- 期刊
Ursodeoxycholic Acid (UDCA)治療慢性肝炎病患之短期療效
Short-termed Efficacy of Ursodeoxycholic Acid (UDCA) in Patients with Chronic Hepatitis
摘要
慢性肝炎盛行於台灣，而慢性肝炎又可導致肝硬化及肝癌，因此國人普遍使用肝庇護劑來保養肝功能。Ursodeoxycholic acid (UDCA)是本院常用的肝庇護劑，藉由UDCA之適當性使用評估，可以探討國內肝庇護劑使用情況及使用之適當性。在2005年七月一日至九月三十日止，為期三個月、92天期間內，共收案165人，其中有105人之治療適應症為肝功能異常。以全民健康保險藥品給付規定中肝庇護劑之最新修正使用規範，針對南部某醫學中心門診肝炎病患使用UDCA之情形進行評估。結果發現使用最多年齡層為50-60歲，使用最多的科別是肝膽胰內科（69人；65.7%），最常見的使用劑量為一天兩次、每次300mg（92人；87.6%），少數患者併用抗病毒藥物（lamivudine或interferon）（12人；11.4%）。治療後GPT值改善與未改善比率並無差異。依全民健保藥品給付規定作適當性評估發現有58人(55.2%)為不適當使用，造成不適當使用的主要原因為未依規定於使用期間每3個月監測ALT值(38.1%)，其次為ALT值正常後仍給藥(15.2%)，開始使用時未測ALT值(11.4%)及開始使用時ALT值為正常(8.6%)。以邏輯迴歸探討影響UDCA治療效果的因子時，發現起始GPT值≧2倍正常上限值是影響UDCA治療3個月及6個月效果的重要因素。但若將起始治療時ALT值大於10倍正常值之病患及併用抗病毒藥物治療之病患排除後，發現並無任何影響UDCA治療效果的因子。UDCA的適應症是用來治療膽結石症，而非使用來治療慢性肝功能異常，因此治療慢性肝功能異常並非其適應症，但是卻常被用來作為肝庇護劑使用。此次的使用評估發現有大於50%病人沒有依全民健康保險藥品給付規定使用，因此為減少不必要之醫療支出，應依肝庇護劑使用規範加強稽核。同時建議使用UDCA治療慢性肝功能異常的標準應設定於起始GPT值≧2倍正常上限值以增加其治療的效益。
並列摘要
Chronic hepatitis is endemic in Taiwan and can cause liver cirrhosis and hepatocellular carcinoma (HCC). Therefore, Ursodeoxycholic acid (UDCA) is popular for minimizing the risk of developing these awful sequelae. To understand the appropriateness of use of UDCA and to evaluate its short-term effectiveness, we conducted a retrospective medication utilization evaluation in a medical center in South Taiwan. All out-patient department (OPD)-prescribed UDCA during July first and September 30, 2005, were reviewed. The appropriateness was judged by the usage criteria of The Bureau of National Health Insurance (BNHI). Totally 105 patients received UDCA for hepatoprotection during a 92-days period. The most frequent prescription rate was found in the hepatobiliary section (65.7%). The most common dosage was 300mg bid (87.6%). 11.4% of patients received anti-viral therapy concomitantly. More than 50% of patients had their ALT elevated after 3-month's and 6-month's therapy. 55.2% of prescription did not fit in with the indication of the usage criteria of BNHI. The reasons of inadequate use of UDCA were no regular follow-up of liver function every 3 months (38.1%), medication after normalization of liver function (15.2%), un-detection of ALT level initially (11.4%) and normal initial ALT level (8.6%). After multivariate analysis, initial ALT≧2×UNL (upper normal limit) was the significant factor affecting the therapeutic effectiveness of UDCA. The indication of UDCA is to resolve cholesterol gallstone, but not as a hepatoprotective agent. Although UDCA had been argued against its role in hepatoprotection, it was still popular. There were more than 50% of prescriptions unfitting in with the usage criteria of BNHI. To make the indication of UDCA well known, to set up the usage criteria as ALT≧2×UNL for hepatoprotection, to audit the use of UDCA and to have its regular medication utilization re-evaluation are necessary in the future.