Chinese Herbal Medicine for Peanut / Food Allergy
اسلاید 1: www.tabaye.ir
اسلاید 2: Chinese Herbal Medicine for Peanut/ Food AllergyJulie Wang, MDMount Sinai School of MedicineNew York, NYOctober 21, 2012
اسلاید 3: Learning objectivesDiscuss the effects of Traditional Chinese Medicine (FAHF-2) in a murine model of food allergyDescribe recent clinical trials using FAHF-2 for food allergic patients
اسلاید 4: Traditional Chinese Medicine (TCM)Used in China to treat diseases for thousands of years. Used as monotherapy or in combination with standard Western medical treatment. Complex interactions produce synergistic effects and reduce possible side effects.Given its reputed effectiveness, low cost, and favorable safety profile, TCM is attracting interest in Western countries as a source of alternative or complementary therapy for a variety of diseases, including allergies and asthma.
اسلاید 5: Development of FAHF-2Food allergy has not been described in TCM literature. Studies of Wu-Mei Wan (10 herbs) on various diseases including gastroenteritis and asthma. No adverse effects in these clinical studies.Ling Zhi was added enhance to its anti-allergy and anti-inflammatory properties FAHF-1 2 herbs, Xi-Xin and Zhi-Fu-Zi, were eliminated due to potential toxicity if processed improperly.This refined formula has been named FAHF-2
اسلاید 6: Traditional Chinese Medicine: FAHF-2HPLC fingerprint of FAHF- 2 at 254 nm Huan–JiaoGang–JiangGui–ZhiHong–ShenWu–MeiDang–GuiHuang–BaiHuang–LianLing–Zhi
اسلاید 7: FAHF-2: Pre-clinical studiesSrivastava K et al. J Allergy Clin Immunol 2009; 123:443-451
اسلاید 8: Persistent effects of FAHF-2: Symptom scores post PN challengeW14W18W22W28W34W40W66*********************FAHF-2NaiveShamFAHF-2NaiveShamFAHF-2NaiveShamFAHF-2NaiveShamW50Early TreatmentLate Treatment012345Symptom Score012345****** , P<0.001 vs Sham
اسلاید 9: Effects on IgE and IgG2aFigure 3 – Srivastava 2009Srivastava K et al. J Allergy Clin Immunol 2009; 123:443-451
اسلاید 10: FAHF-2: Persistent effects on cytokines (Week 50 Post-therapy)*************************IL-4IL-5IL-13IL-10Pg/ml02004006008001000120014001600Mesenteric lymph nodeIL-4IL-5IL-13IFN-IL-10TGF-Pg/ml020040060080010001200140016001800Sham FAHF-2Naive SpleenIL-4IL-13IL-10Pg/ml02004006008001000120014001600IL-4IL-5IL-13IFN--IL-10TGF-β-Pg/ml020040060080010001200140016001800Sham FAHF-2Naive TGF-βIFN-Srivastava K et al. J Allergy Clin Immunol 2009; 123:443-451
اسلاید 11: Safety profile of FAHF-2Mice fed 24x the effective daily doseNo signs of acute toxicity No evidence of abnormal liver and kidney functions, abnormal CBCNormal histology of the major organs Srivastava K et al. J Allergy Clin Immunol 2005; 115:171-178
اسلاید 12: Synergistic effects of the herbsKattan J et al. Phytother Res 2008; 22:651-9
اسلاید 13: Mast cell and basophil effectsReduction in number of peripheral blood basophils and peritoneal mast cells Suppression of IgE-mediated mast cell activationSong Y et al. J Allergy Clin Immunol 2010; 126:1208-1217
اسلاید 14: Multiple food allergiesSrivastava K et al. Ann Allergy Asthma Immunol 2012; 108:351-358Insert Fig 5
اسلاید 15: Multiple food allergiesNo allergic reactions seen at the post-treatment challenges for peanut, codfish, and eggSrivastava K et al. Ann Allergy Asthma Immunol 2012; 108:351-358Insert Fig 3
اسلاید 16: Multiple food allergiesAdditional findings:Decreased allergen-stimulated IL-4 and IL-13 productionIncreased IFN-g in cultured splenocytes and mesenteric lymph node cellsSrivastava K et al. Ann Allergy Asthma Immunol 2012; 108:351-358Insert Fig 5
اسلاید 17: FAHF-2: Clinical trials FDA approval as an investigational new drug IND 77,468 – 2007Phase I clinical trial Study Subjects: 12 – 45 years of age Documented peanut, tree nut, fish and/or shellfish allergy (positive skin test and/or IgE)
اسلاید 18: Acute Phase I trialDouble-blind, placebo-controlled, dose escalation trial4, 6, 12 tablets TID x 7 days18 subjectsNo significant adverse effectsWang J et al. Ann Allergy Asthma Immunol 2010; 105:75-84
اسلاید 19: Wang J et al. Ann Allergy Asthma Immunol 2010; 105:75-84Acute Phase I – immunologic changesEx vivo effect of FAHF-2 on cytokine levels in PBMC cultures pre and post FAHF-2 treatment
اسلاید 20: Extended Phase I trialOpen label 6 tablets TID x 6 months18 subjects enrolled, 14 completed treatmentWell-tolerated, no significant adverse effectsPatil S et al. J Allergy Clin Immunol 2011; 128:1259-1265.
اسلاید 21: Extended Phase I immunologic changesPatil S et al. J Allergy Clin Immunol 2011; 128:1259-1265.P=0.067P=0.08
اسلاید 22: Phase II trial: on-goingDouble-blind, placebo-controlled12-45 years of ageInclusion: allergy to peanut, tree nut, sesame, fish or shellfishTherapy: 10 tablets TID x 6 monthsMulti-center trial Mount Sinai School of Medicine, NY Arkansas Children’s Hospital, AK Children’s Memorial Hospital, IL
اسلاید 23: Phase II trial: on-goingOutcomes: compare threshold for reaction during oral food challenge pre- and post-treatment prick skin tests allergen-specific IgE & IgG4 epitope recognition using peptide microarray basophil activation T cell activity
اسلاید 24: Refined FAHF-2A major drawback of the current FAHF-2 formula is the high daily doseTherefore, a refined FAHF-2 using butanol purification has been developed B-FAHF-2 at ~1/5 the dose of FAHF-2 resulted in protection from peanut anaphylaxis in the murine model that persisted for 6 monthsThe beneficial effects could be re-established with a second treatment course Furthermore, the safety profile and immunologic are similar to FAHF-2
اسلاید 25: B-FAHF-2: clinical effectsSrivastava K et al. Clin Exp Allergy 2011; 41:582-91.
اسلاید 26: B-FAHF-2: decreased IgE and increased IgG2aSrivastava K et al. Clin Exp Allergy 2011; 41:582-91.IgEIgG2a
اسلاید 27: B-FAHF-2: immunologic effectsSrivastava K et al. Clin Exp Allergy 2011; 41:582-91.
اسلاید 28: ConclusionsFAHF-2 treatment in peanut allergic mice results in protection from peanut-induced anaphylaxis that persists for ~6 months. Associated with decreased IgE, increased IgG2a, decreased Th2 cytokines, increased IFN-gHigh safety profilePhase I clinical trial demonstrated safety of FAHF-2 in food allergic individualsPhase II study investigating efficacy is on-goingB-FAHF-2 achieves similar efficacy and safety at a reduced dose
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