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PubMed1995

Respiratory protection and the risk of Mycobacterium tuberculosis infection.

Tuberculosis (TB) can be transmitted to susceptible healthcare workers via inhalation of droplet nuclei carrying viable Mycobacterium tuberculosis bacilli. Several types of respiratory protective devices are compared with respect to efficacy against droplet nuclei penetration: surgical masks, disposable dust/mist particulate respirators (PRs), elastomeric halfmask respirators with high-efficiency (HEPA) filters, and powered air-purifying respirators (PAPRs) with elastomeric halfmask facepieces and HEPA filters. It is estimated that these devices permit, respectively, 42%, 5.7%, 2%, and 0.39% penetration of droplet nuclei into the facepiece. More limited data for the disposable HEPA filtering-facepiece respirator suggest that it would allow droplet nuclei penetration of 3% or less, similar to the value estimated for the elastomeric halfmask HEPA filter respirator. Because a respirator wearer's cumulative infection risk depends on the extent of droplet nuclei penetration, the cumulative risk will differ, given use of these different respirators. Hypothetical but realistic "low-exposure" and "high-exposure" scenarios are posed that involve, respectively, a 1.6% and a 6.4% annual risk of infection for healthcare workers. For the low-exposure scenario, the 10-year cumulative risks given no respirators versus surgical masks versus disposable dust/mist PRs versus elastomeric halfmask HEPA filter respirators versus HEPA filter PAPRs are, respectively, 15%, 6.7%, 0.94%, 0.33%, and .064%. For the high-exposure scenario, the 10-year cumulative risks for no respirator use versus use of the same four types of respirators are, respectively, 48%, 24%, 3.7%, 1.3%, and 0.26%. The use of disposable HEPA filtering-facepiece respirator should permit cumulative risks close to those estimated for the elastomeric halfmask HEPA filter respirator. It is concluded that when an infectious TB patient undergoes a procedure that generates respiratory aerosols, and when droplet nuclei source control is inadequate, healthcare workers attending the patient may need to wear highly protective respirators, such as HEPA filter PAPRs.

Aerosols↗
PubMed2002

De novo interstitial direct duplication 1(q23.1q31.1) in a fetus with Pierre Robin sequence and camptodactyly.

Interstitial duplications of chromosomal region 1q are rarely seen. We report the first prenatal diagnosis of pure partial trisomy 1q. The fetus was karyotyped for polyhydramnios, micrognathia, and flexion of fingers of both hands. Conventional and molecular cytogenetics showed a de novo direct duplication of the chromosomal region 1q23.1q31.1 leading to a partial trisomy 1q. At autopsy, the fetus showed Pierre Robin sequence (PRS) and camptodactyly. The main histological finding was a decreased number of motoneurons with apoptotic features in the anterior horn of the spinal cord. A literature review and our observations suggest that genetic material mapping to chromosome 1q25 could be responsible for PRS with distal arthrogryposis when this is in triple dose.

Chromosome Aberrations↗
PubMed2006

Low vitamin K status is associated with osteoarthritis in the hand and knee.

OBJECTIVE: Poor intake of vitamin K is common. Insufficient vitamin K can result in abnormal cartilage and bone mineralization. Furthermore, osteophyte growth, seen in osteoarthritis (OA), may be a vitamin K-dependent process. We undertook this study to determine whether vitamin K deficiency is associated with radiographic features of OA. METHODS: We conducted an analysis among 672 participants (mean age 65.6 years, 358 women) in the Framingham Offspring Study, a population-based prospective observational cohort. Levels of plasma phylloquinone (the primary form of vitamin K) had previously been measured in these participants, for whom we also had bilateral hand and knee radiographs. The main outcomes were 1) prevalence ratios (PRs) of OA, osteophytes, and joint space narrowing (JSN) per quartile of plasma phylloquinone level for each joint, adjusting for correlated joints using generalized estimating equations, and 2) adjusted mean number of joints with each feature per quartile of plasma phylloquinone level. Analyses were conducted in hands and knees separately and adjusted for age, sex, body mass index, total energy intake, plasma vitamin D, and femoral neck bone mineral density. RESULTS: The PRs for OA, osteophytes, and JSN and adjusted mean number of joints with all 3 features in the hand decreased significantly with increasing plasma phylloquinone levels (P<or=0.03 for all). For example, as plasma phylloquinone levels rose, the PR for hand OA decreased from 1.0 to 0.7 (P=0.005). For the knee, only the PR for osteophytes and the adjusted mean number of knee joints with osteophytes decreased significantly with increasing plasma phylloquinone levels (PR decreased from 1.0 to 0.6, P=0.01). CONCLUSION: These observational data support the hypothesis of an association between low plasma levels of vitamin K and increased prevalence of OA manifestations in the hand and knee.

Adult↗
PubMed2003

Phase III trial of gemcitabine and carboplatin versus mitomycin, ifosfamide, and cisplatin or mitomycin, vinblastine, and cisplatin in patients with advanced nonsmall cell lung carcinoma.

BACKGROUND: The authors compared gemcitabine and carboplatin (GC) with mitomycin, ifosfamide, and cisplatin (MIC) or mitomycin, vinblastine, and cisplatin (MVP) in patients with advanced nonsmall cell lung carcinoma (NSCLC). The primary objective was survival. Secondary objectives were time to disease progression, response rates, evaluation of toxicity, disease-related symptoms, World Health Organization performance status (PS), and quality of life (QoL). METHODS: Three hundred seventy-two chemotherapy-naïve patients with International Staging System Stage III/IV NSCLC who were ineligible for curative radiotherapy or surgery were randomized to receive either 4 cycles of gemcitabine (1000 mg/m(2) on Days 1, 8, and 15) plus carboplatin (area under the serum concentration-time curve, 5; given on Day 1) every 4 weeks (the GC arm) or MIC/MVP every 3 weeks (the MIC/MVP arm). RESULTS: There was no significant difference in median survival (248 days in the MIC/MVP arm vs. 236 days in the GC arm) or time to progression (225 days in the MIC/MVP arm vs. 218 days in the GC arm) between the 2 treatment arms. The 2-year survival rate was 11.8% in the MIC/MVP arm and 6.9% in the GC arm. The 1-year survival rate was 32.5% in the MIC/MVP arm and 33.2% in the GC arm. In the MIC/MVP arm, 33% of patients responded (4 complete responses [CRs] and 57 partial responses [PRs]) whereas in the GC arm, 30% of patients responded (3 CRs and 54 PRs). Nonhematologic toxicity was comparable for patients with Grade 3-4 symptoms, except there was more alopecia among patients in the MIC/MVP arm. GC appeared to produce more hematologic toxicity and necessitated more transfusions. There was no difference in performance status, disease-related symptoms, or QoL between patients in the two treatment arms. Fewer inpatient stays for complications were required with GC. CONCLUSIONS: The results of the current study failed to demonstrate any difference in efficacy between the newer regimen of GC and the older regimens of MIC and MVP. Cancer 2003;98:542-53.

Adenocarcinoma↗
PubMed2004

Interferon-alpha-2a with or without 13-cis retinoic acid in patients with progressive, measurable metastatic renal cell carcinoma.

BACKGROUND: In patients with metastatic renal cell carcinoma (MRCC), interferon-alpha (IFN) monotherapy leads to response rates of 5-15%, dependent on the selection of patients. In 1995, preclinical and clinical data indicated an improvement of these results if IFN was combined with 13-cis retinoic acid (CRA). METHODS: In a randomized Phase II study, patients with measurable MRCC received either subcutaneous IFN (9 MU daily; Arm A) or the same daily subcutaneous dose of IFN plus oral CRA (1 mg/kg; Arm B). A central expert panel reviewed the X-ray documentation of objective responses. RESULTS: In the 50 eligible patients from Arm A, the objective, expert-reviewed response rate was 6% (95% confidence interval [95% CI], 1.3-16.6%; 2 complete responses [CRs] and 1 partial response [PR]). A 19% response rate (95% CI, 9.4-32.0%) was stated for 53 eligible patients from Arm B (2 CRs and 8 PRs). Only one of the four CRs claimed by the clinical investigator was confirmed by the central review committee. Conversely, the expert committee deemed that 3 of 12 investigator-stated PRs were CRs. Constitutional toxicity (flu-like symptoms) and/or side effects from skin, mucosa, or eyes led to discontinuation of treatment in 22% of nonprogressing patients, more often in Arm B than in Arm A. CONCLUSIONS: The results from this randomized Phase II study support expansion of the trial into a Phase III study to evaluate the effect of IFN-CRA combination therapy on the survival of patients who undergo nephrectomy prior to IFN-based immunotherapy. The considerable interobserver variability of response evaluation (individual investigator vs. expert panel) indicates the necessity of a central review of claimed responses in future Phase II studies involving patients with MRCC.

Adult↗
PubMed1991

A phase II pilot study of the combined application of hyperthermia and intra-hepato-arterial chemotherapy using cisplatinum and 5-fluorouracil.

Fourteen patients (group A) with unresectable metastasis to the liver from colorectal cancers (11 patients) and gastric cancers (3 patients) were treated with the combined application of hyperthermia and intra-hepato-arterial (IHA) chemotherapy with cisplatinum and 5-fluorouracil. Ten patients were treated with regional hyperthermia applied with a radiofrequency capacitive heating system and four patients were treated with total-body hyperthermia concurrently with IHA chemotherapy. Thirty-one patients (group B) with liver metastases from colorectal and gastric cancers received only IHA chemotherapy with the same chemotherapeutic regimen. In group B, partial responses (PRs) were obtained in 8 of 17 evaluable patients with colorectal cancer and in 1 of 10 evaluable patients with gastric cancer. In group A, PRs were found in 6 of 11 patients with colorectal cancer and in 2 of 3 patients with gastric cancer. Furthermore, improvements due to the combination of chemotherapy with hyperthermia were noted in 3 of 6 patients with colorectal cancer who had received unsuccessful prior IHA chemotherapy. The 50% survival period was prolonged to 23 months in group A from 11 months in group B, for patients with colorectal cancer. Toxicity of IHA chemotherapy was not potentiated by combination with hyperthermia. These results indicate that the combination of hyperthermia with IHA chemotherapy has a therapeutic benefit in the treatment of unresectable metastatic liver tumors derived from colorectal and gastric cancers.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1991

Comparative analysis of the sequences and structures of HIV-1 and HIV-2 proteases.

The different isolates available for HIV-1 and HIV-2 were compared for the region of the protease (PR) sequence, and the variations in amino acids were analyzed with respect to the crystal structure of HIV-1 PR with inhibitor. Based on the extensive homology (39 identical out of 99 residues), models were built of the HIV-2 PR complexed with two different aspartic protease inhibitors, acetylpepstatin and a renin inhibitor, H-261. Comparison of the HIV-1 PR crystal structure and the HIV-2 PR model structure and the analysis of the changes found in different isolates showed that correlated substitutions occur in the hydrophobic interior of the molecule and at surface residues involved in ionic or hydrogen bond interactions. The substrate binding residues of HIV-1 and HIV-2 PRs show conservative substitutions of four residues. The difference in affinity of HIV-1 and HIV-2 PRs for the two inhibitors appears to be due in part to the change of Val 32 in HIV-1 PR to Ile in HIV-2 PR.

Amino Acid Sequence↗
PubMed2000

Cleavage of vimentin by different retroviral proteases.

Proteases (PRs) of retroviruses cleave viral polyproteins into their mature structural proteins and replication enzymes. Besides this essential role in the replication cycle of retroviruses, PRs also cleave a variety of host cell proteins. We have analyzed the in vitro cleavage of mouse vimentin by proteases of human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2), bovine leukemia virus (BLV), Mason-Pfizer monkey virus (M-PMV), myeloblastosis-associated virus (MAV), and two active-site mutants of MAV PR. Retroviral proteases display significant differences in specificity requirements. Here, we show a comparison of substrate specificities of several retroviral proteases on vimentin as a substrate. Vimentin was cleaved by all the proteases at different sites and with different rates. The results show that the physiologically important cellular protein vimentin can be degraded by different retroviral proteases.

Animals↗
PubMed2001

The clinical utility of liposomal doxorubicin in recurrent ovarian cancer.

OBJECTIVES: The aim of this study was to determine the efficacy and toxicity of single agent off-protocol, liposomal doxorubicin (Doxil Alza), in consecutive patients with recurrent ovarian cancer and to investigate the influence of HER-2/neu expression on response to liposomal doxorubicin. PATIENTS AND METHODS: Retrospective analysis of 72 consecutive patients treated, typically with liposomal doxorubicin 40 mg/m(2) q28 days between January 1997 and December 1998. Results. Twenty-nine patients (40%) had platinum- and taxane-resistant tumors. Nineteen patients (27%) responded with clinical or radiological evidence of response with reduction in CA-125 of >50%. One complete response (CR) and 7 partial responses (PRs) occurred in platinum- and taxane-resistant patients (radiological response (RR) 29%) and 8 PRs occurred in patients with visceral metastases (RR 28%). Time to progression was 5.3 (2.1-12.1) months. Only 7 dose delays (3%) and 20 dose reductions (8%) were necessary in 265 cycles of treatment. Hematological toxicity was generally mild with grade (Gr) > or =III neutropenia in 1 (2%), Gr > or =III thrombocytopenia in 1 (1%), and Gr > or =III anemia in 8 patients (11%). One patient (1%) was admitted with fever and neutropenia. Other toxicity was minimal with Gr > or =III mucositis occurring in 3 patients (4%). Gr > or =III cutaneous toxicity was seen in 6 patients (8%). Three patients (4%) had a >10% fall in ejection fraction but there was no unequivocal clinical heart failure. CONCLUSIONS: The data suggest that liposomal doxorubicin is an active drug in both taxane- and platinum-sensitive and resistant recurrent ovarian cancer. Liposomal doxorubicin is associated with tolerable toxicity and is particularly well tolerated in patients with multiple prior lines of treatment.

Adult↗
PubMed2001

Ligand-independent activation of progestin receptors in sexual receptivity.

Ovarian steroid hormones, estradiol and progesterone, regulate cellular functions in the central nervous system, resulting in the alterations in physiology and reproductive behavior. One means by which steroid hormones exert their neural effects on reproductive behavior is via their intracellular receptors functioning as ligand-dependent transcription factors. Studies from our laboratory in the past few years have shown that in addition to their cognate ligands, neurotransmitters like dopamine can activate intracellular steroid receptors in a ligand-independent manner. Using biochemical and molecular approaches we have demonstrated that the effects of neurotransmitter dopamine, on reproductive behavior in female rats and mice, occur by means of cross talk between membrane receptors for dopamine and intracellular progestin receptors (PRs). In this article, our studies on the integration of intracellular signaling pathways leading to the activation of PRs and its impact on modulation of reproductive behavior are summarized.

Animals↗
PubMed1991

A gene coding for a basic pathogenesis-related (PR-like) protein from Zea mays. Molecular cloning and induction by a fungus (Fusarium moniliforme) in germinating maize seeds.

Pathogenesis-related proteins (PRs) are plant proteins produced in leaves in response to infection by pathogens including viruses, viroids, fungi and bacteria. Information on the presence and/or expression of PRs in monocotyledonous plants is scare. Here we report the identification of cDNA and genomic clones coding for a basic form of a protein from germinating maize seeds having a high homology with the group of PR-1 from tobacco. A cDNA library enriched in aleurone-specific sequences was prepared from maize seeds two days after germination. One clone was found to contain an open reading frame encoding a protein homologous to PR proteins from tomato (p14) and tobacco (PR-1 group). Sequence analysis of the corresponding genomic clone revealed that it was encoded by a single exon. Besides, DNA blot hybridization indicates that this PR-like protein is encoded by a single-copy gene in maize. The accumulation of its mRNA increases after rehydration of desiccated seeds. Furthermore, a relationship was found between its expression and infection by a natural pathogen of maize, the fungus Fusarium moniliforme. The possible role of this protein as a response mechanism following fungal infection in cereal seeds is discussed.

Amino Acid Sequence↗
PubMed1985

A phase II study of mitoxantrone in acute leukemia.

A phase II study of mitoxantrone (Novantrone; dihydroxyanthracenedione) was conducted in 35 patients (22 male: 13 female) with acute leukemia. There were 35 evaluable cases with a mean age of 34 (range 8-61). Twenty-eight patients had acute non-lymphocytic leukemia (ANLL) and seven had acute lymphocytic leukemia (ALL). Mitoxantrone was administered intravenously 2-4 mg/m2 daily for five days and after the nadir a further 2-3 doses were added if necessary. All previously treated cases (22 patients) had been treated with anthracyclines; 13 had no previous treatment. Out of the 13 untreated cases there were six complete remissions (CRs) (46.2%) and five partial remissions (PRs) (38.5%), while out of 22 pretreated cases, four CRs (18.2%) and five PRs (22.7%) were obtained. In seven of the untreated cases the decrease of leukemic cells and neutrophil leukocytes were analysed. Mitoxantrone showed a longer duration of decrease and higher log decrease of leukemic cells in the bone marrow than daunorubicin or cytosine arabinoside. Seventy-three percent of patients showed gastrointestinal disturbances such as nausea or loss of appetite. In 38.1% SGPT elevation and in 8.8% abnormal ECG findings were observed. All side-effects were mild and reversible. From this data mitoxantrone seems a very promising agent in the treatment of acute leukemia and a phase III study is now being carried out.

Aclarubicin↗
PubMed1992

Combination chemotherapy for advanced urothelial-tract carcinoma.

Between December 1982 and November 1990, 31 patients with advanced urothelial carcinoma were treated with one of two combination chemotherapy regimens. A total of 20 patients were treated with 3 mg/m2 mitomycin C and 300 mg/m2 cyclophosphamide given intravenously every 10-14 days and with 180 mg/m2 5-fluorouracil (5-FU) given intravenously every day for as long as possible (CF-Mito regimen). After the patient had been discharged from the hospital, the same treatment with CF-Mito was performed except that 180 mg/m2 5-FU was replaced by 400 mg/m2 UFT (a mixture of tegafur and uracil) given orally. A total of 11 patients whose tumor had relapsed during the first-line treatment were given 60 mg/m2 cisplatin, 40 mg/m2 Adriamycin, and 40 mg/m2 methotrexate intravenously every 28 days (PAM regimen). In all, 20 patients received 4-44 (mean, 9.7) courses of CF-Mito over a period of 1.5-24 (mean, 5.3) months. The results obtained in these 20 patients with evaluable lesions included no complete remission (CR), 4 partial remissions (PRs), 9 cases of stable disease (SD), and 7 cases of progressive disease (PD). The PR duration was 1.5-22 (mean, 7.5) months. The side effects encountered in this group included anorexia, nausea, vomiting, myelosuppression, diarrhea, stomatitis, liver damage, and heart failure. In all, 11 patients received 3-7 (mean, 4.1) courses of PAM over a period of 3-14.5 (mean, 5.2) months. All 11 patients had evaluable lesions, and their responses included no CR, 5 PRs, 3 cases of SD, and 3 cases of PD. The PR duration was 1-3 (mean, 1.6) months. The side effects encountered in this group included anorexia, nausea, vomiting, myelosuppression, heart failure, and hair loss.

Adult↗
PubMed1989

A phase II study of carboplatin and vincristine in previously treated patients with small-cell lung cancer.

A total of 28 previously treated patients with small-cell lung cancer were treated at relapse with 400 mg/m2 carboplatin and 2 mg vincristine on days 1 and 8, every 4 weeks. Ten partial responses (PRs) (37%) but no complete responses (CRs) were seen. Median survival after the start of second-line treatment was 120 days (range, 39-503 days). Toxicity of this regimen was moderate, including WHO grade 3/4 myelosuppression in 26% of courses (n = 66). Eight PRs were seen in a subgroup of 22 patients who relapsed less than 3 months after first-line treatment. The responses seen in this group of patients may be due to the absence of cross-resistance between the regimens used.

Aged↗
PubMed1976

Control of mineralocorticoid substitution in Addison's disease by plasma renin measurement.

In 7 out-patients with Addison's disease, plasma renin activity (PRA), plasma concentrations of angiotensin II (AT II), renin substrate (PRS), potassium, sodium and total protein, hematocrit, blood pressure, heart rate and body weight were studied after 2 weeks each on 2 mg of dexamethasone, 25 mg hydrocortisone (HC), 25 mg HC + 0.05 mg 9-alpha-fluorohydrocortisone (FC), 25 mg HC + 0.1 mg FC and 25 mg HC + 0.2 MG FC. Four further patients were less extensively studied. Mean PRA (upper normal limit, ambulatory: 12 ng AT I-ml-1-h-1) after the 5 steps of incremental substitution, starting with dexamethasone, was 192, 59, 38, 24 and 9 ng AT I-ml-1-h-1 rsp. PRS did not change with increasing substitution. PRA and AT II were significantly correlated (r = 0.91; p less than 0.0001) and proved to be the most sensitive parameters of insufficient mineralocorticoid substitution. With decreasing significance, PRA also correlated with plasma protein concentration, plasma sodium concentration (negative), delta body weight (negative), heart rate, delta mean blood pressure (negative) and plasma potassium concentration. PRA or AT II measurements are useful clinical tools to control mineralocorticoid substitution in Addisonian patients. Inappropriately high substitution can be prevented by keeping PRA in the upper normal range.

Addison Disease↗
PubMed1997

Thallium-201 single-photon emission tomography in the treatment follow-up of nasopharyngeal carcinoma.

In order to assess the usefulness of thallium-201 single-photon emission tomography (SPET) in the treatment follow-up of nasopharyngeal carcinoma (NPC), a total of 75 201T1 SPET studies were performed in 18 patients with histologically proven NPC. The findings were compared with those of magnetic resonance imaging (MRI) before and after therapy. Four patients received radiotherapy alone while the other 14 received concurrent chemo-radiotherapy. Treatment response was classified as complete (CR) or partial (PR) based on the findings of MRI and 201T1 SPET. Intense 201T1 uptake by the tumour was seen in all 18 patients before treatment. After treatment, MRI showed seven CRs and 11 PRs, whereas 201T1 SPET showed 13 CRs and five PRs. In 12 patients, the results of 201T1 SPET were in agreement with those of MRI. In six patients MRI showed PR but 201T1 showed CR. Follow-up (mean 10.6 months) MRI and 201T1 SPET studies of these six patients revealed that tumour gradually decreased and finally vanished in three patients. This preliminary study indicates that 201T1 SPET has potential in the assessment of early response to treatment of patients with NPC when compared with MRI.

Carcinoma↗
PubMed1991

A phase I/II study of high-dose megestrol acetate in the treatment of metastatic breast cancer.

A dose-response relationship has been suggested for medroxyprogesterone acetate in the treatment of advanced breast cancer. To determine the tolerability and efficacy of increasing doses of megestrol acetate in the treatment of metastatic breast cancer, we conducted a phase I/II study among 57 patients. Three patients each received 480, 800, and 1280 mg/d; 48 patients received 1600 mg/d. Of the 57 patients, 56 patients had had disease progression on prior hormone therapy, chemotherapy, or both. Twenty-seven patients had previously received standard-dose MA (160 mg/d). Among the 37 patients with measurable disease, high-dose megestrol acetate (HDMA) produced 6 (16%) complete responses (CRs) and 6 (16%) partial responses (PRs); 11 patients achieved stable disease (SD). HDMA resulted in improvement or stabilization in 12 of the 20 patients with evaluable, non-measurable disease. There were no responses among the 6 patients with liver metastases. Among the 27 patients who were previously treated with standard-dose MA, including 9 patients with primary treatment failure, HDMA resulted in 1 CR, 3 PRs, and 10 SD. Toxicities, which were mild and reversible, included fluid retention, hypertension, hyperglycemia, and mild congestive heart failure. Two patients had superficial phlebitis. The most profound side effect was weight gain which occurred in 43 patients (75%). This study suggests a dose-response relationship for MA in the treatment of advanced breast cancer. A randomized trial to determine the optimal dose is ongoing.

Adult↗
PubMed1994

Patient Rejection Scale: correlations with symptoms, social disability and number of rehospitalizations.

The Patient Rejection Scale (RPS), which was developed to assess rejecting attitudes and feelings of relatives toward mental patients, was administered to a German sample of 44 family members or significant others living with first-admitted schizophrenics. Both at admission (t0) and 6 months later (t6), the PRS was significantly correlated with the number of rehospitalizations during the first 3 years after admission. In comparison, the association between PRS scores and different measures of psychopathology during the 2-year follow-up period was weak. Thus, rejecting attitudes of patients' relatives seem to imply a higher risk of relapse without substantial medication by symptoms. We suspect that relatives with rejecting attitudes towards a patient might tend to apply for readmission more easily than more accepting relatives.

Adolescent↗