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1.
Chinese Medical Journal ; (24): 2665-2673, 2020.
Article in English | WPRIM | ID: wpr-877883

ABSTRACT

BACKGROUND@#Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.@*METHODS@#This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.@*RESULTS@#A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.@*CONCLUSION@#Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.@*TRIAL REGISTRATION@#ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized , China , Double-Blind Method , Humans , Psoriasis/drug therapy , Severity of Illness Index , Treatment Outcome
2.
Article in Chinese | WPRIM | ID: wpr-693709

ABSTRACT

Objective To explore the relationship of the cardiac damage with traditional Chinese medicine (TCM) syndromes and clinical indicators in patients with chronic kidney disease at stage 3 (CKD3). Methods A cross-sectional study was carried out in 108 CKD3 patients. We collected the clinical data of the included subjects, covering syndrome types, clinical indicators, and echocardiographic indices. And then we analyzed the correlation of syndrome types with echocardiography indices and risk factors of cardiac damage. Results(1) There were 48.1% of the included subjects having the cardiac structure changes, 19.4% having myocardial thickening and 82.4% having left ventricular diastolic dysfunction. Hypertension, hypertension-history lasting time, anemia and phosphorus ion levels were risk factors of myocardial hypertrophy (P < 0.05). Age and free thyroxine levels were risk factors of valvular regurgitation (P < 0.05 or P < 0.01). (2) In the patients with healthy-Qi deficiency syndromes, the heart damage in Yin-Yang deficiency syndrome was more severe than that in spleen-kidney Yang deficiency syndrome and Qi-Yin deficiency syndrome, and the impairment of cardiac function was most severe in Yin-Yang deficiency syndrome(P<0.05). An increasing sequence of incidence of ventricular remodeling was shown in the syndromes of spleen-kidney Qi deficiency, spleen-kidney Yang deficiency , Qi-Yin deficiency , liver-kidney Yin deficiency , Yin-Yang deficiency(P < 0 . 05). (3) Left ventricular mass index (LVMI) in the patients with pathogen-excess complicated syndromes was higher than that in the patients without pathogen-excess complicated syndromes (P<0.05). Of the pathogen-excess complicated syndromes, blood-stasis syndrome had higher incidence of ventricular remodeling than damp-heat syndrome(P<0.01) , but the differences were insignificant among the other syndrome types (P > 0.05). Conclusion The decreased diastolic function and cardiac structure damage are relatively commonly-seen in CKD3 patients, and some of CKD3 patients have myocardial hypertrophy. Anemia, hypertension, hypertension-history lasting time and phosphorus ion level are risk factors of myocardial hypertrophy. Heart damage is more severe in CHD3 patients with Yin-Yang deficiency syndrome than that in spleen-kidney Yang deficiency syndrome and Qi-Yin deficiency syndrome, and the impairment of cardiac function is most severe in Yin-Yang deficiency syndrome. The complication of pathogen-excess can aggravate heart damage. Patients complicated with blood-stasis syndrome have more severe myocardial hypertrophy, and ventricular and atrial enlargement degree.

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