中华神经医学杂志
中華神經醫學雜誌
중화신경의학잡지
CHINESE JOURNAL OF NEUROMEDICINE
2011年
2期
192-196
,共5页
罗成义%柯以铨%徐如祥%章翔%顾建文%于如同%王穗暖%王志刚%卢凯旋%万顺
囉成義%柯以銓%徐如祥%章翔%顧建文%于如同%王穗暖%王誌剛%盧凱鏇%萬順
라성의%가이전%서여상%장상%고건문%우여동%왕수난%왕지강%로개선%만순
颅脑损伤%神经功能缺失%奥拉西坦%随机对照试验%双盲法%多中心研究
顱腦損傷%神經功能缺失%奧拉西坦%隨機對照試驗%雙盲法%多中心研究
로뇌손상%신경공능결실%오랍서탄%수궤대조시험%쌍맹법%다중심연구
Craniocerebral injury%Neurological deficit%Oxiracetam%Randomized controlled trials%Double-blind method%Multi-center studies
目的 通过对注射用奥拉西坦与注射用吡拉西坦比较的临床研究,评价注射用奥拉西坦治疗颅脑损伤引起的神经功能缺失的临床疗效及安全性. 方法 本研究为随机、双盲、阳性药平行对照、多中心临床试验,收集自2006年9月至2009年1月珠江医院等5家医院收治的239例颅脑损伤和颅脑手术后患者,按照随机数字表法分为试验组(采用注射用奥拉西坦治疗,120例)和对照组(采用注射用吡拉西坦治疗,119例).比较2组治疗前后美国国立卫生研究院卒中量表(NIHSS)评分、GCS评分、肢体肌力分级、简易智能状态检查量表(MMSE)评分,观察2组的不良反应并进行心电图和实验室检查以了解其安全性. 结果 试验组和对照组NIHSS、GCS评分和肢体肌力分级治疗后较治疗前均有明显改善,差异有统计学意义(P＜0.05),但改善的程度二者差异无统计学意义(P＞0.05),且2组均无药物严重不良事件发生. 结论 注射用奥拉西坦与注射用吡拉西坦一样,在治疗颅脑损伤引起的神经功能缺失中疗效显著,安全性好.
目的 通過對註射用奧拉西坦與註射用吡拉西坦比較的臨床研究,評價註射用奧拉西坦治療顱腦損傷引起的神經功能缺失的臨床療效及安全性. 方法 本研究為隨機、雙盲、暘性藥平行對照、多中心臨床試驗,收集自2006年9月至2009年1月珠江醫院等5傢醫院收治的239例顱腦損傷和顱腦手術後患者,按照隨機數字錶法分為試驗組(採用註射用奧拉西坦治療,120例)和對照組(採用註射用吡拉西坦治療,119例).比較2組治療前後美國國立衛生研究院卒中量錶(NIHSS)評分、GCS評分、肢體肌力分級、簡易智能狀態檢查量錶(MMSE)評分,觀察2組的不良反應併進行心電圖和實驗室檢查以瞭解其安全性. 結果 試驗組和對照組NIHSS、GCS評分和肢體肌力分級治療後較治療前均有明顯改善,差異有統計學意義(P＜0.05),但改善的程度二者差異無統計學意義(P＞0.05),且2組均無藥物嚴重不良事件髮生. 結論 註射用奧拉西坦與註射用吡拉西坦一樣,在治療顱腦損傷引起的神經功能缺失中療效顯著,安全性好.
목적 통과대주사용오랍서탄여주사용필랍서탄비교적림상연구,평개주사용오랍서탄치료로뇌손상인기적신경공능결실적림상료효급안전성. 방법 본연구위수궤、쌍맹、양성약평행대조、다중심림상시험,수집자2006년9월지2009년1월주강의원등5가의원수치적239례로뇌손상화로뇌수술후환자,안조수궤수자표법분위시험조(채용주사용오랍서탄치료,120례)화대조조(채용주사용필랍서탄치료,119례).비교2조치료전후미국국립위생연구원졸중량표(NIHSS)평분、GCS평분、지체기력분급、간역지능상태검사량표(MMSE)평분,관찰2조적불량반응병진행심전도화실험실검사이료해기안전성. 결과 시험조화대조조NIHSS、GCS평분화지체기력분급치료후교치료전균유명현개선,차이유통계학의의(P＜0.05),단개선적정도이자차이무통계학의의(P＞0.05),차2조균무약물엄중불량사건발생. 결론 주사용오랍서탄여주사용필랍서탄일양,재치료로뇌손상인기적신경공능결실중료효현저,안전성호.
Objective To evaluate the efficacy and safety of oxiracetam in the treatment of neurological deficits resulting from brain injury through the comparison of oxiracetam for injection and piracetam for injection in clinical trials. Methods A multiple-center, randomized, double-blind,parallel study was performed on 239 patients; these patients were divided into experimental group (oxiracetam for injection, n=120) and control group (piracetam, n=119). National institutes of health stroke scale (NIHSS), Glasgow coma scale (GCS), myodynamia grading, mini-metal state examination (MMSE) were employed to evaluate the therapeutic effects; electrocardiogram and laboratory examination were performed, and the side effects were also observed. Results The scores of NIHSS,GCS and myodynamia grading after treatment in the 2 groups were all significantly higher than those before treatment (P＜0.05); however, no significant differences on these scores were noted between the experimental group and control group (P＞0.05). No serious adverse events were noted in both groups.Conclusion Oxiracetam, the same as piracetam, is safe and effective in the treatment of neurological deficits secondary to brain injury.
