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.

Objective To translate the Health Behavior Scale for Cancer Patients(HBSCP)into Chinese and conduct reliability and validity tests.The measurement invariance of the Chinese version of the scale among differ-ent cancer patients was measured to form a health behavior scale suitable for assessing cancer patients in China.Methods The original scale was translated and translated back according to the Brislin translation model.The Chinese version of the HBSCP was formed through cross-cultural adaptation and pre-test.A questionnaire survey was conducted on 600 cancer patients from 2 tertiary A hospitals in Tianjin and Nanchang from February to July 2024 by convenience sampling method to test the reliability,validity,and measurement invariance of the Chinese version of the HBSCP.Results 567 valid questionnaires were collected.The Chinese version of the HBSCP in-cludes 9 items with 2 factors.Confirmatory factor analysis supported the 2-factor model,and all indexes meet the ideal fitting standard.The factor load of each item on the scale ranged from 0.697 to 0.815.The composite relia-bility of the 2 dimensions was 0.815 and 0.874.Average variance extracted was 0.656 and 0.526.The Chinese version of the HBSCP was positively correlated with Health Promoting Lifestyle Profile-Ⅱ(r=0.760,P＜0.001).The con-tent validity index of items ranges of the scales from 0.930 to 1.000,and the content validity index/average of the scales was 0.993.The total Cronbach's alpha coefficient of the scale was 0.900,and the two-factor Cronbach's alpha coefficient was 0.849 and 0.873,respectively.The scale has measurement invariance in the equivalence test for 3 clusters of lung,gastrointestinal,and gynecologic cancers.Conclusion The Chinese version of the HBSCP has good reliability and validity and measurement invariance across cancer types,and can be used to measure the health behavior level of cancer patients.

Objective To translate the Health Behavior Scale for Cancer Patients(HBSCP)into Chinese and conduct reliability and validity tests.The measurement invariance of the Chinese version of the scale among differ-ent cancer patients was measured to form a health behavior scale suitable for assessing cancer patients in China.Methods The original scale was translated and translated back according to the Brislin translation model.The Chinese version of the HBSCP was formed through cross-cultural adaptation and pre-test.A questionnaire survey was conducted on 600 cancer patients from 2 tertiary A hospitals in Tianjin and Nanchang from February to July 2024 by convenience sampling method to test the reliability,validity,and measurement invariance of the Chinese version of the HBSCP.Results 567 valid questionnaires were collected.The Chinese version of the HBSCP in-cludes 9 items with 2 factors.Confirmatory factor analysis supported the 2-factor model,and all indexes meet the ideal fitting standard.The factor load of each item on the scale ranged from 0.697 to 0.815.The composite relia-bility of the 2 dimensions was 0.815 and 0.874.Average variance extracted was 0.656 and 0.526.The Chinese version of the HBSCP was positively correlated with Health Promoting Lifestyle Profile-Ⅱ(r=0.760,P＜0.001).The con-tent validity index of items ranges of the scales from 0.930 to 1.000,and the content validity index/average of the scales was 0.993.The total Cronbach's alpha coefficient of the scale was 0.900,and the two-factor Cronbach's alpha coefficient was 0.849 and 0.873,respectively.The scale has measurement invariance in the equivalence test for 3 clusters of lung,gastrointestinal,and gynecologic cancers.Conclusion The Chinese version of the HBSCP has good reliability and validity and measurement invariance across cancer types,and can be used to measure the health behavior level of cancer patients.

Objective: To observe the clinical therapeutic effect of Tang Shen Ning(TSN,a prescription of traditional Chinese medicine)for curing the early stage of diabetic nephropathy(DN).Methods: Adopting random and double-blind controlled trial methods,several indexes were observed in terms of uric micro-amount albumin excretion rate,creatinine clearance,hemorheology and platelet function et al.Results: TSN could significantly reduce urinary albumin,glomerulus's hyper-filtration,improve blood stream transform and inhibit platelet aggregation.Conclusion: TSN could protect renal functions during the early stage of DN.