目的:探讨核周型抗中性粒细胞胞浆抗体(perinuclear antineutrophil cytoplasmic antibody, p-ANCA)阳性对应用维得利珠单抗(vedolizumab, VDZ)治疗的溃疡性结肠炎(ulcerative colitis, UC)患者的长期治疗临床疗效的预测价值。方法:回...目的:探讨核周型抗中性粒细胞胞浆抗体(perinuclear antineutrophil cytoplasmic antibody, p-ANCA)阳性对应用维得利珠单抗(vedolizumab, VDZ)治疗的溃疡性结肠炎(ulcerative colitis, UC)患者的长期治疗临床疗效的预测价值。方法:回顾性收集2019年1月至2024年7月在青岛大学附属医院接受VDZ治疗的中重度活动性UC患者共55例,根据p-ANCA检测结果分为阳性组及阴性组,于用药52 ± 8周时进行疗效评价,主要包括临床有效率、临床缓解率、内镜好转率及内镜愈合率,同时比较两组患者药物继发性失应答率及不良反应发生率。结果:本研究共纳入55例UC患者,其中p-ANCA阴性组患者33 (60%)例,阳性组患者22 (40%)例;与阴性组相比,阳性组临床缓解率(50.00% vs 21.21%)更高,其余临床有效率、内镜好转率和内镜愈合率差异均无统计学意义(P > 0.05);治疗期间,9 (16.36%)例患者出现继发性失应答,阴性组患者7 (21.21%)例,阳性组患者2 (9.09%)例,差异不具有统计学意义(P > 0.05);18 (32.73%)例患者出现不良反应,其中p-ANCA阴性组12 (36.36%)例,阳性组患者6 (27.27%)例,两组患者对比不具有统计学意义(P > 0.05)。结论:p-ANCA阳性组的患者在52 ± 8周时临床缓解率显著高于阴性组,提示p-ANCA对VDZ长期疗效具有一定的预测价值;两组继发性失应答率及不良反应发生率大致相似。Objective: To explore the predictive value of perinuclear antineutrophil cytoplasmic antibody (p-ANCA) positivity in the long-term clinical efficacy of ulcerative colitis (UC) patients treated with vedolizumab (VDZ). Methods: A total of 55 patients with moderately to severely active UC who received VDZ treatment at the Affiliated Hospital of Qingdao University from January 2019 to July 2024 were retrospectively collected and divided into positive and negative groups according to the p-ANCA test results. The efficacy evaluation was carried out at 52 ± 8 weeks, mainly including clinical effective rate, clinical remission rate, endoscopic improvement rate, and endoscopic healing rate. At the same time, the secondary drug non-response rate and the incidence of adverse reactions were compared between the two groups of patients. Results: A total of 55 UC patients were included in this study, including 33 (60%) patients in the p-ANCA negative group and 22 (40%) patients in the positive group;Compared with the negative group, the clinical remission rate of the positive group was higher (50.00% vs 21.21%). There was no statistical significance in the other clinical effective rates, endoscopic improvement rates and endoscopic mucosal healing rates (P > 0.05);during treatment, 9 (16.36%) patients had secondary unresponsiveness, 7 (21.21%) patients in the negative group and 2 patients in the positive group (9.09%) cases, the difference was not statistically significant (P > 0.05);18 (32.73%) patients had adverse reactions, including 12 (36.36%) patients in the p-ANCA negative group and 6 (27.27%) patients in the positive group. For example, the comparison between the two groups of patients was not statistically significant (P > 0.05). Conclusion: The clinical remission rate of patients in the p-ANCA positive group at 52 ± 8 weeks was significantly higher than that in the negative group, suggesting that p-ANCA has certain predictive value for the long-term efficacy of VDZ;The rates of secondary non response and adverse reactions were roughly similar between the two groups.展开更多
目的介绍1例维得利珠单抗(VDZ)致间质性肺炎的病例,汇总分析该药相关肺毒性的发生特点,为临床安全用药提供参考。方法从临床药师角度出发,回顾性分析1例VDZ致间质性肺炎患者的诊治过程,并进行不良反应相关性分析;检索中国知网、维普网、...目的介绍1例维得利珠单抗(VDZ)致间质性肺炎的病例,汇总分析该药相关肺毒性的发生特点,为临床安全用药提供参考。方法从临床药师角度出发,回顾性分析1例VDZ致间质性肺炎患者的诊治过程,并进行不良反应相关性分析;检索中国知网、维普网、PubMed、Web of Science等中英文数据库,对VDZ相关肺毒性的病例报道进行汇总分析。结果该患者在使用VDZ期间发生间质性肺炎,予抗菌药物经验性抗感染治疗无改善;停用VDZ并予甲泼尼龙治疗后,患者的症状及影像学检查均有改善但仍提示间质性肺炎。经Naranjo's不良反应评估量表评估并根据我国《药品不良反应报告和监测工作手册》判断,VDZ与间质性肺炎的关联性均为“很可能”。文献分析结果显示,纳入的29例患者(含本文报道的患者)中,男性19例、女性10例,平均年龄(49.24±17.06)岁;肺毒性主要包括VDZ相关性肺炎、嗜酸性粒细胞肺炎、肺肉芽肿或坏死性结节、间质性肺损伤等,多发生在用药后24周以内(58.62%),主要临床表现为咳嗽、呼吸困难、发热等;绝大多数患者经停药和/或给予糖皮质激素等治疗后好转或康复,1例患者因呼吸衰竭死亡。结论肺毒性为VDZ较罕见的不良反应,起病隐匿且症状无特异性。一旦患者出现咳嗽、呼吸困难等症状,临床应早期判断、及时停药,并给予糖皮质激素等对症治疗,以保障患者用药安全。展开更多
目的 探讨维得利珠单抗与美沙拉嗪治疗活动期溃疡性结肠炎(UC)的临床疗效及安全性。方法 选择2019年1月至2023年12月海安市人民医院活动期UC患者105例为研究对象,随机分为维得利珠单抗组(n=53)和美沙拉嗪组(n=52)。2组患者均给予常规治...目的 探讨维得利珠单抗与美沙拉嗪治疗活动期溃疡性结肠炎(UC)的临床疗效及安全性。方法 选择2019年1月至2023年12月海安市人民医院活动期UC患者105例为研究对象,随机分为维得利珠单抗组(n=53)和美沙拉嗪组(n=52)。2组患者均给予常规治疗,在此基础上维得利珠单抗组予维得利珠单抗治疗,美沙拉嗪组给予美沙拉嗪治疗。观察并对比2组患者临床疗效,治疗前后肠黏膜屏障功能相关指标、炎症因子水平及肠道菌群含量,并记录不良反应发生率。结果 维得利珠单抗组总有效率为94.34%,高于美沙拉嗪组的80.77%(χ^(2)=4.456,P <0.05)。治疗后,维得利珠单抗组D-乳酸、内毒素水平及炎症因子白细胞介素17(IL-17)、IL-23水平[分别为(4.98±1.23)μg/L、(2.26±0.92) U/mL、(206.74±15.34) pg/L、(252.93±19.43) pg/L]均低于美沙拉嗪组[分别为(6.25±1.87)μg/L、(3.41±1.13) U/mL、(224.89±16.56) pg/L、(280.32±20.89) pg/L](t=4.119、5.724、5.828、6.958,均P <0.05),乳酸杆菌、双歧杆菌含量[分别为(19.65±2.34) lg CFU/g、(17.34±1.98) lg CFU/g]高于美沙拉嗪组[分别为(14.89±1.76) lg CFU/g、(14.01±1.45) lg CFU/g],大肠杆菌、肠球菌含量[分别为(3.92±0.78) lg CFU/g、(3.71±0.56) lg CFU/g]低于美沙拉嗪组[分别为(6.25±1.23) lg CFU/g、(6.05±0.89) lg CFU/g](t=11.763、9.817、11.615、16.157,均P <0.05)。治疗期间,2组患者的不良反应发生率差异无统计学意义(P> 0.05)。结论 维得利珠单抗治疗活动期UC较美沙拉嗪能更有效地缓解临床症状,改善肠道黏膜屏障功能及菌群水平,降低炎症因子水平,且不良反应发生率低。展开更多
背景:生物制剂已成为中重度溃疡性结肠炎(UC)重要的治疗方法,研究表明维得利珠单抗(VDZ)具有较好的疗效。目的:系统评价VDZ对中重度UC的有效性和安全性。方法:检索PubMed、Web of Science、EBSCO、The Cochrane Library、中国期刊全文...背景:生物制剂已成为中重度溃疡性结肠炎(UC)重要的治疗方法,研究表明维得利珠单抗(VDZ)具有较好的疗效。目的:系统评价VDZ对中重度UC的有效性和安全性。方法:检索PubMed、Web of Science、EBSCO、The Cochrane Library、中国期刊全文数据库(CNKI)、中国生物医学文献服务系统(SinoMed)等数据库中关于VDZ、抗肿瘤坏死因子-α(TNF-α)单抗治疗中重度UC的文献,检索时限均从建库至2021年8月。按照纳入与排除标准筛选文献、提取数据,采用RevMan 5.4软件进行meta分析。结果:最终纳入11项研究、3921例患者。Meta分析结果显示,与抗TNF-α组相比,VDZ组临床应答率(OR=2.14,95%CI:1.73~2.64,P<0.00001)、临床缓解率(OR=1.67,95%CI:1.42~1.96,P<0.00001)、内镜缓解率(OR=1.62,95%CI:1.29~2.03,P<0.0001)、组织学缓解率(OR=1.98,95%CI:1.61~2.44,P<0.00001)明显升高,而两组不良反应发生率无明显差异(OR=0.51,95%CI:0.26~1.01,P=0.05)。结论:与抗TNF-α单抗相比,VDZ治疗中重度UC的疗效更确切,而不良反应发生率无明显差异。展开更多
文摘目的:探讨核周型抗中性粒细胞胞浆抗体(perinuclear antineutrophil cytoplasmic antibody, p-ANCA)阳性对应用维得利珠单抗(vedolizumab, VDZ)治疗的溃疡性结肠炎(ulcerative colitis, UC)患者的长期治疗临床疗效的预测价值。方法:回顾性收集2019年1月至2024年7月在青岛大学附属医院接受VDZ治疗的中重度活动性UC患者共55例,根据p-ANCA检测结果分为阳性组及阴性组,于用药52 ± 8周时进行疗效评价,主要包括临床有效率、临床缓解率、内镜好转率及内镜愈合率,同时比较两组患者药物继发性失应答率及不良反应发生率。结果:本研究共纳入55例UC患者,其中p-ANCA阴性组患者33 (60%)例,阳性组患者22 (40%)例;与阴性组相比,阳性组临床缓解率(50.00% vs 21.21%)更高,其余临床有效率、内镜好转率和内镜愈合率差异均无统计学意义(P > 0.05);治疗期间,9 (16.36%)例患者出现继发性失应答,阴性组患者7 (21.21%)例,阳性组患者2 (9.09%)例,差异不具有统计学意义(P > 0.05);18 (32.73%)例患者出现不良反应,其中p-ANCA阴性组12 (36.36%)例,阳性组患者6 (27.27%)例,两组患者对比不具有统计学意义(P > 0.05)。结论:p-ANCA阳性组的患者在52 ± 8周时临床缓解率显著高于阴性组,提示p-ANCA对VDZ长期疗效具有一定的预测价值;两组继发性失应答率及不良反应发生率大致相似。Objective: To explore the predictive value of perinuclear antineutrophil cytoplasmic antibody (p-ANCA) positivity in the long-term clinical efficacy of ulcerative colitis (UC) patients treated with vedolizumab (VDZ). Methods: A total of 55 patients with moderately to severely active UC who received VDZ treatment at the Affiliated Hospital of Qingdao University from January 2019 to July 2024 were retrospectively collected and divided into positive and negative groups according to the p-ANCA test results. The efficacy evaluation was carried out at 52 ± 8 weeks, mainly including clinical effective rate, clinical remission rate, endoscopic improvement rate, and endoscopic healing rate. At the same time, the secondary drug non-response rate and the incidence of adverse reactions were compared between the two groups of patients. Results: A total of 55 UC patients were included in this study, including 33 (60%) patients in the p-ANCA negative group and 22 (40%) patients in the positive group;Compared with the negative group, the clinical remission rate of the positive group was higher (50.00% vs 21.21%). There was no statistical significance in the other clinical effective rates, endoscopic improvement rates and endoscopic mucosal healing rates (P > 0.05);during treatment, 9 (16.36%) patients had secondary unresponsiveness, 7 (21.21%) patients in the negative group and 2 patients in the positive group (9.09%) cases, the difference was not statistically significant (P > 0.05);18 (32.73%) patients had adverse reactions, including 12 (36.36%) patients in the p-ANCA negative group and 6 (27.27%) patients in the positive group. For example, the comparison between the two groups of patients was not statistically significant (P > 0.05). Conclusion: The clinical remission rate of patients in the p-ANCA positive group at 52 ± 8 weeks was significantly higher than that in the negative group, suggesting that p-ANCA has certain predictive value for the long-term efficacy of VDZ;The rates of secondary non response and adverse reactions were roughly similar between the two groups.
文摘目的介绍1例维得利珠单抗(VDZ)致间质性肺炎的病例,汇总分析该药相关肺毒性的发生特点,为临床安全用药提供参考。方法从临床药师角度出发,回顾性分析1例VDZ致间质性肺炎患者的诊治过程,并进行不良反应相关性分析;检索中国知网、维普网、PubMed、Web of Science等中英文数据库,对VDZ相关肺毒性的病例报道进行汇总分析。结果该患者在使用VDZ期间发生间质性肺炎,予抗菌药物经验性抗感染治疗无改善;停用VDZ并予甲泼尼龙治疗后,患者的症状及影像学检查均有改善但仍提示间质性肺炎。经Naranjo's不良反应评估量表评估并根据我国《药品不良反应报告和监测工作手册》判断,VDZ与间质性肺炎的关联性均为“很可能”。文献分析结果显示,纳入的29例患者(含本文报道的患者)中,男性19例、女性10例,平均年龄(49.24±17.06)岁;肺毒性主要包括VDZ相关性肺炎、嗜酸性粒细胞肺炎、肺肉芽肿或坏死性结节、间质性肺损伤等,多发生在用药后24周以内(58.62%),主要临床表现为咳嗽、呼吸困难、发热等;绝大多数患者经停药和/或给予糖皮质激素等治疗后好转或康复,1例患者因呼吸衰竭死亡。结论肺毒性为VDZ较罕见的不良反应,起病隐匿且症状无特异性。一旦患者出现咳嗽、呼吸困难等症状,临床应早期判断、及时停药,并给予糖皮质激素等对症治疗,以保障患者用药安全。
文摘目的 探讨维得利珠单抗与美沙拉嗪治疗活动期溃疡性结肠炎(UC)的临床疗效及安全性。方法 选择2019年1月至2023年12月海安市人民医院活动期UC患者105例为研究对象,随机分为维得利珠单抗组(n=53)和美沙拉嗪组(n=52)。2组患者均给予常规治疗,在此基础上维得利珠单抗组予维得利珠单抗治疗,美沙拉嗪组给予美沙拉嗪治疗。观察并对比2组患者临床疗效,治疗前后肠黏膜屏障功能相关指标、炎症因子水平及肠道菌群含量,并记录不良反应发生率。结果 维得利珠单抗组总有效率为94.34%,高于美沙拉嗪组的80.77%(χ^(2)=4.456,P <0.05)。治疗后,维得利珠单抗组D-乳酸、内毒素水平及炎症因子白细胞介素17(IL-17)、IL-23水平[分别为(4.98±1.23)μg/L、(2.26±0.92) U/mL、(206.74±15.34) pg/L、(252.93±19.43) pg/L]均低于美沙拉嗪组[分别为(6.25±1.87)μg/L、(3.41±1.13) U/mL、(224.89±16.56) pg/L、(280.32±20.89) pg/L](t=4.119、5.724、5.828、6.958,均P <0.05),乳酸杆菌、双歧杆菌含量[分别为(19.65±2.34) lg CFU/g、(17.34±1.98) lg CFU/g]高于美沙拉嗪组[分别为(14.89±1.76) lg CFU/g、(14.01±1.45) lg CFU/g],大肠杆菌、肠球菌含量[分别为(3.92±0.78) lg CFU/g、(3.71±0.56) lg CFU/g]低于美沙拉嗪组[分别为(6.25±1.23) lg CFU/g、(6.05±0.89) lg CFU/g](t=11.763、9.817、11.615、16.157,均P <0.05)。治疗期间,2组患者的不良反应发生率差异无统计学意义(P> 0.05)。结论 维得利珠单抗治疗活动期UC较美沙拉嗪能更有效地缓解临床症状,改善肠道黏膜屏障功能及菌群水平,降低炎症因子水平,且不良反应发生率低。
