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钝顶螺旋藻与水飞蓟宾治疗慢性丙型肝炎病毒感染。一项随机、对照的临床试验。

Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial.

机构信息

Green Clinic and Research Centre, Alexandria 21121, Egypt.

出版信息

BMC Gastroenterol. 2012 Apr 12;12:32. doi: 10.1186/1471-230X-12-32.

DOI:10.1186/1471-230X-12-32
PMID:22497849
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3353193/
Abstract

BACKGROUND

Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ) and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation.

METHODS

Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment.The two groups were followed up and blindly compared for early (after 3 months) and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT), Chronic Liver Disease Questionnaire scores (CLDQ), Arizona Sexual Experience Scale scores (ASEX) and the occurrence of any attributable adverse events were also compared.

RESULTS

Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3%) had a complete end of treatment virological response and 2 patients (6.7%) had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12) and 3 months treatment (p = 0.22) by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group.

CONCLUSIONS

Our results could suggest a therapeutically feasible potential for Spirulina platensis in chronic HCV patients, worthy to conduct a larger sized and longer study to confirm these safety and efficacy encouraging results.

TRIAL REGISTRATION

WHO Clinical Trial Registration ID: ACTRN12610000958088http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000958088.

摘要

背景

螺旋藻,一种常用于膳食补充剂的蓝藻,已被发现具有多种免疫刺激和抗病毒活性。它被发现能激活巨噬细胞、NK 细胞、T 细胞、B 细胞,并刺激干扰素 γ(IFN-γ)和其他细胞因子的产生。从螺旋藻中分离出的天然物质已被发现是几种包膜病毒的有效抑制剂,通过阻断病毒的吸收/穿透和穿透后细胞内子代病毒的一些复制阶段。我们旨在研究这种膳食补充剂是否具有任何值得进一步更大规模对照临床试验评估的治疗可行性活性。

方法

66 例慢性丙型肝炎病毒感染患者符合纳入标准,随机分为螺旋藻或水飞蓟素治疗组,治疗 6 个月。两组均进行随访,并对治疗后 3 个月和 6 个月的病毒学应答进行盲法比较。还比较了两种治疗方法对丙氨酸氨基转移酶(ALT)、慢性肝病问卷评分(CLDQ)、亚利桑那性体验量表评分(ASEX)的影响,以及任何可归因的不良反应的发生情况。

结果

30 例接受螺旋藻治疗并完成 6 个月方案的患者中,4 例(13.3%)完全达到治疗结束时的病毒学应答,2 例(6.7%)达到部分治疗结束时的病毒学应答,定义为病毒载量至少下降 2 对数 10。虽然螺旋藻组的应答者比例高于水飞蓟素组,但在 6 个月和 3 个月治疗结束时,Exact 检验的差异均无统计学意义(p=0.12 和 p=0.22)。螺旋藻组的丙氨酸氨基转移酶以及 CLDQ 和 ASEX 评分均较水飞蓟素组有显著改善。

结论

我们的结果提示螺旋藻在慢性丙型肝炎患者中具有治疗可行性潜力,值得进行更大规模和更长时间的研究,以确认这些安全和疗效令人鼓舞的结果。

试验注册

世界卫生组织临床试验注册 ID:ACTRN12610000958088http://apps.who.int/trialsearch/trial.aspx?trialid=ACTRN12610000958088。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dee/3353193/f7da32be3f93/1471-230X-12-32-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dee/3353193/f57a5a0ce70b/1471-230X-12-32-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dee/3353193/8bf925766994/1471-230X-12-32-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dee/3353193/f7da32be3f93/1471-230X-12-32-3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dee/3353193/f57a5a0ce70b/1471-230X-12-32-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dee/3353193/8bf925766994/1471-230X-12-32-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3dee/3353193/f7da32be3f93/1471-230X-12-32-3.jpg

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