Long-term Outpatient Treatment Research Articles

Immunotherapy of advanced renal cell cancer using subcutaneous recombinant interleukin-2 and interferon-α

The combined administration of subcutaneous recombinant human interleukin-2 (rIL-2) and interferon-α (rIFN-α) was studied in a phase II trial on patients with advanced progressive renal cell cancer. Safety, tolerance and clinical response rate of this outpatient treatment protocol were assessed in 29 evaluable patients who received a total of 47 cycles, each consisting of s.c. rIL-2 at 14.4–18 million IU m−2day−1 on days 1 and 2, followed by 6 weeks of combined administration of s.c. rIL-2 at 3.6–4.8 million IU m−2 day−1 on 5 days a week, and s.c. rIFN-α at 3–6 million units m−2 three times weekly over a period of 6 consecutive weeks. In patients exhibiting stable or regressive disease upon combined IL-2 and rIFN-α, the therapy was continued. The overall response rate was 31% (95% confidence limits = 15%–51%), with 6 out of 29 patients achieving partial remission (PR, 21%) and 3 patients complete remission (CR, 10%). In addition, 12 patients presented with stable disease. The median duration of response was 8.5 months in PR and 19+ months in CR. Long-term treatment using this regimen was associated mainly with moderate (WHO grade I–II) toxicity including fevers, chills, malaise, nausea and/or vomiting, anorexia and transient local inflammation at the injection sites. No toxic deaths occurred. Altered thyroid function was observed in more than half the patients. The combination regimen resulted in a significant increase in peripheral blood eosinophils and natural killer cells (P<0.005). Up-on treatment, 14 patients developed non-neutralizing activity against rIL-2, and 2 of these developed specific neutralizing antibodies after consecutive cycles; no anti-rIFN-2b antibodies were detected. In summary, subcutaneous long-term outpatient treatment with low-dose rIL-2 and rIFN-α is feasible, with moderate toxicity, and results in an objective tumor response rate comparable to that obtained previously with high-dose rIL-2 i.v. regimens.

Psychiatric Symptoms in Alcoholics Attending Outpatient Treatment

The importance of psychiatric symptomatology for the treatment course of alcoholics was analyzed in a long-term outpatient treatment study. Seventy-two patients, 60 men and 12 women, were personally interviewed during treatment and after 3 years. Before treatment psychiatric symptoms were rated according to the Comprehensive Psychopathological Rating Scale (CPRS). Women had significantly higher scores than men. Men with many symptoms and women had more psychological benefits from drinking and a more impaired personality structure than men with few symptoms. Men with many symptoms also had a lower level of social functioning. The severity of abuse did not differ between the three groups. Men with many symptoms had a less favorable outcome between 25 and 36 months after start of treatment than men with few symptoms and women. Among men who completed treatment, those with many symptoms showed a less successful course after 6 months and during the 3rd year after start of treatment, while differences after 3 months and during later stages of treatment were less pronounced. It is suggested that before start of treatment a psychiatric evaluation should be performed including psychiatric diagnosis, personality analysis, and an assessment of psychological benefits from drinking.

Long-term outpatient treatment of CMV retinitis with ganciclovir in AIDS patients.

Cytomegaloviral retinitis was diagnosed in nine eyes of seven patients with acquired immune deficiency syndrome (AIDS) on the basis of the characteristic ocular findings and a positive culture for cytomegalovirus (CMV) obtained systemically. Treatment with ganciclovir was begun on a protocol which provided two weeks of inpatient therapy at daily doses of 2.5 to 10 mg/kg followed by outpatient therapy at a reduced dosage three to six days per week. Outpatient maintenance dosage ranged from 15 mg/kg per week to 30 mg/kg per week. In seven eyes of six patients the treatment decreased retinal inflammation and stabilised the margins of the lesions. Six patients have tolerated long term maintenance therapy for 10-30 weeks. Six of seven patients (85%) in this study developed side effects from ganciclovir which required periods of a reduction in dosage or interruption of therapy. The side effects from ganciclovir included neutropenia, thrombocytopenia, drug fever, and neuropathy. Physicians using ganciclovir in AIDS patients must watch for the signs of drug toxicity and adjust treatment accordingly. Ganciclovir appears to be a promising therapy for CMV retinitis, but further work is necessary to determine the best regimen for optimal efficacy with minimal side effects.

Cocaine Abuse: Clinical Aspects

The cocaine epidemic which started in the USA in the 1970s has become a pandemic. Cocaine is at present snorted among affluent people in the capitals in the Nordic countries. In this paper clinical signs and symptoms following cocaine abuse are presented. Psychiatric symptoms from anxiety states to paranoid psychoses may follow the abuse. The symptoms mimic traditional mental disorders An overview of treatment aspects is given. The clinician may have to handle cases of cocaine overdose among experimental users. The cocaine abusers may need detoxification from cocaine and from secondary polydrug abuse. Long-term outpatient treatment programs seem to be necessary to help the cocaine abusers abstain and avoid dramatic relapses.

Bioavailability of oral trimetrexate in patients with acquired immunodeficiency syndrome.

The combination of the lipophilic antifolate trimetrexate and the rescue agent leucovorin has shown promise in the treatment of Pneumocystis carinii pneumonia in patients with acquired immunodeficiency syndrome. The pharmacokinetic behavior of trimetrexate administered either by intravenous bolus or orally was studied in six patients with acquired immunodeficiency syndrome with a reversed-phase high-pressure liquid chromatography assay. The mean clearance following bolus injection was 38 ml/min per m2, with a range of 15 to 55 ml/min per m2. The postdistributive half-life ranged from 6 to 16 h. With oral administration, the mean bioavailability was 44% (range, 19 to 67%). An oral dose of 60 mg/m2 (162 mumol/m2) resulted in concentrations in plasma that approximated those achieved with a 30-mg/m2 (81-mumol/m2) intravenous dose. The toxicity of this combination regimen was minimal. It appears that the oral route is a practical route of administration for trimetrexate in patients with acquired immunodeficiency syndrome requiring long-term outpatient treatment or prophylaxis for P. carinii pneumonia.

Use of immunocorrectors in patients with chronic lymph leukemia

Chronic lymphatic leukemia is second only to acute leukemia in the frequency of infectious complications. In most cases, severe infectious complications are the cause of death in these patients. Modern chemotherapy makes it possible to preserve the ability to work and the life expectancy of patients for a long time. However, the negative effect of cytostatic drugs on the already altered immune system leads to an even greater suppression of immunity and an increase in the number of infectious complications. The search for new ways to combat infections has shown the advisability of long-term outpatient treatment with antibacterial drugs.

A German multicentre study on the long-term treatment of schizophrenic outpatients.

Planning a major, multicentre study on effects of neuroleptic treatment in schizophrenic outpatients requires attention to many methodological, ethical and administrative matters. This report describes the study planned by the German neuroleptic therapy study group. Three types of treatment have been chosen: prophylactic maintenance medication, neuroleptic crisis intervention and prophylactic early intervention. Patients who meet the criteria for inclusion in the study are assigned to each treatment on a random basis, provided their informed consent has been obtained. Their psychopathological symptoms, social status and physical condition are measured by means of standardised examinations and rating scales. The study is expected to continue during five years, after which computerised data analysis will be carried out to test the central hypotheses for the study.

Elective conversion from cyclosporine to azathioprine in recipients with stable renal function 6 months after kidney transplantation

The average cost of cyclosporine over the first 6 months after renal transplantation has been $2450/recipient for recipients with stable renal function. Fifty-nine percent of all patients transplanted in 1984 do not have a third-party payment mechanism for outpatient medicines and many cannot afford cyclosporine. The expense of cyclosporine has, thus, mandated developing a protocol for conversion from cyclosporine to azathioprine. Using a protocol, which included a short overlap of cyclosporine and azathioprine and a temporary, modest increase in prednisone dose, 27 renal allograft recipients with stable renal function have undergone conversion of their immunosuppressive regimen approximately 6 months posttransplant with a minimum follow-up of 4 months from conversion. There has been no graft loss or patient death. Mean serum creatinine has been reduced in recipients with stable function after conversion (1.4 mg/dl 3 months post-conversion compared to 1.8 mg/dl perconversion). However, acute breakthrough rejection has occurred in four recipients (15%), and, after reversal of rejection, mean serum creatinine is elevated (3.1 mg/dl) in this group. Only a single patient developed an infection during the conversion period. Thus, a policy of conversion from azathioprine appears to be a reasonable compromise for those patients who cannot afford long-term outpatient treatment with cyclosporine.

Patient reactions to long-term outpatient treatment with continuous subcutaneous insulin infusion.

Fourteen of the first 15 insulin-dependent diabetics to be treated in our unit by three weeks or more of outpatient continuous subcutaneous insulin infusion with a portable syringe pump completed a questionnaire about their reactions to the system. Motivation was more important to a favourable response than occupation or intelligence. Most patients thought that diabetic control was better with the pump than conventional injection treatment and several felt subjectively better. Features such as the greater flexibility of diet and insulin delivery rates during continuous subcutaneous infusion were appreciated. The most consistent adverse criticism was about the size of the device used, nearly all patients thinking that smaller and lighter infusion systems should be developed. Psychological reactions to the infusion and difficulties with interpersonal relationships were identified; these must be clearly appreciated and discussed with patients and family before and during treatment. Nine of the 14 patients said they would undertake continuous subcutaneous infusion for one year and a further two said they would do so if the infuser was smaller. These results provide guidance on future technological development of continuous subcutaneous insulin infusion and indicate that the major constraint to long-term trials of the present system is the size of the pump.

Oral Butorphanol Tartrate for the Long-Term Treatment of Out-Patients with Moderate to Severe Cancer Pain

The safety, tolerance and analgesic efficacy of multiple oral doses of butorphanol tartrate for the long-term treatment of cancer pain were evaluated in this open study. Thirty-five patients were treated with various doses (1 to 12 tablets per day) for 4 to 147 days. The median pain relief was fair, good, very good or excellent in 51% of the patients and poor in 49% of the patients. Global assessments were very similar. No clinically significant changes in blood pressure, weight, blood and urine chemistries were observed. Seventeen patients reported side-effects (only sedation and dry mouth) ranging from mild to severe.

Group psychotherapy.

Group psychotherapy is perhaps a misleading term and the concept of the group psychotherapies probably better represents the broad range of psychological treatments in psychiatry in which the group process is an essential component: from psychotherapy with a married couple to the large community group meeting in a psychiatric hospital. Group psychotherapy most commonly refers to the long-term treatment of neurotic out-patients in small groups, and this will be my main focus. Marital and family therapy have their own distinctive literatures, while the therapeutic community has been well covered in a previous column (Mandelbrote, 1979).

The long-term maintenance treatment of schizophrenic out-patients with depot flupenthixol.

SummaryAfter initial stabilisation, flupenthixol decanoate injections were given to 134 outpatient schizophrenics over a period of 28 months. Thirty percent showed extrapyramidal side-effects and 8% severe depression. Persistent anergia and hypomania were also seen. There was a significant reduction in adapted Wing's scale scores over 6 months in the first 56 patients. Severe and unpredictable extra-pyramidal side-effects were less frequent than with fluphenazine, the relapse rate among aggressive paranoid schizophrenics tending to be higher with flupenthixol. Flupenthixol-treated patients seemed more active, sociable and able to communicate than phenothiazine-treated patients, which helped in their rehabilitation. No toxic effects were seen. Flupenthixol is considered to be an effective anti-psychotic and suitable for out-patient stabilisation and maintenance therapy.

Development of out-patient services in Psychiatric departments: A study of the activities of an after-care clinic

The authors studied 214 patients who attended the aftercare clinics of the University of Helsinki Psychiatric Clinic. They found that the indiscriminating referral of nearly all discharged patients resulted in an accumulation of patients receiving long-term outpatient treatment, so that the numbers of new patients who could be accepted fell rapidly. There seemed to be two main kinds of patients, both needing careful selection while still in hospital but each needing rather different type of treatment. Both groups needed continuity of care and attention to interpersonal relationships within the family. Rehabilitation and social work services were insufficient.