A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis / 中华医学杂志(英文版)

BACKGROUND@#Benvitimod cream, a novel synthetic small molecule, was effective in treating mild-to-moderate plaque psoriasis. We conducted a phase III clinical trial to assess the efficacy and safety of benvitimod cream in patients with mild-to-moderate plaque psoriasis.@*METHODS@#We randomly assigned 686 patients (2:1:1) to receive 1% benvitimod cream, 0.005% calcipotriol ointment or placebo twice a day for 12 weeks. The primary efficacy end points were the percentage of patients with a 75% or greater reduction from baseline in the psoriasis area and severity index (PASI 75) score and with a score of 0 or 1 in static physician's global assessment (sPGA) at week 12.@*RESULTS@#The results showed that 50.4% of patients in the benvitimod group achieved PASI 75, which was significantly higher than that in the calcipotriol (38.5%, P < 0.05) and placebo (13.9%, P < 0.05) groups. The proportion of patients achieving an sPGA score 0 or 1 was 66.3% in the benvitimod group and 63.9% in the calcipotriol group, which were both significantly higher than that in the placebo group (34%, P < 0.05). In the long-term follow-up study, 50.8% of patients experienced recurrence. After retreatment with 1% benvitimod, 73.3% of patients achieved an sPGA score of 0 or 1 again at week 52. Adverse events included application site irritation, follicular papules, and contact dermatitis. No systemic adverse reactions were reported.@*CONCLUSION@#During this 12-week study, benvitimod cream was demonstrated with high effectiveness and safety in patients with mild-to-moderate plaque psoriasis.@*TRIAL REGISTRATION@#Chinese Clinical Trial Registry (ChiCTR), ChiCTR-TRC-13003259; http://www.chictr.org.cn/showprojen.aspx?proj=6300.

Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis / 中华医学杂志(英文版)

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.

Experience of the details on the phacoemulsification and intraocular lens implantation combined with goniosynechialysis for primary acute angle-closure glaucoma / 国际眼科杂志(Guoji Yanke Zazhi)

AIM: To discuss the details about the phacoemulsification and intraocular lens implantation combined with goniosynechialysis for the treatment of primary acute angle-closure glaucoma (PAACG).METHODS: Totally 21 patients (21 eyes) with PAACG from February 2013 to October 2015 were performed phacoemulsification and intraocular lens implantation combined with goniosynechialysis.The details such as incision, circular capsulorhexis, water separation, intraocular lens selection, goniosynechialysis were discussed.The vision, intraocular pressure, complications were observed.RESULTS: Postoperative intraocular pressure of all patients with were controlled under 21mmHg followed up for 1mo.Visual acuity was improved to some extent.The patients were observed with rapid recovery and fewer complications.There was 1 eye with posterior capsule rupture intraoperatively and 1 eye with decompensated corneal edema postoperatively.CONCLUSION: It makes this surgery more safe and perfect by disposing the details during operation.

Clinical Features of Adult/Adolescent Atopic Dermatitis and Chinese Criteria for Atopic Dermatitis / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Atopic dermatitis (AD) is an inflammatory skin disease characterized by chronic recurrent dermatitis with profound itching. Most patients have personal and/or family history of atopic diseases. Several criteria have been proposed for the diagnosis of AD. Although the clinical features of childhood AD have been widely studied, there has been less large-scale study on adult/adolescent AD. The aim of this study was to investigate the clinical features of adult/adolescent patients with chronic symmetrical eczema/AD and to propose Chinese diagnostic criteria for adult/adolescent AD.</p><p><b>METHODS</b>A hospital-based study was performed. Forty-two dermatological centers participated in this study. Adult and adolescent patients (12 years and over) with chronic symmetrical eczema or AD were included in this study. Questionnaires were completed by both patients and investigators. The valid questionnaires were analyzed using EpiData 3.1 and SPSS 17.0 software.</p><p><b>RESULTS</b>A total of 2662 valid questionnaires were collected (1369 male and 1293 female). Of all 2662 patients, 2062 (77.5%) patients had the disease after 12 years old, while only 600 (22.5%) patients had the disease before 12 years old, suggesting late-onset eczema/AD is common. Two thousand one hundred and thirty-nine (80.4%) patients had the disease for more than 6 months. One thousand one hundred and forty-four (43.0%) patients had a personal and/or family history of atopic diseases. One thousand five hundred and forty-eight (58.2%) patients had an elevated total serum IgE and/or eosinophilia and/or positive allergen-specific IgE. Based on these clinical and laboratory features, we proposed Chinese criteria for adult/adolescent AD. Of all 2662 patients, 60.3% were satisfied with our criteria, while only 48.2% satisfied with Hanifin Rajka criteria and 32.7% satisfied with Williams criteria, suggesting a good sensitivity of our criteria in adult/adolescent AD patients.</p><p><b>CONCLUSION</b>Late-onset of eczema or AD is common. The clinical manifestations of AD are heterogeneous. We have proposed Chinese diagnostic criteria for adolescent and adult AD, which are simple and sensitive for diagnosis of adult/adolescent AD.</p>

Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Tumor necrosis factor-α is a key mediator in the pathogenesis of psoriasis. Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-α. The purpose of this study was to validate the efficacy and safety of 5 mg/kg infliximab therapy in Chinese patients with moderate to severe plaque psoriasis.</p><p><b>METHODS</b>In this multicenter, double-blind, placebo-controlled trial, 129 patients with moderate-to-severe psoriasis were randomized to the induction therapy (weeks 0, 2 and 6) with infliximab 5 mg/kg (n = 84) or placebo (n = 45), followed with infliximab 5 mg/kg scheduled at week 14 and week 22 in the infliximab group, and infliximab 5 mg/kg scheduled at weeks 10, 12 and 16 in the placebo group. The primary end point was the proportion of patients who achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI 75 response rate) from baseline at week 10.</p><p><b>RESULTS</b>At week 10, 81.0% of patients treated with infliximab (5 mg/kg) achieved a 75% or greater improvement compared with 2.2% of patients treated with placebo (P < 0.001). A significant improvement in PASI, Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), was seen from week 6 through week 14 in the infliximab group compared with the placebo group. Through week 22, PASI, PGA, DLQI were well maintained. The incidence of adverse events for the infliximab treatment group was slightly higher in comparison to the placebo treatment group during the first 10 weeks without statistical significance. However, there were 3 cases of tuberculosis that developed during the 26 weeks treatment with infliximal.</p><p><b>CONCLUSIONS</b>Infliximab treatment was effective as induction and maintenance treatments for Chinese patients with moderate to severe plaque psoriasis. Most drug-induced adverse events were mild to moderate, and well tolerated. Screening for tuberculosis is essential and prophylactic treatment should be given if necessary.</p>

Effect of light rhythm on the expression of cryptochrom 2 in retina / 中华实验眼科杂志

Background The cryptochrom 2 (Cry2)in mammalian retina is a main influential factor of circadian clock.Objective Purpose of this study was to investigate the effect of light exposure rhythm on expression of Cry2 in retina.Methods Thirty clean healthy Sprague Dawley(SD)rats were collected and divided into two groups randomly.The rats of the control group exposed to natural light with the normal rhythm for 30 days,but rats of the experimental group exposed to the artificial light (light: dark =18 hours:6 hours) for 3 months with the light intensity of(533± 16)lx.The histopathological change and ultrastructural alteration of rat retina in both groups were examined under the light microscope and transmission electron microscope at the end of the experiment.Expressions of Cry2 protein and its mRNA were assayed by immunohistochemistry and quantitative PCR(Q-PCR).Results The rat retinal morphology and ultrastructure were clear and order-arranged under the light microscope and transmission electron microscope in the control group.However,atrophy and disorganization of retina were found under the light microscope,and liquefaction and vacuole of outer segments of photoreceptors were observed.The vacuolar degeneration of mitochondria in the inner segments of photoreceptors,cellular nuclear shrinkage,chromatin margination,nuclear notch and destruction were seen in the outer nuclear layer under the transmission electron microscope.Immunohistochemistry showed that the expression of Cry2 protein located in cytoplasm and nuclei membrane of the retinal ganglion cell layer and inner nuclear layer in both normal rats and experimental rats.The scores of Cry2 protein expression were 0.833±0.197 in the experimental group,and 1.700±0.245 in the control group,with a significant difference between them (P=0.009).The quantities of Cry2 mRNA were 0.962 ± 0.125 in the control group and 0.615±0.100 in the experimental group,showing a significant difference between the two groups (P =0.006).Conclusions Long-term light exposure under the 533 lx leads to retinal structural and functional damage probably by down-regulating Cry2 expression in retina.Whether the regulation of Cry2 expression is helpful for stabilizing the biorhythm or not is a worthy question to explore.

The experimental study on trabeculectomy combined with implantation of anterior lens capsule / 眼科

Objective To evaluate the effects on trabeculectomy combined with implantation of anterior lens capsule.Design Radomized,controlled experimental study.Participants 36 experimental albino rabbits.Methods 36 albino rabbits were divided into 3 groups randomly.The rabbit and human anterior lens capsules were implanted under the scleral flap in trabeculectomy in group A and group B respectively,while only trabeculectomy in control group.The average follow-up period was 12 months.Main Outcome Mea- sures Intraocular pressures(IOP),filtering bleb,complications.Results The postoperative IOP of the experimental groups decreased sig- nificantly as compared with preoperative IOP at 12 week postoperatively.Retention of reflective filtering bleb in experimental groups was longer than that in contral group(5.12?0.43week,5.05?0.59week,2.74?0.32week,P＜0.05).The passage of humor outflow kept open in ex- perimental groups and became closed in control group at 12 week postoperatively.Anterior lens capsule wasn't attacked by T or B lym- phocyte seen with electron microscope.Conclusions Implantation of anterior lens capsule may help to postpone filtering bleb scarring in the trabeculectomy.This study provides experimental basis for the clinical practice.