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中西醫腎病聯合討論會 主題：鉛中毒

中西醫腎病聯合討論會 主題：鉛中毒. 報告日期： 2011/8/17 報告醫師： R4 楊晉瑋 指導醫師：陳俊良主任. Outline. Adulterants in Asian Patent Medicines Chinese proprietary medicine in Singapore: regulatory control of toxic heavy metals and undeclared drugs Toxic heavy metals and undeclared drugs in Asian herbal medicines

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中西醫腎病聯合討論會 主題：鉛中毒

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  1. 中西醫腎病聯合討論會主題：鉛中毒 報告日期：2011/8/17 報告醫師：R4楊晉瑋 指導醫師：陳俊良主任

  2. Outline • Adulterants in Asian Patent Medicines • Chinese proprietary medicine in Singapore: regulatory control of toxic heavy metals and undeclared drugs • Toxic heavy metals and undeclared drugs in Asian herbal medicines • Heavy Metal Content of Ayurvedic Herbal Medicine Products • Lead, Mercury, and Arsenic in US- and Indian-ManufacturedAyurvedic Medicines Sold via the Internet • Blood Lead Below 0.48 μmol/L (10 μg/dL) and Mortality Among US Adults • Herbal Supplement Use and Blood Lead Levels of United States Adults • Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan • Lead nephropathy and lead-related nephrotoxicity • Protective effect of herbs extract against lead-poison in rats

  3. Adulterants in Asian Patent Medicines N Engl J Med. 1998 Sep 17;339(12):839-41

  4. Seven percent of the 251 products tested contained undeclared pharmaceuticals (e.g. ephedrine, chlorpheniramine, methyltestosterone and phenacetin). • Twenty-four products contained at least 10 ppm lead, 36 contained an average of 14.6 ppm arsenic, 35 contained an average of 1046 ppm mercury, and 23 had more than one contaminant and/or adulterant.

  5. Chinese proprietary medicine in Singapore: regulatory control of toxic heavy metals and undeclared drugs Drug Saf. 2000 Nov;23(5):351-62.

  6. 2080 samples of such medicines in Singapore and tested them for heavy metal content. • Forty-two (2%) different medicines were found to contain metals in amounts exceeding the legal limits. • Mercury was found in 28 products, lead in eight, arsenic in six and copper in one. One product contained both mercury and lead and another product contained both mercury and arsenic.

  7. Toxic heavy metals and undeclareddrugs in Asian herbal medicines TRENDS in Pharmacological Sciences Vol.23 No.3 March 2002

  8. Indian medical systems (e.g. Ayurveda and Unani) • Traditional Chinese medicines (TCMs)

  9. Heavy Metal Content ofAyurvedic Herbal Medicine Products JAMA, December 15, 2004—Vol 292, No. 23

  10. US Pharmacopeia 4.5 21 3 US Environmental Protection Agency

  11. Conclusions • Limits: Sample sizes, Metals chemical forms • One of 5 Ayurvedic HMPs produced in South Asia and available in Boston South Asian grocery stores contains potentially harmful levels of lead, mercury, and/or arsenic. • Users of Ayurvedic medicine may be at risk for heavy metal toxicity, and testing of Ayurvedic HMPs for toxic heavy metals should be mandatory

  12. Lead, Mercury, and Arsenicin US- and Indian-ManufacturedAyurvedic Medicines Sold via the Internet JAMA, August 27, 2008—Vol 300, No. 8

  13. Objectives • To determine the prevalence of Ayurvedic medicines available via the Internet containing detectable lead, mercury, or arsenic and to compare the prevalence of toxic metals in US- vs Indian-manufactured medicines and between rasa shastra and non–rasa shastra medicines. • Rasa shastra is an ancient practice of deliberately combining herbs with metals (eg, mercury, lead, iron, zinc), minerals (eg, mica), and gems (eg, pearl).

  14. AHPA, US-based American Herbal Products Association; ADMA, India-based Ayurveda Drug Manufacturers’ Association; GMPs, Good Manufacturing Practices.

  15. 20 250 0.5

  16. 20 21 50 21 150

  17. Conclusion • Limits: Sample source • One-fifth of both US-manufactured and Indian-manufactured Ayurvedic medicines purchased via the Internet contain detectable lead, mercury, or arsenic. • We suggest strictly enforced, government mandated daily dose limits for toxic metals in all dietary supplements and requirements that all manufacturers demonstrate compliance through independent third-party testing.

  18. Blood Lead Below 0.48 μmol/L (10 μg/dL) and Mortality Among US Adults Circulation. 2006 Sep 26;114(13):1388-94

  19. Background & Methods • Blood lead levels above 0.48 μ mol/L (10 μ g/dL) in adults have been associated with increased risk of cardiovascular, cancer, and all-cause mortality. • Blood lead levels were measured in a nationally representative sample of 13946 adult participants of the Third National Health and Nutrition Examination Survey recruited in 1988 to 1994 and followed up for up to 12 years for all-cause and cause-specific mortality.

  20. Conclusion • The geometric mean blood lead level in study participants was 0.12 μmol/L (2.58 μg/dL). • Blood lead level was significantly associated with both myocardial infarction and stroke mortality, and the association was evident at levels 0.10 μmol/L (2 μg/dL). • There was no association between blood lead and cancer mortality in this range of exposure.

  21. Herbal Supplement Use and Blood Lead Levels of United States Adults General Internal Medicine Med 24 2009 11:1175–82

  22. OBJECTIVE & STUDY POPULATION • To examine whether use of specific herbal dietary supplements during the last 30 days is associated with blood lead levels in US men and women. • NHANES participants from 1999–2004, a representative sample of the civilian non-institutionalized US population.

  23. Among 6,712 women ≥20 years, those using herbal supplements had lead levels that were 10% higher than non-users (95% CI 3%–17%, p=0.005). Women using Ayurvedic or traditional Chinese medicine herbs, St. John’s wort, and “other” herbs had lead levels 24% (95% CI 5%–45%, p=0.01), 23% (95% CI 4%–46%), p=0.02), and 21% (95% CI 2%–44%, p= 0.03) higher, respectively, than non-users.

  24. No significant associations were observed between herb use and lead levels among men (n=6,095). • Among reproductiveaged women (16–45 years), herbal supplement users had lead levels 20% higher than non-users (95% CI 5%–34%, p=0.008). • In contrast, garlic and other dietary supplements were not associated with higher lead levels.

  25. Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan J ClinPharmacol April 1, 1997 37: 344-350

  26. The term "adulteration" refers to traditional Chinese medicines that are tested and found to contain chemical substances not prescribed or labeled as part of the intended use. • An average of 23.7% (n = 618) of the samples collected from the eight hospitals were adulterated.

  27. 密陀僧(黃丹) • 【品種來源】: 本品為鉛石礦冶煉而成的粗製氧化鉛。 • 【性味歸經】: 鹹辛，平，有毒。 • 【功效】: 消腫殺蟲，收斂防腐，墜痰鎮驚。 • 【主治】: 內服治久痢，驚癇；外用療痔瘡，腫毒，潰瘍，白癜風，疥癬，狐臭，濕瘡，搔癢流水等症。 • 【用法用量】: 外用：適量，研末撒或調塗，或製成膏藥、軟膏、油劑等。內服：研末，0.2～0.5g；或入丸、散。

  28. 鉛丹(紅丹) • 【品種來源】: 本品係用鉛、硫磺、硝石等合煉而成，主要成份為四氧化三鉛(Pb3O4)。出自《神農本草經》。 • 【性味歸經】: 辛、鹹，寒，有毒。 入心、脾、肝經。 • 【功效】: 解毒，生肌，墜痰鎮驚。 • 【主治】: 治癰疽、潰瘍，金瘡出血，口瘡，目翳，湯火灼傷，驚癇癲狂，瘧疾，痢疾，吐逆反胃。 • 【用法用量】: 外用：研末撒、調敷；或熬膏。內服：入丸、散。

  29. 衛生署相關條文 • 杜仲等七種中藥材之重金屬限量標準及其相關規定(93/01/13修正) • 自九十三年二月一日起，杜仲、枇杷葉、肉桂、桂枝、桂皮、白及及 五加皮等七種中藥材，須加做重金屬 (鎘、鉛、汞) 檢測，其限量標 準為：鎘 (Cd) 2ppm 以下、鉛 (Pb) 30ppm 以下、汞 (Hg) 2 ppm 以下。

  30. 地龍等中藥藥材含污穢物質之限量 民國 98 年 07 月 22 日

  31. 中藥濃縮製劑含異常物質之限量 民國 99 年 05 月 28 日

  32. Lead nephropathy and lead-related nephrotoxicity 2011 UpToDate

  33. Definition & Diagnosis • High levels of chronic lead exposure can cause lead nephropathy. In addition, lower levels of chronic lead exposure may contribute to lead-related nephrotoxicity in patients who already have or are at increased risk for chronic kidney disease. • Lead may be measured in whole blood, bone, and, following administration of a chelating agent, urine. Blood lead is used most commonly in the clinical setting, while bone lead is primarily a research tool. Diagnostic chelation is sometimes used to assess bioavailable lead body burden.

  34. Pathology • Acute, high-level lead poisoning (blood lead level >100 mcg/dL [4.8 micromol/L]) initially injures the proximal tubules in association with intranuclear inclusion bodies composed of a lead-protein complex. • With more prolonged lead exposure, renal biopsy reveals the typical changes of a chronic interstitial nephritis, including nonspecific tubular atrophy, interstitial fibrosis, a paucity of inflammatory cells and hypertrophic arteriolar changes; glomerular scarring is a secondary event. Proximal tubular intranuclear inclusion bodies are often absent.

  35. Clinical manifestations-acute • Abdominal pain ("lead colic") • Constipation • Anorexia • Joint pains • Muscle aches • Headache • Decreased libido • Difficulty concentrating and deficits in short-term memory • Anemia (“Basophilic stippling”) • Nephropathy (“Fanconi-type syndrome”) • A "lead line," a bluish pigmentation seen at the gum-tooth line • A peripheral neuropathy that frequently manifests with extensor weakness or "wrist/ankle drop" due to an axonal degeneration

  36. Clinical manifestations-chronic • Adults with lower level, chronic or recurrent exposures (blood lead levels in the 30 to 70 mcg/dL range) may be asymptomatic or present with vague nonspecific symptoms such as myalgias, fatigue, irritability, insomnia, anorexia, impaired short-term memory, and difficulty concentrating. • After more prolonged high-level exposure, patients present with an elevated serum creatinine, little or no proteinuria, and a relatively normal urine sediment. Hyperuricemia, gout, and hypertension may also be present.

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