Saydam, O., Karapinar, K., Gokce, M., Kilic, L., Metin, M., Oz, I.I., & Tanriverdi, O. (2015). The palliative treatment with intrapleural streptokinase in patients with multiloculated malignant pleural effusion: A double-blind, placebo-controlled, randomized study. Medical Oncology, 32, 179. 

DOI Link

Study Purpose

To study the effect of using streptokinase in pleurodesis for the management of multiloculated malignant pleural effusion (MPE)

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to either the treatment group, which received streptokinase 250,000 IU into pleural space via a thoracostomy tube, or the control group, which received 50 ml of saline at 24, 36, 48, and 60 hours post tube placement. Data were collected regarding volume of pleural drainage, chest computerized tomography (CT) images before and after treatment, dyspnea before and after treatment, and recurrence rate of effusion. Coagulation profiles were assessed prior to administering streptokinase, and all patients had a chest CT to locate the largest locule of fluid. A 20 Fr chest tube was placed and connected to an underwater seal at a continuous suction of -20 cm H2O. For both groups, daily pleural drainage at 48 and 72 hours were measured. After the third day, a CT thorax was taken and read by one radiologist. On the fourth day, pleurodesis was performed using 4 g of sterile talc. On the fifth day, the chest tubes were removed. Patients that continued to be dyspneic (oxygen dependent) were not discharged from the hospital, and nondyspneic patients were discharged (n = 29) and later evaluated in regard to whether or not they required a repeat pleural catheterization within 30 days because of the redevelopment of dyspnea.

Sample Characteristics

  • N = 40   
  • MEAN AGE = 57.8 years
  • MALES: 60%, FEMALES: 40%
  • CURRENT TREATMENT: Immunotherapy
  • KEY DISEASE CHARACTERISTICS: All had multiloculated MPE; 40% had diagnosis of lung cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: Other cancer diagnoses included breast, colon, ovarian, lymphoma, and others.

Setting

  • SITE: Not stated/unknown   
  • SETTING TYPE: Not specified    
  • LOCATION: Istanbul, Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

  • Randomized, double-blind, placebo-controlled trial

Measurement Instruments/Methods

Measurements were given as mean and standard deviations, and the two groups were compared using the Mann-Whitney U test. The chi-square test was used to compare the improvement scores of the groups via CT evaluation, dyspnea scores, and recurrence rate. SPSS, version 15.0, was also used.

Results

The differences between drainage volumes between groups was statistically significant. Mean drainage volumes for the intervention group versus the control was 493/248 at 24–48 hours, 446/198 at 48–72 hours, and 939/446 overall (p <  0.001). Dyspnea symptoms (defined as oxygen dependent) improved in 90% of the fibrinolytic group and 55% of the control group (p = 0.03). Post discharge of 29 nondyspneic (nonoxygen dependent) patients, 11% of fibrinolytic group had recurrence versus 45% of the control group (p = 0.07). A thorax CT demonstrated a 40% or greater improvement in 85% of the fibrinolytic group and 35% of the control group (p = 0.001).

Conclusions

The treatment group receiving streptokinase via a chest tube prior to pleurodesis had greater improvement in symptoms of dyspnea, greater reduction in volume of MPE, and a lower rate of effusion recurrence.

Limitations

  • Small sample (< 100)
  • Measurement/methods not well described

 

Nursing Implications

The use of fibrinolytic agents for management of MPE prior to pleurodesis may improve outcomes for reducing dyspnea and reducing recurrence post-pleurodesis leading to enhanced patient quality of life. Additional large-scale studies are indicated for validation. Having a basic understanding of pathophysiology and rationale is important for self-knowledge, patient monitoring, and education in settings using fibrinolytic therapy to treat MPE.