臺灣博碩士論文加值系統

Teicoplanin是近幾年來，針對革蘭氏陽性菌感染所發展出，做為對methicillin具有抗藥性細菌感染的後線抗生素。有鑑於在日本及美國已出現對vancomycin、甚至對teicoplanin已有抗藥性的金黃色葡萄球菌及腸球菌等，因此應對vancomycin及teicoplanin的使用，加以管控。
台大醫院於九十一年三月訂定vancomycin及teicoplanin的使用規範，用以評估vancomycin及teicoplanin使用的合理性。由於teicoplanin的劑量會因不同的感染部位、不同的病原菌而有不同。又因為目前teicoplanin的劑量與療效相關性不明確，因此藉由本研究，了解台大醫院的處方型態，如適應症及劑量的合理性、使用teicoplanin而不用vancomycin的原因，並分析台大醫院teicoplanin使用之療效及不良反應發生率。
34.9%的teicoplanin療程的使用日數超過14天；而35.8%以上的療程是因為不能耐受vancomycin的不良反應（主要是皮疹、藥物熱及腎毒性）而使用teicoplanin。雖然骨科感染只有34個療程，但因使用日數長，使用量高達33.8%；也因骨科的療程長而取teicoplanin不用監測血中濃度的方便性，其中只有9個療程是因不能耐受vancomycin而改用teicoplanin。本研究所納入之teicoplanin療程中，52.6%的療程用於methicillin- resistant Staphylococcus aureus （MRSA）的感染；高達58.6%的療程有重覆感染的現象，但不能排除有colonization的情形。高達78.0%的teicoplanin的療程有併用抗生素。75.4%的療程是依據細菌敏感性試驗而給藥；經驗性給藥的醫療部門主要是內科部中的內科加護病房及血液內科。依據台大醫院及美國感染症學會針對嗜中性白血球低下合併發燒使用規範，91.0%的療程合乎使用規範。有39個療程是因為嗜中性白血球低下合併發燒而使用teicoplanin，而合乎規範的有31個療程（佔嗜中性白血球低下合併發燒療程的79.5%）。
本研究發現，是否有用速效劑量，並對療效影響不大，但速效劑量的給法相當歧異。在排除主要病原菌非革蘭氏陽性菌、因不良反應而未達應有療程的療程後，teicoplanin的成功率有64.6%，針對MRSA的治療失敗率較高，其中以心內膜炎及肺炎較易失敗。以原始維持劑量對療效做卡方檢定及logistic regression有統計上的相關性，但對療效預測能力影響不大。本研究發現原始維持劑量在 ≧ 6 mg/kg與 < 6 mg/kg時，對療效有統計上差異；但有重複感染及併用抗生素等影響療效因素的存在，且互有相關性，因此對預測能力改善並不大。
研究中發現與teicoplanin相關的不良反應發生率為10.8%，和文獻報告的發生率相近，但其中藥物熱及白血球減少不良反應的發生率則高於文獻報告。對於已有中重度腎衰竭的病人使用teicoplanin時，仍可能發生腎毒性，大多發生在老人。腎毒性發生率的稍高於文獻報告，但確實低於文獻報告vancomycin腎毒性的發生率，但vancomycin有可監測血中濃度的優點。研究中亦發現vancomycin和teicoplanin亦有可能有cross-reaction，皆為過敏性反應。

Teicoplanin was an antibiotic developed for the Gram-positive bacterial infection in the recent years. It should reserved drug for the methicillin-resistant pathogens. Because of the emergence of vancomycin-resistant, even teicoplanin-resistant S. aureus and enterococcus, the usage of vancomycin and teicoplanin should be restricted.
In March 2002 a guideline of vancomycin and teicoplanin was developed to evaluate the clinical use of vancomycin and teicoplanin at the National Taiwan University Hospital (NTU Hospital). The dosage regimen was not included in the guideline. As the dosage of teicoplanin should be adjusted according to the sites of infection and the pathogens, the study was conducted to survey the prescribing pattern of teicoplanin at the hospital. Indications, dosages, as well as the reasons why teicoplanin was used instead of vancomycin were examined. The adverse effects and the efficacy of teicoplanin therapy were also analyzed.
Thirty-five percent of the teicoplanin regimens have a duration of more than 14 days. Over 35.8% of teicoplanin uses were due to intolerance of vancomycin, which included skin rash, drug fever and nephrotoxicity. Although osteomyelitis accounted for only 36 courses (15.5%) of teicoplanin use, it accounted for 33.8% of the amount teicoplanin consumed due to prolonged duration of therapy. The main pathogen isolated in this study was methicillin-resistant Staphylococcus aureus. Because of the high incidence of superinfection, including colonization, and uncertainty of the pathogens, up to 78.0% of teicoplanin courses had been prescribed concomitantly with other antibiotics. More than 75.4% of teicoplanin use were prescribed according to culture/sensitivity test. Over 91.0% of teicoplanin use followed the guidelines. Thirty-nine courses were used for febrile neutropenia.
Loading doses were not associated with the successfulness of treatment in the study, but the dosage of loading dose varied widely. Over 22.3% of maintenance doses used teicoplanin in our hospital were lower than the recommended maintenance dose after the severity of infections were identified. The failure rate of the teicoplanin treatment in this study was 27.2%. Higher failure rate was seen in MRSA infection, especially endocarditis and pneumonia. The efficacy of teicoplanin was significantly better when the maintenance dose was ≧ 6 mg/kg than when the maintenance dose was < 6 mg/kg（p = 0.043）.
The incidence of adverse events of teicoplanin in this study was similar to those reported in the literature, but the incidences of drug fever and leucopenia were higher than those reported. Nephrotoxicity still occurred in patients with renal failure, especially the elderly; but the incidence was lower than vancomycin. It seemed likely that there was the cross-reaction between vancomycin and teicoplanin, e.g., drug fever and skin rash.

第一章 前言 1
第二章 文獻探討 3
第一節 Teicoplanin 簡介 3
第二節 Teicoplanin藥品動態學 7
第三節 Teicoplanin適應症 16
第四節 Teicoplanin使用劑量之探討 21
第五節 Teicoplanin之不良反應 25
第六節 Teicoplanin與Vancomycin安全性比較 28
第三章 研究目的 32
第四章 研究對象與方法 33
第一節 研究對象 33
第二節 資料收集 34
第三節 資料分析 35
第四節 研究方法 36
一、處方型態之分析： 36
二、適應症合理性分析： 37
三、劑量合理性評估： 40
四、療效評估： 46
五、可能影響療效之變項與療效相關性分析 50
六、評估劑量與不良反應之關係： 53
七、不良反應評估： 53
第五章 研究結果 56
第一節 Teicoplanin處方型態分析 56
第二節 給藥目的及適應症合理性評估 68
第三節 劑量分析 73
第四節 劑量與療效分析 75
第五節 可能影響療效之變項與療效相關性分析 82
第六節 嗜中性白血球低下合併發燒病人 95
第六節 使用Teicoplanin的原因分析 97
第七節 Teicoplanin不良反應分析 99
第六章 討論 103
第一節 研究限制 103
第二節 結果探討 104
第七章 結論及建議 112
參考文獻 115
附錄1 台大醫院Vancomycin/Teicoplanin使用評估表 128
附錄2 本研究與藥師評估差異比較表 129

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