
Chinese General Practice ›› 2024, Vol. 27 ›› Issue (32): 4085-4092.DOI: 10.12114/j.issn.1007-9572.2023.0895
Special Issue: 新型冠状病毒肺炎最新文章合辑
• Review & Perspectives • Previous Articles Next Articles
Received:2024-01-10
Revised:2024-03-15
Published:2024-11-15
Online:2024-08-08
Contact:
BAO Hairong
通讯作者:
包海荣
作者简介:作者贡献:
黄丽惠负责文章的构思与设计、负责撰写论文;舒娟、陶会会负责制定检索策略、收集与整理文献;包海荣对论文整体负责。
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URL: https://www.chinagp.net/EN/10.12114/j.issn.1007-9572.2023.0895
| 药物 | 作用机制 | 临床试验编号 | 研究阶段 | 试验类型 | 研究设计 | 主要观察指标 | 次要观察指标 |
|---|---|---|---|---|---|---|---|
| 雷帕霉素 | 抑制雷帕霉素激酶以抑制病毒复制 | NCT04948203 | Ⅱ/Ⅲ | 多中心随机不同剂量对照临床试验 | 三组每日分别服用雷帕霉素0.5 mg、1 mg、2 mg,疗程为14 d | 12周时胸部CT扫描示发生肺纤维化的比例 | 胸部CT示肺纤维化>10%、纤维化成像标志物、纤维化定量评分、肺功能等 |
| NCT04461340 | Ⅱ | 单中心随机对照临床试验 | 试验组:雷帕霉素(第1天6 mg,第2~9天2 mg)联合SoC 对照组:SoC | 14~28 d内临床症状恢复时间、14 d内病毒清除时间 | 肺部影像学表现、药物不良事件、死亡率、入住ICU比例、住院时长 | ||
| NCT04341675 | Ⅱ | 随机双盲安慰剂对照临床试验 | 试验组:雷帕霉素(第1天6 mg,以后2 mg/d),疗程为14 d或直到出院 对照组:安慰剂 | 第28天存活且不需呼吸支持的患者比例 | 治疗方案升级比例、出院患者比例、不良事件发生率、住院时长及实验室结果等 | ||
| 胶原蛋白-聚乙烯吡咯烷酮 | 下调IL-1、TNF-α、TGF-β1、ICAM-1、VCAM-1、胶原纤维的表达以减轻气道炎症和肺纤维化 | NCT04517162 | Ⅰ/Ⅱ | 随机双盲安慰剂对照临床试验 | 试验组:胶原蛋白-聚乙烯吡咯烷酮1.5 mL、1次/12 h、前3 d,1.5 mL、1次/24 h、后4 d 对照组:安慰剂 | 第14天时血氧饱和度、临床表现及淋巴细胞水平 | IP-10、TNF-α、IL-1β、IL-7、循环效应T细胞百分比及影像学表现 |
| 染料木黄酮 | 抑制核因子κB的表达和激活、减少炎性细胞因子 | NCT04482595 | Ⅱ | 随机双盲安慰剂对照临床试验 | 试验组:染料木黄酮1 500 mg/d,疗程为12周 对照组:安慰剂 | 12周时DLCO、6MWT | FVC、SGRQ、影像学纤维化征象、再次住院发生率、FEV1、FEV1/FVC、SpO2、实验室结果等 |
| 秋水仙碱 | 干扰白细胞的活化和募集,减轻炎性肺损伤和呼吸衰竭 | NCT04818489 | Ⅳ | 随机对照临床试验 | 试验组:秋水仙碱(0.5 mg、2次/d)联合SoC,疗程为3周 对照组:SoC | 2周时临床表现、2周及45 d肺纤维化患者比例 | CRP、铁蛋白、ESR、LDH、FVC、FEV1、不良事件 |
| 坎利酮钾 | 抗氧化、抗炎、抗纤维化作用 | NCT04912011 | Ⅳ | 随机安慰剂对照临床试验 | 试验组:坎利酮钾200 mg、2次/d,疗程为7 d 对照组:安慰剂 | 30 d内接受机械通气时间和被动氧疗时间 | 入住ICU时间和胸部CT、肺部超声、IL水平、6MWT等 |
| PamrevLumab | 针对CTGF的完全重组人单克隆抗体,起抗炎、抗纤维化作用 | NCT04419558 | Ⅲ | 随机双盲安慰剂对照临床试验 | 试验组:PamrevLumab 30 mg/kg每3周,疗程为48周 对照组:安慰剂 | 48周时FVC | 疾病进展的时间、肺纤维化体积、纤维化进展恶化时间等 |
| NCT05262309 | Ⅱ/Ⅲ | 随机开放平行对照临床试验 | 试验组:PamrevLumab 30 mg/kg(第1天、第7天和第14天),14 d后3周/次,疗程最长为11周 对照组:SoC | 15 d时不需呼吸机支持的患者比例 | 氧合指数、呼吸机辅助治疗时间、胸部CT对肺部病变行定量和定性评估等 | ||
| 透明质酸酶偶氮肟钠 | 催化透明质酸降低其浓度,达到抗炎、抗氧化、免疫调节等作用 | NCT04645368 | 前瞻性开放性多中心观察性队列研究 | 试验组:透明质酸酶偶氮肟钠3 000 U/次,15次/5 d 对照组:动态观察 | 第75天肺纤维化、肺间质病变的程度 | 6个月后肺纤维化和肺间质病变程度、FVC、呼吸困难评分、SpO2等 |
Table 1 Clinical research progress on other drugs for the treatment of PCPF
| 药物 | 作用机制 | 临床试验编号 | 研究阶段 | 试验类型 | 研究设计 | 主要观察指标 | 次要观察指标 |
|---|---|---|---|---|---|---|---|
| 雷帕霉素 | 抑制雷帕霉素激酶以抑制病毒复制 | NCT04948203 | Ⅱ/Ⅲ | 多中心随机不同剂量对照临床试验 | 三组每日分别服用雷帕霉素0.5 mg、1 mg、2 mg,疗程为14 d | 12周时胸部CT扫描示发生肺纤维化的比例 | 胸部CT示肺纤维化>10%、纤维化成像标志物、纤维化定量评分、肺功能等 |
| NCT04461340 | Ⅱ | 单中心随机对照临床试验 | 试验组:雷帕霉素(第1天6 mg,第2~9天2 mg)联合SoC 对照组:SoC | 14~28 d内临床症状恢复时间、14 d内病毒清除时间 | 肺部影像学表现、药物不良事件、死亡率、入住ICU比例、住院时长 | ||
| NCT04341675 | Ⅱ | 随机双盲安慰剂对照临床试验 | 试验组:雷帕霉素(第1天6 mg,以后2 mg/d),疗程为14 d或直到出院 对照组:安慰剂 | 第28天存活且不需呼吸支持的患者比例 | 治疗方案升级比例、出院患者比例、不良事件发生率、住院时长及实验室结果等 | ||
| 胶原蛋白-聚乙烯吡咯烷酮 | 下调IL-1、TNF-α、TGF-β1、ICAM-1、VCAM-1、胶原纤维的表达以减轻气道炎症和肺纤维化 | NCT04517162 | Ⅰ/Ⅱ | 随机双盲安慰剂对照临床试验 | 试验组:胶原蛋白-聚乙烯吡咯烷酮1.5 mL、1次/12 h、前3 d,1.5 mL、1次/24 h、后4 d 对照组:安慰剂 | 第14天时血氧饱和度、临床表现及淋巴细胞水平 | IP-10、TNF-α、IL-1β、IL-7、循环效应T细胞百分比及影像学表现 |
| 染料木黄酮 | 抑制核因子κB的表达和激活、减少炎性细胞因子 | NCT04482595 | Ⅱ | 随机双盲安慰剂对照临床试验 | 试验组:染料木黄酮1 500 mg/d,疗程为12周 对照组:安慰剂 | 12周时DLCO、6MWT | FVC、SGRQ、影像学纤维化征象、再次住院发生率、FEV1、FEV1/FVC、SpO2、实验室结果等 |
| 秋水仙碱 | 干扰白细胞的活化和募集,减轻炎性肺损伤和呼吸衰竭 | NCT04818489 | Ⅳ | 随机对照临床试验 | 试验组:秋水仙碱(0.5 mg、2次/d)联合SoC,疗程为3周 对照组:SoC | 2周时临床表现、2周及45 d肺纤维化患者比例 | CRP、铁蛋白、ESR、LDH、FVC、FEV1、不良事件 |
| 坎利酮钾 | 抗氧化、抗炎、抗纤维化作用 | NCT04912011 | Ⅳ | 随机安慰剂对照临床试验 | 试验组:坎利酮钾200 mg、2次/d,疗程为7 d 对照组:安慰剂 | 30 d内接受机械通气时间和被动氧疗时间 | 入住ICU时间和胸部CT、肺部超声、IL水平、6MWT等 |
| PamrevLumab | 针对CTGF的完全重组人单克隆抗体,起抗炎、抗纤维化作用 | NCT04419558 | Ⅲ | 随机双盲安慰剂对照临床试验 | 试验组:PamrevLumab 30 mg/kg每3周,疗程为48周 对照组:安慰剂 | 48周时FVC | 疾病进展的时间、肺纤维化体积、纤维化进展恶化时间等 |
| NCT05262309 | Ⅱ/Ⅲ | 随机开放平行对照临床试验 | 试验组:PamrevLumab 30 mg/kg(第1天、第7天和第14天),14 d后3周/次,疗程最长为11周 对照组:SoC | 15 d时不需呼吸机支持的患者比例 | 氧合指数、呼吸机辅助治疗时间、胸部CT对肺部病变行定量和定性评估等 | ||
| 透明质酸酶偶氮肟钠 | 催化透明质酸降低其浓度,达到抗炎、抗氧化、免疫调节等作用 | NCT04645368 | 前瞻性开放性多中心观察性队列研究 | 试验组:透明质酸酶偶氮肟钠3 000 U/次,15次/5 d 对照组:动态观察 | 第75天肺纤维化、肺间质病变的程度 | 6个月后肺纤维化和肺间质病变程度、FVC、呼吸困难评分、SpO2等 |
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