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PubMed1994

Absorption of therapeutic drugs by barrier gels in serum separator blood collection tubes. Volume- and time-dependent reduction in total and free drug concentrations.

The stability of seven commonly monitored therapeutic drugs in serum was examined following storage in Vacutainer SST and Corvac serum separator blood collection tubes. Significant decreases (ranging from 5.9% to 64.5%) in the measured concentrations of phenytoin, phenobarbital, lidocaine, quinidine, and carbamazepine were observed, as a function of both time and sample volume, when serum was stored in Vacutainer SST serum separator blood collection tubes. In contrast, measured concentrations of theophylline and salicylate did not change under identical specimen storage conditions. No significant changes in the concentrations of phenytoin, phenobarbital, carbamazepine, theophylline, quinidine, and salicylate were observed when serum was stored in Corvac serum separator blood collection tubes. Only serum lidocaine concentrations decreased (ranging from 31.5% to 72.6%, depending on sample volume) after storage in Corvac tubes for 24 hours. The apparent decreases in serum concentrations of therapeutic drugs in both Vacutainer SST and Corvac tubes were most pronounced when small volumes (200-500 microL) of serum remained in contact with the barrier gels for prolonged periods of time (> 2-6 hours). These decreases were due to absorption of drugs by the barrier gels, as demonstrated by the recovery of drugs following chemical extraction of the barrier gels with methanol. For phenytoin and phenobarbital, the reduction in total drug concentrations also resulted in a proportional decrease in free drug concentrations and was dependent on the extent of protein binding by the drug. None of the therapeutic drugs used in this study were adversely affected by prolonged storage in standard red top Vacutainer blood collection tubes without barrier gels. The data suggest that serum separator blood collection tubes should be used with extreme caution for therapeutic drug monitoring, particularly when reduced sample volumes or prolonged specimen storage may be required.

Absorption↗

PubMed1998

Establishing an institution-specific therapeutic range for heparin.

The relationship between heparin concentration and activated partial thromboplastin time (aPTT) in pooled plasma was compared with that in patient samples to assess the feasibility of using heparin-spiked pooled plasma in determining a therapeutic range for aPTT. Blood samples were taken from 32 patients who had been receiving intravenous unfractionated heparin sodium for more than 24 hours. The samples were stored at -70 degrees C until anti-Xa assay within three months of collection. Pooled normal plasma was spiked with unfractionated heparin sodium to produce nominal anti-Xa concentrations of 0, 0.05, 0.1, 0.2, and 0.5 unit/mL. Heparin concentrations and a aPTT values were measured, and the relationship between the two was determined by linear regression. For the ex vivo samples, the range of aPTT values corresponding to therapeutic heparin concentrations of 0.3-0.7 anti-Xa unit/mL was 64-106 seconds, which corresponds to an aPTT range of 2.3-3.9 times the mean of the normal range (compared with the traditionally defined therapeutic range of 1.5-2.5 times the control value). For the in vitro samples, the aPTT range corresponding to heparin concentrations of 0.3-0.7 unit/mL was 121-256 seconds, which corresponds to an aPTT range of 4.4-9.4 times the mean of the normal range. Each institution should establish a therapeutic aPTT range by calibrating aPTT values against heparin concentrations from blood samples of patients receiving intravenous heparin.

Angina, Unstable↗

PubMed2002

Implementation of a therapeutic-interchange clinic for HMG-CoA reductase inhibitors.

A therapeutic-interchange clinic for statins is described. In 1999, the Department of Defense mandated the use of cerivastatin and simvastatin as the formulary statins in all military health care facilities by April 2000. Cerivastatin was the preferred agent; the goal was to use this agent in 60-65% of all patients. Walter Reed Army Medical Center developed a voluntary therapeutic-interchange clinic for patients receiving statins. Goals included facilitating the rapid switching of patients to the formulary statins, maximizing the use of the preferred agent, maintaining or improving lipid control, monitoring safety, determining costs, educating patients about their treatment, and documenting satisfaction with the clinic. Written educational materials were prepared, an algorithm for statin conversion was created, and laboratory tests were performed, among other measures. Between January and April 2000, 1356 patients were seen by the therapeutic-interchange clinic; of these, 942 agreed to have the efficacy and safety of their therapy monitored by the clinic. Before the formulary change, the most commonly prescribed statins were atorvastatin (44% of patients) and pravastatin (42%). Under the conversion policy, 96% of patients received cerivastatin and 4% simvastatin. The percentage of patients achieving their targeted low-density-lipoprotein cholesterol concentration increased from 65% to 75%. The policy saved an average of $115 per patient in the first year. Most patients were satisfied with the clinic, but only 36% of providers were satisfied. Cerivastatin was withdrawn from the market in August 2001; simvastatin became the only formulary statin. A therapeutic-interchange clinic at a military medical center provided an efficient means of switching a large number of patients to alternative statin therapy, monitoring the outcomes, and individualizing patient care.

Aged↗

PubMed2002

Selecting targets for therapeutic validation through differential protein expression using chromatography-mass spectrometry.

The identification of potential targets for therapeutic intervention can be accomplished on a systematic basis by a variety of techniques that include quantitative analysis of gene-specific mRNA levels and expressed proteins in normal and diseased cells. Differences in the expression levels of nucleic acid and protein gene products could suggest protein drug targets that are directly causative of disease, or reveal biochemical pathways that could be modulated by therapeutic molecules. Any effort based on mRNA or protein expression level comparisons could be confounded by a number of factors: level in steady-state may not be correlated with actual encoded protein levels; differentially expressed protein levels might be a result of disease process, and not causative of the process, and therapeutic intervention based on such a difference will be unproductive and the differential expression of mRNA or protein may be the result of biological variation unrelated to the disease process under study. In order to address these possibly confounding factors, it is necessary to validate potential targets by establishing their firm association with disease, and their minimal distribution in non-diseased tissues of any type. This requirement suggests that emphasis on true and reproducible quantitation of protein expression levels in a variety of samples will be an effective and highly efficient method of generating drug targets with a high degree of utility. To achieve this aim, we have established an industrial-scale proteomics-based discovery platform consisting of cell biology, protein chemistry, and mass spectrometry technical groups together with bioinformatics groups. The analytical method used for quantitation employs isotope labeling for differential analysis (ICATTM, Applied Biosystems, Inc.). With this technique, tryptic peptides are generated from labeled proteins that have been specifically captured from various subcellular locations or protein families. The resulting peptides are identified and quantified by mass spectrometry. To evaluate this approach on a large-scale, we have applied it to a study of continuous cell lines derived from human pancreatic adenocarcinomas. We have been able to establish processes for target discovery for small molecule drug targets as well as therapeutic antibody target identification for cell surface proteins. In addition, we have developed a process for identification of serum markers of this disease based upon standardized fractionation procedures. The results of these analyses will be presented together with the some of the issues from both the wet and dry (computational) lab that need to be addressed in such an undertaking.

Biomarkers, Tumor↗

PubMed1999

Intraoperative therapeutic suggestions in day-case surgery: are there benefits for postoperative outcome?

To determine if improved postoperative recovery in surgical inpatients receiving intraoperative therapeutic suggestions are applicable in an outpatient population, 70 consenting, unpremedicated adults undergoing elective outpatient hernia repair under general anaesthesia were allocated randomly to either a therapeutic tape (TT) or a comparison tape (CT) group. A standardized general anaesthetic technique was used with propofol, fentanyl or alfentanil, isoflurane and nitrous oxide in oxygen. Pain, and nausea and vomiting were assessed after operation at 30, 60 and 90 min and at 2, 6 and 24 h. The presence of other side effects, such as headache and muscular discomfort, in addition to recall of tape contents, were also evaluated after operation. Absorption ability was measured before operation. The groups were similar in patient characteristics, preoperative, surgical and anaesthetic characteristics, and level of absorption. There were no differences in pain ratings or need for analgesics administered at any time after operation. Nausea/vomiting was experienced significantly fewer times by patients in group TT compared with group CT over the first 90 min (group CT 15%, group TT 4%; P < 0.02), but not over the last three assessment times (group CT 10%, group TT 14%; P < 0.25). The therapeutic tape group experienced fewer side effects over the entire postoperative assessment period (P = 0.03), in particular less headaches (P = 0.03) and less muscular discomfort (P < 0.02). Use of intraoperative therapeutic suggestions could present mildly significant postoperative benefits in outpatients.

Adolescent↗

PubMed2006

Insulin-like growth factor-I receptor as a marker for prognosis and a therapeutic target in human esophageal squamous cell carcinoma.

Insulin-like growth factor (IGF)-I receptor (IGF-Ir) signaling is required for tumorigenicity and progression of many tumors but this pathway has not been well studied as a prognostic factor or potential therapeutic target in esophageal squamous cell carcinoma (ESCC). In this paper, the association between the expression of IGF-Ir and IGF-II ligand and prognosis was investigated immunohistochemically in 100 surgically resected ESCC. We then assessed the therapeutic effect of blocking IGF receptor signaling using dominant negative IGF-Ir (IGF-Ir/dn) in ESCC in vitro. Expression of IGF-Ir and IGF-II were detected in 60 and 50% of tumors, respectively, and were associated with invasion depth, metastasis, advanced tumor stage and recurrence. Patients with tumors expressing both IGF-Ir and IGF-II had a significantly shorter survival than those expressing either alone or neither in both single and multivariate analysis. IGF-Ir/dn suppressed proliferation and motility as well as upregulating chemotherapy-induced apoptosis through blocking ligand-induced Akt activation. We propose that detection of IGF-Ir/IGF-II in ESCC may be useful for the prediction of recurrence and poor prognosis and for selecting patients for IGF-Ir-targeted therapy. Therapeutic blockade of IGF-Ir may be a useful anticancer therapeutic for ESCC.

Adenoviridae↗

PubMed1992

A critical reevaluation of the "therapeutic range" of aminoglycosides.

Routine pharmacokinetic drug monitoring has become an inherent component of aminoglycoside therapy over the last 10-15 years. The intent of this monitoring is to improve the outcome of treatment and to decrease the incidence of toxicity through the attainment and maintenance of serum aminoglycoside concentrations within a normal therapeutic range. The primary objective of this review was to critically analyze the scientific support for the following premises: (1) there is a causal relation between peak serum aminoglycoside concentrations in serum and the outcome of treatment; (2) there is a causal relation between trough serum aminoglycoside concentrations in serum and the outcome of treatment; (3) outcome is improved by monitoring and maintenance of serum aminoglycoside concentrations in the normal therapeutic range; (4) there is a causal relation between serum aminoglycoside concentrations and toxicity; and (5) monitoring and maintenance of serum aminoglycoside concentrations within a normal therapeutic range decrease the risk of toxicity. After a critical review of the literature, it was concluded that the evidence was insufficient to support the presently accepted normal therapeutic range. Recommendations for the monitoring of aminoglycoside therapy were drawn up.

Aminoglycosides↗

PubMed2026

A therapeutic atlas of monogenic inflammatory bowel disease.

BACKGROUND AND AIMS: Evidence-based, mechanism-guided therapies are urgently needed for treating monogenic inflammatory bowel disease (mIBD). For such rare diseases, mechanistic insight is essential to guide treatment when conventional clinical trials are often not feasible. We aimed to summarize literature-based evidence and to identify knowledge gaps. METHODS: We conducted a systematic review of published manuscripts evaluating the therapeutic efficacy in mIBD. We quantified and compared the global therapeutic response score across treatments and conditions. In a subset of conditions, biomarkers of longitudinal therapeutic response were evaluated in comparison to non-monogenic pediatric IBD cohorts. RESULTS: Responses to 35 therapeutics across the 102 known genetic causes of mIBD were evaluated in 241 articles and 669 patients, summarizing 302 gene-drug responses. The efficacy of at least one pharmacological intervention was identified in 61% (n = 62/102) of the mIBD conditions, highlighting a major unmet need for effective medications in many others. Gene- and pathway-specific responses were demonstrated for several therapies, including allogeneic hematopoietic stem cell transplantation, gene therapy, and advanced therapies such as anti-TNF agents, IL-1 inhibitors, mTOR inhibitors, as well as eculizumab in CD55 deficiency, abatacept in CTLA4 deficiency, and the immunometabolic agent empagliflozin in glycogen storage disease type 1b. CONCLUSIONS: This study highlights the potential of precision medicine approaches tailored to genetic and pathway-specific mechanisms, while underscoring the urgent need for effective therapies in many monogenic conditions that remain without established treatment options.

Humans↗

PubMed1999

Highly sensitive quantitative telomerase assay of diagnostic testicular biopsy material predicts the presence of haploid spermatogenic cells in therapeutic testicular biopsy in men with Sertoli cell-only syndrome.

The role of a telomerase assay in the recognition of Sertoli cell-only syndrome with testicular foci of haploid cells was evaluated. Men with Sertoli cell-only syndrome (n = 23) were given a new diagnostic testicular biopsy. Part of the biopsy was stained and the remainder was processed for the quantitative telomerase assay. After 3-13 months, a therapeutic testicular biopsy was performed. This material was minced and then examined using confocal laser scanning microscopy and fluorescent in-situ hybridization. Histology of diagnostic testicular biopsy material confirmed the diagnosis of Sertoli cell-only syndrome in all the participants. All seven men with a telomerase assay value in their diagnostic testicular biopsy of >42 total product generated (TPG) U/microg protein had haploid cells (i.e. spermatozoa and/or spermatids) in their therapeutic testicular biopsy. Among participants with telomerase assay values <42 TPG U/microg protein, only one man had haploid cells in his therapeutic testicular biopsy. Thus, telomerase assay values >42 TPG U/microg protein in the diagnostic biopsy identified 87.5% of the Sertoli cell-only syndrome men with haploid cells in their therapeutic testicular biopsy. Significantly higher values of the telomerase assay were found in men with testicular foci of haploid cells than in men without these foci. The use of a quantitative telomerase assay biopsy appears to be important for identifying those men with Sertoli cell-only syndrome who have foci of haploid cells and can be candidates for assisted reproduction techniques.

Adult↗

PubMed2004

Anomaly and correlation of killing in the therapeutic properties of silver (I) chelation with glutamic and tartaric acids.

OBJECTIVES: To investigate whether silver chelates or silver ions are more effective as therapeutic agents, and to examine their mode of action so that safer and stable compounds that have a broad spectrum of therapeutic activities can be developed. METHODS: Efficacy was investigated against Pseudomonas aeruginosa (ATCC 15442) by determining MIC via a broth macrodilution procedure using NCCLS methods for antibiotic susceptibility testing. RESULTS: It was found that the responsible agent for silver therapeutic properties is the silver chelates rather than silver ions, contradicting previous findings, and the efficacy profiles mimic that of free silver ions present in solution. CONCLUSIONS: Silver therapeutic activities seem to be more effective as complexes-an intracellular package-rather than free silver ions, demonstrating that the effect of silver is linked to cells' DNA unwinding, and not respiratory or membrane functionality as was traditionally recognized.

Bacteria↗

PubMedDate not supplied

A rapid gas chromatographic method quantitating clozapine in human plasma or serum for the purpose of therapeutic monitoring.

A gas chromatographic method using nitrogen-phosphorus detection was developed to quantitate clozapine in plasma or serum. Methyl clonazepam was used as an internal standard. Sample preparation included a single-step extraction with ethyl acetate, which was injected directly onto a wide-bore capillary column. Within-run and total precision, measured as percent coefficient of variation, were determined at low, therapeutic, and high clozapine plasma concentrations. The within-run precision for the low, therapeutic, and high clozapine plasma samples was 5.2, 2.7, and 2.4%, respectively. The total precision for the low, therapeutic, and high clozapine plasma samples was 10.0, 2.6, and 2.0%, respectively. Analytical accuracy was evaluated by comparing quantitative results with those obtained from a reference laboratory. Those samples containing therapeutic or high concentrations agreed within 3%; the sample containing a subtherapeutic concentration differed by 11.9%. The limit of quantitation was determined to be 35 ng/mL, and the upper limit of linearity was 3000 ng/mL. No significant interferences were detected after testing more than two dozen drugs and metabolites.

Antipsychotic Agents↗

PubMed2006

Modified and bilateral retroperitoneal lymph node dissection for testicular cancer: peri- and postoperative complications and therapeutic outcome.

OBJECTIVE: To characterize surgical invasiveness and morbidity and to verify therapeutic efficacy, we reviewed perioperative and postoperative courses and therapeutic outcomes of patients who underwent retroperitoneal lymph node dissection (RPLND) for testicular germ cell cancers. METHODS: The study included 31 patients who underwent retroperitoneal lymph node dissection. A modified template was used if retroperitoneal metastasis was limited to the areas below the level of the renal hilus and above the level of the inferior mesenteric artery (IMA). Perioperative and postoperative courses and complications were reviewed as well as therapeutic outcomes. RESULTS: Overall, 27 perioperative and postoperative complications were observed in 15 patients (48.4%). Superficial surgical site infection and paralytic ileus were seen most frequently. All of them were resolved without special additional treatments; however, patients who underwent retrocrural dissection had a tendency to have severe symptomatic complications such as chylothorax, phrenic nerve palsy and orthostatic hypotension. Antegrade ejaculation was preserved in 94.1% of patients with modified template dissection, whereas no patients with additional dissection below the level of the IMA had the function preserved. One patient (3.2%) developed a postoperative recurrent disease in the retroperitoneum, which was outside the dissection field, as well as in the mediastinum. CONCLUSIONS: Although RLND had high morbidity, most peri- and postoperative complications were manageable conservatively. Modified template dissection enabled patients to preserve antegrade ejaculation without compromising its therapeutic efficacy, if the disease extension allowed us to use the template.

Adolescent↗

PubMed2002

TTD: Therapeutic Target Database.

A number of proteins and nucleic acids have been explored as therapeutic targets. These targets are subjects of interest in different areas of biomedical and pharmaceutical research and in the development and evaluation of bioinformatics, molecular modeling, computer-aided drug design and analytical tools. A publicly accessible database that provides comprehensive information about these targets is therefore helpful to the relevant communities. The Therapeutic Target Database (TTD) is designed to provide information about the known therapeutic protein and nucleic acid targets described in the literature, the targeted disease conditions, the pathway information and the corresponding drugs/ligands directed at each of these targets. Cross-links to other databases are also introduced to facilitate the access of information about the sequence, 3D structure, function, nomenclature, drug/ligand binding properties, drug usage and effects, and related literature for each target. This database can be accessed at http://xin.cz3.nus.edu.sg/group/ttd/ttd.asp and it currently contains entries for 433 targets covering 125 disease conditions along with 809 drugs/ligands directed at each of these targets. Each entry can be retrieved through multiple methods including target name, disease name, drug/ligand name, drug/ligand function and drug therapeutic classification.

Databases, Nucleic Acid↗

PubMed1996

Prognostic value of histopathological therapeutic effects and mitotic index in locally advanced breast cancers after neoadjuvant chemotherapy.

A study was conducted to examine whether or not the histopathological therapeutic effects of preoperative chemotherapy could be useful for determining prognosis in women with locally advanced breast cancer. The patients were 37 women with locally advanced breast cancer who received preoperative chemotherapy between 1977 and 1987. The histological grade of malignancy (HGM) and histopathological therapeutic effects of chemotherapy (TEf) were examined in resected specimens. Patients with HGM 3 showed a poorer 10-year overall survival (38%) than those with HGM 1 or 2 (62%). Patients showing a better histopathological response (TEf 1b plus 2) had a poorer 10-year overall survival (20%) than those with a poorer response (TEf 0 plus 1a) (60%). Therapeutic effects were significantly related to histological grade, nuclear atypia and mitotic index (p = 0.03, 0.005 and 0.002, respectively). Histopathological therapeutic effects were not directly correlated with patient prognosis. Cox proportional hazard regression analysis revealed that mitotic index was the most significant prognostic factor related to 10-year overall survival.

Adult↗

PubMed1981

Evaluation of electromyographic biofeedback as an adjunct to therapeutic exercise in treating the lower extremities of hemiplegic patients.

The following controlled, preliminary investigation was designed to determine whether electromyographic biofeedback, in conjunction with therapeutic exercise, could influence the reacquisition of functional lower extremity movements in chronic hemiplegic patients. Both the control (standardized therapeutic exercise regimen) and experimental (therapeutic exercise regimen combined with electromyographic biofeedback) groups improved in ankle active range of motion; only the experimental group significantly shortened its timed ambulation over a carpeted surface. One patient in the experimental group who was given 12 additional training sessions showed further gains in knee and ankle joint angle measurements during walking. The apparent potential for rehabilitation of chronic hemiplegic patients and the benefits afforded to physical therapists from a standardized therapeutic exercise protocol are discussed.

Biofeedback, Psychology↗

PubMed1988

Physiology and therapeutic implications of negative work. A review.

Energy efficiency is an important attribute of negative work (W neg). Eccentric muscle contractions characteristic of W neg can generate greater force at reduced oxygen cost and perceived exertion compared with concentric muscle contractions in positive work (W pos). Thus, activities incorporating W neg could have important implications in improving the functional capacity of an individual with limited physiologic reserves or ability to use these reserves. Other characteristics of W neg such as muscle trauma or soreness and increased total heat production and cutaneous blood flow, however, may be counter-therapeutic and even hazardous. The purpose of this review is to describe the physiology and therapeutic implications of W neg. Because the body of knowledge with respect to the therapeutic effects of W neg is relatively scant compared with W pos, clinical trials are needed to establish the indications, contraindications, possible limitations, guidelines for prescription, and therapeutic efficacy of W neg.

Energy Metabolism↗

PubMed1995

Effects of continuous therapeutic ultrasound on growth and metastasis of subcutaneous murine tumors.

BACKGROUND AND PURPOSE: The use of therapeutic ultrasound (US) in the presence of malignant neoplasms has been contraindicated in physical therapy practice despite a lack of convincing scientific evidence. Some studies have shown that high levels of US, which increase tissue temperatures greater than 42 degrees C, can kill tumors. We sought to determine whether the application of continuous therapeutic US would alter the growth or metastasis of methylcholanthrene-induced solid tumors in mice. SUBJECTS: Seventy-one female C57BL/6 mice, age 6 to 8 weeks, received subcutaneous injections of 5 x 10(5) tumor cells. METHODS: When tumors grew to 0.5 cm in diameter, the mice were randomly assigned to either a control group (n = 34) or an experimental group (n = 37). The experimental group received 10 treatments over a 2-week period of 3-MHz continuous US at 1.0 W/cm2 for 5 minutes, using a 0.5-cm2 sound head directly over the tumor. The control group received the same handling except for the US treatment. Tumor dimensions were measured on days 1 (baseline), 7 (midtreatment), and 14 (preexcision and postexcision). Tumors were weighed after excision, and the mice were evaluated by necropsy and histopathology of regional lymph nodes. RESULTS: All tumors grew larger over time, but final tumor volume and weight were larger in the experimental group (789 mm3 and 0.932 g) than in the control group (395 mm3 and 0.506 g). No significant difference existed in the number of metastatic lymph nodes between groups. CONCLUSION AND DISCUSSION: Continuous therapeutic US increased the volume and weight of subcutaneous murine tumors in mice. We urge caution in the use of continuous therapeutic US in the areas of tumors or suspected tumors.

Analysis of Variance↗

PubMed1995

Therapeutic monoclonal antibodies.

Monoclonal antibodies have been used extensively over the last few years in clinical trials of rheumatoid arthritis (RA). Not only are they potential therapeutic agents, but they are also useful probes into the immunopathogenesis of RA. Anti-tumour necrosis factor alpha (TNF alpha) monoclonal antibodies have been shown to be clinically efficacious. Although they produced rapid disease amelioration, the duration of clinical improvement was limited to 4-6 weeks. Re-treatments were again effective but long-term studies are required to assess their therapeutic role in RA. So far, the therapeutic effects of lymphocyte-depleting antibodies have been disappointing. From the data, it is clear that synovial lymphocytes are more difficult to eliminate than peripheral blood lymphocytes and it is likely that in order to delete all synovial lymphocytes, high doses of depleting antibodies will be required which could lead to severe immunosuppression. Hence, lymphocyte depletion may not be a feasible therapeutic strategy. However, there are a number of clinical trials currently underway attempting to inhibit CD4 lymphocyte function by non-depleting antibodies. In animal models of RA, such antibodies have been shown to induce long-term disease remission. Another possibility is to combine several monoclonal antibodies in order to induce disease remission in RA. This strategy has been used in murine collagen-induced arthritis in which a combination of anti-CD4 and anti-TNF alpha monoclonal antibodies was shown to be synergistic.

Antibodies, Monoclonal↗