Zolotovskaya I A, Davydkin I L
Samara State Medical University, Ministry of Health of Russia, Samara, Russia; Samara City Polyclinic Nine.
Samara State Medical University, Ministry of Health of Russia, Samara, Russia.
Ter Arkh. 2015;87(12):18-25. doi: 10.17116/terarkh2015871218-25.
To evaluate the safety of etoricoxib in patients with acute nonspecific back pain associated with the high risk of cardiovascular events (CVE) in clinical practice.
The open prospective follow-up by a simple randomization method included 80 patients, including 49 women and 31 men (mean 60.8±4.7 years). The patients were randomized into 4 groups of 20 persons each: 1) etoricoxib 90 mg/day; 2) nimesulide 100 mg/day; 3) diclofenac 100 mg/day; 4) meloxicam 15 mg/day. The investigation lasted 90±4.5 days. The interim evaluation criteria (study points) were pain changes using a visual analog scale (VAS); blood pressure (BP) changes; diurnal BP rhythm; and changes in coagulation hemostatic parameters and blood biochemical markers. The primary evaluation criteria (study endpoints) were the incidence of CVE in the use of nonsteroidal anti-inflammatory drugs (NSAIDs).
The patients with acute back pain were shown to have a high incidence of comorbidities during outpatient care. The administration of NSAIDs resulted in a significant reduction in the magnitude and intensity of pain syndrome according to VAS in all the groups just on day 3 of therapy with a more marked analgesia in patients receiving etoricoxib and diclofenac. All the groups exhibited an increase in average daily systolic and diastolic BP with the most favorable profile in Group 1 patients. The intake of etoricoxib and other NSAIDs provided no evidence for changes in hemostatic parameters and biochemical markers during 10 weeks. The safety of etoricoxib was comparable with that of NSAIDs in its effect on the plasma hemostatic system.
Unlike nimesulide, diclofenac, and meloxicam, etoricoxib was characterized by a rapid steady-state analgesic effect with a less pronounced action on diurnal BP rhythm. Within 3 months after treatment, no acute CVE was recorded in the patients taking etoricoxib.
在临床实践中评估依托考昔在伴有心血管事件（CVE）高风险的急性非特异性背痛患者中的安全性。
采用简单随机化方法进行开放前瞻性随访，纳入80例患者，其中女性49例，男性31例（平均年龄60.8±4.7岁）。患者被随机分为4组，每组20人：1）依托考昔90毫克/天；2）尼美舒利100毫克/天；3）双氯芬酸100毫克/天；4）美洛昔康15毫克/天。研究持续90±4.5天。中期评估标准（研究点）包括使用视觉模拟量表（VAS）评估疼痛变化；血压（BP）变化；血压昼夜节律；以及凝血止血参数和血液生化标志物的变化。主要评估标准（研究终点）是非甾体抗炎药（NSAIDs）使用过程中CVE的发生率。
门诊治疗期间，急性背痛患者的合并症发生率较高。在治疗第3天，所有组使用NSAIDs后，根据VAS评估，疼痛综合征的程度和强度均显著降低，接受依托考昔和双氯芬酸的患者镇痛效果更明显。所有组的平均每日收缩压和舒张压均升高，第1组患者的情况最有利。服用依托考昔和其他NSAIDs 10周期间，未发现止血参数和生化标志物有变化。依托考昔在对血浆止血系统的影响方面，其安全性与NSAIDs相当。
与尼美舒利、双氯芬酸和美洛昔康不同，依托考昔具有快速的稳态镇痛作用，对血压昼夜节律的影响较小。治疗后3个月内，服用依托考昔的患者未记录到急性CVE。
