OBJECTIVE
To present the interim results of the Observational Program for monitoring the effectiveness and safety of Tafalgin in real clinical practice “NIKITA” in a group of patients receiving anticancer treatment.
MATERIAL AND METHODS
The analysis of intermediate data in separate groups of patients receiving radiation therapy and chemotherapy (RT and ChT) was carried out. The proportion of patients who responded to therapy after the first injection of Tafalgin was revealed, the analgesic effect of Tafalgin was assessed: the average time of onset and duration of analgesia, the effectiveness of anesthesia on a 10-point numerological evaluation scale (NRS); assessment of the dynamics of physical activity on the ECOG scale, the quality of night sleep, assessment of doctor satisfaction and safety of Tafalgin.
RESULTS
In the RT group, there was a statistically significant decrease in pain intensity to 3.2±2.0 on the NRS (p<0.001) 15 min. after subcutaneous injection 4 mg of Tafalgin and — 2.0± 1.5 after 1 hour. The median time to achieve the maximum analgesic effect was 13.5 (10; 30) min., and the median time to maintain the achieved analgesic effect was 360 (300; 660) min. The proportion of patients with an acceptable level of pain relief was achieved in 85% of patients. In the ChT group maximum analgesic effect was 2.4±1.7 after injection, the median time to achieve the maximum effect was 40 (30; 60) min., and to maintain the achieved analgesic effect was 240 (180; 420) min. The proportion of patients with an acceptable level of analgesia was 72.9% of patients. Side effects prevailed in ChT group and were detected in 38.9%, in the in RT group it was 15%. Severity of side effects were mild or moderate, resolved independently within 30—60 minutes. Satisfaction with the analgesic effect of Tafalgin was high in patients of both groups and in research physicians.
CONCLUSION
Tafalgin has a strong analgesic efficiency and an acceptable security profile. Tafalgin may be recommended for use in broad clinical practice in oncology in radiation and drug therapy.
