We conducted a prospective study to assess the non-inferiority of adjuvant chemotherapy alone versus adjuvant concurrent chemoradiotherapy (CCRT) as an alternative strategy for patients with early-stage (FIGO 2009 stage IB-IIA) cervical cancer having risk factors after surgery. The condition was assessed in terms of prognosis, adverse effects, and quality of life. This randomized trial involved nine centers across China. Eligible patients were randomized to receive adjuvant chemotherapy or CCRT after surgery. The primary end-point was progression-free survival (PFS). From December 2012 to December 2014, 337 patients were subjected to randomization. Final analysis included 329 patients, including 165 in the adjuvant chemotherapy group and 164 in the adjuvant CCRT group. The median follow-up was 72.1 months. The three-year PFS rates were both 91.9%, and the five-year OS was 90.6% versus 90.0% in adjuvant chemotherapy and CCRT groups, respectively. No significant differences were observed in the PFS or OS between groups. The adjusted HR for PFS was 0.854 (95% confidence interval 0.415-1.757; P = 0.667) favoring adjuvant chemotherapy, excluding the predefined non-inferiority boundary of 1.9. The chemotherapy group showed a tendency toward good quality of life. In comparison with post-operative adjuvant CCRT, adjuvant chemotherapy treatment showed non-inferior efficacy in patients with early-stage cervical cancer having pathological risk factors. Adjuvant chemotherapy alone is a favorable alternative post-operative treatment.
Female ; Humans ; Uterine Cervical Neoplasms/drug therapy* ; Prospective Studies ; Quality of Life ; Neoplasm Staging ; Chemoradiotherapy ; Chemotherapy, Adjuvant/adverse effects* ; Adjuvants, Immunologic ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Retrospective Studies

Bacillus Calmette-Guérin (BCG) is a live vaccine and has the potential to cause local disease and systemic dissemination in immunocompromised hosts, including infants who are infected with human immunodeficiency virus (HIV) through vertical transmission, and patients with primary immunodeficiencies (PID) such as severe combined immunodeficiency (SCID), chronic granulomatous disease (CGD), hyper-IgM syndrome, and defects of the IL12- IFNγ axis (Mendelian susceptibility to mycobacterial diseases, MSMD). Disseminated BCG is extremely difficult to treat. The chance of complete eradication is low unless functional immune response is restored by haematopoietic stem cell transplant. Prolonged use of anti-mycobacterial drugs often causes organ toxicities and drug resistance. Inflammatory complications which develop upon immunoreconstitution post-transplant may necessitate immunosuppressive treatment, which adversely affect immune recovery and increases risks of opportunistic infections. Multiple BCG reactivations can occur in patients with CGD and MSMD, and BCG can remain latent until reactivations take place in adulthood and manifest as disease. It is important for neonatologists, general practitioners, primary care clinicians and nurses working in maternal and child care centres to be aware of BCG-related complications, which may be the first sign of an underlying immunodeficiency. As neonatal BCG is included in standard vaccination schedule in many countries, it is a challenge to identify and avoid administration of BCG to infants who potentially have PIDs. Deferring BCG vaccination is recently advocated to protect highly vulnerable populations, but the appropriate strategy is yet to be determined. Newborn screening for SCID offers a potential to avoid this complication, if an integrated system of screening and vaccination can be organised.
Adjuvants, Immunologic ; adverse effects ; therapeutic use ; BCG Vaccine ; adverse effects ; immunology ; therapeutic use ; Humans ; Immunologic Deficiency Syndromes ; diagnosis ; immunology ; Infant, Newborn ; Mycobacterium Infections ; prevention & control ; Mycobacterium bovis ; drug effects ; Neonatal Screening ; methods ; Risk Assessment ; Vaccination ; adverse effects ; methods

Globally, about 70% of cervical cancers are associated with human papillomavirus (HPV)-16 or HPV-18 infection. A meta-analysis of epidemiologic studies in China showed that HPV was present in 98% of cervical cancer samples. The HPV-16/18 AS04-adjuvanted vaccine Cervarix has shown a high level of protection against HPV-16/18 infections and associated cervical lesions. This phase I trial (NCT00549900) assessed the safety, tolerability, and immunogenicity of the vaccine in Chinese. Thirty healthy Chinese females, aged 15 to 45 years with a median age of 29.5 years, received three doses of Cervarix in Months 0, 1, and 6. Safety was assessed via recording solicited local and systemic symptoms within 7 days and unsolicited symptoms within 30 days after each vaccination. Serious adverse events, new onset of chronic diseases, and other medically significant conditions were recorded throughout this trial. As an exploratory objective, HPV-16/18 antibody titers were determined by enzyme-linked immunosorbent assay in serum samples collected in Months 0 and 7. Pain at the injection site was the most frequently reported local symptom. Two subjects reported medically significant adverse events. Both cases were assessed as unrelated to vaccination by the investigator. In Month 7, 100% seroconversion was observed for both anti-HPV-16 and anti-HPV-18 with high geometric mean antibody titers. HPV-16/18 AS04-adjuvanted vaccine, evaluated for the first time in Chinese females, was generally well tolerated and immunogenic, as previously shown in global studies.
Adjuvants, Immunologic ; Adolescent ; Adult ; Antibodies, Viral ; blood ; Asian Continental Ancestry Group ; China ; Female ; Human papillomavirus 16 ; immunology ; Human papillomavirus 18 ; immunology ; Humans ; Middle Aged ; Papillomavirus Infections ; immunology ; prevention & control ; virology ; Papillomavirus Vaccines ; administration & dosage ; adverse effects ; therapeutic use ; Uterine Cervical Neoplasms ; immunology ; prevention & control ; virology ; Young Adult

OBJECTIVETo evaluate the efficacy and safety of high doses of thymopentin (10 mg/d) combined with transartery chemoembolization for primary liver cancer.

METHODSFifty primary liver cancer patients were randomly divided into two groups: therapeutic and control group, and all were treated with transfemoral artery chemoembolization (TACE) with oxaliplatin 150 mg, pharmorubicin 50 mg, 5-Fu 750 mg, CF 300 mg and lipiodol 20 ml. Therapeutic group (25) were added 10 mg thymopentin daily after TACE: i.v. on dl - d5, and im on D6 - D21.

RESULTSThere was a significant difference in adverse effect and toxicity such as naupathia,fever, swirl, asthenia observed between two groups (P < 0.05). No difference in either pre- or post-chemotherapy peripheral blood examination and biochemical assay was found between two groups (P > 0.05). In control group, CD4+ cell was 37.92% +/- 8.71% in pre-treatment, which decreased to 29.16% +/- 8.21% in post-treatment with a significant difference (P < 0.01), whereas there was no evident difference in CD4+ cell between pre-treatment and post-treatment in the treatment group.

CONCLUSIONTransartery chemoembolization combined with high dose of thymopentin in the treatment for primary liver cancer is effective and safe, and can significantly improve the immune function and the chemotherapy tolerance.

Adjuvants, Immunologic ; adverse effects ; therapeutic use ; Adult ; Aged ; Asthenia ; chemically induced ; CD4-Positive T-Lymphocytes ; Chemoembolization, Therapeutic ; Combined Modality Therapy ; Disease-Free Survival ; Epirubicin ; administration & dosage ; Female ; Fever ; chemically induced ; Fluorouracil ; administration & dosage ; Humans ; Iodized Oil ; administration & dosage ; Liver Neoplasms ; therapy ; Lymphocyte Count ; Male ; Middle Aged ; Nausea ; chemically induced ; Organoplatinum Compounds ; administration & dosage ; Remission Induction ; Survival Rate ; Thymopentin ; administration & dosage ; adverse effects ; therapeutic use

Adjuvants, Immunologic ; adverse effects ; therapeutic use ; Azathioprine ; adverse effects ; therapeutic use ; Cyclosporine ; adverse effects ; therapeutic use ; Glucocorticoids ; adverse effects ; therapeutic use ; Humans ; Mycophenolic Acid ; adverse effects ; analogs & derivatives ; therapeutic use ; Tacrolimus ; adverse effects ; therapeutic use

OBJECTIVETo evaluate of therapeutic efficacy of deoxyribouncleotidum on pulmonary tuberculosis.

METHODSEighty patients with pulmonary tuberculosis sustaining hepatic lesion after treatment with antituberculosis drugs were randomized into therapeutic group and control group. Patients in the control group received regular treatment and those in the therapeutic group had additional deoxyribouncleotidum injection.

RESULTSALT, AST, ALP and TBIL levels were significantly higher in the therapeutic group than in the control group 4 weeks after treatment. IgG, IgA, IgM levels, and CD3(+) and CD8(+) lymphocytes were significantly increased in the therapeutic group after treatment (P<0.05).

CONCLUSIONdeoxyribouncleotidum can improve hepatic function and immunity in patients with pulmonary tuberculosis.

Adjuvants, Immunologic ; administration & dosage ; therapeutic use ; Adult ; Alanine Transaminase ; metabolism ; Antitubercular Agents ; adverse effects ; therapeutic use ; Aspartate Aminotransferases ; metabolism ; CD3 Complex ; immunology ; CD8-Positive T-Lymphocytes ; cytology ; drug effects ; immunology ; Chemical and Drug Induced Liver Injury ; Deoxyribonucleotides ; administration & dosage ; therapeutic use ; Female ; Humans ; Immunoglobulin A ; blood ; Immunoglobulin G ; blood ; Immunoglobulin M ; blood ; Injections ; Liver Diseases ; blood ; drug therapy ; Male ; Middle Aged ; Treatment Outcome ; Tuberculosis, Pulmonary ; blood ; drug therapy

BACKGROUNDThere has been increasing interest in the research into cytomegalovirus (CMV) pneumonia after liver transplantation (LT). This study was undertaken to investigate the immunomodulatory therapy of CMV pneumonia after LT.

METHODSSix patients with CMV pneumonia after LT from October 2003 to November 2005 were analyzed retrospectively. They were diagnosed according to clinical manifestations, chest X-ray findings and pathogenic changes and given comprehensive therapy including mainly immunomodulation therapy and anti-viral medication. At the early stage of CMV pneumonia, the dose of immunosuppressive agents was decreased or ceased, instead replaced by immunoenhancement therapy. During recovery period from CMV pneumonia, the dose of immunosuppressive agents was given again or enhanced, and immunoenhancement therapy was ceased. The liver function of the patients was monitored closely during the treatment.

RESULTSIn this series, five patients were survived and one died. The liver function of the six patients remained normal during the treatment, and no episode of acute rejection took place.

CONCLUSIONSPoor immunity is the pathogenic basis of CMV pneumonia after LT. At early stage of CMV pneumonia, the immunity of the patients should be enhanced, and during the recovery period from CMV pneumonia, immunosuppressants should be given again but immunoenhancement therapy ceased. Individualized immunomodulatory therapy is essential to the treatment of CMV pneumonia after LT.

Adjuvants, Immunologic ; therapeutic use ; Adult ; Cytomegalovirus Infections ; drug therapy ; immunology ; Humans ; Liver Transplantation ; adverse effects ; immunology ; Lymphocyte Activation ; Male ; Middle Aged ; Pneumonia, Viral ; drug therapy ; immunology

OBJECTIVETo evaluate the preventive and therapeutic effect of thymosin alpha(1) on lung infections in critical patients with tracheotomy.

METHODSForty-two patients were randomly divided into treatment group and control group to receive daily subcutaneous thymosin injection at 11.6 mg and saline of 2 ml for 7 days, respectively.

RESULTSCompared with the control group, the infection rate, white blood cell count, C-reactive protein, tumor necrosis factor-alpha and interleukiu-6 were significantly lower in the treatment group.

CONCLUSIONThymosin alpha(1) can be effective for prevention and treatment of lung infections in critical patients with tracheotomy and may improve the patients' immunity and prognosis.

Adjuvants, Immunologic ; therapeutic use ; Adolescent ; Adult ; Aged ; Brain Injuries ; drug therapy ; surgery ; Cerebral Infarction ; drug therapy ; Critical Illness ; Female ; Humans ; Intensive Care Units ; Male ; Middle Aged ; Pneumonia ; prevention & control ; Thymosin ; analogs & derivatives ; therapeutic use ; Tracheotomy ; adverse effects

OBJECTIVETo study the anti-tumor effect and immune function modulation of Xiaoliu decoction (XLD) and to explore the possible mechanism.

METHODSS180 tumor bearing mice were treated with large or small dose of XLD and cyclophosphamide (CTX) to observe the tumor suppressive rate, lymphocyte transformation rate, natural killer cell (NK) activity, tumor necrosis factor alpha (TNFalpha) level in the mice, as well as the tumor cell apoptosis in vitro.

RESULTSThe tumor suppressive rate of XLD on tumor bearing mice was over 30%. XLD showed obvious trend in enhancing the tumor suppressing rate of chemotherapy, could increase the lymphocyte transformation rate, NK activity, and TNFalpha level. It also could accelerate the tumor cell apoptosis in vitro.

CONCLUSIONXLD has significant anti-tumor effect, it could elevate the immune function or organism and alleviate the chemotherapy induced lowering of immune function.

Adjuvants, Immunologic ; pharmacology ; therapeutic use ; Animals ; Antineoplastic Agents, Phytogenic ; pharmacology ; therapeutic use ; Cyclophosphamide ; adverse effects ; therapeutic use ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; pharmacology ; therapeutic use ; Female ; Killer Cells, Natural ; immunology ; Lymphocyte Activation ; drug effects ; Male ; Mice ; Phytotherapy ; Sarcoma 180 ; drug therapy ; immunology ; Tumor Necrosis Factor-alpha ; analysis

In a patient receiving 5-fluorouracil and levamisole, neurologic deficits suggest the cerebral demyelinating syndrome as a differential diagnosis. The authors report a patient diagnosed as multifocal inflammatory leukoencephalopathy for which thallium-201 ((201)Tl) single photon emission computed tomography (SPECT) and proton magnetic resonance spectroscopy (MRS) were employed as noninvasive diagnostic tools. (201)Tl SPECT study was negative and proton MRS showed an increase of choline and lactate and well preserved N-acetylaspartate. These findings support histopathologic findings of multifocal inflammatory leukoencephalopathy revealing demyelination with relative axonal sparing in the patient.
Adjuvants, Immunologic/adverse effects/therapeutic use ; Antimetabolites, Antineoplastic/adverse effects/therapeutic use ; Aspartic Acid/*analogs & derivatives/metabolism ; Axons/pathology ; Biopsy ; Brain/pathology ; Brain Neoplasms/secondary ; Choline/metabolism ; Colorectal Neoplasms/drug therapy/pathology ; Diagnosis, Differential ; Fluorouracil/adverse effects/therapeutic use ; Human ; Lactic Acid/metabolism ; Leukoencephalopathy, Progressive Multifocal/*diagnosis/etiology ; Levamisole/adverse effects/therapeutic use ; Magnetic Resonance Spectroscopy/*methods ; Male ; Middle Aged ; Neoplasm Metastasis ; Thallium Radioisotopes/*diagnostic use ; Tomography, Emission-Computed, Single-Photon/*methods