Clinical Focus ›› 2022, Vol. 37 ›› Issue (2): 170-173.doi: 10.3969/j.issn.1004-583X.2022.02.015
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Received:
2021-10-11
Online:
2022-02-20
Published:
2022-03-04
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URL: https://huicui.hebmu.edu.cn/EN/10.3969/j.issn.1004-583X.2022.02.015
安慰剂(n=4 904) | 恩格列净10/25 mg (n=10 177) | ||||
---|---|---|---|---|---|
例(%) | 率/ 100人年 | 例(%) | 率/ 100人年 | ||
尿路感染(BIcMQ) | 691(14.1) | 9.7 | 1 382(13.6) | 9.27 | |
生殖道感染(BIcMQ) | 75(1.5) | 0.95 | 565(5.6) | 3.54 | |
低血糖(狭义SMQ) | 1 045(21.3) | 16.32 | 2 067(20.3) | 15.69 | |
确认低血糖不良事件 | 987(20.1) | - | 1 948(19.1) | - | |
基线使用胰岛素和(或) 磺脲类后确认的低血糖a | 915(30.2) | 20.36 | 1 833(31.5) | 20.88 | |
DKA(狭义BIcMQ) | 4(0.1) | 0.05 | 6(0.1) | 0.04 | |
尿路致癌性b(BIcMQ) | 9(0.2) | 0.11 | 23(0.2) | 0.14 | |
肝损伤(SMQ) | 157(3.2) | 2.02 | 247(2.4) | 1.51 | |
骨折(BIcMQ) | 134(2.7) | 1.72 | 233(2.3) | 1.42 | |
胰腺炎(SMQ) | 11(0.2) | 0.14 | 15(0.1) | 0.09 | |
截肢风险(ITT 人群) | 46(0.9) | 0.52 | 95(0.9) | 0.52 | |
轻微 | 27(0.6) | 0.30 | 76(0.8) | 0.41 | |
严重 | 19(0.4) | 0.21 | 19(0.2) | 0.10 | |
肾损害 | 169(3.4) | 2.18 | 291(2.9) | 1.78 | |
急性肾损伤c | 44(0.9) | 0.56 | 57(0.6) | 0.34 |
安慰剂(n=4 904) | 恩格列净10/25 mg (n=10 177) | ||||
---|---|---|---|---|---|
例(%) | 率/ 100人年 | 例(%) | 率/ 100人年 | ||
尿路感染(BIcMQ) | 691(14.1) | 9.7 | 1 382(13.6) | 9.27 | |
生殖道感染(BIcMQ) | 75(1.5) | 0.95 | 565(5.6) | 3.54 | |
低血糖(狭义SMQ) | 1 045(21.3) | 16.32 | 2 067(20.3) | 15.69 | |
确认低血糖不良事件 | 987(20.1) | - | 1 948(19.1) | - | |
基线使用胰岛素和(或) 磺脲类后确认的低血糖a | 915(30.2) | 20.36 | 1 833(31.5) | 20.88 | |
DKA(狭义BIcMQ) | 4(0.1) | 0.05 | 6(0.1) | 0.04 | |
尿路致癌性b(BIcMQ) | 9(0.2) | 0.11 | 23(0.2) | 0.14 | |
肝损伤(SMQ) | 157(3.2) | 2.02 | 247(2.4) | 1.51 | |
骨折(BIcMQ) | 134(2.7) | 1.72 | 233(2.3) | 1.42 | |
胰腺炎(SMQ) | 11(0.2) | 0.14 | 15(0.1) | 0.09 | |
截肢风险(ITT 人群) | 46(0.9) | 0.52 | 95(0.9) | 0.52 | |
轻微 | 27(0.6) | 0.30 | 76(0.8) | 0.41 | |
严重 | 19(0.4) | 0.21 | 19(0.2) | 0.10 | |
肾损害 | 169(3.4) | 2.18 | 291(2.9) | 1.78 | |
急性肾损伤c | 44(0.9) | 0.56 | 57(0.6) | 0.34 |
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