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Efficacy and safety of recombinant human tumor necrosis factor application for the treatment of malignant pleural effusion caused by lung cancer

机译:重组人肿瘤坏死因子治疗肺癌恶性胸腔积液的疗效和安全性

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摘要

Malignant pleural effusion (MPE) signifies a poor prognosis for patients with lung cancer. For treating physicians, the primary goals are to achieve sufficient control of MPE and minimize invasive intervention. Recombinant human mutant tumor necrosis factor‐alpha (rhu‐TNF) has been used in the treatment of MPE. The aim of our research was to evaluate the efficacy and safety of rhu‐TNF application via ultrasound‐guided chest tube for the treatment of MPE. rhu‐TNF was administered as a single dose to 102 patients with MPE caused by lung cancer, and dexamethasone (Dxm, 5 mg) was administered 30 minutes before rhu‐TNF in 35 randomly selected patients in order test its ability to prevent side effects. The primary endpoint was the efficacy of the rhu‐TNF treatment (disease response rate) and side effects (pain, fever, and flu‐like symptoms), evaluated four weeks after instillation. The disease response rate of rhu‐TNF treatment was 81.37%. Side effects included 13 (12.75%) patients complaining of flu‐like symptoms, 15 (14.71%) with fever/chill, and 14 (13.73%) with chest pain. A significantly higher efficacy was observed for treatment with 3 MU versus 2 MU of rhu‐TNF (P = 0.036), while the adverse effects were similar. There was no significant association between the dose of rhu‐TNF and progression‐free survival (P = 0.752). In conclusion, our study shows that intra‐pleural instillation of rhu‐TNF achieves sufficient control of MPE and minimizes invasive intervention.
机译:恶性胸腔积液(MPE)表示肺癌患者预后不良。对于治疗医师而言,主要目标是实现对MPE的充分控制并最大程度地减少侵入性干预。重组人突变型肿瘤坏死因子-α(rhu-TNF)已用于治疗MPE。我们研究的目的是评估通过超声引导胸管应用rhu-TNF治疗MPE的有效性和安全性。对102例由肺癌引起的MPE患者以单一剂量给予rhu-TNF,并在35位随机选择的患者中于rhu-TNF之前30分钟给予地塞米松(Dxm,5μmg),以测试其预防副作用的能力。主要终点是滴注后四周评估的rhu-TNF治疗的功效(疾病反应率)和副作用(疼痛,发烧和流感样症状)。 rhu-TNF治疗的疾病反应率为81.37%。副作用包括13名(12.75%)抱怨有流感样症状的患者,15名(14.71%)发烧/发冷的患者和14名(13.73%)的胸痛的患者。相对于2 MU的rhu-TNF,治疗3 MU的疗效显着提高(P = 0.036),而不良反应相似。 rhu-TNF剂量与无进展生存期之间无显着关联(P = 0.752)。总之,我们的研究表明,胸膜内滴入rhu-TNF可实现对MPE的充分控制,并最大限度地减少了侵入性干预。

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