舞茸D-fraction對健康人群的安全性研究

1、聲明：本文摘自alternative & complementary therapies ,即補充和替代療法,該雜 志提供個人實踐和醫(yī)院綜合醫(yī)療項目中關于替代療法最權威、實用的信息。雜志內容包扌舌 補充和替代醫(yī)學界最新的研究進展以及該領域最頂尖的觀點，如慢性疾病的預防和治療， 補充替代療法的臨床應用等。本文摘白舞茸dfraction官方網站,轉載請注明safety of maitake d-fraction in healthy patients舞茸d-fraction對健康人群的安全性研究常見的血液學參數的評估舞茸的字面意思是''跳舞的蘑菇，其名稱的來源尚不清楚，但可

2、以確泄的是古人在發(fā) 現這種對健康有益的美味蘑菇時會高興的手舞足蹈?？?20世紀80年代中期，舞茸人工栽 培技術被開發(fā)以來，科研人員對其傳承而來和潛在的藥用價值進行了廣泛研究。研究確認了舞茸的許多功效，其范圍從抗腫瘤作用到改善高血壓、糖尿病、高膽固醇血癥 和肥胖。而且，舞茸還被證實有抗乙型肝炎病毒的作用，美國癌癥研究所還通過抗hiv藥物 篩選試驗證實舞茸有抗人類免疫缺陷病毒的作用。safety of maitake d-fraction in healthy patients assessment of common hematologic parameters smadelli glauco,

3、 m.d.,freddo jano.m.dgiordo paolo,m.d., and sensuke konno.ph.d.maitake literally means udancing mushroom."the origin of its name is unclear but it has bee n claimed that people who found this tasty mushroom with great health ben efits had danced with joy. maitake has been made available by cult

4、ivation since the mid-1980s, enabling scientists and researchers to study the herb's potential medicinal properties, that has been claimed in anecdotal sources and in folklore.numerous physiologic ben efits of maitake have bee n dem on strated or postulated, ranging from antitumor effects 1,2 to

5、 effects on hypertension, diabetes, hypercholesterolemia, and obesity.3-7 moreover, maitake's antiviral effect on hepatitis p has been reported8 and the herb's antiviral activity against human immunodeficiency virus (hiv) was con firmed by an ti-hiv drug scree ning tests con ducted by the u.

6、s.national cancer institute.9maitake d-fractionmost research on maitake has been performed with maitake's potent fraction/ extract (grifron-pro maitake d-fraction4; maitake products, inc. , ridgefield park, nj), focusing on the treatment of various malignancies. this biaoactive d-fraction is the

7、 proteirvbound polysaccharide compound, which is prepared by a standardized procedure developed by maitake products, inc.characteristically, the d-fraction is the acid-insoluble, alkali-soluble, and hot-water extractable fraction, consisting of either p-l,6-linked glucan with (3-1,3 branches or p-1,

8、3 glucan branched with p-la6 glucosides. the fraction has molecular weight of lxl06 dalt ons.3among the various maitake fractions prepared, the d-fraction was found to be most pote nt for en hanci ng the immune system via oral admi nistrati on or injectionzdem on strati ng the highest reducti on rat

9、e in can cer-cell growth. 1 this an titumor effect was associated with enhanced cytotoxic activity of macrophagesl and with the elevated interleukiproduction in tumor-bearing mice, leading to the activation of cytotoxic t-lymphocytes (ctl).2 these findings are highly suggestive that the d-fraction a

10、cts not only through direct activation of various immune effectors (macrophages, ctl, natural killer cells, etc.) targeting tumor cells, but also through potentiation the activity or production of various lymphoki nes. thus, such a pote nt immuno stimulatory activity of d-fraction may account primar

11、ily for its antitumor effect on cancer cells.recentl* an in vitro study of d-fraction showed that it was capable of inducing apoptosis in prostate-cancer cells.10 a separate study also demonstrated a chemosensitizing effect of d-fractionn which the cytotoxic effect of the anticancer age nt carmusti

12、ne, was sign ifica ntly enhan ced in combi natio n with d-fracti on, resulti ng in 90-percent cell viability reduction (cell death) .11 these results suggest that the d fractio n may be an alter native treatme nt modality for prostate cancer and may also work cooperatively with ongoing chemotherapy.

13、although a nu mber of an imal and in vitro studies have con firmed that d-fracti on in hibits can cer proliferati on, not many huma n trials have yet bee n con ducted.however, prior to such clin ical trials,the most im porta nt issuethe safety of d- fractionneeds to be adequately addressed. some ear

14、ly animal and clinical studies showed that it was safe with no toxic or adverse effects. 12 this was suddorted further by the fact that the u.s food and drug administration(fda) had exemdted dfraction from a phase i study of toxicoloqv and had also addroved it for an investigational new drug (ind) a

15、ddlicatio n to con duct a phase ii dilot study on datie nts with advanced breast and prostate cancers.13 while these trials are underway, we were interested in studying the actual effects of d-fraction on healthy human subjects, which had not yet been fully assessed and documented.(劃線部分翻譯：先前的動物及臨床研究

16、屮，該產品并未顯示出毒副作用，美國食品及藥 物管理局(fda)免除了舞茸d-fraction產品的一期毒性試驗，批準直接用于晚期乳腺癌 和前列腺癌的二期臨床試驗，由此可見該產品安全可靠。)clinical study on d-fraction on healthy human subjectstwenty-eight (28) healthy subjects (ages35-73; average age 50), including 14 males and 14 females, participated in a randomized double-blinded trial of

17、d-fraction for a month in italy. various hematologic parameters, such as complete blood count, serum glucose, total cholesterol and high-density lipoprotein (hdl), bilirubin, creatinin, hepatic en zymes, iron, et cetera, were evaluated before and after a month of d-fracti on in take.three italian ph

18、ysicians -jano, paolo, and glauco-were primarily in charge of this trial, which was con ducted in three separate public hospitals.twe ntyeight participa nts were randomized into three groups (in the three hospitals): group i consisted of 4 males and 5 females; group ii had 3 males and 6 females; and

19、 groupiu had 7 males and 3 females.fifteen (15) participants were instructed to take 1 drop of d-fraction per kg in body weight per day, equally distributed at each meal (3 times per day) in water. for example, a 60-kg person would ingest a total of 60 drops a day, taking 20 drops at each meal.thirt

20、een (13) participants received a placebo preparation and were told to follow the same instructions as the subjects in the d-fraction group.all participants were also instructed to continue their daily activities or routines, such as working, eating, exercising, having sex, and so on. following the t

21、rial's completior statistical analysis of hematologic parameters was performed using factorial analysis of varianee for repeated measures. this analysis was performed by francesca gigli berzolari, ph.d., department of scienze sanitarie applicate e psicocomportamentali, university of pavia, italy

22、.the results of the statistical analysis are summarized in table 1. first, no participants had palpable ailments or adverse effects during the trial, confirming the basic safety of d-fracti on in healthy subjects. sec ond, no essential and clear d iff ere nces/cha nges in 24 parameters tested was se

23、en between the control and the d-fraction groups after this 1 month trial.however, there were significant statistical differences (p<0.05) in the measures for hemoglobir hematocrit, and glutamic-pyruvic transaminase/alanine aminotransferase (gpt/alt) between the treatment and placeo group, althou

24、gh those differences were actually very small. similarly, the differences in red blood cells, lymphocytes, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentratior and hdl were nearly statistically significant (p<0.1).thus, these results suggest that these 8 parameters might be prim

25、arily affected or modulated with d-fracti on, although the degree of such an in flue nee would be min imal and hardly noticeable in healthy subjects. it is also indicative of the possibility that some changes in 9 other parameters could be induced by d-fraction with iong-term use. in other words, if

26、 people take d-fraction or longer than 1 month, the values for granulocytes (eosinophil), mean corpuscular value, total cholesterol, triglycerides, creatinin, alkaline phosphatase, glutamic-oxaloacetic transaminase/ aspartate aminotransferase (got/ast), bilirubir and transferrin, may subsequently be

27、 subject to some changes.it should be reemphasized that even if this prediction was correct, such changes would be considerably small but only significant statistically. overall, 17of 24 parameters tested seemed to be somewhat affected by d-fractior presumably providing some health ben efits. for ex

28、ample, cha nges in the hdl and triglycide levels in dicate that d fraction may improve lipid metabolism, lowering the triglyceride concentration while elevating the hdl level, there by preventing potential atherosclerosis or thrombosis and the morbid sequelae associated with vascular disease. in add

29、itior lowering the creatinin concentration could indicate improved renal function, while lowering the levels of bilirubin, gpt/alt, and got/ast may indicate improved liver function with reduced hepatic cell damage/injury. these effects are still unproven; what the present study confirmed is that d-f

30、raction is undoubtedly safe for normal patients in normal health and may eve n provide additi onal health ben efits.table 1. effects of d-fraction on hematologic pai ameteis iii hiunan subjectsparametersstatistical difference between placebo and dfranctionrbc countbvs(p-0.082)wbc countn/s(p>0.1)h

31、emoglobinsigni ficant(p< 05)hematocrit|significant(p<0e 05)lymphocytesbvs(p-0.082)platelets:bvs(p>0.1)monocytes:bvs(p>0.1)granulocytes(eosinophil)possible4granulocytes(neutrophil) bvs(p>0.1)granulocytes(basophil)n/s(p>0.1)mcvpossible4mvhn/s(p0.059)mchcnzs(p-0.081)glucose:m<s(p&g

32、t;0.1)chilesterol( total)possible*hdln/s(p0.082)tnglyc eridespossible4creatininpossible4alkaline phosphatasepossible4gpt/altsignificant(p<0, 05)got/astpossible4bilirubinpossible4transferrinpossible4iron! n/s(p>0.1)“there is a possibility that a difference may become significant with time.rbc=r

33、ed blood cdl;n/s=not significant;wbc=white blood cdl;mcv=mean corpuscular volume,mch=mean corpuscular hemoglobin;mchc=mean corpuscular hemoglobin concentration, hdl=hi gh- density lip opr otein, gp t=gjutami c -pyiuvic transaminase;alt=alanine aminotrans ferase;got=glutamic oxaloacetic transaminas e

34、, a s t=aspartate aminotranferase.con elusionsboth in vivo and in vitro studies and limited clinical trials thus far support a potent immuno stimulatory, an tica ncer or an titumor as well as apoptosis-i nduci ng activity for d- fractiorv which may have great potential for cancer treatment and preve

35、ntion. however, information on the safety of d-fraction or actual positive or negative effects of d-fraction on healthy human subjects had yet been lacking or insufficient. to the best of our knowledge, this is the first study to assess the safety of d-fraction in normal, healthy subjects; d-fractio

36、n is indeed safe with negligible or few side-effects.lt is also indicative that d-fraction may help reduce the risk of cardiovascular disease and improve renal and liver function. h owever, larger ran domized studies are still required to con firm these interesting findings further and delineate the

37、 clinical effectiveness and potential health ben efits of d-fracti on. such studies are thus warra nted.acknowledgmentswe thank mr. paolo clauser for his great support and assistanee. our special gratitude goes to mr.mike shi rota (maitake products; inc.) for kindly providi ng grifron-pro maitake d-

38、fraction used in the trial.referenceis hishida i, nanba h, kuroda, h. antitumor activity exhibited by orally administered extract from fruit body of grifola frondosa (maitake). chem pharm bui l(tokyo) 1988;36:1819-1827.2、adachi k, nanba h, kuroda, h. potentiation of host-mediated antitumor activity

39、in mice by p-glucan obtained from grifola frondosa (maitake), chem pharm bull (tokyo) 1987;5:262-2703 mizuno t, zhuang c. maitake, grifola frondosa: pharmacological effects. food rev int 1995;11:135-149.4. adachi k, aoki h, nanba h. otsuka m.et al. blood pressure-lowering activity present in the fruit body of grifola frondosa. chem pharm bull (tokyo) 1988;36:1000-10065. kubo k, aoki h, nanba h. anti-diabetic activity present in the fruit body of grifola frondosa (maitake). biol pharm bull 1994;17:1106-1110.6 kubo k, nanba h.the effect o