台灣某三家區域教學醫院C型肝炎以peginterferon alfa 2b與ribavirin合併治療結果分析

The analysis of hepatitis C treatment with peginterferon alfa 2b and ribavirin in three regional hospitals in Taiwan

柯維信(Wei-Hsin Ko)

指導教授 ： 吳信昇

高雄醫學大學/藥學院/藥學研究所碩士在職專班/碩士(2006年)

摘要

【前言】
C型肝炎病毒的感染在全世界影響了約一百七十萬人。在台灣，C型肝炎的盛行率約為2-5%，但在某些區域可高到20-60%。C型肝炎的治療目前以長效型干擾素（pegylated interferon）與ribavirin的合併使用為主，治療時間的長短可以基因型來調整。基因型1的病患可治療四十八週並且合併標準劑量的ribavirin，基因型2或3的病患，可以合併低劑量之ribavirin即已足夠。

【研究目的】
本研究的目的為收集C型肝炎治療的病患的資料，分析持續性治療反應的相關因子、不良反應的產生情形與藥物劑量的關係，以供醫護人員治療參考。

【研究方法】
本研究採取回溯性病歷回顧的方式，自2002年1月1日起至2005年12月31日止，收集三家區域教學醫院的門診病患，診斷為C型肝炎並且以peginterferon alfa 2b及ribavirin合併治療處方者。分析的參數包括病患的年齡、性別、體重、肝纖維化的級數、C型肝炎病毒的基因型與治療反應的相關性，檢驗項目異常與peginterferon alfa 2b與ribavirin劑量的相關性。
統計方法使用chi-square test、independent-samples T test及paired T test來檢驗，並使用SPSS (statistical package for social science) 8.0 for Windows統計套裝軟體進行分析。

【結果與結論】
在病患治療結束後六個月，病患治療成功的有46人（intention-to-treat模式為47.6%，per protocol模式為60.6%）。在不良反應方面，在總數91位病患中，出現白血球數異常的有66位(75.0 %)，出現血色素異常的有65位(73.9 %)，絕對中性球數異常的有27位(64.2 %)，血小板異常的有31位(47.7 %)，總膽紅素異常的有8位(10.8 %)，甲狀腺刺激賀荷爾蒙異常的有2位(2.5 %)。
針對治療成功與否因素分析，僅對年齡及病毒基因型具有相關性（P < 0.05），與性別、體重都沒有相關性（P > 0.05）。
檢驗值異常出現的比率相當高，但是這些異常値包括白血球數，血色素、血小板數、絕對中性球數及總膽紅素無法判定與peginterferon alfa 2b或是ribavirin使用的劑量是否有關聯性。

關鍵字

C型肝炎 ； peginterferon alfa 2b ； ribavirin

並列摘要

Background:
Chronic hepatitis C virus (HCV) infection affects 170 million people worldwide. The prevalence of chronic hepatitis C is 2% to 5% in Taiwan, but 20-60% in some areas. The optimal therapeutic regimen for hepatitis C is pegylated interferon in combination with ribavirin. The duration of treatment may be individualized by the genotype. Patients with genotype 1 required treatment for 48 weeks and a standard dose of ribavirin; those with HCV genotype 2 or 3 seem to be adequately treated with a low dose of ribavirin.

Objectives:
The objectives of this study are to analyze the predictive factors of sustained response and the relationship medication dose and adverse reaction, so as to provide references of treatment.

Methods:
Data was collected from an outpatient computerized prescription data base of three regional hospitals from January 1, 2002, through December 31, 2005. Patients who were diagnosed as hepatitis C and were treated by combination of peginterferon alfa 2b and ribavirin were included.
The data analysis includes the relationship between therapeutic response and genotype, age, stage of fibrosis; the relationship between abnormality of laboratory data and ribavirin dose and peginterferon alfa 2b dose.
Statistical methods used in this study are chi-square test, independent-samples T test and paired T test. We used SPSS (statistical package for social science) 8.0 for Windows software to compile statistics.

Results and conclusions:
After six months finished treatment, 46 patients are of the sustained biochemical response (47.6 % for intention-to-treat, 60.6 % for per protocol). In total 91 treated patients, there are 66 patients with abnormal white blood cell count (75.0 %), 65 patients (73.9 %) with abnormal hemoglobulin, 27 patients (64.2 %) with abnormal absolute neutrophil count, 31 patients (47.7 %) with abnormal platelet count, 8 patients (10.8%) with abnormal total bilirubin, and 2 patients (2.5 %) with abnormal thyroid stimulating hormone.
The response of treatment is related to age and the genotype of hepatitis C virus (P < 0.05), but not related to gender and weight (P > 0.05). We can not conclude if the occurrences of abnormal laboratory data are related to the dosage of peginterferon alfa 2b and ribavirin.

並列關鍵字

hepatitis C ； peginterferon alfa 2b ； ribavirin

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