鹽酸奧洛他定片治療慢性特發(fā)性蕁麻疹療效和安全性的多中心臨床研究
發(fā)布時(shí)間:2018-04-30 15:18
本文選題:鹽酸奧洛他定 + 氯雷他定 ; 參考:《中國醫(yī)院藥學(xué)雜志》2017年16期
【摘要】:目的:觀察鹽酸奧洛他定片治療慢性特發(fā)性蕁麻疹的臨床療效及安全性。方法:采用隨機(jī)、雙盲雙模擬、陽性藥物平行對(duì)照、多中心的試驗(yàn)方法,試驗(yàn)組和對(duì)照組共納入150例。分別采用鹽酸奧洛他定片,每次1片,每日2次;氯雷他定片,每次1片,每日1次,2組分別給予鹽酸奧洛他定和氯雷他定模擬片,連續(xù)給藥4周。療程結(jié)束時(shí)以癥狀體征總積分下降指數(shù)、總有效率及疾病總體改善情況等來評(píng)估其臨床療效,以不良事件及不良反應(yīng)、實(shí)驗(yàn)室檢查來評(píng)估其安全性。結(jié)果:納入符合方案分析集(PPS)的病例數(shù)為143例,試驗(yàn)組72例,對(duì)照組71例?傆行史謩e為83.33%和80.28%(P0.05)。25例患者發(fā)生43例次不良事件(試驗(yàn)組14人20例次,對(duì)照組11人23例次),其中37例次不良事件與藥物相關(guān),主要表現(xiàn)為口干、頭暈、嗜睡、乏力、上腹痛、谷丙轉(zhuǎn)氨酶ALT升高、谷草轉(zhuǎn)氨酶AST升高等。2組間不良事件及不良反應(yīng)發(fā)生率差異無統(tǒng)計(jì)學(xué)意義(P0.05),無嚴(yán)重不良事件發(fā)生。結(jié)論:鹽酸奧洛他定片治療慢性特發(fā)性蕁麻疹,療效顯著,安全性好。
[Abstract]:Objective: to observe the clinical efficacy and safety of oloatadine hydrochloride in the treatment of chronic idiopathic urticaria. Methods: a randomized, double-blind, double-simulated, positive drug parallel control, multicenter trial method was used. 150 cases were enrolled in the trial group and control group. Olitadine hydrochloride and loratadine hydrochloride were given for 4 weeks respectively in two groups: ollotadine hydrochloride and loratadine hydrochloride, one tablet per day, and one tablet, one tablet per day, and two groups were treated with ollotadine hydrochloride and loratadine hydrochloride respectively for 4 weeks. At the end of the course, the clinical efficacy was evaluated by the index of the total score of symptoms and signs, the total effective rate and the overall improvement of the disease, and the safety was evaluated by the adverse events and adverse reactions, and the laboratory examination. Results: 143 cases of PPS were included in the protocol analysis, 72 cases in the trial group and 71 cases in the control group. The total effective rate was 83.33% and 43 adverse events occurred in 80.28%(P0.05).25 patients (n = 14, n = 20) and control group (n = 11, n = 23). Among them, 37 cases were related to drugs, such as dry mouth, dizziness, lethargy, fatigue and upper abdominal pain. There was no significant difference in the incidence of adverse events and adverse reactions between the two groups (P 0.05), and no serious adverse events occurred. Conclusion: olitadine hydrochloride tablet is effective and safe in the treatment of chronic idiopathic urticaria.
【作者單位】: 華中科技大學(xué)同濟(jì)醫(yī)學(xué)院附屬同濟(jì)醫(yī)院;武漢大學(xué)人民醫(yī)院;皖南醫(yī)學(xué)院弋磯山醫(yī)院;
【分類號(hào)】:R758.24
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