对初治的1型慢性丙型肝炎患者在接受聚乙二醇干扰素α-2b加利巴韦林治疗时加用口服降糖药的一项试点研究。

A pilot study of add-on oral hypoglycemic agents in treatment-naïve genotype-1 chronic hepatitis C patients receiving peginterferon alfa-2b plus ribavirin.

作者信息

Hsu Ching-Sheng, Hsu Shih-Jer, Lin Hans Hsienhong, Tseng Tai-Chung, Wang Chia-Chi, Chen Ding-Shinn, Kao Jia-Horng

机构信息

Division of Gastroenterology, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taipei, Taiwan; School of Medicine, College of Medicine, Tzu Chi University, Hualien, Taiwan.

Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou City, Yun-Lin County, Taiwan.

出版信息

J Formos Med Assoc. 2014 Oct;113(10):716-21. doi: 10.1016/j.jfma.2014.05.007. Epub 2014 Jun 25.

DOI:10.1016/j.jfma.2014.05.007

PMID:24974131

Abstract

BACKGROUND/PURPOSE: Insulin resistance (IR) affects sustained virological response (SVR) to peginterferon alfa plus ribavirin (PR) in patients with chronic hepatitis C (CHC). Whether add-on oral hypoglycemic agents (OHAs) to PR improve SVR remains unclear; therefore, we conducted a prospective, randomized pilot trial on 23 consecutive patients with genotype 1 CHC and IR in Taiwan.

METHODS

Patients were randomized to receive acarbose (Arm A; n = 7) or metformin (Arm B; n = 6) or pioglitazone (Arm C; n = 5) in addition to peginterferon alfa-2b (1.5 μg/kg/week) plus ribavirin (1000-1200 mg/day) or just PR (Arm D; n = 5). The primary end point was SVR, and secondary end points were viral clearance at Weeks 17, 29, and 53. There were no differences among all arms at baseline.

RESULTS

Using intent-to-treat analysis, SVR was observed in 66.7% (4/6), 83.3% (5/6), 66.7% (4/6), and 60% (3/5) in Arms A, B, C, and D, respectively. SVR was higher in female patients receiving OHA [90% (9/10)] than in male patients [50% (4/8)]. Results of per protocol analysis showed that SVR was 80.0% (4/5) in Arm A, 100% (5/5) in Arm B, 66.7% (4/6) in Arm C, and 60% (3/5) in Arm D. Patients receiving OHA had a higher rapid virologic response: 11/18 (61%) versus 2/5 (40%). Complete early virologic response was comparable between patients receiving OHA and PR [15/18 (83%) vs. 4/5 (80%)].

CONCLUSION

Our preliminary data show add-on OHAs to PR might achieve better early viral kinetics and SVR. However, further larger studies are needed to confirm these findings.

摘要

背景/目的：胰岛素抵抗（IR）会影响慢性丙型肝炎（CHC）患者对聚乙二醇干扰素α联合利巴韦林（PR）治疗的持续病毒学应答（SVR）。在PR治疗基础上加用口服降糖药（OHAs）是否能改善SVR尚不清楚；因此，我们对台湾地区连续23例基因1型CHC且伴有IR的患者进行了一项前瞻性随机试验。

方法

患者被随机分为四组，除接受聚乙二醇干扰素α-2b（1.5μg/kg/周）加利巴韦林（1000 - 1200mg/天）外，A组（n = 7）加用阿卡波糖，B组（n = 6）加用二甲双胍，C组（n = 5）加用吡格列酮，D组（n = 5）仅接受PR治疗。主要终点为SVR，次要终点为第17、29和53周时的病毒清除情况。各治疗组在基线时无差异。

结果

采用意向性分析，A、B、C、D组的SVR率分别为66.7%（4/6）、83.3%（5/6）、66.7%（4/6）和60%（3/5）。接受OHA治疗的女性患者SVR率[90%（9/10）]高于男性患者[50%（4/8）]。符合方案分析结果显示，A组SVR率为80.0%（4/5），B组为100%（5/5），C组为66.7%（4/6），D组为60%（3/5）。接受OHA治疗患者的快速病毒学应答率更高：11/18（61%）对比2/5（40%）。接受OHA治疗患者与接受PR治疗患者的完全早期病毒学应答相当[15/18（83%）对比4/5（80%）]。