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131I activity for remnant ablation in patients with differentiated thyroid cancer: A systematic review.

CONTEXT: Radioiodine ablation of the thyroid remnant after thyroidectomy is commonly performed in the management of patients with differentiated thyroid cancer. Although many centers administer an activity of 100 mCi, there is uncertainty over using a lower activity. OBJECTIVE: A systematic review of the published literature was used to compare the success rates of remnant ablation using approximately 30 mCi with approximately 100 mCi (1.1 vs. 3.7 GBq). DATA SOURCES: Data were obtained from MEDLINE and EMBASE for the years 1966 to March 2006. STUDY SELECTION: All studies that reported rates of successful ablation associated with approximately 30 or approximately 100 mCi of radioiodine were reviewed. DATA EXTRACTION: Studies were based on reviews of patient case notes (n = 41), prospective cohorts (n = 12), and randomized trials (n = 6). We obtained the success of thyroid remnant ablation according to different administered activities of radioiodine. Where a study reported on two or more activities, the risk ratio of having a successful ablation (approximately 30 vs. approximately 100 mCi) was calculated and combined in a meta-analysis. DATA SYNTHESIS: Observational studies confirmed the high ablation success rate ( approximately 80%) using approximately 100 mCi, although 22% of studies reported a rate of 90% or greater. The pooled ablation success rate in these studies was 10% lower using 30 mCi compared with 100 mCi (95% confidence interval, 3-17%; P = 0.01). The meta-analysis of the randomized trials produced equivocal results. For example, the rate of successful ablation in patients given 30 mCi was 8% lower compared with 100 mCi (95% confidence interval, 29% lower or up to 20% greater, P = 0.58), consistent with there being no difference or that 30 mCi is much less effective. CONCLUSIONS: From the published data, it is not possible to reliably determine whether ablation success rates using 30 mCi are similar to using 100 mCi. Large randomized trials are needed to resolve the issue and guide clinical practice.

Humans↗

Comparison of prescription reimbursement methodologies in Japan and the United States.

OBJECTIVES: To compare methods of prescription reimbursement in Japan and the United States. DATA SOURCES: Data were obtained through interviews and a search of the pharmacy literature using MEDLINE, International Pharmaceutical Abstracts, the Iowa Drug Information Service, and the Internet. Search terms were pharmacy, dispensing fee, reimbursement, prescriptions, Japan, United States, and average wholesale price (AWP). A comprehensive search was done (i.e., no year limits were observed). STUDY SELECTION AND DATA EXTRACTION: Performed manually by the authors. DATA SYNTHESIS: The reimbursement systems for prescriptions differ widely between Japan and the United States. The reimbursement system in the United States is fairly straightforward and easy to understand; it is generally based on product cost (e.g., AWP minus a percentage) plus a small dispensing fee. The system in Japan is extremely complex. Reimbursement formulae have four components, including fees for professional dispensing, drug cost, counseling and administration, and medication supplies and devices. Additionally, various adjustments to the final amount are made based on dosage form, length of therapy, number of prescriptions dispensed by the pharmacy per month, and when the prescription is filled (e.g., after hours, on Sundays or holidays). In Japan, each pharmacist is limited to filling 40 prescriptions per day, but each "prescription" can involve several medication orders, making it difficult to compare Japanese pharmacists' workloads with those of their counterparts in the United States. In addition, Japanese pharmacists are provided remuneration for providing various cognitive services, such as taking a patient history, counseling a patient, consulting with a physician, and identifying drug-related problems. CONCLUSION: Japan and the United States have very different methods of reimbursing pharmacists for dispensing prescriptions, each with positive and negative features. Based on the features of pharmacy reimbursement systems in each country, perhaps the optimal pharmacy practice system would have workload limits that reflect safety standards and amount of support staff available, provide a fair and standardized method for determining drug cost, are relatively straightforward, pay for cognitive services, and provide care for all of citizens through of some type of national health care system.

Costs and Cost Analysis↗

Intravenous valproate in status epilepticus.

OBJECTIVE: To evaluate the role of intravenous valproate sodium (IV VPA) in the treatment of status epilepticus (SE). DATA SOURCES: A literature search of the English language was performed (MEDLINE 1966-July 2000). Search terms included valproate, valproic acid, and status epilepticus. Bibliographies of articles chosen were reviewed to identify other possible sources. DATA SYNTHESIS: A review of the medical literature was conducted to evaluate the safety and efficacy of IV VPA in the treatment of SE. CONCLUSIONS: Experience with IV VPA in the treatment of SE is too limited to recommend its use as a first-line agent. IV VPA may represent a third- or fourth-line option in cases of SE when other agents are ineffective or contraindicated.

Adult↗

Intraperitoneal thrombolytic therapy for peritoneal dialysis-associated peritonitis.

OBJECTIVE: To review the literature pertaining to the use of adjunctive thrombolytic therapy for the treatment of peritoneal dialysis-associated peritonitis (PDAP). DATA SOURCES: A MEDLINE search was conducted (January 1966-December 1997) to find articles using the terms peritonitis, peritoneal dialysis, and each thrombolytic drug. References from these articles were then reviewed to identify further sources. DATA EXTRACTION: Representative case reports and clinical trials are summarized in this report. Information regarding thrombolytic dosing, administration techniques, and reported efficacy rates are included from both case reports and clinical trials. DISCUSSION: Thrombolytic agents administered intraperitoneally appear to facilitate antibiotic penetration into the biofilm formed by certain bacteria. Numerous case reports of intraperitoneal thrombolytic adjunctive therapy for recurrent or persistent PDAP have indicated that these agents may have a role in the treatment of selected patients. Urokinase and streptokinase are the only thrombolytics that have been studied. They appear to have similar efficacy, but the adverse drug event rate with streptokinase is unacceptably high. The efficacy of therapy with urokinase is probably inferior to removal of the peritoneal dialysis catheter, but, if successful, allows for the continuation of peritoneal dialysis therapy. CONCLUSIONS: In conjunction with appropriate antibiotic therapy, intraperitoneal instillation of urokinase should be reserved for patients who develop two or more episodes of recurrent or persistent PDAP in the absence of poor compliance and in whom dialysis catheter removal should be avoided (i.e., they cannot tolerate hemodialysis).

Clinical Trials as Topic↗

Ranitidine bismuth citrate in the treatment of Helicobacter pylori infection and duodenal ulcer.

OBJECTIVE: To review the clinical pharmacology of ranitidine bismuth citrate in the treatment of Helicobacter pylori (HP) infection and duodenal ulcer. DATA SOURCES: A MEDLINE search of the English-language literature from 1992 to January 1997 was conducting using the key terms Tritec, ranitidine, and bismuth. References of articles pertaining to treatment of duodenal ulcer or HP were extensively searched for relevant sources. DATA EXTRACTION: All articles pertaining to ranitidine bismuth citrate were considered for inclusion, with emphasis placed on randomized, double-blind trials. Priority was placed on data pertaining to regimens that are currently approved by the Food and Drug Administration for the treatment of duodenal ulcer in conjunction with HP. DATA SYNTHESIS: Each tablet of ranitidine bismuth citrate 400 mg contains 162 mg of ranitidine base, 128 mg of trivalent bismuth, and 110 mg of citrate. It uses the acid-suppressive actions of ranitidine and the antimicrobial and mucosal protective effects of bismuth to eradicate HP. Ranitidine bismuth citrate in conjunction with clarithromycin represents one of four treatment regimens currently approved in the US for duodenal ulcer associated with HP infection. In four double-blind, randomized trials, this agent has achieved HP eradication rates of 73-94% and duodenal ulcer healing rates of 73-89%. It is given twice daily for 28 days, and is associated with very low rates of adverse effects. CONCLUSIONS: Relative to some therapeutic alternatives, ranitidine bismuth citrate plus clarithromycin may be simpler to take and have less adverse effects, but may be more expensive. Compared with omeprazole plus clarithromycin, it is less expensive, may have lower ulcer healing rates, but may be more effective in eradicating HP. The role of ranitidine bismuth citrate will continue to evolve as more patients are treated, and other regimens continue to be tested for duodenal ulcer healing and HP eradication.

Anti-Ulcer Agents↗

Lamotrigine--an effective mood stabilizer?

OBJECTIVE: To review the literature regarding the use of lamotrigine as a mood stabilizer, and to discuss its efficacy in treating this condition. DATA SOURCES: Data were obtained from MEDLINE, Micromedex, and Cochrane collaboration searches from January 1985 to July 1998. DATA SUMMARY: There are insufficient data to confirm that lamotrigine is an effective mood stabilizer. There are no controlled studies, and the current evidence is from case studies and open trials. Furthermore, only one study shows any evidence of effectiveness in the manic phase, although this may be because the data tend to relate to a treatment-refractory population. CONCLUSIONS: From the current evidence, lamotrigine cannot be recommended as a mood stabilizer except when conventional therapies have failed.

Affect↗

Docetaxel as an alternative to paclitaxel after acute hypersensitivity reactions.

OBJECTIVE: To review the mechanism involved in paclitaxel-induced hypersensitivity reactions and to evaluate the potential use of docetaxel after acute hypersensitivity reactions (HSRs) to paclitaxel. DATA SOURCES: Literature identified through a MEDLINE search (1966-September 2000) and through secondary sources. DATA SYNTHESIS: HSRs to paclitaxel can be life-threatening. The exact etiology involved in paclitaxel-induced HSRs has not been fully elucidated; the reactions may be due to the Cremophor EL vehicle or to paclitaxel itself. Options for treatment following HSRs are limited. A rechallenge attempt can be made, but is not always successful. Docetaxel, a semisynthetic taxane, may have a role in therapy for patients unable to tolerate paclitaxel therapy. This review examines the etiology of paclitaxel-induced HSRs and the potential role of docetaxel following these acute reactions. CONCLUSIONS: Docetaxel may be a viable alternative for patients who experience HSRs to paclitaxel.

Adult↗

FDA labeling system for drugs in pregnancy.

OBJECTIVE: To review the current Food and Drug Administration (FDA) pregnancy labeling system, examine the new FDA-proposed pregnancy labeling system for form and content, and provide comments on its suitability for implementation. DATA SOURCES: Data were obtained from the FDA's Web site (www.fda.gov), PubMed, Federal Register, LexisNexis, Physician's Desk Reference (PDR), Drugdex, and Current Contents. STUDY SELECTION: Research and articles involving drugs and pregnancy, drugs and lactation, and the subcommittee meeting of the FDA were included. DATA EXTRACTION: Prospective, case-control studies from pregnancy registries. DATA SYNTHESIS: Currently, only 40% of drugs in the PDR have pregnancy categories listed. The medical profession has resorted to other means to assess pregnancy risk, such as retrospective chart review, case reports, and consultation with experts such as regional drug information centers. CONCLUSIONS: The proposed pregnancy labeling system strives for more clinical usefulness by reliance on human data derived from pregnancy registries. The clinical usefulness of the new labeling remains to be seen.

Drug Labeling↗

Low-dose ritonavir for protease inhibitor pharmacokinetic enhancement.

OBJECTIVE: To examine the use of low-dose ritonavir as a pharmacokinetic enhancer for HIV protease inhibitors. DATA SOURCES: Primary articles, review articles, and conference abstracts identified by MEDLINE search (1995-May 2001) and secondary sources. DATA SYNTHESIS: Low-dose ritonavir (100-200 mg) is increasingly being combined with HIV protease inhibitors to improve their effectiveness and allow less frequent dosing. An evaluation of the clinical evidence supporting this practice was conducted. CONCLUSIONS: Limited outcome data exist for low-dose ritonavir-based regimens in general. Although preliminary data appear promising, more clinical evidence is needed to determine the optimal dosing, long-term safety, and relative effectiveness of this approach. The role of these regimens in early therapy remains to be defined.

Clinical Trials as Topic↗

Adjuvant ketamine analgesia for the management of cancer pain.

OBJECTIVE: To review the clinical literature evaluating the utilization of intravenous ketamine for the management of cancer-related pain, to summarize the data that suggest ketamine is an appropriate adjuvant method of providing analgesia and to report a case of successful pain management using ketamine in a patient with recurrent testicular cancer at our institution. DATA SOURCES: Primary literature was identified through a MEDLINE search (1966-March 2002), and additional information was obtained through secondary and tertiary sources. DATA SYNTHESIS: The available data suggest that supplementation of morphine with ketamine improves analgesia in patients with cancer, and also provides insight to the controversy regarding the efficacy and adverse effects of various ketamine doses. At subanesthetic doses, ketamine may be beneficial at reducing opioid requirements and related adverse effects. CASE SUMMARY: A 34-year-old white man with recurrent testicular cancer was admitted with radiating neuropathic pain of the legs and lower back. The patient was suspected to also be experiencing opioid adverse effects; therefore, alternative analgesic options were warranted. Ketamine was successful in reducing patient-reported pain and was also well tolerated. CONCLUSIONS: Ketamine is an adjuvant analgesic for the treatment of cancer-related pain when other agents either fail or are intolerable. Accordingly, there are several factors that may prevent adequate pain control with opioid use; therefore, alternative analgesic options should be considered. Promise exists for ketamine as a contemporary analgesic in the appropriate patient.

Adult↗

Chromium as adjunctive treatment for type 2 diabetes.

OBJECTIVE: To review the chemistry, pharmacology, efficacy, and safety of trivalent chromium in the treatment of type 2 diabetes and hyperlipidemia. DATA SOURCES: The English literature was searched from 1966 through May 2002 using MEDLINE, International Pharmaceutical Abstracts, and EMBASE. The key words included chromium, glucose, lipids, and diabetes. Pertinent references from review articles and studies were used as additional sources. DATA SYNTHESIS: Trivalent chromium is an essential nutrient and has a key role in lipid and glucose metabolism. Supplementation with chromium does not appear to reduce glucose levels in euglycemia. It may, however, have some efficacy in reducing glucose levels in hyperglycemia. The effects of chromium on lipid levels are variable. Chromium in doses <1000 microg/d appears to be safe for short-term administration. Kidney function and dermatologic changes need to be monitored. CONCLUSIONS: Chromium appears to be a safe supplement and may have a role as adjunctive therapy for treatment of type 2 diabetes. Additional large-scale, long-term, randomized, double-blind studies examining the effect of various doses and forms of chromium are needed.

Animals↗

LMWH for perioperative anticoagulation in patients on chronic warfarin therapy.

OBJECTIVE: To review current data regarding low-molecular-weight heparin (LMWH) use for perioperative anticoagulation in patients receiving chronic warfarin therapy. DATA SOURCES: Data were obtained from the Sixth American College of Chest Physicians Consensus Conference on Antithrombotic Therapy guidelines and a MEDLINE search (1996-January 2003). Search terms included heparin, low-molecular-weight heparin, warfarin, perioperative care, and anticoagulants. DATA SYNTHESIS: Heparin is the most common agent used as bridge therapy for perioperative anticoagulation in patients on chronic warfarin therapy; LMWHs are also used. Studies that evaluated enoxaparin and/or dalteparin were reviewed. CONCLUSIONS: Although published studies demonstrate efficacy and safety of LMWHs, more data are needed to support their use as bridge therapy.

Anticoagulants↗

Combining quinupristin/dalfopristin with other agents for resistant infections.

OBJECTIVE: To review the resistance mechanisms of Enterococcus and Staphylococcus spp. and summarize quinupristin/dalfopristin's (QD's) effects on these resistant organisms when combined with other antibiotics via review of the literature and unpublished data. DATA SOURCES: Data were identified by a PubMed search (1996-May 2003) using the search terms quinupristin/dalfopristin, synergy, in vitro, in vivo, vancomycin-resistant Enterococcus faecium (VREF), methicillin-resistant Staphylococcus aureus (MRSA), and individual antibiotic names. Bibliographies of the resultant PubMed searches were reviewed and included if applicable. STUDY SELECTION AND DATA EXTRACTION: All studies reviewed were analyzed; specific drug data were included only if clinically pertinent. In vitro data from studies with adequate design were discussed, whereas all case reports and clinical trials were utilized. DATA SYNTHESIS: In the treatment of VREF, available information seems conflicting, although some clear differences have become apparent. QD-ampicillin and QD-doxycycline combinations have demonstrated beneficial activity, usually displaying synergistic or additive effects even in macrolide-, lincosamine-, and streptogramin-resistant (MLSB) isolates. Vancomycin and chloramphenicol have shown some efficacy, but antagonistic or null results also have been observed. Regarding MRSA, results from many studies of QD combinations have been ambiguous. More common combinations displayed synergy or additive effects against MRSA, but only QD-rifampin showed consistent beneficial activity against MRSA and MLSB isolates. Most other combinations displayed antagonism when tested in vitro. CONCLUSIONS: Data supporting the use of various QD-antibiotic combinations against VREF and MRSA are increasing, but further in vitro and in vivo data are needed to confirm the findings.

Anti-Bacterial Agents↗

Drug therapy recommendations from the 2005 ACC/AHA guidelines for treatment of chronic heart failure.

OBJECTIVE: To review and discuss key aspects of the drug therapy recommendations in the American College of Cardiology (ACC)/American Heart Association (AHA) 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure (HF) in the Adult. DATA SOURCES: Data were obtained from the ACC/AHA 2005 Guideline Update for Chronic HF. English-language clinical trials, observational studies, and pertinent review articles evaluating the pharmacotherapy of chronic HF were identified, based on MEDLINE searches through January 2006. STUDY SELECTION: Articles presenting information that impacts the evidence base for recommendations regarding the use of various drug therapies in patients with chronic HF were evaluated. DATA SYNTHESIS: The ACC/AHA 2005 Guideline Update for HF provides revised, evidence-based recommendations for the treatment of chronic HF. The new guidelines are based on a staging system that recognizes both the development and progression of HF. Recommendations are provided for 2 stages of patients (A and B) who do not yet have clinical HF but are clearly at risk and 2 stages (C and D) that include patients with symptomatic HF. The guidelines continue to emphasize the important role of neurohormonal blockade with angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, beta-adrenergic blockers, and aldosterone antagonists. Based on recent trials, updated recommendations address the roles of combination therapy and the selective addition of hydralazine and isosorbide dinitrate. Along with specific drug recommendations, information on the practical use of various drugs is provided. Although the guidelines primarily focus on HF due to systolic dysfunction, general recommendations are also provided for patients with preserved systolic function. CONCLUSIONS: The ACC/AHA 2005 Guideline Update provides evidence-based recommendations for healthcare professionals involved in the care of adults with chronic HF. Recent clinical trial findings have further clarified the evolving role of neurohormonal-blocking drugs in the prevention and treatment of HF.

American Heart Association↗

The struggle for language: perspectives and practices of urban parents with children who are deaf or hard of hearing.

Research is scarce on young children with hearing impairments growing up in urban environments. A qualitative study was used to explore and describe the perspectives and practices of these children's parents. An ethnographic approach enabled documentation of parents' routines, daily activities, thoughts (perceptions), and behaviors (practices). In-depth interviews and observations were the primary data sources. Data collection occurred within a 6-month period. Research questions focused on efforts parents make independently and with others (e.g., educational staff, family members) to facilitate and support their child's efforts to communicate and acquire language. Nine parents, two grandparents, and six staff members disclosed their perspectives and practices. While similarities and differences arose, universal perspectives and practices emerged among the parents that are discussed as prevailing themes. Results suggest that the parents' struggle, systemic barriers, and the urban environment are the greatest challenges facing families. Addressing these challenges will contribute to establishment of truly equitable and effective interventions for urban children, whether deaf or hard of hearing, their parents, and other family members.

Child↗

Parents' mood and the content of pediatric care for young children.

OBJECTIVE: To assess the relationship between parents' mood and the provision of anticipatory guidance by pediatric health care providers. DATA SOURCE: Data analyzed were from the National Survey of Early Childhood Health, a cross-sectional nationally representative survey concerning young children 4-35 months of age (n = 2068). KEY VARIABLES: Parents were asked whether the children's health care providers had discussed 10-12 age-appropriate health promotion topics and 5 psychosocial issues during the past 12 months. Parents also identified missed opportunities for guidance (ie, topics not discussed for which discussion would have been helpful) and reported whether providers should discuss psychosocial issues. Parents' mood was assessed using factor scores derived from the Mental Health Inventory. ANALYSES: Log-linear regression analyses determined if parents' mood was a significant predictor of the number of topics and issues discussed, the number of missed opportunities, and the reported number of issues that providers should discuss. RESULTS: Parents who were more often in a positive mood discussed more health promotion topics (B =.06, P <.001) and psychosocial issues (B =.10, P <.01) with their child's health care providers. Parents who were more often in a negative mood identified more missed opportunities (B =.08, P =.02) and more issues that providers should discuss (B =.04, P <.001). CONCLUSIONS: Increased attention to parents' mood and emotional well-being may help pediatricians identify parents who desire additional anticipatory guidance and ensure that opportunities for the provision of guidance are not inadvertently missed.

Affect↗

Biomedical data integration: using XML to link clinical and research data sets.

Data integration occurs when a query proceeds through multiple data sets, thereby relating diverse data extracted from different data sources. Data integration is particularly important to biomedical researchers since data obtained from experiments on human tissue specimens have little applied value unless they can be combined with medical data (i.e., pathologic and clinical information). In the past, research data were correlated with medical data by manually retrieving, reading, assembling and abstracting patient charts, pathology reports, radiology reports and the results of special tests and procedures. Manual annotation of research data is impractical when experiments involve hundreds or thousands of tissue specimens resulting in large, complex data collections. The purpose of this paper is to review how XML (eXtensible Markup Language) provides the fundamental tools that support biomedical data integration. The article also discusses some of the most important challenges that block the widespread availability of annotated biomedical data sets.

Data Collection↗

The relationship of host immune cells, cytokine and nitric oxide production to tumor cells in ovarian carcinoma.

AIMS: This brief review focuses on the current understanding of the complex relationship of tumor-associated mononuclear cells (TAMs) with neoplastic cells, summarizing their immunological efficiency, cytokine profile and production of nitric oxide (NO) in the tumor microenvironment, with current insights on how this might affect tumor growth. DATA SOURCE: Data was obtained through Medline from articles indexed during the last 10 years. The main key words used in the research were: cancer, ovarian cancer, cytokine, nitric oxide (NO), mononuclear cell, lymphocyte, macrophage. SELECTION OF STUDIES AND DATA COLLECTION: 30 studies were reviewed, which contained data regarding the production of cytokines and NO by TAMs or malignant cells, and tried to establish a correlation between these mediators and tumor growth, especially in ovarian carcinoma. DATA SUMMARY: TAMs consist mainly of macrophages and T lymphocytes which present lower proliferative indices and cytotoxicity compared to autologous blood monocytes, although they are able to release various cytokines. The profile of cytokine expression could help to explain both the immunological impairment observed in patients with advanced carcinoma diseases and the potential of TAMs to exert antitumor activity, which makes these cells an attractive target for therapeutic intervention. NO is also produced in the tumor microenvironment. Several reports in animals suggest a tumoricidal role for NO, but in human tumors its role has not been well-established and may change during tumor progression.

Cytokines↗