【文章內(nèi)容簡(jiǎn)介】 受西格列汀 100 mg/day單藥治療或與另一口服降糖藥聯(lián)用 (西格列汀 100 mg qd 或 50 mg bid) – 非暴露組 : 患者未服用西格列汀 (PBO, MET, PIO, SU, SU + MET, or ROS + MET) AHA=antihyperglycemic agent。 MET=metformin。 PBO=placebo。 PIO=pioglitazone。 ROS=rosiglitazone。 SU=sulfonylurea. WilliamsHerman D et al. BMC Endocr Disord. 2022。8:14. Copyright BioMed Central. Pooled safety and tolerability analysis 30 西格列汀治療組與非西格列汀治療組間 總體不良事件相似 Sitagliptin N=3145 n (%) Nonexposed N=2724 n (%) BetweenGroups Difference, % (95% CI)a 1次或多次臨床不良事件 2150 () 1711 () (–, ) 藥物相關(guān)臨床不良事件 b 440 () 483 () – (–, –) 嚴(yán)重臨床不良事件 230 () 184 () – (–, ) 藥物相關(guān) 嚴(yán)重 臨床不良事件 b 8 () 8 () – (–, ) 死亡， n (%) 11 () 16 () – (–, ) 中止治療 , n (%) 臨床不良事件 藥物相關(guān)臨床不良事件 嚴(yán)重臨床不良事件 藥物相關(guān)嚴(yán)重臨床不良事件 106 () 30 () 51 () 4 () 101 () 40 () 47 () 4 () – (–, ) – (–, –) – (–, ) – (–, ) AE=adverse experience。 CI=confidence interval. aPositive differences indicate that the proportion for the sitagliptin group is higher than the proportion for the nonexposed group. “ – ” represents rounding for values that are slightly less than zero. bDetermined by the investigator to be possibly, probably, or definitely drug related. WilliamsHerman D et al. BMC Endocr Disord. 2022。8:14. Copyright BioMed Central. Pooled safety and tolerability analysis 31 任一組發(fā)生的 ≥3% 的臨床不良事件 Sitagliptin N=3415 n (%) Nonexposed N=2724 n (%) BetweenGroups Difference, % (95% CI)a 任一組中 ≥3% 的臨床不良事件 腹瀉 170 () 144 () – (– , ) 支氣管炎 135 () 83 () (– , ) 流感 145 () 127 () – (– , ) 鼻咽炎 244 () 162 () (– , ) 上呼吸道感染 265 () 228 () – (– , ) 尿道感染 134 () 100 () (– , ) 低血糖 b 117 () 296 () – (– , – ) 關(guān)節(jié)痛 113 () 92 () – (– , ) 背痛 142 () 108 () (– , ) 頭痛 169 () 129 () (– , ) 高血壓 110 () 89 () – (– , ) aPositive differences indicate that the proportion for the sitagliptin group is higher than the proportion for the nonexposed group. “ – ” represents rounding for values that are slightly greater and slightly less than zero, respectively. bIncludes studies in which a sulfonylurea was an active parator or a background agent. WilliamsHerman D et al. BMC Endocr Disord. 2022。8:14. Copyright BioMed Central. Pooled safety and tolerability analysis 32 西格列汀治療組與對(duì)照組嚴(yán)重不良事件發(fā)生率相似 Sitagliptin N=3415 n (%) Nonexposed N=2724 n (%) BetweenGroups Difference, % (95% CI)a 任一組 ≥ %嚴(yán)重臨床不良事件 冠心病 5 () 7 () – (– , ) 心肌梗塞 4 () 5 () – (– , ) 非心源性胸痛 4 () 9 () – (– , ) 膽結(jié)石 6 () 2 () (– , ) 肺炎 4 () 5 () – (– , ) aPositive differences indicate that the proportion for the sitagliptin group is higher than the proportion for the nonexposed group. “” represents rounding for values that are slightly greater than zero. WilliamsHerman D et al. BMC Endocr Disord. 2022。8:14. Copyright BioMed Central. Pooled safety and tolerability analysis 33 胰腺炎發(fā)生率低，且治療組間相似 Sitagliptin N=3415 Nonexposed N=2724 作用機(jī)制可能導(dǎo)致的不良事件 胰腺炎 , % 0 急性胰腺炎 , % 0 慢性胰腺炎 , % 0 ? 兩組間胰腺炎發(fā)生率無差異 WilliamsHerman D et al. BMC Endocr Disord. 2022。8:14. Copyright BioMed Central. Pooled safety and tolerability analysis 34 安全性薈萃分析：心血管相關(guān)不良事件 Sitagliptin N=3415, % Nonexposed N=2724, % BetweenGroups Difference, % (95% CI)a 心血管相關(guān)不良事件 嚴(yán)重心血管不良事件 – (– , ) 心肌缺血不良事件 – (– , ) 嚴(yán)重心機(jī)缺血不良事件 – (– , ) AEs=adverse experiences。 CI=confidence interval。 CV=cardiovascular. aPositive differences indicate that the proportion for the sitagliptin group is higher than the proportion for the nonexposed group. WilliamsHerman D et al. BMC Endocr Disord. 2022。8:14. Copyright BioMed Central. Pooled safety and tolerability analysis 35 安全性薈萃分析： 可能與免疫功能相關(guān)的臨床不良事件 Sitagliptin N=3415 n (%) Nonexposed N=2724 n (%) BetweenGroups Difference, % (95% CI)a 發(fā)生率 ≥1% 的可能與免疫功能相關(guān)的臨床不良事件 支氣管炎 135 () 83 () (– , ) 蜂窩織炎 28 () 26 () – (– , ) 腸胃炎 68 () 48 () (– , ) 病毒性腸胃炎 29 () 27 () – (– , ) 流感 145 () 127 () – (– , ) 鼻咽炎 244 () 162 () (– , ) 咽炎 52 () 35 () (– , ) 鼻竇炎 80 () 60 () (– , ) 上呼吸道感染 265 () 228 () – (– , ) 尿道感染 134 () 100 () (– , ) 病毒感染 36 () 21 () (– , )