中华内科杂志
中華內科雜誌
중화내과잡지
CHINESE JOURNAL OF INTERNAL MEDICINE
2011年
1期
23-26
,共4页
车婷婷%王曦%刘圆圆%田浩明%杨刚毅%徐勉%肖常青%朱旅云%吕肖锋%喻红玲%张翔迅%任艳
車婷婷%王晞%劉圓圓%田浩明%楊剛毅%徐勉%肖常青%硃旅雲%呂肖鋒%喻紅玲%張翔迅%任豔
차정정%왕희%류원원%전호명%양강의%서면%초상청%주려운%려초봉%유홍령%장상신%임염
胰岛素%糖尿病%可重复性,结果%安全
胰島素%糖尿病%可重複性,結果%安全
이도소%당뇨병%가중복성,결과%안전
Insulin%Diabetes mellitus%Reproducibility of results%Safety
目的 多中心、随机、开放、阳性药物对照评价重组人胰岛素注射液(优思灵R)治疗糖尿病的有效性和安全性.方法 共人选糖尿病患者211例,按1∶1比例随机进入优思灵R组(106例)和诺和灵R组(105例).比较两组受试者治疗12周前后糖化血红蛋白(HbA1c)、空腹血糖(FPG)、混合餐后2 h血糖(2hPG)水平以及低血糖事件和不良事件的发生率.结果 治疗12周后,优思灵R组和诺和灵R组HbA1c分别从10.77%和10.33%下降至7.72%和7.62%;2hPG分别从15.49 mmol/L和15.33 mmol/L下降至9.72 mmol/L和10.07 mmol/L;FPG分别从10.90 mmol/L和10.22 mmol/L下降至7.31 mmol/L和7.21 mmol/L.两组上述各指标治疗前后比较P值均＜0.05,但组间比较差异均无统计学意义(P值均＞0.05).此外,优思灵R组和诺和灵R组低血糖事件(26.42%比30.48%)、其他不良事件(13.21%比16.19%)及严重不良事件的发生率(1.89%比1.90%)差异均无统计学意义(P值均＞0.05).结论 优思灵R控制总体血糖的能力与诺和灵R相当,并有较好的安全性和依从性.
目的 多中心、隨機、開放、暘性藥物對照評價重組人胰島素註射液(優思靈R)治療糖尿病的有效性和安全性.方法 共人選糖尿病患者211例,按1∶1比例隨機進入優思靈R組(106例)和諾和靈R組(105例).比較兩組受試者治療12週前後糖化血紅蛋白(HbA1c)、空腹血糖(FPG)、混閤餐後2 h血糖(2hPG)水平以及低血糖事件和不良事件的髮生率.結果 治療12週後,優思靈R組和諾和靈R組HbA1c分彆從10.77%和10.33%下降至7.72%和7.62%;2hPG分彆從15.49 mmol/L和15.33 mmol/L下降至9.72 mmol/L和10.07 mmol/L;FPG分彆從10.90 mmol/L和10.22 mmol/L下降至7.31 mmol/L和7.21 mmol/L.兩組上述各指標治療前後比較P值均＜0.05,但組間比較差異均無統計學意義(P值均＞0.05).此外,優思靈R組和諾和靈R組低血糖事件(26.42%比30.48%)、其他不良事件(13.21%比16.19%)及嚴重不良事件的髮生率(1.89%比1.90%)差異均無統計學意義(P值均＞0.05).結論 優思靈R控製總體血糖的能力與諾和靈R相噹,併有較好的安全性和依從性.
목적 다중심、수궤、개방、양성약물대조평개중조인이도소주사액(우사령R)치료당뇨병적유효성화안전성.방법 공인선당뇨병환자211례,안1∶1비례수궤진입우사령R조(106례)화낙화령R조(105례).비교량조수시자치료12주전후당화혈홍단백(HbA1c)、공복혈당(FPG)、혼합찬후2 h혈당(2hPG)수평이급저혈당사건화불량사건적발생솔.결과 치료12주후,우사령R조화낙화령R조HbA1c분별종10.77%화10.33%하강지7.72%화7.62%;2hPG분별종15.49 mmol/L화15.33 mmol/L하강지9.72 mmol/L화10.07 mmol/L;FPG분별종10.90 mmol/L화10.22 mmol/L하강지7.31 mmol/L화7.21 mmol/L.량조상술각지표치료전후비교P치균＜0.05,단조간비교차이균무통계학의의(P치균＞0.05).차외,우사령R조화낙화령R조저혈당사건(26.42%비30.48%)、기타불량사건(13.21%비16.19%)급엄중불량사건적발생솔(1.89%비1.90%)차이균무통계학의의(P치균＞0.05).결론 우사령R공제총체혈당적능력여낙화령R상당,병유교호적안전성화의종성.
Objective A multicenter, randomized, controlled and open-labled clinical trial was performed to compare the efficacy and safety of recombinant human insulin injection ( Yousilin R) and treated with Yousilin R versus Novolin R for 12 weeks respectively. Results Compared with baseline,the levels of glycosylated hemoglobin A1c ( HbA1c ) at the end of 12 weeks treatment decreased from 10. 77% to 7. 72% ( P ＜0. 05 ) in Yousilin R group and from 10. 33% to 7. 62% ( P ＜0. 05 ) in Novolin R group,2-hour postprandial plasma glucose ( 2hPG ) decreased from 15.49 mmol/L to 9. 72 mmol/L ( P ＜ 0. 05 ) in Yousilin R group and from 15.33 mmol/L to 10. 07 mmol/L( P ＜ 0. 05 ) in Novolin R group, and fasting plasma glucose (FPG) decreased from 10. 90 mmol/L to 7. 31 mmol/L( P ＜0. 05 ) in Yousilin R group and from 10. 22 mmol/L to 7.21 mmol/L (P ＜0. 05) in Novolin R group. The changes of HbA1c, 2hPG and FPG from baseline to endpoint in Yousilin R group was similar to those in Novolin R group ( P ＞ 0. 05 ).Furthermore, hypoglycemic events(26. 42% vs 30. 48% ), other adverse events( 13.21%vs 16. 19% ) ,and serious adverse events( 1.89%vs 1.90% )were comparable between Yousilin R and Novolin R groups(P ＞0. 05 ). Conclusions Yousilin R has similar efficacy, safety and compliance profiles to Novolin R group in the treatment of diabetic patients.
