皮下注生物学的製剤の注射時痛に関する検討
目的：生物学的製剤の使用で関節リウマチ（RA）患者のquality of lifeは向上した．しかし，皮下注生物学的製剤の注射時痛を強く訴える患者が存在する．今回，皮下注射製剤の注射時痛を検討した． 対象・方法：エタネルセプト（ETN），アダリムマブ（ADA），ゴリムマブ（GOL）を１剤以上使用したことのあるRA患者123例を対象とし，痛みのVASスケールを用いて注射時痛を評価した． 結果：VAS値（中央値，IQR）はETN（41，22-55），ADA（59，30-82），GOL（35，27-41）であった．対照として評価したインフルエンザワクチンのVAS値で除した値（中央値）はETN：1.1...
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| Published in | 臨床リウマチ Vol. 26; no. 2; pp. 121 - 125 |
|---|---|
| Main Authors | , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
一般社団法人 日本臨床リウマチ学会
2014
The Japanese Society for Clinical Rheumatology and Related Research |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0914-8760 2189-0595 |
| DOI | 10.14961/cra.26.121 |
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| Abstract | 目的：生物学的製剤の使用で関節リウマチ（RA）患者のquality of lifeは向上した．しかし，皮下注生物学的製剤の注射時痛を強く訴える患者が存在する．今回，皮下注射製剤の注射時痛を検討した． 対象・方法：エタネルセプト（ETN），アダリムマブ（ADA），ゴリムマブ（GOL）を１剤以上使用したことのあるRA患者123例を対象とし，痛みのVASスケールを用いて注射時痛を評価した． 結果：VAS値（中央値，IQR）はETN（41，22-55），ADA（59，30-82），GOL（35，27-41）であった．対照として評価したインフルエンザワクチンのVAS値で除した値（中央値）はETN：1.140，ADA：1.627，GOL：0.949で，GOLの注射時痛が有意に低かった．約2/3の症例で注射針の刺入時よりも薬液注入時の痛みを不快に感じると回答した． 結論：“痛み”の数値化には患者個人間でのばらつきが存在するが，注射時痛は薬剤間で有意な差がみられた． |
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| AbstractList | Background: Biologics have dramatically changed the treatment of rheumatoid arthritis (RA). In recent years, several biologics have become available, and about half of these drugs are delivered by subcutaneous (s.c.) injections. However, the pain caused by s.c. injection may become a problem in some cases.
Methods: The visual analogue scale (VAS) scale was used to assess the impact of the s.c. injection-related pain. Each patient gave assessments for a maximum of 4 types of s.c. injections. Etanercept (ETN), adalimumab (ADA), and golimumab (GOL) were the selectable drugs that the patients received at present and / or in the past, and s.c. of influenza vaccination (Flu-V) was used as a control.
Results: A total of 123 RA patients (mean age, 59 years;range, 30-84 years) participated in this study. There were 104 women (84.6%). The numbers of patients who provided VAS scores for IV, ETN, ADA, and GOL injections were 123, 70, 60, and 17, respectively. The VAS scores (median, IQR) were as follows: Flu-V, 26, 15-46; ETN, 41, 22.5-57; ADA, 59, 30-82.7; and GOL, 35, 27-41. The VAS score of GOL was about the same as that of Flu-V, and s.c. injections of GOL seemed to be the least painful(GOL vs. ADA, p=0.0052 and ETN vs. ADA, p=0.0060). Conclusion: Patient-orientated evaluations of pain caused by s.c. injections showed that injec tions of GOL caused less pain than those of the other biologics. Although evaluations of injection-associated pain differ with each patient, more comfortable s.c. injections are necessary to improve patient convenience and increase compliance with RA treatment.
目的：生物学的製剤の使用で関節リウマチ（RA）患者のquality of lifeは向上した．しかし，皮下注生物学的製剤の注射時痛を強く訴える患者が存在する．今回，皮下注射製剤の注射時痛を検討した．
対象・方法：エタネルセプト（ETN），アダリムマブ（ADA），ゴリムマブ（GOL）を１剤以上使用したことのあるRA患者123例を対象とし，痛みのVASスケールを用いて注射時痛を評価した．
結果：VAS値（中央値，IQR）はETN（41，22-55），ADA（59，30-82），GOL（35，27-41）であった．対照として評価したインフルエンザワクチンのVAS値で除した値（中央値）はETN：1.140，ADA：1.627，GOL：0.949で，GOLの注射時痛が有意に低かった．約2/3の症例で注射針の刺入時よりも薬液注入時の痛みを不快に感じると回答した．
結論：“痛み”の数値化には患者個人間でのばらつきが存在するが，注射時痛は薬剤間で有意な差がみられた． 目的：生物学的製剤の使用で関節リウマチ（RA）患者のquality of lifeは向上した．しかし，皮下注生物学的製剤の注射時痛を強く訴える患者が存在する．今回，皮下注射製剤の注射時痛を検討した． 対象・方法：エタネルセプト（ETN），アダリムマブ（ADA），ゴリムマブ（GOL）を１剤以上使用したことのあるRA患者123例を対象とし，痛みのVASスケールを用いて注射時痛を評価した． 結果：VAS値（中央値，IQR）はETN（41，22-55），ADA（59，30-82），GOL（35，27-41）であった．対照として評価したインフルエンザワクチンのVAS値で除した値（中央値）はETN：1.140，ADA：1.627，GOL：0.949で，GOLの注射時痛が有意に低かった．約2/3の症例で注射針の刺入時よりも薬液注入時の痛みを不快に感じると回答した． 結論：“痛み”の数値化には患者個人間でのばらつきが存在するが，注射時痛は薬剤間で有意な差がみられた． |
| Author | 佐藤, 正夫 竹村, 正男 四戸, 隆基 |
| Author_FL | Takemura Masao Sato Masao Shinohe Ryuki |
| Author_FL_xml | – sequence: 1 fullname: Sato Masao – sequence: 2 fullname: Takemura Masao – sequence: 3 fullname: Shinohe Ryuki |
| Author_xml | – sequence: 1 fullname: 四戸, 隆基 organization: 西美濃厚生病院整形外科 – sequence: 1 fullname: 佐藤, 正夫 organization: 岐阜大学大学院医学系研究科脊椎骨関節再建外科 – sequence: 1 fullname: 竹村, 正男 organization: 岐阜大学大学院医学系研究科病態情報解析医学 |
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| References | 5) Frenken LAM, van Lier HJJ, Koene RAP: Analysis of the efficacy of measures to reduce pain after subcytaneou administration of epoetin alfa. Nephrol Dial Transplant, 9:1295-1298, 1994. 4) Jorgensen JT, Romsing J, Rasmussen M, et al: Pain assessment of subcutaneous injections. Ann Pharmacother, 30:729-732, 1996. 1) Fransson J, Espander-Jansson A: Local tolerance of subcutaneous injections. J Pharm Pharmacol, 48: 1012-1015, 1996. 3) Frenken LAM, van Lier HJJ, Jordans JGM, et al: Identification of the component part in an epoetin alfa preparation that causes pain after subcutaneous injection. Am J Kid Dis, 22:553-556, 1993. 6) Jaber A, Bozzato GB, Vedrine L, et al: A novel needle for subcutaneous injection of interferon beta-Ia: effect on pain in volunteers and satisfaction in patients with multiple sclerosis. BMC Neurology, 8:38, 2008. 7) Takeuchi T, Tanaka Y, Kaneko Y, et al: Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study). Mod Rheumatol, 22:327-338, 2012. 9) 佐藤正夫，四戸隆基，清水克時：関節リウマチに対する生物学的製剤の継続率．中部 整災誌，56：185-186，2013 8) Takeuchi T, Harigai M, Tanaka Y, et al: Golimumab monotherapy in Japanese patients with rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomized, double-blind, placebo controlled GO-MONO study through 24 weeks. Ann Rheum Dis, 72:1488-1495,2013. 2) Laursen T, Hansen B, Fisker S: Pain perception after subcutaneous injectionsof media containing different buffers. Basic Clin Pharmacol Toxicol, 98: 218-221, 2006. |
| References_xml | – reference: 9) 佐藤正夫，四戸隆基，清水克時：関節リウマチに対する生物学的製剤の継続率．中部 整災誌，56：185-186，2013． – reference: 3) Frenken LAM, van Lier HJJ, Jordans JGM, et al: Identification of the component part in an epoetin alfa preparation that causes pain after subcutaneous injection. Am J Kid Dis, 22:553-556, 1993. – reference: 7) Takeuchi T, Tanaka Y, Kaneko Y, et al: Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study). Mod Rheumatol, 22:327-338, 2012. – reference: 5) Frenken LAM, van Lier HJJ, Koene RAP: Analysis of the efficacy of measures to reduce pain after subcytaneou administration of epoetin alfa. Nephrol Dial Transplant, 9:1295-1298, 1994. – reference: 6) Jaber A, Bozzato GB, Vedrine L, et al: A novel needle for subcutaneous injection of interferon beta-Ia: effect on pain in volunteers and satisfaction in patients with multiple sclerosis. BMC Neurology, 8:38, 2008. – reference: 2) Laursen T, Hansen B, Fisker S: Pain perception after subcutaneous injectionsof media containing different buffers. Basic Clin Pharmacol Toxicol, 98: 218-221, 2006. – reference: 4) Jorgensen JT, Romsing J, Rasmussen M, et al: Pain assessment of subcutaneous injections. Ann Pharmacother, 30:729-732, 1996. – reference: 8) Takeuchi T, Harigai M, Tanaka Y, et al: Golimumab monotherapy in Japanese patients with rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomized, double-blind, placebo controlled GO-MONO study through 24 weeks. Ann Rheum Dis, 72:1488-1495,2013. – reference: 1) Fransson J, Espander-Jansson A: Local tolerance of subcutaneous injections. J Pharm Pharmacol, 48: 1012-1015, 1996. |
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| Snippet | 目的：生物学的製剤の使用で関節リウマチ（RA）患者のquality of lifeは向上した．しかし，皮下注生物学的製剤の注射時痛を強く訴える患者が存在する．今回，皮下注射製剤の注射時痛を検討した．... Background: Biologics have dramatically changed the treatment of rheumatoid arthritis (RA). In recent years, several biologics have become available, and about... |
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| SubjectTerms | biologics pain rheumatoid arthritis subcutaneous injection |
| Title | 皮下注生物学的製剤の注射時痛に関する検討 |
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