Efficacy and safety of infliximab biosimilar Inflectra® in severe sarcoidosis.

BACKGROUND: Infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF-α) is effective third-line therapy in severe sarcoidosis. The originator product of Infliximab, Remicade®, is expensive, limiting universal access. Recently, a less expensive biosimilar of infliximab, Inflectra®, has become available, but the efficacy and tolerability has not been studied in sarcoidosis. METHODS: In this retrospective cohort study, 29 patients treated with the infliximab biosimilar Inflectra®, were analysed. Patients received Inflectra® intravenously monthly at a dose of 5 mg/kg. We measured trough levels before every infusion. Before and after 6 months of induction therapy pulmonary function and disease activity were evaluated using Standardised Uptake Value (SUV) of the 18F-fluorodeoxyglucose by positron emission tomography (18F-FDG PET), soluble interleukin-2 receptor (sIL-2R), angiotensin converting enzyme (ACE) and health-related quality of life (HRQOL). RESULTS: In patients with pulmonary sarcoidosis as main treatment indication (n = 15) the predicted FVC improved with 8.1%, p < 0.05. Furthermore, in the whole group HRQoL improved significantly (p < 0.001), whereas SUVmax and sIL-2R significantly reduced (p < 0.001 and p = 0.001 respectively). Hospitalisation due to infections occurred in four patients. None of the patients discontinued Inflectra® due to side-effects. Furthermore, all patients had detectable trough levels indicating development of neutralizing antibodies. CONCLUSION: Infliximab biosimilar Inflectra® seems effective in the treatment of refractory sarcoidosis with a comparable safety profile to the reference product Remicade®. Inflectra® can be considered as an alternative and less expensive option for patients with refractory sarcoidosis.

Modulatory effects of proinflammatory cytokines for action cascading processes - evidence from neurosarcoidosis.

Neurosarcoidosis is a rare central nervous system manifestation of sarcoidosis. T cell, T-helper cell and macrophage activation via the major histocompatibility complex (MHC) II-mediated pathway causes this disease. Little is known about the possible cognitive disturbances in this disease as most reported instances are case studies. Here, we provide the first in-depth analysis of psychomotor functions in a sample of 30 neurosarcoidosis patients. We investigated action control processes using a paradigm that is able to examine how different tasks are cascaded to achieve the task goal. We integrated electrophysiological (EEG) data with behavioural and neuroimmunological data. Our results show that there was no general cognitive decline in patients with neurosarcoidosis. Patients only presented deficits when two response options have to be prioritized. Patients apply an inefficient processing strategy where they try to processes different response options in parallel. The electrophysiological data show that the deficits are due to dysfunctions at the response selection stage. Behavioural and neurophysiological changes are predictable on the basis of soluble interleukin 2 receptor serum concentrations. The results show that neurosarcoidosis is not associated with nonspecific changes in cognitive functions but does lead to specific alterations in cognitive control that are strongly dependent on immunological parameters.

Assessment of immune status in relation to vitamin D levels in children on regular hemodialysis.

The two most common causes of death in patients with chronic kidney disease (CKD) are cardiovascular diseases and infections, and both have been linked to impaired vitamin D levels and dysregulated immune response. The aim of this work is to study the relation between vitamin D levels in children with end-stage renal disease (ESRD) on regular hemodialysis (HD) and their immune status. This case-control study was conducted at the Nephrology Unit, Department of Pediatrics, the Zagazig University Hospital, from April 2010 to August 2010. We studied 27 children with ESRD on regular HD (group-A) whose mean age was 8 ± 1.3 years; there were 15 males and 12 females. The study patients were divided into two groups depending on the degree of vitamin D deficiency; group-A1 had 12 patients, all of whom had vitamin D deficiency defined as serum concentration of 25-hydroxy vitamin D3 [25(OH) D3] of 15-30 ng/mL. Group-A2 had 15 patients with more severe vitamin D deficiency (<15 ng/mL). Twenty healthy age- and sex-matched children served as the control group (group-B); their mean age was 7.8 ± 1.6 years and they included 12 males and eight females. All subjects underwent thorough history taking, clinical examination and the following investigations: complete blood count, lymphocyte count, blood urea, serum creatinine, total serum calcium, ionized calcium, serum phosphorus, plasma 25(OH)D3, intact para-thormone (iPTH), serum interleukin-10 (IL-10) and soluble IL-2 receptor (SIL-2R). We found that the vitamin D level was significantly lower in the patient group (group-A) than in the control-group (group-B). The IL-10 level was significantly lower in group-A than in group-B, and the SIL-2R level was significantly higher in group-A than in group-B. We found a significant positive correlation between serum 25(OH)D3 levels and serum IL-10, while there was a negative correlation between 25(OH)D3 levels and SIL-2R; this correlation was not significant. Our findings suggest that 25(OH)D3 levels affect the immune state in patients through their effect on both limbs of immunity, the anti-inflammatory and the pro-inflammatory, but the effect was higher on the anti-inflammatory IL-10. We conclude that the serum levels of vitamin D are lower in children with ESRD than in age-matched controls, and that it is significantly positively related to the anti-inflammatory IL-10 and negatively related to the pro-inflammatory SIL-2R. Further studies are required to throw more light on the role of vitamin D supplementation in children with ESRD in maintaining immune balance.

A comparative study on efficacy of UVA1 vs. narrow-band UVB phototherapy in the treatment of vitiligo.

BACKGROUND/PURPOSE: Narrow-band ultraviolet B (NB-UVB) is considered the most effective and safe initial treatment for moderate-to-severe vitiligo but phototoxicity and possible carcinogenicity are the reported side effects. Ultraviolet A1 (UVA1) phototherapy has overlapping biological effects to NB-UVB and is relatively free of side effects associated with other phototherapy regimens. METHODS: Forty patients with vitiligo were included in this prospective, randomized controlled comparative clinical trial. Twenty patients received NB-UVB and 20 received UVA1 three times weekly for 12 weeks. The UVA1 group was divided into two subgroups. Ten patients received moderate and 10 received low dose of UVA1. Serum samples were collected before and after 36 sessions to assess soluble interleukin 2 receptor level. Patients were clinically evaluated before therapy then monthly according to Vitiligo Area Scoring Index (VASI) and Vitiligo European Task Force (VETF) scores. In addition, extent of response was determined by a blinded dermatologist comparing before and after therapy photographs. Pattern of response and side effects were recorded. RESULTS: NB-UVB was superior to UVA1 with a significant difference in blinded dermatological assessment (P<0.001), percentage change in VASI score (P<0.001) and percentage change in VETF area score (P=0.001). No significant difference in side effects was observed between both groups. Comparing UVA1 subgroups, better response in moderate-dose group was found as regard to percentage change in VASI (P<0.001) and percentage change in VETF area score (P=0.001), while no significant difference was found in blinded dermatological assessment (P=0.121). CONCLUSION: NB-UVB phototherapy remains to be an effective and safe therapeutic option in vitiligo. Response to UVA1 in vitiligo seems to be dose dependent and seems to be of limited value in treatment of vitiligo as a monotherapy. Further studies combining it with other lines of therapy such as systemic steroids may prove beneficial.

[Effects of electroacupuncture on IL-2-IFN-NKC immunity immunoloregulation net and IL-2 receptor in rats with exercise stress].

OBJECTIVE: To explore the effects of electroacupuncture on exercise-induced immunosuppression in rats and its mechanism. METHODS: Sports immunosuppressive model was established successfully by the rats were conducted high intensity swimming training 150 min/day, 6 days/wk for 8 weeks in this study. Forty-three SD rats were randomly divided into a control group (group A, n = 10), a high intensity swimming training group (group B, n = 17), and a high intensity plus electroacupuncture group (group C, n = 16). Group A did not receive any intervention. Group B was conducted 150 min/day, 6 days/wk swimming training for 8 weeks. Group C was treated with electroacupuncture at "Baihui" (GV 20), "Guanyuan" (CV 4) and "Zusanli" (ST 36) after every exercise-time from the second week, once each day for 7 weeks. The changes of the rats' weight, gamma-interferon (gamma-IFN), interleukin-2 (IL-2), solubility IL-2 receptor (SIL-2R) and nature killer cell (NKC) were detected. RESULTS: (1) Compared with group A, gamma-IFN and IL-2 in group B were significantly decreased (P < 0.01, P < 0.05), and NKC in group C was significantly increased (P < 0.01). Meanwhile, gamma-IFN and NKC in group C were both significantly higher than that in group B (P < 0.05, P < 0.01). (2) Compared with group A, the weight of the rats in group B and group C were significantly decreased (both P < 0.01), but SIL-2R in group B was significantly increased (P < 0.05). The weight of the rats in group C was significantly higher than that in group B (P < 0.05) and SIL-2R in group C was significantly lower than that in group B (P < 0.01). CONCLUSION: Lasting gravis exercise stress does decrease the immune function in rats and is even inhibited significantly, but electroacupuncture can up-regulate the exercise-induced immunosuppression.

Soluble interleukin-2 receptor levels correlated with positive symptoms during quetiapine treatment in schizophrenia-spectrum disorders.

BACKGROUND: Some but not all antipsychotics have been shown to modulate plasma cytokine levels in schizophrenia patients. Thus far, the most consistent finding has been the increase in plasma levels of soluble interleukin (IL)-2 receptor (sIL-2R) associated with clozapine treatment. Quetiapine is a second-generation antipsychotic with a pharmacological profile similar to that of clozapine, but its immunomodulatory effects have not been investigated in schizophrenia yet. The purpose of this exploratory study was to examine the changes in plasma levels of sIL-2R in schizophrenia during quetiapine treatment and association with psychopathology. METHODS: Participants were 29 schizophrenia-spectrum disorder patients (DSM-IV criteria), and 28 healthy controls. Patients had a comorbid substance use disorder (cannabis>alcohol>cocaine), since quetiapine is increasingly used in this population of dual diagnosis. No participant suffered from infection or overt inflammatory diseases. On baseline, patients taking mostly second-generation antipsychotics were switched to quetiapine for a 12-week open-label trial. Five patients were drop-outs. Mean dose of quetiapine for trial completers (n=24) was 466.6mg±227.3. Psychiatric variables were evaluated with the Positive and Negative Syndrome Scale and the Calgary Depression Scale for Schizophrenia. Plasma sIL-2R levels were assessed at baseline, weeks 6 and 12 in patients, and in healthy controls, using sandwich immunoassay. Plasma IL-6 and IL-1 receptor antagonist (IL-1RA) were measured for comparison purposes. RESULTS: On baseline, plasma sIL-2R, IL-6 and IL-1RA levels were higher in dual-diagnosis patients, compared to controls. Plasma sIL-2R further increased after quetiapine treatment (p=0.037), while plasma IL-6 and IL-1RA did not change. Clinical improvements were observed in positive, negative and depressive symptoms, and substance abuse severity (all p<0.01). Interestingly, changes in sIL-2R levels during treatment were inversely correlated with changes in positive symptoms (r=-0.524; p=0.009). That is, increases in sIL-2R levels were associated with reductions in positive symptoms. CONCLUSION: These data show that quetiapine elevates, like clozapine, sIL-2R levels in schizophrenia. Furthermore, the results suggest that sIL-2R alterations in schizophrenia rely on complex interplays between antipsychotics and the positive symptoms of the disorder. Future randomized controlled trials involving larger samples of schizophrenia patients are warranted to determine whether changes in plasma sIL-2R are quetiapine-related.

Effects of dexamethasone and Salvia miltiorrhizae on the small intestine and immune organs of rats with severe acute pancreatitis.

To observe the protecting effects and mechanisms of Dexamethasone and Salviae miltiorrhizae on intestinal mucosa and immune organs (spleen, thymus and lymph node) in rats with severe acute pancreatitis (SAP). The rats were randomly divided into sham-operated, model control, Dexamethasone treated group and Salviae miltiorrhizae treated group. At 3, 6 and 12 h after operation, the mortality rate, pathological changes of intestinal mucosa and immune organs as well as the contents of serum PAF, IL-1 beta and sIL-2R were observed, respectively. The mortality rate and the contents of PAF (at 3 and 6 h), IL-1 beta (at all time points) and sIL-2R (at 3 and 6 h) as well as the pathological scores of thymus (at all time points) and spleen (at 3 h) in Dexamethasone treated group were significantly lower than those in model control groups (P < 0.05). The contents of PAF (at 3 and 12 h), IL-1 beta (at 6 and 12 h) and sIL-2R (at 3 and 6 h) as well as the pathological scores of thymus (at all time points) and spleen (at 3 and 12 h) in Salviae miltiorrhizae treated group were markedly lower than those in model control groups (P < 0.05). Since both Dexamethasone and Salvia miltiorrhizae can reduce the contents of serum PAF, sIL-2R and IL-1 beta, mitigate the pathological changes in the small intestine, spleen and thymus and reduce the mortality rate of SAP rats, they show good therapeutic effects on SAP rats.

Fish oil n-3 polyunsaturated fatty acids selectively affect plasma cytokines and decrease illness in Thai schoolchildren: a randomized, double-blind, placebo-controlled intervention trial.

OBJECTIVE: To determine whether very long-chain n-3 polyunsaturated fatty acids (PUFAs) affect illness and selected plasma cytokines in schoolchildren. STUDY DESIGN: Thai schoolchildren aged 9 to 12 years consumed milk containing placebo (soybean) oil (n = 86) or fish oil (n = 94) on 5 days per week for 6 months; the latter provided 200 mg eicosapentaenoic acid plus 1 g docosahexaenoic acid daily. Episodes and duration of illness were recorded, and plasma interleukin (IL)-2 receptor, IL-6, IL-10, and transforming growth factor (TGF)-beta1 concentrations and the fatty acid profile of plasma phosphatidylcholine determined. RESULTS: After intervention, very long-chain n-3 PUFAs were higher in plasma phosphatidylcholine in the fish oil group than in the placebo group (P < .001). The fish oil group showed fewer episodes (P = .014) and shorter duration (P = .024) of illness (mainly upper respiratory tract) than the placebo group. Plasma IL-2 receptor, IL-10, and IL-6 were not affected by either treatment. Plasma TGF-beta1 increased in both groups, but the increase was smaller in the fish oil group, and at the end of supplementation TGF-beta1 concentration was lower in the fish oil group (P < .001). CONCLUSIONS: Very long-chain n-3 PUFAs reduce illness, mainly infections, in healthy Thai schoolchildren.

[Effects of Jinlong Capsule on expressions of interleukin-2 and soluble interleukin-2 receptor in patients with primary liver cancer after transarterial chemoembolization therapy].

OBJECTIVE: To observe and discuss the dynamic changes of interleukin-2 (IL-2) and soluble interleukin-2 receptor (sIL-2R) and their significance in the patients with primary liver cancer after transarterial chemoembolization (TACE) therapy combined with Jinglong Capsule. METHODS: A total of 48 patients with primary liver cancer, who failed to be treated by major surgery, were randomly divided into two groups: Jinlong Capsule group (TACE therapy plus Jinlong Capsule) and control group (TACE therapy alone). There were 24 cases in each group. The levels of peripheral blood IL-2 and slL-2R were measured before the first TACE and 1, 7 and 15 days after the second TACE respectively by using double-antibody sandwich enzyme-linked immunosorbent assay. The data from Jinlong Capsule group were compared with those from the control group. RESULTS: The level of sIL-2R in Jinlong Capsule group was significantly lower than that in the control group (P<0.05), while the level of IL-2 was significantly higher than that in the control group (P<0.05). CONCLUSION: Jinlong Capsule can significantly improve the lymphocyte function of the patients with primary liver cancer after TACE. The levels of IL-2 and sIL-2R can be considered as the valuable parameters for evaluating the effects on primary liver cancer, and Jinlong Capsule is helpful for the patients with primary liver cancer.

Effects of a Shuangling Fuzheng anticancer preparation on the proliferation of SGC-7901 cells and immune function in a cyclophosphamide-treated murine model.

AIM: To study the inhibitory effects of a Shuangling Fuzheng anticancer preparation (SFAP) on the human gastric cancer cell line SGC-7901 in vitro as well as its immune-modulated effects in a cyclophosphamide-treated murine model. METHODS: MTT experiments and immunocytochemistry ABC experiments were performed for detecting the proliferation of SGC-7901 cells in vitro and protein expression of c-myc. The staphylococcal protein A (SPA) rosette test was utilized for measuring the ratio of T-lymphocyte subsets from peripheral blood in a cyclophosphamide-treated murine model. Enzyme-linked immunosorbant assay (ELISA) was performed for measuring the levels of serum sIL-2R in treated mice, while immunoturbidimetry was used for measuring the levels of immunoglobulins (Ig). RESULTS: SFAP (40-640 mg/L, 48 h) inhibited the proliferation of SGC-7901 cells, and a positive correlation was noted between inhibitory effects and dosage. At a dosage of 160-320 mg/L in cultured cells, the expression of c-myc was decreased. SFAP (50-200 mg/kg) increased the percentage of CD3+ and CD4+ T-lymphocytes, the ratio of CD4/CD8, and the contents of Ig such as IgM, IgG or IgA, but decreased the levels of serum sIL-2R in peripheral blood from cyclophosphamide-treated mice. CONCLUSION: SFAP can inhibit the proliferation of SGC-7901 cells via the c-myc gene. In addition, SFAP can modulat the cellular and humoral immunity in cyclophosphamide-induced immunosuppressed mice.

Fish oil supplementation modulates immune function in healthy infants.

(n-3) PUFA influence immune function in adults and may also affect immune maturation during development. This randomized trial is, to our knowledge, the first to investigate whether fish oil supplementation in late infancy modifies immune responses. The study was a 2 x 2 intervention in 64 healthy Danish infants, who received cow's milk or infant formula alone or with fish oil (FO) (3.4 +/- 1.1 mL/d) from 9 to 12 mo of age. Before and after the intervention, fatty acid composition of erythrocyte membranes, plasma IgE, C-reactive protein, and soluble IL-2 receptor concentrations were measured. TNF-alpha, INF-gamma, and IL-10 concentrations in whole-blood cultures, stimulated for 22 h with LPS+phytohemaglutinin (PHA) or Lactobacillus paracasei, were also determined. IgA was measured in feces when infants were 10 mo of age. FO supplementation effectively raised erythrocyte (n-3) PUFA (P < 0.001), increased L. paracasei-induced INF-gamma (P = 0.05) and tended to reduce LPS+PHA-induced IL-10 (P = 0.08). The FO intervention did not affect any of the other analyzed immune variables. The erythrocyte content of eicosapentanoic acid was negatively associated with LPS+PHA-induced IL-10 (r = -0.38, P = 0.02). Feeding milk rather than formula did not affect cytokine production, but plasma soluble IL-2 receptor concentration was greater in the formula group than in the cow's milk group (P = 0.03). Since the capacity to produce INF-gamma has been proposed as a maturation marker for the immune system in early life, this study suggests a faster immune maturation with FO supplementation with no apparent reduction in immune activation. The implications for later health need further investigation.

[Effects of injection of Huangqi injectio into Zusanli (ST 36) on immune function in the patient of schizophrenia].

OBJECTIVE: To study on effects of injection of Huangqi Injectio into Zusanli (ST 36) on the hospital infection and immune function in the patient of schizophrenia. METHODS: Thirty inpatients of chronic schizophrenia were treated with injection of Huangqi Injectio into bilateral Zusanli (ST 36), 2 mL each point, thrice each week, for 8 weeks. Relative immune indexes and the hospital infection were investigated. RESULTS: The hospital infection and the sub-infection were 4 cases (13.3%), 7 cases-times (23.3%) in the injection group; and 9 cases (15.0%), 19 cases-times (31.7%) in the control group, respectively, with no significant difference between the two groups (P>0.05). The drug-administration duration was 7.77 days/case and 11.87 days/case in the two groups, respectively (P<0.01). In the injection group, as compared with that of last 3 years the duration was 7.77 days/case and 14.08 days/case (P<0.01). IgG, IgA, IgM and T-cell subgroups did not have significant changes, but there was the most different value before and after injection in SIL-2R of the no-infection group, and the longer the drug administration duration, the smaller the different values. CONCLUSION: Injection of Huangqi Injectio into Zusanli (ST 36) has definite effect for prevention of the hospital infection in inpatients of chronic schizophrenia, and SIL-2R is a valuable index for investigation of the hospital of infection.

Reduced cytokines release and myocardial damage in coronary artery bypass patients due to L-arginine cardioplegia supplementation.

BACKGROUND: Recently, L-arginine has been added to cardioplegia to limit myocardial ischemic damage. The mechanism of action is related to the production of nitric oxide, with vasodilatation and reduction of endothelial dysfunction. Our prospective randomized study on coronary artery bypass patients investigates the effect of L-arginine on myocardial stress as expressed by myocardial cytokines release and myocardial ischemia in terms of troponin T concentration. METHODS: Coronary artery surgery patients were randomly assigned to receive 7.5 g L-arginine in 500 mL of cardioplegic solution (group A). Group B was used as control. Cold blood 4:1 anterograde and retrograde cardioplegia with warm induction was administered. Blood samples were collected from the retrograde coronary sinus catheter to determine interleukin-2 receptor, interleukin-6, and tumor necrosis factor levels. Serum samples at different time points were also analyzed to measure myocardial ischemia markers. Hemodynamic and echocardiographic evaluations were obtained perioperatively. RESULTS: Sixty-five patients were enrolled (group A, treated with L-arginine, n = 33; group B, control, n = 32). Wedge pressure and intensive care unit stay were significantly reduced in group A (p = 0.023 and p = 0.03, respectively). Cytokines levels were lower in group A, with a significance for interleukin-6 (p = 0.026); troponin T was reduced in treated patients (0.33 versus 0.57 ng/mL at 18 hours: p = 0.009). CONCLUSIONS: Coronary artery surgery patients benefit from L-arginine cardioplegia supplementation in terms of reduced inflammatory reaction, limitation of myocardial ischemia, and better hemodynamic performance. Moreover, a clinical advantage is evident in terms of a shorter intensive care unit stay in patients treated with L-arginine.

Effect of Kang'ai Injection on serum level of soluble interleukin-2 receptor and vascular endothelial growth factor in patients with esophageal carcinoma during radiotherapy.

OBJECTIVE: To observe the effect of Kang'ai Injection (KAI) on serum level of soluble interleukin-2 receptor (slL-2R) and vascular endothelial growth factor (VEGF) in patients with esophageal carcinoma (EC) during radiotherapy (RT), and to investigate its synergistic effect with RT and its influence on immunological function of the body. METHODS: One hundred and seventy patients with EC, who had missed the chance of surgical operational therapy, were assigned to the treated group (90 cases) and the RT group (80 cases), and at the same time a control group consisting of 80 inpatients without tumors was set up. Patients in the RT group were treated with RT alone but KAI was given additionally to those in the treated group, with 50 ml given once per day via intravenous dripping, 15 days as one course, and 2 courses administered in total. The immediate therapeutic efficacy and changes of serum slL-2R and VEGF levels were observed, and the effect of KAI on patients' quality of life (QOF) was evaluated by Karnofsky scoring. RESULTS: In 16 patients of the treated group it was completely remission (CR), in 54 partially remission (PR), in 18 it was stabilized disease (SD) and in 2 progressive disease (PD), with the total effective rate (CR + PR) as 77.8%, while in those of the control group it was 12, 46, 18, 4 and 72.5%, respectively, the immediate therapeutic efficacy in the treated group was somewhat better than that in the RT group, but showed no statistical significance (P>0.05). Serum levels of slL-2R and VEGF in all the patients before treatment were higher than those in the control group, which were decreased after treatment in both groups ( P<0.05), but the improvement in the treated group was better than that in the RT group, showing significant difference (P<0.05), and patients' QOF improved more significantly in the former as well (62.2% vs 40.0%, P< 0. 05). CONCLUSION: KAI in combination with RT in treating patients with EC could enhance the immunological function of patients, improve their QOF and enhance their sensitivity to RT.

[Effect of early intestinal dripping of jianpi tongli Chinese herbs on serum level IL-2, sIL-2R and IL-12 in patients with gastric cancer after operation].

OBJECTIVE: To explore the regulation and clinical significance of intestinal dripping of Jianpi Tongli (JPTL) Chinese herbs on levels of serum cytokines, such as interleukin-2 (IL-2), soluble interleukin-2 receptor (sIL-2R) and interleukin-12 (IL-12) in treating patients with gastric cancer (GC) at early post-operational stage. METHODS: Sixty patients with GC were randomly divided into two groups, i. e. the studied group (n = 30), treated with JPTL Chinese herbs, and the control group (n = 30) treated with normal saline. The medication was started from the 1st day after operation by intestinal dripping daily, 7 days as one course. Levels of IL-2, sIL-2R and IL-12 were observed before and after operation. RESULTS: Significant difference was seen on the 7th day post-operation between the studied and the control group, mainly in aspects of obvious increase of IL-2 and decrease of sIL-2R (P <0.05), no significant difference in IL-12 was found (P >0.05) though there was certain improvement. Compared with pre-operation of the same group, significant difference was found in the studied group in the increased IL-2 and IL-12 and decreased sIL-2R on the 7th day post-operation, while no significant difference in these indexes was found in the control group (P >0.05), though certain improvement was shown. CONCLUSION: Early intestinal dripping of JPTL Chinese herbs to post-operational patients with GC could improve their immune function, which was of important significance in early preventing the severe complications, improving the prognosis, and elevating the survival rate.

Immunomodulatory activities of Yunzhi and Danshen in post-treatment breast cancer patients.

Breast cancer is the most common cancer among women worldwide. Discomfort and fatigue are usually arisen from anticancer therapy such as surgery, radiotherapy, chemotherapy, hormonal therapy, or combination therapy, because of the suppressed immunological functions. Yunzhi (Coriolus versicolor) can modulate various immunological functions in vitro, in vivo, and in human clinical trials. Danshen (Salvia miltiorrhiza) has been shown to benefit the circulatory system by its vasodilating and anti-dementia activity. The purpose of this clinical trial was to evaluate the immunomodulatory effects of Yunzhi-Danshen capsules in post-treatment breast cancer patients. Eighty-two patients with breast cancer were recruited to take Yunzhi [50 mg/kg body weight, 100% polysaccharopeptide (PSP)] and Danshen (20 mg/kg body weight) capsules every day for a total of 6 months. EDTA blood samples were collected every 2 months for the investigation of immunological functions. Flow cytometry was used to assess the percentages and absolute counts of human lymphocyte subsets in whole blood. Plasma level of soluble interleukin-2 receptor (sIL-2R) was measured by enzyme-linked immunosorbent assay (ELISA). Results showed that the absolute counts of T-helper lymphocytes (CD4+), the ratio of T-helper (CD4+)/T suppressor and cytotoxic lymphocytes (CD8+), and the percentage and the absolute counts of B-lymphocytes were significantly elevated in patients with breast cancer after taking Yunzhi-Danshen capsules, while plasma slL-2R concentration was significantly decreased (all p < 0.05). Therefore, the regular oral consumption of Yunzhi-Danshen capsules could be beneficial for promoting immunological function in post-treatment of breast cancer patients.

Follow-up efficacy of integrative Chinese and Western drugs on localized scleroderma with vitamine B6 and Xuefu Zhuyu decoction.

OBJECTIVE: To investigate the therapeutic effects of vitamine B(6) (Vit B(6)) and Xuefu Zhuyu Decoction (XFZY, for activating blood circulation to remove stasis) in patients with localized scleroderma(LSD). METHODS: Thirty-three patients were treated with XFZY and Vit B(6), with 15 cases taking orally prednisone acetate and 20 healthy volunteers as the control. Their level of soluble interleukin-2 receptor (sIL-2R) and tumor necrosis factor-alpha (TNF-alpha) in the patients with LSD before and after treatment were observed. RESULTS: The level of sIL-2R and TNF-alpha in the serum from the patients with LSD were higher than those of healthy volunteers (P < 0.01). After treatment with Vit B(6) and XFZY, the level of sIL-2R and TNF-alpha from the patients with LSD decreased significantly (P < 0.01), but there were no difference between the group taking Vit B(6) plus XFZY and the group given prednisone. CONCLUSION: The activating blood circulation to remove stasis approach in treating LSD with integrative Chinese and Western drugs got better results, and metabolic disorder of tryptophan might be correlated with the etiology of LSD.

Study of the effect of leeching on plasma endothelin and soluble interleukin-2 receptor in patients with systemic lupus erythematosus.

OBJECTIVE: to explore the mechanism of leeching in treating systemic lupus erythematosus (SLE). METHODS: Forty-four patients with SLE were randomly divided into conventional corticosteroid treated group (control group, n = 20) and conventional treatment group with leeching intervention added (leeching group, n = 24). Before and after treatment the concentration of plasma endothelin (ET) and soluble interleukin-2 receptor (sIL-2R) were determined. RESULTS: Before treatment the level of plasma ET and sIL-2R in the SLE patients were all higher than those in the normal healthy group, (P < 0.01). But after treatment the level of these in both groups were significantly improved than those of before treatment (P < 0.05), and comparison between these two treated groups showed that the difference between them was significant (P < 0.05). CONCLUSION: Leeching added to conventional treatment of SLE could be more effective in improving the level of plasma ET and sIL-2R, and ameliorating the impairment of renal tissues.

Peritoneal taurolidine lavage in children with localised peritonitis due to appendicitis.

Despite aggressive surgical treatment, rational antibiotic therapy, and modern intensive care, generalised peritonitis remains a major threat in the paediatric age group. Several adjuvant strategies such as peritoneal saline lavage and peritoneal drainage have been utilised. Taurolidine, derived from the amino acid taurine, has bactericidic, antiendotoxic, and antiinflammatory properties. It has been introduced previously for intraoperative peritoneal lavage in treating peritonitis in adults. The aim of our study was to evaluate the effect of peritoneal taurolidine lavage on the clinical course and serological inflammation markers in children with perforated appendicitis and localised peritonitis. A series of 27 children presenting with appendicitis between January 1999 and July 2001 were included in the study after parental informed consent. All patients underwent open appendectomy. Taurolidine peritoneal lavage was applied in 15 randomly selected children (eight girls and seven boys; mean age 10 years and 10 months). Twelve children received saline peritoneal lavage and served as the control group (six girls and six boys; mean age 9 years and 7 months). Blood was taken preoperatively and on postoperative days 1, 3, 7, and 14. Full blood cell count, C-reactive protein, endotoxin, interleukin-1, interleukin-6, soluble interleukin-2 receptor, tumour necrosis factor alpha, and procalcitonin were investigated to evaluate the serological course of inflammation. Both groups initially presented with severe inflammation as evidenced clinically and serologically. The clinical postoperative course was uneventful in 13/15 patients in the treatment group and 10/12 patients in the control group. The remaining patients presented complications: intraperitoneal abscess or early postoperative bowel obstruction. With regard to the serological inflammatory parameters, no significant differences were found between the two groups except for the soluble interleukin-2-receptor on the 7th postoperative day. In conclusion, the expected reduction of endotoxin levels and inflammatory activity in the treatment group was not evident. A significant advantage of adjuvant peritoneal taurolidine lavage in the surgical therapy of children with localised peritonitis due to appendicitis could not be shown in our study.

Immunomodulatory effects of blood letting cupping therapy in patients with rheumatoid arthritis.

This study was carried out in order to evaluate the efficiency of blood-letting cupping (BLC) therapy as a complementary therapy in management of rheumatoid arthritis (RA) and to investigate its modulatory effects on natural killer cells (NK) and soluble interleukin-2 receptor (SIL-2R). Two groups of RA patients diagnosed according to American Rheumatology Association were included: Group I included 20 patients who received the conventional medicinal therapy of RA, Group II included 30 patients who received combined conventional and BLC therapy. Ten age and sex matched normal controls were also included, as group III. Visual analogue score (VAS), tender joint count (TJC), swollen joint count (SJC), disease activity scores (DAS), laboratory markers of disease activity [erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Rheumatoid factor (RF)] were evaluated on 3 successive months, NK cell (%) measured by flowcytometry and SIL-2R concentrations measured by ELISA were also assessed. After one month of combined therapy there was significant (P < 0.001) reduction in VAS (5.16 +/- 0.28), TJC (11.62 +/- 1.03), SJC (10.13 +/- 1.02) and DAS (5.35 +/- 0.14). Early and marked reductions in laboratory markers of disease activity (26.90 +/- 3.68) for CRP, (51.46 +/- 6.06) for RF and (40.56 +/-3.36) for ESR were also detected as compared to base line, while the effects of conventional therapy appeared late after 3 months of treatment. Conventional therapy induced significant depression in white blood cell (WBC %) (p < 0.001) whereas combined therapy induced marked (p < 0.001) elevation since the first month (8.44 +/- 1.58) compared to base line (6.94 +/- 1.58). There was a significant (P < 0.05) lowering in NK cell (%) with conventional therapy while combined therapy induced significant (P < 0.001) increase (11.33 +/- 0.4.7) compared to base line level (8.50 +/- 0.46). Additionally, combined therapy resulted in marked reduction (P < 0.001) in SIL-2R conc. after 3 months of treatment (1790 +/- 68.11) compared to base line (2023 +/- 92.95), while insignificant reduction was detected with the conventional therapy. The improvement rate (%) of clinical, laboratory cellular & immunological parameters were significantly higher with combined therapy than with conventional therapy. Moreover, strong positive correlations (p < 0.0001) were detected between SIL-R conc. and clinical parameters VAS (r = 0.890), TJC (r = 0.905), SJC (r = 0.872) and DAS (r = 0.923) and also between SIL-R conc. and ESR (r = 0.973), CRP (r = 0.933), RF (r = 0.941), while a strong negative correlation was found with NK count cell % (r = 0.927). In conclusion, BLC therapy combined with conventional therapy may improve the clinical condition of patients with RA. It has modulatory effects on the innate (NK %) and adaptive cellular (SIL-2R conc.) immune responses that could be used as monitoring tools for disease activity and prognosis.