Comparison between pleurodesis results by 50% glucose solution, versus Bleomycin pleurodesis in patients with malignant pleural effusion.

International journal of physiology, pathophysiology and pharmacology Pub Date : 2023-10-15 eCollection Date: 2023-01-01
Hamid Talebzadeh, Milad Nazari Sabet
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Abstract

Background: Following parapneumonic effusions, malignant pleural effusions (MPEs) stand as the second most common cause of exudative pleural effusions. These effusions typically remain unresponsive to systemic chemotherapy, necessitating novel therapeutic approaches. This study aims to ascertain the effectiveness of intrapleural injection with a 50% glucose solution and to compare it with intrapleural injection of Bleomycin sulfate in treating malignant pleural effusion.

Methods: This prospective, double-blind, randomized clinical trial was conducted at Al-Zahra Hospital in Isfahan. The study protocol gained approval from the Iranian Registry of Clinical Trials (IRCT code: IRCT20201013049017N1) (https://en.irct.ir/trial/52739). The study population encompassed patients with malignant pleural effusion. Sampling occurred through a census approach from October 2019 to March 2020. The first group received a pleurodesis solution containing 12.5 cc of 2% lidocaine with Bleomycin, while the second group received a solution comprising 200 cc of 50% glucose solution (10 grams of glucose) and 12.5 ml of 2% lidocaine, within the same volume. These solutions were injected into the pleural space via the chest tube.

Results: The complete response rate to treatment three months post-injection was 71.9% in the Bleomycin sulfate group and 65.6% in the 50% dextrose group. However, the difference between the two groups did not achieve statistical significance (P = 0.689). The incidence of post-injection fever and pain intensity exhibited comparability in both groups.

Conclusion: The treatment involving a combination of 50% glucose solution with Bleomycin for pleurodesis in patients with malignant pleural effusion demonstrated outcomes akin to other treatment options.

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恶性胸腔积液患者50%葡萄糖溶液胸膜清除率与博来霉素胸膜清除率的比较。
背景:恶性胸腔积液是排在肺旁积液之后的第二大常见原因。这些积液通常对全身化疗没有反应,因此需要新的治疗方法。本研究旨在探讨50%葡萄糖溶液胸腔内注射治疗恶性胸腔积液的效果,并与硫酸博莱霉素胸腔内注射治疗恶性胸腔积液的效果进行比较。方法:这项前瞻性、双盲、随机临床试验在伊斯法罕的Al-Zahra医院进行。该研究方案获得了伊朗临床试验注册中心(IRCT代码:IRCT20201013049017N1) (https://en.irct.ir/trial/52739)的批准。研究人群包括恶性胸腔积液患者。从2019年10月到2020年3月,通过人口普查方法进行了抽样。第一组接受含有12.5毫升2%利多卡因和博莱霉素的胸膜溶解溶液,而第二组接受含有200毫升50%葡萄糖溶液(10克葡萄糖)和12.5毫升2%利多卡因的溶液,体积相同。这些溶液通过胸管注入胸腔。结果:注射后3个月博莱霉素组治疗完全缓解率为71.9%,50%葡萄糖组治疗完全缓解率为65.6%。但两组间差异无统计学意义(P = 0.689)。两组患者注射后发热发生率和疼痛强度具有可比性。结论:50%葡萄糖溶液联合博来霉素治疗恶性胸腔积液患者胸膜积液的效果与其他治疗方案相似。
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