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Objective To compare the effects of mizolastine intensive dose and mizolastine conventional dose+momestasone furoate on symptom score and laboratory index of patients with allergic rhinitis caused by pollen allergy.Methods From June 2016 to January 2018,one hundred and fifty allergic rhinitis patients caused by pollen allergy were chosen in the First People＇s Hospital of Taizhou and randomly divided into two groups according to the digital table,with 75 patients in each group.A group was treated with mizolastine intensive dose scheme,and B group was treated with mizolastine conventional dose +momestasone furoate. The short -term efficacy,rhinitis symptoms score,the levels of histamine,leukotrienes C4,IL-6,IL-8 and TNF-α before and after treatment,the incidence of adverse reactions and daily treatment cost of the two groups were compared.Results The short-term efficacy of B group was significantly better than that of A group(93.33% vs.81.33% ,χ2 =9.15,P<0.05).The rhinitis symptoms scores of B group[(0.49 ± 0.19)points,(1.02 ± 0.20) points,(0.95 ± 0.28) points,(0.84 ± 0.20)points] after treatment were significantly lower than those of A group [(0.87 ± 0.21) points,(1.40 ± 0.24) points,(1.63 ± 0.36)points,(1.19 ± 0.27) points] and before treatment[(3.13 ± 1.06) points,(2.88 ± 0.57) points,(2.81 ± 0.79)points,(2.85 ± 0.61)points](t=2.45,2.71,2.66,2.89,3.78,3.75,3.44,4.53,all P<0.05).The levels of histamine,leukotrienes C4,IL-6,IL-8 and TNF-α of B group[(15.76 ± 3.54) mg/L,(12.17 ± 3.58) mg/L, (1.23 ± 0.19)mg/L,(3.27 ± 0.62)mg/L,(3.96 ± 1.05)mg/L] after treatment were significantly lower than those of A group [(19.58 ± 5.25) mg/L,(15.44 ± 4.14) mg/L,(1.96 ± 0.33)mg/L,(5.40 ± 0.88) mg/L,(5.01 ± 1.40)mg/L] and before treatment[(24.57 ± 7.67) mg/L,(18.90 ± 6.33) mg/L,(2.58 ± 0.54) mg/L,(7.66 ± 1.17)mg/L,(6.81 ± 1.67)mg/L](t=2.31,2.50,2.53,2.39,3.05,3.60,3.10,3.57,3.90,all P<0.05).There was no statistically significant difference in the incidence rate of adverse reactions between the two groups ( P >0.05).The daily treatment cost of B group after treatment was significantly less than that of A group and before treatment[(7.56 ± 1.02)CNY vs.(6.88 ± 0.80)CNY,t=3.12,P<0.05].Conclusion Compared with mizolas-tine intensive dose scheme,mizolastine conventional dose + momestasone furoate in the treatment of patients with allergic rhinitis caused by pollen allergy can efficiently relieve the nasal symptoms, down - regulate the levels of histamine,leukotriene C4 and inflammatory cytokines,reduce the treatment cost and has the approved safety.
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OBJECTIVE:To observe the efficacy and safety of tripterygium glycosides combined with mizolastine in the treatment of dermatitis and eczema. METHODS:138 patients with dermatitis and eczema were randomly divided into control group (69 cases) and observation group (69 cases). Control group received Mizolastine sustained release tablet 10 mg,orally,once a day. Observation group additionally received Tripterygium glycosides tablet 20-30 mg,orally taking after a meal,3 times a day. All patients treated for 3 weeks,patients’life way remained unchanged during treatment. Clinical efficacy,total score of symptoms, IL-2,IL-6,CRP levels and the incidence of adverse reactions in 2 groups were observed. RESULTS:The total effective rate in observation group was significantly higher than control group,with significant difference (P<0.01). After treatment,the total score of symptoms,IL-2,IL-6,CRP levels in 2 groups were significantly lower than before,and observation group was lower than control group,with significant differences(P<0.05 or P<0.01). The incidence of adverse reactions in observation group was significantly lower than control group,with significant difference (P<0.05). CONCLUSIONS:Tripterygium glycosides combined with mizolastine shows better efficacy than mizolastine alone in the treatment of dermatitis and eczema,with better safety.
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OBJECTIVE:To systematically review the efficacy and safety of mizolastine combined with H2 recepter antagonists in the treatment of chronic urticaria,and provide evidence-based reference for the clinical treatment. METHODS:Retrieved from PubMed,Cochrane Library,EMBase,CBM,CJFD,etc.,randomized controlled trials (RCT) or QRCT about mizolastine com-bined with H2 recepter antagonists(test group)versus mizolastine alone(control group)in the treatment of chronic urticaria. After quality evaluation and data extract,Meta-analysis was conducted by using Stata 12.0 statistics software. RESULTS:A total of 12 RCT were included,involving 1 188 patients. Results of Meta-analysis showed the effective rate [RR=1.23,95%CI(1.16,1.31), P0.05]. CONCLUSIONS:The effective rate of mizo-lastine combined with H2 recepter antagonists is significantly higher than mizolastine in the treatment of chronic urticaria,with bet-ter safety. Due to the limit of methodological quality and sample size,it remains to be further verified with more rigorously de-signed and long-term follow-up of large-scale RCT.
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Objective To estimate the effect of bacille calmette-guerin polysaccharide nucleic acid(BCG-PSN)on skin prick test(SPT)reactions,and to assess the clinical efficacy and therapeutic mechanism of BCG-PSN combined with mizolastine,in patients with chronic idiopathic urticaria.Methods A non-randomized,openlabel clinical trial was carried out.Totally,168 patients with chronic idiopathic urticaria were divided into 2 groups to be treated with mizolastine 10 mg once a day combined with BCG-PSN injection at a dose of 2 ml every other day(experiment group,n =85)or mizolastine 10 mg once a day only(control group,n =83).All the patients underwent SPT,and were evaluated by symptom score at the baseline and after 12 weeks of treatment.Statistical analysis was performed by using the SPSS 10.0 software,t test and Chi-square test were used to analyze the intra-and inter-group differences in symptom score reducing index(SSRI)and SPT results.Results After 12-week treatment,SSRI was significandy higher in the experiment group than in the control group(0.92 ± 0.33 vs.0.74 ± 0.35,t =2.39,P ＜ 0.05).In the experiment group,50 patients were cured,28 patients received a marked response,with a total response rate of 92.0％;meanwhile,32 patients were cured and 30 patients received a marked response in the control group with a total response rate of 74.6％;there was a significant difference in the total response rate between the experiment group and control group(x2 =5.62,P ＜ 0.05).The percentage of positive SPT to Dermatophagoides pteronyssinus and Dermatophagoides farinae was 24.7％ and 17.6％ respectively at the baseline,9.4％ and 5.9％ respectively after treatment,in the experiment group,24.1％ and 16.9％ respectively at the baseline,24.1％ and 15.7％ respectively after treatment,in the control group.Significant differences were observed in the percentage of positive SPT between the control group and experiment group after treatment(x2 =5.82,P ＜0.05),but not at the baseline.A statistical decrease in the percentage of positive SPT was induced by the combined therapy with BCG-PSN and mizolastine(x2 =4.56,P＜ 0.05),but not by mizolastine alone.Conclusions BCG-PSN combined with mizolastine appears superior to mizolastine alone in the treatment of chronic idiopathic urticaria,with a decrease in the percentage of positive SPT reactions and in the sensitivity to allergens.
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Purpose The aim of this study was to compare the pharmacokinetic(PK) profile and relative bioavailability of two sustained release tablets containing 10 mg mizolastine in healthy, young Chinese volunteers. Methods A single oral dose of mizolastine was given under fasting conditions to volunteers aged from 21 to 24 years in this open-label, randomized, crossover study. A ten-day washout period was applied between each of the two formulations. Plasma samples were obtained before dosing and at predetermined time points after dosing up to 48 hours and were analyzed for plasma concentration with a high-performance-liquid chromatography-UV method. PK parameters representing the extent and the rate of absorption of mizolastine were obtained. An analysis of variance, 90% confidence intervals, and two one-sided tests were employed for statistical analysis of relative difference between the two formulations. Results According to the pharmacokinetic and statistical analysis, parameters were not statistically different between the two formulations except the peak concentration (cmax). The point estimates of the ratios of AUC0→t, AUC0→∞ of mizolastine were (101.26 + 9.82) % and (102.52 + 8.61)% with 90% confidence intervals (CIs) of 95. 5% - 106. 5% and 97. 7% -106.9% respectively, comprised in the stipulated 80% - 125% range; for cmax values, the ratios was 82.17% - 15.32% with the 90% CIs of 71. 7% - 91.1%, fell in the recommended range of 70% -143%. Conclusions The results indicate that there is no statistically significant difference in PK parameters except cmax between the two sustained release tablets of mizolastine. The 90% CIs of AUC0→t,AUC0→∞ and cmax are within the predefined range. Thus, the two sustained release tablets of mizolastine are considered bioequivalent and generally well tolerated.
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OBJECTIVE:To prepare mizolastine sustained-release tablet and evaluate its quality.METHODS:The tablet was prepared with hydroxy propyl methylcellulose as controlled release agent,bitartaricum kalium as antacid and mizolastine as principal agent.The contents of mizolastine and the relative substances,the drug release rate in different medium(water,hydrochloric acid,and buffer phosphate),and the stability of the preparation were investigated(within 10 days).RESULTS:The preparation was well-formed in shape.the labeled content of the principal agent was 99.56%～102.39%;the content of the relative substances was less than 0.2%;its in vitro release rates in 3 different medium,were all above 80% after 2 h,and its stability was up to the standard.CONCLUSION:The prepared mizolastine sustained-release tablet is reasonable in formulation,feasible in preparation process and its quality is up to the standard.
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Objective:To investigate the clinical efficacy of mizolastine in the treatment of dermatographism. Method:32 patients were randomly allocated to two groups.Their efficacy was compared with ketotifen.A two-period cross trial was adopted.Result:The clinical efficacy of mizolastine in the treatment of dermatographism corresponded to ke- totifen,the ADRs were markedly lower than ketotifen.Conclusion:Mizolastine is effective in the treatment of dermatogra- phism.
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OBJECTIVE:To evaluate the therapeutic effect of compound glycyrrhizin plus mizolastine for patients with generalized neurodermatitis(GND)and its influence on patietents' psychology.METHODS:60 patients with GND were randomly assigned to receive compound glycyrrhizin plus mizolastine(treatment group)or mizolasitine alone(control group)for 28 days.The psychological factors were examined before and after treatment using self-rating anxiety scale(SAS),and the curative effects and the psychological changes between two groups were compared.RESULTS:The SAS scores of treatment group and control group were 30.53? 1.50 and 33.20? 1.67,respectively(P
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Objective To investigate the anti-inflammatory properties of mizolastine and explore its possible mechanisms. Methods Edema at hind-paw of rat was induced by a single injection of arachidonic acid(AA), each containing 0.1 mL of prepared AA(0.3%). The intensity of AA-induced reactions was ex-pressed as an increasing of rat paw thickness, which was measured by micrometer. After the drugs (mizolastine, loratadine, cetirizine) were given orally separately, the inhibitory effects were determined by the de-creasing of edema intensity. Zileuton and mizolastine were given orally separately and the inhibitory effects were compared subsequently. Results The intensity of AA-induced edema was significantly inhibited by mizolastine, but not by loratadine or cetirizine There was no significant difference between mizolastine and zileuton in the inhibition of AA-induced edema. Conclusion Mizolastine possesses anti-inflammatory properties in vivo, which may be related to the inhibition of the 5-lipogenase pathway.
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Objective To investigate the inhibition effects of different antihistamines on the expressions of chemokines and cytokines released by nasal polyps in vitro.Methods The fresh nasal polyps resected under endoscope from the patients admitted to our hospital were cultured with mizolastine,cetirizine,loratadine,fexofenadine,dexamethasone,or ciclosporin A respectively for 24 h,with the addition of histamine and arachidonic acid.The total RNA of polyps was obtained and purified with tripure isolation reagent.The mRNA expression levels of monocyte chemoattractant protein-1(MCP-1),monocyte chemoattractant protein-3(MCP-3),regulated on activation,normal T cell expressed and secreted(RANTES),eotaxin were analyzed by RT-PCR.The concentrations of interleukin(IL)-4,IL-5 and tumor necrosis factor-?(TNF-?)in cultured supernatant was detected by ELISA.Results The MCP-1 mRNA expression in nasal polyps treated by mizolastine was weaker than those by loratadine and fexofenadine;the MCP-3 mRNA expression by mizolastine was weaker than those by cetirizine and loratadine;the RANTES mRNA expression by mizolastine was weaker than those by loratadine and fexofenadine;the eotaxin mRNA expression by mizolastine was weaker than that by cetirizine(all P
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AIM: To evaluate the effect of mizolastine in patients with ch ronic urticaria and to explore the role of IL-4 in the process of chronic urtic aria. METHODS: 32 cases of chronic urticaria were treated with m izolastine, and the therapeutic effects and the side-effect were evaluated. The serum IL-4 levels were tested by ELISA. RESULTS: The total ef fective rates were 62.5 % and 84.4 % (P 0.05 ), and before treatment were significantly higher than tho se after treatment (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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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.
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OBJECTIVE: To evaluate the therapeutic efficacy and pharmacoeconomic results of 3 varieties antihistamines in the treatment of chronic idiopathic urticaria. METHODS: 96 patients with idiopathic urticaria were randomly divided into Group A, B and C, treated with mizolastine ,cetirizine and loratatine for 28 days, respectively. The therapeutic effects and recurrence within 7 days after drug withdrawl were observed, and the results were analyzed using cost-minimization analysis. RESULTS: The effective rates in Group A, B, and C were 96.7%, 94.1% and 93.8%, respectively. The recurrent rates within 7 days after discontinuation of the treatment were 40.0%, 35.3% and28.1%, respectively . The cost of drugs were 116.76 yuan, 45.64 yuan and 128.8 yuan, respectively. CONCLUSION: Cetirizine is the preferable treatment prescription for idiopathic urticaria
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OBIECTIVE:To establish a method for the determination of mizolastine in tablet.METHODS:HPLC was carried out,using a HiQ sil C 18 column and a mobile phase consisting of0.025mol/L KH 2 PO 4 buffer solution-acetonitrile(72∶28).The flow rate was0.5ml/min.RESULTS:The standard curve was linear over the range of4.16～416?g/ml of mizolastine(r=0.9998).The recovery of mizolastine was99.98%(RSD=0.44%,n=3).CONCLUSION:The proposed method is sim?ple,accurate and can be used for the content determination of Mizolastine tablet.