接受一个以上疗程治疗的患者对关节内Hylan GF-20 (Synvisc)的急性局部反应频率增加

S. Leopold, W. Warme, Patrick D Pettis, S. Shott
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引用次数: 127

摘要

背景:膝关节内注射hylan GF-20 (Synvisc)已被证明可以暂时缓解骨关节炎症状。几项研究表明,重复使用本产品的疗程可能不会增加不良反应的可能性。目前的研究是为了验证一个假设,即接受一个以上疗程治疗的患者对海兰GF-20产生疼痛反应的可能性不会增加。方法:将所有接受海兰GF-20治疗超过一个疗程的患者的记录与在同一中心15个月期间只接受一个疗程的患者进行比较。作为一项正在进行的随机试验的一部分,单疗程组被前瞻性地纳入并随访。对两组进行了人口统计学和临床参数的比较,以及注射海兰GF-20后疼痛急性局部反应的频率。结果:接受一个疗程以上治疗的患者比只接受一个疗程的患者更容易发生海兰GF-20的局部反应;前一组19例患者中有4例(21%)发生反应,后一组42例患者中有1例(2%)发生反应(p = 0.029)。所有的反应都严重到足以导致患者寻求计划外的护理。注射皮质类固醇后,反应减弱,无明显后遗症。根据现有的数据,在多疗程组和单疗程组之间,在年龄、性别、体重指数、疾病的严重程度或双侧性方面没有发现显著差异。结论:目前的研究表明,如果患者已经接受了一个疗程的海兰GF-20治疗,并且希望再接受一个疗程的治疗,那么出现疼痛的急性局部反应的可能性似乎会增加,这可能是合理的。对重复使用海兰GF-20后急性局部反应频率的进一步研究和对这些反应机制的调查是有必要的。
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Increased Frequency of Acute Local Reaction to Intra-Articular Hylan GF-20 (Synvisc) in Patients Receiving More Than One Course of Treatment
Background: Intra-articular knee injections with hylan GF-20 (Synvisc) have been shown to provide temporary relief of osteoarthritic symptoms. Several studies have suggested that repeated courses of treatment with this product may be administered without an increase in the likelihood of an adverse reaction. The present study was performed to test the hypothesis that the likelihood of a painful reaction to hylan GF-20 does not increase in patients who receive more than one course of treatment.Methods: The records of all patients who had received more than one course of treatment with hylan GF-20 were compared with a group of patients who had received only one course of treatment during the same fifteen-month period at a single center. The single-course group was prospectively enrolled and followed, as part of an ongoing randomized trial. The two groups were compared with respect to several demographic and clinical parameters as well as with respect to the frequency of painful acute local reactions following injections of hylan GF-20.Results: Local reactions to hylan GF-20 occurred significantly more often in patients who had received more than one course of treatment than they did in patients who had received only a single course of treatment; the reactions occurred in four (21%) of nineteen patients in the former group and in one (2%) of the forty-two patients in the latter (p = 0.029). All of the reactions were severe enough to cause the patient to seek unscheduled care. Following corticosteroid injection, the reactions abated without apparent sequelae. With the numbers available, no significant differences were detected between the multiple-course and single-course groups in terms of age, gender, body-mass index, or severity or bilaterality of the disease.Conclusions: The present study suggests that it may be reasonable to counsel patients who have been treated with a course of hylan GF-20 and who desire an additional course that the likelihood of a painful acute local reaction to the medication appears to be increased. Additional study of the frequency of acute local reactions following repeated courses of hylan GF-20 and investigation of the mechanisms of those reactions are warranted.
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