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At least 235 records · Page 13Linked to original sources
PubMed2005

Twenty-four-hour control with latanoprost-timolol-fixed combination therapy vs latanoprost therapy.

OBJECTIVE: To evaluate the 24-hour efficacy and safety of the latanoprost-timolol maleate-fixed combination vs latanoprost therapy in patients with primary open-angle glaucoma. METHODS: A prospective, observer-masked, crossover, active-controlled, randomized comparison in which after a 6-week medicine-free period, patients were randomized to either latanoprost-timolol-fixed combination therapy or latanoprost therapy, both dosed once each evening, alone for 8 weeks. Patients were then switched to the opposite treatment for 8 weeks. At the end of the washout and treatment periods, a 24-hour diurnal curve was performed. RESULTS: The baseline untreated mean +/- SD diurnal curve in 37 patients who completed the study was 24.2 +/- 2.0 mm Hg. The mean diurnal curve was 19.2 +/- 2.6 mm Hg for those who received latanoprost therapy alone and 16.7 +/- 2.1 mm Hg for those who received the fixed combination therapy (P<.001). The fixed combination therapy also provided a lower absolute intraocular pressure level (1.5-2.9 mm Hg, P<.001) and a greater intraocular pressure reduction from the untreated baseline (P<.001). Stinging was statistically lower with latanoprost therapy alone (P = .04), but itching was statistically increased compared with the fixed combination therapy (P = .04). CONCLUSION: The result of this study suggests that the latanoprost-timolol-fixed combination compared with latanoprost therapy alone provides improved intraocular pressure reduction over the 24-hour diurnal curve and for each individual time point in patients with primary open-angle glaucoma.

Aged↗
PubMed2000

Therapy for patients with high grade astrocytoma using intraarterial chemotherapy and radiation therapy.

BACKGROUND: High grade astrocytomas account for approximately 40% of all primary brain tumors. The median survival is approximately 8-10 months for patients with glioblastoma multiforme and 36 months for patients with anaplastic astrocytoma. The results of systemic chemotherapy in the treatment of brain tumors have been reported to be less than satisfactory, mainly because of the blood-brain barrier impermeability for chemotherapeutic drugs. Intraarterial chemotherapy has been an attractive alternative with which to overcome this problem. METHODS: Eighty-three patients with high grade astrocytoma (glioblastoma multiforme [63 patients] and anaplastic astrocytoma--[20 patients]) were treated with intraarterial (intracarotid and/or intravertebral) chemotherapy and radiation therapy between 1987 and 1997. Patients received cisplatin, 60 mg/m2, and etoposide, 40 mg/m2. Radiation therapy was delivered either after completion of the chemotherapy or concomitantly with the chemotherapy. RESULTS: Thirty-four of 71 evaluable patients with high grade astrocytoma (48%) responded to the chemotherapy. The median survival for patients with glioblastoma multiforme who received chemotherapy prior to radiation therapy was 20 months versus 7 months for those patients who underwent concomitant chemotherapy/radiation therapy. Patients with anaplastic astrocytoma who received chemotherapy prior to radiation therapy had a median survival of 45 months compared with 12 months for patients who received concomitant chemotherapy/ radiation therapy. The toxicity profile has been reported to be mild and well tolerated. CONCLUSIONS: Intraarterial chemotherapy for patients with glioblastoma multiforme, delivered prior to radiation therapy, appears to result in a median survival three times longer than that achieved with concomitant chemotherapy/radiation therapy. In addition, patients appear to survive substantially longer than they do after radiation therapy with the addition of systemic chemotherapy. Side effects are reported to be acceptable.

Adult↗
PubMedDate not supplied

Combined radiation therapy and surgery in the management of advanced head and neck cancer: final report of study 73-03 of the Radiation Therapy Oncology Group.

Between March 1973 and June 1979, patients with advanced operable squamous cell carcinoma of the supraglottic larynx or hypopharynx were randomly allocated to receive either preoperative radiation therapy (5,000 rad) or postoperative radiation therapy (6,000 rad). Patients with oral cavity or oropharynx lesions were randomly assigned either preoperative radiation, postoperative radiation, or definitive radiation therapy (6,500-7,000 rad), with surgery reserved for salvage if residual disease was present 6 weeks after completion of irradiation. Three hundred twenty patients were evaluable with a median follow-up of 60 months. Based on results in 277 patients across all four regions combined, locoregional control was significantly better for patients assigned to receive postoperative radiation therapy (65%) compared with those assigned to receive preoperative radiation therapy (48%, P = 0.04). This was due to a higher rate of both persistent and recurrent local and regional disease in the preoperative group. Survival also showed a trend to be better in the postoperative group (38%) compared with the preoperative group (33%, P = 0.10). Rates of severe surgical and radiation therapy complications were similar overall. Forty-three patients were evaluable for each of the three treatment regimens assigned to patients with oral cavity or oropharynx lesions. Due to the small number of patients available for this portion of the trial, the observed differences for overall survival (4-year percentage 33% overall; 30% preoperative, 36% postoperative, 33% definitive radiation therapy) and for locoregional control (45% overall; 43% preoperative, 52% postoperative, 38% definitive radiation therapy) were not statistically significant. The use of definitive radiation therapy with surgical rescue as an ethically justified alternative treatment for these tumors remains a question for further research.

Carcinoma, Squamous Cell↗
PubMed1996

Dual therapy versus triple therapy for Helicobacter pylori-associated duodenal ulcers.

We compared the ulcer healing effect and eradication of H. pylori by one-week triple therapy of bismuth, metronidazole, and tetracycline with two-week dual therapy of amoxicillin and omeprazole. One hundred twelve patients with confirmed H. pylori infection and duodenal ulcers were recruited in a prospective, randomized, single-blinded trial. Ulcer healing, eradication of H. pylori in the stomach six weeks after randomization and side effect reported by patients during the therapy. Duodenal ulcers were healed in 44 of 49 (89.8%, 95% CI, 81.3-98.3 %) patients receiving triple therapy and in 44 of 53 (83.0%, 95% CI, 72.9-93.1%) patients receiving dual therapy (P=0.32). H. pylori was successfully eradicated in 41 of 49 (83.6%, 95% CI 73.4-94%) patients and in 40 of 53 (75.5%, 95% CI 63.9-87.1%) patients in the triple therapy group and the dual therapy group respectively (P=0.31). Side effects experienced by patients who received triple therapy were significantly more frequent than those who received dual therapy (P=0.0076). In conclusion, a two-week course of omeprazole and amoxicillin achieves a comparable rate of H. pylori and ulcer healing with fewer side effect.

Adolescent↗
PubMed2006

Therapeutic effect of spa therapy and short wave therapy in knee osteoarthritis: a randomized, single blind, controlled trial.

Spa therapy and short wave therapy are two of the most commonly used non-pharmacological approaches for osteoarthritis. The aim of this study was to assess their efficacy in comparison to conventional therapy in patients with osteoarthritis of the knee in a single blind, randomized, controlled trial. Seventy-four outpatients were enrolled; 30 patients were treated with a combination of daily local mud packs and arsenical ferruginous mineral bath water from the thermal resort of Levico Terme (Trento, Italy) for 3 weeks; 24 patients were treated with short wave therapy for the same period and 20 patients continued regular, routine ambulatory care. Patients were assessed at baseline, upon completion of the 3-week treatment period, and 12 weeks later. Spa therapy and short wave therapy both demonstrated effective symptomatic treatment in osteoarthritis of the knee at the end of the treatment, but only the spa therapy was shown to have efficacy persistent over time. Our study demonstrated the superiority of arsenical ferruginous spa therapy compared to short wave therapy in the treatment of osteoarthritis of the knee, probably in relationship to the specific effects of the minerals in this water.

Acetaminophen↗
PubMed1997

Beneficial effect of combination hormonal therapy administered prior and following external beam radiation therapy in localized prostate cancer.

PURPOSE: The aim of the present study is to investigate whether combined androgen blockade associated with radiation therapy for localized prostate cancer decreases at 12 and 24 months the rate of positive follow-up biopsies and serum PSA compared to radiation therapy alone. This is the report of an interim analysis. METHODS AND MATERIALS: One hundred and twenty patients with clinical Stage B1-T2a, B2-T2b/T2c, and C-T3/T4, adenocarcinoma of the prostate were entered in a prospective randomized study. After written informed consent, the subjects were randomly allocated between external beam radiation therapy (EBRT) alone (group 1), 3 months of neoadjuvant combination therapy (LHRH-agonist + Flutamide) prior to EBRT (group 2), and a third group receiving combination therapy 3 months before, during, and 6 months after EBRT. There is no significant difference between the three groups concerning age, stage of disease, grade of tumor, and pretreatment PSA levels. Control transrectal ultrasound (TRUS)-guided needle biopsies (one core was taken from the initial cancer site regardless of the presence or absence of TRUS abnormalities) were done 12 and 24 months after the end of EBRT. Serum PSA measurements were done on schedule visits. RESULTS: Ninety-two and 68 patients underwent biopsies at 12 and 24 months, respectively, after the end of radiation therapy. While 62% of control patients at 12 months in Group 1 disclosed residual neoplasm, only 30% and 4% showed residual disease in groups 2 and 3, respectively (p = 0.00005). When looking at 24 months, 65, 28, and 5% showed residual cancer for groups 1, 2, and 3, respectively (p = 0.00001). The PSA measurements indicate also at 12 months a difference between the three groups (p < 0.0001), except at 24 months, the difference between the group 2 and 3 is no longer significant. CONCLUSION: The preliminary analysis of this clinical trial indicates that patients treated with radiation therapy alone show a significantly higher rate of positive biopsies at 12 and 24 months after the end of radiation therapy as compared with those treated with total antiandrogen blockade (TAB) and radiation therapy. When analyzing the median PSA serum levels, we found the same advantage at 12 months, but, at the time of the analysis at 24 months, the PSA levels are not different between groups 2 and 3.

Aged↗
PubMed2002

Status and potential of gene therapy in clinical medicine. Assessment of an emerging health technology through systematic survey of clinical gene therapy protocols and published results.

OBJECTIVE: Somatic gene therapy is a new method in the rapidly expanding field of molecular medicine. Due to recent encouraging results and the promising prospect for some disease groups, Norwegian health authorities wanted to assess somatic therapy with evidence-based standards for strategic use. This article presents the results of this assessment, discussed in the context of the policy-making process in Norway, including ethical and legislational considerations. METHODS: Clinical gene therapy protocols, ongoing or completed with published results, where available, were identified through a systematic survey of descriptive protocols and publications. Preclinical literature was also reviewed. RESULTS: Gene therapy is dominated by preclinical and clinical research. Most of the gene therapy protocols identified are in early phases (phases I and II) with only a few patients in each study. Of the protocols included in the assessment, only three phase III studies are represented. Except for the use of soluble antisense oligonucleotides against cytomegalovirus eye infection, gene therapy is presently not an established treatment modality. Promising results have been observed in treatment of cancer and cardiovascular diseases and, most recently, in inherited severe combined immunodeficiency and hemophilia. Several interesting principles addressing a large panel of conditions are currently being developed and tested. CONCLUSIONS: Gene therapy is developing into an important medical concept that needs to be included within the Norwegian healthcare system. It is recommended that the Norwegian Ministry of Health and Social Affairs fund a national program to boost infrastructure in selected scientific groups both in preclinical and clinical research. The national procedures regulating approval of gene therapy trials should be made more efficient while at the same time allowing for proper control and ethical considerations. It is emphasized that gene therapy trials should be carefully monitored for side effects.

Clinical Protocols↗
PubMed2002

Rationale for combination therapy of intraurethral prostaglandin E(1) and sildenafil in the salvage of erectile dysfunction patients desiring noninvasive therapy.

Corpus cavernosum smooth muscle relaxation and hence penile erection are regulated in part by increases in smooth muscle synthesis of the second messengers cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). The object of this study was to determine 30-month follow-up results in motivated patients desiring noninvasive medical therapy using sildenafil citrate (Viagra) in combination with intraurethral prostaglandin E(1) (PGE(1)) (Medicated Urethral System for Erection [MUSE]). Twenty-eight patients (mean +/- s.d. age, 59 +/-7.3 y; 17 who had undergone radical prostatectomy and 11 who had a diagnosis of organic erectile dysfunction) were included in this study. Detailed history taking and physical examinations were performed and vascular risk factors noted. In these patients, treatment with either 100 mg of sildenafil citrate and/or 1000 microg of MUSE had failed. None of these patients desired intracavernosal injection. Duplex Doppler ultrasonography after redosing was carried out on all patients. Dynamic infusion corpus cavernosography/cavernosometry was obtained in 17 of 28 patients, and combination therapy was initiated using 100 mg of sildenafil citrate orally 60 min before intercourse and 500 microg of MUSE intraurethrally immediately before intercourse. Independently, either 100 mg of sildenafil citrate or 1000 microg of MUSE was not efficacious in inducing an erection sufficient for vaginal penetration in any of the 28 patients. After initiating a combination therapy, at 30 months, all 28 patients were reporting erections sufficient for vaginal penetration, with 3.6 intercourse episodes per month. None of the patients crossed over to intracavernosal therapy or penile prosthesis. During therapy, eight of 28 patients reduced the dose of sildenafil citrate to 50 mg. Combination therapy with MUSE and sildenafil may be more efficacious in the salvage of patients who desire noninvasive therapy but in whom single-treatment modalities fail. Although both cAMP- and cGMP-mediated vasodilation can lead to penile erection, combining therapies that incorporate both pathways may succeed when single therapies fail.

Aged↗
PubMed2003

A prospective, randomized study of quadruple therapy and high-dose dual therapy for treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin.

BACKGROUND AND AIM: Failure of primary anti-H. pylori therapy results in a high rate of antimicrobial resistance. Here, we investigated the efficacy of high-dose dual therapy and quadruple therapy as salvage treatments for eradication of H. pylori resistant to both metronidazole and clarithromycin. PATIENTS AND METHODS: Patients with at least one treatment failure and infected with H. pylori resistant to both metronidazole and clarithromycin, were randomized to receive either omeprazole 4 x 40 mg and amoxicillin 4 x 750 mg; or omeprazole 2 x 20 mg, bismuthcitrate 4 x 107 mg, metronidazole 4 x 500 mg and tetracycline 4 x 500 mg. Both regimens were given for 14 days. In cases of persistent infection, a cross-over therapy was performed. RESULTS: Eighty-four patients were randomized. Cure of H. pylori infection was achieved in 31 patients after dual therapy and in 35 patients after quadruple therapy (per protocol: 83.8% (95% CI, 67.9-93.8) and 92.1% (95% CI, 78.6-98.3), respectively (p=0.71); intention to treat: 75.6% (95% CI: 59.7-87.6) and 81.4% (95% CI: 66.6-91.6), respectively (p=0.60)). Cross-over therapy was performed in six of nine patients, four of whom were cured of the infection. CONCLUSION: Both high-dose dual therapy and quadruple therapy are effective in curing H. pylori infection resistant to both metronidazole and clarithromycin in patients who experienced previous treatment failures.

Adult↗
PubMed2003

Higher renal replacement therapy dose delivery influences on drug therapy.

Higher doses of renal replacement therapy have profound effects on pharmacotherapy, yet little research has been conducted in this area. High-volume renal replacement therapies influence both the pharmacokinetic and the pharmacodynamic profiles of all drugs administered to these critically ill patients. Intermittent high-dose "hybrid" hemodialysis therapies remove drugs to a much different degree than standard thrice-weekly hemodialysis, yet pharmacokinetic studies have not been performed in patients receiving these therapies. High-volume continuous renal replacement therapies offer dosing challenges not seen with standard low-dose therapies. This article describes the pharmacokinetic and pharmacodynamic issues presented by high-volume renal replacement therapies. Given the importance that pharmacotherapy has on optimal patient outcomes, a better understanding of the influence that high-volume renal replacement therapy has on drugs is essential if these high volume therapies are to be used successfully in the intensive care unit.

Acute Kidney Injury↗
PubMed1998

Maintenance antiretroviral therapies in HIV-infected subjects with undetectable plasma HIV RNA after triple-drug therapy. AIDS Clinical Trials Group Study 343 Team.

BACKGROUND: Combination antiretroviral therapy with indinavir, zidovudine, and lamivudine can suppress the level of human immunodeficiency virus (HIV) RNA in plasma below the threshold of detection for two years or more. We investigated whether a less intensive maintenance regimen could sustain viral suppression after an initial response to combination therapy. METHODS: HIV-infected subjects who had CD4 cell counts greater than 200 per cubic millimeter, who had been treated with indinavir, lamivudine, and zidovudine, and who had less than 200 copies of HIV RNA per milliliter of plasma after 16, 20, and 24 weeks of induction therapy were randomly assigned to receive either continued triple-drug therapy (106 subjects), indinavir alone (103 subjects), or a combination of zidovudine and lamivudine (107 subjects). The primary end point was loss of viral suppression, which was defined as a plasma level of at least 200 copies of HIV RNA per milliliter on two consecutive measurements during maintenance therapy. RESULTS: During maintenance treatment, 23 percent of the subjects receiving indinavir and 23 percent of those receiving zidovudine and lamivudine, but only 4 percent of those receiving all three drugs, had loss of viral suppression (P<0.001 for the comparison between triple-drug therapy and the other two maintenance regimens). Subjects with greater increases in CD4 cell counts during induction therapy, higher viral loads at base line (i.e., at the beginning of induction therapy), and slower rates of viral clearance were at greater risk for loss of viral suppression. The presence of zidovudine-resistance mutations in HIV RNA at base line was strongly predictive of the loss of viral suppression in subjects treated with zidovudine and lamivudine. CONCLUSIONS: The suppression of plasma HIV RNA after six months of treatment with indinavir, zidovudine, and lamivudine is better sustained by the continuation of these three drugs than by maintenance therapy with either indinavir alone or zidovudine and lamivudine.

Adult↗
PubMed2001

Changes in profiles of circulating insulin-like growth factor components during hormone replacement therapy according to the responsiveness to therapy in postmenopausal women.

OBJECTIVES: Objectives of this study were (1) to evaluate the changes in the profiles of circulating insulin-like growth factor and of insulin-like growth factor-binding proteins during hormone replacement therapy and their relation with responsiveness to hormone replacement therapy and (2) to investigate the relationship between the changes in these insulin-like growth factor components and the annual changes in bone mineral density in postmenopausal women. STUDY DESIGN: Insulin-like growth factor and insulin-like growth factor-binding proteins were measured by immunoradiometric assay and Western ligand blotting in sera from 39 postmenopausal women treated with sequential hormone replacement therapy for 1 year. Bone mineral density at the lumbar spine and the proximal portion of the femur was determined by dual-energy x-ray absorptiometry. RESULTS: No significant change in the serum levels of insulin-like growth factor II and insulin-like growth factor-binding protein was noted during hormone replacement therapy in either the responders to therapy or the nonresponders (women with >3% bone loss per year), but serum levels of insulin-like growth factor I and proportions of insulin-like growth factor-binding proteins 1, 2, and 4 decreased during hormone replacement therapy only in the former group. Changes in insulin-like growth factor components during hormone replacement therapy did not correlate with annual bone mineral density changes. CONCLUSION: Profiles of circulating insulin-like growth factor I and insulin-like growth factor-binding proteins might be involved in responsiveness to hormone replacement therapy, but changes in these components during hormone replacement therapy do not predict annual changes in bone mineral density.

Absorptiometry, Photon↗
PubMed1999

Gene gun-mediated IL-12 gene therapy induces antitumor effects in the absence of toxicity: a direct comparison with systemic IL-12 protein therapy.

Using three murine tumor models, we compared the antitumor efficacy and certain physiological effects of an in vivo interleukin-12 (IL-12) gene therapy protocol and a systemic IL-12 protein therapy protocol. An IL-12 cDNA gene construct was administered in situ into skin tissue via gene gun delivery, and recombinant IL-12 protein was administered subcutaneously at a dose of 1 microgram/mouse/treatment. Both treatment regimes induced a comparable level of regression of established intradermal MethA sarcomas. In B16 melanoma and P815 mastocytoma models, antitumor efficacy of IL-12 protein therapy appeared to be slightly higher than that of IL-12 gene therapy; however, the protein therapy protocol in this comparative study resulted in a high level of mortality of mice. It was also demonstrated that IL-12 gene therapy, in contrast to the IL-12 protein therapy, was not associated with weight loss, splenomegaly, increased Ly6 antigen expression in the spleen, or visible signs of toxicity, such as fur ruffling and lethargy. Moreover, serum levels of interferon-gamma (IFN-gamma) induced in response to IL-12 gene therapy were 300-1000 times lower than those induced by the systemic IL-12 protein administration. Together, these results suggest that gene gunmediated in vivo delivery of IL-12 cDNA may be considered as a safer alternative to IL-12 protein therapy for certain human cancers.

Animals↗
PubMed1998

Cure of Helicobacter pylori infection and healing of duodenal ulcer: comparison of pantoprazole-based one-week modified triple therapy versus two-week dual therapy. The International Pantoprazole HP Study Group.

OBJECTIVE: Eradication of Helicobacter pylori (H. pylori) is recommended as the first-line therapeutic concept for reliable long-term prevention of duodenal ulcer (DU) relapse. Current treatment regimens vary in efficacy, complexity, and compliance. To assess the efficacy of pantoprazole in H. pylori eradication in parallel groups of patients using two eradication regimens. METHODS: Patients, (18-85 yr old; intention-to-treat, n=286) with proven DU, positive rapid urease test (biopsy), and 13C-urea breath test (UBT) were included in a prospective, randomized, multicenter study. Modified triple therapy consisted of 40 mg pantoprazole b.i.d., 500 mg clarithromycin t.i.d., and 500 mg metronidazole t.i.d. for 7 days (PCM therapy); dual therapy consisted of 40 mg pantoprazole b.i.d. and 500 mg clarithromycin t.id. for 14 days (PC therapy). In both groups 40 mg pantoprazole o.d. was given until day 28 when healing of DU was evaluated endoscopically; H. pylori status was assessed by UBT on day 56. RESULTS: H. pylori eradication rate was 95% in PCM versus 60% in PC therapy groups (perprotocol population, p < 0.001), and 82% in PCM versus 50% in PC therapy in the intention-to-treat patient population (p < 0.001). The DU healing rate was 98% in the PCM and 95% in the PC therapy groups (per-protocol population). Both regimens were similarly well tolerated. Adverse events in both regimens included taste disturbance, diarrhea, and increased serum concentration of liver enzymes, at an incidence of < 10%. CONCLUSIONS: Compared to 2-wk PC therapy (pantoprazole and clarithromycin), the 1-wk PCM therapy (pantoprazole, clarithromycin, and metronidazole) is a significantly superior and highly promising strategy for eradication of H. pylori.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

Combination therapy of intravenous maxacalcitol and percutaneous ethanol injection therapy lowers serum parathyroid hormone level and calcium x phosphorus product in secondary hyperparathyroidism.

BACKGROUND: Percutaneous ethanol injection therapy (PEIT) is an alternative treatment for secondary hyperparathyroidism (SHPT). Although maxacalcitol has been recently developed as a new vitamin D3 and its efficacy is anticipated in SHPT, there are only few reports on the usefulness of combination therapy of intravenous maxacalcitol and selective PEIT. METHODS: The study population comprised 10 hemodialysis patients (6 males and 4 females, mean age; 51.5 +/- 13.5 years, mean HD period 13.7 +/- 3.5 years), with high intact-PTH level (>400 pg/ml) and 1 or 2 enlarged parathyroid glands detected by power Doppler ultrasonography. Intravenous maxacalcitol therapy commenced one week after PEIT at 15 microg/week. The effect of combination therapy was monitored by measuring intact-PTH, serum Ca and P, bone metabolic markers, parathyroid gland volume and bone mineral density, prior to and at 6 and 12 months after PEIT. RESULTS: Successful control of intact-PTH, bone metabolic markers and parathyroid gland volume was achieved using the combination therapy. Serum P and CaxP product were significantly decreased 12 months after PEIT. The mean values of serum intact-PTH, P and CaxP product fulfilled all of the K/DOQI guidelines at 12 months after PEIT. None of the patients developed complications related to PEIT-maxacalcitol therapy during 12 months following PEIT. CONCLUSION: Combination therapy of intravenous maxacalcitol therapy and selective PEIT is safe and effective for the treatment of refractory SHPT. This combination therapy results in suppression of PTH secretion, regression of parathyroid hyperplasia and the control of CaxP product, which may prevent calcific uremic arteriolopathy in dialysis patients.

Adult↗
PubMed2004

Antithrombotic therapy in children: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.

This article about antithrombotic therapy in children is part of the 7th American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines. Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh the risks, burden, and costs. Grade 2 suggests that individual patients' values may lead to different choices (for a full understanding of the grading see Guyatt et al, CHEST 2004; 126:179S-187S). Among the key recommendations in this article are the following. In neonates with venous thromboembolism (VTE), we suggest treatment with either unfractionated heparin or low-molecular-weight heparin (LMWH), or radiographic monitoring and anticoagulation therapy if extension occurs (Grade 2C). We suggest that clinicians not use thrombolytic therapy for treating VTE in neonates, unless there is major vessel occlusion that is causing the critical compromise of organs or limbs (Grade 2C). For children (ie, > 2 months of age) with an initial VTE, we recommend treatment with i.v. heparin or LMWH (Grade 1C+). We suggest continuing anticoagulant therapy for idiopathic thromboembolic events (TEs) for at least 6 months using vitamin K antagonists (target international normalized ratio [INR], 2.5; INR range, 2.0 to 3.0) or alternatively LMWH (Grade 2C). We suggest that clinicians not use thrombolytic therapy routinely for VTE in children (Grade 2C). For neonates and children requiring cardiac catheterization (CC) via an artery, we recommend i.v. heparin prophylaxis (Grade 1A). We suggest the use of heparin doses of 100 to 150 U/kg as a bolus and that further doses may be required in prolonged procedures (both Grade 2 B). For prophylaxis for CC, we recommend against aspirin therapy (Grade 1B). For neonates and children with peripheral arterial catheters in situ, we recommend the administration of low-dose heparin through a catheter, preferably by continuous infusion to prolong the catheter patency (Grade 1A). For children with a peripheral arterial catheter-related TE, we suggest the immediate removal of the catheter (Grade 2C). For prevention of aortic thrombosis secondary to the use of umbilical artery catheters in neonates, we suggest low-dose heparin infusion (1 to 5 U/h) (Grade 2A). In children with Kawasaki disease, we recommend therapy with aspirin in high doses initially (80 to 100 mg/kg/d during the acute phase, for up to 14 days) and then in lower doses (3 to 5 mg/kg/d for > or = 7 weeks) [Grade 1C+], as well as therapy with i.v. gammaglobulin within 10 days of the onset of symptoms (Grade 1A).

Child↗
PubMed2003

Hormone replacement therapy and the risk of breast cancer: assessment of therapy acceptance in a cohort of previously treated breast cancer patients.

INTRODUCTION: In the postmenopausal period, an average of 25% of women will present symptomatic ovarian failure requiring hormonal replacement therapy. Estrogen can relieve vasomotor symptoms. Hormonal replacement therapy is generally not recommended for breast cancer patients due to the potential risk of tumor recurrence. To answer the questions about the safety of hormonal replacement therapy in this subgroup of women, it is necessary to establish the acceptance of treatment. METHODS: Between September 1998 and February 2001, a cohort of 216 breast cancer patients were asked to complete a questionnaire. All patients had completed their treatment and were informed about survival rates after breast cancer and hormonal replacement therapy. RESULTS: Among the 216 patients, 134 (62%) would refuse hormonal replacement therapy. A hundred patients were afraid of relapse (74.6%). Adjuvant tamoxifen therapy was the only statistically significant variable (70.3% versus 29.7% p=0.003). Understanding clinical stage (p= 0.045) and type of medical assistance (private versus public, p=0.033) also seemed to influence the decision. Early stage disease (p= 0.22), type of surgical procedure (radical versus conservative, p=0.67), adjuvant chemotherapy (p=0.082) or marital status (p=0.98 ) were not statistically significant in decision making. Several patients submitted to adjuvant chemotherapy (41.6%) would accept hormonal replacement therapy under medical supervision, as did most of advanced clinical stage patients (58.3%; p=0.022). CONCLUSION: There is a high level of rejection for hormonal replacement therapy among breast cancer patients when current data on tumor cure rates, and potential risks of estrogen use is available. Adverse effects of tamoxifen in the adjuvant setting may be the reason for refusal of hormonal replacement therapy.

Adolescent↗
PubMed2006

Psychological therapies including dialectical behaviour therapy for borderline personality disorder: a systematic review and preliminary economic evaluation.

OBJECTIVES: To summarise the available evidence on the clinical effectiveness and cost-effectiveness of psychological therapies including dialectical behaviour therapy (DBT) for borderline personality disorder (BPD). DATA SOURCES: Electronic databases were searched up to March 2005. REVIEW METHODS: Relevant studies were assessed using standard checklists and data were abstracted by two reviewers using standardised forms. Separate economic evaluations were undertaken for six selected randomised controlled trials (RCTs). Cost-effectiveness was assessed in terms of cost per parasuicide event avoided in all six trials and cost per quality-adjusted life-year (QALY) in four of them. All results are at 2003-4 prices and for 12 months follow-up. RESULTS: Nine RCTs and one non-RCT of moderate to poor quality were identified in the clinical effectiveness review. They provided some evidence that DBT is more effective than treatment as usual (TAU) for the treatment of chronically parasuicidal and drug-dependent borderline women; that DBT-orientated therapy is more effective than client-centred therapy (CCT) for the treatment of BPD; and that DBT is as effective as comprehensive validation therapy plus 12-Step for the treatment of opioid-dependent borderline women. There was also some evidence that partial hospitalisation is more effective than TAU in the treatment of BPD, good evidence that manual-assisted cognitive behavioural therapy (MACT) is no more effective than TAU in the treatment of BPD and some evidence that interpersonal group therapy is no more effective than individual mentalisation-based partial hospitalisation (MBT) for the treatment of BPD. However, these results should be interpreted with caution as not all studies were primarily targeted to borderline symptoms and there were considerable differences between the studies. The assessment of cost-effectiveness found a mix of results in the four trials of DBT, along with the high levels of uncertainty and the limitations in the analyses. The findings do not support the cost-effectiveness of DBT though they suggest it has the potential to be cost-effective. The results for MBT are promising, though again surrounded by a high degree of uncertainty and for MACT, the analysis suggests that the intervention is unlikely to be cost-effective. CONCLUSIONS: The overall efficacy of psychological therapies is promising; however, at this stage the evidence is inconclusive. The cost-effectiveness of the intervention in six RCTs examined, however, does not support the cost-effectiveness of DBT although potential is suggested. There is a need for considerable research in this area. This research should involve appropriately powered head-to-head RCTs of psychological therapies; a survey of current practice and the use of the full range of services by people with BPD to inform future economic analyses; full resource-use data collected in the context of pragmatic clinical trials; psychometric assessment of the validity of the EQ-5D or other generic and condition-specific preference-based measures in BPD, and the development of a more formal cost-effectiveness model using the above data.

Behavior Therapy↗