CAJ | 학술논문

目的：观察注射用甲磺酸齐拉西酮治疗精神发育迟滞伴发急性激越症状患者的临床疗效与安全性。方法将80例精神发育迟滞急性激越症状患者以随机数字表法随机分为两组各40例,治疗组给予注射用甲磺酸齐拉西酮肌内注射,首日首次10 mg,间隔4 h肌内注射20 mg,第2天、第3天均肌内注射1次(30 mg)。对照组给予氟哌啶醇注射液肌内注射,每次5 mg,4~6 h后重复使用。氟哌啶醇每日总量20 mg。观察期间不合用其他抗精神病药物、抗躁狂药物和苯二氮类药物,不预防性使用抗帕金森病药物。于治疗前和治疗开始后1,2,4,6,8,12,24,48,72 h采用阳性与阴性量表( PANSS)减分率、临床疗效总评量表( CGI)评定疗效,治疗结束时采用不良反应症状量表( TESS)评定安全性。结果治疗结束时 PANSS减分率治疗组46.31%,对照组48.81%；临床好转率治疗组80.00%,对照组82.50%,两组疗效差异无统计学意义；不良反应发生率治疗组(27.5%)低于对照组(40.0%),差异有统计学意义(P<0.05)。对照组锥体外系反应发生率明显高于治疗组(P<0.05)。结论注射用甲磺酸齐拉西酮治疗精神发育迟滞伴发急性激越症状有效,疗效与氟哌啶醇注射液相当,且锥体外系反应明显少于后者。
목적：관찰주사용갑광산제랍서동치료정신발육지체반발급성격월증상환자적림상료효여안전성。방법장80례정신발육지체급성격월증상환자이수궤수자표법수궤분위량조각40례,치료조급여주사용갑광산제랍서동기내주사,수일수차10 mg,간격4 h기내주사20 mg,제2천、제3천균기내주사1차(30 mg)。대조조급여불고정순주사액기내주사,매차5 mg,4~6 h후중복사용。불고정순매일총량20 mg。관찰기간불합용기타항정신병약물、항조광약물화분이담류약물,불예방성사용항파금삼병약물。우치료전화치료개시후1,2,4,6,8,12,24,48,72 h채용양성여음성량표( PANSS)감분솔、림상료효총평량표( CGI)평정료효,치료결속시채용불량반응증상량표( TESS)평정안전성。결과치료결속시 PANSS감분솔치료조46.31%,대조조48.81%；림상호전솔치료조80.00%,대조조82.50%,량조료효차이무통계학의의；불량반응발생솔치료조(27.5%)저우대조조(40.0%),차이유통계학의의(P<0.05)。대조조추체외계반응발생솔명현고우치료조(P<0.05)。결론주사용갑광산제랍서동치료정신발육지체반발급성격월증상유효,료효여불고정순주사액상당,차추체외계반응명현소우후자。
Objective To investigate the clinical efficacy and safety of ziprasidone mesylate injection on the acute agitation symptom in mental retardation. Methods The total of 80 patients of mental retardation with acute agitation symptoms were randomly divided into two groups:the treatment group (40 patients) were intra-muscarly given with ziprasidone mesylate injection at the initial dose of 10 mg, 20 mg 4 h later, and 30 mg once on the second day and third day. And the control group (40 patients) were treated with haloperidol injection. The volume dose of haloperidol was 20 mg everyday. Other antipsychotic drugs, antimanic drugs and benzodiazepines were not allowed to be used during the observation, neither does the prophylactic use of drugs against parkinson's disease. Before and 1, 2, 4, 6, 8, 12, 24, 48, 72 h after treatment, the positive and negative scale ( PANSS) reduction rate, the end of the clinical global impression scale ( CGI) were assessed. By the end of the treatment, the adverse reactions symptom, cale ( TESS) was assessed for the safety. Results By the end of treatment PANSS reduction rate was 46. 31% in the test group and 48. 81% in the control group, the clinical improvement rate was 80. 00% in the treatment group and 82. 50% in the control group. No statistically significant difference on efficacy was found between two groups. The side reaction rate in the treatment group was 27. 5%, that in the control group was 40. 0%, there was significant difference ( P<0. 05) between two groups, but the extrapyramidal reaction in the control group was significantly more than that in the treatment group(P<0. 05). Conclusion Ziprasidone mesylate injection is effective on treating the symptoms of mental retardation, in corresponding to the effect of haloperidol injection,and with less extrapyramidal reactions.