OBJECTIVETo analyze the correlation between drug exposure (AUC0-4) and blood concentration of different sample points during Neoral absorption phase in Chinese adult liver transplant recipients, and to evaluate the possibility of using post-dose 2 hour level (C2) as a surrogate marker of AUC0-4 for the therapeutic drug monitoring (TDM) of Neoral.

METHODSNeoral levels at 0, 1, 2, 3, and 4 hours (C1, C2, C3, C4) after morning dose of 22 de novo Chinese adult liver transplant recipients were monitored during different posttransplant periods. Liner regression was used to analyze the correlation between CsA concentration at different time points and the AUC0-4.

RESULTSThe best correlation was found at C2, while the correlation of C0 was the lowest. During following-up, the correlation between C2 and AUC0-4 was very stable.

CONCLUSIONC2 had the best correlation with drug exposure. This correlation is very stable. C2 may be used as a good surrogate marker of AUC0-4 for the TDM of Neoral.

Adult ; Area Under Curve ; Asian Continental Ancestry Group ; Cyclosporine ; blood ; pharmacokinetics ; Drug Monitoring ; methods ; Emulsions ; Female ; Graft Rejection ; prevention & control ; Humans ; Immunosuppressive Agents ; blood ; pharmacokinetics ; Intestinal Absorption ; physiology ; Liver Transplantation ; immunology ; Male ; Middle Aged ; Monitoring, Immunologic ; methods ; Postoperative Period

The current cytomegalovirus (CMV) prevention strategies in solid organ transplantation (SOT) recipients have contributed towards overcoming the detrimental effects caused by CMV lytic infection, and improving the long-term success rate of graft survival. Although the quantification of CMV in peripheral blood is the standard method, and an excellent end-point for diagnosing CMV replication and modulating the anti-CMV prevention strategies in SOT recipients, a novel biomarker mimicking the CMV control mechanism is required. CMV-specific immune monitoring can be employed as a basic tool predicting CMV infection or disease after SOT, since uncontrolled CMV replication mostly originates from the impairment of immune responses against CMV under immunosuppressive conditions in SOT recipients. Several studies conducted during the past few decades have indicated the possibility of measuring the CMV-specific cell-mediated immune response in clinical situations. Among several analytical assays, the most advancing standardized tool is the QuantiFERON®-CMV assay. The T-Track® CMV kit that uses the standardized enzyme-linked immunospot assay is also widely employed. In addition to these assays, immunophenotyping and intracellular cytokine analysis using flow cytometry (with fluorescence-labeled monoclonal antibodies or peptide-major histocompatibility complex multimers) needs to be adequately standardized and validated for potential clinical applications.
Antibodies, Monoclonal ; Cytomegalovirus* ; Enzyme-Linked Immunospot Assay ; Flow Cytometry ; Graft Survival ; Immunity, Cellular ; Immunophenotyping ; Major Histocompatibility Complex ; Methods ; Monitoring, Immunologic ; Organ Transplantation* ; Transplants*

Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.
Consensus ; Drug Hypersensitivity ; etiology ; immunology ; Drug Monitoring ; adverse effects ; methods ; standards ; Drugs, Chinese Herbal ; adverse effects ; Expert Testimony ; Humans ; Immunologic Techniques ; methods ; standards ; Product Surveillance, Postmarketing ; methods ; standards ; Th1 Cells ; immunology ; Th2 Cells ; immunology

OBJECTIVETo investigate on the expression of some cytokines and other immunity makers right after the operation, the effect of femoral nailing on systemic immunity and sought to differentiate any differences between reamed and unreamed IMN.

METHODSFifty-nine patients presenting with acute femoral fractured including 55 male and 4 female, 32.1 years old on average, are divided into 2 group depend on ISS. All patients were treated by close reduction and intramedullary nail for fixation. In group 1, 23 reamed and 23 unreamed; in group 2, 7 reamed and 6 unreamed. Venous blood samples were taken at 24 hr pre-operationally, and 1 hr, 24 hr, 48 hr post operationally. Serum TNF, IL-6, IL-8, IL-10 were measured by enzyme-linked immunosorbent assay. CRP was measured by protein assay apparatus. We also collected venous samples from 22 healthy uninjured volunteers, which formed control group.

RESULTSAll immune marks were elevated post operation, for IL-6, IL-8, IL-10, this elevation began at 1 hr after operation, reached to the peak at 24 hr, and then down but never to the normal at 48 hr. For TNF and CRP, the level were raised at 24 hr, and then fallen at 48 hr. All mediators were raised significantly above the control group (< 0.05). Between reamed and unreamed patients both in group 1 and group 2, Although there was a trend towards higher levels of TNF, IL-6, IL-8, IL-10 and CRP in RFN than in the URFN, no significant difference was found except that there was a greater release of serum IL-10 in RFN than in URFN at 24 hr post operation (P = 0.047). Two patients have become SIRS, but the markers have shown no significant difference with those that have no SIRS symptoms.

CONCLUSIONSTo the patient not injured severely, using IMN for treatment will make the inflammatory mediators re-released on higher level than normal, which will be balanced by immunity itself soon, so IMN won't make any damage severely. And no significant difference were found between reamed and unreamed nail. But the changing of IL-10 show us that after IMN, especially the reamed nailing, the level of anti-inflammatory mediators will show the difference more apparently between RFN and URFN while the patient got injured more severely. Under this condition, the RFN will aggravate the restrain of immunity.

Adult ; Biomarkers ; blood ; Female ; Femoral Fractures ; immunology ; surgery ; Fracture Fixation, Intramedullary ; adverse effects ; methods ; Fractures, Closed ; immunology ; surgery ; Humans ; Interleukin-10 ; blood ; Interleukin-6 ; blood ; Interleukin-8 ; blood ; Male ; Middle Aged ; Monitoring, Immunologic ; Postoperative Period ; Tumor Necrosis Factors ; metabolism

BACKGROUND/AIMS: Advanced human immunodeficiency virus (HIV) infection, despite sustained viral suppression by highly active antiretroviral therapy (HAART), is a risk factor for poor immunologic recovery. However, some patients with advanced infection do show immunologic recovery. In this study, predictive factors of immunologic recovery were analyzed in advanced HIV patients showing sustained viral suppression. METHODS: A case-control study was conducted in HIV-infected adult patients with HIV-1 RNA < 50 copies/mL maintained for 4 years or longer and who were receiving HAART. Advanced HIV infection was defined as a baseline CD4 T cell count < 200/mm3. Immunologic responders were defined as patients showing immunologic recovery (CD4 T cell counts > or = 500/mm3 at 4 years with HAART). To analyze the CD4 T cell kinetics, the CD4 slope (monthly changes in the CD4 T cell count) was estimated for each patient using a linear regression between the CD4 T cell count and the time since HAART initiation. RESULTS: Of 102 eligible patients, 73 had advanced HIV, and 33 (45.2%) showed immunologic recovery. The median CD4 slopes (cells/mm3 per month) during 0 to 6 and 0 to 12 months of HAART in the 73 advanced patients were significantly higher in responders than in non-responders (0 to 6 months, 38.6 vs. 22.8; 0 to 12 months, 24.5 vs. 13.5). Multivariate analyses showed opportunistic infections at the start of HAART (adjusted odds ratio [OR], 0.28) and a CD4 slope > or = 20 during 0 to 12 months of HAART (adjusted OR, 10.10) were independently associated with immunologic recovery. CONCLUSIONS: The CD4 slope can be an early predictor of long-term immunologic recovery in advanced HIV patients.
Adult ; Anti-HIV Agents/therapeutic use ; Antiretroviral Therapy, Highly Active ; Biomarkers/blood ; *CD4 Lymphocyte Count ; Case-Control Studies ; Chi-Square Distribution ; Female ; HIV Infections/*diagnosis/drug therapy/*immunology/virology ; HIV-1/drug effects/genetics/*immunology ; Humans ; Linear Models ; Logistic Models ; Male ; Middle Aged ; Monitoring, Immunologic/*methods ; Multivariate Analysis ; Odds Ratio ; Predictive Value of Tests ; RNA, Viral/blood ; Time Factors ; Treatment Outcome ; Viral Load