药物不良反应杂志
藥物不良反應雜誌
약물불량반응잡지
ADVERSE DRUG REACTIONS JOURNAL
2015年
2期
104-111
,共8页
利拉鲁肽%超重%肥胖症%Meta分析
利拉魯肽%超重%肥胖癥%Meta分析
리랍로태%초중%비반증%Meta분석
Liraglutide%Overweight%Obesity%Meta-analysis
目的系统评价利拉鲁肽治疗超重和肥胖的安全性。方法以“liraglutide”“overweight”“obesity”“weight loss”“glucagon-like peptide-1”和“利拉鲁肽”“超重”“肥胖”“减重”“胰高血糖素样肽1”为主题词,检索Cochrane图书馆、PubMed,Medline、Embase、中国知网、维普数据库和万方数据库,筛选利拉鲁肽与安慰剂或胰岛素或艾塞那肽或格列美脲对照治疗超重和肥胖(伴或不伴糖尿病)的随机对照试验( RCT),采用RevMan 5.3.0软件进行Meta分析。安全性指标为一般不良反应(轻微低血糖、恶心、腹泻、头痛、鼻咽炎)发生率和严重不良反应(严重低血糖、胃肠道反应、胰腺炎)发生率。结果共12个RCT纳入Meta分析,超重和肥胖患者共3260例(伴和不伴2型糖尿病者各2596、664例)。药物治疗疗程为8~56周。一般不良反应发生率:利拉鲁肽组与安慰剂组分别为75.6%(436/577)和68.5%(316/461),差异有统计学意义[相对危险度( RR)=1.37,95%置信区间(CI)为1.02~1.86,P=0.04];利拉鲁肽组与艾塞那肽组分别为74.9%(176/235)和78.8%(183/232),差异无统计学意义(RR=0.95,95%CI为0.86~1.05,P=0.31);利拉鲁肽组与胰岛素组分别为57.1%(24/42)和33.3%(14/42),差异有统计学意义( RR=1.71,95%CI为1.04~2.83,P=0.04);利拉鲁肽组与格列美脲组分别为92.7%(228/246)和78.2%(194/248),差异有统计学意义(RR=1.18,95%CI为1.10~1.28,P<0.01)。一般不良反应中,利拉鲁肽组轻微低血糖发生率高于安慰剂组[17.7%(82/464)和9.6%(22/228)]、低于胰岛素组[7.5%(7/94)比21.2%(21/99)]和格列美脲组[8.1%(20/246)比24.2%(60/248)],恶心发生率高于安慰剂组[25.6%(202/790)比9.6%(54/563)],腹泻发生率高于格列美脲组[18.7%(46/246)和8.9%(22/248)],差异均有统计学意义(均P<0.01)。严重不良反应发生率:利拉鲁肽组与安慰剂组分别为4.3%(13/302)和1.9%(6/308),差异无统计学意义( RR=2.19,95%CI为0.85~5.68,P=0.11);利拉鲁肽组与艾塞那肽组分别为5.1%(12/235)和2.6%(6/232),差异无统计学意义( P=0.17)。利拉鲁肽组1例患者因胰腺炎死亡,9例患者因严重胃肠道反应退出治疗。结论利拉鲁肽治疗肥胖伴或不伴2型糖尿病患者的安全性稍逊于胰岛素和格列美脲,但患者耐受性良好。
目的繫統評價利拉魯肽治療超重和肥胖的安全性。方法以“liraglutide”“overweight”“obesity”“weight loss”“glucagon-like peptide-1”和“利拉魯肽”“超重”“肥胖”“減重”“胰高血糖素樣肽1”為主題詞,檢索Cochrane圖書館、PubMed,Medline、Embase、中國知網、維普數據庫和萬方數據庫,篩選利拉魯肽與安慰劑或胰島素或艾塞那肽或格列美脲對照治療超重和肥胖(伴或不伴糖尿病)的隨機對照試驗( RCT),採用RevMan 5.3.0軟件進行Meta分析。安全性指標為一般不良反應(輕微低血糖、噁心、腹瀉、頭痛、鼻嚥炎)髮生率和嚴重不良反應(嚴重低血糖、胃腸道反應、胰腺炎)髮生率。結果共12箇RCT納入Meta分析,超重和肥胖患者共3260例(伴和不伴2型糖尿病者各2596、664例)。藥物治療療程為8~56週。一般不良反應髮生率:利拉魯肽組與安慰劑組分彆為75.6%(436/577)和68.5%(316/461),差異有統計學意義[相對危險度( RR)=1.37,95%置信區間(CI)為1.02~1.86,P=0.04];利拉魯肽組與艾塞那肽組分彆為74.9%(176/235)和78.8%(183/232),差異無統計學意義(RR=0.95,95%CI為0.86~1.05,P=0.31);利拉魯肽組與胰島素組分彆為57.1%(24/42)和33.3%(14/42),差異有統計學意義( RR=1.71,95%CI為1.04~2.83,P=0.04);利拉魯肽組與格列美脲組分彆為92.7%(228/246)和78.2%(194/248),差異有統計學意義(RR=1.18,95%CI為1.10~1.28,P<0.01)。一般不良反應中,利拉魯肽組輕微低血糖髮生率高于安慰劑組[17.7%(82/464)和9.6%(22/228)]、低于胰島素組[7.5%(7/94)比21.2%(21/99)]和格列美脲組[8.1%(20/246)比24.2%(60/248)],噁心髮生率高于安慰劑組[25.6%(202/790)比9.6%(54/563)],腹瀉髮生率高于格列美脲組[18.7%(46/246)和8.9%(22/248)],差異均有統計學意義(均P<0.01)。嚴重不良反應髮生率:利拉魯肽組與安慰劑組分彆為4.3%(13/302)和1.9%(6/308),差異無統計學意義( RR=2.19,95%CI為0.85~5.68,P=0.11);利拉魯肽組與艾塞那肽組分彆為5.1%(12/235)和2.6%(6/232),差異無統計學意義( P=0.17)。利拉魯肽組1例患者因胰腺炎死亡,9例患者因嚴重胃腸道反應退齣治療。結論利拉魯肽治療肥胖伴或不伴2型糖尿病患者的安全性稍遜于胰島素和格列美脲,但患者耐受性良好。
목적계통평개리랍로태치료초중화비반적안전성。방법이“liraglutide”“overweight”“obesity”“weight loss”“glucagon-like peptide-1”화“리랍로태”“초중”“비반”“감중”“이고혈당소양태1”위주제사,검색Cochrane도서관、PubMed,Medline、Embase、중국지망、유보수거고화만방수거고,사선리랍로태여안위제혹이도소혹애새나태혹격렬미뇨대조치료초중화비반(반혹불반당뇨병)적수궤대조시험( RCT),채용RevMan 5.3.0연건진행Meta분석。안전성지표위일반불량반응(경미저혈당、악심、복사、두통、비인염)발생솔화엄중불량반응(엄중저혈당、위장도반응、이선염)발생솔。결과공12개RCT납입Meta분석,초중화비반환자공3260례(반화불반2형당뇨병자각2596、664례)。약물치료료정위8~56주。일반불량반응발생솔:리랍로태조여안위제조분별위75.6%(436/577)화68.5%(316/461),차이유통계학의의[상대위험도( RR)=1.37,95%치신구간(CI)위1.02~1.86,P=0.04];리랍로태조여애새나태조분별위74.9%(176/235)화78.8%(183/232),차이무통계학의의(RR=0.95,95%CI위0.86~1.05,P=0.31);리랍로태조여이도소조분별위57.1%(24/42)화33.3%(14/42),차이유통계학의의( RR=1.71,95%CI위1.04~2.83,P=0.04);리랍로태조여격렬미뇨조분별위92.7%(228/246)화78.2%(194/248),차이유통계학의의(RR=1.18,95%CI위1.10~1.28,P<0.01)。일반불량반응중,리랍로태조경미저혈당발생솔고우안위제조[17.7%(82/464)화9.6%(22/228)]、저우이도소조[7.5%(7/94)비21.2%(21/99)]화격렬미뇨조[8.1%(20/246)비24.2%(60/248)],악심발생솔고우안위제조[25.6%(202/790)비9.6%(54/563)],복사발생솔고우격렬미뇨조[18.7%(46/246)화8.9%(22/248)],차이균유통계학의의(균P<0.01)。엄중불량반응발생솔:리랍로태조여안위제조분별위4.3%(13/302)화1.9%(6/308),차이무통계학의의( RR=2.19,95%CI위0.85~5.68,P=0.11);리랍로태조여애새나태조분별위5.1%(12/235)화2.6%(6/232),차이무통계학의의( P=0.17)。리랍로태조1례환자인이선염사망,9례환자인엄중위장도반응퇴출치료。결론리랍로태치료비반반혹불반2형당뇨병환자적안전성초손우이도소화격렬미뇨,단환자내수성량호。
Objective To evaluate the safety of liraglutide treatment in patients with obesity or overweight. Methods Liraglutide,overweight,obesity,weight loss,and glucagon-like peptide-1 were selected as the key words and the Cochrane Library,PubMed,Medline,Embase,VIP,CNKI,and WanFang databases were searched. Randomized controlled trails( RCT)of liraglutide treatment for obesity or overweight were selected and the Meta-analysis were performed using RevMan 5. 3. 0 software. The safety were evaluated by the incidence of common ( mild hypoglycaemia, nausea, diarrhea, headache, nasopharyngitis)and serious adverse drug reactions( severe hypoglycaemia,gastrointestinal reactions,and pancreatitis). Results A total of 12 RCTs and 3 260 patients with overweight or obesity(2 956 and 664 patients respectively)were entered in this study. The treatment course was 8-56 weeks. The results of the incidence of common adverse drug reactions were as follows. The difference of the incidence of common adverse drug reactions in the liraglutide group[75. 6%(436/577)]and the placebo group[68. 5%(316/461)]was statistically significant[relative risk(RR)=1. 37,95% confidence interval(CI):1. 02-1. 86, P=0. 04],the difference between the liraglutide group[74. 9%(176/235)]and the exenatide group[78. 8%(183/232)]was not statistically significant( P =0. 31 ),the difference between the liraglutide group [57. 1%(24/42)]and the insulin group[75. 6%(436/577)]was statistically significant(P<0. 01),the difference between the liraglutide group[92. 7%(228/246)]and the glimepiride group[57. 1%(24/42)] was statistically significant(P<0. 01). The incidence of mild hypoglycaemia in the liraglutide group was higher than that in the placebo group[17. 7%(82/464)vs. 9. 6%(22/228)],lower than that in the insulin group[7. 5%(7/94)vs. 21. 2%(21/99)]and in the glimepiride group[8. 1%(20/246)vs. 24. 2%(60/248)],and the incidence of diarrhea in the liraglutide group was higher than that in the glimepiride group[18. 7%(46/246)vs. 8. 9%(22/248)](P < 0. 01 for all comparisons). The incidences of the serious adverse events were 4. 3%(13/302)in the liraglutide group and 2. 0%(6/308) in the placebo group(RR=2. 19,95%CI:0. 85-5. 68,P=0. 11),5. 1%(12/235)in the liraglutide group and 2. 6%(6/232)in the exenatide group. There were no statistically significant differences( P=0. 17). One patient in the liraglutide group died of pancreatitis and 9 patients stopped treatment because of serious gastrointestinal reactions. Conclusion The safety of liraglutide treatment is slightly inferior to that of insulin and glimepiride,but the patients'tolerance to liraglutide is good.