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3.
JAMA Ophthalmol ; 138(11): 1160-1166, 2020 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-33001159

RESUMO

Importance: Oral ß-blockers used for the prevention of migraine headache are not effective for the treatment of acute pain. Small case series have suggested that topically applied ß-blockers may be useful in the management of acute migraine pain, warranting evaluation with randomized clinical trials. Objective: To evaluate the short-term efficacy and safety of topically applied timolol maleate ophthalmic solution, 0.5%, compared with topically applied placebo eyedrops in the treatment of acute migraine attacks. Design, Setting, and Participants: In this randomized, masked placebo-controlled crossover trial conducted from May 27, 2015, to August 28, 2017, 50 patients with migraine were randomized to receive either timolol eyedrops, 0.5%, or a placebo eyedrop (carboxymethyl cellulose, 0.5%). After a 3-month treatment period, patients completed a 1-month washout period and were crossed over to receive the opposite treatment for a final 3 months. Analysis was performed on a modified intent-to-treat basis. Intervention: After random assignment, patients were instructed to use 1 drop of the assigned medication in each eye at the earliest onset of migraine. Main Outcomes and Measures: The main outcome measure was reduction in pain score with treatment. The primary end point was reduction of pain score by 4 points, or to zero, 20 minutes after instillation of the eyedrop. Results: Of the 50 patients, 42 (84%) were females and the mean (SD) age was 27.3 (11.3) years. Of a total of 619 migraine attacks, 284 (46%) were treated with timolol, 271 (44%) were treated with the placebo, and 64 (10%) occurred during the washout period when no study medications were used. Seven patients (14%) withdrew after randomization. A total of 233 of the timolol-treated migraine attacks (82%) were associated with a reduction in pain score by 4 points, or to zero, at 20 minutes compared with 38 of the placebo-treated attacks (14%), with a difference of 68 percentage points (95% CI, 62-74 percentage points). A generalized estimating equation analysis revealed that pain score reduction at 20 minutes was greater in the timolol group compared with the placebo group by a mean (SE) of 4.63 points (0.34) (P < .001). Conclusions and Relevance: This randomized crossover trial supports consideration of timolol eyedrops in the acute treatment of migraine. Further research is warranted to determine if the improvements observed are sustained for a longer follow-up and with larger groups. Trial Registration: CTRI/2015/05/005829, UTN: U1111-1167-6439.


Assuntos
Transtornos de Enxaqueca/tratamento farmacológico , Timolol/administração & dosagem , Doença Aguda , Adolescente , Antagonistas Adrenérgicos beta/administração & dosagem , Adulto , Criança , Estudos Cross-Over , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Masculino , Soluções Oftálmicas , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
4.
Br J Ophthalmol ; 99(4): 464-70, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25326519

RESUMO

AIMS: To assess the efficacy of securing conjunctival autograft (CAG) without glue or sutures, using the patient's own blood at the surgical site, and to compare it with the current accepted standard of using fibrin glue for graft adherence, in pterygium surgery. METHODS: A single-centre, prospective, randomised controlled trial was carried out in 200 eyes of patients with primary pterygia who were advised pterygium excision with CAG. Enrolled participants were assigned to Group I or II by randomisation. After excision of pterygium, they underwent CAG with autologous blood in Group I (100 eyes) and CAG with fibrin glue in Group II (100 eyes). During follow-up of 1 year, the eyes were assessed for graft adherence and recurrence. RESULTS: Of the 200 eyes randomised, 6 eyes that did not complete intended follow-up were excluded from final analysis. Of the 194 eyes (Group I n=96, Group II n=98), on the first postoperative day, 3 eyes in Group I (3.13%) had total graft dislodgement requiring regrafting from another site or reattachment with glue. In Group II also 2 eyes (2.04%) had graft dislodgement on the first postoperative day requiring regrafting from another site. During the 1-year follow-up, 6 eyes in Group I (6.25%) and 8 eyes in Group II (8.16%) developed recurrence. CONCLUSIONS: Feasibilty of adherence of the graft without glue in pterygium surgery is promising and has results comparable with the fibrin glue technique in terms of long-term outcome and recurrence, suggesting the potential for autologous blood to replace fibrin glue in graft fixation. TRIAL REGISTRATION NUMBER: Clinical Trial Registry, India: CTRI/2013/06/003764 and UTN: U1111-1140-6572.


Assuntos
Sangue , Túnica Conjuntiva/transplante , Adesivo Tecidual de Fibrina/administração & dosagem , Sobrevivência de Enxerto/efeitos dos fármacos , Pterígio/cirurgia , Adesivos Teciduais/administração & dosagem , Adulto , Autoenxertos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Técnicas de Sutura , Adulto Jovem
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