恶性胸腔积液患者胸腔穿刺术与胸腔镜下滑石粉置入术联合留置胸膜导管与胸腔镜下滑石粉置入术成功率的比较,一项随机、非劣效临床试验

Jitanong Sootlek
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引用次数: 0

摘要

背景:恶性胸腔积液(MPE)可导致呼吸困难症状,严重影响患者的生活质量。滑石粉胸膜穿刺术或置入胸膜导管(IPC)是两种治疗方法,可预防 MPE 复发、缓解呼吸困难并提高生活质量。然而,滑石粉胸膜穿刺术需要较长的住院时间,而置入 IPC 的胸膜穿刺术成功率较低。由于医院床位有限,我们设计了一种结合 TTP 和 IPC 的实用方法来治疗 MPE。 研究目的本研究旨在评估胸腔镜滑石粉置入术(TTP)和 IPC 联合术对无症状 MPE 患者的疗效。 研究方法:该研究是在一个中心进行的随机非劣效性试验。患者被随机分配接受 TTP 和 IPC 或单纯 TTP 治疗。研究收集了人口统计学数据、住院时间(LOS)、症状和胸膜腔穿刺成功率。研究的主要结果是胸膜腔穿刺术后12周时的成功率。 研究结果对26名平均年龄为61岁的患者进行的初步数据分析显示,除了基线平均VAS呼吸困难评分显著高于TTP+IPC组之外,两组患者的基线特征相似。12周时,88.89%的TTP+IPC组和64.29%的单用TTP组患者成功进行了胸膜腔穿刺,两者相差24.6% [95% CI, -7.83% to 57.03%]。此外,TTP+IPC 组呼吸困难减轻幅度更大,术后疼痛更轻,镇痛药物用量更少。住院时间也更短,整体生活质量明显提高。此外,两组的并发症发生率没有差异。 结论胸腔镜滑石粉胸膜穿刺术和 IPC 对治疗有症状的 MPE 患者既有效又安全。
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Comparing the Success Rate of Pleurodesis with Thoracoscopic Talc Poudrage Combined with Indwelling Pleural Catheter versus Thoracoscopic Talc Poudrage in Patient with Malignant Pleural Effusion, A Randomized, Non-inferiority Clinical Trial
Background: Malignant pleural effusion (MPE) can cause dyspnea symptoms that greatly impact a patient's quality of life. Talc pleurodesis or indwelling pleural catheter (IPC) insertion are two treatment options that can prevent recurrent MPE, alleviate dyspnea, and improve quality of life. However, talc pleurodesis requires a lengthy hospital stay, while IPC insertion is associated with lower pleurodesis success rates. Due to limited hospital bed capacity, we have devised a practical approach to managing MPE by combining TTP and IPC. Objective: This study aims to evaluate the efficacy of combined Thoracoscopic talc poudrage (TTP) and IPC compared to TTP alone in patients with symptomatic MPE. Methods: The study was conducted as a randomized non-inferiority trial at a single center. Patients were randomly allocated to receive either TTP and IPC or TTP alone. The study collected demographic data, hospital length of stay (LOS), symptoms, and pleurodesis success rates. The primary outcome of the study was the success rate of pleurodesis at�12 weeks post-procedure. Results: Preliminary data analysis from 26 patients with a mean age of 61 years showed that the baseline characteristics were similar between the two groups, except for the baseline mean VAS dyspnea score, which was significantly higher in the TTP+IPC group. Successful pleurodesis at 12 weeks was achieved in 88.89% of the TTP+IPC group and 64.29% of the TTP alone group, with a difference of 24.6% [95% CI, -7.83% to 57.03%]. Additionally, the TTP+IPC group showed a greater reduction in dyspnea, less pain following the procedure, and less analgesic medication use. The hospital LOS was also shorter, and the overall quality of life was significantly better. Furthermore, there was no difference in the incidence of complications between the two groups. Conclusion: Combining thoracoscopic talc pleurodesis and IPC is both effective and safe for treating symptomatic MPE patients.
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