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珍宝类藏药中汞在人体血液和代谢物中含量的变化规律研究
于明杰
学位类型硕士
导师魏立新 ; 杜玉枝
2014-05
学位授予单位中国科学院研究生院
学位授予地点北京
学位专业中药学
关键词 七十味珍珠丸 仁青常觉 当佐 血液 代谢物
摘要本研究根据藏医药传统理论,结合现代药物临床安全性评价方法,通过对服用含重
金属藏成药“七十味珍珠丸”、“仁青常觉”、“当佐”的120例受试者进行临床安全性
初探,采用随机、单盲、自身前后对照、阴性药物(安置精华散)对照、多中心临床研
究,检测分析受试者血液、尿液、粪便中汞含量随时间、剂量变化的代谢规律。同时,
通过药物对人体血常规、肝肾功能、尿常规等的影响变化,分析药物中汞对人体可能的
不良影响,为藏药的临床用药安全提供数据参考。
本研究主要得出以下结果:
1. 七十味珍珠丸、仁青常觉、当佐中的汞主要是通过粪便形式排出体外。与服药前
相比,服药中便汞升高135%~491%,差异极显著 (P<0.001),停药后恢复至服药前水平。
2. 七十味珍珠丸的血汞因服药时间不同而不同,与服药前相比,服药7 天,服药中
血汞升高6.78%,停药后恢复;服药15 天,服药中血汞升高12.38%,且停药后升高40.00%。
3. 七十味珍珠丸的尿汞因服药时间不同而不同,与服药前相比,服药7 天,服药中
尿汞升高53.21%,停药后没有变化;服药15 天,服药中尿汞升高7.56%,且停药后升
高15.13%。
4. 与服药前相比,仁青常觉服药中血汞、尿汞分别升高64.94%和78.46%,差异显著
(P<0.05),停药后恢复。
5. 当佐与安置精华散比较,与服药前相比,当佐服药中血、尿汞均升高(19.83%和
48.07%),停药后恢复。安置精华散血汞、尿汞、便汞服药前、服药中、停药后15天均没
有明显的变化。
6. 七十味珍珠丸血常规、肝肾功能检测结果,与服药前相比,服药中血小板比服药
前增加6.74%,有显著性差异(P<0.05);与服药前相比,停药后嗜碱性粒细胞增加35.90%,
有极显著性差异(P<0.01),血肌酐增加7.91%,有显著性差异(P<0.05)。
7. 仁青常觉肝肾功能检测结果,与服药前相比,尿素氮服药中升高18.52%,有显著
性差异(P<0.05),停药后有所恢复。
8. 当佐肝肾功能检测结果,与服药前相比,胆汁酸服药中下降31.09%,肌酐升高
13.19%,差异显著(P<0.05),停药后有所恢复。
本论文进行了含重金属藏成药临床安全性观察研究,研究表明,服用七十味珍珠丸、
仁青常觉、当佐后,药物中的汞主要以粪便的形式排出体外,按藏医理论服用药物对人
体的血常规、肝肾功能、尿常规等均没有明显影响。
其他摘要This study is based on the traditional Tibetan medicine theory, combined with modern
clinical drug safety evaluation method. Through gather 120 cases for clinical with Tibetan medicine "Ratnasampil", "RenQingChangJue" and "DangZuo" that contains heavy metals the safety evaluation of clinical research. By random, single blind, self control, negative drugs(AnZhiJingHuaSan) controlled, multicenter clinical research. Through detection and analysis mercury content in the blood, urine and feces, come to a conclusion that the metabolic rule of change with time and dose of subjects. Meanwhile, through study on the change and influence of routine blood, liver and kidney function and urine routines indexs change, analysis the possible adverse effect of mercury of drugs to the human body, providing reference data for the clinical safety of Tibetan medicine.
This study mainly concluded the following results:
1. The mercury in Tibetan medicine containing heavy metal was mainly through the
form of feces expel from the body. Compared with before taking the medicine, the mercury in faeces increased by 135%~491%,extremely significant difference(P<0.001),recovered before taking the medicine when after the medicine withdrawal.
2. Ratnasampil’s mercury of blood was different because of the time:Compared with
before taking the medicine, the blood and urine mercury increased by 6.78% during the period of taking the medicine when taking 7 days, recovered after the drug discontinuation. Blood mercury increased by 12.38% during the period of taking the medicine when taking 15 days, increased by 40.00% after the medicine withdrawal.
3. Ratnasampil’s mercury of urine was different because of the time:Compared with
before taking the medicine, the urine mercury increased by 53.21% during the period of
taking the medicine when taking 7 days, recovered after the medicine withdrawal. Urine
mercury increased by 7.56% during the period of taking the medicine when taking 15 days, increased by 15.13% after the medicine withdrawal.
4. RenQingChangJue: Compared with before taking the medicine, blood and urine
mercury increased by 64.94% and 78.46% during the period of taking the medicine, recovered after the medicine withdrawal.
5. Compared DangZuo and AnZhiJingHuaSan: Compared with before taking the
medicine, blood and urine mercury increased by19% and 48% after taking DangZuo,
recovered after the medicine withdrawal. Negative control drug (AnZhiJingHuaSan): Before taking the medicine, during the period of medicine and after taking the medicine have no obvious significant differences.
6. The routine blood, liver and kidney function result of Ratnasampil: Platelets increased
by 6.74% during the period of taking medicine than before taking medicine, there has
significant differences (P<0.05); Compared with before taking medicine, after taking
medicine, Basophils increased by 35.90%, it has significant differences (P<0.01), serum
creatinine increased by 7.91%, it has significant differences (P<0.05).
7. The liver and kidney function result of RenQingChangJue: Compared with before
taking the medicine, creatinine increased by 18.52%, recovered after the medicine withdrawal.
8. The liver and kidney function result of DangZuo: Compared with before taking the
medicine,Bile acid treatment in fell by 31.09%, Creatinine increased by 13.19%, Indirect bilirubin fell by 34.90%, they have significant difference (P < 0.05), recovered after the medicine withdrawal.
This thesis carried on the Tibetan medicine contained heavy metal preliminary clinical security observation. From this study learned that the mercury of the drug in the form of feces excretion body outside. By studying the effect of Ratnasampil, RenQingChangJue and DangZuo on human liver and kidney function, blood system indicators and urine routines preliminary judging that according to the theory of Tibetan medicine indicated that the safety of the Tibetan medicine to human.
文献类型学位论文
条目标识符http://210.75.249.4/handle/363003/4039
专题中国科学院西北高原生物研究所
推荐引用方式
GB/T 7714
于明杰. 珍宝类藏药中汞在人体血液和代谢物中含量的变化规律研究[D]. 北京. 中国科学院研究生院,2014.
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