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目的探讨牛痘疫苗致炎兔皮提取物注射液(商品名:恩再适)治疗原发性纤维肌痛综合征的临床效果和安全性。方法将86例原发性纤维肌痛综合征患者随机分为两组,A组给予阿米替林25 mg/d,B组给予阿米替林12.5 mg/d加恩再适每2天6 mL治疗,分别在基线治疗2周和4周时以视觉类推量表(visual analogue scales,VAS)评估疗效,同时记录不良反应。结果与基线时相比,治疗2周时,两组的疼痛程度显著减轻(P<0.01),B组优于A组(P<0.05);治疗4周时,疼痛继续减轻,但与治疗2周比较差异无统计学意义(P>0.05),两组间的疼痛程度差异也无统计学意义(P>0.05)。不良反应,例如心悸、口干、肝酶升高等,其发生率B组显著低于A组(P<0.01)。结论恩再适联合小剂量阿米替林治疗原发性纤维肌痛综合征的疗效优于单药阿米替林,不良反应较少。
Objective To investigate the clinical efficacy and safety of injecting vaccinia vaccination rabbit skin extract (trade name: En again) in the treatment of primary fibromyalgia syndrome. Methods Totally 86 patients with primary fibromyalgia syndrome were randomly divided into two groups. A group received amitriptyline 25 mg / d, group B received amitriptyline 12.5 mg / d, mL. The therapeutic effect was assessed by visual analogue scales (VAS) at baseline and at 2 and 4 weeks respectively, and the adverse reactions were recorded. Results Compared with baseline, the two groups had a significant reduction in pain (P <0.01) at 2 weeks and group A (P <0.05), and pain continued to decrease at 4 weeks. However, compared with treatment 2 The difference was not statistically significant (P> 0.05) between the two groups. There was also no significant difference in pain between the two groups (P> 0.05). Adverse reactions, such as palpitations, dry mouth, increased liver enzymes, the incidence was significantly lower in group B than in group A (P <0.01). Conclusion Enqiu combined with low-dose amitriptyline in the treatment of primary fibromyalgia syndrome is superior to single-agent amitriptyline, with fewer adverse reactions.