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A 30-year-old veteran heroin addict being treated with methadone maintenance suffered renal failure. He underwent haemodialysis, peritoneal dialysis and cadaveric renal transplantation while being maintained on methodone. This report illustrates long-term treatment of heroin addicts with renal failure.
Clinical, biochemical and immunological variables were analyzed in 30 patients with orcein-negative (ON) chronic active hepatitis (CAH), 4 patients with ON primary biliary cirrhosis (PBC), 8 patients with orcein-positive (OP; intracellular copper-binding protein seen histologically in liver biopsy specimens) CAH and 15 patients with OP-PBC. A marked elevation of serum bile acids, alkaline phosphatase, leusine aminopeptidase, gammaglutamyl transpeptidase and cholesterol concentrations, and highly pathological BSP Tm values were characteristic for OP-cases. In addition the faecal fat level was increased and bile acids decreased in OP-cases. Serum levels of IgG or IgM and the occurrence of smooth muscle, mitochondrial or glomerular antibodies were identical in ON- and OP-CAH as well as also in ON- and OP-PBC. 49 patients were treated with a combination of prednisone and azathioprine from 4 to 72 months (mean 22). 26 patients with ON-CAH responded biochemically and morphologically to the treatment. No treatment failures were found in ON-CAH. In contrast treatment failure was confirmed in every treated OP-PBC or OP-CAH. The results suggest that orcein-positivity indicates a poor response to prednisone-azathioprine treatment of CAH.
Patients with severe symptomatic renal osteodystrophy were treated with either 1,25(OH)2D3 or 1 alpha(OH)D3. In 39 instances, there was either reversal of symptoms and/or a marked fall in plasma alkaline phosphatase. Bone biopsies showed improvement of either osteomalacia or osteitis fibrosa, and serum iPTH often fell. In thirteen patients, no improvement occurred. In seven patients, bone biopsy disclosed osteomalacia, and serum iPTH was normal or only slightly elevated. Thus, there was a defect in mineralisation. apparently unrelated to the lack of 1,25(OH)2D3 and in the absence of evidence of phosphate depletion. The other 'treatment failure' group showed osteitis fibrosa on biopsy and iPTH levels were markedly elevated. They are presumed to have marked secondary hyperparathyroidism. These 'treatment failure' groups had higher pre-treatment levels of serum Ca and Mg than in those showing a favourable response; also, hypercalcaemia developed rapidly during 1,25(OH)2D3 treatment. Thus, 1,25(OH)2D3 is efficacious in treating symptomatic osteodystrophy in many uraemic patients, and in other patients, it may help identify bone disease of other, as yet unknown, pathogenesis.
Surgical therapy has been the accepted method for management of most soft tissue sarcomas of the extremities, although it has been associated frequently with local treatment failure. Even when local control was achieved, over 50% of the patients with soft tissue sarcomas eventually developed and succumbed to distant metastases of their disease. Therefore, single modality therapy for soft tissue sarcomas by operation alone results in an unacceptably high incidence of treatment failure. Fortunately, new adjuvant treatment techniques have been developed that seem to have activity against these neoplasms. It is the purpose of this article to discuss our experience with a number of these techniques.
1. Psychiatry is in dire need of research in all areas--from psychopharmacology to psychotherapy. 2. It is unethical not to undertake research as long as hundreds of thousands of patients suffer from incapacitating mental disorders. 3. It is unethical not to apply proper research principles to obtain maximal information from the observations of patients treated by different drugs or techniques. 4. The Tokyo (Helsinki II) declaration takes cognizance of the special problems in psychiatric (and certain other areas of) research, and should help to heighten the standard of all clinical research. 5. Psychopharmacology is based on the principles of the biological sciences. In the behavioral aspects of clinical psychopharmacological research non-objective observations cannot solely be based on these principles, but we should always be able to aim at: a. Description of spontaneous history. b. Description of diagnostic and therapeutic techniques and processes. c. Description of goals. d. Description of results (with as detailed information on treatment failures as on treatment successes). e. Prospective studies instead of retrospective ones. 6. Psychopharmacology is probably the area within psychiatry where the ethical issues have been most protected against the uncritical introduction of unproven therapeutic principles.
The results of staging and treatment of 18 patients with diffuse histiocytic lymphoma involving the gastrointestinal tract are summarized. Widespread disease (Stage IV) was found in the majority (72%) of patients after rigorous staging, indicating the relative rarity of localized gastrointestinal lymphoma and the resulting need for systemic therapy in most of these patients. Chemotherapy combined with surgical resection and/or radiation therapy produced complete remissions in only 5 of 18 patients (28%). Patients failed to achieve complete remission due to 1) tumor resistance to drug therapy (46% of treatment failures), and 2) massive intestinal hemorrhage or bowel perforation secondary to tumor necrosis (38% of treatment failures). These findings indicate the need for more active chemotherapeutic regimens and for measures aimed at preventing complications such as bowel perforation or hemorrhage, possibly by combining surgical resection of bowel lesions with systemic chemotherapy.
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The prevalence of gonococcal infection of the rectum and pharynx in 239 consecutive women with gonorrhoea presenting as named contacts was 47% and 10% respectively. In 2% of all patients the rectum and pharynx were each the sole sites of infection. Treatment failure occurred in three patients given a single dose of aqueous procaine penicillin 2.4 megaunits intramuscularly, two of whom had rectal infections; no treatment failures occurred in patients with pharyngeal infections. The incidence of rectal gonorrhoea significantly increased with the duration of infection (P less than 0.001). This suggests that autoinoculation from infected vaginal material is of major importance in the transmission of gonococcal infection to the rectum.
Three hundred and eighty-nine subjects, ages 21-55, with diastolic blood pressures between 90 and 115 mm Hg were studied prospectively for 7-10 years in a controlled intervention trial to determine whether pressure lowering reduces the incidence of cardiovascular complications and death. The assignment to therapy, either a combination of a diuretic and rauwolfia serpentina, or an identical placebo, was random. Adverse effects required termination in only 23 (5.9%) cases. Diastolic blood pressure (DBP) was reduced an average of 10 mm Hg (systolic equals 16 mm Hg) in the active treatment group with no change in the placebo group. The major end points of death, myocardial infarction, and stroke totaled 17 and were nearly equally divided between treatment and placebo. Other manifestations of coronary disease were also equally distributed. Complications such as electrocardiographic hypervoltage, left ventricular hypertrophy, radiogrpahic cardiomegaly, and retinopathy occurred in the placebo group at a rate of 53.1 per 100 subjects compared to 23.8 per 100 in those on active drugs. Treatment failure occurred in 24 placebo-treated cases and none of the active group. The overall effectiveness of pressure lowering in reducing these complications and treatment failure was 60%. It is concluded that given the lower level of excess risk in mild uncomplicated hypertension, and the failure of active drug therapy to protect against coronary disease, systematic follow-up without drugs while attempting hygienic intervention and control of other risk factors may be a reasonable alternative for this large group.
In hope of reducing the duration of adjuvant treatment in premenopausal patients with operable breast cancer and histologically positive axillary lymph nodes, a prospective controlled study was started in September 1975. A total of 160 patients were randomized to receive 12 cycles of adjuvant CMF, while 165 were allocated to receive 6 cycles. At 3 years from radical mastectomy, the relapse-free survival was 85.4% in the 12-cycle group compared to 82.6% for the 6-cycle subset (P = 0.29). In both treatment groups, the incidence of treatment failure was directly proportional to the number of involved axillary nodes and to the clinical tumor size. Drug-induced amenorrhea as well as estrogen receptor status failed to significantly affect the results obtained. Treatment failures were more often documented in distant sites, while only 4--5% relapse was observed in local-regional areas. Overall survival was also similar for both treatment arms (86.2% vs. 85.1%, P = 0.49). Toxicity was moderate and reversible and no drug-induced neoplasms were so far observed. Present results achieved with 6 cycles of adjuvant CMF appear encouraging. However, they are still too preliminary to recommend the routine use of 6 cycles instead of the classical 12 cycles.
This paper reports the results of treating 152 women with carnidazole, a new trichomonacidal drug. They were divided into two groups. The first comprised 91 patients who were treated with 2 g, while the second group comprised 61 patients who were treated with 1-5 g carnidazole in a single oral dose. Defaulter rates were 6-6% for the first group and 13-1% for the second. Of the remaining 85 patients in the first group, 76 (89-5%) were negative at the first follow-up one to three weeks after treatment, three (3-5%) were considered to be treatment failures, and six (7-0%) were considered to be reinfected. Of 53 women treated with 1-5 g, 39 (73-6%) were negative at first follow-up, eight (15-1%) were considered to be treatment failures, and six (11-3%) were considered to be reinfected. The difference between the number of patients cured in both groups is statistically significant. Fourteen patients experienced side-effects, but these were of little significance. Carnidazole given in a single oral dose of 2 g in 16 women did not cause consistent changes in any of the haematological and biochemical parameters studied.
126 female patients with proven gonococcal infection were treated with 4 g. spectinomycin bihydrochloride given intramuscularly in a single does. In 120 cases followed up there were four possible treatment failures, giving a cure rate of 97-6 per cent. 99 male patients with acute gonococcal urethritis were treated with a single dose of 2, g. sectinomycin bihydrochloride. Of 88 cases followed up, there were three possible treatment failures, giving a cure rate of 96-6 per cent. Spectinomycin is an important addition to gonorrhoea therapy but should be reserved for penicillin sensitive patients and penicillin insensitive infections.
Survival and treatment failure are analyzed in a homogeneous group of 70 pre- or post-menopausal patients with operable breast cancer and histologically involved axillary nodes. From March 1968 to December 1975, all patients underwent simple or radical mastectomy, followed by radiotherapy in 67. The period of observation varied from 11 months to 10 years. Treatment failures were observed on 34 patients: 10 loco-regional relapses, 21 distant metastatizations, and 3 tumors in the other breast. Analysis of actuarial survival curves shows a statistically significant difference between patients with 1 to 3 positive axillary nodes and patients with 4 or more, but no difference with regard to the volume of the tumor and the patient's age. Comparison of disease-free period curves shows statistically significant differences between patients aged below and over 55 years, tumor of less or more than 2 cm, and 4 or fewer axillary nodes. These results are comparable to those in the literature and form a contribution to a Swiss study of post-operative adjuvant chemotherapy in breast cancer with positive axillary nodes.
In a prospective randomized study adjuvant combination chemotherapy with CMF was administered for 12 monthly cycles to 207 patients subjected to radical mastectomy (Halsted or extended) and treatment failure was compared to that observed in 179 patients whose primary therapy consisted only of radical surgery (control group). All patients of both groups had histologically positive axillary lymph nodes. At three years from mastectomy the total failure time distribution was 45.7% in control patients compared to 26.3% in women given CMF (P less than 0.0001). New disease manifestations were higher in the subgroup with four or more nodes (64.9% vs 41.5%) compared to that with one to three nodes (37.9% vs 19.1%). Premenopausal controls showed a progressively higher incidence of treatment failure compared to CMF patients (P=0.00001). The decreased recurrence rate in postmenopausal women given CMF was appreciable only during the first 12 months. From this time on, the difference no longer existed. The cumulative percent of recurrence in patients without or with drug-induced amenorrhea (27.2% vs 9.2%) was not statistically significant. At three years 21.4% of control patients have died of progressive cancer compared to 10.4% of CMF patients. The difference in the survival curves was not significant (P=0.08). Toxicity was moderate and reversible. No drug induced neoplasm was observed. Present results confirm the efficacy of 12 CMF cycles in premenopausal patients. Postmenopausal women probably require a more intensive and prolonged adjuvant chemotherapy.
The inter-relationships of 32 pathologic and 7 clinical parameters encountered in the study of 1000 examples of invasive breast carcinoma have been presented. In some instances the biological significance of these associations is at present unclear. In others it is to be noted that there is no information provided as to the rank of their significance. Nevertheless, the associations that were encountered not only help further characterize the various forms of breast cancer but also provide information regarding the possible biological significance of some of their features. Although it is not our intention to minimize the possible significance of the inter-relationships of pathologic parameters, most emphasis in the summarizing statements which follow has been placed upon those correlations which may relate to prognosis. In this regard reference has been made to short-term treatment failure, vis a vis local recurrence and/or metastases, which may not necessarily accurately reflect patient survival, although generally such a relationship exists. Information in this regard as well as to the rank of the significance of these pathologic features shall be forthcoming when sufficient time has elapsed since the inception of this study to allow for such conclusions, i.e. survival or long-term treatment failure rates. Lastly, it becomes evident that the guidelines followed in the examination of these specimens appear to represent at least the minimum requirements necessary for a meaningful pathologic evaluation of breast carcinoma.
The authors conducted an EEG study of 28 patients with chronic renal insufficiency, 20 of whom were on a programme hemodyalysis and 8 were studied at different periods following kidney transplantation. Background registrations detected mild and moderate changes of the bioelectric brain activity, mainly with disorders of alpha-rhythm. Only in 1/3 of the patients there were moderate slow forms of activity of paroxysmal signs. A worsening of the EEG indices after hemodialysis, seen in 11 of the 20 patients was expressed in abundant polymorphic slow activity or paroxysmal hilateral synchronous discharges of a large amplitude and was combined with an appearance of neurological disorders. In a successful kidney transplantation there was a distinct normalization of the EEG picture, whereas in a rejection of the transplant there were signs of expressed anomalies of brain electrogenesis.
Metabolic, hemodynamic and neuroendocrine responses to the combined use of halothane and succinylcholine (SCh) were measured in five normal swine and five swine susceptible to malignant hyperthermia (MH). Constant-volume ventilation was used, and no therapy was instituted. The overall response in susceptible swine was fulminant, in that it involved the rapid onset of SCh-induced MH combined with the more severe metabolic, endocrine, and cardiovascular effects of halothane-induced MH. Maximal changes in VO2 were equivalent with either drug or both combined, while changes in lactate, potassium (K+), pH, and catecholamines were perhaps synergistic. Utilizing similar measurements, procaine or procainamide was used in 20 susceptible swine in attempts to prevent MH initiated by halothane, SCh, or both. Recommended therapeutic doses of either drug did not prevent characteristic MH changes in oxygen consumption, cardiac output, lactate, K+, pH, catecholamines, or temperature.
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