Parenteral Troxerutin and Carbazochrome Combination in the Treatment of Post-hemorrhoidectomy Status: A Randomized, Double-blind, Placebo-controlled, Phase IV Study

Abstract

Flavonoids, such as troxerutin, have been shown to be safe and effective agents for the treatment of chronic venous insufficiency. The fixed combination between troxerutin 150 mg and carbazochrome 1.5 mg (Fleboside ampoules) was previously shown to have a good efficacy and safety profile in non-surgical patients with acute uncomplicated hemorrhoids. The purpose of this randomized, double-blind, placebo-controlled study was to investigate the efficacy and tolerability of the active combination in the treatment of post-hemorrhoidectomy patients. 30 patients were randomized to receive one of two treatments: troxerutin 150 mg and carbazochrome 1.5 mg, or placebo, i.m. 3 ml ampoules twice a day for five consecutive days after the surgical procedure, starting from the day of surgery. Efficacy parameters were assessed as follows: at baseline (T1), after the first administration (T2; day of surgery), the second day after the surgical procedure (T3), and the fifth day after the surgical procedure (T4); hemorrhoidal symptoms based on a visual analogue scale (VAS): pain, discharge, bleeding, inflammation, and pruritus; analgesic intake, if any; time to restore a physiological defecation; edema evaluation (based on a four-point scale: 0 = absent; 1 = mild; 2 = moderate; 3 = severe); camera pictures taken at T1 and T4 (in selected patients); and blood coagulation tests. Analysis between treatment groups revealed a highly significant difference at T3 and T4 for the total VAS score (p = 0.007 and p = 0.001, respectively) in favor of the active combination treatment. A statistically significant difference was also observed for bleeding and pruritus at T3 and for these two parameters and both inflammation and edema at T4 (p < 0.001) in favor of the active combination group. No adverse events were reported. Neither the active combination nor placebo affected blood coagulation tests. We conclude that intramuscular administration of the fixed combination of troxerutin 150 mg and carbazochrome 1.5 mg is effective, well tolerated and superior to placebo in improving hemorrhoidal and post-surgical symptoms during the five days following surgery.

Carbazochrome sodium sulfonate and tranexamic acid combination therapy to reduce blood transfusions after 24 h of injury: A retrospective study

“…CSS is one of the oldest drugs that has been used for various indications, such as in surgical settings, 7 , 8 , 10 , 19 , 20 gastrointestinal bleeding, 4 , 5 trauma, 6 pulmonary hemorrhage, 9 refractory chronic prostatitis 21 , hereditary hemorrhagic telangiectasia, 22 or dengue vascular permeability. 23 , 24 Accordingly, CSS has applications other than as a hemostatic agent.…”

Design, Synthesis, and Biological Evaluation of 2-Mercaptobenzoxazole Derivatives as Potential Multi-Kinase Inhibitors

“…Another important nucleus in medicinal chemistry is the N-acylhydrazone. The N-acylhydrazone scaffold (-CO-NH-N=CH-) is illustrated by the fusion between two subunits, imine and amide, which displays a broad spectrum of pharmacological activities, including antibacterial, antihemorrhagic, antitumor, and antidiarrhea properties [ 15 , 16 , 17 ]. The N-acylhydrazone derivatives are both proton donor and acceptor species, which are a required component of potent kinase inhibitors [ 18 , 19 , 20 , 21 , 22 ].…”

Combining an in silico approach with an animal experiment to investigate the protective effect of troxerutin for treating acute lung injury

“…Previous studies have shown that TRX has multiple biological functions, such as antioxidative, anti-inflammatory and antiplatelet activities [1–3]. Pretreatment with TRX can induce cardioprotection by modulating the inflammatory response after myocardial ischaemia/reperfusion injury in rat models [4]. Pre-treatment with TRX can induce cardioprotection through modulating the inflammatory response after myocardial ischaemia/reperfusion injury in rat models [1].…”