論文 - 河添　仁

再発・難治性悪性軟部腫瘍に対するpazopanib治療の検討

長谷部晋士, 木谷彰岐, 河添　仁, 竹内一人, 薬師神芳洋

愛媛医学 36 （ 1 ） 41 - 46 2017年03月

研究論文（学術雑誌）, 共著, 査読有り

Non-steroidal anti-inflammatory drugs induce severe hematologic toxicities in lung cancer patients receiving pemetrexed plus carboplatin: A retrospective cohort study

Kawazoe H, Yano A, Ishida Y, Takechi K, Katayama H, Ito R, Yakushijin Y, Moriguchi T, Tanaka M, Tanaka A, Araki H

PloS One （PUBLIC LIBRARY SCIENCE ）  12 （ 2 ） e0171066 2017年02月

研究論文（学術雑誌）, 共著, 筆頭著者, 査読有り

　概要を見る

Purpose: As the major toxicity induced by pemetrexed plus carboplatin is severe hematologic toxicities, the aim of this study was to determine the risk factors for severe hematologic toxicities in lung cancer patients.
Methods: We retrospectively investigated data from lung cancer patients who had received pemetrexed plus carboplatin, with or without bevacizumab. This observational study was carried out at Ehime University Hospital using electronic medical records dating from July 2009 to March 2015. Severe hematologic toxicities were defined as grade 3 or 4, according to the Common Terminology Criteria for Adverse Events, version 4.0.
Results: Forty-two patients were included in the study. The incidence of grade 3 or 4 hematologic toxicities during the first cycle of chemotherapy and during all cycles was 19.0% and 16.1%, respectively. Multivariate time-depend generalized estimating equations logistic regression analysis revealed that regular use of non-steroidal anti-inflammatory drugs (NSAIDs) was significantly associated with an increased risk of severe hematologic toxicities during all cycles (adjusted odds ratio (OR): 8.32, 95% confidence interval (CI): 1.27–54.38; p = 0.03), whereas creatinine clearance of <45 mL/min was not significantly associated with an increased risk of severe hematologic toxicities during all cycles (adjusted OR: 0.91, 95% CI: 0.25–3.34; p = 0.88).
Conclusions: The results suggest that severe hematologic toxicities in patients receiving carboplatin-based pemetrexed may be significantly induced by the inhibition of renal tubular pemetrexed secretion through drug–drug interactions between NSAIDs and pemetrexed rather than through glomerular filtration of pemetrexed, even with moderate to sufficient renal function.

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S-1における副作用モニタリングシートを利用した病院と保険薬局の患者情報共有システム導入の副作用発見率への貢献

河添　仁, 岡田由季, 矢野安樹子, 白石沙弥, 酒井　瞳, 亀田慶太, 橋岡多津, 木下清司, 古川　清, 田中　守, 田中亮裕, 荒木博陽

医療薬学 （(一社)日本医療薬学会）  43 （ 2 ） 94 - 103 2017年02月

研究論文（学術雑誌）, 共著, 筆頭著者, 査読有り

　概要を見る

Limited sharing of information occurs between hospitals and community pharmacies regarding outpatients receiving oral chemotherapy. We therefore developed the sharing system of patient information between hospital and community pharmacies using the monitoring sheet of tegafur/gimeracil/oteracil potassium (S-1). After October 2013, community pharmacies monitored adverse events in patients receiving S-1 using the monitoring sheet, and subsequently provided this information to our hospital by fax. A medical clerk entered the information into the electronic medical records, thus providing feedback to hospital physicians. In this study, we retrospectively investigated adverse events in outpatients who had received S-1 between September 2012 and October 2014. In total, sixty-seven patients were included in the study. The proportion of patients who experienced adverse events in the control group and the monitoring sheet group was 69.0％ and 76.0％, respectively. The proportion of patients who developed lacrimation in the control group and the monitoring sheet group was 11.9％ and 36.0％, respectively, which was statistically significant (P = 0.03). On the other hand, the proportion of patients who managed any adverse events in the control group and the monitoring sheet group was 45.2％ and 68.0％, respectively. The proportion of patients who managed lacrimation in the control group and the monitoring sheet group was 11.9％ and 32.0％, respectively, which was not statistically significant (P = 0.06). These results suggest that this sharing system contributed to the identification of adverse events induced by S-1, resulting in appropriate management for patients who developed these adverse events by hospital physicians and community pharmacists.

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アプレピタント併用によりデキサメタゾンの前投与を減量時にパクリタキセルの過敏症反応が生じた1例

佐々木優, 河添　仁, 村上　聡, 守口淑秀, 田中亮裕, 荒木博陽

日本臨床腫瘍薬学会雑誌 （(一社)日本臨床腫瘍薬学会）  5   19 - 22 2016年12月

研究論文（学術雑誌）, 共著, 査読有り

外来患者におけるハザーダス・ドラッグ調製から投与管理までの閉鎖式薬物移送システム導入の臨床的アウトカムと医療経済効果の推算

河添　仁, 中内香菜, 矢野安樹子, 白石沙弥, 薬師神芳洋, 竹内　茜, 井門静香, 恒岡菊江, 松尾真由美, 中井昌紀, 田中　守, 田中亮裕, 荒木博陽

医療薬学 （(一社)日本医療薬学会）  42 （ 7 ） 518 - 528 2016年07月

研究論文（学術雑誌）, 共著, 筆頭著者, 査読有り,  ISSN  1346-342X

　概要を見る

Following the publication of a guideline on the safe handling of hazardous drugs (HDs) in Japan, the issue of cost-effectiveness has been become a problem. We introduced the PhaSeal™ system in June 2015, a closed system drug transfer devices (CSTD) used for all outpatients, from preparation to administration. We retrospectively compared clinical outcomes before and after the introduction of CSTD of HDs included chemotherapy. Furthermore, we evaluated the medical fee income and the cost of providing CSTD between July and December 2015. The mean number of outpatient chemotherapy treatments per day before and after CSTD introduction was 15 ± 6 and 14 ± 5, respectively (P = 0.947). The mean preparation time by pharmacists before and after introduction was 21 ± 9 and 24 ± 9 minutes, respectively (P = 0.002). The mean time of nursing preparation before and after introduction was 29 ± 16 and 25 ± 14 minutes, respectively (P = 0.068). The mean time of patients waiting for chemotherapy before and after introduction was 36 ± 17 and 37 ± 17 minutes, respectively (P = 0.735). Based on the mean differences between the medical fee income and the cost of CSTD per month, we estimated that the annual cost associated with the introduction of CSTD for all outpatient to administer HDs was approximately JPY 21,000,000. After April 2016, we estimated that the amount of increase of the medical fee income of CSTD was approximately JPY 2,000,000 per year. These results suggest that the medical fee income should be increased so CSTD can be implemented for all outpatients.

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外来化学療法におけるがん患者指導管理料3の臨床的アウトカムと医療経済効果の推算

河添　仁, 矢野安樹子, 田坂祐一, 中内香菜, 田中　守, 田中亮裕, 薬師神芳洋, 荒木博陽

医療薬学 （(一社)日本医療薬学会）  42 （ 4 ） 228 - 236 2016年04月

研究論文（学術雑誌）, 共著, 筆頭著者, 査読有り,  ISSN  1346-342X

　概要を見る

We retrospectively evaluated the clinical outcomes of pharmaceutical interventions relating to outpatient chemotherapy and estimated their associated economic impact between August 2014 and August 2015. We developed a novel pharmaceutical system, involving JPY1,164,000 allocated to a total of 582 patients. There were 117 proposals for pharmaceutical interventions, 106 (90.6%) of which were accepted by physicians. The number of proposals for supportive therapy was 56, 29 (51.8%) of which significantly decreased the grade of chemotherapy-induced adverse events compared to before pharmaceutical interventions (P < 0.001). The number of reductions in grade 1, 2, and 3 events was 14, 11 and 4, respectively. In this study, the potential economic costs associated with reduction of grade 1, 2 and 3 chemotherapy-induced adverse events were calculated as JPY112,000, JPY112,000, and JPY2,140,000, respectively, based on the costs paid by the Adverse Drug Reaction Relief System of the Pharmaceuticals and Medical Devices Agency. According to this cost calculation, we estimated that the total cost saving associated with the clinical outcomes of pharmaceutical interventions was JPY11,360,000. This is the first study to estimate the economic impact associated with the clinical outcomes of pharmaceutical interventions for outpatient chemotherapy. These results suggest that pharmaceutical interventions contribute to the quality and safety of outpatient chemotherapy by decreasing chemotherapy-induced adverse events.

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トラマドール/アセトアミノフェン誘発悪心・嘔吐における予防対策の有用性と関連因子

芳野知栄, 河添　仁, 井門敬子, 田中亮裕, 田中　守, 荒木博陽

日本緩和医療薬学会雑誌 8 （ 4 ） 99 - 102 2015年12月

研究論文（学術雑誌）, 共著, 査読有り

抗がん剤の調製から投与までの医療従事者に対する抗がん剤曝露対策の評価

上野昌紀, 河添　仁, 済川聡美, 中内香菜, 竹内　茜, 井門静香, 恒岡菊江, 樋口則子, 岡本千恵, 田中　守, 田中亮裕, 朝井洋晶, 薬師神芳洋, 荒木博陽

医療薬学 （(一社)日本医療薬学会）  41 （ 11 ） 811 - 820 2015年11月

研究論文（学術雑誌）, 共著, 査読有り

　概要を見る

The BD PhasealTM administration set, a new device for the BD PhasealTM closed system drug transfer device (CSTD), can prevent the occupational exposure of health caregivers to antineoplastic agents during all stages of the treatment process from preparation to administration. Further, a revised nursing approach for administration may prevent inadvertent antineoplastic agent spills. In this study, we compared the exposure levels of cyclophosphamide (CPA) and paclitaxel (PTX) between conventional methods and the new method described above; by sampling drug absorption sheets (a sampling sheet method) was used. In both methods, CPA was prepared using the BD PhasealTM CSTD and PTX was a plastic needle open system. For the new method, CPA was administered using the BD PhasealTM administration set and PTX was the revised nursing administration approach. Five pharmacists undertook the preparation process, and five nurses the administration process. Within the administration process using the conventional method, the following levels were detected: CPA 1.67 ng/cm2 and PTX 0.077 ng/cm2. No measurable levels were detected with the new method. For the preparation process, no CPA was detected, but PTX was detected. These results suggest that the use of the BD PhasealTM administration sets and the revised nursing administration approach is useful for preventing the occupational exposure of health caregivers to antineoplastic agents; this applies to both the preparation process and the administration processes.

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オキサリプラチンの静脈炎および血管痛の危険因子の解析と加温投与ならびに温罨法による予防効果の評価

中内香菜, 河添　仁, 宮嶋理沙, 和泉千恵子, 六角由紀, 恒岡菊江, 樋口則子, 藤原光子, 児島　洋, 薬師神芳洋

癌と化学療法 （癌と化学療法社）  42 （ 11 ） 1397 - 1400 2015年11月

研究論文（学術雑誌）, 共著, 査読有り

学習成果の定量的評価を用いた外来化学療法室実習プログラムの導入と評価

済川聡美, 河添　仁, 上野昌紀, 田中亮裕, 田中　守, 荒木博陽

医療薬学 （(一社)日本医療薬学会）  41 （ 6 ） 442 - 449 2015年06月

研究論文（学術雑誌）, 共著, 査読有り

　概要を見る

A quantitative evaluation method has not yet been established for pharmacy students in relation to learning achievements and their hospital-based practical training. We therefore developed an outpatient chemotherapy educational program to address this issue. To assess the learning achievements quantitatively, we carried out four examinations - twice at the halfway point (first) and at the program's term-end (second); a perfect score was 100. This study was conducted between May and November 2013 and 24 pharmacy students participated. The results showed that the first and second mean scores relating to their cytotoxic agent handling knowledge were 91.5 ± 5.2 and 99.1 ± 1.8, respectively. The first and second mean scores relating to preparation skills for vials (how to handle anticancer drugs) were 68.5 ± 13.1 and 78.9 ± 18.5, respectively. For their preparation skills (using closed systems to handle anticancer drugs) the mean scores were 85.2 ± 13.1 (first) and 97.0 ± 3.7 (second). The first and second mean scores about the processes involved in solving chemotherapy-related patient problems were 52.1 ± 23.7 and 77.8 ± 21.9, respectively. All of the scores were significantly increased at the end of the program compared with scores halfway through. These results suggest that our program may be useful for supporting pharmacy students to learn more effectively during their hospital-based practical training in Japan.

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Risk Factors for Discontinuation of S-1 Adjuvant Chemotherapy for Gastric Cancer

Kawazoe H, Shimasaki M, Ueno M, Sumikawa S, Takatori S, Namba H, Yoshida M, Sato K, Kojima Y, Watanabe Y, Moriguchi T, Tanaka A, Araki H

Journal of Cancer （IVYSPRING INTERNATIONAL PUBLISHER）  6 （ 5 ） 464 - 469 2015年03月

研究論文（学術雑誌）, 共著, 筆頭著者, 査読有り

　概要を見る

Purpose: The aim of this study was to clarify the risk factors for discontinuing tegafur/gimeracil/oteracil potassium (S-1) adjuvant chemotherapy following gastrectomy in patients with gastric cancer.
Methods: We retrospectively investigated patients with curatively-resected gastric cancer who received S-1 adjuvant chemotherapy. S-1 was administered orally at 80-120 mg/day, depending on body surface area, on days 1-28 every 6 weeks for 1 year. The dose and treatment schedule were modified at the clinicians' discretion, according to toxicity.
Results: Seventy-one patients were included in the study, 26 of whom discontinued S-1 therapy. The relapse-free survival rates in the S-1-completed and S-1-discontinuation groups at 5 years post-surgery were 88.1% and 55.8%, respectively. The overall survival rates in the S-1-completed and S-1-discontinuation groups at 5 years post-surgery were 89.4% and 59.8%, respectively. The hazard ratios for relapse and death were significantly lower in the S-1-completed group compared with those in the S-1-discontinuation group (0.18; p<0.001 and 0.19; p=0.002, respectively). Multivariate logistic regression analysis revealed that S-1 discontinuation was significantly associated with an initial overdose of S-1, having stage I cancer, creatinine clearance <66 mL/min, and a side effect of nausea.
Conclusions: These results suggest that assessing renal function to avoid initial overdose of S-1, together with the early management of side effects, may support the continuation of S-1 adjuvant chemotherapy in patients with gastric cancer.

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実務実習におけるがん化学療法レジメンの構成を学ぶ実習の試み

岡本千恵, 木村博史, 桝田麻矢, 安永大輝, 田坂祐一, 立川登美子, 河添　仁, 田中亮裕, 末丸克矢, 荒木博陽

日本病院薬剤師会雑誌 50 （ 9 ） 1122 - 1125 2014年09月

研究論文（学術雑誌）, 共著, 査読有り

S-1における院外処方せんを利用した双方向性の情報共有の取り組みとその評価

河添　仁, 上野昌紀, 済川聡美, 田中　守, 田中亮裕, 荒木博陽

医療薬学 （(一社)日本医療薬学会）  40 （ 8 ） 441 - 448 2014年08月

研究論文（学術雑誌）, 共著, 筆頭著者, 査読有り

　概要を見る

Community pharmacies play a significant role in home healthcare. However, patient information from hospitals is not shared with community pharmacies. We attempted the bidirectional sharing of patient information regarding chemotherapy between hospitals and community pharmacies. We developed a “medicine message board,” which was a modified prescription format. Hospital pharmacists recorded information regarding patients taking tegafur/gimeracil/oteracil (S-1) on the message board. In turn, community pharmacists monitored side effects in the S-1 patients and returned the information by fax to our hospital also using the message board. A medical clerk entered the side effects into the electronic medical record, providing feedback to doctors. We distributed questionnaires to community pharmacies around our hospital between December 2013 and January 2014 and assessed their understanding using a five-point Likert scale (where 1 = insufficiency and 5 = sufficiency). The results showed that the mean scores on understanding about the presence or absence of cancer notification before and after the initiation of the message board were 2.10 ± 1.02 and 4.20 ± 1.06, respectively. The mean understanding about the name of a cancer patient's disease before and after the message board was 2.25 ± 0.91 and 4.45 ± 0.83, respectively. All these differences were significant. Understanding about the purpose of treatment, dose adjustments of S-1 due to body surface area and renal function, administration schedule, presence or absence of combination chemotherapy, pharmaceutical instructions, treatment adherence, and side effects monitoring were also significantly improved in community pharmacies after the initiation of the message board. These results suggest that there is scope to improve the support provided to oral chemotherapy patients by hospitals and community pharmacists.

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がん診療連携拠点病院に勤務する医師の「高額医療」と「限度額適応認定証」の認識

薬師神芳洋, 森田純子, 矢野琢也, 松久哲章, 河添　仁, 児島　洋, 岡田憲三, 亀井治人, 原　雅道, 藤井元廣, 松野　剛, 谷水正人, 新海　哲

癌と化学療法 （癌と化学療法社）  41 （ 5 ） 605 - 610 2014年05月

研究論文（学術雑誌）, 共著, 査読有り

病院実務実習における多職種間を想定したコミュニケーション・スキルアップ実習プログラムの導入と評価

河添　仁, 田中亮裕, 田中　守, 末丸克矢, 荒木博陽

医療薬学 （(一社)日本医療薬学会）  39 （ 12 ） 733 - 740 2013年12月

研究論文（学術雑誌）, 共著, 筆頭著者, 査読有り

　概要を見る

There is a lack of opportunities in Japan to engage in communication skills education about effective interactions between pharmacists and medical staff. This is despite the fact that current pharmacy education programs should be producing clinical experts in this area. Because of this, we delivered an educational program relating to building communication skills when working in a multidisciplinary team; 29 pharmacy students took part between May and November 2011. The program was based on two components: a lecture about communication skills by a facilitator (including “active listening”, “assertiveness” and “conflict management”), and a small group discussion (SGD) relating to decisions about opioid increases/rotation using a cancer pain case as an alternative opioid treatment. After the students finished the SGD, we distributed questionnaires to them and assessed outcomes using a five-grade Likert scale. As a result of the questionnaires, their mean understanding about opioid increasing and opioid rotation were 4.59 ± 0.68 and 4.48 ± 0.69, respectively. The mean implementation score of communication skills relating to “assertiveness” was 3.62 ± 0.94, which was significantly worse when compared with that of “active listening” (4.31 ± 0.60, P = 0.003). In addition, the mean satisfaction levels of the SGD group work and the overall educational program were 4.31 ± 0.81 and 4.38 ± 0.62, respectively. Care is required when interpreting the results given the study was limited to a single institution. However, these results suggest that this type of program may be useful for supporting pharmacy students to learn about communication skills. Improved skills should result in more effective communication, when pharmacists interact with medical staff.

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外来化学療法における薬学的管理の業務展開と医療安全への質的貢献の評価

河添　仁, 井門敬子, 田中亮裕, 末丸克矢, 荒木博陽

日本病院薬剤師会雑誌 （(一社)日本病院薬剤師会）  49 （ 9 ） 981 - 985 2013年09月

研究論文（学術雑誌）, 共著, 筆頭著者, 査読有り

オキサリプラチン投与時の血管痛に対する加温ならびに温罨法の試み

宮嶋理沙, 河添　仁, 恒岡菊江, 藤原光子, 児島　洋, 薬師神芳洋

癌と化学療法 （癌と化学療法社）  40 （ 4 ） 537 - 540 2013年04月

研究論文（学術雑誌）, 共著, 査読有り

タクロリムス眼軟膏の製剤学的安定性の検討

公平恵崇, 渡邉真一, 河添　仁, 原　祐子, 末丸克矢, 荒木博陽

愛媛県病薬会誌 （(一社)愛媛県病院薬剤師会）  110   3 - 7 2012年04月

研究論文（学術雑誌）, 共著, 査読有り

Comparison of antiemetic efficacy between single and repeat treatment with dexamethasone in patients receiving carboplatin-based combination chemotherapy

Kawazoe H, Motoki Y, Takechi Y, Shishino Y, Ido K, Suemaru K, Araki H

Methods and Findings in Experimental and Clinical Pharmacology （THOMSON REUTERS）  32 （ 7 ） 499 - 505 2010年09月

研究論文（学術雑誌）, 共著, 筆頭著者, 責任著者, 査読有り

　概要を見る

A retrospective study was carried out to compare the preventive effects of single and repeat treatment with dexamethasone (DEX) on delayed nausea and emesis in patients who had received carboplatin (CBDCA)-based combination chemotherapy. Sixty-four patients were evaluated. Efficacy was assessed using the nausea and emesis score, food intake score and the requirement for antiemetic medication. These forward scores were categorized as three-grade during the first 5 days after chemotherapy. Acute nausea and emesis were well controlled in both groups on day 1. Mean values of the nausea and emesis score on day 3 evening and the food intake score on day 4 morning in the repeat-treatment group was 1.31 ± 0.93 and 3.46 ± 1.03, respectively, which were significantly better when compared with the singletreatment group (2.00 ± 1.52; P = 0.028 and 2.79 ± 1.12; P = 0.018, respectively). Multivariate logistic regression analysis revealed that less frequent dispensing of antiemetic medication was significantly associated with the repeat-treatment group (adjusted odds ratio, 0.153; 95% confidence interval, 0.026-0.734; P = 0.018). These results suggest that repeat-dose DEX may be more effective than single-dose DEX for the prevention of delayed nausea and emesis after CBDCA-based combination chemotherapy.

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注射用抗がん剤調製の知識・手技の均てん化を目指した多施設共同研修

河添　仁, 刀根潤一, 吉田陽子, 木村博史, 村上　朋, 亀岡春菜, 武智宣佳, 小暮友毅, 村上通康, 浅川隆重, 井上智喜, 江口久恵, 末丸克矢, 荒木博陽

日本病院薬剤師会雑誌 （(一社)日本病院薬剤師会）  46 （ 8 ） 1086 - 1090 2010年08月

研究論文（学術雑誌）, 共著, 筆頭著者, 査読有り