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皮下注射不同制剂重组人促红细胞生成素后的疼痛体验:一项随机、双盲交叉研究。

Experience of pain after subcutaneous administration of different preparations of recombinant human erythropoietin: a randomized, double-blind crossover study.

作者信息

Granolleras C, Leskopf W, Shaldon S, Fourcade J

机构信息

Department of Nephrology, University Hospital, Nîmes, France.

出版信息

Clin Nephrol. 1991 Dec;36(6):294-8.

PMID:1769141
Abstract

Subcutaneous erythropoietin (SCEPO) is considered to be more effective than intravenously administered erythropoietin. Patient compliance with SC injections will be important in long-term therapy as there have been reports of pain associated with SCEPO. A double-blind randomized study was performed upon 18 ESRD hemodialysis patients receiving regular subcutaneous erythropoietin replacement therapy for treatment of their anemia. The study involved pain assessment by a visual analogue scale VAS and a verbal descriptive scale VDS following 2 subcutaneous injections of preparation A: rhEPO 2000 IU in 1 ml (Cilag), preparation B: rhEPO 2000 IU in 1 ml (Boehringer Mannheim) and 0.9% saline 1 ml (placebo) over a two-week period. The injections were all administered by the same person and replaced the normal EPO injections for the patient during the study period. Results by VAS and VDS based upon 107 responses showed that preparation A was significantly more painful than preparation B (p less than 0.001) or saline (p less than 0.01). An unexpected finding was that preparation B was less painful than the placebo for VAS (p less than 0.05). It seems unlikely that the erythropoietin itself was responsible for the difference. Further work will be necessary to determine the pain causing factor in preparation A, and the possible local anaesthetic factor in preparation B.

摘要

皮下注射促红细胞生成素(SCEPO)被认为比静脉注射促红细胞生成素更有效。由于有报道称SCEPO注射会引起疼痛,因此患者对皮下注射的依从性对于长期治疗至关重要。对18例接受常规皮下促红细胞生成素替代疗法治疗贫血的终末期肾病血液透析患者进行了一项双盲随机研究。该研究包括在两周内,通过视觉模拟评分量表(VAS)和语言描述量表(VDS)对患者进行疼痛评估,评估内容为皮下注射制剂A(1毫升含重组人促红细胞生成素2000国际单位,Cilag公司生产)、制剂B(1毫升含重组人促红细胞生成素2000国际单位,勃林格殷格翰公司生产)和1毫升0.9%生理盐水(安慰剂)各2次后的情况。所有注射均由同一人进行,在研究期间替代患者的正常促红细胞生成素注射。基于107份回复的VAS和VDS结果显示,制剂A比制剂B(p<0.001)或生理盐水(p<0.01)疼痛明显更剧烈。一个意外发现是,对于VAS而言,制剂B比安慰剂疼痛程度更低(p<0.05)。促红细胞生成素本身似乎不太可能是造成这种差异的原因。有必要进一步开展研究,以确定制剂A中导致疼痛的因素,以及制剂B中可能存在的局部麻醉因素。

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