该项研究中,10例持续性HPV感染的女性患者,每日口服一次AHCC(剂量3克),连续服用6个月。结果发现,有5例患者实现HPV转阴,其中3例被证实已根除HPV并已停止服用AHCC,另外2例患者仍在继续研究。
该项研究的首席研究员——美国德克萨斯大学休斯顿健康科学中心产科妇科和生殖科学系副教授Judith A.Smith博士指出,该研究中未实现HPV转阴的5例患者,实际上并没有接受完整的6个月AHCC治疗。
Smith博士指出,最初,研究人员乐观地认为,1个月就能够消灭HPV感染,同时每周进行检测;然而,当第一例患者在第5周仍没有反应时,研究人员认为AHCC无效,所以停止了治疗。之后,研究人员意识到可能需要更长的时间,于是第2例患者治疗时间延长致8周,但仍没有反应,于是也停止了治疗。另外2例患者,经过3个月治疗后仍未清除病毒,也停止了治疗。现在研究人员已经知道,至少需要6个月的治疗才能实现全部疗效。
Smith博士强调,该试点研究的目的是确定合适的剂量和治疗持续时间,接下来即将开展一项II期随机双盲试验。另外,Smith博士表示,还想调查AHCC是否能预防HPV感染或预防再次感染。
HPV病毒感染通常为局部限制性,不引起炎症反应。大多数人都能自行清除病毒,只有一小部分人由于免疫系统的原因无法清除病毒,造成HPV持续感染,继而发展为宫颈癌。目前,针对持续性感染,尚无有效治疗药物,因此该项研究结果非常邻人鼓舞。
AHCC是由几种担子菌类蘑菇的共培养菌丝体制备而成的提取物。临床前研究表明,AHCC具有抗癌特性;体内和体外研究也证实,AHCC能够消灭HPV;而AHCC能够消灭致癌性HPV类型16/18的能力,归因于对干扰素α、β、γ的表达和信号通路的调控。
AHCC是一种非处方(OTC)营养补充剂,使用时无副作用,在日本和中国被广泛地使用,用于维持健康状态及治疗严重疾病。(
英文原文:Japanese Mushroom Extract Could Help Treat HPV Infections
A Japanese mushroom extract, active hexose correlated compound (AHCC), appears to be effective in eradicating persistent human papillomavirus (HPV) infection, according to results of a small pilot study.
Ten women with persistent HPV infection received a once-daily oral dose (3 g) of AHCC for up to 6 months, and half of the participants achieved a negative result for HPV infection.
Three of these women with a confirmed eradication have stopped using AHCC, and the remaining two responders are continuing on the study.
The results were presented at the 11th International Conference of the Society for Integrative Oncology.
Lead investigator Judith A. Smith, PharmD, pointed out that the five women who didn't respond did not receive a full 6 months of treatment.
"We were initially optimistic that we were going to clear the infection in a month, and at first we were testing the women weekly," said Dr Smith, associate professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Texas Health Sciences Center at Houston Medical School. "When our first patient didn't respond at 5 weeks, we assumed that it wasn't effective and we took her off treatment."
The researchers then realized that more time was needed, so after waiting 8 weeks, another nonresponder was removed from therapy. Two more participants were also taken off treatment at 3 months, after they did not clear the virus. "Now we know that we need to give it at least 6 months to realize the full effect," she told Medscape Medical News. "These patients will be eligible to go back on treatment."
While most HPV infections are self-limiting and resolve without causing any symptoms, there is currently no effective treatment for those that persist and that the body's innate immune system cannot clear.
"That is why this is so encouraging," said Dr Smith. "We test women for HPV, and if they have a persistent infection, there is nothing we can do for them except watch and wait."
Phase 2 in the Works
AHCC is an extract prepared from co-cultured mycelia of several species of Basidiomycete mushrooms. Preclinical studies have shown it to have anticancer properties, and both in vitro and in vivo studies have confirmed that it can eradicate HPV. Its ability to eradicate oncogenic HPV types 16/18 is attributed to modulation of the expression and signaling of interferon-α, β, and γ.
"We've been evaluating the efficacy of AHCC with chemotherapy for over a decade," said Dr Smith. "It is a nutritional supplement with no known side effects, and it modulated the immune system to fight off infections and inhibit tumor growth."
It is commercially available over the counter, and no adverse effects were associated with its use, Dr Smith noted. "This study confirms our preclinical findings, that it can eradicate HPV."
Dr Smith emphasized that these are preliminary data, and the pilot study's purpose was to define the appropriate dose and duration of therapy. A phase 2 randomized, double-blind trial is getting underway, and they will begin enrollment in about 2 weeks. "We would also like to investigate at some point if AHCC can actually prevent infection, or prevent re-infection," she explained. "We'd like to see if it can help build up the immune system to the point of resisting infection with HPV."
Treating Warts?
Anecdotally, she has had inquiries from both men and women about using AHCC to treat genital warts caused by HPV. "Since it's a commercially available product sold without a prescription, and AHCC has had no reported side effects when taken appropriately, I told them they could try it," she said, "Even though we have no information on that."
Several people have reported that their lesions cleared up after using AHCC and have not returned. "One woman told me that a plantar wart disappeared, which was very interesting," Dr Smith continued. "We don't have any details on these cases with warts, but I have told them to keep me in the loop, because this may be something we can study later on in future trials."
Because about 75% of adults in the United States have been exposed to HPV, the researchers were very careful to make sure that the study participants had a persistent infection, one that was not likely to clear on its own.
To minimize potential confounders, all of the participants were older than age 30 years and had a positive HPV test result within 3 months of entry into the study. To establish persistent infection, they had to have another positive test result no less than 6 months and no more than 18 months before enrollment.
11th International Conference of the Society for Integrative Oncology. Abstract 138. Presented October 26, 2014.
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