齐拉西酮注射液治疗精神分裂症激越症状的研究

目的本研究应用氟哌啶醇注射液作为对照,评价齐拉西酮注射液治疗精神分裂症激越患者的疗效、安全性和耐受性。方法连续入组急性精神分裂症患者,按照1：1的比例随机分配到齐拉西酮注射液治疗组（试验组）和氟哌啶醇注射液治疗组（对照组）,对患者进行筛选访视、基线访视,以及肌注治疗第一剂药后的2、4、24、48h和72h的访视。采用简明精神评定量表（BPRS）评价主要疗效,Simpson-Angus量表评定药物的锥体外系反应。结果两组均纳入受试者30例。药物治疗72h后与基线比较,试验组BPRS总分减分平均为12.55±6.88,对照组BPRS总分减分平均为15.60±5.94。两组主要疗效指标差异无统计学意义（P=0.110）。试验组未见锥体外系不良反应,Simpson-Angus量表评分在治疗前后差异无统计学意义（P=0.16）;对照组出现锥体外系不良反应,治疗前后差异有统计学意义（P=0.02）。结论甲磺酸齐拉西酮注射液能够快速有效控制精神分裂症急性激越症状,疗效与氟哌啶醇注射液相当,不良反应轻微,安全性、耐受性好,值得临床推广应用。

A study of intramuscular ziprasidone and haloperidol in treating acute agitation in schizophrenia

Objective To explore the efficacy,safety and tolerance of intramuscular ziprasidone for acute agitation in Chinese schizophrenia patients contrasting with haloperidol injection.Methods The acute schizophrenia patients were enrolled consecutively.They were randomly assigned to the intramuscular ziprasidone treatment group （experimental group） and haloperidol injection treatment group （control group） with the ration of 1：1.Study visits included screening visit,baseline visit,as well as 2,4,24,48 and 72-hour point of visit after the first dose was injected.BPRS were used to assess the primary efficacy of these drugs.According to Simpson-Angus Scale,the drugs＇ adverse event of extra pyramidal symptoms （EPS） were assessed.Results Experimental group and control group both enrolled 30 cases.72 hours after treatment,compared with baseline,experimental group lowered BPRS total score by an average of 12.55 ±6.88,while control group lowered BPRS total score by an average of 15.60 ±5.94.The primary effect of the two groups had no significant difference （P=0.110）.For Simpson-Angus Scale score,there was no significant difference between the experimental group before and after treatment （P=0.16）.The control group had extrapyramidal side effects,and the difference was statistically significant （P=0.02） before and after treatment.Conclusion Ziprasidone mesylate injection can be as effective as haloperidol injection in the treatment of schizophrenia by rapidly and effectively control acute agitation symptoms.Its adverse reactions are minor and has no extrapyramidal side effects.Ziprasidone injection is effective,safe and well tolerated for schizophrenia patients with agitation symptoms and is worthy of clinical application.