OBJECTIVE

Retrospective comparative analysis of the use of SYSADOA preparations containing chondroitin sulfate (Chondroguard, 2 ml, 25 amp., glycosaminoglycan-peptide complex, 1 ml 25 amp., bioactive concentrate of small marine fish, 2 ml, 10 amp.) in patients with chronic non-specific low back pain (LBP) of lumbar and sacral localization caused by spondylosis and osteochondrosis of the lumbar spine, at the stage of outpatient care.

MATERIAL AND METHODS

Data of medical records of patients (n=120; men — 32, women — 88, age — 54.1±7.6 years, duration of disease exacerbation 4.0±1.7 months) with nonspecific LBP were systematized according to the inclusion/exclusion criteria. All patients were divided into 4 groups: Group 1 (n=30) received Chondroguard im., 2 ml every other day, the course of treatment was 25 injections, 25 days; Group 2 (n=30) received glycosaminoglycan-peptide complex on the 1st day — 0.3 ml, on the 2nd day — 0.5 ml, and then 3 times a week for 1 ml, course of treatment — 25 injections, 25 days; Group 3 (n=30) received bioactive concentrate of small marine fish, 2 ml im., every other day, the course of treatment was 10 injections; repeated courses of treatment — after 6 months; Group 4 (n=30) received Amelotex (meloxicam) at a dose of 15 mg once a day for 15 days. All patients of the first 3 groups received Amelotex at a dose of 15 mg with the possibility of reducing the dose to 7.5 mg or completely discontinuing the drug if necessary. Retrospectively, dynamic monitoring was performed in the medical records of outpatients after 50 days and 6 months from the start of therapy according to the following parameters: intensity of pain according to VAS, short form of the McGill pain questionnaire, vital signs of patients (Oswestry Disability Index, version 2.1a [Oswestry Disability Index], and Roland-Morris questionnaire), propensity to chronic pain syndrome according to the STarT Back Screening Tool questionnaire, the presence and severity of comorbid fibromyalgia according to the Fibromyalgia Rapid Screening Tool questionnaire, the level of pain catastrophization according to the Pain Catastrophizing Scale, the severity of comorbid anxiety and depression according to the Hospital Anxiety and Depression Scale, the severity comorbid insomnia (Insomnia Severity Index), quality of life according to the SF-36 scale, the effectiveness of drugs according to the patient on a 5-point scale, the need to take NSAIDs and analgesics, tolerability on a 4-point system. The safety of therapy was monitored using the WHO and Naranjo scales.

RESULTS

In patients with nonspecific LBP, a greater degree of reduction in the intensity of the pain syndrome, a smaller number of exacerbations of the pain syndrome over 6 months of observation, an improvement in the functional status and life activity, a tendency to a decrease in the severity of anxiety and depression, sleep disturbances and comorbid fibromyalgia, limiting the risk of chronicity and catastrophization of pain, the presence of a structure-modifying effect on IVD and degenerative changes in the facet joints, a significant improvement in the physical and mental components of health, high satisfaction and safety of therapy, which included taking Chondroguard with meloxicam, with a decrease in the need to take the latter by the 50th day observation period compared to other regimens. The effects of Chondroguard and meloxicam turned out to be long-term and were recorded by the 6th month in the absence of Chondroguard, which indicated the preservation of the influence of highly purified cholesterol on the pathogenetic mechanisms of the formation of LBP.

CONCLUSION

The study allows us to recommend the use of a parenteral form of cholesterol (Chondroguard, CJSC «PharmFirma «Sotex», Russia) for the treatment of nonspecific LBP with moderate or severe pain, chronic relapsing or persistent course, in combination with NSAIDs and their subsequent cancellation or administration on demand.