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Objective:To investigate the correlation between food-specific IgG (sIgG) antibodies and phenotypes of chronic spontaneous urticaria (CSU) .Methods:Serum samples were collected from outpatients with active CSU, symptomatic dermographism (SD) , or acute urticaria (AU) , and healthy controls from 5 third-grade class-A hospitals such as the First Hospital of China Medical University between April 2014 and March 2015. Enzyme-linked immunosorbent assay was conducted to detect serum levels of 90 food-sIgG antibodies and total IgE, Western blot analysis to detect levels of 20 allergen-specific IgE antibodies, and chemiluminescent microparticle immunoassay to detect levels of anti-thyroid peroxidase IgG antibodies and anti-thyroglobulin IgG antibodies. Comparisons of normally distributed quantitative data between two groups and among several groups were performed by t test and one-way analysis of variance, respectively; comparisons of non-normally distributed quantitative data between two groups were performed by Mann-Whitney U test; for comparisons of proportions, chi-square test and Fisher′s exact test were used. Results:A total of 248 patients with CSU, 22 with SD, 15 with AU and 13 healthy controls were recruited. The cut-off level for sIgG positivity was 100 U/ml (at least 2+) , and the positive rate of food-sIgG antibodies was slightly higher in the patients with CSU (176/248, 70.97%) , SD (15/22, 68.18%) and AU (11/15) than in the healthy controls (7/13; χ2 = 1.80, P = 0.615) . Among the 248 CSU patients, the proportion of patients with family history of allergic diseases was significantly higher in the sIgG-positive group (71/176, 40.34%) than in the sIgG-negative group (19/72, 26.39%; χ2 = 4.30, P = 0.042) , while no significant difference was observed in the 1-day urticaria activity score (UASday) between the two groups ( Z = 0.18, P = 0.859) . Totally, 177 CSU patients completed 12- to 40-week treatment; their condition could be completely controlled by second-generation H1-antihistamines, and there was no significant difference in the required dosage of second-generation H1-antihistamines between the sIgG-positive group (128 cases) and sIgG-negative group (49 cases; Z = -1.06, P = 0.298) . Conclusions:The prevalence of family history of allergic diseases was relatively high in food-sIgG-positive patients with CSU. However, food-sIgG could not be used as an indicator to reflect the disease activity of CSU and treatment response.
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Objective To evaluate the safety and efficacy of a domestic recombinant human tumor necrosis factor receptor type Ⅱ- IgG Fc fusion protein (rhTNFR-Fc)for the treatment of moderate to severe psoriasis vulgaris. Methods A multicenter, randomized, double blind, parallel-group, positive drug-controlled clinical trial was conducted. According to random numbers generated by a hierarchical segmentation method using the SAS 9.2 software, patients with moderate to severe psoriasis vulgaris were randomly divided into two groups to be injected with two kinds of domestic rhTNFR-Fc under the trade names of Anbainuo(test group)and Yisaipu(control group)respectively at a dose of 25 mg twice a week for 12 consecutive weeks. The primary endpoint was the proportion of patients achieving a 50%, 75% and 90% reduction in psoriasis area and severity index(PASI50, PASI75 and PASI90)at week 2, 6 and 12 after initiation of the treatment. Adverse reactions were also recorded. Statistical analysis was carried out by using the chi-square test, Fisher′s exact test, two-sample t-test, and noninferiority trials with the software SAS 9.2. Results A total of 180 patients were enrolled in this study from 5 centers, and 174 completed this trial, of whom, 88 were assigned to the test group and 86 to the control group. Analysis of the full analysis set (FAS)revealed no significant differences in PASI50(75.6%(68/90)vs. 82.2%(74/90), P > 0.05)or PASI75(51.1%(46/90)vs. 50.0%(45/90), P > 0.05) between the test group and control group, but a significant increase in PASI90 in the test group compared with the control group (30.0% (27/90)vs.16.7% (15/90), χ2 = 4.472, P 0.05), most of which were mild, and subsided spontaneously or after appropriate treatment. Conclusion The domestic rhTNFR-Fc (trade name:Anbainuo)25 mg twice a week for 12 weeks is effective and safe for the treatment of moderate to severe psoriasis——————————vulgaris.
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ObjectiveTo determine the levels of 8-iso-prostaglandin F2α (PGF2α) in sera and lesions as well as antioxidant capacity in sera of psoriatic patients,and to assess their correlations with disease severity.MethodsSerum and skin tissue samples were collected from 15 healthy controlsand 50 patients with psoriasis vulgaris.Spectrophotometry was performed to determine the levels of total antioxidant capacity (T-AOC) and the activities of antioxidant enzymes such as superoxide dismutase (SOD),catalase (CAT) and glutathione peroxidase (GSH-Px) in serum samples.Enzyme-linked immunosorbent assay (ELISA) and immunohistochemical SP method were carried out to detect the expression level of 8-iso-PGF2α in the serum and tissue specimens respectively.ResultsThe psoriatic patients showed a significant decrease in the serum level of TAOC((12.78 ± 7.75) U/ml vs. (23.17 ± 8.81) U/ml,P＜ 0.01) as well as the activities of SOD((28.91 ±9.35) U/ml vs.(51.36 ± 7.92) U/ml,P＜ 0.01) and GSH-Px ((180.64 ± 47.70) U vs.(244.20 ± 66.68) U,P ＜ 0.01 ) compared with the healthy controls.The serum T-AOC level and SOD activity were lower in patients with severe psoriasis than those with mild or moderate psoriasis ((9.06 ± 5.30) U/ml vs. (15.27 ± 8.18) U/ml,(21.63 ± 5.28) U/ml vs. (33.76 ± 8.28) U/ml,both P＜ 0.01 ),while there was no significant difference in the activity of GSH-Px between patients with severe and mild or moderate psoriasis.The serum CAT activity was significantly higher in patients with mild or moderate psoriasis than in the healthy controls and patients with severe psoriasis ( (36.92 ± 11.31 ) U/ml vs.( 28.55 ± 8.51 ) U/ml and (24.15 ± 9.36 ) U/ml,P ＜ 0.05 and 0.01 ).Increased serum and lesional 8-iso-PGF2α levels were observed in psoriatic patients compared with the healthy controls ( (88.77 ± 25.27) ng/L vs.(38.34 ± 8.94) ng/L,0.0186 ± 0.0082 vs.0.0027 ± 0.0014,both P ＜ 0.01),as well as in patients with severe psoriasis compared with those with mild or moderate psoriasis(( 114.24 ±13.93) ng/L vs.(71.78 ± 14.35) ng/L,0.0279 ± 0.0027 vs.0.0125 ± 0.0030,both P＜ 0.01 ).The psoriasis area and severity index(PASI) score was negatively correlated with T-AOC level,SOD and CAT activities(r =-0.384,-0.573 and -0.444,all P ＜ 0.01 ),positively correlated with serum and lesional 8-iso-PGF2α levels (r =0.710,0.783,both P ＜ 0.01 ),and uncorrelated with GSH-Px activity.None of the parameters was correlated with the course of disease.ConclusionThe serum and lesional levels of 8-iso-PGF2α may be a more sensitive marker for oxidative damage and disease severity.
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Objective To evaluate the efficacy and safety of Qingpeng ointment in the treatment of eczema.Methods A multi-center,randomized,double-blind and placebo-controlled clinical trial was conducted.A total of 246 patients with eczema were randomly assigned with a ratio of 2∶1 to the treatment group and control group to topically apply Qingpeng ointment and placebo respectively twice daily for 3 weeks.Total symptom scores were calculated for the patients at the baseline,on week 1,2 and 3 during the treatment according to the individual scores for pruritus,lesions including erythema,papules,papulovesicles or vesicles,desquamation,crusting,infiltration and lichenification.The occurrence of adverse events was recorded.Results Totally,228 patients completed the trial,including 154 patients in the treatment group and 74 patients in the control group.After 3 weeks of treatment,a statistical difference was observed in the response rate (85.71％ vs.41.89％,Z=47.16,P＜ 0.01) and cure rate (31.82％ vs.12.16％,Z=12.30,P＜ 0.01) between the treatment and control group.There was no significant difference in the incidence of adverse events between the two groups (2.48％ vs.2.56％,x2 =0,P ＞ 0.05).Conclusion Qingpeng ointment displays a promising efficacy for the treatment of mild to moderate eczema with a rapid onset and high safety.
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Objective To investigate the significance of immunostainning for Ber EP4and EMA in the diagnosis of basal cell carcinoma and squamous cell carcinoma of the skin.Methods Immunohisto-chemical stainning for Ber EP4and EMA was performed on115cases of basal cell carcinoma,squamous cell carcinoma,Bowen' s disease,actinic keratosis,basosquamous cell carcinoma,seborrheic keratosis,and verruca vulgaris.Specimens were taken from neoplastic tissues as well as the surrounding skin and ap-pendages.Results Ber EP4was positively stained in all cases of basal cell carcinoma and basosquamous cell carcinoma,but negatively stained in squamous cell carcinoma,Bowen's disease,actinic keratosis,sebor-rheic keratosis and verruca vulgaris.Expression of EMA was found in most cases of squamous cell carcinoma and Bowen' s disease,and a few cases of actinic keratosis,and in none of basal cell carcinoma,basosqua-mous cell carcinoma,seborrheic keratosis and verruca vulgaris.Conclusions Routine immunohistochemical staining with both Ber EP4and EMA is helpful for distinction of skin basal cell carcinoma,squamous cell carcinoma,precancerosis and benign hyperplastic dermatoses.
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Objective To observe the clinical efficacy and safety of5%imiquimod cream in the top-ical treatment of condyloma acuminatum(CA).Methods A randomized,double-blind,parallel placebo-controlled clinical study was conducted.The test drug was topically used in CA patients,three times a week for8weeks.Patients whose warts cleared completely were followed up for one month to determine recurrence rates.Results Two hundred fifty-eight patients with anogenital warts were enrolled into this trial.One hun-dred twenty-nine patients were randomly selected to receive5%imiquimod cream;129patients were ran-domly chosen to receive placebo cream.Results showed that the cure rates were12.30%,32.79%,50%,60.66%respectively in study group for2,4,6,8weeks and were4.88%,14.63%,19.51%,26.02%respec-tively in control group for2,4,6,8weeks(P
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Objective To study the relationship between bcl-2 , Fas and Fas ligand (FasL) and the role of them in the pathogenesis of systemic lupus erythematosus (SLE). Method Flow cytometry was used. Results Apoptosis of peripheral lymphocytes was significantly increased in SLE patients than that of normal controls(P
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Objective To observe the clinical efficacy and safety of 5% imiquimod cream in topical treatment of anogenital warts. Methods A randomized, double-blind, parallel placebo-controlled clinical study was conducted. Patients with anogenital warts were instructed to apply the test drug topically and then clean the drug with water 6 ~ 8 hours later, three times a week for 8 weeks. Patients whose warts cleared completely were followed up for one month to determine recurrence rates. Results Two hundred and thirty-one patients with anogenital warts were enrolled in this trial. One hundred and sixteen patients were randomly selected to receive 5% imiquimod cream; and the other receive placebo cream. For 2, 4, 6, 8 weeks, the cure rates were 8.41%, 30.84%, 49.53%, 61.68%, respectively in the study group, and 2.68%, 7.14%, 16.07%, 24.11%, respectively in the control group (P
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Objective To investigate the mechanism of mizolastine inhibiting allergic contact dermatitis (ACD) in murine model. Methods The murine model of allergic contact dermatitis by topical DNFB was used. Using this model murine inhibition of ear swelling was observed after oral administration of mizolastine in different doses. The levels of IFN-?, TNF-? and IL-4 in the sera of these mice were detected by enzyme-linked immunosorbent assay (ELISA). Results Murine ear swellings were markedly suppressed in each dose group of mizolastine (P 0.05). Different doses of mizolastine inhibited the expression of these three cytokines to different degrees. Conclusion The therapeutic effect of mizolastine on murine ACD may be played by inhibiting the expression of some cytokines.
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Objective To investigate the relationship between CD3+T, CD4+T, CD8+T cells, Th1/Th2 cytokines IL-2, IL-4, IL-6, sIL-2R and the pathogenesis as well as disease activity in patients with cutaneous nodular vasculitis (NV). Methods Cytokines IL-2, IL-6, sIL-2R and cell surface markers CD3+, CD4+ and CD8+ were detected by flow cytometry and ELISA with peripheral blood mononuclear cells from patients and controls. Expressions of IL-2, IL-4 and CD3+, CD4+, CD8+ were determined by immunohistochemistry in patients′ lesions in situ. Results Serum levels of IL-2, IL-6 and sIL-2R were significantly increased in patients with active NV compared with those in inactive stage(P
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0.05).No serious adverse events were reported in these two groups.The incidences of adverse event of mizolastine and loratadine were28.6%and25.5%respectively,there were no statistically significant difference between two groups(? 2 =0.25,P=0.62).Conclusions The efficacy of mizolastine and loratadine is similar in the treatment of CIU,but mizolastine is quicker in action than loratadine.The incidences of adverse events are not different in the two groups.