ĐÁNH GIÁ HIỆU LỰC VÀ AN TOÀN THUỐC PYRONARIDINE - ARTESUNATE (Pyramax®) TRONG ĐIỀU TRỊ SỐT RÉT DO Plasmodium falciparum CHƯA BIẾN CHỨNG TẠI TỈNH ĐĂK NÔNG (2017 - 2019)

Abstract

Background: Artemisinin - based combination therapies (ACTs) served as first - line treatment for uncomplicated falciparum malaria. However, artemisinin resistance need to have better initiatives to develop new partner drugs to protect artemisinin derivatives in ACTs, and pyronaridine in combined artesunate - pyronaridine is a current candidate. This study aimed o evaluate the efficacy and safety of pyronaridine - artesunate for treating uncomplicated P. falciparum malaria.

Methods: With study design of non - randomized uncontrolled trials (non - RCTs) of pyronaridine - artesunate for treating uncomplicated P. falciparum malaria, data collection and analysis by standard anttimalarial drug resistance protocol (WHO, 2017).

Results: Total 55 malaria patients enrolled in clinical trial and 42 - day follow - up course. Overall, the data showed the PCR - adjusted adequate clinical and parasitological response (97.6%), late parasitological failure (2.4%), slope half - life 6.73 hrs, the PC50, PC75, PC90, and PC99 is 15.21; 19.75; 23.40, and 29.78, respectively. Artesunate - pyronaridine combination is oral well - tolerance and safe, low adverse events, and some cases had mild elevated liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) without drugs’discontinuation. Conclusions: artesunate - pyronaridine have high cure rate, low side-effects may be a new ACTs in treating for unclomplicated falciparum malaria.