【摘要】：目的:評(píng)價(jià)棕櫚酸帕利哌酮治療精神分裂癥急性期臨床療效及安全性,初探長效針劑在首發(fā)精神分裂癥患者中的應(yīng)用。方法:采用開放性、單臂臨床觀察研究。共入組58例患者,男性23例,女性35例(其中首發(fā)患者27例,復(fù)發(fā)急性期患者3 1例),患者均按照棕櫚酸帕利哌酮的說明書,第一針起始劑量150 mg,d 8注射100 mg,之后每月注射1針,劑量視臨床癥狀控制及既往治療情況在75~150 mg中選擇。觀察時(shí)間為13周。療效評(píng)價(jià)指標(biāo)為PANSS總分及CGI-S,應(yīng)用藥物不良反應(yīng)量表(TESS)評(píng)定安全性。結(jié)果:治療13周末,入組總體患者有效率達(dá)82.8%,首發(fā)患者組有效率為85.2%,復(fù)發(fā)患者組有效率為80.6%;兩組間比較無統(tǒng)計(jì)學(xué)差異(P=0.549)。不良事件2/3左右發(fā)生于注射藥物后的1~2周內(nèi),多為一過性,無需特殊處理,主要為注射部位疼痛、失眠和靜坐不能等。結(jié)論:棕櫚酸帕利哌酮對(duì)精神分裂癥急性期療效顯著,可顯著改善首發(fā)精神分裂癥患者癥狀,并具有良好的安全性。
[Abstract]:Objective: to evaluate the clinical efficacy and safety of palmitazone palmitate in the treatment of schizophrenia in acute phase, and to explore the application of long-acting injection in patients with first-episode schizophrenia. Methods: open, single arm clinical observation was used. A total of 58 patients, including 23 males and 35 females (27 patients with first episode and 31 patients with acute recurrence) were enrolled in the study group. The patients were given one injection per month after the initial dose of mg, mg,d 8, including 27 patients with first onset and 31 patients with acute recurrence. The dose was selected from 75 脳 150 mg depending on the clinical symptom control and previous treatment. The observation time was 13 weeks. The total score of PANSS and the safety of CGI-S, were evaluated by adverse drug reaction scale (TESS). Results: at the end of 13 weeks, the overall effective rate was 82.8%, the effective rate was 85.2% in the first group and 80.6% in the recurrent group, and there was no significant difference between the two groups (P 鈮，

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