中华肝脏病杂志
中華肝髒病雜誌
중화간장병잡지
CHINESE JOURNAL OF HEPATOLOGY
2009年
11期
847-851
,共5页
茅益民%曾民德%陈勇%陈成伟%傅青春%蔡雄%巫善明%陈亚岗%孙樱%李军%隋云华%赵伟%陆伦根%曹爱平%陈红专
茅益民%曾民德%陳勇%陳成偉%傅青春%蔡雄%巫善明%陳亞崗%孫櫻%李軍%隋雲華%趙偉%陸倫根%曹愛平%陳紅專
모익민%증민덕%진용%진성위%부청춘%채웅%무선명%진아강%손앵%리군%수운화%조위%륙륜근%조애평%진홍전
丙氨酸氨基转移酶%治疗%肝病%慢性%异甘草酸镁注射液
丙氨痠氨基轉移酶%治療%肝病%慢性%異甘草痠鎂註射液
병안산안기전이매%치료%간병%만성%이감초산미주사액
Alanine transaminase%Therapy%Liver diseases,chronic%Magnesium isoglycyrrhizinate
目的 通过与阳性药物复方甘草酸苷比较,观察异甘草酸镁注射液治疗ALT升高的慢性肝病的临床疗效和安全性. 方法多中心,随机、双盲、多剂量、阳性药物平行对照的试验设计,480例患者随机进入异甘草酸镁100 mg/d剂量组(A组,180例)、150 mg/d剂量组(B组,180例)和阳性药复方甘草酸苷对照组(C组,120例).试验A组:异甘草酸镁注射液100nag加入到10%葡萄糖注射液250ml中静脉滴注,1次/d;试验B组:异甘草酸镁注射液150mg加入到1%葡萄糖注射液250ml中静脉滴注,1次/d;对照组:复方甘草酸苷注射液120 mg加入到10%葡萄糖注射液250ml中静脉滴注,1次/d.疗程为4周,停药2周后随访.治疗前,治疗第2周、第4周和停药后2周观察症状、体征及ALT,AST变化情况;治疗前、治疗第4周观察其他肝功能指标.采用t检验分析计量资料,Fisher确切概率法分析计数资料,Wilcoxon秩和检验分析等级资料.组内疗效指标比较采用非参数的符号秩和检验方法,组间疗效指标比较采用中心效应的方差分析法或CMH方法.结果 412例患者按方案完成研究,其中A组152例,B组160例,C组100例.治疗2周和4周后,三组患者ALT、AST水平均明显下降(P值均<0.05);治疗2周时的ALT下降幅度,B组明显大于C组(P<0.01),治疗4周时ALT下降幅度三组间差异无统计学意义(P>0.05).治疗4周后,A,B、C组ALT改善的总有效率分别为92.59%、91.76%、88.29%,差异无统计学意义(P>0.05).4周后,A、B、C组的临床总有效率和总体疗效的总有效率分别为90.41%、89.86%、86.46%和72.22%,73.53%、68.47%,三组间差异均无统计学意义(P值均>0.05).停药后,三组患者均无明显反跳.三组患者的不良反应发生率差异无统计学意义(P>0.05).结论 异甘草酸镁注射液可以安全、有效地治疗ALT升高的慢性肝病.
目的 通過與暘性藥物複方甘草痠苷比較,觀察異甘草痠鎂註射液治療ALT升高的慢性肝病的臨床療效和安全性. 方法多中心,隨機、雙盲、多劑量、暘性藥物平行對照的試驗設計,480例患者隨機進入異甘草痠鎂100 mg/d劑量組(A組,180例)、150 mg/d劑量組(B組,180例)和暘性藥複方甘草痠苷對照組(C組,120例).試驗A組:異甘草痠鎂註射液100nag加入到10%葡萄糖註射液250ml中靜脈滴註,1次/d;試驗B組:異甘草痠鎂註射液150mg加入到1%葡萄糖註射液250ml中靜脈滴註,1次/d;對照組:複方甘草痠苷註射液120 mg加入到10%葡萄糖註射液250ml中靜脈滴註,1次/d.療程為4週,停藥2週後隨訪.治療前,治療第2週、第4週和停藥後2週觀察癥狀、體徵及ALT,AST變化情況;治療前、治療第4週觀察其他肝功能指標.採用t檢驗分析計量資料,Fisher確切概率法分析計數資料,Wilcoxon秩和檢驗分析等級資料.組內療效指標比較採用非參數的符號秩和檢驗方法,組間療效指標比較採用中心效應的方差分析法或CMH方法.結果 412例患者按方案完成研究,其中A組152例,B組160例,C組100例.治療2週和4週後,三組患者ALT、AST水平均明顯下降(P值均<0.05);治療2週時的ALT下降幅度,B組明顯大于C組(P<0.01),治療4週時ALT下降幅度三組間差異無統計學意義(P>0.05).治療4週後,A,B、C組ALT改善的總有效率分彆為92.59%、91.76%、88.29%,差異無統計學意義(P>0.05).4週後,A、B、C組的臨床總有效率和總體療效的總有效率分彆為90.41%、89.86%、86.46%和72.22%,73.53%、68.47%,三組間差異均無統計學意義(P值均>0.05).停藥後,三組患者均無明顯反跳.三組患者的不良反應髮生率差異無統計學意義(P>0.05).結論 異甘草痠鎂註射液可以安全、有效地治療ALT升高的慢性肝病.
목적 통과여양성약물복방감초산감비교,관찰이감초산미주사액치료ALT승고적만성간병적림상료효화안전성. 방법다중심,수궤、쌍맹、다제량、양성약물평행대조적시험설계,480례환자수궤진입이감초산미100 mg/d제량조(A조,180례)、150 mg/d제량조(B조,180례)화양성약복방감초산감대조조(C조,120례).시험A조:이감초산미주사액100nag가입도10%포도당주사액250ml중정맥적주,1차/d;시험B조:이감초산미주사액150mg가입도1%포도당주사액250ml중정맥적주,1차/d;대조조:복방감초산감주사액120 mg가입도10%포도당주사액250ml중정맥적주,1차/d.료정위4주,정약2주후수방.치료전,치료제2주、제4주화정약후2주관찰증상、체정급ALT,AST변화정황;치료전、치료제4주관찰기타간공능지표.채용t검험분석계량자료,Fisher학절개솔법분석계수자료,Wilcoxon질화검험분석등급자료.조내료효지표비교채용비삼수적부호질화검험방법,조간료효지표비교채용중심효응적방차분석법혹CMH방법.결과 412례환자안방안완성연구,기중A조152례,B조160례,C조100례.치료2주화4주후,삼조환자ALT、AST수평균명현하강(P치균<0.05);치료2주시적ALT하강폭도,B조명현대우C조(P<0.01),치료4주시ALT하강폭도삼조간차이무통계학의의(P>0.05).치료4주후,A,B、C조ALT개선적총유효솔분별위92.59%、91.76%、88.29%,차이무통계학의의(P>0.05).4주후,A、B、C조적림상총유효솔화총체료효적총유효솔분별위90.41%、89.86%、86.46%화72.22%,73.53%、68.47%,삼조간차이균무통계학의의(P치균>0.05).정약후,삼조환자균무명현반도.삼조환자적불량반응발생솔차이무통계학의의(P>0.05).결론 이감초산미주사액가이안전、유효지치료ALT승고적만성간병.
Objective To evaluate the efficacy and safety of Magnesium isoglycyrrhizinate intreatment of chronic liver diseases. Methods It is a randomized, double-blind, multi-doses, active drug controlled, multi-center study. 480 proper patients were randomlly devided into group A (180 patients),group B (180 patients) or group C (120 patients). Patients in group A received magnesium isoglycyrrhizinate 100 mg once daily. Patients in group B received magnesium isoglycyrrhizinate 150rag once daily. Patients in group C received compound glycyrthizin 120rag once daily. The treatment course was 4 weeks. Patients were followed up 2 weeks after the treatment. Patients visited once every 2 weeks. Clinical symptoms, ALT, AST were evaluated in all the patients before treatmenti￠at week 2, at week 4 and at 2weeks later after treatment.The other liver function test was done before treatment and at week 4. Results 412 patients completed the study according to the protocol,152 in group A, 160 in group B and 100 in group C. ALT and AST level were significantly decreased in all groups at week 2 and week 4 (P < 0.05). The degree of ALT decrease is greater in group B than in group C at week 2 (P < 0.01). The degree of ALT decrease was not significant different among three groups at week 4 (P > 0.05). The rates of ALT improvement at week 4 in group A, B, C were 92.59%, 91.76%, 88.29%, respectively (P > 0.05). The rates of symptoms improvement at week 4 in group A, B, C were 90.41%, 89.86%, 86.46% and 72.22%, 73.53%, 68.47%, respectively (P > 0.05). No relapse were found in all three groups after treatment. The rate of adverse event in three groups was similar (P > 0.05). Conclusion Magnesium isoglycyrrhizinate is an effective and safe treatment for chronic liver diseases.
