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.

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.

The histopathological growth patterns (HGPs) of colorectal cancer (CRC) liver metastasis reflect the complicated and varied interactions between tumor cells and host microenvironment. Exploring the tumor vascular and immunological features of HGPs, the relationship between HGPs and anti-tumor treatment efficacy, and HGPs prediction methods may have potential clinical aplication value for making optimal treatment strategies, evaluating patients' prognosis, and monitoring disease progression.

Objective:To investigate the effects of external application of Sanying Plaster on the size of thyroid nodules and the states of depression and anxiety in patients with benign thyroid nodules.Methods:A randomized controlled trial was conducted. A total of 120 patients with benign thyroid nodules from the outpatient clinic of the Department of Thyroid Diseases at Shanghai Traditional Chinese Medicine Hospital from June to December 2022 were selected as the subjects of the study. They were divided into two groups using the random number table method, with 60 patients in each group. The control group received lifestyle intervention treatment, while the treatment group received Sanying Ointment in addition to the treatment of the control group. Both groups were treated for 3 months. TCM syndrome scores were measured before and after treatment; the maximum diameter of thyroid nodules was measured using a color Doppler ultrasound transverse section; the quality of life was assessed using the short form 36 (SF-36); the degree of anxiety and depression was evaluated using the self-rating anxiety scale (SAS) and the self-rating depression scale (SDS); adverse reactions during the treatment period were recorded, and the clinical efficacy was evaluated.Results:During the treatment period, 4 cases in the treatment group and 3 cases in the control group did not complete the treatment. Finally, 56 cases in the treatment group and 57 cases in the control group entered the efficacy evaluation. The total effective rate of the treatment group was 71.4% (40/56), and that of the control group was 14.0% (8/57), with a statistically significant difference between the two groups ( χ2=26.82, P<0.001). After treatment, the TCM syndrome score of the treatment group (10.02±3.65 vs. 16.65±3.44, t=-10.24) was lower than that of the control group ( P<0.001); the maximum diameter of thyroid nodules [11.00 (4.65, 19.93) mm vs. 15.00 (7.15, 28.50) mm, Z=-2.43] was lower than that of the control group ( P<0.05); the SF-36 score [121.83 (117.00, 130.00) vs. 114.42 (104.25, 127.50), Z=-2.62] was higher than that of the control group ( P<0.01); the SDS (46.72±4.59 vs. 57.02±5.99, t=14.80) and SAS (42.25±5.72 vs. 50.60±7.12, t=10.04) scores were lower than those in the control group ( P<0.001). The incidence of adverse reactions during the treatment period in the treatment group was 3.5% (2/57), and no adverse reactions occurred in the control group. Conclusion:The external application of Sanying Ointment helps to reduce the size of thyroid nodules in patients with benign thyroid nodules, improve the quality of life and anxiety and depression, and increase clinical efficacy with good safety.

Background: and Purpose By measuring a newly defined parameter, the carotid–cerebral pulse wave velocity (ccPWV), this study aimed to determine the association of intracranial artery calcification (IAC) with arterial stiffness as reflected by the pulse wave velocity between the carotid and middle cerebral arteries using transcranial Doppler sonography in patients with acute stroke. Methods: We recruited 146 patients with ischemic stroke from our stroke center. Computed tomography of the head was used to assess the presence and severity of IAC. Arterial stiffness was evaluated using ccPWV. Data are presented as quartiles of ccPWV. A multivariable logistic regression model was used to assess the independent relationship between ccPWV and IAC. Results: The IAC prevalence increased with the ccPWV quartile, being 54%, 76%, 83%, and 89% for quartiles 1, 2, 3, and 4, respectively (p<0.001) as did IAC scores, with median [interquartile range] values of 0 [0–2], 3 [2–4], 4 [2–5], and 5 [4–6], respectively (p<0.001). After additionally adjusting for age and hypertension, a significant correlation was only found between quartiles 3 and 4 of ccPWV and IAC scores. The odds ratio (95% confidence interval) for the IAC scores was 1.78 (1.28–2.50) (p=0.001) in quartile 4 of ccPWV and 1.45 (1.07–1.95) (p=0.015) in quartile 3 compared with quartile 1. Conclusions We found that in patients with acute ischemic stroke, ccPWV was positively related to the degree of IAC. Future longitudinal cohort studies may help to identify the potential role of IAC in the progression of cerebral arterial stiffness.

Objective: To investigate adolescent haze weather health protection behavior, and to provide scientific basis for behavioral intervention and health guidance for adolescents in haze weather. Methods: From June 2015 to April 2016, 1 025 adolescents were selected from 22 classes in two middle schools of Baoding City, Hebei Province, by stratified cluster sampling method. General information questionnaire and the Brief Haze Weather Health Protection Behavior Assessment Scale Adolescent Version (BHWHPBAS AV) were used. Multiple linear regressions were conducted to explore factors affecting adolescent haze weather health protection behavior. Different models were used to confirm associations between influencing factors and BHWHPBAS AV scores. Results: Adolescents had a low overall score of BHWHPBASAV (45.81±13.16). The score rate of self adjustment after haze weather was the highest (64.54%). The score rate of obtaining relevant knowledge before haze weather was the lowest (50.28%). Compared with adolescents in urban area, rural adolescents had a lower BHWHPBAS AV score ( β=-3.20, P <0.01). Compared with students (living with parents), those living without parents had a lower BHWHPBAS AV score ( β=-4.16, P =0.01). Compared with students never receive physical examination,those had received physical examination during the past years had a higher BHWHPBAS AV score ( β=4.44，5.66，9.04, P <0.01). Compared with students with no knowledge of respiratory system diseases, those with moderate to sufficient knowledge had a higher BHWHPBAS AV score ( β=9.34，12.19，P <0.01). These associations were stable and consistent.Multiple linear regression analysis showed that residence, residence with parents, physical examination and knowledge of respiratory diseases were the relevant factors of BHWHPBAS AV score ( P <0.05). Conclusion Adolescent haze weather health protection behavior level is low and is affected by many factors. Cooperation should be strengthened to conduct behavioral interventions and health guidance on haze health protection for adolescents, so as to promote healthy growth of adolescents.

OBJECTIVE: To investigate the prevalence and relevant influencing factors of gynecological diseases of grassroot level female medical staffs. METHODS: A total of 2 308 female medical workers from county, town and village in hengxian County of Guangxi Zhuang Autonomous Region were selected as study subjects by cluster sampling method. The basic information, occupational history, reproductive health and fertility of these subjects were investigated by Reproducetive Health Survey Questionnaine of Female Workers. RESULTS: The total prevalence of gynecological diseases in female medical staffs was 21.6%. Among them, the prevalence of genital tract infections was 15.6%, and gynecological tumors was 6.0%. The top three gynecologic diseases were vaginitis(9.2%), uterine fibroids(4.3%) and cervicitis(3.5%). Multivariate logistic regression analysis results indicated that the younger the patients, the higher the risk of reproductive tract infectious diseases(P<0.01), and the lower the risk of gynecological tumors(P<0.01). The risk of reproductive tract infectious diseases and gynecological tumors in married patients was higher than that in unmarried staffs(P<0.05). The higher the number of abortions, the higher the risk of reproductive tract infectious diseases and gynecological tumors(P<0.01). The risk of reproductive tract infectious diseases was higher and the risk of gynecological tumors was lower in female shift workers than that of non-shift workers(P<0.05). CONCLUSION: Vaginitis, uterine fibroids and cervicitis are the main gynecological diseases in grassroot level female medical staffs. The incidence of gynecological diseases is related to age, history of marriage, childbirth and abortion, and work-shifts.

Objective To investigate the correlation of lacune of presumed vascular origin and microalbu-minuria in elderly inpatients. Methods 237 elderly patients (184 males and 53 females) at Guangzhou First People's Hospitalwho aged from 70 to 94 years old with a median age of 83.92 ± 5.32 were included in this study. We collected data on age,gender,medical history,smoking history,renal function test,blood lipid test,C-reactive protein,microalbuminuria,cerebral MR. Logistic regression was conducted to analyze all the data. Based on the MR findings ,the patients were divided into two groups:a group with lacune of presumed vascular origin (132 patients)and a control group(105 patients). Results The group with lacune of presumed vascular origin had higher mean systolic blood pressure than the control group. Median MAU was higher in the groupwith lacune of presumed vascular origin.Single factor or multiple factors logistic regression showed that increased systolic blood pressure and positive rates of MAU and MAU were independent risk factors for lacune of presumed vascular origin and were also significantly associated with the severity of lacune of presumed vascular origin. Conclusion Microalbuminuria is significantly associated with lacune of presumed vascular origin in elderly patients.

Objective To explore the clinical features,electroneurophysiology,neuroimaging and gene characteristics of one juvenile dentatorubral-pallidoluysian atrophy (DRPLA) pedigree with an onset of epilepsy.Methods The clinical data of the elder sister and younger brother in a family with juvenile DRPLA were collected.Furthermore,their clinical manifestations,electroneurophysiology results,neuroimaging characteristics and atrophin-1 gene CAG repeat numbers were detected and analyzed in detail.Results There were four patients in this family in total.The probands were two siblings,and they both had the onset manifestation of epilepsy.The younger brother had frequently epileptic seizure,marked cerebellar ataxia,involuntary movement and mental retardation.Compared with her younger brother,the sister had light symptoms such as mild memory deterioration without ataxia and involuntary movement,and she could undertake some simple work.The spike wave and sharp wave complex can be detected in electroencephalogram (EEG) examination,the cortical center segment lesions pathological changes were revealed in somatosensory evoked potentials (EP),and the latency period of P300 was prolonged in the both siblings.Magnetic resonance imaging (MRI) showed that the younger brother had marked atrophies in the cerebral cortex,brainstem and cerebellum.Furthermore,MRI showed that the elder sister had only mild atrophies in the cerebral cortex,brainstem and cerebellum,and that on the contrary some abnormally high signals were observed in cerebral cortex but not white matter.DRPLA gene detection revealed that the numbers of CAG repeats were 15/68 (the younger brother) and 15/64 (the elder sister),respectively.Conclusions Epilepsy,especially the myoclonus,is a common clinical manifestation for juvenile DRPLA,and many other types of epileptic seizures may arise with the development of DRPLA.DRPLA has diverse clinical heterogeneity.EEG,EP and brain MRI examination are great for DRPLA diagnosis and differential diagnosis,and the specific gene detection can be helpful for a definitive diagnosis.