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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.
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White & Black Tablet is a kind of over-the-counter drugs commonly used in the treatment of common cold, excessive use may cause poisoning symptoms, the light symptom can be cleared without treatment, the serious manifestation is the appearance of central nervous system signs and symptoms, and even the most serious one may die of respiratory or/and circulatory failure. Our department recently admitted a patient with acute "White & Black Tablet" poisoning leading to ataxia syndrome, and the diagnosis and treatment experiences of this case were summarized in this report.
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ABSTRACT Purpose: Administration of eye drops containing antihistamines or sodium cromoglycate and its derivatives for the treatment of allergic keratoconjunctivitis is often insufficient and usually requires the addition of corticosteroids. However, the risk of complications, such as glaucoma and cataract, limits the use of corticosteroids to short courses, resulting in inadequate long-term treatment response. Immunosuppressive drugs have been considered as a valid alternative to steroids for atopic keratoconjunctivitis and vernal keratoconjunctivitis. This study aimed to evaluate the use of topical tacrolimus (TCL) in improving the clinical signs of severe allergic keratoconjuctivitis in children. Methods: Patients with severe allergic keratoconjunctivitis associated with corneal epitheliopathy, gelatinous limbal infiltrates, and/or papillary reaction, along with a history of recurrences and resistance to conventional topical anti-allergy agents, were included in this open clinical trial. Patients were treated with 0.03% TCL ointment for ocular use. A severity score ranging from 0 to 9, with 9 being the highest and 0 being the lowest, was assigned based on signs observed on biomicroscopy prior to and following TCL treatment. Results: Analyses included 66 eyes of 33 patients. After a mean follow-up period of 13 months (range, 12-29 months), TCL treatment significantly decreased the mean symptom score severity for the right (from 5.56 ± 1.18 to 2.76 ± 1.5; p<0.001) and left (from 5.94 ± 1.16 to 2.86 ± 1.64; p<0.001). Conclusion: Topical TCL was effective and significantly improved the clinical signs of allergic keratoconjuctivitis in children. Thus, it is a potential new option for severe and challenging cases of ocular allergy.
RESUMO Objetivos: O tratamento da ceratoconjuntivite alérgica baseado em colírios que contenham anti-histamínicos ou cromoglicato de sódio e seus derivados geralmente são insuficientes. A adição de corticosteróides geralmente é mandatória. No entanto, o risco de complicações como glaucoma e catarata limita o uso dos corticosteróides em curtos períodos de tratamento resultando em respostas inadequadas a longo prazo. Drogas imunossupressoras vem sendo consideradas como uma opção terapêutica alternativa válida para as ceratoconjuntivite atópica (AKC) e ceratoconjuntivite vernal (VKC). Este trabalho tem como objetivo avaliar a melhora nos sinais clínicos durante o uso de tacrolimus (TCL) tópico em crianças com ceratoconjuntivites alérgicas. Métodos: Pacientes com ceratoconjuntivite alérgica severa associada a ceratites, infiltrados limbares gelatinosos e/ou papilas gigantes, com história de recorrências e resistência ao tratamento anti-alérgico tópico convencional foram incluídos neste estudo. Os pacientes foram tratados com TCL 0,03% pomada tópica para uso ocular. Um escore variando de 0 a 9 foi atribuído para os sinais observados na biomicroscopia antes e depois do tratamento. Quanto maiores os escores, mais severos eram os sinais. Resultados: Foram estudados 66 olhos de 33 pacientes. Antes do tratamento a média do escore para o olho direito foi 5,56 ± 1,18 e para o olho esquerdo 5,94 ± 1,16. Após o tratamento com TCL a média do escore para o olho direito foi 2,76 ± 1,5 e para o olho esquerdo 2,86 ± 1,64 (p<0.001 para os dois olhos). O tempo de seguimento médio foi de 13 meses (12-29 meses). Conclusão: O presente estudo sugere que o TCL tópico foi efetivo e demonstrou resultado satisfatório, com melhora nos sinais clínicos na ceratoconjuntivite alérgica em crianças, constituindo uma nova opção para o tratamento de casos severos de alergia ocular.
Subject(s)
Humans , Male , Female , Child , Adolescent , Conjunctivitis, Allergic/drug therapy , Tacrolimus/administration & dosage , Immunosuppressive Agents/administration & dosage , Keratoconjunctivitis/drug therapy , Severity of Illness Index , Prospective Studies , Follow-Up Studies , Administration, Topical , Treatment Outcome , Cyclosporine/administration & dosage , Microscopy/methodsABSTRACT
ABSTRACT Purpose: To evaluate the use of supratarsal injection of triamcinolone acetonide in severe vernal keratoconjunctivitis (VKC) in children. Methods: Patients included in this open clinical trial were those with severe VKC-associated with keratitis, gelatinous limbal infiltrates, and/or giant papillae, with a history of recurrence and resistance to conventional topical antiallergic agents. Patients were treated with a supratarsal injection of 20 mg triamcinolone acetonide. Results: Analysis included 27 injections in 23 eyes of 17 patients with severe allergic keratoconjunctivitis. Mean age was 12.3 (range: 7-19) years. Mean follow-up time was 39.3 months (SD=19.21). In the 17 patients, the disease was successfully controlled for an average of 3.6 months (range: 1-16), during which allergy symptoms and signs were significantly improved, with complete resolution of lid edema and conjunctival chemosis, significant decline of pannus and keratitis, and reduction of giant papillae size. Conclusion: Treatment of severe, acute VKC in children with supratarsal injection of 20 mg triamcinolone acetonide showed satisfactory results and was well tolerated by patients; it may therefore constitute a safe option for severe and challenging cases. While full disease remission was not achieved, a significant improvement was found in ocular allergy symptoms and signs, with a reduction in the frequency of acute recurrences.
RESUMO Objetivo: Avaliar o uso da injeção supratarsal de triancinolona na ceratocon junti vite primaveril grave (VKC) em crianças. Métodos: Pacientes com VKC grave associada à ceratite, limbo gelatinoso e/ou papilas gigantes, com história de recidivas e resistência a agentes antialérgicos tópicos convencionais foram incluídos neste ensaio clínico. Os pacientes foram tratados com injeção de 20 mg de acetato de triancinolona supratarsal. Resultados: A análise incluiu 23 olhos de 17 pacientes com ceratoconjuntivite alérgica grave. A idade média foi de 12,3 com intervalo de 7-19 anos. O tempo médio de acompanhamento foi de 39,3 meses (DP 19,21). Dos 17 pacientes, a doença foi controlada com sucesso por uma média de 3,6 meses (intervalo 1-16) em que os sinais e sintomas foram significativamente melhorados com resolução completa do edema palpebral e quemose conjuntival, redução significativa de pannus, ceratite e redução do tamanho das papilas gigantes. Conclusão: O tratamento da VKC grave em crianças com injeção supratarsal de 20 mg de acetato de triancinolona mostrou resultados satisfatórios, sendo bem tolerada pelas crianças às quais foram submetidas, podendo constituir uma opção segura para casos graves e difíceis de VKC. Uma melhora significativa foi encontrada nos sinais e sintomas alérgicos oculares, com diminuição da frequência de recidivas agudas, no entanto sem se mostrar efetiva para a completa remissão da doença.
Subject(s)
Humans , Male , Female , Child , Adolescent , Young Adult , Conjunctivitis, Allergic/drug therapy , Triamcinolone Acetonide/administration & dosage , Injections, Intraocular , Glucocorticoids/administration & dosage , Time Factors , Prospective Studies , Reproducibility of Results , Treatment Outcome , Age of Onset , Eyelids/drug effects , Administration, Ophthalmic , Medical IllustrationABSTRACT
As alergias oculares englobam uma série de doenças inflamatórias da superfície ocular, causadas por diferentes mecanismos de hipersensibilidade. Acometem aproximadamente 20% da população e podem ser classificadas em formas mediadas por hipersensibilidade tipo I (CAS, CAP), tipo I e IV (CCV, CCA) e tipo IV (BCC, CPG). As formas mais prevalentes são CAS e CAP. As formas crônicas (CCV, CCA) estão mais frequentemente relacionadas a complicações e comprometimento da função visual decorrentes do processo inflamatório e consequente remodelação da superfície ocular. Comorbidades como olho seco e ceratocone podem estar presentes. O tratamento envolve diagnóstico e afastamento dos fatores etiológicos envolvidos, uso de drogas anti-inflamatórias que atuem na ação de linfócitos Th2, eosinófilos, mastócitos e células dendríticas Avanços no conhecimento da ativação e tráfego de células do sistema imune têm sido promissores na perspectiva de novas abordagens terapêuticas.
Ocular allergies encompass a number of inflammatory diseases in the ocular surface which have different hypersensitivity mechanisms and occur in 20% of population. They can be classified as being type I hypersensitivity mediated (PAC, SAC), type I and IV (VKC, AKC) and type IV (BKC, GPC). The most prevalent forms are PAC and SAC. The chronic presentations are mostly related to visual impairment due to remodeling in the ocular surface caused by chronic inflammation. Dry eye disease and keratoconus are comorbidities observed in severe cases. The management is based on accurate diagnosis, avoidance of etiological factors and the rational use of drugs that control the inflammatory events caused by Th2 driven. The advances in knowledge on activation and traffic of immune cells are providing new drugs and many perspectives on different approaches.
Subject(s)
Humans , Conjunctivitis, Allergic/physiopathology , Conjunctivitis, Allergic/drug therapy , Drug Hypersensitivity , Hypersensitivity, Immediate , Immunoglobulins , KeratoconjunctivitisABSTRACT
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.