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.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.
3.Clinical outcome of arthroscopic partial and complete repair in patients of massive rotator cuff tear
Lin LIN ; Fengyuan ZHAO ; Jiahao ZHANG ; Xin YAN ; Chunming KE ; Guoqing CUI ; Hui YAN
Chinese Journal of Orthopaedics 2024;44(14):963-969
Objective:To compare the clinical efficacy of arthroscopic partial and complete repair for massive rotator cuff tears.Methods:A total of 32 patients who underwent arthroscopic partial repair of massive rotator cuff tears in the Department of Sports Medicine, Peking University Third Hospital from March 2016 to December 2019 were retrospectively analyzed, including 15 males and 17 females, aged 62±6.8 years (range, 51-77 years), with 5 cases on the left side and 27 cases on the right side. Cause of injury: 4 cases were injured by car accident, 8 were injured by fall, and 20 had no obvious cause. 32 patients who underwent arthroscopic complete repair of massive rotator cuff tears during the same period were included according to a sample size of 1∶1 matched based on age, sex, tear size and fat infiltration index. Clinical outcomes were evaluated using the visual analogue scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, University of California Los Angeles (UCLA) shoulder score, Simple Shoulder Test (SST) score, and range of motion. Fatty infiltration and cuff healing were assessed using the Goutallier and Sugaya classifications on MRI, respectively.Results:All patients successfully completed the surgery and were followed up for 46.1±11.3 months (range, 36-72 months). Preoperative and final follow-up VAS scores were 6.6±1.8 and 1.6±1.1 in the complete repair group, and 6.4±1.9 and 1.4±1.3 in the partial repair group. Both groups showed significant postoperative improvement ( P<0.05), with no significant difference between groups at the final follow-up ( t=-0.729, P=0.468). The ASES score, UCLA shoulder score, and SST at the final follow-up were 81.7±6.5, 28.6±2.9, and 9.8±2.5, respectively, in the complete repair group, and 82.4±7.3, 28.1±2.6, and 9.1±1.9 in the partial repair group, and the difference between the groups was not statistically significant ( P>0.05). In the complete repair group, one case underwent reverse shoulder replacement for rotator cuff re-tear two years after surgery, and one case developed pseudoparalysis for rotator cuff re-tear 8 months after surgery but had no significant pain and did not receive further treatment; in the partial repair group, two cases underwent tendon transposition surgery for shoulder pain. Conclusion:Arthroscopic partial repair improves shoulder function and reduces pain in patients with massive rotator cuff tears, with similar efficacy to complete repair and has high surgical safety.
4.Application value of non-invasive prenatal genetic testing technology in twin pregnancy
Ming SHI ; Yuan ZHANG ; Jing ZHANG ; Shu WANG ; Chunming CUI ; Xiaoxue LIU ; Wenxiu ZHU ; Wei WANG ; Xiaoguang SHAO
Chinese Journal of Postgraduates of Medicine 2022;45(6):493-497
Objective:To explore the application value of non-invasive prenatal testing (NIPT) technology in twin pregnancy.Methods:A total of 339 twin pregnant women who underwent NIPT at Dalian Municipal Women and Children′s Medical Center(Group), Dalian Jinpu New District Maternity and Child Health Hospital, and Dalian Lvshunkou District People′s Hospital from July 1, 2019 to June 30, 2021 were continuously retrospectively included. The clinical characteristics and test results of pregnant women with high-risk and low-risk were analyzed.Results:Among 339 pregnant women, 336 were successfully tested, with a success rate of 99.12%(336/339); 6 pregnant women were at high risk of NIPT, with a positive screening rate of 1.77%(6/339), including 1 case of high risk of trisomy 13, 2 cases of high risk of trisomy 18, and 3 cases of high risk of Trisomy 21; the results of amniocentesis for 2 high-risk pregnant women were not abnormal.Conclusions:NIPT technology is non-invasive, safe and efficient, and is suitable for large-scale prenatal screening. However, the detection accuracy of pregnant women with twin pregnancy needs to be improved.
5.Comparison of mental health status of pregnant women with assisted reproductive technology and natural pregnancy
Lina LI ; Qiang SUN ; Chunming CUI ; Xiuhua XU ; Huihua WANG
Chinese Journal of Practical Nursing 2022;38(1):40-45
Objective:To explore whether assisted reproductive technology (ART) can affect the mental health of pregnant women during pregnancy.Methods:Convenient sampling method was used to select 500 pregnant women who underwent prenatal examination in Dalian Women and Children′s Medical Group from July 2019 to July 2020, including 193 cases of ART pregnant women (observation group) and 307 cases of natural pregnant women (control group). PEM-D psychosomatic holistic diagnosis and treatment system combined with Symptom Checklist- 90 (SCL-90), 7- item Generalized Anxiety Disorder Scale (GAD-7), 9-item Patient Health Questionnaire (PHQ-9) and Pittsburgh Sleep Quality Index (PSQI) were used to evaluate and compare the mental health status between the two groups.Results:The total score of SCL-90 in the observation group was (154.34 ± 14.42), which was significantly higher than that in the control group (142.42 ± 14.39), the difference was statistically significant ( t=5.35, P<0.05). The scores of anxiety, depression and paranoia in the observation group were (2.17 ± 0.47), (2.15 ± 0.68), (1.78 ± 0.45), which were significantly higher than those in the control group (1.95 ± 0.52), (1.77 ± 0.55), (1.58 ± 0.39), the differences were statistically significant ( t=2.86, 3.88, 3.20, all P<0.015). The scores of GAD-7 and PHQ-9 in the observation group were (6.72 ± 2.44), (5.43 ± 2.54), which were significantly higher than those in the control group (5.76 ± 2.47), (3.74 ± 1.66), the differences were statistically significant ( t=2.52, 3.57, both P<0.05). There was no significant difference in PSQI scores between the two groups ( P>0.05). Conclusions:ART affects the mental health of pregnant women, especially increases the level of depression and anxiety. We should provide corresponding psychological support and help for these pregnant women to reduce their depression and anxiety level.
6.Prognostic value of modified Charlson comorbidity index combined with serum albumin for long-term prognosis in peritoneal dialysis patients
Mingzhuo ZHANG ; Qingyan ZHANG ; Chunming JIANG ; Cheng SUN ; Yuan CUI ; Ying LIU ; Pengfei XU ; Miao ZHANG
Chinese Journal of Nephrology 2021;37(4):333-340
Objective:To assess the prognostic value of modified Charlson comorbidity index (mCCI) combined with serum albumin for long-term prognosis in peritoneal dialysis (PD) patients.Methods:From January 1, 2007 to June 30, 2015, patients who started PD in Nanjing Drum Tower Hospital were enrolled in this retrospective cohort study. Clinical data including gender, age, underlying diseases, laboratory examination and prognosis were collected. The mCCI at the beginning of PD was calculated. Whether the duration of PD exceeded 5 years was used as an indicator to evaluate the prognosis. The patients were divided into≥5 years group and<5 years group according to the duration of PD, and the data were compared between the two groups. Cox regression model was constructed to analyze the influencing factors of all-cause death in PD patients. Multivariate logistic regression model and receiver operating characteristic (ROC) curve were used to analyze the predictive value of mCCI and serum albumin levels on whether patients could maintain long-term PD.Results:Of the 183 patients included [males 106(57.9%), females 77(42.1%); (53.35±16.50) years old; 162 cases (88.5%) with hypertension, 55 cases (30.1%) with diabetes], 97 cases had PD duration for ≥5 years and 86 cases less than 5 years. The overall 5-year technical survival rate was 65.1%. At the beginning of PD, compared with the dialysis age≥5 years group, the patients in the dialysis age less than 5 years group had older age, higher mCCI, lower serum albumin level, and higher C-reactive protein (CRP) level (all P<0.05), but there were no significant differences in gender, education level, electrolyte, mean arterial pressure, high densitv lipoprotein (HDL), low-density lipoprotein (LDL) and PD adequacy index between the two groups (all P>0.05). Multivariate logistic regression analysis showed that increased age ( OR=1.022, 95% CI 1.000-1.043, P=0.046), increased mCCI ( OR=1.620, 95% CI 1.300-2.018, P<0.001) and decreased serum albumin ( OR=0.807, 95% CI 0.730-0.893, P<0.001) were independent predictors for the duration of PD<5 years. ROC curve analysis showed that the area under ROC curves ( AUC) of mCCI, serum albumin level and combined prediction probability of the two for the duration of PD<5 years were 0.647(95% CI 0.568-0.727), 0.655(95% CI 0.577-0.734), and 0.767(95% CI 0.700-0.835), respectively, indicating that the accuracy of combined parameters to predict survival outcome was higher than that of any single parameter. Multivariate Cox analysis showed that increased age ( HR=1.073, 95% CI 1.046-1.100, P<0.001), increased mCCI ( HR=1.198, 95% CI 1.044-1.375, P=0.010) and decreased serum albumin ( HR=0.904, 95% CI 0.843-0.969, P=0.004) were independent influencing factors for all-cause death in PD patients. Conclusions:Old age, high mCCI and low serum albumin level are influencing factors for dialysis age<5 years and all-cause death in PD patients. mCCI combined with serum albumin level can improve the accuracy of predicting the long-term dialysis in PD patients.
7.Screening and influence of common psychological disorders in the perinatal period
Yuewen LYU ; Qiang SUN ; Chunming CUI
Chinese Journal of Practical Nursing 2021;37(31):2477-2481
With the change of medical model, the impact of common psychological disorders on the occurrence, development and treatment has been paid more attention to. If the diagnosis is not timely, it can result in serious long-term effects on the wellbeing of women, their partners and infants. We reviewed the recent foreign studies on the common psychological problems of perinatal women and summarize the epidemiology, identification and interventions, so as to understand the impact on the offspring. It is of great significance to strengthen the training for health professionals in wider psychosocial assessment and to adopt effective intervention methods to alleviate the adverse psychological state of perinatal women.
8.Study on magnetic resonance monitoring index of fetal gallbladder during lategestation
Chunming CUI ; Wenshi FAN ; Jingshi WANG ; Hong YU ; Qiang SUN
Chinese Journal of Postgraduates of Medicine 2019;42(5):454-457
Objective To explore the normal reference range of fetal gallbladder in 28 to 35 weeks of pregnancy under magnetic resonance imaging characteristics, observe and explore the growth and development of fetal gallbladder, and provide a new detection method for evaluating fetal growth and development for prenatal examination. Methods One hundred single pregnant women who had underwent fetal abdominal magnetic resonance imaging from June 2017 to May 2018 in Dalian Municipal Women and Children′s Medical Center were selected. The pregnant women were divided into 2 groups according to the gestational weeks: group A (pregnancy 28 to 31 weeks, 64 cases) and group B (pregnancy 32 to 35 weeks, 36 cases). The length, width and transverse diameter of fetal gallbladder were measured by magnetic resonance, and the gallbladder volume was calculated. Results In group A, magnetic resonance result showed that 1 case had no gallbladder and 1 case had double gallbladder, but the fetal gallbladders of these 2 cases were normal after birth. The display rate of fetal gallbladder in group A was 98.4% (63/64), and that in group B was 100.0% (36/36); the abnormal rate in group A was 3.1% (2/64), and that in group B was 0. The length, width, transverse diameter and volume of gallbladder in group B were significantly higher than those in group A: (16.5 ± 6.0) mm vs. (13.2 ± 4.2) mm, (6.5 ± 3.5) mm vs. (5.2 ± 1.1) mm, (6.8 ± 2.6) mm vs. (6.4 ± 3.4) mm and (373.3 ± 284.1) mm3 vs. (258.5 ± 232.4) mm3, and there were statistical differences (P<0.05). Conclusions Fetal magnetic resonance during lategestation has the new means of prenatal evaluation of fetal growth and development, which has clinical application value.
9.Study on the prediction of premature rupture of membranes with inhibin A
Chunming CUI ; Qing WANG ; Mei GAO ; Qiang SUN ; Nan WU
Chinese Journal of Postgraduates of Medicine 2018;41(1):34-36
Objective To explore the relationship between the level of the pregnant women serum inhibin A and premature rupture of membranes.Methods Thirty-two pregnant women with the gestational age 36-37+6weeks were selected,including 18 cases with premature rupture of membranes (premature rupture of membranes group) and 14 cases without premature rupture of membranes (none premature rupture of membranes group).The serum level of inhibin A was measured by enzyme-linked immunosorbent assay method.Results The serum level of inhibin A in premature rupture of membranes group was significantly higher than that in none premature rupture of membranes group(1 253.5 ng/L vs.698.1 ng/L), and there was statistical difference (P<0.05).The receiver-operating characteristic curve analysis result showed that the optimal cut-off value of serum level of inhibin A to predict premature rupture of membranes was 984.45 ng/L,with a sensitivity of 72.2% and a specificity of 78.6%,and the area under the curve was 0.77(95% CI 0.59-0.95).Conclusions The serum level of inhibin A has a certain predictive value for premature rupture of membranes.
10.The application of prenatal MRI in congenital abdominal wall defect
Chunming CUI ; Yuewen LYU ; Qiang SUN ; Jingshi WANG ; Limei WANG
Chinese Journal of Postgraduates of Medicine 2018;41(3):205-207
Objective To investigate the MRI findings and diagnostic value of congenital abdominal wall defect.Methods Eighteen fetuses with congenital abdominal wall defect were analyzed retrospectively, and the MRI features were analyzed. Results In 18 cases of congenital defect of abdominal wall, fetal MRI showed 6 cases had gastroschisis and 12 cases had omphalocele. They were diagnosed accurately by MRI. Conclusions Congenital abdominal wall defect has characteristic MRI findings.MRI is of great significance in prenatal diagnosis.

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