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At least 217 records · Page 12Linked to original sources
PubMed1996

[Cibenzoline versus propafenone by the oral route for preventing recurrence of atrial arrhythmia: multicenter, randomized, double-blind study].

This multicentre, randomized, double-blind study, conducted in parallel groups, was designed to compare the efficacy and safety of cibenzoline (C) and oral propafenone (P) in the prevention of recurrent atrial arrhythmias (M) over a 6-month period. Patients of either sex with reduced atrial fibrillation or flutter and predominantly in sinus rhythm (> 50%), with a left ventricular shortening fraction greater than or equal to 20% and not receiving any antiarrhythmic treatment were included. Patients presenting severe conduction disorders, severe heart failure (NYHA class III or IV), marked hypotension or recent myocardial infarction were not included. Treatments were administered at the dosage of one tablet twice a day, i.e. 260 mg/day of cibenzoline or 600 mg/day of propafenone. This dosage was reduced by one half in elderly patients (> 70 years). Patients were seen on inclusion (Dzero), and at the third and sixth months or in the case of recurrence of symptoms. Recurrent arrhythmias were assessed by ECG and 24-hour Holter monitoring and according to the symptoms experienced by the patients. Sixty-five patients, 36 men and 29 women, between the ages of 34 to 86 years and presenting an atrial arrhythmia-atrial fibrillation (80%) or atrial flutter (20%)-were included in the trial: 34 patients received cibenzoline and 31 received propafenone. The arrhythmia had already been treated in 78% of cases. Its aetiology was related to hypertensive heart disease (32%), valvular heart disease (8%), other (17%) or idiopathic (43%). The arrhythmia was symptomatic in 91% of patients on inclusion. The ultrasonographic left ventricular shortening fraction was 32.8 +/- 8.1% in group C and 32.6 +/- 6.4% in group P. The two groups were comparable before treatment. The efficacy of the two treatments was comparable: no significant difference in the number of recurrences was demonstrated: 11 patients treated with C and 12 patients treated with P; cumulative percentages of patients without recurrence with good tolerance of treatment (Kaplan-Meier acturial curves) at 6 months were 55.9% with C and 48.4% with P(NS); probability of no recurrence at 6 months (0.63 +/- 0.09 in group C and 0.57 +/- 0.09 in group P); mean time to recurrence (53.4 +/- 44.3 days in group C and 61.6 +/- 35.3 days in group P). Adverse events leading to discontinuation of treatment occurred in 4 patients from each group, and one proarrhythmic effect at 6 months in a patient in group P. The treatments were well tolerated in the majority of cases: there was no significant difference in the number of patients presenting at least one adverse event: 9(26.5%) in group C, 11(35.5%) in group P. Most events were considered to be mild or moderate. The effects of the two treatments on the course of blood pressure, heart rate, PR interval and QT interval calculated at 3 and 6 months compared to DO were not statistically different. The QRS interval increased to a significantly greater extent in group C that in group P (p = 0.02 at 3 months; p = 0.0005 at 6 months). No significant difference was observed between the two groups for the course of laboratory parameters at 3 and 6 months compared to DO in the patients present at these three visits. Cibenzoline can therefore constitute a good alternative to propafenone in the prevention of symptomatic recurrences of atrial tachyarrhythmias. The preferential use of one or other treatment can be guided by individual factors, including tolerance.

Administration, Oral↗
PubMed1996

[Total colectomy with ileorectal anastomosis (IRA): our experience in 57 patients].

Total colectomy with IRA in ulcerative colitis, Crohn's disease, familial polyposis and multicentric colonic cancer is still debated. In this paper the Authors present their experience with a retrospective review of 57 patients, treated in the Surgical Department of Pisa's University from 1978 to 1990. Through the results obtained, it is concluded that total colectomy with IRA is a valid procedure in the treatment of multiple polyposis, but must be associated with a long and careful follow up using fulguration for local recurrence. The usefulness of this treatment in multicentric colonic cancer is confirmed. However, the use of IRA in ulcerative colitis is debatable. This series shows the failure of colectomy with IRA in patients with Crohn's disease, due to the high incidence of local recurrences requiring reoperation.

Adenomatous Polyposis Coli↗
PubMed1994

Efficacy and safety of pidotimod in the treatment of recurrent respiratory infections in children.

The activity of pidotimod ((R)-3-[(S)-(5-oxo-2-pyrrolidinyl) carbonyl]-thiazolidine-4-carboxylic acid, PGT/1A, CAS 121808-62-6) was evaluated in a double-blind, placebo-controlled, randomized, multicentre trial, on 120 pediatric patients affected by recurrent respiratory infections. The clinical course of acute infections was favourable both in placebo and in treatment group, but recovery was quicker with pidotimod than with placebo. Antibiotic therapy and time of hospitalization were shorter in the patients taking pidotimod, and main symptomatic parameters (pharyngalgia, dysphagia, mucous membrane inflammation, adenopathy, anorexia) receded quickly. In patients receiving the drug as well as in placebo group changes in laboratory parameters, indicating recovery from the acute infectious events, were observed. A significant trend to normalization of the immune response, evidenced by chemotaxis and leukocyte phagocytosis index, was found only in patients treated with pidotimod. A significant decrease in the risk of relapses was observed in patients treated with pidotimod (35%), as well as a reduction of hospitalization (86%) and a decreased antibiotic therapy (47%). If a relapse occurred, the response of treated patients was quicker (fever, antibiotic therapy, hospitalization). These findings allow to correlate the individual immune response activation to the resistance to recurrent infections and also to a better response to therapy in case of clinically relevant disease. No side effects were observed. Only in 12 patients (5 pidotimod, 7 placebo) mild reactions were observed, but they were attributed to concomitant antibiotic treatment or other factors. No alterations in main laboratory parameters were seen.(ABSTRACT TRUNCATED AT 250 WORDS)

Adjuvants, Immunologic↗
PubMed1993

[Indication and limitation of hepatectomy for hepatocellular carcinoma].

Hepatectomy for hepatocellular carcinoma (HCC) has become safer with recent advances in diagnostic methods, operative techniques and understanding of how to evaluate liver function. Hepatectomy is the treatment of choice for HCC provided that patients are selected carefully, because cure is possible with hepatectomy (some patients survive long without recurrence). However, the rate of recurrence after hepatectomy is high. Recurrences can arise because of either intrahepatic dissemination or factors that give rise to multicentric carcinoma, so one must decide the operative method, to prevent recurrence and the treatment if such occurs, based on the pathogenesis of HCC.

Carcinoma, Hepatocellular↗
PubMed2003

Chromosome aberrations in canine multicentric lymphomas detected with comparative genomic hybridisation and a panel of single locus probes.

Recurrent chromosome aberrations are frequently observed in human neoplastic cells and often correlate with other clinical and histopathological parameters of a given tumour type. The clinical presentation, histology and biology of many canine cancers closely parallels those of human malignancies. Since humans and dogs demonstrate extensive genome homology and share the same environment, it is expected that many canine cancers will also be associated with recurrent chromosome aberrations. To investigate this, we have performed molecular cytogenetic analyses on 25 cases of canine multicentric lymphoma. Comparative genomic hybridisation analysis demonstrated between one and 12 separate regions of chromosomal gain or loss within each case, involving 32 of the 38 canine autosomes. Genomic gains were almost twice as common as losses. Gain of dog chromosome (CFA) 13 was the most common aberration observed (12 of 25 cases), followed by gain of CFA 31 (eight cases) and loss of CFA 14 (five cases). Cytogenetic and histopathological data for each case are presented, and cytogenetic similarities with human non-Hodgkin's lymphoma are discussed. We have also assembled a panel of 41 canine chromosome-specific BAC probes that may be used for accurate and efficient chromosome identification in future studies of this nature.

Animals↗
PubMed2001

[Prevention of recurrent hepatocellular carcinoma with retinoid].

The annual rate of recurrent hepatocellular carcinoma (HCC) after curative treatment of the initial tumor is reportedly as high as 20-25%. Such a high recurrence rate is responsible for the poor prognosis of patients with HCC. One third of the recurrent HCC arises from intrahepatic metastasis of the initial tumor, one third from multicentric carcinogenesis, and one third from unknown origin. In any type of recurrence, elimination of the transformed cell clone from the remnant liver is essential to prevent the recurrence of HCC. A retinoid analog, acyclic retinoid, induces differentiation and apoptosis of HCC cell lines in vitro. An early clinical trial showed a preventive effect of the compound on recurrent HCC. A further trial of acyclic retinoid is now under way.

Apoptosis↗
PubMed1983

Resolution of recurrent Verner-Morrison syndrome by resection of metastatic vipoma.

The case of a woman with recurrent Verner-Morrison syndrome associated with a multicentric and metachronously metastatic pancreatic islet cell tumor is described. Her original symptoms resolved after distal pancreatectomy and splenectomy for an islet cell carcinoma of the tail of the pancreas. Recurrent symptoms were associated with a raised plasma vasoactive intestinal polypeptide (VIP) level, an islet cell tumor in the neck of the pancreas, and liver metastases. After partial pancreatectomy and resection of the liver metastases, her symptoms resolved and plasma VIP level normalized. This case emphasized the potential role of resection in the management of the Verner-Morrison syndrome associated with a recurrent, metastatic vipoma.

Adenoma, Islet Cell↗
PubMed1985

Chemotherapy trials in recurrent primary intracranial germ cell tumors.

Gonadal germ cell tumors respond favorably to chemotherapy either at diagnosis or when they recur. Histologically similar tumors may arise in the CNS usually in the pineal or suprasellar regions. Although radiation therapy may produce a 5 year disease-free survival in excess of 60% in localized pure germinoma, germ cell tumors of other histology tend to recur. We have conducted 14 chemotherapy trials in 8 patients with recurrent CNS germ cell tumors using 3 different single agent and 2 multi-agent chemotherapy regimens. The histologic diagnoses of the patients were germinoma (4), endodermal sinus tumor (2), embryonal carcinoma (1), and mixed tumor - germinoma plus choriocarcinoma (1). There were 7 males and 1 female with a median age of 13 years. The primary tumor arose in the pineal region in 6 and was multicentric in 2. Seven patients had local recurrences and one developed an initial recurrence in the spinal canal. Three patients had CNS metastases at relapse and 2 had systemic metastases. Objective responses were documented in 7 of 14 trials (50%). Responses were observed with cyclophosphamide (80 mg/kg) in 3 of 4 patients for 2+, 3, and 5 mos, cisplatin (120 mg/m2) in 1 of 2 patients for 2+ mos, and the VAB 6 protocol (vinblastine, bleomycin, cyclophosphamide, actinomycin-d, cisplatin) in 3 of 5 patients for 5, 8, and 18 mos. The median duration of response was 5 mos. (2+-18). High doses of single chemotherapy agents such as cyclophosphamide and cisplatin as well as VAB 6 regimen have definite activity in recurrent CNS germ cell tumors, especially germinoma. Good palliation may be achieved with chemotherapy alone with acceptable morbidity.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1998

[Hemangioendotheliomas--evolution of a concept of a heterogeneous group of vascular neoplasms].

The term haemangioendothelioma has been used in the past for a number of vascular lesions, which vary not only by their morphological features, but more importantly, also by their biological behavior. In the recent WHO-classification of mesenchymal tumours haemangioendotheliomas have been defined as vascular tumours of "intermediate" or "borderline" malignancy, and spindle cell haemangioendothelioma (SHE), epithelioid haemangioendothelioma (EHE), and rare malignant endovascular papillary angioendothelioma (Dabska's tumour) were included in this category. To this list might be added the more recently delineated kaposiform (KHE), retiform (RHE), polymorphous (PHE), and composite haemangioendothelioma (CHE). Although very popular, the concept of "borderline" or "intermediate" malignancy encompasses a wide variety of clinical situations, prognosis, and biological behavior. Therefore uncritical use of the term haemangioendothelioma represents a potential source of confusion to patients and oncologists, and it should not be used without further clarification. SHE was originally described as low-grade angiosarcoma, however, the study of large series with expanded follow-up information clarified that these lesions are often multicentric in one anatomic region, whereas true recurrences are rather rare, and systemic metastases and tumour progression do not occur. Therefore redesignation of these lesions as spindle cell haemangioma has been proposed. EHE of skin and soft tissues represents a distinctive vascular neoplasm characterized by nests and cords of epithelioid endothelial tumour cells with characteristic cytoplasmic vacuoles, which are set in a myxohyaline matrix. The reported rates of systemic metastases (20-30%), and tumour related death of patients (13-17%) in EHE, and the occurrence of multicentric EHE argue against the classification of EHE as a low-grade or "borderline" malignant neoplasm; EHE should be better regarded as a clearly malignant vascular tumour (G2). Although it seems that KHE is associated with a high mortality rate, the deaths are almost always related to locally invasive effects or as result of bleeding and consumption coagulopathy. So far no metastasizing case of KHE has been reported, and it seems that the prognosis in KHE is mainly related to size, anatomical site and depth of the lesion. KHE should be classified as a locally aggressive, non-metastasizing vascular tumour. The remaining entities (RHE, Dabska's tumour, PHE, and CHE) are characterized by an infiltrative growth, a high rate of (often repeated) local recurrences, and a definitive risk of metastases. Therefore these lesions fulfil criteria for low-grade malignant vascular neoplasms.

Diagnosis, Differential↗
PubMed1984

The biology and treatment of superficial bladder cancer.

Management of the superficial bladder cancer patient consists of two complementary but separate therapeutic goals: treatment of the existing tumor(s) and prevention of tumor recurrence. At present, the stage, grade, and multicentricity are the major determinants in the natural and therapeutic history of the disease. Although intravesical instillation of chemotherapeutic agents has been used for greater than 20 years, neither its exact role nor the optimal dose or schedule of administration have been established. To date, no dramatic differences in efficacy between the agents commonly used for intravesical chemotherapy, either as definitive therapy or prophylaxis, have been appreciated. These agents do appear to lower the recurrence rate as well as extend the disease-free interval. Since the most thorough experience is with thiotepa, it is the drug against which other agents should be compared in terms of both efficacy and toxicologic evaluation. Different administration schedules and methodologies need further study, such as the utility of continuous bladder irrigation, the use of sequential chemotherapeutic agents to gain cell synchronization, and the use of multiple drug regimens. Because there are multiple factors that influence the occurrence and recurrence of bladder cancer, combined modality therapy deserves testing. Modes of therapy that could be used together because they act through different mechanisms are intravesical chemotherapy, radioactive needle implants, carcinogen modifiers such as pyridoxine, chemoprotective agents such as retinoic acid, and immune stimulants such as BCG. These studies should be performed in a randomized prospective controlled fashion, which may require cooperative multi-institutional involvement to accrue adequate numbers of patients. At this time there are a number of important questions that remain to be answered concerning the treatment of superficial bladder cancer: (1) does this mode of therapy affect overall survival, (2) does prophylactic intravesical chemotherapy alter the incidence of subsequent muscle invasive disease, (3) does intravesical chemotherapy alter the sites, incidence, or responsiveness to systemic chemotherapy of subsequent metastatic disease, and (4) and what is the optimal timing and duration of prophylactic therapy from a cost-effectiveness standpoint?

Adenocarcinoma↗
PubMed1994

Intravenous immunoglobulin in the prevention of recurrent miscarriage. The German RSA/IVIG Group.

OBJECTIVE: This study was undertaken to verify a specific effect of intravenous immunoglobulin on the outcome of pregnancy in patients with a history of recurrent miscarriage as an alternative to immunotherapy with allogeneic leucocytes. STUDY DESIGN: In a randomised double-blind multicentre study 64 patients with a history of unexplained primary recurrent miscarriage were treated with intravenous immunoglobulin (verum) or 5% human albumin (placebo) infusions during their following pregnancy. RESULTS: Success rates for both verum and placebo, were compared excluding seven patients with explained miscarriage (20/27 (74%) versus 21/30 (70%)) and without any such exclusion (20/33 (61%) versus 21/31 (68%)). The difference between the two groups was not statistically significant. CONCLUSIONS: A specific effect of intravenous immunoglobulin in primary recurrent miscarriage could not be demonstrated. These results imply the possibility of psychological influence, i.e. a placebo effect of intravenous immunoglobulin, on the outcome of pregnancy. Since success rates for both verum and placebo were in the same range as for treatment with allogeneic leucocytes, psychological effects might be responsible also for other kinds of immunotherapy for prevention of recurrent miscarriage. However, it cannot be excluded that success rates only reflect background values as reported for recurrent miscarriage patients without any treatment.

Abortion, Habitual↗
PubMed1997

Short-term therapy for recurrent abortion using intravenous immunoglobulins: results of a double-blind placebo-controlled Italian study.

It is still unclear whether i.v. immunoglobulins (Ig) can facilitate the reproductive prognosis of women who have suffered recurrent pregnancy loss. We report the results of a multicentre placebo-controlled study on the effect of Ig administration on pregnancy outcome in 46 women who had suffered at least three recurrent miscarriages. All were screened to exclude chromosomal or Müllerian abnormalities, the presence of antinuclear antibodies, lupus anticoagulant (LA) or elevated titres of anticardiolipin antibodies which may have revealed an underlying autoimmune problem. To avoid a selection bias towards ongoing pregnancies, i.v. Ig or placebo were administered between weeks 5 and 7 of gestation for 2 consecutive days as soon as each woman knew she was pregnant and before embryonic heart activity could be detected. A further infusion was administered at week 8 when ultrasonography confirmed an ongoing embryonic development. In all, 68% of the women who received Ig went to term versus 79% of those who received a placebo (not significant), with no significant differences in the pregnancy course or the perinatal outcome. These results suggest either that women with recurrent miscarriages who have no recognized cause of pregnancy loss have a good reproductive prognosis without any treatment or that the emotional care associated with the administration of a placebo can indirectly facilitate the progression of pregnancy.

Abortion, Habitual↗
PubMed1993

[The use of thymopentin in the prevention of recurrent infections of the respiratory system. Multicenter study].

Eighty children, between 1-12 years, suffering from recurrent respiratory infections were admitted to a multicentre study and treated with thymopentin, an immunomodulating compound that represents the active site of the natural thymic hormone thymopoietin. Thymopentin efficacy, measured as reduction in the number of infective episodes, and tolerability were assessed and, at the end of the study a global evaluation was made by each investigator. Moreover, the following factors were recorded: clinical course, duration of symptoms/signs, frequency of administration of antipyretic, antibiotic, anti-inflammatory and mucolytic therapy, school attendance and hospitalization. Thymopentin treatment resulted in a statistically significant decrease of infective recurrences. The use of symptomatic and antibiotic drugs was also reduced. Side effects were few and mild. The investigators' overall evaluation of thymopentin's efficacy and tolerability was favourable. In conclusion, thymopentin, administered subcutaneous for 5 weeks in winter, may be useful in the treatment of children with recurrent infections of the respiratory tract.

Child↗
PubMed2006

Rationale and design of the GISSI-Atrial Fibrillation Trial: a randomized, prospective, multicentre study on the use of valsartan, an angiotensin II AT1-receptor blocker, in the prevention of atrial fibrillation recurrence.

BACKGROUND: The possibility of preventing atrial fibrillation recurrence with anti-arrhythmic agents is very limited, given the discouraging results obtained with current drugs in many patients. Data from experimental studies suggest that angiotensin II AT1-receptor blockers can influence atrial remodelling, a key factor in atrial fibrillation initiation and maintenance. Moreover, some preliminary clinical data show that angiotensin II AT1 -receptor blockers can prevent atrial fibrillation episodes. The GISSI-Atrial Fibrillation (AF) trial is a randomized, prospective, parallel group, placebo-controlled, multicentre study designed to test whether angiotensin II AT1-receptor blockers can reduce atrial fibrillation recurrence. OBJECTIVES AND METHODS: The primary objective of the study is to demonstrate that, in patients with a history of recent atrial fibrillation who are treated with the best recommended therapies, the addition of the angiotensin II AT1-receptor blocker valsartan (titrated up to 320 mg) is superior to placebo in reducing atrial fibrillation recurrence. A substudy will analyse the effect of valsartan on left atrial dimensions and on neurohormones. The study population consists of patients with symptomatic atrial fibrillation (at least two electrocardiogram documented atrial fibrillation episodes in the previous 6 months or successful cardioversion in the last 2 weeks) with underlying cardiovascular diseases or comorbidities. With approximately 100 centres participating in Italy, a total of 1402 patients are randomized in a 1 : 1 ratio to receive valsartan or placebo. The enrolment period will last 12 months and the patients will be followed for 12 months from study entry. CONCLUSIONS: The GISSI-AF is the largest trial aimed at assessing the role of angiotensin receptor blockade in reducing the recurrence of atrial fibrillation and its possible mechanisms of action in terms of its effects on atrium remodelling and neurohormones.

Angiotensin II Type 1 Receptor Blockers↗
PubMed2001

Characteristics and course of small hepatocellular carcinomas in patients with hepatitis C virus types 1 and 2.

The associations between types of HCV and tumor characteristics and recurrence and survival after treatment of small HCC were investigated. Viral genotype-specific antibodies were measured in sera obtained at the time of diagnosis of HCC, in 92 patients with HCC < or = 2 cm in diameter who were treated between 1990 and 1998. The degrees of tumor differentiation and angiographically-evaluated hypervascularity were compared between patients infected with HCV type 1 and those with type 2. Survival, time to recurrence, and patterns of recurrence after initial treatment also were compared. On pathologic evaluation, 6 of 21 HCC (28.6%) in patients with HCV type 2 were well-differentiated, whereas 28 of 48 HCC (58.3%) in patients with HCV type 1 were well-differentiated (P = 0.0229). HCC in patients with HCV type 2 showed hypervascularity more frequently than HCC in patients with HCV type 1, with tumor staining evident by digital subtraction arteriography in 17 of 22 patients with HCV type 2 (77.3%) vs. 20 of 50 in patients with HCV type 1 (40.0%, P = 0.0036). Survival and overall recurrence rates were similar in patients infected with HCV type 1 and with HCV type 2 (P = 0.5537). In the analyses of patterns of recurrence, recurrences in patients infected with HCV type 2 were relatively more likely to be intrahepatic metastases (P = 0.0342), that was closely related to the differentiation of HCC. Multicentric occurrence of HCC was a more frequent type of recurrence in patients with HCV type 1 (P = 0.1619), and infection of HCV type 1 was an independent factor for multicentric occurrence in multivariate analysis (P = 0.0021). In HCC < or = 2 cm in diameter, HCV type 2 is associated with more progression of HCC than HCV type 1, whereas patients with HCV type 1 may be at higher risk for multicentric HCC occurrence after the treatment of HCC.

Aged↗
PubMedDate not supplied

Treatment of solitary small hepatocellular carcinoma: consideration of hepatic functional reserve and mode of recurrence.

BACKGROUND/AIMS: Hepatocellular carcinoma (HCC) recurs frequently after initial treatment. The subsequent prognosis varies with the mode of recurrence. Some patients die of hepatic failure even though the HCC is controlled. We consider the clinical stage (CS), using the modified Child-Pugh classification, to be an important factor influencing the prognosis of these patients. METHODOLOGY: To determine the most effective treatment for HCC, we examined 105 patients with solitary small HCC who were followed-up for more than 1 year after initial treatment. All of them were judged to be cured according to imaging or histological studies. The initial treatments were hepatic resection (n = 43), percutaneous ethanol injection therapy (PEIT, n = 33), and percutaneous microwave coagulation therapy (PMCT, n = 29). The modes of recurrence were divided into intrahepatic metastasis (IM) and multicentric occurrence (MO). RESULTS: Prognosis of MO was superior to that of IM in CS I patients, but there was no difference in prognosis between these modes in CS II. The hepatic resection group had more MO recurrences in CS I patients and more IM recurrences in CS II patients. IM developed frequently after PEIT and PMCT, regardless of the CS. Prognosis with hepatic resection was superior to that of the other treatments in CS I patients, but there was no difference in prognosis among the 3 treatment modalities in CS II patients. CONCLUSIONS: These data indicate that hepatic resection is the first choice for treating HCC in CS I patients, and that PEIT or PMCT is preferable for CS II patients.

Aged↗
PubMedDate not supplied

[Multicentric extra-abdominal fibromatosis: a rare case].

Extra-abdominal aggressive fibromatosis is a benign fibroblastic neoplasia with an infiltrative nature and a high tendency of local recurrence. Here, we report on a very rare case of multicentric fibromatosis. Low complaints led to considerable size of the tumours. The aim of the multimodal treatment was a limb salvage procedure. Adjuvant radiation therapy and chemotherapy was necessary because of the renunciation of wide resections in favour of the functionality of the limb.

Abdomen↗
PubMed1999

Prophylactic efficacy of lithium administered every second day: a WHO multicentre study.

OBJECTIVES: To study the prophylactic efficacy of lithium administered every second day to patients with bipolar disorder or recurrent unipolar depressive disorder. METHODS: The study was carried out as a WHO multicentre study in five different psychiatric clinics: Russia (Moscow), Canada (Montreal), India (Lucknow), Germany (Munich) and South Korea (Pusan), with the lithium tablets being supplied from Denmark (Copenhagen). Participation in the study was conditional on the patient having been in prophylactic lithium treatment for the preceding 2-year period and having been free of depressive or manic phases during the preceding 6 months. After a 2-month baseline period during which lithium was administered every day, the treatment was changed to lithium intake every second day, this regimen in most cases being continued for 22 months. RESULTS: Forty-seven patients, 42 with a diagnosis of bipolar disorder and five with a diagnosis of recurrent unipolar depressive disorder, participated in the study. The number of patients from each centre ranged from six to 11. The mean lithium dose every second day was 36 mmol lithium, leading to a mean 12-h standard serum lithium concentration during the last month of treatment at 0.78+/-0.16 mmol/L. Lithium intake every second day was effective in 38 out of 47 patients. The remaining nine patients had recurrences, a number not differing from the 16 patients in the same group of 47 patients who, during the 2-year period preceding the study, had recurrences. The mean 12-h standard serum lithium concentration was lower in the patients who had recurrences than in those who stayed euthymic. The results suggest that to be effective when administered every second day, lithium must be given in a dose leading to a 12-h standard serum lithium concentration at 0.8 mmol/L or above. CONCLUSIONS: In the dose administered, lithium intake every second day was as effective as lithium intake every day. The amount and severity of lithium-related side effects were apparently not influenced by the change to lithium intake every second day.

Adult↗