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PubMedDate not supplied

Inhibitory effect of enzyme therapy and combination therapy with cyclosporin A on collagen-induced arthritis.

OBJECTIVE: There is increasing interest in the use of combination therapy for rheumatoid arthritis and in the possibility of combining the conventional drug approach with newer antirheumatic therapy. The present study investigates the efficacy of long-term prophylactic enzyme therapy and combination therapy with cyclosporin A in rats with collagen-induced arthritis. METHODS: Rats with collagen-induced arthritis were administered the following drugs: cyclosporin A (5 mg/kg/day and 10 mg/kg/day orally); a mixture of enzymes containing pure substances (bromelain, trypsin, rutin) in the same ratio as in Phlogenzym (PHL, 150 mg/kg, twice daily intrarectally); and a combination of 5 mg/kg/day cyclosporin A plus 300 mg/kg/day PHL for a period of 50 days from the immunization. Levels of serum albumin, serum nitrite/nitrate concentrations, changes in hind paw swelling and bone erosions were measured in the rats as variables of inflammation and destructive arthritis-associated changes. RESULTS: Treatment with 10 mg/kg cyclosporin A, as well as combination therapy with half dosages of cyclosporin A (5 mg/kg) plus PHL significantly inhibited both inflammation and destructive arthritis-associated changes. Significant differences in favor of combination therapy with 5 mg/kg CsA + 300 mg/kg PHL as compared to 5 mg/kg CsA alone were seen in hind paw swelling. Also, reduction of the radiographic scores was more significant in the combination therapy group. Five mg cyclosporin A or PHL alone reduced the disease markers studied to a lesser extent, and in the case of enzyme therapy this occurred at a later stage of arthritis development. CONCLUSION: Our results show the inhibitory effect of enzyme therapy on collagen-induced arthritis in rats, as well as the efficacy of cyclosporin A given in low doses in combination with enzyme therapy, which may be useful in the treatment of rheumatoid arthritis.

Animals↗
PubMed2006

[A randomized controlled study comparing uracil-tegafur (UFT)+tamoxifen (UFT+TAM therapy) with cyclophosphamide+adriamycin+5-fluorouracil (CAF therapy) for women with stage I , II, or IIIa breast cancer with four or more involved nodes in the adjuvant setting].

We performed a controlled study to compare the response to cyclophosphamide (CPA), adriamycin (ADM), and fluorouracil (5-FU) (CAF therapy) with that to uracil-tegafur (UFT) plus tamoxifen (TAM) (UFT+TAM therapy), when given as postoperative adjuvant therapy to women with breast cancer. The patients were registered from September 1991 through February 1995 at 51 institutions in the Kinki district of Japan. All patients had stage I, II, or IIIa breast cancer with four or more lymph-node metastases and underwent mastectomy. CAF therapy and UFT+TAM therapy were started within 4 weeks after surgery. CAF therapy consisted of CPA (100 mg/day) on days 1 to 14, followed by 2 weeks of rest, plus ADM (20 mg/m(2)/day) on days 1 and 8 and 5-FU (300 mg/m(2)/day) on days 1 and 8. A total of 6 courses were delivered. UFT+TAM therapy consisted of 3 years of UFT (400 mg/day) plus TAM (20 mg/day), given daily. CAF therapy and UFT+TAM therapy were each assigned to 82 patients. The 5-year survival rate was significantly higher in the UFT+TAM group (82.1%) than in the CAF group (66.2%; p=0.04, logrank test). The 5-year relapse-free survival rate was higher in the UFT+TAM group (61.8%) than in the CAF group (46.3%; p=0.07, logrank test). As for adverse events, the rates of leukopenia, anorexia, nausea and vomiting, general malaise, and hair loss were lower in the UFT+TAM group than in the CAF group. These results suggest that long-term treatment with UFT+TAM may be a useful alternative adjuvant therapy for the management of breast cancer, especially in elderly patients.

Anorexia↗
PubMed1988

Combination therapy with flutamide and castration (orchiectomy or LHRH agonist): the minimal endocrine therapy in both untreated and previously treated patients with advanced prostate cancer.

One hundred fifty-four patients with clinical stage D2 prostate cancer with no previous endocrine therapy or chemotherapy received the combination therapy with the pure antiandrogen Flutamide and the LHRH agonist [D-Trp]LHRH ethylamide for an average of 22 months (3 to 49). The objective response to the treatment was assessed according to the criteria of the US NPCP. There was a 6.3-fold increase (29.2 versus 4.6%) in the percentage of patients who achieved a complete response as compared to the results achieved in 5 recent studies limited to removal (orchiectomy) or blockade (DES or Leuprolide) of testicular androgens. Only 4.5% of patients did not respond to the combination therapy as compared to an average of 18% by standard therapy. The duration of response is also significantly increased in the patients who received the combination therapy while the death rate was decreased by approximately 2-fold between 2 and 3 years of treatment. The marked (6.3-fold) improvement in the rate of complete objective responses coupled with the 4-fold decrease in the number of non responders, the increased duration of the positive responses and the 2-fold decrease in the death rate at 2 to 3 years of treatment are obtained with the combination therapy using Flutamide and castration with no or minimal secondary effects. In addition, two hundred nine patients with biopsy-proven stage D2 prostatic adenocarcinoma showing disease progression after orchiectomy, DES or an LHRH agonist used alone received the combination therapy with the pure antiandrogen Flutamide. In patients treated with DES, the estrogen was replaced by the LHRH agonist [D-Trp6]LHRH ethylamide. Objective response to therapy was also assessed according to the criteria of the US NPCP. Thirteen patients (6.2%) had a complete response to treatment while partial and stable responses were achieved in 20 (9.6%) and 39 (18.7%) patients, respectively, for a total objective response rate of 34.5%. The mean duration of response was 24 months. While, in the non responders, the median survival was 8.13 months with a 17% probability of survival at 2 years, the probability of survival of patients who showed partial and stable responses at 2 years was 87 and 67%, respectively. All patients who achieved a complete response are still alive. Considering the excellent tolerance coupled with an objective response observed in 34.5% of the patients, the combination therapy with Flutamide and castration (surgical or LHRH agonist) appears to be the treatment of choice for prostate cancer patients in relapse after standard endocrine therapy.

Adenocarcinoma↗
PubMed2001

Efficacy of candesartan cilexetil as add-on therapy in hypertensive patients uncontrolled on background therapy: a clinical experience trial. ACTION Study Investigators.

A large-scale, 8-week, open-label, clinical experience trial evaluated the efficacy of the angiotensin II receptor (AT1 subtype) blocker candesartan cilexetil (16 to 32 mg once daily) either alone or as add-on therapy in 6465 hypertensive patients. The study population was 52% female and 16% African American with a mean age of 58 years. It included 5,446 patients who had essential hypertension (HBP) and 1,014 patients who had isolated systolic hypertension (ISH). These patients had either untreated or uncontrolled hypertension (systolic blood pressure [SBP] 140 to 179 mm Hg or diastolic blood pressure [DBP] 90 to 109 mm Hg inclusive at baseline) despite a variety of antihypertensive medications including diuretics, calcium antagonists, angiotensin converting enzyme (ACE) inhibitors, and alpha- or beta-blockers, either singly or in combination. The mean baseline blood pressure for the HBP group was 156/97 mm Hg. Candesartan cilexetil as monotherapy (in 51% of HBP patients) reduced mean SBP/DBP by 18.7/ 13.1 mm Hg. As add-on therapy (in 49% of HBP patients) to various background therapies, candesartan cilexetil consistently reduced mean SBP/DBP further, irrespective of the background therapy: diuretics (17.8/11.3 mm Hg), calcium antagonists (16.6/11.2 mm Hg), beta-blockers (16.5/ 10.4 mm Hg), ACE inhibitors (15.3/10.0 mm Hg), alpha-blockers (16.4/10.4 mm Hg). The mean baseline blood pressure for the ISH group was 158/81 mm Hg. Candesartan cilexetil, as monotherapy (in 34% of ISH patients), reduced SBP/DBP by 17.0/4.4 mm Hg. As add-on therapy (in 66% of ISH patients) to various background therapies, candesartan cilexetil consistently reduced mean SBP/DBP further, irrespective of the background therapy: diuretics (17.4/5.1 mm Hg), calcium antagonists (15.6/3.6 mm Hg), beta-blockers (14.0/4.8 mm Hg), ACE inhibitors (13.4/4.3 mm Hg), and alpha-blockers (11.6/4.5 mm Hg). The further blood pressure lowering effects of candesartan cilexetil as add-on therapy were seen regardless of age, sex, and race. Overall, 6.8% of the 6465 patients withdrew because of adverse events, most commonly headache (6.3%) and dizziness (5.0%). Orthostatic hypotension was infrequent; 0.2% with candesartan cilexetil alone, and 0.8% with candesartan cilexetil as add-on therapy. Thus, candesartan cilexetil either alone or as add-on therapy was highly effective for the control of systolic or diastolic hypertension regardless of demographic background when used in typical clinical practice settings.

Adult↗
PubMed1998

Early transition to oral antibiotic therapy for community-acquired pneumonia: duration of therapy, clinical outcomes, and cost analysis.

Our objective was to compare therapeutic outcome and analyse cost-benefit of a 'conventional' (7-day course of i.v. antibiotic therapy) vs. an abbreviated (2-day i.v. antibiotic course followed by 'switch' to oral antibiotics) therapy for in-patients with community-acquired pneumonia (CAP). We used a multicenter prospective, randomized, parallel group with a 28 day follow-up, at the University-based teaching hospitals: The Medical Center of Louisiana in New Orleans, LA and hospitals listed in the acknowledgement. Ninety-five patients were randomized to receive either a 'conventional' course of intravenous antibiotic therapy with cefamandole 1 g i.v. every 6 h for 7 days (n = 37), or an abbreviated course of intravenous therapy with cefamandole (1 g i.v. every 6 h for 2 days) followed by oral therapy with cefaclor (500 mg every 8 h for 5 days). No difference was found in the clinical courses, cure rates, survival or the resolution of the chest radiograph abnormalities among the two groups. The mean duration of therapy (6.88 days for the conventional group compared to 7-30 days for the early oral therapy group) and the frequencies of overall symptomatic improvement (97% vs. 95%, respectively) were similar in both groups. Patients who received early oral therapy had shorter hospital stays (7.3 vs. 9.71 days, P = 0.01), and a lower total cost of care ($2953 vs. $5002, P < 0.05). It was concluded that early transition to an oral antibiotic after an abbreviated course of intravenous therapy in CAP is substantially less expensive and has comparable efficacy to conventional intravenous therapy. Altering physicians' customary management of hospitalized patients with CAP can reduce costs with no appreciable additional risk of adverse patient outcome.

Administration, Oral↗
PubMed2005

Endoscopic therapy versus medical therapy for bleeding peptic ulcer with adherent clot: a meta-analysis.

BACKGROUND & AIMS: The optimal management of bleeding peptic ulcer with adherent clot is controversial and may include endoscopic therapy or medical therapy. METHODS: We searched MEDLINE, BIOSIS, EMBASE, and the Cochrane Library to identify all randomized controlled trials comparing the 2 interventions. Outcomes evaluated in the meta-analysis were recurrent bleeding, need for surgical intervention, length of hospitalization, transfusion requirement, and mortality. RESULTS: Six studies were identified that included 240 patients from the United States, Hong Kong, South Korea, and Spain. Patients in the endoscopic therapy group underwent endoscopic clot removal and treatment of the underlying lesion with thermal energy, electrocoagulation, and/or injection of sclerosants. Rebleeding occurred in 5 of 61 (8.2%) patients in the endoscopic therapy group, compared with 21 of 85 (24.7%) in the medical therapy group (P = .01), for a pooled relative risk of 0.35 (95% confidence interval, 0.14-0.83; number needed to treat, 6.3). There was no difference between endoscopic therapy and medical therapy in length of hospital stay (mean, 6.8 vs 5.6 days; P = .27), transfusion requirement (mean, 3.0 vs 2.8 units of packed red blood cells; P = .75), or mortality (9.8% vs 7%; P = .54). Patients in the endoscopic therapy group were less likely to undergo surgery (pooled relative risk, 0.43; 95% confidence interval, 0.19-0.98; number needed to treat, 13.3); however, this outcome became nonsignificant when only peer-reviewed studies were considered. CONCLUSIONS: Endoscopic therapy is superior to medical therapy for preventing recurrent hemorrhage in patients with bleeding peptic ulcers and adherent clots. The interventions are comparable with respect to the need for surgical intervention, length of hospital stay, transfusion requirement, and mortality.

Blood Transfusion↗
PubMed1996

Comparison of hormonal therapy and chemohormonal therapy in patients with newly diagnosed clinical stage D prostatic cancer.

BACKGROUND: In order to examine the usefulness of chemohormonal therapy, we conducted a multicentered randomized trial comparing hormonal therapy, using a luteinizing hormone-releasing hormone (LH-RH) agonist, with chemohormonal therapy, hormonal therapy plus cyclophosphamide (CPM), in patients with newly diagnosed clinical stage D prostatic cancer. METHODS: Between January 1991 and March 1995, 41 evaluable patients with stage D prostatic cancer were randomized into 2 groups: group A (hormonal therapy alone), goserelin acetate depot 3.6 mg subcutaneously every 4 weeks: group B (chemohormonal therapy), goserelin acetate depot 3.6 mg subcutaneously and CPM 1000 mg/m2 intravenously every 4 weeks. The responses to the therapies were evaluated based on the criteria of The Japanese Urological Association. RESULTS: There were no significant differences between the 2 groups with regard to objective and subjective response rates. No advantage in chemohormonal therapy was observed in the survival rate and progression-free survival rate. However, the survival rate and progression-free survival rate of responders were significantly higher than those of nonresponders in both groups. When the results were categorized by histologic grade patients with poorly-differentiated adenocarcinoma had significantly higher response rates, survival rates, and disease-progression-free survival rates in Group B compared to similar patients in Group A. CONCLUSIONS: We conclude that chemohormonal therapy does not definitely improve the clinical response and prognosis of patients with stage D prostatic cancer; however, for patients with poorly-differentiated adenocarcinoma, chemohormonal therapy is a useful treatment.

Aged↗
PubMed1998

The usefulness of Holter monitoring in selecting pharmacologic therapy for patients with sustained monomorphic ventricular tachycardia: studies in patients in whom no effective pharmacologic therapy could be determined by electrophysiologic study.

The usefulness of Holter monitoring (HM) in selecting pharmacologic therapy for patients with sustained monomorphic ventricular tachycardia (VT) was evaluated in patients in whom no effective pharmacologic therapy could be determined in an electrophysiologic study (EPS). The study population consisted of 49 consecutive patients with sustained VT who were receiving long-term pharmacologic therapy despite the fact that no pharmacologic therapy had been found to be effective in the EPS. The efficacy of the pharmacologic therapies was assessed by HM. A reduction in frequent (10/h) premature ventricular contractions (PVCs) was used as an index of treatment efficacy, with therapies achieving substantial PVC suppression (>70% of all PVCs) being considered to be effective (HM effective group). When no therapy was found to be effective when assessed by HM, a drug with any other beneficial effect, eg, reduction in VT rate, was chosen (HM ineffective group). VT recurrence and survival were compared between groups. During the follow-up period of 31+/-28 months, VT recurrence was observed in a total of 25/49 patients: 3/17 patients in the HM effective group, in 18/25 in the HM ineffective group, and in 4/7 in the HM undetermined group (p=0.0487). Sudden cardiac death occurred in a total 7/49 patients: 2/17 patients in the HM effective group, 4/25 patients in the HM ineffective group, and 1/7 patient in the HM undetermined group (p=0.2828). Among patients in whom no effective therapy could be determined by EPS, the VT recurrence rate was significantly lower in the group in whom treatment was effective as assessed by HM than among those in whom treatment was assessed by HM to be ineffective. Sudden cardiac death rate was also lowest in the HM effective group, although the difference was not statistically significant. HM assessment was considered useful in selection of pharmacologic therapy for patients in whom no effective therapy could be determined in the EPS.

Adolescent↗
PubMed1991

The efficacy of Lasix-vitamin therapy (L-V therapy) for sudden deafness and other sensorineural hearing loss.

The efficacy of Lasix-vitamin therapy (L-V therapy) for sudden deafness (SD) was compared with that of conventional therapeutic regimens. There was no significant difference in efficacy between the two therapies. However, in fresh cases (within 7 days from onset of SD), L-V therapy gave a cure rate of 42.3% and an effectiveness rate of 88.4%, these rates being higher than those obtained with conventional therapy; and in cases treated within 4 weeks, L-V therapy was significantly more effective than conventional therapy. Besides, in cases with severe hearing loss (more than 70 dB hearing level) or vestibular symptoms, which were important factors of prognosis, L-V therapy proved more efficient. The efficacy of L-V therapy for other sensorineural hearing loss was also evaluated. In Meniere's disease, L-V therapy proved effective in 45.9% of cases, but with only a 20-30% effectiveness rate in other cases, e.g. idiopathic hearing loss, head and neck injury, noise-induced hearing loss and chronic otitis media.

Adult↗
PubMed1991

[A comparative study of CHOP therapy and COP-BLAM therapy for non-Hodgkin's lymphoma in elderly patients].

Elderly patients (aged greater than or equal to 65 years) with non-Hodgkin's lymphoma were treated either with CHOP or COP-BLAM therapy, and the effectiveness and reverse effects of COP-BLAM therapy were compared with those of CHOP therapy. Thirty-three patients (aged greater than or equal to 65 years) with previously untreated non-Hodgkin's lymphoma were entered either on CHOP or COP-BLAM regimen between September, 1979 and February 1990. To CHOP therapy was performed in 15 patients (median age; 70 years). Eight of them had diffuse large cell type lymphoma (large), five had diffuse medium-sized cell type (medium) and two had diffuse mixed cell type (mixed). As to clinical stage, there were patients in stage II, 4 in stage III and 9 in stage IV in CHOP group. Of 18 patients (median age; 68 years), who were treated with COP-BLAM therapy, 8 had of large lymphoma and 10 medium lymphomas in histopathological classification. In terms of clinical stage, there were 5 patients in stage II, 4 in stage III and 9 in stage IV. CHOP therapy and COP-BLAM therapy were performed according to the method reported by McKelvey et al, and by Laurence et al., respectively, using the full doses of drugs without consideration the age. Complete remission (CR) was achieved in seven (46.7%) of 15 patients treated with CHOP therapy. In this group, five (38.5%) of 13 patients in advanced stages (stage III or IV) entered CR. Of 18 patients subjected to COP-BLAM therapy, 15 (83.3%) achieved CR. Among 13 patients in advanced stage treated with COP-BLAM therapy, CR was achieved in 11 (84.6%).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed2005

Low dose prednisolone reduces CD4+ T cell loss in therapy-naive HIV-patients without antiretroviral therapy.

BACKGROUND: A favorable development of CD4+ T cells was noticed in therapy-naive HIV-patients without antiretroviral therapy (ART) taking 5 mg prednisolone daily. Based on these encouraging observations, prednisolone therapy in further HIV-patients without antiretroviral therapy was initiated. OBJECTIVE: To evaluate the effect of low dose prednisolone on therapy-naive HIV patients without antiretroviral therapy. METHODS: A retrospective analysis has been conducted comparing the development of CD4+ T cells, viral load and clinical outcome in all therapy-naive HIV-patients with (n = 65; CD4 > or =300/microl) or without (n = 136; CD4 > or =300/microl) prednisolone treatment for > or =6 months. RESULTS: After 3 years, therapy-naive patients on prednisolone therapy showed a CD4+ T cell increase of +50.1/microl whereas in the untreated group a decrease of -186.1/microl (p = 0.0021) was noted. After 12 months, nearly twice as much untreated patients experienced a first-time CD4+ T cell loss of >100/microl or initiation of HAART due to clinical development compared to prednisolone-treated patients (64.1% vs. 35.0%). CD4+ T cell increase was associated with viral load at baseline: Patients with lower viral loads at baseline (<30,000 copies/ml) showed a favorable development with statistically significant less drop-outs (defined as HAART-onset and/or prednisolone discontinuation for the prednisolone group) than patients with higher viral loads at baseline in the first 3 years in the prednisolone group. - CONCLUSION: Low dose prednisolone seems to be associated with a stabilization of CD4+ T cell count in therapy-naive HIV patients resulting in a pronounced prolongation of the potential time without HAART for many HIV patients.

CD4 Lymphocyte Count↗
PubMedDate not supplied

[Therapy goals, change of goals and goal attainment in the process of psychoanalytically oriented and behavior long-term therapy--a comparative study from the private practices of insurance-registered psychotherapists].

In a prospective naturalistic design 31 patients with long-term behavior therapy (average 63 treatment hours) and 31 patients with psychoanalytically-oriented long-term therapy (average 185 treatment hours) were compared. All patients were examined by extern interviewers with the Structured Clinical Interview for Diagnosis (SCID) before they were included in the study. Only patients that showed DSM-III-R criteria of a depressive or anxiety disorder were included. At four times the patient goals in therapy and the actual state was examined: At the beginning of treatment, after 1, after 2,5 and after 3,5 years. At all times the patients could formulate new goals and release old ones. The symptoms were registered by SCL-90-R and the interpersonal problems were recorded by IIP-D. After 3,5 years a follow-up interview was conducted. Although all patients were comparable in their diagnoses the patients in behavior therapy and those in psychoanalytically-oriented therapy differed in a number of characteristics, for example by the way they gained access to therapy (doctors' subscription versus personal initiative for an appointment), the education, the consuming of psychotropic medication and the strain of symptoms. The patients did not differ remarkably in their goals in therapy. The symptoms as a goal did not have the highest priority in both groups, but the category "self-worth-problems" was found in both groups with a high priority. About one third of therapy goals were redefined by the patients in both groups within one year. After 2,5 years the number of goals in the category "interpersonal conflicts" increases remarkably in both treatment groups. For both groups we found the extent of reaching aimed goals in therapy (recorded by GAS) was significant over time. The results seem to prove that psychotherapy under naturalistic conditions aims more at improving the general level of functioning than at reducing the symptoms.

Adult↗
PubMedDate not supplied

One-week quadruple therapy is an effective salvage regimen for Helicobacter pylori infection in patients after failure of standard triple therapy.

Standard triple therapy remains an important option for eradicating Helicobacter pylori (Hp) in developing countries because of its relatively low cost. However, salvage therapies after failure of this regimen remain undefined. The authors therefore investigate the efficacy of 1-week quadruple therapy as a second-line treatment of Hp infection after failure of standard triple therapy. Seventy-eight patients who failed Hp eradication using a 2-week bismuth-based triple therapy were enrolled and received a course of 1-week quadruple therapy (lansoprazole, 30 mg twice daily; bismuth subcitrate, 120 mg four times daily; clarithromycin, 500 mg twice daily; and amoxicillin, 1,000 mg twice daily) as a salvage regimen. The Hp status was reassessed 7 weeks after cessation of therapy. Among the 78 patients, Hp eradication was achieved in 65 (83%, 95% confidence interval = 75-91%) by intention-to-treat analysis. Only five (6%) patients had side effects, and all (100%) showed good drug compliance. Multivariate analysis disclosed that coffee drinking was an independent factor for treatment failure (odds ratio = 5.3, 95% confidence interval = 1.2-23.6, p = 0.028). The authors therefore conclude that their 1-week quadruple therapy is an effective salvage regimen for Hp infection after failure of standard triple therapy in the population examined. The benefits of this regimen include the high eradication rate, the short duration of treatment, fewer side effects, and good drug compliance. Coffee consumption possibly is an important factor in failure of the rescue regimen. The mechanisms underlying the association between coffee drinking and eradication failure require further research.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2002

Colloidal bismuth subcitrate-based twice-a-day quadruple therapy as primary or salvage therapy for Helicobacter pylori infection.

OBJECTIVE: Helicobacter pylori (H. pylori) eradication rates in northern Sardinia using standard 1-wk triple therapies (i.e., a proton pump inhibitor and two antibiotics) are typically <60%, primarily because of antibiotic resistance. The aim of this study was to test b.i.d. quadruple therapy as primary and as salvage therapy in this population. METHODS: This was a prospective, single center study of consecutive dyspeptic H. pylori-infected patients. Therapy consisted of omeprazole 20 mg, tetracycline 500 mg, metronidazole 500 mg, and bismuth subcitrate caplets 240 mg, all b.i.d. with the midday and evening meals for 14 days. H. pylori status was evaluated by 13C-urea breath test and histology before and 4-6 wk after therapy. Eradication was defined as no positive test. RESULTS: We enrolled 118 consecutive dyspeptic patients (mean age 46 yr; 73 men, including 15 with peptic ulcer disease). Of the patients, 42 (38%) had failed prior therapy: twice in 21 cases, three times in 12, and four or more times in nine. The intention-to-treat cure rate was 95% (110 of 116) (95% CI = 90-98%) overall, and 98% per protocol, irrespective of diagnosis, age, prior treatment failure, or smoking status. Moderate or severe side effects were experienced by only 5% of patients. CONCLUSIONS: Bismuth subcitrate-based b.i.d. quadruple therapy was an excellent primary and salvage therapy and should be considered as first line therapy.

Adult↗
PubMed1994

Cost effectiveness of group physical therapy compared to individualized therapy for ankylosing spondylitis. A randomized controlled trial.

OBJECTIVE: Cost effectiveness analysis is helpful in setting priorities for funding of health care programs. We studied the cost effectiveness of supervised group physical therapy compared to unsupervised exercises at home in patients with ankylosing spondylitis (AS). METHODS: A total of 144 patients with AS (modified New York criteria; mean age: 43 years) were randomized to unsupervised daily individualized exercises at home for 9 months or the same plus supervised group physical therapy (3 h weekly). At baseline and after 9 months we measured spinal mobility (thoracolumbar flexion and extension), fitness (maximum work capacity by ergometry), and patient's global assessment of change as measured on a visual analog scale. We used a questionnaire at baseline and a diary during the trial to measure AS related direct medical costs, such as doctor visits, paramedical treatment, medication and hospitalization. RESULTS: The mean effects of group therapy and home exercises were, respectively, +0.9 cm (16%) and +0.5 cm (9%) for mobility, +7 watts (4%) and -2 watts (-1%) for fitness, and +1.7 (34%) and +0.3 (6%) for global health. These 3 differences were significant (p < 0.01 for mobility, p = 0.05 for fitness and p < 0.01 for global health). During the trial total medical costs decreased by an average of US $379 (44%) for group therapy, and by $257 (35%)/patient/year for the "home" group. Additional costs of group therapy were estimated at $531/patient/year ($177 for accommodation, $256 for therapist and $98 for materials). After the study 75% of the patients wanted to continue group physical therapy and were willing to pay for it. CONCLUSION: Compared to therapy at home, additional benefits of group therapy cost $531/year, but reduced direct medical costs by $122/year. Hence, the beneficial effects of group therapy cost $409/patient with AS/year.

Adult↗
PubMedDate not supplied

Chemogene therapy: osteocalcin promoter-based suicide gene therapy in combination with methotrexate in a murine osteosarcoma model.

We previously reported that the recombinant adenovirus (Ad) vector containing the thymidine kinase (TK) gene driven by the osteocalcin (OC) promoter (Ad-OC-TK), when delivered concurrently with acyclovir (ACV), is highly selective in blocking the growth of osteosarcoma in experimental models (Cancer Res. 1996;56:4614-4619). To investigate the possible additive effects of the combined treatment of gene therapy and conventional chemotherapy (chemogene therapy), we compared the effect of low dose (IC10) methotrexate (MTX) and OC promoter-based toxic gene therapy with either of these single modalities alone. We choose low dose MTX with the intent of determining whether chemosensitization of the osteosarcoma may be possible in combination with gene therapy with an overall reduced toxicity profile and enhanced therapeutic efficacy when compared to a single agent alone. In vitro, the combined treatments of MTX (3 ng/mL) and Ad-OC-TK (20 multiplicity of infection (MOI)/target cell) plus ACV (10 mg/mL) had an additive therapeutic effect over that of either MTX (P < 0.05) or Ad-OC-TK plus ACV treatment alone (P < 0.05). In vivo, nude mice with subcutaneous tumors of either human osteosarcoma (MG-63) or rat osteosarcoma (ROS) received three intratumoral injections of Ad-OC-TK (5 x 10(8) PFU) plus daily intraperitoneal ACV (40 mg/kg body weight) for 2 weeks in combination with five weekly bolus intraperitoneal MTX (87.5 mg/kg). Osteosarcoma tumor growth was inhibited more efficiently than by either Ad-OC-TK plus ACV (P < 0.05) or MTX treatment (P < 0.005) alone. At day 45 in the ROS group, 100% of the animals survived when treated with chemogene therapy, whereas 80% survived with gene therapy and no animals survived in the MTX-treated or untreated controls. In summary, we developed a novel therapeutic strategy for the treatment of osteosarcoma employing both chemotherapy and gene therapy. Chemogene therapy could potentially achieve better antitumor effects with reduced toxicity than the conventional chemotherapy or gene therapy protocols alone.

Acyclovir↗
PubMed2001

Speech and language therapy for dysarthria due to non-progressive brain damage.

BACKGROUND: Dysarthria is a common sequel of non-progressive brain damage (typically stroke and traumatic brain damage). Impairment-based therapy and a wide variety of compensatory management strategies are undertaken by speech and language therapists with this patient population. OBJECTIVES: To determine the efficacy of speech and language therapy interventions for adults with dysarthria following non-progressive brain damage. SEARCH STRATEGY: This review has drawn on the search strategies developed for the following Cochrane Groups as a whole: Stroke, Injuries, and Infectious Diseases. Relevant trials were identified in the Specialised Registers of Controlled Trials (see Review Group Details for more information). We also searched the trials register of the Cochrane Rehabilitation and Related Therapies Field. The Cochrane Controlled Trials Register, MEDLINE, EMBASE, CINAHL, PsycLIT, and Linguistics and Language Behavior Abstracts were electronically searched. Hand-searching of The International Journal of Language and Communication Disorders and of reference lists from relevant articles and conference proceedings was also undertaken. Colleagues were approached to identify other possible published and unpublished studies. Date of most recent searches: May 2000. SELECTION CRITERIA: Unconfounded randomised controlled trials. DATA COLLECTION AND ANALYSIS: One reviewer assessed trial quality. Two co-reviewers were available to examine any potential trials for possible inclusion in the review. MAIN RESULTS: No trials of the required standard were identified. REVIEWER'S CONCLUSIONS: There is no evidence of the quality required by this review to support or refute the effectiveness of Speech and Language Therapy interventions for dysarthria following non-progressive brain damage. There is an urgent need for good quality research in this area.

Adult↗
PubMed2001

Comparison between intravenous immunoglobulin and conventional immunosuppressive therapy regimens in patients with severe oral pemphigoid: effects on disease progression in patients nonresponsive to dapsone therapy.

CONTEXT: Mucous membrane pemphigoid has a wide clinical spectrum. The clinical context was to determine whether pemphigoid disease that initiates in the oral cavity progresses to involve other mucosae and to determine the influence of systemic therapy on such progression. OBJECTIVE: To determine the clinical outcomes and disease progression in patients with oral pemphigoid for whom dapsone therapy was impossible. DESIGN: Retrospective analysis of a cohort of 20 patients with immunopathologic-proven oral pemphigoid studied between September 1, 1994, and October 31, 2000. Twelve patients received conventional therapy that consisted of a combination of oral prednisone with an immunosuppressive agent. Eight patients in whom such therapy was contraindicated received intravenous immunoglobulin therapy. Patients were followed up for 33 to 62 months (mean follow-up, 47.5 months). SETTING: Patients were treated in an ambulatory tertiary medical care facility of a university-affiliated hospital. PATIENTS: The 20 patients had pemphigoid disease limited to the oral cavity only at the initial clinical presentation and when enrolled in the study. MAIN OUTCOME MEASURES: The following variables were compared between the 2 groups of patients: (1) duration of treatment, (2) frequency of relapses, (3) induction of remission, (4) adverse effects of therapy, (5) extra oral involvement, and (6) quality of life. RESULTS: Using the aforementioned factors, the group treated with intravenous immunoglobulin had statistically significant shorter treatment duration, fewer relapses, higher remission rate, fewer adverse effects, no extraoral involvement, and a better quality of life compared with the group who received conventional therapy. CONCLUSIONS: Intravenous immunoglobulin is a safe and effective modality to treat mucous membrane pemphigoid. It seems to be a good option for patients who cannot be treated with dapsone and in whom conventional therapy is contraindicated or results in the development of serious adverse effects. In patients with progressive mucous membrane pemphigoid, intravenous immunoglobulin therapy may arrest disease progression.

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