Tohen M, Jacobs T G, Grundy S L, McElroy S L, Banov M C, Janicak P G, Sanger T, Risser R, Zhang F, Toma V, Francis J, Tollefson G D, Breier A
Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285. USA.
Arch Gen Psychiatry. 2000 Sep;57(9):841-9. doi: 10.1001/archpsyc.57.9.841.
We compared the efficacy and safety of olanzapine vs placebo for the treatment of acute bipolar mania.
Four-week, randomized, double-blind, parallel study. A total of 115 patients with a DSM-IV diagnosis of bipolar disorder, manic or mixed, were randomized to olanzapine, 5 to 20 mg/d (n = 55), or placebo (n = 60). The primary efficacy measure was the Young-Mania Rating Scale (Y-MRS) total score. Response and euthymia were defined, a priori, as at least a 50% improvement from baseline to end point and as a score of no less than 12 at end point in the Y-MRS total score, respectively. Safety was assessed using adverse events, Extrapyramidal Symptom (EPS) rating scales, laboratory values, electrocardiograms, vital signs, and weight change.
Olanzapine-treated patients demonstrated a statistically significant greater mean (+/- SD) improvement in Y-MRS total score than placebo-treated patients (-14.8 +/- 12.5 and -8.1 +/- 12.7, respectively; P<.001), which was evident at the first postbaseline observation 1 week after randomization and was maintained throughout the study (last observation carried forward). Olanzapine-treated patients demonstrated a higher rate of response (65% vs 43%, respectively; P =.02) and euthymia (61% vs 36%, respectively; P =. 01) than placebo-treated patients. There were no statistically significant differences in EPSs between groups. However, olanzapine-treated patients had a statistically significant greater mean (+/- SD) weight gain than placebo-treated patients (2.1 +/- 2.8 vs 0.45 +/- 2.3 kg, respectively) and also experienced more treatment-emergent somnolence (21 patients [38.2%] vs 5 [8.3% ], respectively).
Olanzapine demonstrated greater efficacy than placebo in the treatment of acute bipolar mania and was generally well tolerated.
我们比较了奥氮平与安慰剂治疗急性双相躁狂症的疗效和安全性。
为期四周的随机、双盲、平行研究。总共115例符合《精神疾病诊断与统计手册》第四版（DSM-IV）双相情感障碍躁狂或混合发作诊断标准的患者被随机分为奥氮平组（5至20毫克/天，n = 55）或安慰剂组（n = 60）。主要疗效指标为杨氏躁狂量表（Y-MRS）总分。事先将缓解和心境正常分别定义为从基线到终点至少改善50%以及Y-MRS总分在终点时不低于12分。使用不良事件、锥体外系症状（EPS）评定量表、实验室检查值、心电图、生命体征和体重变化来评估安全性。
奥氮平治疗的患者在Y-MRS总分上的平均（±标准差）改善在统计学上显著大于安慰剂治疗的患者（分别为-14.8±12.5和-8.1±12.7；P<.001），这在随机分组后1周的首次基线后观察时就很明显，并在整个研究过程中持续存在（末次观察值结转）。奥氮平治疗的患者缓解率（分别为65%对43%；P =.02）和心境正常率（分别为61%对36%；P =.01）高于安慰剂治疗的患者。两组之间的EPS无统计学显著差异。然而，奥氮平治疗的患者平均（±标准差）体重增加在统计学上显著大于安慰剂治疗的患者（分别为2.1±2.8千克对0.45±2.3千克），并且出现更多治疗中出现的嗜睡情况（分别为21例患者[38.2%]对5例[8.3%]）。
奥氮平在治疗急性双相躁狂症方面显示出比安慰剂更高的疗效，并且总体耐受性良好。
