilateral heel pain group,and finally the unilateral heel pain group,and the differences among 3 groups were statistically signifi-cant(P<0.05),there was also statistically significant difference between pairwise comparisons in 3 groups(P<0.05).Conclusion In the static condition,the pressure of the healthy heel and affected forefoot in the patients with PF is increased;while in the dynamic condition,the pressure of the toes of the healthy foot and forefoot of the affected foot in the patients with PF is also increased.The distribution of plantar stress in the patients with PF has larger difference compared with the healthy population,and the stability is poor.Meas-ures can be taken to improve the abnormal force on the foot,reduce pain and reduce the risk of falling.
3.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.
4.Diagnostic value of serum ferritin in Mycoplasma pneumoniae pneumonia was analyzed based on the decision curve
Dachen BIAN ; Jungu WANG ; Yuqing QI ; Zhuqi YANG ; Yanhua CHEN ; Hui GAO
International Journal of Laboratory Medicine 2024;45(19):2403-2407
Objective To analyze the value of serum ferritin(SF)in the early diagnosis of Mycoplasma pneumoniae pneumonia(MPP)based on decision curve analysis(DCA)and dose-response relationship.Meth-ods A total of 104 MPP patients in Taizhou People's Hospital from October 2016 to October 2021 were se-lected as the MPP group,and 90 healthy adults who underwent physical examination in Taizhou People's Hos-pital during the same period were selected as the healthy group.The clinical data of the two groups were com-pared.The influencing factors of MPP in patients were screened.The diagnostic value of SF for MPP was analyzed,the best cut-off value was sought,and the clinical predictive value of SF for MPP was evaluated.Results White blood cell count,C-reactive protein,tumor necrosis factor-α,lactate dehydrogenase,SF were independent risk factors for MPP,and 25-hydroxyvitamin D was its protective factor(P<0.05).The dose-response relationship analysis showed that there was a nonlinear dose-response relationship between the continuous change of SF and MPP(P<0.05).When SF>127.68 ng/mL,the risk of MPP increased with the increase of SF level.DCA analysis showed that SF had important clinical value in the early prediction of MPP.Conclusion SF has a high value in the early diagnosis of MPP,and there is a nonlinear dose-response relationship between SF and MPP.When SF>127.68 ng/mL,the risk of MPP increases with the increase of SF level.
5.The expression and significance of bone sialoprotein and matrix metalloproteinase-9 in calcified valves of patients with rheumatic heart disease
Chuanming BAI ; Bin ZHANG ; Nan ZHANG ; Shutian SONG ; Zhigang ZHANG ; Yuqing BIAN ; Jiewu ZHOU
Chinese Journal of Postgraduates of Medicine 2012;35(20):13-15
ObjectiveTo observe the expression of bone sialoprotein(BSP) and matrix metalloproteinase-9 (MMP-9) in calcified valves of patients with rheumatic heart disease.MethodsA total of 150 mitral valves which were resected by surgery were divided into rheumatic group ( 120 valves) and nonrheumatic group (30 valves).Immunohistochemical staining was taken by SP method and the expressions of BSP and MMP-9 in two groups were observed and compared.ResultsThe positive expressions of BSP and MMP-9 in rheumatic group were 91.7%(110/120) and 90.8%(109/120),respectively,which were significantly higher than those in non-rheumatic group [23.3%(7/30) and 20.0%(6/30) ](P< 0.01 ).Conclusions The expressions of both BSP and MMP-9 are higher in the valves of patients with rheumatic heart disease.The calcification of rheumatic mitral valves is closely related with the degradation and remodeling of extracellular matrix caused by MMP-9,and osteoblast-like bone formation induced by BSP.
6.Expression and significance of bone sialoprotein and matrix metalloproteinase-9 in calcified metral valves of rheumatic heart disease
Chuanming BAI ; Bin ZHANG ; Nan ZHANG ; Shutian SONG ; Zhigang ZHANG ; Yuqing BIAN ; Jiewu ZHOU
Clinical Medicine of China 2012;28(10):1056-1058
Objective To investigate the expression and significance of bone sialoprotein and matrix metalloproteinase-9 in calcified mitral valves in patients with rheumatic heart disease.Methods A total of 150 mitral valves were divided into the rheumatic group (n =120) and the non-rheumatic group (n =30 ).Expressions of bone sialoprotein and matrix metalloproteinase-9 were determined by immunohistochemistry.Results Expressions of bone sialoprotein ( 91.6%,x2 =56.6354 ) and matrix metalloproteinase-9 ( 90.8%,x2 =59.4272) in the rheumatic group increased significantly than in the non-rheumatic group (P < 0.01).Conclusion Both bone sialoprotein and matrix metalloproteinase-9 are highly expressed in the calcified rheumatic group.This suggests that caficify of rheumatic mitral valves is related with the degradation and remodeling of extra cellular matricx by matrix metalloproteinase-9,as well as osteoblastlike bone formation by bone sialoprotein.
7.Expression and ultrastructure location of PPAR-γ and COX-2 in endometrial carcinoma
Haiyan BIAN ; Yuanyuan LI ; Hongjuan WU ; Yuqing LIU
Acta Anatomica Sinica 2010;41(1):114-118
Objective To investigate the development and prognosis of peroxisome proliferator-activated recepor-γ(PPAR-γ) and cyclooxygenase-2(COX-2) in endometrial carcinoma. Methods The electron microscopic immunohistochemical technique was used to observe the ultrastructure location of COX-2 protein labeled by colloidal gold in the endometrial carcinoma. Results 1.There were negative immunohistochemical staining signals of PPAR-γ in both the normal endometrium and hyperplasia endometrium, whereas, was positive staining in the endometrial carcinoma;2.The intensities of the COX-2 immunohistochemical staining were significantly statistical difference among the normal endometrium, the hyperplasia endometriu and the endometrial carcinoma(P<0.01);3. The COX-2 labelled by colloidal gold granules was observed in the endoplasmic reticulum, nuclear membrane and nuclei in the endometrial carcinoma. Conclusion Both PPAR-γ and the COX-2 might play an important role in the development of the endometrial carcinoma.
8.Percutaneous Transhepatic Insertion of Metalic Stent and Arterial Chemoemblization for Malignent Biliary Obstruction
Wenjin BIAN ; Deshui YAN ; Yuqing WU
Journal of Practical Radiology 1991;0(03):-
Objective:To vealuate the effect of percutaneous transhepatic insertion of biliary setents(PTIBS) and arterial chemoenbolization for treatment of malignent biliary obstruction(MBO).Methods:Twelve patients with MBO were treated with PTIBS,following by arterial chemoenbolization in two weeks,one time each months.Results:Fourteen stents were placed in 12 cases.The total serum bilirubin level declined from 534?120 umol/L to 45?23 umol/L in 11 patients.The survival rate of 6 and 12 monthes were 83.3% and 50% respectively.Two cases were reobsturcted after 5 months of first stent implacemnt and were retreated by insertion of second stents.The total thirty-five times arterial chemoembolization was performed in 12 cases with remarkable effect.Conclusion:PTIBS combined arterial chemoembolization was an safe ;effective interventional treatment for MBO. [

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