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.
Antibodies, Monoclonal/therapeutic use* ; Antibodies, Monoclonal, Humanized ; China ; Double-Blind Method ; Humans ; Psoriasis/drug therapy* ; Severity of Illness Index ; Treatment Outcome

Objective:Endometriosis is a common gynecologic disease that frequently leading to chronic pelvic pain,severe dysmenorrhea,and subfertility.As first-line hormonal treatment can interfere with ovulation and may cause recurrent pelvic pain,exploration of new non-hormonal therapeutic approaches becomes increasingly necessary.This review aimed to evaluate the pre-clinical and clinical efficacy and safety of non-hormonal treatment for endometriosisData sources:Databases including PubMed,Embase,Cochrane Library,SINOMED,ClinicalTrials.gov,and Google Scholar were searched up to October 2019,using search terms "endometriosis" and "non-hormonal therapy."Study selection:Twenty-four articles were reviewed for analysis,including nine animal studies and 15 human trials;all were published in English.Results:Twenty-four articles were identified,including 15 human trials with 861 patients and nine animal studies.Some agents have been evaluated clinically with significant efficacy in endometriosis-related pelvic pain and subfertility,such as rofecoxib,etanercept,pentoxifylline,N-palmitoylethanolamine,resveratrol,everolimus,cabergoline (Cb2),and simvastatin.Other drugs with similar pharmacological properties,like parecoxib,celecoxib,endostatin,rapamycin,quinagolide,and atorvastatin,have only been tested in animal studies.Conclusions:Clinical data about most of the non-hormonal agents are not sufficient to support them as options for replacement therapy for endometriosis.In spite of this,a few drugs like pentoxifylline showed strong potential for real clinical application.

BACKGROUNDAtopic 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.

METHODSA 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.

RESULTSA 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.

CONCLUSIONLate-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.

Adolescent ; Adult ; Dermatitis, Atopic ; diagnosis ; immunology ; Eczema ; diagnosis ; Female ; Humans ; Immunoglobulin E ; blood ; Male ; Middle Aged ; Retrospective Studies ; Surveys and Questionnaires

To evaluate the efficacy of changing grains on the prevention and treatment of Kashin-Beck Disease (KBD) in children, community-based trials were acquired from seven electronic databases (up to July 2014). As a result, the methodological quality of the six trials that have been included into our analysis was low. The pooled ORs favoring the prevention and treatment effects of changing grains were 0.15 (95% CI: 0.03-0.70) and 2.13 (95% CI: 1.44-3.16) respectively by meta-analysis. Subgroup analysis demonstrated the pooled OR favoring treatment effect of exchanging grains rather than drying grains both compared with endemic grains. The results showed that changing grains had obvious effects on the prevention and treatment of KBD in children. However, the evidences were limited by the potential biases and confounders. Large and well-designed trials are still needed.
Adolescent ; Child ; Child, Preschool ; Community-Based Participatory Research ; Edible Grain ; physiology ; Humans ; Infant ; Infant, Newborn ; Kashin-Beck Disease ; etiology ; prevention & control ; therapy

BACKGROUNDMost of endovascular stent-graft modifications to preserve side branch must be customized according to extensive pre-operative assessment, which may not be possible in many hospitals and emergency settings. The study was to develop a novel stent-grafts system that would allow in situ "fenestration", with less reliance on preoperative imaging.

METHODSThe magnitude of pressure difference (PD) between left subclavian artery (LSA) and aortic arch were measured in 12 experimental pigs. Changes of PD before and after LSA was covered were analyzed respectively. The novel stent graft was made by multi-dimensional and multiple textiles forming technology. According to the PD measurement in pigs, we evaluated the feasibility of the stent-graft in a mock circulation system.

RESULTSIn pigs, the blood pressure of aortic arch was significantly higher than that of LSA after it was covered (P < 0.001) and PD was (42.78 ± 5.17) mmHg. After target vessel was covered and when PD between the LSA and aorta reached the magnitude measured in pigs, contrast media oozed from the cranny of graft to the LSA, which was generated by sliding and deformation of yarns of novel stent-graft.

CONCLUSIONSThe study proposes the design of pressure difference-induced perforation aortic stent-grafts system and verifies that the PD between LSA and aortic arch is high enough to allow in situ "fenestration" by stent graft made by multi-dimensional and multiple textiles forming technology.

Animals ; Aorta, Thoracic ; surgery ; Blood Pressure ; physiology ; Blood Vessel Prosthesis ; Blood Vessel Prosthesis Implantation ; Prosthesis Design ; Subclavian Artery ; Swine

OBJECTIVETo observe the effect of salvia miltiorrhiza and ligustrazine injection on the early myocardial damage of severely burned patients.

METHODSTwenty severely burned patients hospitalized from January 2010 to August 2011, with burn area equal to or more than 50% TBSA, were divided into two groups following hospitalization sequence, with odd number patients entering treatment group (T, n = 10) and even number patients entering control group (C, n = 10). Patients in C group were treated with routine methods, including fluid resuscitation based on the Third Military Medical University formula, anti-infection treatment, support treatment, and organ-protection treatment, etc. In addition to routine treatment methods, patients in T group received intravenous infusion of 250 mL glucose injection (50 g/L) containing 10 mL salvia miltiorrhiza and ligustrazine concoction, once a day, and continued for three days. Venous blood of patients was drawn at post burn hour (PBH) 12, 24, 48, and 72 to determine the plasma levels of cardiac troponin I (cTnI), creatine kinase isozyme MB (CK-MB), and atrial natriuretic peptide (ANP). Data were processed with t test.

RESULTSAt each time point, levels of cTnI, CK-MB, and ANP were lower in T group than in C group. Differences in contents of these parameters between two groups were statistically significant at most time points, with t values from 2.136 to 2.918, P < 0.05 or P < 0.01. Plasma levels of cTnI, CK-MB, and ANP in both groups peaked at PBH 12, which were respectively (28 ± 10) ng/mL, (76 ± 13) U/L, (430 ± 87) pg/mL in T group, and (38 ± 11) ng/mL, (87 ± 10) U/L, (453 ± 91) pg/mL in C group. From PBH 24 to 72, contents of above-mentioned parameters decreased gradually in both groups.

CONCLUSIONSEarly use of salvia miltiorrhiza and ligustrazine injection in severely burned patients can effectively reduce myocardial damage, thus protect the myocardium from injury.

Adolescent ; Adult ; Burns ; blood ; drug therapy ; Creatine Kinase, MB Form ; blood ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Myocardium ; pathology ; Pyrazines ; therapeutic use ; Salvia miltiorrhiza ; Troponin I ; blood ; Young Adult

OBJECTIVECystic fibrosis (CF) is rare in Chinese mainland. We present two cases of CF patients diagnosed by gene analysis. Their clinical manifestations and genetic mutation features are analyzed in this article. It will be of special interest to pediatricians in recognition of CF.

METHODThe clinical material of two CF patients who were diagnosed by gene analysis was retrospectively analyzed.

RESULTThe first patient is a 13-year-old girl. She had a complaint of recurrent fever and cough for 6 months, expectoration for 2 months and hemoptysis for 20 days. After 3 months of her birth, she was operated on for bullae of lung. She was susceptible to upper respiratory tract infection. There was no family history of recurrent wheeze and other special diseases. Aspergillus fumigatus specific IgE was at grade 3 and aspergillus fumigatus IgG was high. Pseudomonas aeruginosa was positive in sputum culture. Sweat testing was performed and Na+ was higher. Pulmonary CT indicated bronchiectasis. Nasal sinus CT showed optical density of soft tissue within maxillary sinus and chronic bilateral sinusitis. The electron microscopy of cilia suggested immobile cilia syndrome. A heterozygotic mutation (263T > G, 2909G > A) was found after CFTR genetic mutation analysis. Both her parents were carriers. She was treated with inhalation of nebulized hypertonic saline and postural drainage for a long time. And she got better during a follow up period of 1 year. The second patient was a 10-year-old girl who complained of recurrent expectoration for 3 years and shortness of breath for half a year. She had a history of sinusitis and steatorrhea. The family history was normal. Both the lipase and insulin level in blood serum was lower.Pseudomonas aerugino and Aspergillus fumigatus were both positive in sputum culture. Aspergillus fumigatus IgE was normal. Pulmonary CT indicated bronchiolitis and bronchiectasis. Nasal sinus CT showed bilateral maxillary sinusitis. CFTR genetic mutation analysis revealed a homozygous mutation (3196C > T). Her parents and relatives did not participate in this study. Unfortunately, this child died of respiratory failure 3 months after discharge.

CONCLUSIONCFTR gene mutation was a main cause of CF. Common symptoms are those of bronchiectasis, pancreatitis and sinusitis. The two Chinese patients were diagnosed by gene analysis. One had a heterozygous mutation (263T > G, 2909G > A) and the other had a homozygous mutation (3196C > T), not ΔF508 which is common in western countries.

Adolescent ; Asian Continental Ancestry Group ; genetics ; Bronchiectasis ; etiology ; genetics ; Child ; Cystic Fibrosis ; complications ; diagnosis ; genetics ; Cystic Fibrosis Transmembrane Conductance Regulator ; genetics ; DNA Mutational Analysis ; Female ; Heterozygote ; Homozygote ; Humans ; Mutation ; Retrospective Studies ; Sinusitis ; etiology ; genetics

BACKGROUNDMorphologic imaging after radiofrequency ablation (RFA) of liver metastases is hampered by an inflammatory response in the ablation margin, making the identification of local tumor progression (LTP) difficult. The aim of this study was to evaluate the efficacy of early (18)F-FDG PET/CT scanning to monitor the effectiveness of RFA in colorectal liver metastases.

METHODSTwelve patients with 20 metastases were treated with RFA for colorectal liver metastases. They underwent PET/CT within 2 weeks before RFA and within 24 hours after RFA (so termed "early PET/CT"). PET/CT was repeated at 1, 3, and 6 months, and then every 6 months after ablation. The standard of reference was based on available clinical and radiological follow-up data.

RESULTSEarly PET/CT revealed total photopenia in 16 RFA-treated metastases, which were found to be without residual tumor on the final PET/CT scan. Three RFA-treated metastases with focal uptake were identified as local tumor progression, which necessitated further treatment. One RFA-treated metastasis with rim-shaped uptake was regarded as inflammation. The results of the early PET/CT scanning were consistent with the findings of the final follow-up.

CONCLUSIONSPET/CT performed within 24 hours after RFA can effectively detect whether residual tumor exists for colorectal cancer liver metastases. The results can guide further treatment, and may improve the efficacy of RFA.

Adult ; Aged ; Aged, 80 and over ; Catheter Ablation ; Colorectal Neoplasms ; complications ; diagnostic imaging ; therapy ; Female ; Fluorodeoxyglucose F18 ; therapeutic use ; Humans ; Liver Neoplasms ; diagnostic imaging ; secondary ; therapy ; Male ; Middle Aged ; Positron-Emission Tomography ; methods ; Tomography, X-Ray Computed ; methods

OBJECTIVETo evaluate the method and effectiveness of rigid-bronchoscopic cryosurgery for advanced central lung cancer.

METHODSForty-eight patients were enrolled in this study from June 2002 to December 2008, including 33 male and 15 female. The average age was 70 years (ranged from 45 to 83 years old). For the 48 patients, 38 cases were patients with advanced central lung cancer who were not suitable for surgery, and the remaining 10 cases were patients with local recurrence in trachea or main bronchus postoperatively. Cryosurgery was performed 120 times for all patients, 2.5 times per patient on average. The trachea or bronchus station, symptom such as dyspnea, hemoptysis, respiratory function and quality of life were observed.

RESULTSThe unblocked ratio of trachea and bronchi was 97%. All patients got satisfied improvement ratio of symptoms, 87.5% for dyspnea, 72.9% for cough, 93.8% for hemoptysis and 62.5% for chest pain. Respiratory function tests showed that both the mean forced expiratory volume in first second and forced vital capacity got an improvement from (1.03+/-0.05) L to (1.85+/-0.13) L and from (1.69+/-0.18) L to (2.96+/-0.14) L respectively (P<0.01). Karnofsky score also got no less than 20 scores improvement. The Follow-up time was 6 to 62 months. The longest survival was 62 months. The median survival time was 20 months. There was no severe perioperative complications and mortality except for 3 cases of moderate exeduation.

CONCLUSIONSCryosurgery is easy to perform with minimal complications. Not only could it provide an effective and rapid control of symptoms caused by central lung cancer, it could also unobstructed bronchus promptly and improve patients' quality of life.

Aged ; Aged, 80 and over ; Bronchoscopy ; Cryosurgery ; methods ; Female ; Humans ; Lung Neoplasms ; surgery ; Male ; Middle Aged ; Treatment Outcome

OBJECTIVETo assess the effect of a liquid embolic agent 2-poly-hydroxyethyl -methacrylate (2-P-HEMA) for renal artery embolization in rabbits.

METHODSThe precipitation time of different concentrations (2%, 3.5%, 5%, 6.5%, 8% and 9.5%) of 2-P-HEMA dissolved in different solutions (ethanol, ethanol/iobitridol, and ethanol/Bi2O3) were determined in flowing water. The mixtures of 2-P-HEMA (2%, 5%, and 8%) with ethanol/ Bi2O3 were injected into the renal arteries of the rabbits, and the artery-embolizing effects were assessed using angiography at 2 and 12 weeks after the injection, with also macroscopic and microscopic examination of the embolized kidneys.

RESULTSThe mixtures of 2-P-HEMA and ethanol formed flocculent precipitation a few seconds after injection into flowing water, and the precipitation time showed no significant variations with the concentration of 2-P-HEMA in the mixture. Low and moderate concentrations of 2-P-HEMA could pass through the microcatheter smoothly with little injection resistance, and resulted in complete occlusion of the renal arteries without adhesion to the microcatheter. Angiography at 2 and 12 weeks detected no recanalization of the occluded renal arteries. Macroscopically, the lumen of the renal arteries was found to be occluded by the embolic agents, and deep penetration of the embolic agents into the glomerular arteries was observed microscopically. The mixture containing high-concentration 2-P-HEMA was difficult to deliver through the microcatheter due to high injection resistance.

CONCLUSION2-P-HEMA can be rapidly precipitated after injection into flowing water, and allows complete embolization of the renal arteries of rabbits at proper concentrations, suggesting its great potential as an endovascular liquid embolic agent.

Animals ; Embolization, Therapeutic ; methods ; Female ; Male ; Polyhydroxyethyl Methacrylate ; Rabbits ; Radiography ; Random Allocation ; Renal Artery ; diagnostic imaging ; pathology