RESUMO
BACKGROUND: Tianshu capsule (TSC), a formula of traditional Chinese medicine, has been widely used in clinical practice for prophylactic treatment of headaches in China. However, former clinical trials of TSC were small, and lack of a standard set of diagnostic criteria to enroll patients. The study was conducted to re-evaluate the efficacy and safety of TSC post-marketing in an extending number of migraineurs who have diagnosed migraine with the International Classification of Headache Disorders, 3rd edition (beta version, ICHD-3ß). METHODS: The study was a double-blind, randomized, placebo-controlled clinical trial that conducted at 20 clinical centers in China. At enrollment, patients between 18 and 65 years of age diagnosed with migraine were assigned to receive either TSC (4.08 g, three times daily) or a matched placebo according to a randomization protocol. The primary endpoint was a relative reduction of 50% or more in the frequency of headache attacks. The secondary outcomes included a reduction in the incidence of headache, the visual analogue scale of headache attacks, days of acute analgesic usage, and percentage of patients with a decrease of 50% or more in headache severity. Accompanying symptoms were also assessed. RESULTS: One thousand migraine patients were initially enrolled in the study, and 919 of them completed the trial. Following the 12-week treatment, significant improvement was observed in the TSC group concerning both primary and secondary outcomes. After therapy discontinuation, the gap between the TSC group and the placebo group in efficacy outcomes continued to increase. There were no severe adverse effects. CONCLUSIONS: TSC is an effective, well-tolerated medicine for prophylactic treatment of migraine, and still have prophylactic effect after medicine discontinuation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.
Assuntos
Analgésicos/uso terapêutico , Medicamentos de Ervas Chinesas/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Adulto , Analgésicos/efeitos adversos , Método Duplo-Cego , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
With the development of vacuum electronic devices toward high power, high frequency, and miniaturization, the voltage holdoff capacity of the insulation materials in devices has also been raised to a higher demand. Cr/Mn/Ti-doped Al2O3 ceramics were prepared, and the bulk density, micromorphology, phase composition, resistivity, secondary electron emission coefficient, and surface flashover threshold in the vacuum of the Al2O3 were characterized. The results show that the addition of TiO2 to the Al2O3 ceramic can promote the sintering of the ceramic. The Cr/Mn/Ti-doped Al2O3 ceramic with a homogeneous microstructure can be obtained by an appropriate amount of TiO2 addition. In the process of the heat treatment, the TiO2 in the ceramics was reduced to a certain degree, which had an impact on the microstructure of the Al2O3 ceramic. Adding a small amount of TiO2 can improve the voltage holdoff performance in the vacuum. The value of the surface flashover threshold in the vacuum of the Cr/Mn/Ti-doped Al2O3 ceramic containing 1 wt.% TiO2 reached a value of 33 kV, which is 32% higher than that of the basic Al2O3 ceramic. The preparation of Al2O3 ceramics with a high voltage holdoff capacity in a vacuum provides fundamental technical support for the development of vacuum electronic devices.