Sarvilina I V, Danilov A B
LLC «Medical Center «Novomedicina», Rostov-on-Don, Russia.
First Moscow State Medical University named after I.M. Sechenov, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(1):81-96. doi: 10.17116/jnevro202312301181.
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.
Data of medical records of patients (=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 (=30) received Chondroguard im., 2 ml every other day, the course of treatment was 25 injections, 25 days; Group 2 (=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 (=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 (=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.
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.
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.
对门诊治疗阶段因腰椎骨质增生和骨软骨病导致的腰骶部慢性非特异性腰痛(LBP)患者使用含硫酸软骨素的SYSADOA制剂(Chondroguard,2毫升,25支安瓿装;糖胺聚糖 - 肽复合物,1毫升,25支安瓿装;小海鱼生物活性浓缩物,2毫升,10支安瓿装)进行回顾性对比分析。
根据纳入/排除标准,对非特异性腰痛患者(n = 120;男性32例,女性88例,年龄54.1±7.6岁,疾病加重持续时间4.0±1.7个月)的病历数据进行整理。所有患者分为4组:第1组(n = 30)每2天肌肉注射Chondroguard 2毫升,疗程为25次注射,共25天;第2组(n = 30)第1天注射糖胺聚糖 - 肽复合物0.3毫升,第2天注射0.5毫升,之后每周3次,每次1毫升,疗程为25次注射,共25天;第3组(n = 30)每2天肌肉注射小海鱼生物活性浓缩物2毫升,疗程为10次注射;6个月后重复疗程;第4组(n = 30)每天服用15毫克阿美洛泰(美洛昔康),共15天。前3组所有患者均服用15毫克阿美洛泰,必要时可将剂量减至7.5毫克或完全停药。回顾性地,在门诊患者病历中,从治疗开始后的50天和6个月,根据以下参数进行动态监测:根据视觉模拟评分法(VAS)评估的疼痛强度、麦吉尔疼痛问卷简表、患者的生命体征(奥斯特里残疾指数,2.1a版[Oswestry Disability Index],以及罗兰 - 莫里斯问卷)、根据STarT Back筛查工具问卷评估的慢性疼痛综合征倾向、根据纤维肌痛快速筛查工具问卷评估的合并纤维肌痛的存在及严重程度、根据疼痛灾难化量表评估的疼痛灾难化程度、根据医院焦虑抑郁量表评估的合并焦虑和抑郁的严重程度、合并失眠的严重程度(失眠严重程度指数)、根据SF - 36量表评估的生活质量、患者对药物疗效的5分制评分、服用非甾体抗炎药和镇痛药的必要性、4分制的耐受性。使用世界卫生组织(WHO)和纳兰霍量表监测治疗安全性。
在非特异性腰痛患者中,疼痛综合征强度降低程度更大,观察6个月期间疼痛综合征发作次数更少,功能状态和生活活动得到改善,焦虑和抑郁严重程度有降低趋势,睡眠障碍和合并纤维肌痛减轻,限制了疼痛慢性化和灾难化风险,对椎间盘(IVD)有结构改善作用以及小关节退变,身心健康的生理和心理成分有显著改善,治疗满意度高且安全性好,其中包括Chondroguard与美洛昔康联用,与其他治疗方案相比在观察期第50天时美洛昔康服用需求减少。Chondroguard和美洛昔康的效果是长期的,在第6个月停用Chondroguard时仍有记录,这表明高纯度胆固醇对LBP形成的发病机制仍有影响。
该研究使我们推荐使用肠胃外形式的胆固醇(Chondroguard,俄罗斯“Sotex”制药公司股份公司)治疗中度或重度疼痛、慢性复发性或持续性病程的非特异性LBP,联合非甾体抗炎药并随后按需停用或给药。