- 學位論文
某醫學中心加強抗生素管制之影響
Impact of an Intensive Antibiotic Control Program in a Medical Center
摘要
近年來由於細菌抗藥性問題有愈來愈嚴重的趨勢，不但健保已訂定抗生素使用規範，各醫療院所亦已陸續著手實施配合訂定抗生素使用原則之相關管制規定，期望醫師可以適當地使用抗生素於疾病治療或預防，以減緩抗藥性細菌產生及控制抗生素使用費用支出。本研究針對某醫學中心於2002年7月所開始實施之「加強抗生素管制措施」，並選取於實施前後同季各三個月期間（分別為”基礎期”-2001年10月至12月以及”管制期”-2002年10月至12月）住院病患中，至少有使用一種為抗感染劑進行臨床治療結果、抗生素使用費用的評估，以及相關之抗生素使用量、細菌對藥物之敏感性趨勢的分析。依上述納入條件，本研究共納入10100住院人次，其中於基礎期入院的有5046人次、於管制期的有5054人次。兩組病人之基礎條件包括年齡、男性比例及院內感染率之分析並無統計上顯著差異；此外在臨床治療結果之指標譬如住院天數、死亡率及三十天內再入院率，亦無統計上顯著差異。然而在抗生素藥費方面，平均每人日注射型藥費減少30元 （302.7±509.9 vs. 272.4±450.5, P=0.002）；同時注射型抗生素的花費占所有藥費百分比也由47.6% 減少至 44.9%；就醫院管理層面來分析，管制期間注射型抗生素成本較基礎期節省了1,070,954元。而注射型抗生素使用總量，則是由藥劑部之藥物耗用紀錄，依每一百個病人日所使用之定義每日劑量數（DDDs/100PDs）概念來分析的。結果基礎期與管制期之使用總量減少9.4 DDDs/100PDs（71.2 vs. 61.8），約減少為原使用量的13.2%。從臨床分離之院內感染細菌對抗生素敏感性來看，大多無明顯改變，僅Pseudomonas aeruginosa對amikacin及ciprofloxacin、Serratia spp.對ciprofloxacin的敏感性有顯著增加 （P<0.05）。本研究亦針對臨床分離細菌對抗生素抗藥性進行趨勢分析，結果發現Klebsiella pneumonia、Escherichia coli及Serratia spp.對amikacin的抗藥性增加，但P. aeruginosa對amikacin的敏感性有顯著增加的趨勢（P<0.001）；Enterobacter spp.及Acinetobacter spp.對ciprofloxacin的抗藥性增加，但Serratia spp.對ciprofloxacin的敏感性亦有顯著的增加趨勢（P<0.001）。由上述臨床用藥的分析結果可知該醫學中心所實施之「加強抗生素管制措施」，雖然對臨床治療指標譬如住院日等並無明顯改變，而細菌敏感性數據的分析在短期內並無法解釋與管制之因果關係；但在抗生素藥物使用相關指標譬如藥物用量（包括實施後第二年度同季期）與藥費、以及藥費使用成本都有較實施前顯著減少；未來將需針對其他管制措施的成效指標譬如藥物適當性、成本-效益分析等進行研究。
並列摘要
For many years, excessive and inappropriate uses of antibiotics have been recognized as a major problem and a reason for high costs, as well as the spread of drug-resistant microorganisms. In Taiwan, guidelines for antibiotic-uses were implemented by the Bureau of National Health Insurance, and various strategies have been approached in the hospitals in order to improve the overuse or the appropriate use of antibiotics for therapy and prophylaxis. In current studies, patients admitted in the fourth quarter (October to December) of the year before and after implementation of the program were included. The impacts of intensive antibiotic control programs were analyzed by comparing indicators including clinical outcomes and related antibiotic costs, antibiotic consumptions and bacterial susceptibilities. Among the total of 10100 admissions administered at least one antibiotic, the sample sizes for two periods (before and after the implemented programs) were similar (5046 vs. 5054). There was no statistical difference in the demographic variables such as age, gender, and the incidence of nosocomial infections. The characteristics of the clinical outcomes including length of hospital stay, mortality, and readmission rate were also similar between two periods of time. The mean costs of intravenous antibiotics per patient-day decreased NT$30 (NT$302.7±509.9 vs. NT$272.4±450.5, P=0.002). Therefore, the cost savings for intravenous antibiotics were NT$1,070,954. Intravenous antibiotic consumption was also evaluated by collecting drug-uses records obtained from the pharmacy according to the concept of the defined daily doses per hundred patient-days (DDDs/100PDs). Consumption of intravenous antibiotics decreased by 13.2% (71.2 vs. 61.8) compared to the basal study period. The susceptibilities of the bacterial organisms isolated from the patients of the nosocomial infections towards antibiotics did not decline significantly, except Pseudomonas aeruginosa to amikacin and ciprofloxacin, Serratia spp. to ciprofloxacin increased significantly. The status of antibiotic resistance of clinical isolated pathogens was also analyzed. There were significant trends (P<0.001) in increased susceptibilities of P. aeruginosa towards amikacin, though increased resistance of Klebsiella pneumonia, Escherichia coli and Serratia spp.. There were also significant trends (P<0.001) in increased susceptibilities of Serratia spp. towards ciprofloxacin, though increased resistance of Enterobacter spp. and Acinetobacter spp.. Conclusively, the parameters related to the antibiotic-uses such as consumptions (including in the same quarter period of year 2003), antibiotic expenditures or hospital’s drug budget were decreased significantly without compromising patient clinical outcomes. Further investigations on other quality indicators such as appropriate uses of antibiotics, cost-benefit analysis for the implemented intensive antibiotic control programs are required.