1.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
2.Effect of somatosensory exercise based on artificial intelligence technology in home pulmonary rehabilitation of elderly patients with COPD
Qin FU ; Xiumin ZHANG ; Ming HOU ; Caihong WANG ; Xiaomei LI ; Yongqin MAO ; Ping LI
Chinese Journal of Nursing 2025;60(5):517-524
Objective To explore the application effect of multimodal somatosensory exercise based on artificial intelligence technology in home rehabilitation exercise for elderly patients with chronic obstructive pulmonary dis-ease(COPD),so as to promote COPD patients to participate in home rehabilitation exercise.Methods Using the convenient sampling method,80 elderly patients with COPD admitted to the Department of Respiratory Medicine of a tertiary A hospital in Urumqi from November 2023 to February 2024 were selected as the research subjects.Ac-cording to the random number table method,they were divided into a control group and an experimental group,with 40 cases in each group.The control group adopted the traditional exercise training method,and the experimental group adopted the multi-modal somatosensory movement based on artificial intelligence technology for exercise in-tervention,with 5 times a week,and the intervention was implemented for 12 weeks.The pulmonary function index,modified Medical Research Council scale score,physical fitness level,Chronic Obstructive Pulmonary Disease As-sessment Test scale score and exercise compliance of the 2 groups were compared before intervention and 12 weeks after intervention.Results 77 patients completed the study,with 39 in the experimental group and 38 in the control group.The forced vital capacity,forced expiratory volume in one second,forced expiratory volume in one second to forced vital capacity ratio,physical fitness level and exercise compliance of the experimental group were higher than those of the control group,while the modified British Medical Research Council scale score and Chron-ic Obstructive Pulmonary Disease Assessment Test score were lower than those of the control group.The differences were statistically significant(P<0.05).Conclusion Somatosensory exercise based on artificial intelligence technology can improve the lung function of the patients with COPD,improve the exercise compliance and physical fitness in-dicators of elderly patients and improve the quality of life of the patients.
3.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
4.Effect of somatosensory exercise based on artificial intelligence technology in home pulmonary rehabilitation of elderly patients with COPD
Qin FU ; Xiumin ZHANG ; Ming HOU ; Caihong WANG ; Xiaomei LI ; Yongqin MAO ; Ping LI
Chinese Journal of Nursing 2025;60(5):517-524
Objective To explore the application effect of multimodal somatosensory exercise based on artificial intelligence technology in home rehabilitation exercise for elderly patients with chronic obstructive pulmonary dis-ease(COPD),so as to promote COPD patients to participate in home rehabilitation exercise.Methods Using the convenient sampling method,80 elderly patients with COPD admitted to the Department of Respiratory Medicine of a tertiary A hospital in Urumqi from November 2023 to February 2024 were selected as the research subjects.Ac-cording to the random number table method,they were divided into a control group and an experimental group,with 40 cases in each group.The control group adopted the traditional exercise training method,and the experimental group adopted the multi-modal somatosensory movement based on artificial intelligence technology for exercise in-tervention,with 5 times a week,and the intervention was implemented for 12 weeks.The pulmonary function index,modified Medical Research Council scale score,physical fitness level,Chronic Obstructive Pulmonary Disease As-sessment Test scale score and exercise compliance of the 2 groups were compared before intervention and 12 weeks after intervention.Results 77 patients completed the study,with 39 in the experimental group and 38 in the control group.The forced vital capacity,forced expiratory volume in one second,forced expiratory volume in one second to forced vital capacity ratio,physical fitness level and exercise compliance of the experimental group were higher than those of the control group,while the modified British Medical Research Council scale score and Chron-ic Obstructive Pulmonary Disease Assessment Test score were lower than those of the control group.The differences were statistically significant(P<0.05).Conclusion Somatosensory exercise based on artificial intelligence technology can improve the lung function of the patients with COPD,improve the exercise compliance and physical fitness in-dicators of elderly patients and improve the quality of life of the patients.
5.Applicative value of acoustic radiation force impulse imaging in differential diagnosis of small hypoechoic thyroid nodules
Jinxiang HOU ; Xingtian WANG ; Rong WANG ; Xiumin HOU ; Ceng LI ; Jiao LU ; Zhiyong LI
Chinese Journal of Ultrasonography 2014;23(1):27-31
Objective To investigate the applicative value of acoustic radiation force impulse imaging (ARFI) in the differential diagnosis of small hypoechoic thyroid nodules.Methods 31 patients were pathologically confirmed as having a total of 44 small hypoechoic thyroid nodules ≤ 1 cm in diameter,followed by analyses of the characteristics of their ARFI images,including virtual touch tissue imaging (VTI) and virtual touch tissue quantification (VTQ).Based on VTI images of the nodules,the hardness of small hypoechoic thyroid nodules was respectively scored,and the ratios of VTI images to gray scale image areas were calculated.With pathological diagnosis as the gold standard,VTI scores,area ratios and VTQ values of the ROC curve in diagnosis of thyroid malignant nodules were sketched so as to explore the optimal cut-off points in VTI scores,area ratios and VTQ values in the diagnosis of malignant nodules.Results By the ROC curve test,VTI score of 3 was determined as the cut-off point of areas ratio,with the sensitivity and specificity of diagnosing thyroid cancer being 96.0 % and 94.7%,respectively.There were 34 nodules with VTI score greater than 3 (including 9 benign nodules and 25 malignant nodules) and 10 nodules with VTI score of 3 or less (all benign nodules).Malignant thyroid nodules had higher ratio of VTI images to gray scale image area than that of the benign nodules (1.58 ± 0.18 vs 1.30 ± 0.10,P <0.05).When 1.47 was set as the cut-off point of areas ratio,the sensitivity and specificity of diagnosing thyroid cancer were 80.0% and 94.7%,respectively.The VTQ value of 2.76 m/s in diagnosis of thyroid malignant nodules was designated as the cut-off point,with a sensitivity of 88.0 %,specificity of 94.7 %.Conclusions The ARFI technique is able to provide information of thyroid nodule hardness,which guarantees its high applicative value in the differential diagnosis of small hypoechoic thyroid nodules.
6.Comparison between transthoracic and transesophageal echocardiography in diagnosing adult multiple atrial septal defect
Chuanju HOU ; Yanping LI ; Dongan DENG ; Xianyang ZHU ; Xiumin HAN ; Jianli LIU ; Bin HU ; Qiaoling WANG
Chinese Journal of Medical Imaging Technology 2010;26(3):488-491
Objective To explore the value of transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) in diagnosing adult multiple atrial septal defect (MASD). Methods Thirty adult patients with MASD were examined with TTE, 25 patients were examined also with TEE, 26 patients were examined with cardiac catheterization as well. Transcatheter closure of MASD was performed in 20 patients and succeeded in 18, while open-chest operation was performed in 4 patients. Results Foramen secundum atrial septal defect was diagnosed with both TTE and TEE with an accuracy rate of 60.00% (18/30) and 96.00% (24/25), respectively. The main color Doppler flow imaging (CDFI) feature of adult MASD was multiple colorful left-to-right shunt signals through the atrial septal designated, i.e. colander sign of CDFI. Conclusion TTE has some difficulties and TEE has specific value in diagnosing adult MASD. TTE can be used before open-chest operation. TEE is necessary before transcatheter occlusion to make sure of the amount and location of atrial septal defect.
7.Color Doppler echocardiographic characteristics of bilocular heart and associated cardiac malformations
Chuanju HOU ; Yanmei QI ; Dongan DENG ; Xianyang ZHU ; Xiumin HAN ; Jun YANG
Chinese Journal of Ultrasonography 2009;18(6):479-481
Objective To probe into the color Doppler echocardiographic characteristics of bilocular heart (BH) and associated malformations. Methods Twenty patients of BH were examined with color Doppler echocardiography (CDE) and the characteristics were observed. All the CDE results were compared with angiocardiography and 14 were confirmed by operation. Results Nineteen cases were properly diagnosed based on the CDE characteristics,1 case were misdiagnosed as mitral atresia. CDE characteristics of BH were obvious:① Apical four-chamber view of two-dimensional echocardiography (2DE) showed total echo dropout in both the interatrial septum and the interventricular septum and disappearance of the intracardiac "cross". The common atrioventricular valve closed during systole and appeared as figure "8", named 2DE "8" sign. During diastole, the common atrioventricular valve opened to a common ventricle. ② Color Doppler flow imaging (CDFI) showed common intra-atrial flow signal entereda common ventricle through common atrioventricular valve during diastole in all patients and colorful reflux through common atrioventricular valve during systole in 15 cases. ③ Among the 20 eases, 16 of the common atria were situs solitus,4 were situs inversus; 10 of the common ventricles were type A,2 were type B and 8 were type C. According to the spatial relationship of the great arteries,there were 4 type Ⅰ ,7 type Ⅱ and 9 type Ⅲ.There were 18 pulmonary stenosis and 2 pulmonary hypertension. ④ In the presence of pulmonary stenosis, CDFI showed colorful shunt signals through pulmonary artery during systole. Conclusions BH and associated malformations have obvious echocardiographic characteristics. CDE has a specific value in diagnosing BH and associated malformations.
8.Imaging characteristics and regularity of adult congenital coronary artery fistula in color Doppler echocardiography
Chuanju HOU ; Dongan DENG ; Xianyang ZHU ; Xiumin HAN ; Xiaotang SHENG
Chinese Journal of Ultrasonography 2009;18(2):128-131
Objective To probe into the imaging characteristics and regularity of color Doppler echocardiography(CDE) in congenital coronary artery fistula(CAF) in adults. Methods CDE was used to examine 31 adult patients with CAF and the imaging characteristics and regularity were observed. Angiocardiography was performed in 26 cases. Seven of the 31 cases were treated interventionally and 24 of them surgically. Results Of the 31 patients, 29 were correctly diagnosed according to the CDE characteristics (diagnosis accuracy was 93.5%) and all the complicated anomalies were correctly diagnosed. artery is the origin and whichever heart chamber is the entry site of the fistula, the left atrium and the left showed abnormal blood flow signals in the heart chamber into which the fistula drained and in pulmonary drained into the right ventricle was more common than that into the right atrium, the left atrium, the left or the pulmonary artery was easily misdiagnosed because left ventricular systolic pressure was equal to aortic pressure which made the abnormal blood flow in CDFI indistinct. Conclusions CDE showed obvious imaging characteristics and regularity for CAF in adults and has specific value for the diagnosis of this disease. But CAF that drained into the left ventricle or the pulmonary artery is easily misdiagnosed.

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