1.Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial
Yan ZHAO ; Jianzhong ZHANG ; Bin YANG ; Jingyi LI ; Yangfeng DING ; Liming WU ; Litao ZHANG ; Jinyan WANG ; Xiaohong ZHU ; Furen ZHANG ; Xiaohua TAO ; Yumei LI ; Chunlei ZHANG ; Linfeng LI ; Jianyun LU ; Qingchun DIAO ; Qianjin LU ; Xiaoyong MAN ; Fuqiu LI ; Xiujuan XIA ; Hao CHENG ; Yingmin JIA ; Guoqing ZHAO ; Jinchun YAN ; Bo CHEN
Chinese Medical Journal 2024;137(2):200-208
Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.
2.Application of task-driven approach combined with "7E" learning cycle in nurse refresher training on endoscopic retrograde cholangiopancreatography
Li LIU ; Xiujuan LIU ; Qun LUO ; Xia OU ; Lei LIU ; Li WANG
Chinese Journal of Medical Education Research 2024;23(4):512-516
Objective:To explore the application of the task-driven method combined with the "7E" learning cycle mode in nurse refresher training on endoscopic retrograde cholangiopancreatography (ERCP).Methods:We assigned 54 nurses who received refresher training on ERCP in the Department of Hepatobiliary Surgery of The First Affiliated Hospital of Army Medical University from January 2019 to December 2022 into control group (28 nurses from January 2019 to December 2020) to shadow and practice ERCP in a traditional way or experimental group (26 nurses from January 2021 to December 2022) to be taught using the task-driven method combined with the "7E" learning cycle method. At the end of training, the two groups undertook a theoretical and practical examination and a questionnaire survey. SPSS 25.0 was used to perform the t test, Wilcoxon test, chi-square test, and Fisher's exact test. Results:After training, compared with the control group, the experimental group had significantly higher scores of theory [87.50 (85, 90) vs. 90.51 (89, 92), P<0.05], and practice [84.11 (82.75, 85) vs. 90.52 (89, 92), P<0.05]. The proportions of trainees rating teaching methods excellent in the experimental group and control group were 76.92% ( n=20) and 42.86% ( n=12), respectively, and the proportions of teachers rating teaching effects excellent in the experimental group and control group were 84.62% ( n=22) and 42.86% ( n=12), respectively, both showing significant between-group differences (both P<0.05). Conclusions:The combination of the task-driven method and the "7E" learning cycle mode can mobilize learning initiative and enthusiasm, improve collaboration ability, promote learning interest and comprehensive practical ability for ERCP in nurses, which is suitable for ERCP training and teaching.
3.Effect of perceived stress on independent learning ability of nursing undergraduates: the chain mediating role of psychological capital and self-control
Qingqing ZHANG ; Wenkai ZHENG ; Meifang WANG ; Juan DU ; Xiujuan FENG ; Hua LI ; Xia LI ; Jing ZHANG
Chinese Journal of Modern Nursing 2024;30(17):2316-2323
Objective:To explore the relationship between the perceived stress and the independent learning ability of nursing undergraduates, to establish a chain mediation model to investigate the role of psychological capital and self-control in the relationship between the two, aiming to provide a new direction for nursing educators to improve the independent learning ability of nursing undergraduates.Methods:Using the convenient sampling method, a total of 913 nursing undergraduates from 10 universities in Shaanxi Province were selected as research objects from February to March 2023. Perceived Stress Scale (PSS), Positive Psychological Capital Questionnaire (PPQ), Self-control Scale (SCS) and Self-directed Learning Ability Scale (SLAS) were used to investigate the nursing undergraduates.Results:A total of 913 questionnaires were sent out in this study, and 900 were effectively collected, with an effective recovery rate of 98.58% (900/913). The total SLAS score of 900 nursing undergraduates was (87.12±9.20). The perception of stress among undergraduate nursing students could directly predict their self-directed learning ability negatively ( P<0.01), or indirectly affected their self-learning ability through psychological capital and self-control ( P<0.05). Psychological capital (indirect effect value=-0.160) and self-control (indirect effect value=-0.106) played a mediating role between stress perception and self-directed learning ability, and the mediating effect accounted for 38.55% and 25.54%, respectively. Moreover, psychological capital and self-control also played a chain mediating role (indirect effect value=-0.053), and the proportion of chain mediated effect was 12.77%. Conclusions:Perceived stress, psychological capital and self-control are important influencing factors on the self-directed learning ability of nursing undergraduate students. Perceived stress not only directly affects the self-directed learning ability of nursing undergraduate students, but also indirectly affects their self-directed learning ability through the chain mediation effect of psychological capital and self-control.
4.Risk factor assessment and adverse outcome prediction of placenta accreta in pregnant women after cesarean section complicated with placenta previa: a national multicenter retrospective study
Guiqin BAI ; Weilin CHEN ; Xianghua HUANG ; Shaojie ZHAO ; Shuping ZHAO ; Xiujuan CHEN ; Suwen CHEN ; Hua YANG ; Xia LU ; Guanyuan LIU ; Qionghua CHEN ; Lin′ai ZHANG ; Li JIN
Chinese Journal of Obstetrics and Gynecology 2023;58(1):26-36
Objective:To study the risk factors of adverse pregnancy outcomes for the diagnosis and treatment of pregnancy after cesarean section complicated with placenta previa.Methods:A national multicenter retrospective study was conducted to select a total of 747 pregnant women with the third trimester singleton pregnancy after cesarean section complicated with placenta previa from 12 tertiary hospitals in January 1st to December 31st, 2018. The risk factors of severe adverse outcomes [hysterectomy, intraoperative blood loss ≥1 000 ml, intraoperative diagnosis of placenta accreta spectrum disorders (PAS)] in pregnant women with second pregnancy complicated with placenta previa after cesarean section were investigated by logistic regression analysis. The roles of prenatal ultrasonography and magnetic resonance imaging (MRI) in the prediction of PAS and severe adverse outcomes were observed. According to whether vascular intervention was performed (uterine artery embolization or abdominal aortic balloon occlusion), the pregnant women were divided into the blocked group and the unblocked group, and the maternal and infant perinatal outcomes between the two groups were compared.Results:(1) General information: the hysterectomy rate of 747 pregnant women with second pregnancy complicated with placenta previa after cesarean section was 10.4% (78/747), the intraoperative blood loss ≥1 000 ml in 55.8% (417/747), and PAS was confirmed in 47.5% (355/747). The incidence of uterine rupture was 0.8% (6/747). (2) Analysis of risk factors for severe adverse outcomes: based on binary unconditioned logistic regression univariate and multivariate analysis, the risk factors for hysterectomy were the mode of vascular embolization and intraoperative blood loss. The probability of hysterectomy with uterine artery embolization was 5.319 times higher than that with abdominal aortic balloon occlusion (95% CI: 1.346-21.018). The risk factors of intraoperative blood loss ≥1 000 ml were the number of cesarean section delivery, ultrasonography indicated PAS and suspected PAS, intraoperative PAS and complete placenta previa. The risk factors for intraoperative PAS were uterine scar thickness, ultrasonography indicated PAS and suspected PAS, MRI indicated PAS and suspected PAS, and complete placenta previa. (3) The roles of ultrasonography and MRI in predicting PAS: the sensitivity and specificity of ultrasonography in predicting PAS were 47.5% and 88.4%; the kappa value was 0.279 ( P<0.001), with fair agreement. The sensitivity and specificity of MRI to predict PAS were 79.2% and 97.8%, respectively. The kappa value was 0.702 ( P<0.001), indicating a good agreement. The intraoperative blood loss and hysterectomy rate of pregnant women with PAS indicated by ultrasonography and MRI were significantly higher than those with PAS only by ultrasonography or MRI. (4) Influence of vascular occlusion on pregnancy outcome: there were no significant differences in intraoperative blood loss and incidence of intraoperative bleeding ≥1 000 ml between the blocked group and the unblocked group (all P>0.05). There was no significant difference in intraoperative blood loss between the pregnant women with abdominal aortic balloon occlusion, uterine artery embolization and those without occlusion ( P=0.409). The hysterectomy rate of pregnant women with uterine artery embolization was significantly higher than those with abdominal aortic balloon occlusion [39.3% (22/56) vs 10.0% (5/50), P=0.001]. Conclusions:In the third trimester of pregnancy with placenta previa after cesarean section, MRI examination has better consistency in predicting PAS than ultrasonography examination. Ultrasonography examination combined with MRI examination could effectively predict the hysterectomy rate and intraoperative blood loss. Vascular occlusion could not reduce the amount of intraoperative blood loss. The hysterectomy rate of pregnant women with uterine artery embolization is higher than those with abdominal aortic balloon occlusion.
5.Evaluation of the diagnosis and treatment of cesarean scar pregnancy induced in the second trimester: a national multicenter retrospective study
Guiqin BAI ; Weilin CHEN ; Xianghua HUANG ; Shaojie ZHAO ; Shuping ZHAO ; Xiujuan CHEN ; Suwen CHEN ; Hua YANG ; Xia LU ; Guanyuan LIU ; Qionghua CHEN ; Lin′ai ZHANG ; Li JIN
Chinese Journal of Obstetrics and Gynecology 2021;56(8):545-553
Objective:To study the risk factors of adverse pregnancy outcomes for induced abortion of cesarean scar pregnancy in midtrimester.Methods:A national multicenter retrospective study was conducted. A total of 154 singletons pregnant women with cesarean scar pregnancy during the second trimester induced abortion by various reasons in 12 tertiary A hospitals were selected, their pregnant outcomes were observed and the risk factors of serious adverse outcomes were analyzed with univariate and multivariate logstic regression; the role of ultrasound and MRI in predicting placenta accreta and severe adverse outcomes was evaluated, the effectiveness of uterine artery embolization (UAE) in preventing hemorrhage in pregnant women with and without placenta accreta was compared.Results:Among 154 subjects, the rate of placenta accreta was 42.2% (65/154), the rate of postpartum hemorrhage≥1 000 ml was 39.0% (60/154), the rate of hysterectomy was 14.9% (23/154), the rate of uterine rupture was 0.6% (1/154). The risk factor of postpartum hemorrhage≥1 000 ml and hysterectomy was placenta accreta ( P<0.01). For each increase in the number of parity, the risk of placenta accreta increased 2.385 times (95% CI: 1.046-5.439; P=0.039); and the risk of placenta accreta decreased with increasing ultrasound measurement of scar myometrium thickness ( OR=0.033, 95% CI: 0.001-0.762; P=0.033). The amount of postpartum hemorrhage and hysterectomy rate in the group with placenta accreta diagnosed by ultrasound combined with MRI were not significantly different from those in the group with placenta accreta diagnosed by ultrasound only or MRI only (all P>0.05). For pregnant women with placenta accreta, there were no significant difference in the amount of bleeding and hysterectomy rate between the UAE group [median: 1 300 ml; 34% (16/47)] and the non-embolization group (all P>0.05); in pregnant women without placenta accreta, the amount of bleeding in the UAE group was lower than that in the non-embolization group (median: 100 vs 600 ml; P<0.01), but there was no significant difference in hysterectomy rate [2% (1/56) vs 9% (3/33); P>0.05]. Conclusions:(1) Placenta accreta is the only risk factor of postpartum hemorrhage≥1 000 ml with hysterectomy for induced abortion of cesarean scar pregnancy in midtrimester; multi-parity and ultrasound measurement of scar myometrium thickness are risk factors for placenta accreta. (2) The technique of using ultrasound and MRI in predicting placenta accreta of cesarean scar pregnancy needs to be improved. (3) It is necessary to discuss of UAE in preventing postpartum hemorrhage for induced abortion of cesarean scar pregnancy in midtrimester.
6.Efficacy and safety of two prolonged therapeutic regimens in patients with plaque psoriasis after treatment with tazarotene/betamethasone dipropionate cream: a multicenter clinical observation
Hao CHEN ; Litao ZHANG ; Chengzhi LYU ; Xiumin YANG ; Fengming HU ; Xuefei LI ; Lijuan ZHANG ; Chunxia HE ; Qingchun DIAO ; Xiujuan XIA ; Tao LU ; Yuzhen LI ; Ruzhi ZHANG ; Jianfang SUN
Chinese Journal of Dermatology 2021;54(6):475-479
Objective:To explore the prolonged therapeutic regimen for patients with plaque psoriasis, who showed a positive response to 4-week treatment with tazarotene/betamethasone dipropionate cream, but were not completely cured.Methods:A multicenter, randomized, open-labelled, parallel-controlled clinical study was conducted. A total of 232 patients with plaque psoriasis were collected, who showed a positive response to previous 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured with the psoriasis area and severity index[PASI] improvement rate being 50%-90%. At week 5, they were randomly and equally divided into 2 groups: test group receiving treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream once a day, and control group receiving a sequential regimen of 0.05% tazarotene gel on weekdays once a day followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream on weekends once a day. After 2-and 4-week prolonged treatment, the efficacy and safety of the 2 therapeutic regimens were evaluated and compared. Measurement data were compared between 2 groups by using covariance analysis or t test, and enumeration data were compared by using chi-square test. Results:From the 5th to the 8th week, 200 out of the 232 patients completed the treatment. Data collected from 110 patients in the test group and 112 in the control group were enrolled into the full analysis set, and those from both 113 patients in the test group and control group were enrolled into safety analysis set. After consecutive 6-and 8-week treatment, the decline rates of the PASI score were 73.05% ± 16.69% and 78.46% ± 15.40% respectively in the test group, which were significantly higher than those in the control group (66.73% ± 21.77%, 67.02% ± 34.19%, respectively, both P < 0.05) . After 6-week treatment, the proportion of subjects who achieved PASI90 was significantly higher in the test group (14 cases, 12.7%) than in the control group (5 cases, 4.5%, χ2=4.842, P=0.028) ; After 8-week treatment, the proportions of subjects who achieved PASI75 and PASI90 (61.8%, 23.6%, respectively) were significantly higher in the test group than in the control group (48.2%, 12.5%, respectively, both P < 0.05) . During the consecutive 8-week treatment, there was no significant difference in the incidence rate of adverse reactions between the test group (15.0%) and control group (23.9%, χ2=2.822, P=0.093) . Conclusion:For patients who showed a positive response to 4-week treatment with 0.05%/0.05% tazarotene/betamethasone dipropionate cream, but were not completely cured, the continuous use of 0.05%/0.05% tazarotene/betamethasone dipropionate cream for 4 weeks is a superior therapeutic regimen compared with the sequential regimen of 0.05% tazarotene gel followed by 0.05%/0.05% tazarotene/betamethasone dipropionate cream.
7.Comparison of the disinfection effects of different skin disinfectants on central venous catheter in immune-deficient patients
Wei HU ; Xiujuan GUO ; Yan SONG ; Xiaodong XU ; Ting WANG ; Yanchao CAO ; Xia YAN
Chinese Journal of Practical Nursing 2020;36(8):579-582
Objective:To compare the effect of the 2% chlorhexidinegluconate disinfectant and 0.5% iodophor disinfectant on the maintenance of central venous catheter (CVC) in patients with immunodeficiency.Methods:The patients were randomly divided into two groups. 2% chlorhexidinegluconate disinfectant was used in the experimental group, and 0.5% iodophor disinfectant was used in the control group. The CVC was sterilized once a week and continuously maintained for 3 weeks. According to the condition of catheter, the dressing was changed in time in case of any problem,and the reason and time for the catheter nursing care were recorded. The duration of changing the catheter dressing in different disinfectant, incidence rate of dressings looseness and incidence of catheter-related infections in two groups were analyzed.Results:The duration of skin drying and duration of caring in the experimental group were (0.62±0.10)min, (11.67±0.33) min, significantly shorter than the control group [(1.97±0.18) min, (14.48±0.33) min]( t values were 63.044, 57.296, P<0.01).In term of the adverse effects on CVC,there were no statistical differences between two groups ( P> 0.05). Conclusions:Both 2% chlorhexidinegluconate and 0.5% iodophor disinfectant have similar disinfection effect on CVC caring, but 2% chlorhexidinegluconate disinfection is more efficient and worthy of application in clinical settings.
8.Clinical therapeutic effect of recombinant human brain natriuretic peptide and levosimendan on AMI patients undergoing emergency PCI and its safety/
Qunmei WU ; Xiujuan LIANG ; Xia WANG ; Weisheng LIU
Chinese Journal of cardiovascular Rehabilitation Medicine 2019;28(1):52-56
Objective :To explore therapeutic effect of recombinant human brain natriuretic peptide (rhBNP) and le‐vosimendan on patients with acute myocardial infarction (AMI) undergoing emergency percutaneous coronary inter‐vention (PCI) and its safety .Methods :A total of 110 AMI patients undergoing PCI ,who were treated in our hospi‐tal from Jan 2017 to Oct 2017 ,were selected .Patients were randomly divided into rhBNP group (n=53 ,received rhBNP based on routine medication ) and levosimendan group (n=57 ,received levosimendan based on routine medi‐cation) ,both groups were treated for 7d.The 24h urine volume ,heart rate (HR ) ,respiratory rate (RR ) before and 24h after PCI ,level of brain natriuretic peptide (BNP) , LVEF , LVEDd ,LVESd before and 7d after PCI were observed and compared between two groups .Results : Compared with before PCI on 24h after PCI ,there was significant rise in 24h urine volume ,and significant reductions in HR and RR in two groups , P=0.001 all.Com‐pared with levosimendan group on 24h after PCI ,there was significant rise in 24h urine volume [(1732.00 ± 243. 75) ml vs.(1854.23 ± 264.24) ml] ,and significant reductions in HR [ (79.24 ± 9.43) beats/min vs.(73.43 ± 8.24) beats/min] and RR [ (18. 32 ± 4. 76) times/min vs.(15.32 ± 4. 23) times/min ] in rhBNP group ( P<0. 05 or <0.01) ;on 7d after PCI ,compared with rhBNP group , LVEF [ (40.45 ± 5. 65)% vs .(44.75 ± 5.87)%] , BNP lev‐el [(256. 54 ± 9.38) pg/ml vs.(395.25 ± 8. 34) pg/ml] was significantly higher ,and LVESd [(47. 87 ± 4.65) mm vs.(43. 83 ± 3.65) mm] were significantly lower ( P=0.001 all) in levosimendan group .There was no significant difference in incidence rates of adverse reactions between two groups after PCI ( P>0.05 all).Conclusion :Myo‐cardial contraction capacity of levosimendan is significantly better than that of rhBNP ,while rhBNP is significantly better than levosimendan in reducing BNP level and improving renal function .
9.Effect of preventive nursing on infection of patients with continuous renal replacement therapy
Jing WANG ; Xiujuan YI ; Xinxin YANG ; Maosheng XIA
Journal of Clinical Medicine in Practice 2018;22(4):42-44,48
Objective To investigate the effect of preventive nursing on infection of patients with continuous renal replacement therapy (CRRT).Methods A total of 45 patients with CRRT treatment in our department were selected as observation group,given prevention nursing for infection,another 40 CRRT patients during the same period were selected as control group,given routine nursing.The changes of clinical correlated index,APACHE score and the rates of infection and mortality,hospitalization time of two groups were compared.Results The levels of BUN,SCr and CRP after the treatment in the observation group were lower than that in the control group,and the differences were statistically significant (P < 0.05).The APACHE Ⅱ score,the infection rate after treatment in the observation group were lower,and the hospitalization time was shorter than that in the control group,the differences were statistically significant (P < 0.05).Conclusion Preventive nursing can prevent the occurrence of infection in patients with CRRT,promote the improvement of clinical indexes and shorten the hospitalization time of patients.
10.Effect of preventive nursing on infection of patients with continuous renal replacement therapy
Jing WANG ; Xiujuan YI ; Xinxin YANG ; Maosheng XIA
Journal of Clinical Medicine in Practice 2018;22(4):42-44,48
Objective To investigate the effect of preventive nursing on infection of patients with continuous renal replacement therapy (CRRT).Methods A total of 45 patients with CRRT treatment in our department were selected as observation group,given prevention nursing for infection,another 40 CRRT patients during the same period were selected as control group,given routine nursing.The changes of clinical correlated index,APACHE score and the rates of infection and mortality,hospitalization time of two groups were compared.Results The levels of BUN,SCr and CRP after the treatment in the observation group were lower than that in the control group,and the differences were statistically significant (P < 0.05).The APACHE Ⅱ score,the infection rate after treatment in the observation group were lower,and the hospitalization time was shorter than that in the control group,the differences were statistically significant (P < 0.05).Conclusion Preventive nursing can prevent the occurrence of infection in patients with CRRT,promote the improvement of clinical indexes and shorten the hospitalization time of patients.

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