目的：評估不同廠牌低劑量leucovocin 合併5-flurouracil 治療腸胃道癌症之藥品不良反應之影響。
研究方法：本研究為觀察回溯性研究，對象為某醫學中心非轉移性之腸胃道癌症，於leucovocin更換不同廠牌(A 廠及B 廠)前後4 個月所有使用低劑量之leucovocin 合併5-Fu 之成人病人(20 歲以上)均納入研究，以病歷回顧的方式進行評估，資料收集包括病人的基本特性、使用劑量、適應症、檢驗值、藥物不良反應、緩解藥物、未達療程之停藥記錄。利用卡方檢定(X2 test)進行統計分析。
結果：符合本研究納入條件之病人共173 人，更換廠牌前4 個月，使用A 廠leucovocin，且為低劑量leucovocin (LDLV)合併5-Fu 病人共106 人，其中31 人(29.2%)發生藥品不良反應；更換廠牌後4 個月使用B 廠leucovocin，且為LDLV 合併5-Fu 病人共67 人，其中15人(22.4%)發生藥品不良反應，藥品不良反應症狀主要為腸胃道方面的不良反應，如噁心、嘔吐及腹瀉。統計顯示更換學名藥leucovorin 前後使用低劑量LV (LDLV)合併5-Fu病人發生藥品不良反應的比率不具統計學上的意義(p = 0.320)。
結論：本研究認為使用不同廠牌LV 且為LDLV 合併5-Fu 治療非轉移胃腸道癌症病人所導致之藥品不良反應無統計學上的差異；藥品不良反應沒有更換LV 後而增加。
 

Objectives:The aim of this study was to evaluate the effect of two different brand drugs of leucovorin on the occurrence of adverse drug reactions potentially caused by the combination of low dose leucovorin (LDLV) and 5-Fu in the treatment of gastro-intestinal cancer patients .
Methods:This was an observational retrospective study. All patients aged above 20, who used 5-Fu in combination with LV as an adjuvant therapy in the treatment of gastro-intestinal cancer 4 months before and after the two different brand drugs (A and B) were collected. The data was collected by patients’chart review which included patients characteristics, dose, indications, laboratory data, ADRs, rescue agents,discontinuation of therapy. Chi-square test was used for analysis.
Results:A total of 173 patients used 5-Fu in combination with low dose LV. Thirty-one of 106 patients (29.2%)used A reported ADRs; 15 of 67(22.4%) patients used B reported ADRs. The number of patients occurred ADRs in two defferent generic substitution of leucovorin in low dose LV plus 5-FU regimen were not statistical significance(p=0.320). The most frequent ADRs were vomiting, nausea and diarrhea.
Conclusions:There were no significant difference in ADRs occurred between patients in the use of LDLV for the treatment of non-metastatic gastrointestinal cancer in this study. Using two different generic leucovorin as a substitute, the increase of occurrence of ADRs were not reported.