TJP-008 与含维生素 C 的 2L PEG 在结肠清洁中的疗效和安全性比较：一项随机 3 期试验。

Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial.

机构信息

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Ansan Hospital, Korea University College of Medicine, Ansan, Korea.

Department of Gastroenterology, University of Ulsan College of Medicine, Seoul, Korea.

出版信息

Gut Liver. 2022 Mar 15;16(2):259-268. doi: 10.5009/gnl210092.

BACKGROUND/AIMS: Polyethylene glycol (PEG)-based bowel preparations are effective cleansing agents for colonoscopy. However, they require relatively large volumes to be used even with agents such as 2 L PEG with ascorbate (2LPEG). This phase 3, randomized, single-blinded, multicenter, parallel-group study compared the efficacy of 1 L PEG with high-dose ascorbate, TJP-008, to 2LPEG.

METHODS

Patients undergoing colonoscopy were randomized (1:1:1) to receive TJP-008 as 1-day split dose (TJP-008-1) or 2-day split dose (TJP-008-2) regimen or to receive 2LPEG as a 2-day split dose regimen. Cleansing efficacy was evaluated using the Harefield Cleansing Scale. The primary endpoint was overall bowel cleansing success. Full analysis set (FAS) and per protocol set (PPS) analyses were performed.

RESULTS

Of the 314 screened patients, efficacy was assessed in the following patient numbers (FAS/PPS): total (293/285), TJP-008-1 (98/94), TJP-008-2 (97/95), and 2LPEG (98/96). FAS revealed noninferiority between TJP-008 and 2LPEG with regard to overall success (TJP-008-2, 99.0%; TJP-008-1, 95.9%; 2LPEG, 94.9%; p=0.100 and p=0.733, respectively). PPS also showed noninferiority (p=0.721 and p=0.211, respectively). However, the PPS analyses showed a higher bowel cleansing score for TJP-008-2 for high-quality cleansing in the right colon (TJP-008-2 83.2% vs 2LPEG 62.5%; p=0.005).

CONCLUSIONS

TJP-008 is a new low-volume cleansing agent with a colon cleansing efficacy comparable to that of standard 2LPEG that exhibits significant safety and tolerability.

背景/目的：聚乙二醇（PEG）为基础的肠道准备是有效的结肠镜检查清洁剂。然而，即使使用像 2LPEG 加抗坏血酸（2LPEG）这样的制剂，也需要使用相对较大的体积。这项 3 期、随机、单盲、多中心、平行组研究比较了 1LPEG 与高剂量抗坏血酸、TJP-008 的疗效，与 2LPEG 相比。

方法

接受结肠镜检查的患者按 1:1:1 的比例随机（1:1:1）接受 TJP-008 作为 1 天的分剂量（TJP-008-1）或 2 天的分剂量（TJP-008-2）方案，或接受 2LPEG 作为 2 天的分剂量方案。使用 Harefield 清洁量表评估清洁效果。主要终点是整体肠道清洁成功。进行了全分析集（FAS）和方案分析集（PPS）分析。

结果

在 314 名筛选患者中，以下患者数量（FAS/PPS）进行了疗效评估：总数（293/285）、TJP-008-1（98/94）、TJP-008-2（97/95）和 2LPEG（98/96）。FAS 显示 TJP-008 与 2LPEG 在整体成功率方面无差异（TJP-008-2，99.0%；TJP-008-1，95.9%；2LPEG，94.9%；p=0.100 和 p=0.733）。PPS 也显示无差异（p=0.721 和 p=0.211）。然而，PPS 分析显示 TJP-008-2 在右结肠的高质量清洁方面具有更高的肠道清洁评分（TJP-008-2 83.2%比 2LPEG 62.5%；p=0.005）。