Background: Inhaled indacaterol (Onbrez Breezhaler), a long-acting ${\beta}_2$-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population. Methods: This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or $300{\mu}g$), were evaluated for 12 or 24 weeks. Safety was assessed based on the incidence rates of adverse events (AEs) and serious adverse events (SAEs). Effectiveness was evaluated based on physician's assessment by considering changes in symptoms and lung function, if the values of forced expiratory volume in 1 second were available. Results: Safety data were analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving indacaterol, and 784 patients were included for the effectiveness analysis. AEs were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. The COPD condition improved in 348 patients (44.4%), while the condition was maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited worsening of ailment as compared with baseline. During the treatment period, 90 patients were hospitalized while nine patients died. All deaths were assessed to be not related to the study drug by the investigator. Conclusion: In real-life clinical practice in South Korea, indacaterol was well tolerated in COPD patients, and can be regarded as an effective option for their maintenance treatment.
Sauvage, Severine;Samson, Emilie;Granger, Melanie;Majumdar, Anisha;Nigam, Poonam;Nahar, Lutfun;Celik, Sezgin;Sarker, Satyajit D.
Advances in Traditional Medicine
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제10권4호
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pp.304-309
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2010
Scutellaria pinnatifida A. Hamilt. (Lamiaceae) is an endemic Turkish herb. This plant is also endemic to Iran, and grows abundantly in other central and western Asian countries. Several species of the Scutellaria are known for their traditional uses in the treatment of hypertension, arteriosclerosis, inflammatory diseases, hepatitis, allergy, cancer and diarrhoea. Free-radical-scavenging property, antibacterial activity and brine shrimp toxicity of the n-hexane, dichloromethane (DCM) and methanol (MeOH) extracts of S. pinnatifida were assessed using the 2,2-diphenyl-1-picryl-hydrazyl (DPPH) assay, the resazurin microtitre plate based assay, and the brine shrimp lethality assay, respectively. The DCM and MeOH extracts exhibited free-radical-scavenging property, with the $RC_{50}$ values of 0.362 and 0.127 mg/ml, respectively. Among the solid-phase extraction fractions of the MeOH extract, the 50% aqueous-MeOH fraction showed the highest level of free-radicalscavenging activity ($RC_{50}$ = 0.039 mg/ml). While the DCM extract showed low level of antibacterial activity against Bacillus subtilis and ampicillin-resistant Escherichia coli, the MeOH extract was active against B. cereus, B. subtilis, E. coli and ampicillin-resistant E. coli. However, the minimum inhibitory concentrations (MIC) of the MeOH extract against these bacterial strains were >10 mg/ml. None of the extracts showed any significant toxicity towards brine shrimps ($LD_{50}$ = > 1.00 mg/ml).
Experimental studies were done to research the effects of the Ursi fel and the UDCA on the anti-allergic effects. The results were obtained as follows: 1) In the experimental effects of the Ursi fel and the UDCA on the vascular permeability responses to intradermal Serotonin, though both of the Ursi fel and UDCA revealed the significant effect, the Ursi fel had stronger effect than the UDCA. 2) In the provocative effects of the Ursi fel and the UDCA on the vascular permeability responses to intradermal Histamin, though both of the Ursi powfel and UDCA showed the significant effect, the Ursi fel had moreerful effect than the UDCA. 3) In the 48 hours homologous passive cutaneous anaphylaxis provoked by the IgE-like antibody against white egg albumin, though both of the Ursi fel and UDCA revealed significant effect, the Ursi fel had stronger effect than the UDCA. 4) In the delayed type hypersensitivity response to Picryl Chlorede, though both of the Ursi fel and UDCA were proved to be effective significantly the Ursi fel showed stronger effect. 5) In the delayed type hypersensitivity responses to Sheep red blood cell, the Ursi fel revealed the significant effect, though the UDCA has no significant effect. According to above results, the Ursi fel was approved it could be used widely as antiallergic drug for immediate and delayed type allergic diseases. Although the UDCA revealed efficacy in immediated type allergic diseases, it had less powerful effects than the Ursi fel and it showed no effects in some experiment of delayed type allergy, so it would be difficult to be used clinically.
This paper covers algorithms for the management of regurgitation, constipation and infantile colic in infants. Anti-regurgitation formula may be considered in infants with troublesome regurgitation, while diagnostic investigations or drug therapy are not indicated in the absence of warning signs. Although probiotics have shown some positive evidence for the management of functional gastrointestinal disorders (FGIDs), the evidence is not strong enough to make a recommendation. A partially hydrolyzed infant formula with prebiotics and ${\beta}$-palmitate may be considered as a dietary intervention for functional constipation in formula fed infants. Lactulose has been shown to be effective and safe in infants younger than 6 months that are constipated. Macrogol (polyethylene glycol, PEG) is not approved for use in infants less than 6 months of age. However, PEG is preferred over lactulose in infants >6 months of age. Limited data suggests that infant formula with a partial hydrolysate, galacto-oligosaccharides/fructo-oligosaccharides, added ${\beta}$-palmitate may be of benefit in reducing infantile colic in formula fed infants in cases where cow's milk protein allergy (CMPA) is not suspected. Evidence suggests that the use of extensively hydrolyzed infant formula for a formula-fed baby and a cow's milk free diet for a breastfeeding mother may be beneficial to decrease infantile colic if CMPA is suspected. None of the FGIDs is a reason to stop breastfeeding.
Angioedema is a localized transient swelling of sudden onset that can occur in the face, lips, tongue, hand, feet, respiratory system and gastrointestinal system. Angioedema is classified as allergy, hereditary, idiopathic or induced by medication as like aspirin, nonsteroidal anti-inflammatory agents, opiates, antibiotics, and angiotensin-converting enzyme. Angiotensin-converting enzyme inhibitors are widely prescribed for hypertension and heart failure. This drug is commonly associated with angioedema which may be potentially life threatening. We experienced a case of angioedema induced by ACE inhibitor (angiotensin-converting enzyme inhibitor) in a 74-year-old patient who took ACE inhibitor to control hypertension during hospitalization. We thought the angioedema in the face had relation to myenzhong (面腫, mienjong) in oriental medicine. Weiling-tang (Wiryung-tang) was effective for angioedema in the face. As a result the symptoms disappeared rapidly. After 6 days, the patient's symptoms had notably improved.
Translationally controlled tumor protein (TCTP), also known as histamine releasing factor (HRF), is found abundantly in different eukaryotic cell types. The sequence homology of TCTP between different species is very high, belonging to the MSS4/DSS4 superfamily of proteins. TCTP is involved in both cell growth and human late allergy reaction, as well as having a calcium binding property; however, its primary biological functions remain to be clearly elucidated. In regard to many possible functions, the TCTP of Plasmodium falciparum (Pf) is known to bind with an antimalarial agent, artemisinin, which is activated by heme. It is assumed that the endoperoxide-bridge of artemisinin is opened up by heme to form a free radical, which then eventually alkylates, probably to the Cys14 of PfTCTP. Study of the docking of artemisinin with heme, and subsequently with PfTCTP, was carried out to verify the above hypothesis on the basis of structural interactions. The three dimensional (3D) structure of PfTCTP was built by homology modeling, using the NMR structure of the TCTP of Schizosaccharomyces pombe as a template. The quality of the model was examined based on its secondary structure and biological function, as well as with the use of structure evaluating programs. The interactions between artemisinin, heme and PfTCTP were then studied using the docking program, FlexiDock. The center of the peroxide bond of artemisinin and the Fe of heme were docked within a short distance of $2.6{\AA}$, implying the strong possibility of an interaction between the two molecules, as proposed. When the activated form of artemisinin was docked on the PfTCTP, the C4-radical of the drug faced towards the sulfur of Cys14 within a distance of $2.48{\AA}$, again suggesting the possibility of alkylation having occurred. These results confirm the proposed mechanism of the antimalarial effect of artemisinin, which will provide a reliable method for establishing the mechanism of its biological activity using a molecular modeling study.
Objective : The genus Glycyrrhiza has been used in food and traditional herbal medicine. Many experimental studies reported that Glycyrrhiza species possess several pharmacological properties. Glycyrrhiza new varieties WONGAM and SINWONGAM have been developed by Korea Rural Development Administration doing research for registration on Ministry of Food and Drug Safety. During the evaluations about pharmacological effect of Glycyrrhiza new varieties WONGAM and SINWONGAM, we focused the anti-allergic effect in this study. Methods : We investigated the anti-allergic effect of WONGAM and SINWONGAM compared with Glycyrrhiza uralensis Fischer and G. glabra L. using anti-dinitrophenyl-immunoglobulin E (IgE)/human serum albumin-stimulated RBL-2H3 cells, phorbol 12-myristate 13-acetate plus calcium ionophore A23187-stimulated HMC-1 cells and compound 48/80-induced anaphylaxis mice model. We analyzed the effect on the expression of various cytokines, and IgE from mast cells and the underlying molecular mechanisms of WONGAM and SINWONGAM in presented models. Results : WONGAM and SINWONGAM showed the inhibitory effect on the histamine release from rat peritoneal mast cells or human mast cells without cytotoxicity. WONGAM and SINWONGAM blocked anaphylactic shock and decreased the IgE production. Furthermore, WONGAM and SINWONGAM inhibited the productions of TNF-α and IL-6 in compound 48/80-induced anaphylaxis mice model. Conclusion : These results indicated that WONGAM and SINWONGAM would have protect effect on allergic responses through the inhibition of allergic mediators and pro-inflammatory cytokines. This study may facilitate the development on Glycyrrhiza new varieties for allergy.
Objectives : In this study, we investigated anti-allergic effect of Okbyeongpungsan-Hap-Changijasan (KOB01) in allergic rhinitis(AR) experimental animals and mast cells. Methods : The potential anti-allergic effect of KOB01 was investigated in a rat model of compound 48/80-induced systemic anaphylactic shock and a mouse of ovalbumin(OVA)-induced AR, and human mast cell line, HMC-1 culture. Each animals were divided into four groups: normal, control, KOB01-treated(100 and 200 mg/kg) and anti-histamine drug, dosodium cromoglycate (DSCG)-treated(50 mg/kg). Animals were orally treated with KOB01 and DSCG and intraperitoneally injected with compound 48/80($10\;{\mu}g/kg$) or sensitized with 0.1% OVA. The mortality and serum histamine levels were measured in compound 48/80-induced anaphylatic rats. The histological changes in nasal mucosa were investigated in OVA-induced AR mice. Also, mast cell degranulation was observed in compound 48/80-stimulated HMC-1 cells. Results : KOB01 increased mortality and significantly decreased serum histamine levels in compound 48/80-induced anaphylatic rats. The abnormal histological changes such as expansion of grandular cells and hypertrophy of epithelium in nasal mucosa of OVA-induced AR mice was improved by KOB01 treatment nearby a normal group. Therefore, KOB01 inhibited compound 48/80-induced degranulation in HMC-1 cells. Conclusions : These results indicate that KOB01 decrease allergic response through suppressing the mast cell activation in AR and suggest a potential role for KOB01 as a source of anti-allergic agents for use in allergic disorders including of AR.
Objectives This research was proposed to present Clinical Practice Guideline (CPG) for Prevention of Sasangin disease pattern of Sasang Constitutional Medicine (SCM) and diseases closely related with Sasang constitution. Each CPG was developed by the national-wide experts committee consisting of SCM professors. Methods At first, we searched the literatures related to SCM such as "Dongeuisusebowon", Textbook of SCM and Clinical Guidebook of SCM. Also we searched the articles related to the studies about risk factors for Sasangin disease pattern of both at home and abroad. Finally, we selected leading risk factors of Sasangin disease pattern and developed CPG for prevention of Sasangin disease pattern of SCM. And then, we searched the literatures related SCM such as "Dongeuisusebowon" and the articles on the correlation between disease and Sasang constitution using case-control studies, observational studies or cross sectional studies of both at home and abroad. Next, we selected diseases closely related with Sasang constitution on the basis of articles including prevalence rate and odds ratio between disease and Sasang constitution and finally developed CPG for these diseases. Results and Conclusions We categorized risk factors of Sasang disease pattern into 2 types: non-modifiable and potentially modifiable. 3 items (age, sex and genetic factors) were classified as non-modifiable risk factors of Sasang disease pattern. 6 items (original symptom, stress, diet and nutrition, physical activity, alcohol and drug misuse) were classified as less well-documented or potentially modifiable risk factors of Sasangin disease pattern. We found out Sasang constitution is more likely to develop some diseases. It was proven that Sasang constitution increase the risk of hypertension, diabetes mellitus, metabolic syndrome, stroke, nonalcoholic fatty liver and obstructive sleep apnea. And there is high probability of Sasang constitution being potential risk factor for obesity, hyperlipidemia, allergy and cancer. Also, we found out Taeeumin is independent risk factor for hypertension, diabetes mellitus, metabolic syndrome, stroke, nonalcoholic fatty liver and obstructive sleep apnea. Therefore we recommend that Taeeumin need to prevent these disease by regular checkups and aggressive management.
Objectives : This study aimed to assess the scientific evidence for the use of Hwanglyeonhaedok-tang, a traditional herbal formula, in the treatment of rhinitis, and prepare the basis for the investigational new drug application by analyzing the experimental studies. Methods : Ten electronic databases were searched up to December, 2016 without language limitation. Experimental studies on the anti-inflammatory and anti-allergic effects of Hwanglyeonhaedok-tang against rhinitis were included. We extracted data about study design, characteristics of intervention, outcomes, and pharmacological effects from the included studies and summarized them. Results : Eight hundred and thirty-three potentially relevant studies were identified, of which 18 experimental studies met our inclusion criteria. Of 18 included studies, 5 had conducted cell viability test, and all studies had reported that Hwanglyeonhaedok-tang was non-cytotoxic. Hwanglyeonhaedok-tang exhibits anti-inflammatory effect by regulating the inflammation-related cytokines including nitric oxide(NO), prostaglandin $E_2(PGE_2)$, interleukin-6(IL-6), and tumor necrosis $factor-{\alpha}(TNF-{\alpha})$ in vitro and in vivo. Hwanglyeonhaedok-tang exhibits anti-allergic effect by suppressing eosinophil, and histamine levels. Hwanglyeonhaedok-tang helps in the recovery of nasal mucous membrane by supressing goblet cells, heat shock protein 70, and substance P. Conclusions : This study suggests that Hwanglyeonhaedok-tang has the potential to be developed as therapeutic agent for rhinitis. Further experimental and clinical studies needed to be performed to prove the safety and efficacy.
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