Therapy of hepatitis C: Meta-analysis of interferon alfa-2b trials
Therapy of hepatitis C: Meta-analysis of interferon alfa-2b trials
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DOI：
10.1002/hep.510260715
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发表时间：
1997-09-01
期刊：
影响因子：
13.5
通讯作者：
Emerson, SS
中科院分区：
文献类型：
--
作者：
Carithers, RL;Emerson, SS
我们对所有可用的慢性丙型肝炎患者干扰素α-2b随机临床试验进行了独立的荟萃分析，1986年至1996年发表的文章必须包括以前未接受治疗的患者，他们被随机分配到每周至少服用200万单位(MU)的干扰素α-2b治疗24周，总共有32项试验符合纳入标准，其中20项试验将干扰素治疗患者与安慰剂接受者或未治疗患者进行比较，并用于初步荟萃分析，比较治疗结束和治疗后6个月持续生化(正常丙氨酸氨基转移酶[ALT]水平)应答率。在配对活检的患者中，治疗结束和6个月的持续病毒学反应(没有丙型肝炎病毒RNA)和治疗结束的组织学反应，另外12项试验比较了不同剂量、持续时间或治疗策略，与不治疗相比，干扰素α-2b治疗与所有测量的终点显著改善有关。治疗结束时，47%的患者出现生化反应，而对照组为4%(优势比，25.1；P<；0.0001)；23%的治疗患者的生化反应持续至少6个月，而对照组为2%(优势比，17.8；P<；0.0001)；治疗结束时，29%的患者观察到病毒学反应，对照组为5%(优势比，9.4；P<；与1%的对照组相比，8%的治疗患者记录了6个月的持续病毒学应答(优势比，8.6；P<；.001)。73%的治疗患者记录到了组织学反应，而对照组为38%(优势比，4.8；P<；.0001)。延长治疗12至24个月导致6个月持续反应的显著改善：27%对14%(优势比，2.9；P<；.001)。高剂量治疗还导致治疗结束(61%比52%；优势比1.8；P<；0.02)和6个月持续反应(28%比19%；优势比2.2；P<；0.01)略有增加。
We performed an independent meta-analysis of all available randomized clinical trials of interferon alfa-2b in patients with chronic hepatitis C, Articles published between 1986 and 1996 had to include previously untreated patients who were randomly allocated to therapy with at least 2 million units (MU) of interferon alfa-2b three times weekly for 24 weeks, A total of 32 trials met the inclusion criteria, Of these, 20 compared interferon-treated patients to placebo recipients or untreated patients and were used in the primary meta-analysis that compared rates of end-of-treatment and 6-month posttreatment sustained biochemical (normal alanine aminotransferase [ALT] levels) responses, end-of-treatment and 6-month sustained virological responses (absence of hepatitis C virus [HCV] RNA), and end-of-treatment histological responses in patients with paired biopsies, An additional 12 trials compared different doses, duration, or strategies of treatment, In comparison with no treatment, interferon alfa-2b therapy was associated with significant improvement in all end points measured. End-of-treatment biochemical responses were seen in 47% of treated patients compared with 4% of controls (odds ratio, 25.1; P < .0001), The biochemical responses were sustained for at least 6 months in 23% of treated patients compared with 2% of controls (odds ratio, 17.8; P < .0001), End-of-treatment virologic responses were observed in 29% of treated patients compared with 5% of controls (odds ratio, 9.4; P < .001) and 6-month sustained virologic responses were documented in 8% of treated patients compared with 1% of controls (odds ratio, 8.6; P < .001). Histological responses were recorded in 73% of treated patients compared with 38% of controls (odds ratio, 4.8; P < .0001), Extended therapy for 12 to 24 months resulted in significant improvement in 6-month sustained responses: 27% versus 14% (odds ratio, 2.9; P < .001). Higher dose therapy also resulted in modest increases in end-of-treatment (61% vs. 52%; odds ratio, 1.8; P < .02) and 6-month sustained responses (28% vs, 19%; odds ratio, 2.2; P < .01).