論文 - 山神　彰

Validity and Utility of a Risk Prediction Model for Wound Infection After Lower Third Molar Surgery.

Yamagami A, Narumi K, Saito Y, Furugen A, Imai S, Okamoto K, Kitagawa Y, Ohiro Y, Takagi R, Takekuma Y, Sugawara M, Kobayashi M

Oral diseases （Wiley）  2025年01月

査読有り,  ISSN  1354-523X

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Objectives: To externally validate a clinical prediction model for surgical site infection (SSI) after lower third molar (L3M) surgery and evaluate its clinical usefulness. Methods: We conducted a retrospective cohort study of patients who underwent L3M surgery at Hokkaido University Hospital. The study was designed to evaluate the historical and methodological transportability. Clinical usefulness was evaluated using decision curve analysis on the data of the non-antibiotic-treated patients. Results: We obtained 2543 validation cohorts from April 2020 to March 2023, and 640 non-antibiotic cohorts from July 2010 to September 2023. The incidences of SSI after L3M surgery were 5.3% (135/2543) and 7.7% (49/640) in the validation and non-antibiotic cohorts, respectively. The discrimination ability of the prediction model was acceptable for the external validation cohort (c-statistic: 0.67; 95% CI: 0.62–0.71) and adequate for the non-antibiotic cohort (c-statistic: 0.72; 95% CI: 0.63–0.79). In both cohorts, the model showed excellent calibration between the observed and predicted probabilities. Decision curve analysis showed increased net benefit across a range of meaningful risk thresholds. Conclusion: A simple risk prediction model for SSI after L3M surgery demonstrated clinical transportability and usefulness. This model may help surgeons/clinicians determine the appropriateness of prophylactic antibiotics administration for patients in L3M surgery.

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Reply to Accurate Risk Prediction Model for Surgical Site Infection After Lower Third Molar Surgery.

Yamagami A, Narumi K, Saito Y, Furugen A, Imai S, Kitagawa Y, Ohiro Y, Takagi R, Takekuma Y, Sugawara M, Kobayashi M

Oral diseases 31 （ 4 ） 1374 - 1375 2024年11月

筆頭著者, 査読有り,  ISSN  1354-523X

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Development of a risk prediction model for surgical site infection after lower third molar surgery

Yamagami A., Narumi K., Saito Y., Furugen A., Imai S., Kitagawa Y., Ohiro Y., Takagi R., Takekuma Y., Sugawara M., Kobayashi M.

Oral Diseases 30 （ 5 ） 3202 - 3211 2024年07月

筆頭著者, 査読有り,  ISSN  1354523X

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Background: There is little evidence regarding risk prediction for surgical site infection (SSI) after lower third molar (L3M) surgery. Methods: We conducted a nested case–control study to develop a multivariable logistic model for predicting the risk of SSI after L3M surgery. Data were obtained from Hokkaido University Hospital from April 2013 to March 2020. Multiple imputation was applied for the missing values. We conducted decision tree (DT) analysis to evaluate the combinations of factors affecting SSI risk. Results: We identified 648 patients. The final model retained the available distal space (Pell & Gregory II [p = 0.05], Pell & Gregory III [p < 0.01]), depth (Pell & Gregory B [p < 0.01], Pell & Gregory C [p < 0.01]), surgeon's experience (3–10 years [p = 0.25], <3 years [p < 0.01]), and simultaneous extraction of both L3M [p < 0.01]; the concordance-statistic was 0.72. The DT analysis demonstrated that patients with Pell and Gregory B or C and simultaneous extraction of both L3M had the highest risk of SSI. Conclusions: We developed a model for predicting SSI after L3M surgery with adequate predictive metrics in a single center. This model will make the SSI risk prediction more accessible.

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Evaluation of the strategies to reduce third-generation oral cephalosporins in dentistry at a Japanese academic hospital: An interrupted time series analysis

Yamagami A., Narumi K., Saito Y., Furugen A., Imai S., Kitagawa Y., Ohiro Y., Takagi R., Takekuma Y., Sugawara M., Kobayashi M.

Journal of Clinical Pharmacy and Therapeutics 47 （ 7 ） 1010 - 1019 2022年07月

筆頭著者, 査読有り,  ISSN  02694727

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What is known and objective: Third-generation oral cephalosporins, especially cefcapene-pivoxil (CFPN-PI), have been used frequently in the Japanese dental field. In December 2014 and April 2016, the newly published clinical guidelines recommended the use of amoxicillin (AMPC). Thus, it is important to evaluate the impact of these guidelines on the prescription profiles of prophylactic antibiotics, clinical outcomes and cost-effectiveness of antibiotics. Methods: We conducted a retrospective study to analyse an interrupted time series analysis from April 2013 to March 2020 at the Department of Dentistry of Hokkaido University Hospital. A segmented regression model was used to estimate the changes in the incidence of infectious complications following tooth extraction. Prescribed antibiotic data were evaluated via days of therapy (DOT). Antibiotic costs were calculated in terms of the Japanese yen (JPY). Results and Discussion: We identified 17,825 eligible patients. The incidence rates of infectious complications (SSI + dry socket) and SSI after tooth extraction were 3.2% and 2.2%, respectively, during the entire period. The extraction of impacted third molars corresponded to 5.0% and 3.4%, respectively. However, their incidence rates were not significantly different during this period. The use of prophylactic antibiotics and antibiotic cost showed consistent trends following the implementation of guidelines. The mean DOT of CFPN-PI decreased (ranging from 4893.6 DOTs/1000 patients [March 2013 to November 2014] to 3856.4 DOTs/1000 patients [December 2014 to March 2016]; p < 0.001, and from 3856.4 DOTs/1000 patients [December 2014 to March 2016] to 2293.9 DOTs/1000 patients [April 2016 to March 2020]; p < 0.001). In contrast, the mean DOT of AMPC was found to be increased (ranging from 1379.7 DOTs/1000 patients [March 2013 to November 2014] to 3236.3 DOTs/1000 patients [December 2014 to March 2016]; p < 0.001, and from 3236.3 DOTs/1000 patients [December 2014 to March 2016] to 4597.8 DOTs/1000 patients [April 2016 to March 2020]; p < 0.001). The mean monthly cost was decreased (ranging from 905.3 JPY [March 2013 to November 2014] to 788.7 JPY [December 2014 to March 2016]; p = 0.003, and from 788.7 JPY [December 2014 to March 2016] to 614.0 JPY [April 2016 to March 2020]; p < 0.001). What is new and conclusion: After December 2014, prophylactic antibiotics were switched from CFPN-PI to AMPC, and the incidence rate of infectious complications was not significantly different over time. However, changing antibiotics is useful from a cost-effectiveness perspective.

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腎機能低下患者へのバンコマイシン初回負荷投与の安全性調査

新沼 悠介, 今井 俊吾, 山田 武宏, 鏡 圭介, 山神 彰, 宮井 貴之, 笠師 久美子, 小林 正紀, 井関 健

TDM研究 （(一社)日本TDM学会）  36 （ 3 ） 117 - 124 2019年09月

査読有り,  ISSN  0911-1026

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腎機能低下患者におけるバンコマイシン(VCM)初回負荷投与の安全性は十分に検証されていない。そこで今回、腎機能低下患者に対するVCM初回負荷投与の安全性を明らかにするために、単施設(n=1489)後ろ向き観察研究を実施した。初回負荷投与実施群(n=86)と非実施群(n=206)では、腎機能障害発現割合に有意差は認めなかった。(初回負荷投与実施群:非実施群=6.98%:9.71%、P=0.46)ベースラインの腎機能別でも同様の結果であった。また、VCMの初回トラフ値(中央値)はいずれの群も推奨濃度範囲内であり、両群間に有意差はなかった。多変量ロジスティック回帰分析で腎機能障害発現の危険因子として、投与日数9日以上、フロセミド、ピペラシリン・タゾバクタムの併用、ICU入室、初回トラフ値12.2μg/mL以上が抽出され、初回負荷投与の実施は抽出されなかった。以上より、VCMの初回負荷投与は腎機能低下患者に対しても安全に行える可能性が示唆された。(著者抄録)

下顎埋伏智歯抜歯術におけるセフカペンピボキシルとアモキシシリンの手術部位感染予防効果の比較

山神 彰, 山田 武宏, 北川 善政, 大廣 洋一, 佐藤 淳, 石黒 信久, 今井 俊吾, 小林 正紀, 井関 健

医療薬学 （(一社)日本医療薬学会）  45 （ 5 ） 254 - 261 2019年05月

筆頭著者, 査読有り,  ISSN  1346-342X

　概要を見る

下顎埋伏智歯抜歯術においてセフカペンピボキシル(CFPN-PI)またはアモキシシリン(AMPC)の予防投与を受けた患者の手術部位感染(SSI)発生率を比較した。解析対象となったのはCFPN-PI群129例(男性50例、女性79例、中央値24.0歳)、AMPC群164例(男性75例、女性89例、中央値25.0歳)であった。SSI発生率はCFPN-PI群において11.6%(15/129)、AMPC群において2.4%(4/164)であり、CFPN-PI群のSSI発生率は有意に高かった。次いで、SSI発生に影響する要因分析を行った。単変量解析において抗菌薬(CFPN-PIの使用)、性別(女性)、術後入院、手術難易度、反対側下顎埋伏智歯抜歯の有無、Pell-Gregory分類がP≦0.2となり、これらを多変量解析における解析対象因子として抽出した。解析対象因子のvariance inflation factorはいずれも4未満であり多重共線性はみられなかった。多変量解析の結果、抗菌薬(CFPN-PIの使用)および術後入院がそれぞれオッズ比5.61、4.66を示し、SSIに影響する独立因子として抽出された。

Necessity for a Significant Maintenance Dosage Reduction of Voriconazole in Patients with Severe Liver Cirrhosis (Child-Pugh Class C).

Takehiro Yamada, Shungo Imai, Yasuyuki Koshizuka, Yuki Tazawa, Keisuke Kagami, Naoki Tomiyama, Ryosuke Sugawara, Akira Yamagami, Tsuyoshi Shimamura, Ken Iseki

Biological & pharmaceutical bulletin 41 （ 7 ） 1112 - 1118 2018年07月

査読有り

　概要を見る

Therapeutic drug monitoring for voriconazole, an antifungal agent, is essential for maximizing efficacy and preventing toxicity. The aim of this study was to elucidate the optimal maintenance dose of voriconazole in patients with severe liver cirrhosis (Child-Pugh class C) by reviewing the plasma trough concentrations obtained by therapeutic drug monitoring and daily doses of voriconazole. We retrospectively evaluated 6 patients with Child-Pugh class C cirrhosis who received oral voriconazole treatment and were liver transplant recipients or were awaiting liver transplantation. We compared their voriconazole trough concentrations and daily maintenance doses to those of patients who did not have liver cirrhosis (n=56). We found that plasma voriconazole trough concentrations in all patients with Child-Pugh class C were almost within therapeutic range, and the median plasma trough concentration at steady state was not significantly different from that of patients who did not have liver cirrhosis. In addition, the median daily maintenance dose of voriconazole was significantly lower (2.13 mg/kg/d) than that of the control patients (6.27 mg/kg/d), suggesting that trough voriconazole concentrations are elevated in Child-Pugh class C patients. Thus, we conclude that oral voriconazole maintenance doses in patients with Child-Pugh class C should be reduced to approximately one-third that of patients with normal liver function, with the follow-up dose adjusted by therapeutic drug monitoring.

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予測性評価に基づいたバンコマイシンTDM解析ソフト変更後の効果検証

今井 俊吾, 山田 武宏, 石黒 信久, 宮本 剛典, 鏡 圭介, 冨山 直樹, 新沼 悠介, 長崎 大亮, 鈴木 幸司, 山神 彰, 笠師 久美子, 小林 正紀, 井関 健

薬学雑誌 （(公社)日本薬学会）  137 （ 9 ） 1185 - 1192 2017年09月

査読有り,  ISSN  0031-6903

　概要を見る

バンコマイシン(VCM)-TDM(therapeutic drug monitoring)およびVCM「MEEK」を用い、MEEKからVCM-TDMへの切り替えによる効果を、初回TDMにおける到達割合を指標に検証した。2011年10月～2014年12月(解析ソフト変更前)とし、VCM-TDMで初期投与設計が行われた群(VCM-TDM群)において、解析ソフト切り替えを行った2015年1月～2016年4月(解析ソフト変更後)とした。MEEK群、VCM-TDM両群に解析対象症例数は各162例で、年齢、性別、CCrおよび初期負荷投与の有無で差がみられた。VCMトラフ値の中央値はVCM-TDM群の方が高値であった。治療域への到達割合はMEEK群42.6%、VCM-TDM群64.2%で、解析ソフト切り替えで21.6%改善した。

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