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Efficacy and safety of flurbiprofen for sore throat

Sore throat is one of the most common reasons why people turn to pharmacies to purchase drugs that have a quick symptomatic effect. Much less often in this situation, a consultation with a general practitioner and the prescription of etiopathogenetic therapy are necessary [1].

It has long been believed that the main cause of sore throat is group A b-hemolytic streptococcus (GABHS), and therefore antibiotic therapy is indicated when it occurs. The results of studies conducted in recent years call into question the validity of such treatment tactics. According to CF Dagnelie et al., A-streptococcal infection affects the upper respiratory tract only in 10–15% of cases [2]. In the work of T. P. Grishaeva [3], carried out with the involvement of a contingent of patients who visited clinics in the autumn-winter period, only 80 out of 588 patients with symptoms of acute throat infection corresponded to the diagnosis: acute A-streptococcal tonsillitis. The diagnosis was established based on the presence of at least 3 of 4 Centor clinical criteria, including: increased body temperature, enlargement and tenderness on palpation of the submandibular lymph nodes, purulent exudative phenomena in the tonsil area, absence of cough. Thus, only 13.6% of patients with acute sore throat required antibiotics. Moreover, during a bacteriological examination of throat smears, GABHS was detected in only half of them (52.5%), while the titers of antistreptolysin-O (ASLO) were increased in this entire group. Almost similar results were obtained by H. Seppala et al. [4]: Of 106 patients with sore throat examined, 49% tested negative for GABHS.

It should be taken into account that the detection of GABHS does not always indicate the presence of a true A-streptococcal infection of the pharynx, but may be a consequence of GABHS colonization in the oropharynx. To clarify the diagnosis, it is necessary to study ASLO titers over time, which is rarely carried out in routine practice [1].

In more than 70% of patients, the cause of sore throat is a viral infection [2]. Most often these are influenza viruses, parainfluenza, rhinoviruses, adenoviruses, herpes simplex virus, Epstein-Barr virus, cytomegalovirus, respiratory syncytial virus, etc. [5]. In addition to a sore throat, viral pharyngitis is usually accompanied by rhinitis, nasal congestion, and hoarseness.

Sore throat can also occur due to air pollution from industrial facilities, smokers, overstrain of the vocal cords, etc. [6].

In most patients, symptoms resolve within 7–10 days, regardless of whether they are prescribed antibiotics or not [7, 8]. Prescribing antibiotic therapy for fungal infections of the upper respiratory tract is contraindicated and can significantly worsen the course of the disease.

Thus, in the absence of risk factors, such as a newly grouped contingent (school, college, army), the presence in the family of patients with chronic rheumatic heart disease (rheumatism), glomerulonephritis, as well as in the identification of less than three Centor criteria for acute GABHS tonsillitis the prescription of antibiotics for the treatment of sore throat can be considered insufficiently justified [7, 9].

With various etiologies, the main pathogenetic mechanism for the occurrence of sore throat is inflammation. Considering the fact that any inflammation is associated with hyperfunction of the so-called “pro-inflammatory” prostaglandins, caused by the activation of the enzyme cyclooxygenase (COX), especially its isoform COX-2, it is advisable to prescribe non-steroidal anti-inflammatory drugs (NSAIDs) to relieve it.

However, oral administration of NSAIDs can lead to the development of potentially severe side effects, such as erosive and ulcerative damage to the gastric mucosa, impaired platelet aggregation, and in elderly patients - nephropathy, increased blood pressure, which is associated with the inhibitory effect of this group of drugs on the physiological COX isoform - COX-1. The prescription of selective NSAIDs, which have a predominantly COX-2 inhibitory effect, is not sufficiently justified for sore throat, since these drugs exhibit an anti-inflammatory effect more slowly than “classical” NSAIDs.

To avoid the systemic effect of NSAIDs and at the same time create longer contact of the drug with the mucous membrane of the oral cavity and pharynx, drugs from the NSAID group have been developed in the form of lozenges containing low doses of the active component. These drugs include strepfen. The active ingredient in the drug, flurbiprofen, has been used in medical practice for more than 30 years and has proven itself in the treatment of acute and chronic pain and inflammation.

For sore throat, strepfen has a rapid analgesic effect (after 15–30 minutes), which, as a result of the gradual release of the active substance, lasts for 2–3 hours [10, 11]. A study of the dose-dependent effect of flurbiprofen in the treatment of acute inflammation of the throat showed that 8.75 mg and 12.5 mg of the drug have almost the same effect, which made it possible to produce the drug in the form of lingual tablets with a minimum clinically effective dose of 8.75 mg [12], then The average therapeutic dose of flurbiprofen for systemic use is 100–300 mg/day.

The effectiveness and safety of strepfen has been confirmed in several placebo-controlled, double-blind studies, which have shown, in particular, that the incidence of ulceration of the oral mucosa is comparable to that when taking placebo [11, 13].

While taking the drug, the following occurred: changes in taste, paresthesia, dry mouth, nausea, but no serious side effects requiring discontinuation of the drug or correction of the therapy were noted.

The original large-scale study of the effectiveness and safety of strepfen was conducted in 2000 in the UK (FAST Research-Flurbiprofen Accelerated Switch Trial). The objectives of the study were to determine the incidence of side effects when taking strepfen and compare it in terms of safety of use with soluble acetylsalicylic acid 500 mg. The study involved 45 UK pharmacies through which the test drugs were dispensed.

Of the 7139 patients included in the study, 5311 took strepfen in a daily dose of no more than 5 tablets per day (1 tablet every 3 hours) and 1109 took soluble acetylsalicylic acid in a dose of 500–1000 mg every 4 hours, but not more than 8 tablets per day. day. The duration of therapy ranged from 1 to 4 days. The group of patients receiving strepfen also included 393 patients aged 12 to 17 years.

A telephone survey of patients showed that the main side effect when taking the drug was a change in taste sensations (19.7%). The development of ulcers in the oral cavity was observed in 2.5% while taking strepfen and in 3.11% when taking acetylsalicylic acid. Gastrointestinal side effects occurred in 3.56% and 3.28% of patients, respectively. When the recommended therapeutic dose of strepfen is exceeded, there was no increase in the risk of side effects, which was explained by the low content of the active substance (flurbiprofen) in the drug. Studies have also shown that strepfen combines well with antibiotics.

Given the high safety profile of strepfen, demonstrated in various studies, in the UK the drug is approved for over-the-counter use for diseases of the oropharynx.

The Institute of Rheumatology of the Russian Academy of Medical Sciences conducted a clinical trial of the drug strepfen for sore throat in patients with rheumatic diseases. The study was carried out in the autumn-winter period, a season when the number of patients seeking treatment due to this symptomatology is very high. 30 patients (7 men, 23 women) received strepfen in the form of lozenges at a dose of no more than 5 tablets per day for 3 days. The drug was prescribed as a symptomatic remedy for the treatment of sore throat in infectious and inflammatory diseases of the oral cavity and pharynx.

Exclusion criteria from the study were: gastric ulcer in the acute stage, bronchial asthma and rhinitis while taking acetylsalicylic acid or other NSAIDs, age less than 12 years.

The average age of the patients was 43.5+19.5 years (from 16 to 79 years), the duration of sore throat was from 1 to 120 days (median - 2 days).

In 17 patients included in the study, acute pharyngitis was diagnosed, mainly against the background of ARVI, in 5 - exacerbation of chronic pharyngitis, in 4 - exacerbation of chronic tonsillitis, in 3 - laryngitis, in 1 - acute tonsillitis.

The group included 9 patients diagnosed with rheumatoid arthritis, 2 patients with osteoarthritis, 14 with a diagnosis of osteochondrosis, as well as one patient each with Behcet's disease and hemorrhagic vasculitis, respectively. In addition, 5 people had concomitant diseases such as arterial hypertension (in 4 cases), chronic gastritis without exacerbation (in one case).

Due to concomitant pathology, 6 patients took strepfen in combination with other NSAIDs (diclofenac, nimesulide, solpaflex), 6 with basic drugs (plaquenil, sulfasalazine, azathioprine, leflunomide), 7 patients with oral corticosteroids, 2 with antihypertensive drugs ( enalapril, atenolol).

Before the start of the study and then every 3 hours, patients assessed the severity of sore throat and difficulty swallowing on a visual analogue scale (VAS 0–10 points), the doctor assessed: hyperemia of the pharynx area (0–5 points), severity of swelling of the palatine arches (0–5 points). 3 points), the presence of enanthema, enlargement of the cervical and submandibular lymph nodes. At the end of treatment, the patient assessed the general dynamics of inflammation in the throat and the overall effect of treatment (VAS 0–10 points), as well as drug tolerability (good, satisfactory, unsatisfactory).

Statistical processing of the obtained data was carried out using the methods of variational medical statistics (Statistica program, version 5) using the Friedman, Wilcoxon, Mann-Whitney criteria and descriptive statistics methods.

According to the results of the study, already 3 hours after the first dose of strepfen (by 12 noon on the first day of the study), a significant decrease in the severity of sore throat and difficulty swallowing was noted. Subsequently, a decrease in these parameters occurred every 3 hours (p < 0.001, Friedman). Unreliable dynamics were detected only once, at 9 a.m. on the 2nd day of the study, compared to the evening of the 1st day, when the break in taking strepfen was 12 hours (Table 1).

While taking Srepfen, the severity of symptoms such as hyperemia and swelling of the palatine arches significantly decreased (p < 0.001, Friedmen), the data are presented in Table 2. There was also a decrease in the size and number of cervical and submandibular lymph nodes (p < 0.0001, Friedmen) . Regional lymphadenopathy after the end of strepfen treatment persisted in only 11 of 20 patients who had this symptom before inclusion in the study.

At the end of the course of treatment, 18 patients receiving strepfen (60%) experienced complete recovery; in 6 (20%) cases, the condition was regarded as incomplete recovery, which, however, did not require additional therapy. In two people with ARVI, while taking strepfen, the symptoms of acute pharyngitis were relieved, but catarrhal symptoms persisted, requiring the prescription of symptomatic therapy. Antibacterial therapy was required in 4 (13%) patients (Table 3).

Tolerability of the drug in most cases (97%) was assessed as good. In one patient, when taking strepfen, a change in taste sensations was noted, which, however, did not require either discontinuation of the drug or correction of treatment. Strepfen combined well with concomitant therapy; in particular, there were no side effects in 6 patients who combined the drug with systemic use of other NSAIDs (diclofenac, nimesulide, solpaflex), and 6 patients who took “basic” drugs for the treatment of rheumatoid arthritis. There were no side effects when strepfen was co-administered and antihypertensive therapy.

To summarize, we can say that the drug strepfen, intended for topical use for sore throats, quickly and effectively suppresses the local inflammatory process in the oropharynx. Strepfen is combined with systemic NSAIDs, which is most important for patients with rheumatic diseases in cases where increasing the dose of NSAIDs to relieve inflammation and sore throat is ineffective or impossible.

To avoid a damaging effect on the mucous membrane when using strepfen, it is recommended to constantly move the tablet in the oral cavity.

It is necessary to inform patients about possible side effects of the drug and contraindications for its use (mainly NSAID tolerance, tendency to asthmatic reactions, exacerbation of gastric ulcer, cytopenia).

It should also be borne in mind that the drug is a symptomatic anti-inflammatory drug and does not prevent the development of catarrhal phenomena in ARVI. If there is no effect or insufficient effectiveness of strepfen (5 tablets per day) for 3 days, correction of the treatment regimen is necessary, followed by a decision on the prescription of antibacterial therapy.

For questions regarding literature, please contact the editor.

R. M. Balabanova , Doctor of Medical Sciences, Professor O. V. Stepanets , Candidate of Medical Sciences, Institute of Rheumatology of the Russian Academy of Medical Sciences, MMA named after. I. M. Sechenova, Moscow