Your browser doesn't support javascript.
loading
Montrer: 20 | 50 | 100
Résultats 1 - 7 de 7
Filtrer
Plus de filtres








Gamme d'année
1.
Article de Chinois | WPRIM | ID: wpr-1014814

RÉSUMÉ

AIM: To investigate the design significance, method and content of the oncology clinical trial case report form (CRF) based on the clinical data acquisition standards harmonization (CDASH). METHODS: Compared with CDASH v 2.2, the characteristics of oncology clinical trial data were analyzed, and a standardized CRF was designed to meet the actual needs of oncology clinical trials. RESULTS: The CDASH was applied to the design of the CRF of the oncology clinical trial, and the data collection of the oncology clinical trial was standardized, so that the CRF design of the oncology clinical trial was relatively standardized and the data quality was improved. CONCLUSION: The implementation of oncology CRF design based on CDASH can promote the exchange and sharing of oncology clinical research data, which is conducive to improving the reliability of oncology clinical research results.

2.
Article de Chinois | WPRIM | ID: wpr-862736

RÉSUMÉ

Objective To analyze the prevalence of visual acuity disorder among children aged 4-18 in Xuhui District of Shanghai from 2015 to 2019, and analyze its influencing factors, and to provide a scientific basis for the prevention and control of visual acuity disorder in Xuhui District of Shanghai. Methods Using random cluster sampling, students from 10 kindergartens, 3 primary schools and 2 middle schools were randomly selected as the investigation subjects. Visual acuity examinations and demographic survey were conducted, and chi-square test was used to describe the development trend of poor visual acuity. Results A total of 29 613 people were screened in five years, and the detection rate of poor vision in Xuhui District of Shanghai from 2015 to 2019 was 41.08% in 2015 and 50.59% in 2018, showing an increasing trend year by year (χ2=127.45, P2=7237.84, P2=80.93, P2=12.91, P<0.05). Conclusion In Xuhui District, the detection rate of poor vision among children and adolescents aged 4-18 years old was relatively high, and the development trend of visual problems was severe. In order to prevent the occurrence and development of poor eyesight, education departments, health departments and parents should strengthen the cultivation of good eye use habits and awareness among students, and take reasonable measures to control the development of poor vision.

3.
Chinese Journal of Dermatology ; (12): 330-334, 2020.
Article de Chinois | WPRIM | ID: wpr-870286

RÉSUMÉ

Objective:To evaluate the efficacy and safety of tazarotene/betamethasone dipropionate cream at different concentration ratios in the treatment of psoriasis vulgaris, and to determine the optimal drug concentration ratio for clinical use.Methods:A multicenter, randomized, double-blinded, multi-dose controlled study was conducted. From December 2008 to April 2009, a total of 180 patients with psoriasis vulgaris were enrolled from 7 research centers, such as Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College. These patients were randomly and equally divided into 5 groups: treatment groups 1, 2, 3, 4 treated with tazarotene/betamethasone dipropionate cream at concentration ratios of 0.025%/0.025%, 0.05%/0.025%, 0.025%/0.05% and 0.05%/0.05% respectively once a day, and control group treated with the cream vehicle once a day. The treatment lasted 4 weeks. Efficacy and safety were evaluated after 1, 2 and 4 weeks of treatment. One-way analysis of variance and least significant difference (LSD)- t test were used to compare measurement data among several groups, chi-square test and Fisher′s exact test to compare categorical data among groups, and Cochran-Mantel-Haenszel (CMH) test to compare psoriasis area severity index (PASI) response rates between groups. Results:After 4 weeks of treatment, 11 patients (30.56%) , 12 (33.33%) , 12 (33.33%) , 19 (52.78%) and 2 (5.56%) in the treatment groups 1, 2, 3, 4 and control group respectively achieved a 75% reduction in PASI (PASI75) , and the proportions of patients achieving PASI75 were significantly higher in the treatment groups than in the control group (all P < 0.012 7) . Additionally, the proportions of patients achieving PASI90 were also significantly higher in the treatment groups 1, 2 and 4 than in the control group (all P < 0.012 7) . After 4 weeks of treatment, the rates of reduction in PASI scores were 59.52% ± 26.79%, 57.19% ± 31.98%, 56.85% ± 30.46% and 68.21% ± 37.20% in treatment groups 1, 2, 3, and 4 respectively, which were all significantly higher than the rate of reduction in the control group (20.07% ± 28.55%; LSD- t = 5.36, 5.05, 5.00, 6.55, all P < 0.001) . The treatment group 4 showed marked comprehensive efficacy. All the tested drugs were well tolerated in the patients, and adverse reactions occurred in 11 (30.56%) , 8 (22.22%) , 2 (5.56%) , 4 (11.11%) and 2 (5.56%) cases in the treatment groups 1, 2, 3, 4 and control group respectively. The incidence rate of adverse reactions was significantly higher in the treatment group 1 than in the control group ( P = 0.012) , and there was no significant difference among the treatment groups 2, 3, 4 and control group (all P > 0.05) . Conclusion:The tazarotene 0.05%/betamethasone dipropionate 0.05% cream can be recommended for subsequent clinical trials in psoriasis vulgaris.

4.
Chinese Journal of Dermatology ; (12): 335-339, 2020.
Article de Chinois | WPRIM | ID: wpr-870288

RÉSUMÉ

Objective:To preliminarily evaluate clinical efficacy and safety of tazarotene 0.05%/betamethasone dipropionate 0.05% cream in the treatment of psoriasis vulgaris.Methods:A multicenter, randomized, double-blinded, single-dummy, parallel-controlled clinical trial was conducted. Subjects with mild to moderate psoriasis vulgaris were randomized into 4 groups at a ratio of 2∶1∶1∶1, including tazarotene 0.05%/betamethasone dipropionate 0.05% cream (Taz/Bp) group, betamethasone dipropionate 0.05% cream (Bp) group, tazarotene 0.05% gel (Taz) group and cream vehicle control (Plb) group. The treatment lasted 4 weeks. After 1, 2 and 4 weeks of treatment, efficacy and safety of drugs were evaluated in the above groups. Two-way analysis of variance model with main effects was used to compare continuous indices, least significant difference t-test was used for multiple comparisons, and chi-square test or Fisher′s exact test for comparisons of categorical data. Results:A total of 300 subjects were enrolled from 7 research centers, including 120 in the Taz/Bp group, 60 in the Bp group, 60 in the Taz group and 60 in the Plb group. After 4 weeks of treatment, proportions of patients achieving a 75% reduction in PASI (PASI75) were 35.83%, 20.00%, 18.33% and 6.67% in the Taz/Bp, Bp, Taz and Plb groups respectively, and there was a significant difference among the 4 groups ( P < 0.05) ; the proportion of patients achieving PASI75 was significantly higher in the Taz/Bp group than in the Plb group (α = 0.05, P < 0.05) and Taz group (α = 0.025, P < 0.025) , but there was no significant difference between the Taz/Bp group and Bp group (α = 0.016 7, P > 0.016 7) ; the proportions of patients achieving PASI90 were 25.00%, 8.33%, 5.00% and 1.67% in the Taz/Bp, Bp, Taz and Plb groups respectively, which significantly differed among the 4 groups ( P < 0.05) , and the Taz/Bp group showed a significantly increased proportion of patients achieving PASI90 compared with the Plb group ( P < 0.05) , Taz group ( P < 0.025) and Bp group ( P < 0.016 7) . All the tested drugs were well tolerated in the 4 groups. Adverse drug reactions occurred in 15 (12.50%) , 5 (8.33%) , 19 (31.67%) and 9 (15.00%) patients in the Taz/Bp, Bp, Taz and Plb groups respectively. The incidence rate of adverse drug reactions significantly differed among the 4 groups ( P = 0.004) , and was significantly lower in the Taz/Bp group than in the Taz group ( P < 0.05) , but insignificantly different between the Taz/Bp group and Bp or Plb group (both P > 0.05) . Conclusion:Tazarotene 0.05%/betamethasone dipropionate 0.05% cream is effective and safe for the treatment of psoriasis vulgaris.

5.
Chinese Journal of Dermatology ; (12): 241-243, 2011.
Article de Chinois | WPRIM | ID: wpr-413651

RÉSUMÉ

Objective To evaluate the safety and efficacy of single and local use of a China-made compound betamethasone injection in the treatment of lichen simplex chronicus. Methods A multi-center,randomized, parallel controlled study was conducted. Patients with lichen simplex chronicus were divided into test and control groups to receive a single dose of intralesional compound betamethasone injection made in China or Schering-Plough Labo N.V. Belgium. Patients were visited for the evaluation of efficacy and safety of the China-made injection at the beginning of the treatment (DO), on week 2 (D14) and 4 (D28) after the initiation of treatment. Results A total of 144 patients were enrolled, among which, 68 in the control group and 71 in the test group completed the trial. FAS analysis on week 4 revealed that the response rate and healing rate were 86.11% and 59.72% in the control group, respectively, 86.11% and 54.17% in the test group, respectively (χ2=0.00,0.45,respectively,both P>0.05).There was no severe adverse event in either group after the treatment, and only mild atrophoderma occurred in one patient in the control group, which was improved spontaneously within several weeks of follow-up. There was no statistically significant difference in the occurrence of side reactions between the two groups (P> 0.05). Conclusion The China-made compound betamethasone injection is effective and safe for the treatment of lichen simplex chronicus.

6.
Article de Chinois | WPRIM | ID: wpr-521647

RÉSUMÉ

Objective To evaluate the cumulative irritative effect of topical retinoic acid preparations on normal skin.Methods A randomlized,doubled blind,placebo-controlled clinical trial was carried out with7groups for6tested preparations.All subjects were patch tested with each preparation for24hours on Monday to Thursday,and for72hours on Friday.The patch tests were performed for3consecutive weeks.Results The minimal cumulative irritative effects were found in Group G treated with0.1%adapalene gel,with a cumulative irritative index of0.09?0.11in20days.The cumulative irritative index was significantly lower in Group G than that in Group B treated with0.1%retinoic acid(Diweishuang誖)(0.59?0.24),or in0.025%retinoic acid(Diweishuang誖)(0.41?0.22),or in0.05%retinoic acid(VITAMIN誖Cream)(0.25?0.22).Conclusion Adapalene,the third generation of retinoic acid,is characterized by lower irritative ef-fects in comparison to the first generation of topical retinoic acid agents.

7.
Article de Chinois | WPRIM | ID: wpr-523919

RÉSUMÉ

Objective To observe the clinical efficacy and safety of 0.1% mometasone furoate cream in the topical treatment of eczematous dermatoses including neurodermatitis and eczema. Methods A randomized double-blind parallel controlled clinical trial was conducted. The home made mometasone furoate cream or imported Eloson cream was topically used in patients with such dermatoses once daily for 4 weeks, respectively. Symptom/sign scores were evaluated at the beginning of the treatment and at the 1st, 2nd, 3rd, 4th week after the initiation of the treatment. Results Two hundred and eighty-four patients were enrolled in the trial, including 143 patients with eczema and 141 patients with neurodermatitis. There are 142 patients each in test group and control group separately. All symptom/sign scores and total scores were significantly decreased 1, 2, 3, and 4 week after the treatment. No statistically significant difference was observed between the two groups. The cure rate and improvement rate in eczema patients were 78.87% and 97.18% in the test group; 84.51% and 92.96% in the control group; respectively. While the cure rate and improvement rate in neurodermatitis patients were 75.71% and 100% in the test group; 80.28% and 94.37% in the control group; respectively. The cure rate and improvement rate of total patients were 77.30% and 98.58% in the test group; 82.39% and 93.64% in the control group; respectively. No statistically significant difference in efficacy was observed between the two groups. There was no severe side effect in the two groups. One patient had mild contact dermatitis in the test group. Conclusions These results suggest that 0.1% mometasone furoate cream is an effective and safe drug in the treatment of neurodermatitis and eczema.

SÉLECTION CITATIONS
DÉTAIL DE RECHERCHE