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Biomedical subjects

E Adams

Publications and source records attributed to E Adams.

At least 19 recordsLinked to original sources

Conservative management of pelvic organ prolapse in women.

BACKGROUND: Pelvic organ prolapse is common, and some degree of prolapse is seen in 50% of parous women. Women with prolapse can experience a variety of pelvic floor symptoms. Treatments include surgery, mechanical devices and conservative management. Conservative management approaches, such as giving lifestyle advice and delivering pelvic floor muscle training, are often used in cases of mild to moderate prolapse. OBJECTIVES: To determine the effects of conservative management (physical interventions and lifestyle interventions) for women with pelvic organ prolapse in comparison with no treatment or other treatment options (such as mechanical devices or surgery). SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (searched on 19 September 2005), MEDLINE (January 1966 to August 2005), MEDLINE In Process & Other Citations (15 September 2005), EMBASE (January 1996 to Week 43 2005), CINAHL (January 1982 to October 2005), PEDro (September 2005), the UK National Research Register (Issue 3, 2005), the US National Institute of Health clinical trial register (5 October 2005), Current Controlled Trials register (5 October 2005), Controlled Clinical Trials (September 2005) and ZETOC (September 2005). We searched the reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised trials in women with pelvic organ prolapse that included a physical or lifestyle intervention in at least one arm of the trial. DATA COLLECTION AND ANALYSIS: Two reviewers assessed all trials for inclusion/exclusion and methodological quality. Data were extracted by the lead reviewer onto a standard form and cross checked by another. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook for Systematic Reviews of Interventions. MAIN RESULTS: Three trials of relevance to this review were identified. The largest of these, of pelvic floor muscle training in preventing anterior prolapse from worsening, had significant limitations which affect the generalisability and rigor of the findings. A small feasibility study (which is to be followed up with a larger trial) randomised 47 women to pelvic floor muscle training or control and found suggestions of better outcomes (better self-reported improvement, decreased severity) in the intervention group. The third trial evaluated peri-operative physiotherapy for women undergoing surgery for prolapse and/or incontinence. The authors report that urinary symptoms, pelvic floor muscle function and quality of life were improved more in the treatment group than the control group, but data were not provided to allow this to be assessed. The trial was small and no prolapse-specific outcome measures were used. It was not possible to combine data from the three trials. AUTHORS' CONCLUSIONS: Despite there now being reports of three eligible trials in this update, the evidence available is not significant to guide practice. There is some encouragement from a feasibility study that pelvic floor muscle training, delivered by a physiotherapist to symptomatic women in an outpatient setting, may reduce severity of prolapse. Further evidence from larger, better quality randomised control trials is however still necessary.

Adult↗

Improved reversed-phase liquid chromatographic method combined with pulsed electrochemical detection for the analysis of amikacin.

A two-step gradient liquid chromatographic method combined with pulsed electrochemical detection is described for the determination of amikacin and its impurities. The mobile phase is composed of an aqueous solution containing 1.8 g/l sodium 1-octanesulphonate, 14 ml/l tetrahydrofuran, 50 ml/l of phosphate buffer pH 3.0 and sodium sulphate, which was 20 g/l in mobile phase A and 28 g/l in mobile phase B. 0.5 M sodium hydroxide was added post-column to enhance the detection. An investigation of different reversed-phase columns indicated that the Discovery (C18, 5 microm, 250 mm x 4.6 mm i.d.) column was the most suitable. Compared to previously published investigations, the proposed method showed higher sensitivity and efficiency, allowing the separation of the main component amikacin from 16 impurities, 7 of which were of unknown identity. A central composite experimental design was used to assess the robustness. The method showed good repeatability and linearity in the assay range. The method was further applied to analyze some commercial samples.

Algorithms↗

Characterization of impurities in dirithromycin by liquid chromatography/ion trap mass spectrometry.

With a recently developed liquid chromatographic (LC) method, using a phosphate buffer, several unknown impurities present in dirithromycin samples were separated. In this paper, a reversed-phase liquid chromatography-tandem mass spectrometry method is described for the investigation of dirithromycin and related substances. The method employed uses a Zorbax Extend C18 column (250 mm x 4.6 mm I.D.), 5 microm, and a mobile phase consisting of acetonitrile, 2-propanol, water and ammonium acetate solution pH 8.5. Mass spectral data are acquired on an LCQ ion trap mass spectrometer equipped with an electrospray ion (ESI) source operated in the positive ion mode. The LCQ is ideally suited for the identification of related substances because it provides on-line LC/MS(n) capability, which allows efficient identification without time-consuming isolation and purification procedures. Using this method, the fragmentation behavior of dirithromycin and its related substances was studied and the unknown impurities occurring in commercial samples were investigated. In total the structures of nine impurities were elucidated, among which three were different analogues with a modification in the side chain on the oxazine ring. Two impurities showed a different alkyl group in position C13. In two impurities the desosamine sugar was involved with changes in the degrees of methylation of the amino group. One unknown impurity was identified as dirithromycin F and another unknown was characterized as dirithromycin N-oxide.

Chromatography, Liquid↗

Analysis of neomycin using an improved liquid chromatographic method combined with pulsed electrochemical detection.

An isocratic liquid chromatographic method with pulsed electrochemical detection is described for the determination of neomycin in the presence of its impurities. The mobile phase is composed of an aqueous solution containing 35 g/l of sodium sulphate, 1 g/l of sodium 1-octanesulfonate, 14 ml/l of tetrahydrofuran (THF) and 50 ml/l of 0.2 M phosphate buffer pH 3.0. Sodium hydroxide was added post column to enhance the detection. An investigation of different reversed-phase columns indicated that the Discovery (C18 5 microm, 250 mm x 4.6 mm I.D.) column was the most suitable. The proposed method shows high efficiency, allowing the separation of the main component neomycin B from neomycin C and 15 other impurities. A central composite design was used to assess the robustness of the method. The method showed good selectivity, repeatability, linearity and sensitivity. This method was applied to analyse commercial samples.

Anti-Bacterial Agents↗

Evaluation of an International Pharmacopoeia method for the analysis of indinavir sulfate by liquid chromatography.

A gradient LC method for the determination of indinavir sulfate (IDV) and its impurities has been recently published in a consultation document of the International Pharmacopoeia, WHO Drug Information. The method uses a base-deactivated reversed-phase C18 column (25 cm x 4.6 mm i.d.), 5 microm kept at a temperature of 40 degrees C. The mobile phases consist of acetonitrile, phosphate buffer pH 7.5 and water. The flow rate is 1.0 ml/min. UV detection is performed at 220 nm. A system suitability test (SST) is described to govern the quality of the separation. The separation towards IDV components was investigated on 16 C18 columns and correlation was made with the column classification system developed in our laboratory. The method was evaluated using a Hypersil BDS C18 column (25 cm x 4.6 mm i.d.), 5 microm. A central composite design was applied to examine the robustness of the method. The method shows good precision, linearity, sensitivity and robustness. Six commercial samples were examined using this method.

Chromatography, Liquid↗

Investigation of vancomycin and related substances by liquid chromatography/ion trap mass spectrometry.

Liquid chromatography (LC) methods compatible with mass spectrometry (MS) that are suitable for impurity profiling of vancomycin mixtures have not been described in the literature. The mobile phases of the existing methods contain non-volatile additives and/or solvents that give problems in combination with MS. In this paper, a reversed-phase LC/tandem mass spectrometry method is described for the investigation of vancomycin and related substances. The LC method uses a Zorbax Extend C18 column (250 x 4.6 mm i.d.), 5 microm, and a mobile phase consisting of methanol, water and ammonium acetate solution (pH 9.0). This method allows us to separate vancomycin and its impurities. Mass spectral data are acquired on an LCQ ion trap mass spectrometer equipped with an electrospray interface operated in the positive and negative ion modes. The LCQ is ideally suited for identification of impurities and related substances because it provides on-line LC/MSn capability, which allows efficient identification without time-consuming isolation and purification procedures. Using this method, the fragmentation of vancomycin and known derivatives was studied and the structures of six substances occurring in commercial samples were elucidated.

Anti-Bacterial Agents↗

Improved LC of minocycline drug substance.

An isocratic liquid chromatographic method is described for the separation of minocycline and its impurities. This method uses XTerra RP-18, 5 microm (25 cm x 4.6 mm I.D.), a silica-based stationary phase with reduced silanol activity. A mobile phase composed of acetonitrile-0.2 M tetrabutylammonium hydrogen sulphate pH 6.5-0.2 M ethylenediaminetetraacetic acid pH 6.5-water (20:20:20:40; v/v/v/v) was used at a flow rate of 1 ml/min. The column temperature was set at 35 degrees C. UV detection was performed at 280 nm. Optimisation of the separation method and a robustness study were performed by means of a central composite experimental design. The method allows to separate minocycline from known impurities. Some unidentified impurities are also separated. The total time of analysis is less than 20 min.

Anti-Bacterial Agents↗

Group interpersonal psychotherapy for postnatal depression: a pilot study.

We conducted a pilot study to assess the potential effectiveness of group interpersonal psychotherapy (IPT-G) as a treatment for postnatal depression (PND). The study was also established to test a treatment manual for IPT-G, assess the acceptability of this format for participants and test a recruitment strategy for a randomised controlled trial. 18 mothers diagnosed with PND participated in 2 individual session and 8 sessions of group IPT. A two-hour psychoeducational session was also held for the partners of the participants. Measures of depressive symptomatology and social adjustment were administered by an independent clinician at baseline, 4 weeks, 8 weeks and 3 months post treatment. Patient satisfaction with the treatment was also evaluated. Severity scores on the BDI, EPDS and the HDRS decreased from pre- to post-treatment. This was maintained at three months follow up. No overall improvement in the Social Adjustment Scale-Self Report was noted, although there was improvement in their relationship with their significant other. The results confirm previous work that IPT-G may improve symptom severity for women suffering from postnatal depression. Limitations included the use of antidepressant therapy by 67% of subjects and the lack of a control group. There is a need for further randomised controlled trials of IPT-G with larger sample sizes to establish its effectiveness as treatment for PND.

Adult↗

Evaluation of the stability of chlortetracycline in granular premixes by monitoring its conversion into degradation products.

A methodology for the evaluation of the stability of chlortetracycline (CTC) in granular premixes is described. This methodology is based on the monitoring of the conversion of CTC into its degradation products by an improved gradient liquid chromatography (LC) method, based on one previously described by our laboratory. Sample preparation involves the extraction of CTC and its degradation products prior to LC analysis, using acidified methanol as extraction solvent. The gradient elution LC method proved to be very sensitive, especially towards the late eluting anhydro derivatives. The use of a Hypersil C8 BDS, 5 microm, 250 mm x 4.6 mm i.d. column is recommended since this column allowed a complete separation of the different impurities from each other and from the main component CTC. The applicability of this approach was demonstrated by the analysis of stability samples.

Anti-Bacterial Agents↗

Head-and-neck IMRT treatments assessed with a Monte Carlo dose calculation engine.

IMRT is frequently used in the head-and-neck region, which contains materials of widely differing densities (soft tissue, bone, air-cavities). Conventional methods of dose computation for these complex, inhomogeneous IMRT cases involve significant approximations. In the present work, a methodology for the development, commissioning and implementation of a Monte Carlo (MC) dose calculation engine for intensity modulated radiotherapy (MC-IMRT) is proposed which can be used by radiotherapy centres interested in developing MC-IMRT capabilities for research or clinical evaluations. The method proposes three levels for developing, commissioning and maintaining a MC-IMRT dose calculation engine: (a) development of a MC model of the linear accelerator, (b) validation of MC model for IMRT and (c) periodic quality assurance (QA) of the MC-IMRT system. The first step, level (a), in developing an MC-IMRT system is to build a model of the linac that correctly predicts standard open field measurements for percentage depth-dose and off-axis ratios. Validation of MC-IMRT, level (b), can be performed in a rando phantom and in a homogeneous water equivalent phantom. Ultimately, periodic quality assurance of the MC-IMRT system is needed to verify the MC-IMRT dose calculation system, level (c). Once the MC-IMRT dose calculation system is commissioned it can be applied to more complex clinical IMRT treatments. The MC-IMRT system implemented at the Royal Marsden Hospital was used for IMRT calculations for a patient undergoing treatment for primary disease with nodal involvement in the head-and-neck region (primary treated to 65 Gy and nodes to 54 Gy), while sparing the spinal cord, brain stem and parotid glands. Preliminary MC results predict a decrease of approximately 1-2 Gy in the median dose of both the primary tumour and nodal volumes (compared with both pencil beam and collapsed cone). This is possibly due to the large air-cavity (the larynx of the patient) situated in the centre of the primary PTV and the approximations present in the dose calculation.

Algorithms↗

Regulatory T cells in transplantation tolerance.

Our ability to harness tolerance mechanisms will have a major impact in organ transplantation if it becomes possible to minimize drug maintenance, or even wean off immunosuppressive drugs. An improved understanding of the biology of regulatory T cells will make it possible to replace current induction regimens with those favouring the vaccination and selection of T cells that prevent graft rejection. Once tolerance is established, the continuous supply of graft antigens should sustain T cell mediated regulation as the dominant mechanism preventing graft rejection.

Animals↗

Development of a liquid chromatographic method for ear drops containing neomycin sulphate, polymyxin B sulphate and dexamethasone sodium phosphate.

Two liquid chromatographic methods were developed to analyse ear drops containing neomycin sulphate, polymyxin B sulphate and dexamethasone sodium phosphate. This formulation will be described in the Belgian National Formulary. Since neomycin, an aminoglycoside antibiotic, has no UV chromophore and pre or post column derivatization is complicated, pulsed electrochemical detection on a gold electrode was chosen to determine neomycin. Polymyxin B sulphate and dexamethasone sodium phosphate do have a UV chromophore. So, a single LC method with UV detection was developed for the determination of polymyxin B sulphate and dexamethasone sodium phosphate. The sample pretreatment is simply done by diluting the formulation with water. For each method, the influence of the different chromatographic parameters on the separation, the interference of other active compounds and excipients, the repeatability and the linearity were investigated. Finally, the content of the actives in the formulation was studied at 0, 2, 4, 6, and 8 weeks.

Chemistry, Pharmaceutical↗

Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand.

In this study, 18 copies of PLAVIX tablets containing clopidogrel hydrogensulfate were compared to the innovator drug product for uniformity of mass, impurity profile, content, dissolution properties and stability. In order to be able to separate the R-enantiomer of clopidogrel, an enantiospecific liquid chromatographic method was used to determine the impurities and to perform the assay. The paddle method was used for dissolution testing. Most of the copies were not similar compared to the original drug product: their amount of impurities was higher, the content of clopidogrel lower, the dissolution profiles different and after 3 months under stress conditions in the original packaging, the results for the samples and the reference were significantly different in most of the cases.

Chromatography, High Pressure Liquid↗

Conservative management of pelvic organ prolapse in women.

BACKGROUND: Pelvic organ prolapse is common, and some degree of prolapse is seen in 50% of parous women. Women with prolapse can experience a variety of pelvic floor symptoms. Treatments include surgery, mechanical devices and conservative management. Conservative management approaches, such as giving lifestyle advice and delivering pelvic floor muscle training, are often used in cases of mild to moderate prolapse. OBJECTIVES: To determine the effects of conservative management (physical interventions, such as pelvic floor muscle training and lifestyle interventions) for women with pelvic organ prolapse in comparison with no treatment or other treatment options (such as mechanical devices or surgery). SEARCH STRATEGY: We searched the Cochrane Incontinence Group trials register (February 2004), MEDLINE (January 1966 to January 2003), PREMEDLINE (15 January 2003), EMBASE (January 1996 to January 2003), CINAHL (January 1982 to February 2003), PEDro (October 2003), the UK National Research Register (Issue 3, 2003), Controlled Clinical Trials (April 2003) and ZETOC (April 2003). We searched the reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised trials in women with pelvic organ prolapse that included a physical or lifestyle intervention in at least one arm of the trial. DATA COLLECTION AND ANALYSIS: No eligible completed, published or unpublished, randomised controlled trials were found; therefore no data collection or analysis were undertaken. MAIN RESULTS: No published reports of randomised controlled trials relevant to the review objectives were found. Three ongoing randomised controlled trials of physiotherapy interventions which include some women with prolapse were identified. REVIEWERS' CONCLUSIONS: Currently there is no rigorous evidence from randomised controlled trials regarding the use of conservative interventions in the management of pelvic organ prolapse.

Adult↗

Mechanical devices for pelvic organ prolapse in women.

BACKGROUND: Pelvic organ prolapse is common, with some degree of prolapse seen in up to 50% of parous women in a clinic setting although many are asymptomatic. A number of symptoms may be associated with prolapse and treatments include surgery, mechanical devices and conservative therapies. A variety of mechanical devices or pessaries are described which aim to alleviate the symptoms of prolapse and avert or delay the need for surgery. OBJECTIVES: To determine the effects of mechanical devices for pelvic organ prolapse. SEARCH STRATEGY: We searched the Cochrane Incontinence Group trials register (24 February 2004), MEDLINE (January 1966 to January 2003), PREMEDLINE (15 January 2003), EMBASE (January 1996 to January 2003), CINAHL (January 1982 to February 2003), PEDro (October 2003), the UK National Research Register (Issue 3, 2003), Controlled Clinical Trials (April 2003) and ZETOC (April 2003). We searched the reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials which included a mechanical device for pelvic organ prolapse in one arm of the study. DATA COLLECTION AND ANALYSIS: No eligible, completed, published or unpublished randomised controlled studies were found, therefore no data collection or analysis was possible. MAIN RESULTS: There was a dearth of studies on the use of mechanical devices and no published reports of randomised trials were identified. One study on pessary usage was excluded as it was not a randomised trial. REVIEWERS' CONCLUSIONS: Currently there is no evidence from randomised controlled trials upon which to base treatment of women with pelvic organ prolapse through the use of mechanical devices/pessaries. There is no consensus on the use of different types of device, the indications, nor the pattern of replacement and follow-up care. There is an urgent need for randomised studies to address the use of mechanical devices in comparison with no treatment, surgery and conservative measures.

Female↗

Analysis of erythromycin and benzoylperoxide in topical gels by liquid chromatography.

Gels containing a combination of erythromycin and benzoylperoxide are frequently used in the treatment of acne vulgaris. A method was developed to determine the content of both erythromycin and benzoylperoxide in these gels. Erythromycin was extracted from the gel in conditions where the oxidative power of benzoylperoxide was neutralised by addition of ascorbic acid and this extract was analysed on an Xterra RP(18) column, with a mobile phase containing acetonitrile-0.2 M K2HPO4-water (35:5:60, v/v/v). The detection wavelength was 215 nm. A second extraction procedure was developed for the analysis of benzoylperoxide. The extraction solution was analysed on a Hypersil C(18) BDS column and a mobile phase containing acetonitrile-water (58:42, v/v). Detection was performed at 254 nm. The flow rate was 1.0 ml/min in both methods. The selectivity, repeatability, linearity and recovery of both methods were examined. Special attention was given to determination of the recovery and the uncertainty on the recovery. This allowed evaluation of the bias of the extraction method. The method developed was used to examine the stability of a gel for topical use.

Administration, Topical↗

Hyphenation of liquid chromatography to ion trap mass spectrometry to identify minor components in polypeptide antibiotics.

The application of liquid chromatography-ion trap mass spectrometry for the characterization of linear and cyclic polypeptide antibiotics was investigated. The aim was on-line identification of impurities in those antibiotic complexes without recourse to time-consuming isolation and purification procedures. Hyphenated techniques, such as liquid chromatography coupled to mass spectrometry, are ideally suited for this purpose. Characterization was performed with an ion trap mass spectrometer offering MS(n) capability; this enables more structural information to be obtained. Liquid chromatography in combination with ion trap mass spectrometry was successfully applied for the characterization of impurities in gramicidin, polymyxin B, polymyxin E, and bacitracin and the study of the degradation products of polymyxins B and E.

Amino Acid Sequence↗

Interlaboratory study of a liquid chromatography method for erythromycin: determination of uncertainty.

Erythromycin is a mixture of macrolide antibiotics produced by Saccharopolyspora erythreas during fermentation. A new method for the analysis of erythromycin by liquid chromatography has previously been developed. It makes use of an Astec C18 polymeric column. After validation in one laboratory, the method was now validated in an interlaboratory study. Validation studies are commonly used to test the fitness of the analytical method prior to its use for routine quality testing. The data derived in the interlaboratory study can be used to make an uncertainty statement as well. The relationship between validation and uncertainty statement is not clear for many analysts and there is a need to show how the existing data, derived during validation, can be used in practice. Eight laboratories participated in this interlaboratory study. The set-up allowed the determination of the repeatability variance, s(2)r and the between-laboratory variance, s(2)L. Combination of s(2)r and s(2)L results in the reproducibility variance s(2)R. It has been shown how these data can be used in future by a single laboratory that wants to make an uncertainty statement concerning the same analysis.

Anti-Bacterial Agents↗