Randomized, double-blind, placebo-controlled trial of oromucosal low-dose interferon following prednisone withdrawal for chronic hepatitis B infection in Filipino patients.
Randomized, double-blind, placebo-controlled trial of oromucosal low-dose interferon following prednisone withdrawal for chronic hepatitis B infection in Filipino patients.
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在菲律宾患者中进行泼尼松停药后口腔粘膜低剂量干扰素治疗慢性乙型肝炎感染的随机、双盲、安慰剂对照试验。
DOI：
10.1016/s1201-9712(02)90134-7
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发表时间：
2002
期刊：
影响因子：
--
通讯作者：
N. Mangubat
中科院分区：
文献类型：
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作者：
T. Tupasi;V. Co;Marcus Clarin;Evelyn T. Alesna;E. M. Divinagracia;N. Mangubat
目的评价口服小剂量人α-淋巴母细胞干扰素的疗效和安全性（IF-Nα-n1 [INS]）在菲律宾慢性复制型肝炎B病毒（HBV）感染患者中类固醇停药后的作用。研究设计：对IFN-α-n1 [INS]进行随机、双盲、安慰剂对照试验，两片各200 IU或安慰剂，在激素或安慰剂引发和停药后，舌下给药，每日一次，持续8个月。结果：在统计学上显著清除B e抗原（HBeAg）（50%）和血清转换为HBeAg阳性抗体与安慰剂组相比，IFN-α-n1 [INS]组的抗1-HBe抗体阳性率为42.9%。两组血清HBV-DNA清除率无显著性差异，HBeAg均未被清除。与对照组（31.3%）相比，更多患者（57%）在IFN-α-n1 [INS]下ALT正常化。口腔粘膜IFN-α-n1 [INS]是没有任何证据的toxicity.ConclusionThis研究进行的患者数量有限，证明了口腔粘膜IFN-α-n1 [INS]在慢性HBV感染的治疗效益等于胃肠外给药的干扰素α（IFNα），但没有骨髓抑制的副作用的潜在疗效。由于研究的人群较少，我们无法将这些发现外推至慢性HBV感染的一般人群。需要一项大规模的研究来证实这些发现。
ObjectiveTo evaluate the efficacy and safety of oromucosal low-dose human lymphoblastoid interferon alpha (IF-Nα-n1 [INS]) following steroid withdrawal in Filipino patients with chronic replicative hepatitis B virus (HBV) infection.Study designRandomized, double blind, placebo-controlled trial on IFN-α-n1 [INS], two tablets of 200 IU each or placebo, given sublingually once daily for eight months following steroid or placebo priming and withdrawal.ResultsA statistically significant clearance of hepatitis B e antigen (HBeAg) (50%) and seroconversion to positive antibody to HBeAg (anti-1-HBe) (42.9%) was noted in those given IFN-α-n1 [INS] compared with the placebo group. Clearance of serum HBV-DNA was not significantly different and none cleared HBeAg in both groups. More patients (57%) had normalization of ALT on IFN-a-n1 [INS] compared with controls (31.3%). Oromucosal IFN-α-n1 [INS] was devoid of any evidence of toxicity.ConclusionThis study conducted on a limited number of patients demonstrates the potential efficacy of oromucosal IFN-α-n1 [INS] in chronic HBV infection with therapeutic benefit equal to parenterally administered interferon alpha (IFNα) but without the side effects of myelosuppresion. Owing to the small population studied, we are unable to extrapolate these findings to the general population of patients with chronic HBV infection. A large-scale study is needed to confirm these findings.