Research about clinical comprehensive evaluation methods of pediatric drugs ：taking pediatric anti-allergic drugs as an example / 中国药房

OBJEC TIVE To provide reference for clinical comprehensive evaluation of pediatric drugs in China. METHODS Taking pediatric anti-allergic drugs as an example ，the clinical comprehensive evaluation methods of pediatric drugs in medical institutions were explored from the aspects of theme selection ，evaluation content and dimension ，evaluation index ，evaluation method and evaluation result report. RESULTS & CONCLUSIONS During the clinical comprehensive evaluation of pediatric drugs，under the guidance of relevant national guidelines for clinical comprehensive evaluation ，the evaluation topics could be selected according to the three principles of importance ，relevance and evaluability ，and then an appropriate evaluation index system could be developed around the six dimensions of safety ， effectiveness， economy， suitability，accessibility and innovativeness；qualitative and quantitative data integration analysis of the drugs to be evaluated were performed. In the evaluation ， it is necessary to focus on children ’s clinical basic drug use practice and decision-making needs ，normatively，scientifically and reasonably define the core index set and standard data set required by different dimensions of evidence ，standardize the collection and use of real-world data ，and effectively combine other types of evidence to truly play its advantageous role in the clinical comprehensive evaluation of pediatric drugs in China.

Effect of antihistamine-containing syrup on salivary metabolites: an in vitro and in vivo study

Abstract This study tested the null hypothesis that antihistamine-containing syrup does not change salivary metabolites in vitro and in vivo. For the in vitro experiments, saliva from 10 volunteers was mixed with a syrup or pill suspension of loratadine (1 mg/ml Claritin®, Schering-Plough, Rio de Janeiro, Brazil). For the in vivo experiment, 10 volunteers performed a mouth rinse with 10 mL of antihistamine syrup (Claritin®; Schering-Plough, Rio de Janeiro, Brazil) for 20 seconds and then discarded the rinse water. After 20 seconds, 5 mL of unstimulated whole saliva was spit into a plastic tube kept on ice. The protein profile of in vitro and in vivo experiments was analyzed using 12% sodium dodecyl sulfate-polyacrylamide gel electrophoresis. The samples were also analyzed by nuclear magnetic resonance (NMR) spectroscopy, followed by Principal Component Analysis and Wilcoxon test (p < 0.05). There were differences in salivary metabolites after syrup interaction. The salivary concentrations of acetate, n-caproate, arginine, glutamate, and lysine among other metabolites were reduced with the syrup in both in vivo and in vitro experiments (p < 0.05), but no differences were observed when the pill suspension was used (p > 0.05). Similar changes in metabolite profiles were observed in both in vitro and in vivo experiments. Electrophoresis revealed no difference in the salivary protein pattern. The null hypothesis was rejected because the intake of syrup medicine changes the salivary composition and influences oral homeostasis and susceptibility to oral diseases.

Effect Of Acetone Soluble And Acetone Insoluble Fractions Of Allium Cepa On Some Animal Models Of Asthma

Current Asthma therapy lack satisfactory effect due to various adverse effects, hence patients are moving to Ayurveda. Researchers conducted studies in last decades on plants mentioned in Ayurveda used for asthama has shown Anti-asthamic, Anti-histaminic and Anti-allergic activity. Present study is conducted to study the anti-asthmatic activity of acetone soluble and insoluble extract of Allium cepa. In this process dried peels of Allium cepa were immersed in 95% ethanol for 48hr and the extract obtained was further fractionated with anhydrous acetone to get acetone soluble (ASF) and acetone insoluble (AIF) fractions. Effect of the fractions was studied on isolated goat tracheal chain suspended in Kreb’s solution and percentage contractile response was measured. Albino Swiss mice (22-25g) of either sex were subjected to milk- induced leucocytosis and eosinophilia to study adaptogenic and anti-allergic activity respectively. Effects of both the extracts were also studied on clonidine-induced catalepsy and clonidine induced mast cell degranulation in mice as a measure of central and peripheral mast cell stabilization respectively. Wistar rats (150-180g) were used to study effect of fractions on passive paw anaphylaxis to study immunomodulatory and anti-inflammatory activity.

Therapeutic Effect of Glucosamine on an Atopic Dermatitis Animal Model

BACKGROUND: Recent studies have reported that glucosamine (GlcN) showed therapeutic effects in allergic diseases such as asthma and rhinitis, and its mechanisms include the suppression of T helper type 2 immune responses and the nuclear factor-κB pathway. OBJECTIVE: We aimed to investigate the effect of GlcN on atopic dermatitis (AD) in an animal model. METHODS: Twenty-five BALB/c mice were divided into five groups (groups A~E). Group A was the phosphate-buffered saline (PBS)-treated group without AD induction. Group B was the PBS control group with AD induction. Groups C to E were the AD induction groups, which were treated with three different doses of GlcN (10 mg, 20 mg, and 40 mg, respectively). Histopathological examination was performed after GlcN administration. Interleukin (IL)-4, IL-13, and IL-17 cytokine levels were measured by enzyme-linked immunosorbent assay using skin biopsy specimens. Serum total immunoglobulin E (IgE) concentrations were measured before and after administration with GlcN or PBS. RESULTS: Clinical dermatitis scores decreased with increasing GlcN dose (p<0.001). Concentrations of tissue IL-13 and IL-17 decreased after GlcN administration (each group: p=0.002 and p<0.001, respectively), but the concentrations of tissue IL-4 did not show differences across groups. Serum IgE levels tended to be lower after GlcN administration (p=0.004). Histopathological scores were not significantly different among groups B~E (p=0.394). CONCLUSION: GlcN improved AD symptoms and decreased tissue IL-13, IL-17, and serum total IgE levels in an animal model.

Suppressive Effect of 4-Hydroxy-2-(4-Hydroxyphenethyl) Isoindoline-1,3-Dione on Ovalbumin-Induced Allergic Asthma

4-Hydroxy-2-(4-hydroxyphenethyl)isoindoline-1,3-dione (PD1) is a synthetic phthalimide derivative of a marine compound. PD1 has peroxisome proliferator-activated receptor (PPAR) γ agonistic and anti-inflammatory effects. This study aimed to investigate the effect of PD1 on allergic asthma using rat basophilic leukemia (RBL)-2H3 mast cells and an ovalbumin (OVA)-induced asthma mouse model. In vitro, PD1 suppressed β-hexosaminidase activity in RBL-2H3 cells. In the OVA-induced allergic asthma mouse model, increased inflammatory cells and elevated Th2 and Th1 cytokine levels were observed in bronchoalveolar lavage fluid (BALF) and lung tissue. PD1 administration decreased the numbers of inflammatory cells, especially eosinophils, and reduced the mRNA and protein levels of the Th2 cytokines including interleukin (IL)-4 and IL-13, in BALF and lung tissue. The severity of inflammation and mucin secretion in the lungs of PD1-treated mice was also less. These findings indicate that PD1 could be a potential compound for anti-allergic therapy.

Tacrolimus eye drops as monotherapy for vernal keratoconjunctivitis: a randomized controlled trial / Colírio de Tacrolimus 0, 03% como único agente antialérgico para o tratamento de ceratoconjuntivite primaveril: ensaio clínico randomizado

ABSTRACT Purpose: To assess the efficacy of monotherapy using tacrolimus eye drops versus sodium cromoglycate for the treatment of vernal keratoconjunctivitis (VKC). Methods: Randomized double-masked controlled trial comparing the efficacy of tacrolimus 0.03% eye drops t.i.d. (Group 1) with sodium cromoglycate 4% eye drops t.i.d. (Group 2) for the symptomatic control of VKC at days 0, 15, 30, 45, and 90 of follow-up. Visual acuity, intraocular pressure, and other complications were evaluated to assess safety and side effects. Results: In total, 16 patients were included, with 8 enrolled in each group. Two patients from Group 2 were excluded from the analysis at days 45 and 90 because of corticosteroid use. Most patients were male (81.8%) and presented with limbal VKC (56.3%). There were statistically significant differences in favor of tacrolimus in the following severity scores: itching at day 90 (p=0.001); foreign body sensation at day 15 (p=0.042); photophobia at day 30 (p=0.041); keratitis at day 30 (p=0.048); and limbal activity at days 15 (p=0.011), 30 (p=0.007), and 45 (p=0.015). No relevant adverse effects were reported, except for a burning sensation with tacrolimus, though this did not compromise treatment compliance. Conclusion: Treatment with tacrolimus was superior to sodium cromoglycate when comparing severity scores for symptoms of itching, foreign body sensation, and photophobia, as well as for signs of limbal inflammatory activity and keratitis.

RESUMO Objetivo: Demonstrar a eficácia do colírio de tacrolimus 0,03% como único agente antialérgico versus o colírio de cromoglicato de sódio 4% no tratamento de ceratoconjuntivite primaveril (CCP). Métodos: Ensaio clínico randomizado duplo-mascarado comparando a eficácia do colírio de tacrolimus 0,03% 3 vezes ao dia, versus o colírio de cromoglicato 4% 3 vezes ao dia, no controle dos sintomas e sinais de pacientes com o diagnóstico de ceratoconjuntivite primaveril, durante o período de 3 meses, com avaliações nos dias 0, 15, 30, 45 e 90. Acuidade visual, pressão intraocular e outras possíveis complicações foram avaliadas para determinar segurança e efeitos adversos. Resultados: Dezesseis pacientes foram incluídos no estudo, sendo que oito fizeram uso de colírio de tacrolimus 0,03% (Grupo 1) e oito fizeram uso de colírio de cromoglicato de sódio 4% (Grupo 2). Dois pacientes do Grupo 2 foram excluídos da análise dos dias 45 e 90, devido à necessidade de utilização de corticosteroide tópico. A maioria dos pacientes era do sexo masculino (81,8%) e 56,3% apresentavam a doença em sua forma limbar. Houve diferença estatisticamente significativa entre os Grupos 1 e 2 em relação à graduação de severidade para os sintomas de prurido no dia 90 (p=0,001), sensação de corpo estranho no dia 15 (p=0,042), fotofobia no dia 30 (p=0,041) e para os sinais de atividade inflamatória limbar nos dias 15 (p=0,011), 30 (p=0,007) e 45 (p=0,015), e ceratite no dia 30 (p=0,048). Nenhum efeito adverso relevante foi notado, exceto queixa de queimação ocular quando da instilação de tacrolimus, o que não comprometeu à adesão ao tratamento. Conclusão: O colírio de tacrolimus 0,03% foi superior ao colírio de cromoglicato de sódio 4% comparando a graduação de severidade para os sintomas de prurido, sensação de corpo estranho e fotofobia, assim como para os sinais de atividade inflamatória limbar e ceratite, em determinados períodos de tempo durante o seguimento.

Inhibition of Allergic Response by Intranasal Selective NF-κB Decoy Oligodeoxynucleotides in a Murine Model of Allergic Rhinitis

PURPOSE: It remains unknown whether local inhibition of Nuclear factor-kappa B (NF-κB) could have therapeutic value in the treatment of allergic rhinitis (AR). This study aimed to evaluate the effect of selective NF-κB inhibition using NF-κB decoy oligodeoxynucleotides (ODNs) for the local treatment of AR in ovalbumin (OVA)-sensitized wild-type mice. METHODS: BALB/c mice were sensitized with OVA and alum, and then challenged intranasally with OVA. NF-κB decoy ODNs were given intranasally to the treatment group, and NF-κB scrambled ODNs were given to the sham treatment group. Allergic symptom scores, eosinophil infiltration, cytokine levels in the nasal mucosa, nasal lavage fluid, and spleen cell culture, serum total and OVA-specific immunoglobulins, as well as intercellular adhesion molecure-1 (ICAM-1) in the nasal mucosa, were analyzed. RESULTS: NF-κB decoy ODNs significantly reduced allergic symptoms and eosinophil infiltration in the nasal mucosa. They also suppressed serum levels of total IgE, OVA-specific IgE, and IgG1. IL-5 and TNF-α levels and the expression of ICAM-1 were decreased in the nasal mucosa of the treatment group compared to the positive control and sham treatment groups. In addition, IL-6 levels were significantly decreased in the nasal lavage fluid of the treatment group. Furthermore, NF-κB decoy ODNs significantly reduced expression of the systemic Th2 cytokines, IL-4 and IL-5 in spleen cell culture. CONCLUSIONS: This study demonstrates for the first time that local NF-κB inhibition using NF-κB decoy ODNs suppressed the allergic response in a murine AR model. This shows the therapeutic potential of local NF-κB inhibition in the control of AR.

Review of the medicinal value aboutRhamnusL. extract / 国际中医中药杂志

RhamnusL., a kind of traditional Chinese medicine, is mainly used to treat some diseases as a supplementary component in the formula. This paper, reviewed its potential medicinal value in the antibacterial activity, antioxidantactivity, anti-allergic activity and anti-tumor activity.

Anti-inflammatory Effects of Saxifrage Cream in Hapten-induced Chronic Dermatitis-eczema in Mice / 中草药·英文版

Objective Chronic dermatitis-eczema is a kind of inflammatory skin disease characterized by pruritic and eczematous skin lesions. In the present study, we investigated the anti-allergic effect of Saxifrage cream on eczema-like skin lesions induced by 2,4-dinitrochlorobenzene (DNCB) in mice. Methods KM mice were randomly divided into eight groups: normal group (Norm), model group (DNCB), positive group 1 (Dexamethasone cream, DEX), positive group 2 (Chinese herbal medicine Paeonol cream, PA), Saxifrage cream groups (equivalent to crude herb 1.25, 2.50, 5.00 g/g, S1, S2, S4), and negative group (Norm + S4). Except for the normal control group and negative control group, right ears of mice in other groups were repeatedly induced with 0.5% DNCB for four times for 3 d and previously sensitized with 7% DNCB to induce eczema. Then mice in different groups were treated by DEX, PA, S1, S2, and S4, respectively. After mice were sacrificed, weight difference of two ears, immune organ change, and pathological change of right ear were used to assess the effects of the drugs. Results Compared with model group, DEX, PA, S2, and S4 could significantly lower mice ear thickness and swelling degree, and improve eczema skin symptoms. Meanwhile, the index of thymus and spleen in treatment groups were significantly reduced (P < 0.05). What's more, the histological analysis demonstrated that thickening of the skin lesions were significantly reduced in DEX, S2, and S4-treated group, and the levels of IL-4 and IL-6 in serum could be reduced by DEX, S2, and S4. Conclusion Saxifrage cream has a protective function against DNCB-induced eczematous. The mechanism might be related to alleviate eczematous inflammatory reaction.

Advances in biotransformation of protopanaxatriol rare ginsenoside / 中草药

Ginseng is a traditional medicine in Asian countries. Ginsenoside has the main active ingredient, exhibit cardiovascular, tumor, and central nervous system activities. In particular, protopanaxatriol-type ginsenosides Rh1, exhibits anti-inflammatory, anti-allergic, and memory improvement activities. Ginsenoside Rh1 is only found in trace amounts in Panax ginseng, Panax pseudoginseng var. notoginseng, and Panax quinquefolius. Biotransformation of rare ginsenosides has become an effective way. In this paper, the research progress of transformation of ginsenoside saponins by biotransformation to produce rare ginsenoside Rh1 is reviewed, which provides a useful reference for the further development and preparation of ginsenoside Rh1.

Anti-inflammatory and Anti-allergic Effects of Qifangbimin Particle / 中国药师

Objective: To research the anti-inflammatory and anti-allergic effects of Qifangbimin particle.Methods: The anti-inflammatory effects were observed by the methods of xylene-induced ear-swelling in mice and cotton-ball induced granuloma in rats.The anti-allergic effects were evaluated by the method of passive skin allergy model in rats and ear-heterogeneous passive skin allergy model in mice.Results: In the treatment groups with Qifangbimin particle, the swelling degree of ear edema induced by dimethylbenzene in mice was significantly suppressed when compared with that in the control groups (P<0.01 or 0.05) , however, the particle had no significantly inhibitory effect on granulation tissue hyperplasia induced by cotton-ball in rats.The Qifangbimin particle groups obviously decreased the absorbance value of locus coeruleus on rats' back (P<0.01 or 0.05), and Qifangbimin particle at high dose significantly reduced the absorbance value of locus coeruleus of auricle in mice (P<0.01 or 0.05).Conclusion: Qifangbimin particle has significant anti-inflammatory and anti-allergic effects.

Preoperative tranilast as adjunctive therapy to primary pterygium surgery with a 1-year follow-up / Terapia auxiliar com o tranilast pré-operatório na cirurgia do pterígio primário com um ano de seguimento

Purpose: To determine the efficacy of tranilast as an adjunctive therapy in conjunctival autograft. Methods: Twenty-nine patients were randomly allocated to the Tranilast Group (n=15) or the Control Group (n=14). The Tranilast Group received a subconjunctival injection of 0.5% tranilast 30 days prior to surgery. Conjunctival autograft was performed in both groups using fibrin sealant and 0.02% subconjunctival mitomycin C at the end of the surgery. After the resection of the pterygium, immunohistochemistry was performed with 100 cells to identify epithelial cells positive for transforming growth factor-β (TGF-β). Subjective symptoms were evaluated using a 5-point scale, and the recurrence rate was assessed. Results: Both groups showed improvements in their symptoms and similar clinical results. Compared with the Control Group, the Tranilast Group failed to show a decreased recurrence rate (p=0.59). However, the number of epithelial cells expressing TGF-β was lower in the Tranilast Group (5 cells; 95% CI: 2.56-13.15; Control Group, 16 cells, 95% CI: 11.53-24.76; p=0.01). Minimal but reversible complications, including glaucoma secondary to corticosteroids and granuloma, occurred during the study. Conclusion: Tranilast was effective in decreasing the number of pterygium epithelial cells expressing TGF-β. .

Objetivo: Determinar a eficácia do tranilast, como terapia auxiliar no transplante autólogo de conjuntiva. Métodos: Vinte e nove pacientes foram randomizados em dois grupos: Grupo Tratado (15) e Grupo Controle (14). Trinta dias antes da cirurgia, o Grupo Tratado recebeu uma injeção subconjuntival de tranilast a 0,5%. O transplante autólogo de conjuntiva foi realizado em ambos os grupos, usando-se a cola de fibrina e a mitomicina 0,02% subconjuntival, ao final da cirurgia. Cada paciente foi examinado por 12 meses de acompanhamento. A imuno-histoquímica foi realizada, mediante um total de 100 células, a fim de que se contassem as células epiteliais positivas, para o fator de crescimento transformador beta (TGF-β), após a cirurgia do pterígio. Os sintomas subjetivos foram avaliados usando-se uma escala de cinco pontos, e a taxa de recorrência foi avaliada. Resultados: Os 2 grupos apresentaram melhora dos sintomas e com resultados clínicos similares. Quando comparado com o Grupo Controle, o Grupo Tratado falhou em mostrar uma diminuição da taxa de recorrência (p=0,59). Entretanto o número de células epiteliais expressando o TGF-β foi menor no Grupo Tratado (5 células; 95% CI=2,56-13,15; Grupo Controle, 16 células; 95% CI: 11,53-24,76, p=0,01). Complicações mínimas, mas reversíveis, ocorreram durante o estudo, incluindo glaucoma secundário ao uso de corticoide e granuloma. Conclusão: O tranilast foi efetivo em diminuir o número células epiteliais do pterígio expressando o TGF-β. .

Advances in pharmacologic studies on treatments of allergic diseases by Chinese materia medica / 中草药

Clinical evidences demonstrated the effects of Chinese materia medica (CMM) on allergic diseases. However, the bioactive components in CMM and their mechanims of actions remain unkown. The progress of pharmacological studies on the anti-alleric effects of multi-herb formulation, herbal extracts/fraction, and pure compounds of CMM was summerized, which showed the characteristics of multi-component, multi-target, and multi-mechanism of CMM effects. This review provides the information for clinical use of anti-allergic CMM and drug discovery of anti-allergic CMM products.

Consideration of application of non-steroidal anti-inflammatory drugs in the treatment of allergic conjunctivitis / 中华实验眼科杂志

Allergic conjunctivitis is a very common pathology and its incidence has increased in developing countries with the development of industrialization.At present,the therapy of allergic conjunctivitis is mainly the use of topical eyedrops to eliminate causative factors,relieve symptoms and prevent complications.The drugs used in allergic conjunctivitis have 6 groups,including antihistamine,mastocyte stabilizer,drugs with dual effects (antihistamine and mastocyte stabilizer),non-steroidal anti-inflammatory drugs (NSAIDs),glucocorticoids and immunosuppressors.The goals of topical use of antihistamine,mastocyte stabilizer and drugs of dual effects are to remove the itching and hyperaemia of eye or to treat the patients with acute allergic conjunctivitis; while NSAIDs,glucocorticoids and immunosuppressors are used for the patients with severe or chronic allergic conjunctivitis.The glucocorticoid drugs are more effective because of their arresting effects in several links of the allergic response.Nevertheless,the long-term use of glucocorticoids probably results in ocular hypertension or posterior subcapsular cataract,furthermore,glucocorticoid drugs should be more cautionary in the application of the patients with corneal ulcer.Immunosuppressors inhibit abnormal immune responses,but these drugs should not be used for a long term because of higher cost and adverse effects.NSAIDs have a good anti-inflammatory effect and less irritant,so the topical use of NSAIDs for allergic conjunctivitis appears to be a better choice nowadays.

Evaluation of anti-allergic and anti-anaphylactic activity of ethanolic extract of Zizyphus jujuba fruits in rodents

The present study reports the anti-allergic activity of ethanolic extract of Zizyphus jujuba Mill., Rhamnaceae, and its possible mode of action. The effect of extract of Z. jujuba at different doses (250, 500 and 1000 mg/kg, orally) was simulated on studied animal models of asthma and allergy: a) milk induced eosinophilia and leukocytosis; b) compound 48/80 induced mast cell degranulation; and, c) active and passive cutaneous anaphylaxis. In addition, extract of Z. jujuba's effect on sensitized guinea pig ileum (ex vivo) and tracheal chain preparations (in vitro) were investigated.Treatment with extract of Z. jujuba at all doses significantly: prevented the milk-induced eosinophilia and compound 48/80 induced degranulation of mesenteric mast cells; decreased passive cutaneous and active anaphylactic reactions. In addition, extract of Z. jujuba inhibited acetylcholine as well as histamine induced tracheal chain contraction, and also antigen induced contraction of sensitized guinea pig ileum (Shultz-Dale inhibition test). Furthermore, it exhibited also free radicals scavenging activity (in vitro). The observed anti-allergic and anti-anaphylactic activity of extract of Z. jujuba may be largely through the stabilization of mast cells by the membrane presence of phytoconstituents (steroidal saponins and flavonoids).

Mechanism of action of probiotics

The modern diet doesn't provide the required amount of beneficial bacteria. Maintenance of a proper microbial ecology in the host is the main criteria to be met for a healthy growth. Probiotics are one such alternative that are supplemented to the host where by and large species of Lactobacillus, Bifidobacterium and Saccharomyces are considered as main probiotics. The field of probiotics has made stupendous strides though there is no major break through in the identification of their mechanism of action. They exert their activity primarily by strengthening the intestinal barrier and immunomodulation. The main objective of the study was to provide a deep insight into the effect of probiotics against the diseases, their applications and proposed mechanism of action.

Anti-Oxidative and Anti-Inflammatory Effect of Water Extract from Perillae semen in RBL-2H3 Cells

The present study was to investigate anti-oxidative and anti-inflammatory activity of Perillae semen in RBL-2H3 basophilic leukemia cells. Inhibitory effect of Perillae semen onto free radical generation was determined by measuring DPPH and hydroxyl radical scavenging activities in vitro. Anti-inflammatory actions of Perillae semen extracts (100, 250, 500 microgram/mL) were assessed by testing their effects on the degranulation of mast cells. For this, beta-hexosaminidase released from RBL-2H3 cells was used and proinflammatory cytokines were measured by an ELISA kit. Our results indicated that Perillae semen water extracts effectively inhibited free radical generation. At the concentration of 500 microgram/mL of water extract, the degranulation of RBL-2H3 cells were inhibited by 42.1%. The IgE-antigen complex increased the accumulation of IL-4 and TNF-alpha secretion in RBL-2H3 cells and treatments with 250 and 500 microgram/mL of Perillae semen extracts suppressed the IgE induced secretion of IL-4 and TNF-alpha protein by 20.5, 26.9% and 14.5, 16.5% respectively. We observed that Perillae semen water extract reduced beta-hexosaminidase, IL-4, and TNF-alpha secretion in RBL-2H3 cells. These results provide that Perillae semen may be beneficial in the treatment of allergic inflammatory disease.

The Effects of Anti-allergic Ophthalmic Agents on the Cultured Rabbit Conjunctival Cells

PURPOSE: To investigate the biological effects and cytotoxicity of anti-allergic ophthalmic agents on the cultured conjunctival cells of rabbit in vitro. METHODS: Conjunctival cells of rabbit were exposed to anti-allergic ophthalmic agents. Azelan(R) (Taejoon, Korea), Zaditen(R) (Novartis, USA), Patanol(R) (Alcon, USA) at a concentration 10, 20 and 30% for a period of 30 minutes, 4, 12, and 24 hours respectively. Cell injury assay was performed using lactate dehydrogenase (LDH) leakage assay. We checked the composition, pH, osmolarity of three anti-allergic agents. Light and transmission electron microscopy were performed to compare the cellular damage of rabbit conjunctival cells under various culture treatments. RESULTS: In cultured conjunctival cells of rabbit, the LDH titers increased up to 4 hours after exposure, maintained until 12 hours and then decreased 12 hours after exposed. Azelan(R) and Zaditen(R) showed a higher LDH titer and severe cellular damage of the conjunctival cells, compared with Patanol(R). Of anti-allergic solutions, Azelan(R) and Zaditen(R) revealed markedly lower Na+, Cl- and pH levels than Patanol(R). However, there was no difference in the concentration of preservative or osmolarity of the eye solution among the three anti-allergic agents. CONCLUSIONS: Patanol(R) caused markedly more damage to cultured rabbit conjunctival cells than Azelan(R) and Zaditen(R). If these anti-allergic these agents are clinically used for long periods of time, they may induce the cellular damage of conjunctival cells depending on the composition and pH of anti-allergic drugs.

Anti-Allergic ‘Benifuuki’ Green Tea / 日本補完代替医療学会誌

We have reported that <i>O</i>-methylated EGCG (epigallocatechin-3-<i>O</i>-(3-<i>O</i>-methyl)gallate (EGCG3″Me) had 2.5-fold anti-allergic action compared with EGCG (epigallocatechin gallate), and that the tea (<i>Camellia sinensis </i>L.) cultivar ‘Benifuuki’ was rich in EGCG3″Me. The EGCG3″Me content was high and caffeine content decreased in fully-matured tea leaves in second or third crop season, and EGCG3″Me was disappeared under black tea manufacturing process. ‘Benifuuki’ is a cultivar with strong resistance for diseases, strong vigor of plant, many yield and excellent fragrance. The EGCG3″Me strongly inhibited mast cell activation through the prevention of tyrosine phosphorylation (Lyn, Syk and Btk) of cellular protein, the phosphorylation of myosin light chain and the expression of Fcepsolon RI, and histamine/leukotrienes release. Furthermore, over one consecutive month intake of ‘Benifuuki’ green tea was useful for reduction of some symptoms derived from Japanese cedar pollinosis, and did not affect any normal immune response in the subjects with Japanese cedar-pollinosis. So, in cooperation with food companies, we developed PET beverage and sweet using ‘Benifuuki’ green tea.<br>