Study of the efficacy and safety of hexapeptide succinate in hospitalized patients with community-acquired pneumonia: a single-blind, multicenter, randomized, comparative, placebo-controlled study
Abstract
The search for treatment methods for community-acquired pneumonia (CAP) is currently urgent. Therefore, the search for new therapeutic solutions, including the use of innovative drugs with pronounced anti-inflammatory, antioxidant, and regenerative properties that help prevent lung damage and minimize complications when used as part of combination therapy, is in high demand.
The aim
of the study was to evaluate the efficacy and safety of tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate (Ambervin® Pulmo (AP), Promomed Rus LLC, Russia) in hospitalized patients with CAP.
Methods.
The study included 208 patients hospitalized with CAP and randomized into 2 groups. Along with standard therapy, patients in group 1 (n = 104) received tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate by inhalation for 10 days at a dose of 11.6 mg once daily; group 2 (n = 104) received placebo by inhalation once daily. The prescribed therapy was assessed according to primary and secondary efficacy and safety endpoints.
Results.
Clinical cure by Visit 5 (day 10) was observed in 57 (54.81%) of 104 patients receiving AP (Group 1) and in 35 (36.08%) of 97 patients in the placebo group. The mean time (± SD, per day) to achieving the criteria of clinical stability or discharge from the hospital was 2.54 ± 0.89 days in the AP group and 3.38 ± 1.64 days in the placebo group. Statistically significant advantages of AP over placebo in other secondary endpoints also indicate the high…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 208 participants or records.
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