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Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized Multicenter Double-Blind Placebo-Controlled Trial

机译:玉kan散在抗精神分裂症中的疗效和安全性:一项随机多中心双盲安慰剂对照的试验

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摘要

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted. Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS). Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54: −0.23 ± 0.08; placebo: −0.03 ± 0.08, P < 0.018), tension (TJ-54: −0.42 ± 0.09; placebo: −0.18 ± 0.09, P < 0.045), and poor impulse control (TJ-54: −0.39 ± 0.10; placebo: −0.07 ± 0.10, P < 0.037). Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.
机译:目标。我们旨在评估TJ-54(Yokukansan)在患有难治性精神分裂症患者中的疗效和安全性。进行了这项随机,多中心,双盲,安慰剂对照的研究。方法。包括120名接受抗精神病药物治疗的住院患者。患者被随机分配接受TJ-54或安慰剂的辅助治疗。在4周的随访中,使用阳性和阴性综合征量表(PANSS)评估了精神病理学。结果。 TJ-54在抗药性精神分裂症的总减少,阳性和一般PANSS评分方面显示出优于安慰剂的趋势,但按方案集(PPS)和意向性治疗(PPS)的差异均无统计学意义( ITT)。但是,在PPS分析中,与安慰剂组相比,TJ-54组由于缺乏自发性和交谈流畅性,在各个PANSS子量表得分上具有统计学上的显着改善(TJ-54:-0.23±0.08;安慰剂:-0.03± 0.08,P <0.018),张力(TJ-54:-0.42±0.09;安慰剂:-0.18±0.09,P <0.045),冲动控制差(TJ-54:-0.39±0.10;安慰剂:-0.07±0.10 ,P <0.037)。结论。本研究的结果表明,在抗药性精神分裂症中,TJ-54在降低PANSS评分方面表现出优于安慰剂的趋势,但差异无统计学意义。但是,与安慰剂组相比,TJ-54组在各个PANSS子量表得分上显示出统计学上的显着改善。

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