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研究生:吳銘峻
研究生(外文):MING-CHUN WU
論文名稱:一.全民健康保險大量液體點滴注射液之使用原則及管理策略之評估二.油性筆溶媒(xylenes)對LVP塑膠容器滲透之探討
論文名稱(外文):1.Evaluation of the usage principle and managing policy on Large Volume Parenterals (LVP) by National Health Insurance Bureau 2.A study on the penetration of xylenes from oily markers through LVP plastic containers
指導教授:詹道明詹道明引用關係
指導教授(外文):THAU-MING CHAM
學位類別:碩士
校院名稱:高雄醫學大學
系所名稱:藥學研究所
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2001
畢業學年度:89
語文別:中文
論文頁數:122
中文關鍵詞:大型輸注液二甲苯使用原則塑膠容器
外文關鍵詞:Large Volume Parenteral (LVP)XyleneUsage principlePlastic container
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一.
本研究的主要目的是欲分析高雄屏東地區(簡稱高屏地區)健保特約醫事服務機構使用大量液體點滴注射液(LVP)的情形,評估其使用原則,建立用藥的基本型態,俾能提供中央健康保險局作為管理大量液體點滴注射液策略之訂定。
在針對六家生產廠商的問卷調查方面,從民國85年至88年,總生產量與銷售量均以生理食鹽水製劑最多,其次為葡萄糖5%輸注液。在市場銷售對象方面以醫院佔有比例最大宗。全民健保的總醫療費用中,只有約1/3是用於住院診療,另約2/3則是用於門診費用,醫療資源分配比例與先進國家相比則住院診療之支出偏低;健保總藥費支出從健保開辦以來每年皆持續上升,尤其以醫院市場成長幅度最大。
在住院診療方面,86年度高屏分局的特約醫事機構平均每月申報案件37,362.8筆,以地區醫院申報19,982.5筆最多;用藥金額以醫學中心平均每月8,294.7萬元佔最多。LVP的使用金額也以醫學中心平均每月3,290.2萬元佔最多。LVP的使用金額在診療科別以內科平均每月2,437.8萬元,佔45.46% 最多。在醫學中心LVP用藥金額佔全部用藥金額的39.67%。在各疾病別平均每月使用LVP藥費金額則是以肺炎佔4.21%最多。在87年度,平均每月申報案件38,553.2筆,以地區醫院申報19,700.0筆最多;診療科別以內科平均每月12,253.2筆 31.78% 最多。全部用藥金額與LVP用藥金額也是以醫學中心佔最多。
門診診療方面,86年度高屏分局特約醫事服務機構平均每月申報案件4,185,455.9筆,以診所申報2,238,402.1筆最多;診療科別以不分科佔21.05% 最多。LVP的使用金額以醫學中心平均每月994.0萬元佔65.54%最多,且以內科佔使用金額最多。87年度的使用情形大致和86年度相同。
二.
5種市售大型輸注液塑膠容器包裝,多層膜(ML)軟袋、聚丙烯(PP)、
聚氯乙烯(PVC)材質,內裝注射用水。經含有xylenes的油性筆塗佈,
xylenes 是芳香族碳氫化合物的揮發性有機溶媒,有3個isomers (p-, m-, o-xylene),塗佈1面的面積在1, 4, 8小時後取樣分析。以氣相層析儀分析 ; 檢量線,濃度範圍0.1 ~ 6μg/ml,相關係數0.999以上 ; 同日與異日間精密度,變異係數4% 以下 ; 萃取回收率在88 ~ 105%。
Xylenes 穿透塑膠容器至注射用水的含量檢測 ; 在塑膠容器2, 4的檢品溶液中未檢出含xylenes。而在塑膠容器1, 3, 5的檢品溶液中均能檢測出含xylenes,顯示經塗佈後xylenes能滲透塑膠容器1, 3, 5的包裝到檢品溶液中。


1.
The purpose of this study is to analyze the usage of Large Volume Parenterals--LVP by medical institutes in the Kao-Ping area. The condition that usage of LVP is based on, the results of this study may assist was accessed the Bureau of National Health Insurance in making policies to control LVP usage.
According to a survey of six LVP pharmaceutical companies, from 1996 to 1999, normal saline has the largest total production and sales while 5% glucose is the second. Hospitals are the largest users. Only one third of the expense of NHI is used on hospitalized patients as two thirds is used on outpatients. Compared to some other developed countries, the use of medical resources on hospitalized patients is lower. The pharmaceutical expense of the NHI program has kept increasing since the NHI program started. The increasing percentage of expense used in the hospital market is particularly obvious.
For inpatients, the contractual medical institutes of the Bureau of NHI Kao-Ping office claimed 37,362.8 cases. Of these, area hospitals, having the largest share, claimed 19,982.5 cases. The pharmaceutical expense of medical centers is the highest, which is 3,290.2 ten thousand dollars in average. Internal medicine has the highest percentage of the consumption of LVP which is 45.46 % and the expense is 2,437.8 ten thousand dollars every month on average. LVP expense in medical centers is 39.67% of the total pharmaceutical expense. Among diseases, pneumonia has the highest share of LVP, which is 4.21 % of the total cost. In 1998, the number of case claimed was 38,553.2, on average every month, of which area hospitals (with 19,700 cases) claimed the largest share. Internal medicine has the largest share of LVP and pharmaceutical expense, as it has 12,253.2 cases (31.78 % on average) every month.
For outpatients, in 1997, the contractual medical institutes of Kao-Ping NHI office had 4,185,455.9 cases. Of these, general practitioners at the local clinics, which claimed 2,238,402.1 cases had the biggest share while among clinics, general medicine clinic had the biggest percentage (21.05) in terms of cases claimed. Medical centers still had the largest share of LVP expense since they used 994.0 ten thousand dollars (65.54% of the total expense) on average every month. The situation of usage of LVP in 1998 is generally similar to that in 1997.
2.
Xylenes is an aromatic hydrocarbon of volatile organic solvent consisting three isomers, (para(p), meta(m)- and ortho(o)-xylene). The possible penetration of xylenes through the wall of five commercial plastic containers of large volume parenterals (LVP), multilayer (ML), polypropylene (PP) and polyvinyl chloride (PVC), containing water for injection was studied by painting the outer wall of the containers with an oily marker. The oily marker contains xylenes as the solvent.
The size of painting area and sampling time intervals were two key parameters for evaluation of the penetration of xylenes through the container wall. The analysis method was a validated gas chromatograph. The extract recovery ranged between 88 and 105%.
Xylenes were not detected for all samples from the numbers 2 and 4 plastic containers. However, xylenes were detected for all samples from the numbers 1, 3 and 5 plastic containers, while the previously fixed sampling times were 1, 4 and 8 hours after the container wall had been painted with the oily marker.

第一部份 全民健康保險大量液體點滴注射液之使用
原則及管理策略之評估
中文摘要 i
英文摘要 ii
第一章 前言
第一節 研究動機 1
第二節 研究目的 4
第二章 文獻探討
第一節 大型輸注液之使用時機 6
第二節 注射劑的用途與一般之規定及要求 7
第三節 輸注液使用情形之探討 8
第四節 台灣與美國、德國、加拿大、英國及瑞典等
五國醫療體系的重要特性比較 11
第五節 西醫基層總額支付制度 14
第三章 材料與方法
第一節 資料來源 16
第二節 分析項目 17
第三節 統計分析 17
第四章 結果
第一節 國內大量液體點滴注射液製造廠之生產銷售
分析 18
第二節 大量液體點滴注射液之藥價調查 24
第三節 國內大量液體點滴注射液之使用分析 34
第四節 大量液體點滴注射液消耗費用、藥品總消耗費用
與健保總醫療費用分析比較 75
第五章 討論、結論與建議
第一節 討論與結論 76
第二節 建議 78
參考文獻 80
附錄(藥廠問卷) 83
第二部份 油性筆溶媒(xylenes)對LVP塑膠容器
滲透之探討
中文摘要 iv
英文摘要 v
第一章 前言……………………………………………………86
第一節 xylene物化性質 87
第二節 xylene的各相關監測值 88
第三節 吸收、代謝和排除 89
第四節 副作用、毒性 95
第五節 溫度對塑膠容器的影響 96
第二章 實驗目的…………………………………………….97
第三章 材料與儀器設備………………………………….98
第四章 實驗方法
第一節 三種油性筆xylene含量測定方法 100
第二節 氣相層析儀分析方法
1. 氣相層析儀條件
2. 檢量線的製作
3. 同日間精密度與異日間精密度的測定 101
4. 最低檢出量之分析
5. 檢品溶液之配製、取樣、分析 102
6. 注射用水中o-, m-, p-xylene添加回收率
之探討 103
第五章 結果與討論
第一節 油性筆xylenes含量測定結果 104
第二節 氣相層析儀分析確效 108
1. 檢量線製作 108
2. 同日間精密度與異日間精密度之測定結果 111
3. 最低檢出量分析結果 114
4. 檢品溶液分析結果 115
5. 注射用水中o-, m-, p-xylene添加回收率
分析結果 .……… .…… 119
第六章 結論 ……………………………………………….. .120
參考文獻 ………………………………………………………. .121

第一部份 全民健康保險大量液體點滴注射液之使用
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