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Table of Content

    Volume 13 Issue 2
    26 February 2008
    Guidance for the evaluation and design of clinical trials of new medicinal products in treatment of chronic hepatitis B
    YANG Huan
    2008, 13(2):  121-130. 
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    The global, especially our country's burden of disease of hepatitis B virus (HBV) is a difficult problem to us. Prospects for the development of new anti-HBV drugs in treatment of chronic hepatitis B have improved substantially during the last decade. The practice guidelines for chronic hepatitis B developed by the American Association for the Study of Liver Diseases (AASLD), the European Association for the Study of the Liver (EASL), and the Asian Pacific Association for the Study of the Liver (APASL) have been reviewed. Guideline on the clinical evaluation of medicinal products intended for treatment of hepatitis B and the practice guidelines for chronic hepatitis B have been studied. This article provided recommendations and discussions for sponsors on evaluation and design of clinical trials of new medicinal products in treatment of chronic hepatitis B.
    Effects of several anti-rheumatoid arthritis drugs on expression of acidsensitive ion channels in articular chondrocytes in rats with adjuvant arthritis
    CHEN Fei-hu, YUAN Feng-lai, LI Xia, WU Fan-rong, HUANG Xue-ying, HU Wei, HENG Juan, LI Jun
    2008, 13(2):  131-137. 
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    AIM:To observe the effects of several common used drugs on expression of acid-sensitive ion channels (ASICs) in articular cartilage in rats with adjuvant arthritis (AA), and to explore cartilage protection of different medicines in the treatment of rheumatoid arthritis (RA).METHODS:The rats were randomly divided into the normal group, AA model group, aspirin (15 mg/kg) group, dexamethasone (0.2 mg/kg) group, tripterygium wilfordii (50 mg/kg) group and levamisole (10 mg/kg) group. The AA rat model was induced by a single intradermal injection of 100 μL of Freund's complete adjuvant (CFA) on day 0. The volume of rat hind paw was measured by means of Volume Meter. The secondary inflammation of AA rats appeared on the d 10 after intradermal injection of CFA. Intraperitoneal injection of dexamethasone at this time, other drug groups were gavaged corresponding experimental drugs, and the model group and the normal group were administered with the corresponding capacity of sterile water, lasting for seven days. The morphological changes of synovial membrane was observed by light microscope. The quantitative PCRwas used to detect the ASICs and aggrecan mRNA expression in rat articular cartilage. The immunoblotting analyses was used to detect the ASICs protein expression in rat articular cartilage. The expression of type Ⅱ collagen was measured by immunohistochemical method. RESULTS:It was found that the secondary paw swelling was inhibited significantly in AA rats. Aspirin obviously inhibited the expression of ASICs of articular cartilage cells in AA rats, but the inhibitory effects of other drugs were not obvious. The type II collagen and aggrecan expression of cell matrix of articular cartilage was increased significantly by four kinds of drugs, especially aspirin, in AA rats. CONCLUSION:Aspirin may play a protective role in articular cartilage in AA rats by inhibiting expression of ASICs.
    Natural compound nuciferine activates chloride channel of wild type and △F508 mutant cystic fibrosis transmembrane conductance regulator
    LIN Sen, HOU Shu-guang, JIN Ling-ling, YU Bo, YANG Hong
    2008, 13(2):  138-143. 
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    AIM:To identify CFTR Cl- channel gating potentiators from natural compounds. METHODS:A stably transfected Fischer thyroid epithelial (FRT) cell line co-expressing human CFTR and a green fluorescent protein mutant with ultra-high halide sensitivity (YFP-H148Q) was used to measure CFTR-mediated iodide influx rate stimulated by the 386 natural compounds. RESULTS:Nuciferine was identified as an effective activator of wild-type CFTR chloride channel by screening of 386 single compounds from Chinese medicinal herbs. The CFTR-stimulating activity is rapid and reversible. Nuciferine does not elevate cellular cAMP level and activates phophorylated CFTR, suggesting that it works by direct binding to CFTR molecule. Nuciferine can also potentiate the Cl- transport of △F508 mutant CFTR. CONCLUSION:Nuciferine was identified as an effective CFTR chloride channel activator. Nuciferine may be useful for probing CFTR channel gating mechanisms and as a lead compound to develop pharmacological therapy of CFTR-related disease such as cystic fibrosis, idiopathic chronic pancreatiti, keratoconjunctivitis sicca and habitual constipation.
    Determination of aristolochic acid Ⅰ in rats by HPLC and its toxicokinetics
    XU Xiao-yue, JIANG Zhen-zhou, HUANG Xin, ZHANG Lu-yong
    2008, 13(2):  144-148. 
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    AIM:To establish an HPLC method for the determination of aristolochic acid Ⅰ in rat plasma, study the toxicokinetics of aristolochic acid Ⅰ at the three doses adopted in toxicology research and realize the relationship between the exposure level and toxicity.METHODS:Plasma concentrations at different time were determined after single oral administration at the dose of 100, 30 and 10 mg/kg.The data of concentration-time were fitted and the toxicokinetics parameters were calculated by statistical moment then. RESULTS:The limit of quantitation was 0.02 mg/L, the linear range was 0.02 ~ 40.00 mg/L.The average recovery was between 82.4 % ~ 101.2 %.The intraday and inter-day RSD were less than 1.0 %.The parameters of high, middle and low doses were as follows:t1/2α were (0.8 ±0.4), (0.9 ±0.7) and (1.0 ±0.8) h, t 1/2β were (34 ±19), (133 ±64) and (114 ±50) h, tmax were (0.31 ±0.12), (0.25 ±0.00) and (0.38 ±0.19) h, Cmax were (3.0 ±1.7), (1.0 ±0.7) and (1.0 ±0.7) mg/L, AUC(0-48) were (18 ±3), (18 ±2) and(21 ±5) mgL -1。h, respectively.CONCLUSION:The method was sensitive, specific and suitable for the analysis of concentrations of aristolochic acid Ⅰ in rat plasma.The absorption of aristolochic acid Ⅰ was quick after single oral administration, and then it was distributed fast and eliminated slowly in the plasma.It was indicated the nonlinear toxicokinetics characteristic of aristolochic acid Ⅰ took place in the studied dose range.
    Vasodilative effect and mechanism of enalapril on thoracic aorta of rats
    WANG Dan, ZHANG Xuan-ping, DONG Qiu-ju, ZHANG Ming-sheng, NIU Long-gang, CHANG Hai-liang
    2008, 13(2):  149-153. 
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    AIM:To investigate the vasodilative effects and the possible mechanism of enalapril on thoracic aorta of rats. METHODS:Isotonic tension of thoracic aortic rings precontracted by norepinephrine (NE, 10-5 mol/L) or KCl (20mmol/L) was recorded. The vascular tension was recorded by Powerlab multichannel physiology signal acquisition and analysis computer system by tension transducers. The vasorelaxing action of enalapril and effects of various drugs which include NG-nitro-L-arginine methyl ester (10-4mol/L) and indomethacin (10-8 mol/L) were observed in the rings with endothelium intact or denuded. RESULTS:Enalapril (10-9 -10-4mol/L) induced concentrationdependent relaxation in thoracic aortas with intact endothelium. There was significant difference between the rings with intact and denuded endothelium. NG-nitro- L-arginine methyl ester (10-4mol/L) and indomethacin (10-8mol/L) can significant inhibit the relaxtion effects of enalapril on thoracic aortic rings. CONCLUSION:We conclude that enalapril preferentially antagonized the contraction of rat thoracic artery in a concentration-dependent and endothelium-dependent manner. The vasorelaxation of enalapril is relevant to the production of nitric oxide and prostacyclin.
    Experimental study to allergic animal models of Shuanghuanglian Injection
    XU Guo-liang, ZHANG Zhuo-hui, ZHANG Zeng-zhu, ZHANG Qi-yun
    2008, 13(2):  154-157. 
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    AIM:To establish the allergic animal model of Shuanghuanglian Injection in order to explore the sensitizing substance caused type Ⅰ hypersensitivity by Shuanghuanglian Injection.METHODS:The Shuanghuanglian Injection and rabbit blood serum were used to incubate in vitro to prepare antigen, then the pure bleed Rabbits of New Zealand were immuned to prepare the antiserum of sensitizing substance in Shuanghuanglian Injection.And the potency and antibody specificity were detected by ELISA.RESULTS:A double sandwich ELISA was used to detect the antiserum potency, when the potency were 128 times diluted it was still positive.The indirect competitive ELISA was used to determine the serological specificity and the inhibitory curve was drawn.The regression equation was I =13.362lgC +50.503, the correlation coefficient(r) was 0.966 and the half-inhibition concentration(IC50) was 0.92 mg/mL.CONCLUSION:A hypersensitivity animal model of Shuanghuanglian Injection was preliminary established, and can be used in investigation of the sensitizing substance in Shuanghuanglian Injection.
    Effects of tripterine on the immunosuppression action and expression of IL-6 mRNA in mice
    LI Meng-qiu, DOU Jie, DU Wei, LI Xin-ya, LIN Jian, ZHOU Chang-lin
    2008, 13(2):  158-163. 
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    AIM:To investigate the effects of tripterine on the immunosuppression action and the over expression of IL-6 gene in mice.METHODS:The carbon particle clearance reaction test, delayed hyper-sensitivity reaction test, serum hemolysin assay and lymphocyte transfer test were applied to observe the immunosuppression action of tripterine.Mice were orally pretreated with tripterine, and the IL-6 mRNA level was determined by RT-PCR.RESULTS:The level of serum hemolsin in mice treated with triperine (400 μg/kg) was much lower than that of control group, suggesting that tripterine may suppress the level of serum hemolsin in mice in dose dependent manner.Tripterine (400 μg/kg) had an obvious effect of immunosuppression on mice cells by relieving the delayed hypersensitivity reaction, and tripterine (0.25 μg/mL) had inhibitory effects on the activation and proliferation of mice T lymphocytes stimulated by PHA.In addition, significant increase of IL-6 mRNA level induced by CCl4 was remarkably decreased by 800 μg/kg tripterine.CONCLUSION:Tripterine suppresses the immunological function of mice to some extent and inhibits the over expression of IL-6 gene in mice liver which is related to proinflammatory cytokines.
    Protective effects of delta-opioid receptor agonist on cultured myocardial cells with hypoxia/reoxygenation injury
    LI Jiong
    2008, 13(2):  164-168. 
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    AIM:To investigate the protective effects of a delta opioid receptor agonist, [ D-Ala(2), DLeu(5) ]-enkephalin (DADLE), on cultured myocardial cells with hypoxia/reoxygenation (H/R) injury. METHODS:The H/R injury model of cultured myocardial cells was made by SD suckling mice. The cell shape, livability, the activity of lactate dehdrogenase (LDH) and superoxide dismutase (SOD), and the content of malondialdehyde (MDA) of the cultured myocardial cells injured by H/R were determined. RESULTS:Compared with normal group, the cell livability and the SOD activity of model group after reoxygenation 30 min were decreased respectively, whereas the activity of LDH and the content of MDA of model group were increased significantly (P <0.01). Every index in the model group was changed to normal degree after reoxygenation for 60 min. In myocardial cells injured by H/R which were treated with 1 μmol/L DADLE, the LDH release and MDA content were decreased, while the cell livability and SOD activity were enhanced (P <0.01). A selective delta opioid receptor antagonist, naltrindole, at 10 μmol/L antagonized the effects of DADLE. CONCLUSION:DADLE has protective effects on the cultured myocardial cells injured by H/R by the stimulation of delta opioid receptor.
    Bioequivalence and pharmacokinetics of ribavirin buccal tablets in healthy volunteers
    LUO Chen-hui, CHEN Xiao-yan, SUN Yu-ming, YU Hua-ling, JIANG Yun, QIU Yu, ZHONG Da-fang, ZHOU Xiao1,LIU Ya-li
    2008, 13(2):  169-173. 
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    AIM:To determine ribavirin in human plasma by an LC/MS/MS method and to study the bioequivalence and pharmacokinetics of reference and test ribavirin formulations.METHODS:A double-phased stochastical crossover study design was conducted.18 healthy volunteers were given a single dose of 80 mg ribavirin of reference and test formulations.The drug was extracted from collected plasma and analyzed by LC/MS/MS.The pharmacokinetic parameters as well as relative bioavailability were measured.RESULTS:The calibration curve was linearwithin the range of 2 - 500 ng/mL (r2 =0.9944).The average recovery was more than 90 %.The average RSD within 3 days and between 3 days were all less than 10 %.The major pharmacokinetic parameters tmax 、Cmax 、t 1/2 、AUC0 -72 and AUC0~∞ of reference and test ribavirin formulations were (1.1 ±0.5) and (1.1 ±0.4) h, (249 ±89) and (232 ±65) ng/mL, (34 ±11) and (34 ±11) h, (2828 ±1215) and (2685 ±1096) nghmL -1, (3600 ±1568) and (3416 ±1379) nghmL -1.The relative bioavailability of test buccal tablet was(106 ±16) %. CONCLUSION:The method is more simple, more accurate and much more sensitive.There is no significant difference between the main pharmacokinetic parmeters of two formulations of ribavirin (P >0.05), they are bioequivalent.
    Effects of benazepril on pharmacokinetics of amlodipine in healthy volunteers
    HUANG Yi-ling, TIAN Lei, JIANG Juan-juan, HUA Lu, LIU Hong, LI Yi-shi
    2008, 13(2):  174-178. 
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    AIM:To study the pharmacokinetics of amlodipine after coadministration of benazepril (10mg) plus amlodipine (5mg), or amlodipine (5mg) alone in healthy volunteers, and to evaluate the effects of pharmacokinetic interaction between amlodipine and benazepril.METHODS:Twelve male healthy volunteers were enrolled in a randomized two-way crossover study. An LC-MS-MS method was established for the determination of amlodipine in human plasma, and the data were analysed by WinNonLin software.RESULTS:The mean pharmacokinetic parameters of amlodipine after coadministration with benazepril plus amlodipine, or amlodipine alone were as follows:Cmax were (2.6 ±0.6) and (2.8 ±0.7) μg/L,AUC0 -144 were (99 ±39) and (109 ±26) μgL -1。h, t max were (5.8 ±1.3) and (5.3 ±1.0) h, t1/2 were (37 ±6) and (44 ±12) h, respectively.There were no significant differences in these parameters between coadministration of benazepril plus amlodipine and amlodipine administered alone (P >0.05 ).CONCLUSION:Coadministration with benazepril did not significantly affect the pharmacokinetics of amlodipine.
    Clinical application of microcatheter superselective bronchial artery embolization in acute hemoptysis
    DUAN Run-qing, XIE Chun-ming, XUE Jian-xiu, MA Cheng-jie, GUAN Jing-yue
    2008, 13(2):  179-183. 
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    AIM:To study the clinical efficacy of microcatheter superselective bronchial artery embolization in acute hemoptysis with different embolism agents.METHODS:Microcatheter superselective bronchial artery embolization was performed in 45 patients with massive hemoptysis, among them 9 cases were embolized with simple gelfoam sponge particles (GS), 13 cases with polyvinyl alcohol (PVA) and GS, 23 cases with PVA and GS and suture silk, All cases were followed up for 1 to 2 years.RESULTS:The recent, metaphase and long-term effective power of three groups were as follows:77.8 %, 100 %, 100 %; 77.8 %, 100 %, 100 %;57.1 %, 100 %, 100 %. There was no distinct difference among the recent effective power, but there was discrimination among metaphase and long-term effective power.CONCLUSION:The bronchial artery embolization with PVA plus GS, and PVA plus GS and suture silk group were more efficient therapy in acute hemoptysis.
    Clinical study on efficacy of roxithromycin combined with inhaled budesonide dry powder inhalation on asthma
    YAN Xue-qin, WU Li-qin, LIN Jie, XIA Xiao-dong, DAI Yuan-rong
    2008, 13(2):  184-187. 
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    AIM:To evaluate the therapeutic effect and to observe the changes of levels of serum cytokine soluble interleukin-2 receptors (sIL-2R) and interleukin- 8 (IL-8) and the absolute number of eosinophil in blood (EOS) of roxithromycin combined with inhaled budesonide (BUD) dry powder inhalation (pulmicort turbuhaler) on asthma, comparing with the inhaled pulmicort turbuhaler group.METHODS:45 asthmatic subjects were randomly treated with either roxithromycin combined with pulmicort turbuhaler (treatment group) or pulmicort turbuhaler (control group).The treatment course was 4 weeks.Before the treatment and after 4 weeks of the treatment, the levels of sIL-2R, IL-8, EOS and lung function were detected, as well as the scoring of clinical symptoms.RESULTS :There were 40 subjects who fulfiled their trials.Both clinical symptoms scores and lung function, FEV1, FEV1/pred %, PEF and PEF/pred %were significantly improved in both groups after treatment.The levels of sIL-2R, IL-8 and EOS were significantly decreased in both groups after treatment.Moreover, the indexes in treatment group were significantly improved than those in control group.The side effects in both groups were similar.CONCLUSION:Roxithromycin has anti-inflammatory and immunoregulatory effects on treating asthma.Roxithromycin associated with pulmicort turbuhaler can enhance curative effect on asthma.
    Effects and possible mechanisms of baicalin on the atherosclerosis rabbits
    MA Jun, WU Xiao-dong
    2008, 13(2):  188-194. 
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    AIM:To investigate the effects and possible mechanisms of baicalin on the atherosclerosis rabbits.METHODS:Thirty healthy New Zealand white rabbits were divided randomly into five groups: normal control group (A group, n =6) and fed with normal diet, atherosclerosis model group(B group, n =6), baicalin therapic group(C group, n =6), bacalin preventive group(D group, n =6), and positive control group(E group, n =6), the last four groups fed with hypercholesterol diet for 12 weeks.Treated with bacalin 300 mg/(kg·d), and simvastatin 5 mg/ (kg·d) additionally for 2 weeks in C and E group respectively from the tenth week.Treat with bacalin 100 mg/(kg·d) for 12 weeks in D group.Serum lipids and liver lipids were detected with standard enzymatic assays.Atherosclerotic plaque/intima size ratio of area and NF-κB content in blood vessel tissue were examined.Enzyme-linked immunosorbent assay (ELISA) was employed to monitor the levels of serum TNF-α, IL-1β and Adiponectin.RESULTS:Atherosclerotic plaque intima size ratio of area decreased in C, D and E group than in B group(P <0.01).The levels of Blood lipids, liver lipids decreased in C, D and E group than in B group(P <0.01).Serum TNF-α, IL- 1β, and adiponectin decreased in C and D group than in B group(P <0.01, P <0.05).The NF-κB activity in C and D group were lower than B group(P <0.01). CONCLUSION:Baicalin improve atherosclerosis not only by decreasing blood lipids, but also by anti-inflammation through increasing serum levels of adiponectin, decreasing activity of NF-κB in atherosclerotic focus and serum levels of TNF-α, IL-1β.
    Effects of sesamin on blood glucose, blood lipids and vascular cell adhesion molecule-1 protein expression of aorta in rats with metabolic syndrome
    ZHOU Yong, YANG Jie-ren
    2008, 13(2):  195-200. 
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    AIM:To explore the effects of sesamin on blood glucose, blood lipids and vascular cell adhesion molecule-1 (VCAM-1) protein expression of aorta in rats withmetabolic syndrome.METHODS:A highfat, refined-carbohydrate diet was given to rats to induce metabolic syndrome for 24 weeks.Sesamin (120, 60, 30 mgkg -1 。d -1 ) were given to the metabolic syndrome rats at the ninth week by intragastric administration, which were lasted for 16 weeks.Then, the body weight and abdominal fat of all rats were weighed and the levels of blood lipid, blood glucose, the total anti-oxidation capacity (T-AOC) and the hydrogen peroxide concentration in the serum were determined.In addition, the pathological change and the VCAM-1 protein expression of aorta were observed by H-E staining and immunohistochemical method respectively. RESULTS:Compared with those in model group, the body weight and abdominal fat of sesamin (120, 60 mgkg -1 。d -1 ) groups were obviously decreased, the levels of serum TG, TC, LDL-C and blood glucose were markedly decreased and the level of HDL-C was increased.The VCAM-1 protein expression of aorta was depressed.The pathological change was improved ;The T-AOC and hydrogen peroxide concentrations of serum and aorta were decreased.CONCLUSION:Sesamin can obviously descrease the levels of blood lipid, blood glucose and depress the VCAM-1 protein expression of aorta, improve the pathological change of aorta and protect against the progression of atherosclerosis.
    Pufferfish type Ⅰ collagen extract prevented and cured myelosuppression induced by cyclophosphamide or diamminedichloroplatinum or cytosine arabinoside in mice
    LI Sheng-qian, CHEN Ding-ding, GAO Li-zhong
    2008, 13(2):  201-207. 
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    AIM:To observe the effects of Pufferfish type Ⅰ collagen extract (PTICE) on mouse toxic and adverse reactions induced by cyclophosphamide (CTX) or diamminedichloroplatinum (DDP) or cytosine arabinoside (Ara-c). METHODS:Mouse myelosuppression model was induced by i. p. CTX or DDP or Ara-c, i. g. PTICE to prevent and cure. The mental status, level of body weight and pelage were observed. The peripheral hemogram, spleen index, and contents of bone marrow DNA were determined. RESULTS:PTICE could obviously improve the mental status, protect the pelage, raise the counts of white blood cell, platelet, neutrophil, lymphocyte and increase the spleen index and contents of bone marrow DNA. PTICE decreased the mice mortality rate induced by DDP. CONCLUSION:PTICE could reduce myelosuppression induced by cyclophosphamide or diamminedichloroplatinum or cytosine arabinoside in mice.
    Significance of GABAA receptors in the development of some neuropsychiatric diseases
    LAI Yan-ping, LIU Yan-qiang
    2008, 13(2):  208-212. 
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    γ-aminobutyric acid (GABA) is an inhibitory neurotransmitter in the central nervous system (CNS), with wide physiological role via GABAA, GABAB and GABAC receptors. GABAA receptor, a dominant type of GABA receptors is comprised of different subunits coming from eight subunit clusters. Whereas its typical molecular structure is a hetero-pentameric complex, being comprised of two α, two β and one γ subunits. And different subunits especially different αsubunit combinations give rise to various physiological and pharmacological effects, which makes GABAA receptor play a great role in the development of some neuropsychiatric diseases such as anxiety, depression, epilepsy and memory disorders etc. Thus GABAA receptor might be an effective target for preventing these neuropsychiatric diseases.
    Advances on mechanisms of selective estrogen receptor modulators and their therapy of postmenopausal osteoporosis
    LI Meng-Sen, ZHOU Sheng, LI Gang
    2008, 13(2):  213-219. 
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    The reduction of estrogen is the main cause that leads to osteoporosis(OP). Selective estrogen receptor modulators (SERMs) have been developed and applied for the treatment of postmenopausal OP because breast cancer is triggered while using estrogen to cure OP. SERMs selectively act on the estrogen receptor that could inhibit the absorbability of bone and the formation of osteoclast, this manner may prevent the loss of bone mineral density. Presently, it is considered that SERMs were the ideal drugs for curing postmenopausal OP. In the paper, the functional mechanism of SERMs and their effects on curing OP were summarized, the scientific significance and perspective for application of SERMs on the therapy of postmenopausal OP were discussed.
    Research progress on gene variants of the ABCC family
    YIN Ji-ye, LIU Zhao-qian
    2008, 13(2):  220-227. 
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    The ABCC (ATP-Binding Cassette, Subfamily C, ABCC) family is a large protein family discovered recently. It is comprised of nine members which distribute widely in human body and participate in the transportion of many important substrates. Some chemotherapeutic agents are also substrates of ABCC whose over-expressions have been proved to be associated with multidrug resistance. Recently, some studies showed that some mutations of ABCC family could affect the substance metabolism and lead to tumor multidrug resistance, even result in genetic disorders. The genetic variants of the ABCC family and their association with tumor multidrug resistance were reviewed in this paper.
    Intervention of NF-κB activation pathway and its effects on malignant transformation of hepatocytes
    YU Hong-bo, YAO Deng-fu
    2008, 13(2):  228-233. 
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    The formation of hepatocellular carcinoma (HCC) is a multi-center, multi-etiology and multistage pathological progress with the chronic persistent infection of hepatitis viruses (HBV and HCV). The mutations of multigenes, oncogenes or anti-oncogenes at different stages are the molecular basics of hepatocarcinogenesis. NF-κB participates in initiation and progress of HCC, and the increasing of its expresssion may indicate the early cancerization of hepatocytes. Since NF-κB activation plays an important role in HCC development, the malignant transformation of hepatocytes may be interfered by inhibition of its activation. The approaches such as IKK-B gene knockout or expression of IκBαsuper repressor have been used to intervene the malignant transformation of hepatocytes to explore the molecular mechanisms and application values of HCC therapy.
    Advance in study of monitoring acute rejection of pancreas allograft transplant
    CAO Jun, RUI Jing
    2008, 13(2):  234-240. 
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    The syndrome of insulin-dependent diabetes mellitus (IDDM) includes not only abnor-mal glucose metabolism but also specific microvascular complications that include nephropathy, retinopathy and neuropathy. In the short term, improvement in the quality of life and possible prevention of further morbidity associated with diabetes makes pancreas transplantation an important therapeutic option, particularly when combined with a kidney trans-plant, in appropriately selected diabetic patients. The focus of the early management of the pancreas transplant recipient is the prevention of acute rejection. In this article we review the methods for clinical diagnosis of the early acute rejection due to pancreas transplanta-tion.