CAJ | 학술논문

目的：比较甲磺酸齐拉西酮注射液和氟哌啶醇注射液对精神分裂症急性激越症状的疗效和安全性。方法将86例伴急性激越症状的精神分裂症患者分为观察组（n＝43）和对照组（n＝43），进行随机单盲临床对照研究，观察组给予注射用甲磺酸齐拉西酮10～20 mg／次肌内注射，每日总量不超过40 mg ；对照组给予氟哌啶醇针剂5～10 mg／次肌内注射，每日总量不超过30 m g。两组药物根据病情需要4～6 h后可重复使用，每日注射不超过3次，疗程3 d。于治疗前和治疗后2、6、24、48、72 h采用阳性与阴性症状量表兴奋因子（PANSS‐EC）评定激越症状，于治疗前、治疗后72 h采用阳性和阴性症状量表（PANSS）、临床疗效总评量表‐病情严重程度（CGI‐SI）评价疗效；采用锥体外系不良反应量表（SAS）、药物不良反应量表（TESS）、实验室检查评价不良反应。结果与治疗前比较，观察组在治疗后2 h PANSS‐EC评分即显著降低，其他各观察点 PANSS总分、PANSS‐EC评分及CGI‐SI评分均显著下降（P＜0．01）；但观察组和对照组组间差异无统计学意义（P＞0．05）。两组临床总有效率差异无统计学意义（ P＞0．05）。两组均未出现严重不良事件，观察组药物不良反应发生率为37．21％，显著低于对照组的53．49％（ P＜0．05）。结论注射用甲磺酸齐拉西酮能有效治疗精神分裂症患者急性激越症状，疗效与氟哌啶醇相当，不良反应发生率更低，安全性好。
목적：비교갑광산제랍서동주사액화불고정순주사액대정신분렬증급성격월증상적료효화안전성。방법장86례반급성격월증상적정신분렬증환자분위관찰조（n＝43）화대조조（n＝43），진행수궤단맹림상대조연구，관찰조급여주사용갑광산제랍서동10～20 mg／차기내주사，매일총량불초과40 mg ；대조조급여불고정순침제5～10 mg／차기내주사，매일총량불초과30 m g。량조약물근거병정수요4～6 h후가중복사용，매일주사불초과3차，료정3 d。우치료전화치료후2、6、24、48、72 h채용양성여음성증상량표흥강인자（PANSS‐EC）평정격월증상，우치료전、치료후72 h채용양성화음성증상량표（PANSS）、림상료효총평량표‐병정엄중정도（CGI‐SI）평개료효；채용추체외계불량반응량표（SAS）、약물불량반응량표（TESS）、실험실검사평개불량반응。결과여치료전비교，관찰조재치료후2 h PANSS‐EC평분즉현저강저，기타각관찰점 PANSS총분、PANSS‐EC평분급CGI‐SI평분균현저하강（P＜0．01）；단관찰조화대조조조간차이무통계학의의（P＞0．05）。량조림상총유효솔차이무통계학의의（ P＞0．05）。량조균미출현엄중불량사건，관찰조약물불량반응발생솔위37．21％，현저저우대조조적53．49％（ P＜0．05）。결론주사용갑광산제랍서동능유효치료정신분렬증환자급성격월증상，료효여불고정순상당，불량반응발생솔경저，안전성호。
Objective To compare the curative effect and safety between ziprasidone injection and haloperidol injection in the treatment of acute agitation of schizophrenia .Methods Totally 86 patients with acute agitation of schizophrenia were divided into observational group(n=43)and control group(n=43) ,the study used a random ,single‐blinded and clinical controlled experiment . the observational group was given ziprasidone mesylate 10-20 mg every time by intramuscular injection and the amount was less than 40 mg every day ;control group was given haloperidol injection 5-10 mg every time by intramuscular injection and the amount was less than 30 mg every day .Drugs in the two groups could be repeated according to the state of illness after 4-6 hours ,and the daily injections were no more than 3 times and the course of treatment was 3 days .The Positive and Negative Symptoms Scale Ex‐cited Factor(PANSS‐EC)was used to evaluate the agitated symptoms before treatment and 2 ,6 ,24 ,48 ,72 hours after treatment ,the Positive and Negative Symptoms Scale(PANSS)and Clinical Global Impression Scale‐Severity of Illness(CGI‐SI)was used to evalu‐ate the curative effect ;extrapyramidal side adverse reaction(SAS) ,Treatment Emergent Symptoms Scale(TESS)and the related lab tests were employed to assess the adverse reaction .Results Comparing with the baseline ,PANSS‐EC score of observe group de‐creased significantly at 2 h after the treatment ;at other observation time‐points ,PANSS scores ,PANSS‐EC scores and CGI‐SI scores in the two groups both decreased significantly(P<0 .01);but with no significant difference between the two groups(P>0 .05) .There were no significant difference in the total effective rate between the two groups(P>0 .05) .There were no serious ad‐verse events in the two groups .incidences of adverse reactions of observe group were 37 .21% ,which were significantly lower than that of control group 53 .49% (P<0 .05) .Conclusion Effect of ziprasidone injection and haloperidol injection was comparable in the treating acute agitation of schizophrenia ,which could treat acute agitation of schizophrenia with low incidences and excellent se‐curity .