- 學位論文
Tigecycline 藥品核准標示外使用之研究
The Study on Off-Label Use of Tigecycline
摘要
Tigecycline 是屬於 Glycylcycline 類的抗生素，其體外抗菌範圍包括了革蘭氏陽性菌、革蘭氏陰性菌、非典型細菌、厭氧菌，是屬於廣效型抗生素，且對抗藥性菌株也有效。目前國內對 tigecycline 的核准適應症為複雜性腹腔內感染及複雜性皮膚及皮膚結構感染，但在臨床上仍然有許多病人，尤其是 ICU的病人，感染了多重抗藥性菌株的情況下使用 tigecycline 來治療。 本實驗的目的為探討 tigecycline 使用在 Off-Label Use的情況，可以提供臨床醫師針對嚴重感染的病人使用，並非考慮是否有適應症下使用。本研究資料來源為IMS Data, 探討2007年1月至2008年12月在台灣住院病人使用 tigecycline 的處方狀況，以回溯性方法來分析，隨機抽樣總共收集了6330人次，其中主診斷碼是依據 ICD-9-code 來做分類為符合健保核准適應症(Indication) 及非符合健保核准適應症(Non-Indication)。 2007與2008年健保給付使用tigecycline 總金額為184,573,420元，屬於健保核准適應症給付總金額為28,414,800元，所佔總比例為15.39%,屬於非健保核准適應症給付總金額為156,158,620元，所佔總比例為84.60%,針對在非符合健保核准適應症中使用tigecycline 治療在呼吸道疾病，菌血症，血液腫瘤疾病這三項給付金額的平均數差異情形，結果為在呼吸道疾病與其他非符合健保核准適應症的比較有顯著上的差異。 Tigecycline使用在Off-Label Use也就是非符合健保核准適應症的健保給付金額比例大於符合健保核准適應症,其中使用在呼吸道疾病的病人更為顯著。
並列摘要
Tigecycline is a new class of Glycylcycline antibiotics, its in vitro susceptibility studies have demonstrated that tigecycline has a broad spectrum of activity against many common bacteria, included the gram-positive, gram-negative, atypical bacteria, and anaerobic bacteria, as well as antibiotic-resistant to be also effective. At present, the approved indication of tigecycline for the complicated intra-abdominal infections and complicated skin and skin structure infections, but clinical still many (particularly the ICU patient) infected with multiple drug resistant strain situations of the use of tigecycline to the case treatment. This purpose that investigate the study on the Off-Label Use of tigecycline situation, can provide clinicians use for patients with serious infections, not to consider the indications for use. The data source for the IMS Data, of January 2007 to December 2008 in Taiwan, the prescription status of patients using tigecycline to retrospectively analyze, collected a total of 6330 randomly selected people, including the primary diagnosis code is based on the ICD -9-code to do the approved indications classified as consistent with national health insurance and Off-Label Use of tigecycline (Non-Indication). 2007 and 2008, the total amount of reimbursement for use of tigecycline is NT 184,573,420 dollars, is the total amount of health insurance payment for the approved indications for NT 28,414,800 dollars, and the Off-Label Use of tigecycline to payment the aggregate amount is NT 156,158,620 dollars, proportion respectively is 15.39% and 84.60%, in the Non-Indication for the use of tigecycline in the treatment of respiratory diseases, bacteremia, blood cancer disease an average of the three differences of the amount paid, the result for, in the respiratory disease has the significant on difference with other Non-Indication comparison. The use on Off-Label Use of tigecycline, also the Non-Indication to be the amount of health insurance reimbursement is greater than the proportion of Indication, which use even more significant in patients with respiratory diseases.