Search

Studies addressing the anti-inflammatory properties of citrate dialysate enrolled patients in both hemodialysis (HD) and hemodiafiltration (HDF), the latter not adjusted for adequate convective exchange. This is a potential source of confounding in that HDF itself has anti-inflammatory effects regardless of the buffer, and optimal clinical outcomes are related to the amount of convection. To distinguish the merits of the buffer from those of convection, we performed a 6-month, prospective, randomized, crossover AB-BA study. Comparisons were made during the 3-month study period of on-line HDF with standard dialysate containing three mmol of acetic acid (OL-HDFst) and the 3-month of OL-HDF with dialysate containing one mmol of citric acid (OL-HDFcit). Primary outcome measure of the study was interleukin-6 (IL-6). Klotho, high sensitivity C-reactive protein (hsCRP), fetuin and routine biochemical parameters were also analyzed. We analyzed 47 patients (mean age 64 years, range 27-84 years) enrolled in 10 participating Nephrology Units. Convective volumes were around 25 L/session with 90 percent of sessions > 20 L and s2-microglobulin reduction rate 76% in both HDFs. Baseline median IL-6 values in OL-HDFst were 5.6 pg/ml (25:75 interquartile range IQR 2.9:10.6) and in OL-HDFcit 6.6 pg/ml (IQR 3.4:11.4 pg/ml). The difference was not statistically significant (p 0.88). IL-6 values were lower during OL-HDFcit than during OL-HDFst, both when analyzed as the median difference of overall IL-6 values (p 0.02) and as the median of pairwise differences between the baseline and the 3-month time points (p 0.03). The overall hsCRP values too, were lower during OL-HDFcit than during OL-HDFst (p 0.01). Klotho levels showed a time effect (p 0.02) and the increase was significant only during OL-HDFcit (p 0.01). Citrate buffer modulated IL-6, hsCRP and Klotho levels during high volume OL-HDF. These results are not attributable to differences in the dialysis technology that was applied and may suggest a potential biological effect of citrate on CKD-associated inflammatory state. ClinicalTrials.gov identifier NCT02863016.

The city of Kota Kinabalu features several urban green areas, which become the focal points for the urban inhabitants. This study was conducted to determine the benefits and public perceptions that encourage them to visit the local urban green area. The convenience sampling method was used, in which questionnaires were distributed to 101 respondents of the local park visitors. The present finding revealed that most of the respondents strongly agreed that the urban greens help to improve the physical well-being of the urban dwellers (Mean score, µ=4.27), regulate the urban temperature during sunny days (µ=4.20), encourage people to spend more time on outdoor activities in nature (µ=4.14), help to remove air pollutants (µ=4.09), control the amount of water on the ground surface during the rainy season (µ=4.06), reduce stress, anxiety, and depression (µ=4.04), prevent the occurrence of a flash flood (µ=3.98), and promote social interactions among people (µ=3.81). The correlation between the respondents’ education and the mean benefits of urban green areas in Kota Kinabalu was significant (p

Background and importance Pharmacovigilance (PV) is a public health activity in which clinicians are legally and medically involved. Notification of adverse drug reactions (ADRs) is essential to ensure the safety of medications. Aim and objectives To describe the ADRs notified to the Regional Centre of Pharmacovigilance (RPC). Material and methods A retrospective study was conducted between January 1992 and December 2018. The hospital pharmacist (HP) was responsible for data collection and notification. PV started up in 1992 accompanied by a strong information and communication campaign. Data were recorded and analysed in Excel 2007: sex and age of patients, total number of reported ADR notifications, detection method, severity and outcome of the ADRs, medications involved and therapeutic group (ATC classification). Results During the 27 years of the study period, 1246 ADRs were reported (annual average: 46±2.83): 53.6% of patients were men and 54.2% were >65 years old while 10.6% were In 1992, 19 ADRs were notified, a value that progressively increased over the years, reaching its highest in 2003 (84 ADRs). In 2004 it decreased to 46, remained constant (mean 35.7±9.7) and then declined to 31 in the last year. Conclusion and relevance More than one-third of ADRs were serious, but most patients recovered without sequelae. Most notifications to the RPC come from the MDS-H, but a significant number were detected by health staff and HP. In recent years, reported ADRs has decreased, so the HP could be an essential element to develop the pharmacovigilance programme, which is key to improving the safety of medicines by promoting relevant modifications in the technical data sheets and issuing alerts from the Spanish Agency for Medicines and Health Products. References and/or acknowledgements No conflict of interest.

Background and importance The pervasive use of antibiotics has been identified as a major public health threat due to the emergence of antibiotic resistant bacteria. Antibiotics are among the most commonly prescribed drugs in nursing homes (NHs) and up to 75% of these are considered inappropriate. Aim and objectives To characterise antibiotic therapy in NHs and evaluate adequacy. Material and methods A prospective study was conducted in a NHs (264 residents) over a 3 month period (July–September 2019). All residents with antibiotic prescriptions for suspected infections were included. Data were collected by review of medical and pharmacy records: demographic and clinical characteristics, risk factors for infection, antibiotic prescribed, indication and microbiology data. Inadequate antibiotic therapy was defined as: (1) conditions without an antibiotic indication; (2) non-adherence to therapeutic guidelines; (3) incorrect dose, route of administration or duration; (4) no microbiology sample collection when needed; and (5) microbiological evidence of infection not covered by the chosen antibiotics, or no antibiotic de-escalation. Results We included 62 residents, mean age 81.7±10.7 years, 69.4% women, and 6.5% had an antibiotic allergy. Mean Charlson comorbidity index age adjusted was 5.8±1.9. The majority of residents presented risk factors for infection (RFF) (95.2%), mean 3.1±1.4. RFF included functional dependency (6.9% of patients), previous antibiotic therapy (59.7%) and cognitive impairment (53.2%). The most commonly prescribed antibiotics were amoxicillin/clavulanic (24.2%), quinolones (19.4%), fosfomycin–trometamol (19.4%), cephalosporins (11.2%), fosmomycin calcium (9.7%), cloxacillin (9.7%) and other (6.4%). Mean duration was 5.6±3.5 days. Most treatments were empirical (75.8%), 21% were targeted treatment and 3.2% were prophylactic. Combination therapy was found in only one case; three intravenous route. The most common infection was urinary tract infection (48.4%), followed by skin and soft tissue infection (22.6%) and lower respiratory tract infection (21%). Sample collection was carried out in 41.9% (76.9% before initiating antibiotic): 65.4% uroculture, 11.5% exudate culture and 23.1% others. Most of the cultures were positive (80.8%; 71.4% were monomicrobial infections). The most prevalent microorganisms isolated were gram negative isolates (85.7%); methicillin resistant Staphylococcus aureus was isolated in three cases (14.3%). Antibiotic therapy was inadequate in 51.6%: (1) 9.3%; (2) 56.3%; (3) 12.5%; (4) 3.2%; and (5) 18.7%. Conclusion and relevance Broad spectrum antibiotics are often prescribed. There was a high number of inadequate antibiotic prescriptions. Pharmacy teams are well placed to support prudent selection of antibiotic therapy in NHs. References and/or acknowledgements No conflict of interest.

Background and importance Antimicrobial stewardship programmes (ASPs) aim to optimise antimicrobial prescriptions, enhancing clinical outcomes, minimising antimicrobial resistance and improving the quality and safety of patient care. Guidelines recommend a multidisciplinary team but many hospitals do not have infectious disease (ID) physician support. Aim and objectives To analyse the effectiveness of a pharmacist led ASP in a hospital without an ID physician, with special focus on indicators of the hospital use of antimicrobial agents based on consumption.1 Material and methods A pharmacist led ASP was performed in a 200 bed hospital from 1 January to 30 June 2019. The ASP was presented to the hospital physicians through face to face sessions. To improve the prescription of antibiotics, we revised prophylaxis and antibiotic therapy in management protocols and developed a guideline with local antimicrobial recommendations. Clinical sessions were held on different pathologies included in the ASP. Information about antimicrobial consumption rate was provided to physicians. In addition, the pharmacist performed a daily review of all patients who had a course of antibiotics during their hospital admission, through an electronic prescription programme. Recommendations were made to physicians related to antimicrobial spectrum, dose adjustment, stopping longer courses of antibiotics, interactions, allergies and other. The consumption of defined daily dose (DDD)/1000 patient days was taken from the first half of 2019 and compared with the same period the previous year. Results A total of 248 recommendations were recorded. The global consumption of antibiotics was reduced from 931 DDD/1000 patient days in the first half of 2018 to 747.9 DDD/1000 patient days in 2019 (−19.7%). Carbapenem use was reduced by 41.3% DDD (21.3 vs 12.5 DDD/1000 patient days). With regard to quinolones, consumption was reduced from 192.7 to 125.5 DDD/1000 patient days (−34.9%). There was a significant decrease in consumption of systemic antifungals of 42.9% (35.9 vs 20.5 DDD/1000 patient days). The ratio (cloxacilin+cefazolin)/anti-MRSA agents increased (1.3 vs 1.8). Conclusion and relevance A pharmacist led ASP achieved a reduction in consumption of antibiotics, especially carbapenem and quinolones. In the absence of support and oversight from an infectious disease physician, pharmacists could be key in the improvement in the use of antibiotics. References and/or acknowledgements 1. Gutierrez-Urbon JM, Gil-Navarro MV, Moreno-Ramos F, et al. Indicadores del uso hospitalario de antimicrobianos basados en el consumo. Farm Hosp 2019;43:94–100. No conflict of interest.

Background Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF) with a considerable economic impact on the hospital’s annual budget. Biosimilar therapies are expected to be less costly for healthcare systems. Purpose The primary endpoint was to analyse treatment costs with etanercept biosimilar (EB) vs etanercept reference product (ERP) as initial treatment and the potential economic impact of switching to EB for maintenance therapy. Material and methods Retrospective observacional study including all patients treated with etanercept from March to September 2017. Data on prescription details, number of prescriptions and costs, were retrieved from the Farmatools ® management tool (outpatients clinical module). The Pharmacy and Therapeutics Committee included EB as a cost-effective alternative and in the light of available scientific data, prescribers agreed with the pharmacy staff to use it as initial therapy. Regarding switching maintenance therapy from ERP to EB, prescribers were responsible for individualising the decision according to patients’ medical records. Results During the study period 190 patients were treated with etanercept. Seventy-eight per cent were rheumatology patients and 22% were dermatology patients. EB was prescribed as initial treatment in 100% of cases (25 new treatments in rheumatology, nine in dermatology). No switching to EB was prescribed in maintenance therapy. A total of 256 doses of EB 50 mg were dispensed, which generated savings of €43.491, when compared to ERP’s best offer. Regarding the potential economic impact of switching maintenance therapy, we estimated that this strategy would mean savings of €339.012 to our centre. No adverse effects or low efficacy data were reported with EB treatments. Conclusion Introducing EB as initial therapy for rheumatology and dermatology patients has resulted in a modest reduction in drug spending in our centre. Potential savings justify the urgent need to implement agreed protocols for switching to EB in maintenance therapy as well. This would mean significant cost savings and improved access for patients to these highly effective therapies. A cross-sectoral collaboration among prescribers, pharmacists and nurses facilitate pharmacovigilance activities, in order to assure the quality, safety and efficacy of EB. No conflict of interest

Background Clinical trials (CT) lead to the development of new drugs and new indications for existing ones. The countries that value these as among their priorities, participate in large numbers of high quality CT to ensure the best treatments for their patients, the best development for their scientists, institutions and health centres, and, finally, additional resources from them for the health sector. It is important to know the design of CT to interpret and evaluate the results when applying them to clinical practice. Purpose To characterise the main design aspects of CT managed in the Pharmacy Department of a tertiary hospital with 710 beds. Material and methods This was a retrospective descriptive study of CT that was initiated between 1 January 2016 and 30 September 2017. For each, we collected the phase of the CT, design (randomised/non-randomised, blinded or unblinded, controlled/uncontrolled) and the automatic handling of the CT samples through the Interactive Web Response System (IWRS). In addition, the type of promoter responsible for the development of the CT, clinical departments involved and the international or national scope of the CT were studied. Information was obtained through the computer application PKensayos® and from documentation corresponding to each CT. Results In the studied period, 117 CT were initiated (66 in 2016 and 51 in the study period of 2017). Of these, 74 were phase III, 21 phase II, 11 phase I, six phase IV and in five studies two phases were combined. In terms of design, 79.5% were randomised, 55.6% were open label (the remainder were double-blind), 78.6% were controlled (40.2% were placebo-controlled). For 84.6% of CT, sample management was controlled automatically through IWRS. In 12% of the CT, the sponsor was an independent industry research entity. Clinical departments involved were: oncology 44.4%, endocrinology 12.8%, cardiology 12%, haematology 10.2%, digestive 8.5%, dermatology 4.3%, pneumology 3.4% and others 4. 4%. Only 7.7% were national CT. Conclusion The predominant type was a phase III randomised, open, controlled with placebo, international, oncology trial. There was considerable informatisation (IWRS), and the industry was responsible for the development of CT in most cases. No conflict of interest

Background Hospital Pharmacy Departments are providing pharmaceutical care since January 2017 for institutionalised patients in nursing homes (NH) in our region in order to optimise the available resources. The purpose of the pharmacist interventions (PI) is to improve the medication appropriateness in these patients, to adapt our Hospital Medicines Formulary (HMF) and to promote the rational use of drugs. Purpose To describe PI regarding treatment prescribed for patients in a NH and to analyse its impact according to physicians’ acceptance. Material and methods Prospective, descriptive study conducted in a 140-bed NH from January to September 2017. Prescriptions were reviewed with the NH’s physician, and introduced in our e-prescribing program (e-PP). Patient and treatment data (sex, age, therapeutic groups, doses) were retrieved from e-PP management tool (inpatients’ clinical module). The following PI were described and registered: separate drug combinations (SdC), inclusion of new dose presentation in our HMF (iDP), dosage regimen modification (DRM), inclusion of new pharmaceutical form (iPF), change in the pharmaceutical form (cPF), pharmacological substitution according to HMS (PS), pharmacological substitution including a new drug in our HMF (iPS) and withdrawal of drugs not included in the HMF considered of low therapeutic value (LTV). Results We reviewed the prescriptions of 125 patients (71% males), mean age 72 years (61–95). We introduced 695 medical prescriptions in our e-PP, average number of medications per patient: 5.5 (0–16). A total of 262 PI were registered: 150 accepted, 112 rejected. Regarding most accepted PI we observed: 38% (55) iPS, 16.6% (25) iDP, 10.6% (16) PS, 10.6% (16) cPF, 10% (15) LTV and 9.3% (14) SdC. Only six PI were accepted for DRM, and one for iPF. Regarding pharmacological substitution, the most affected therapeutic groups were antihypertensives (28%), antidepressants (10.6%) and cholesterol-lowering agents (9.3%). Conclusion Institutionalised patients in a NH are elderly and they present high prevalence of polypharmacy. The assessment of the acceptance of PI in this centre (57%) showed that the pharmacist will be a key element in offering integrated care for patients in a NH. The wide variety of antihypertensive drugs on the market leads to increasing efforts to adapt these prescriptions to our HMF. No conflict of interest

Background Drug shortages are becoming more common and may involve a reduction in pharmacotherapeutic efficacy and increased medication errors. Problems caused by medicines’ shortages are serious, threaten patient care in hospitals and require urgent action. Purpose To analyse the impact of shortages and to describe the different actions carried out by the Pharmacy Department. Material and methods A retrospective descriptive study was carried out from January 2017 to October 2017. The data collected were: affected drug, duration of the shortage and measures implemented. The data were obtained from the drug shortages’ list of the Spanish Agency for Medicines and Health Products (AEMPS). We analysed every drug included in the hospital pharmacotherapy guide. Results During the study period, there were 226 drugs affected by supply problems, 172 of them active principles included in our pharmacotherapy guide, specifically 98 pharmaceutical specialties. The strategies for the management were: To change the provider or the form of presentation (packaging) in 38 cases (38.77%). To use a therapeutic alternative in 13 cases (13.26%). The AEMPS authorised temporarily the importation of six medicines with the outer packaging and package leaflet in a language other than Spanish, but this option was not used. In eight cases (8.16%) there was controlled distribution of certain drugs just in case of clinical need. Despite the AEMPS offer to import 17 foreign medicinal products, only nine applications (9.18%) were processed. The foreign medicinal products were relabelled in Spanish before being dispensed in the hospital. No action was taken in 30 cases due to the low prescription rate in our centre or the availability of sufficient stock. Conclusion The unpredictability of shortages and lack of information provided to healthcare professionals make it increasingly difficult to plan effective coping strategies to provide medication to patients. In fact, it implies a greater workload for hospital pharmacists due to administrative procedures, the determination of therapeutic alternatives and the need to inform all health professionals so as not to compromise the continuity of treatment, increased stress and confusion within safety-critical working environments, the frequent high costs of procuring alternative medicines and the cancellation of service improvements due to resources needing to be reallocated to deal with medicines’ shortages. No conflict of interest

Background Proprotein inhibitors convertase subtilisin/kexin9 (i-PCSK9) are new drugs for hypercholesterolaemia used in monotherapy or in combination with statins, which have numerous interactions. It may be useful to study the efficacy of I-PCSK9 as a single therapy. Purpose To compare the efficacy of i-PCSK9 alirocumab and evolocumab in monotherapy versus bitherapy with statins, in order to define the clinical benefit of deprescribing statins in these patients. Material and methods A retrospective observational study was conducted in our centre from March 2016 to March 2017. Patients treated with I-PCSK9 with/without combining it with statins were included. Low-density lipoprotein cholesterol (LDL-C) levels were measured before starting the treatment and at weeks 8 and 24. Data were available from medical histories. Adherence was calculated indirectly by consulting the dispensing of statins at the pharmacy office in the application for external prescription of our Autonomous Community. Results During the study period, 42 patients, 25 males and 17 females, were treated with i-PCSK9 in our centre. Sixteen started i-PCSK9 as a single treatment because of their intolerance to statins. Among the 26 patients who continued their treatment with statins, 58% (15/26) had a treatment adherence of 90%. Forty-two per cent (11/26) of these patients dropped out from treatment with statins before week 8. In the subgroup of patients in treatment with i-PCSK9 in monotherapy (because of lack of adherence or intolerance to statins) the lowering of LDL-C at week 8 (n=10) was compared to patients treated with bitherapy (n=9) (all other patients were excluded because they had not completed 8 weeks of treatment or because of lack of data). An average reduction in LDL-C from a baseline of 57% (95% CI: 40 to 74) and 80% (95% CI: 40 to 74) was obtained respectively. Conclusion A high rate of patients who start i–PCSK9 therapy do not continue statin treatment. In our study, the reduction in LDL–C with i–PCSK9 as a single agent is similar to the results of the LONG TERM trial (60%) in which only patients with biotherapy were included. Regarding the results obtained and the added complexity of using statins, it seems reasonable to research the efficacy of i–PCSK9 in monotherapy. No conflict of interest

Background Macitentan is a new endothelin receptor antagonist (ERA) which was compared with placebo in the SERAPHIN trial. The results showed no superior efficacy or safety compared (indirectly) with other ERAs but better hepatic tolerance. Purpose To assess adaptation of pulmonary arterial hypertension (PAH) treatment prescriptions under our hospital protocol and its economic impact, and to describe the clinical results of using a new ERA, macitentan. Material and methods A use protocol for ERAs was established in September 2016 in our hospital, evaluating cost effectiveness as the main criterion for prescription. Thus bosentan was chosen as the first option for treatment as macitentan had not shown superiority with regard to either efficacy or safety. According to the use protocol, macitentan should be used in naive patients with liver dysfunction or in those patients treated with bosentan who have developed treatment related hepatic toxicity. Several clinical parameters assessed PAH disease before and after treatment: functional class, baseline oxygen saturation (%SpO 2 ) and NT-proBNP levels. Results After designing the use protocol for ERAs, 9 prescriptions for macitentan from the respiratory department were registered. 44% of patients (4/9) met the requirements of use of macitentan (increased transaminases before using bosentan). The treatment cost per month with a standard maintenance dose of bosentan 125 mg/12 hours was €414, while the treatment cost per month with a standard dose of macitentan 10 mg/24 hours was €2063. After 4 months of treatment with macitentan, patients with elevated transaminases had returned to normal levels but all patients maintained the same functional class and there were no clinically significant differences in%SpO 2 or NT-proBNP (p>0.05). Conclusion If compliance with the use protocol for ERAs had been 100%, 5 of the patients would have been treated with bosentan, leading to a cost saving of about €1649 for patient per month, a total amount of €74205 so far this year. Implementation of a consensual use protocol for ERAs could enhance the rational use of this drug, but further collaboration with physicians is needed to achieve better optimisation of available resources. No conflict of interest

Thirst and hyperdipsia of anuric chronic uremics on maintenance hemodialysis and the possible dipsogenic factors were studied. Exaggerated thirst was present in 213 (86%) of the 247 studied patients. It usually started 4-6 h after the end of the dialysis session, persisted during the whole interdialytic period and often disappeared during the subsequent dialysis. Hyperdipsia, as indicated by the high body weight gain (4%) in the interdialytic periods, was present in 33.6% of patients. The highest rate of increase of body weight occurred in the first hours following the end of dialysis sessions. Hypernatremia, potassium depletion, increasing plasma urea levels and elevated plasma angiotensin II levels were considered as the possible dipsogenic factors of a nonpsychic nature. Sodium is certainly of paramount importance for its obliged extracellular position, and when sodium intake is elevated, hypernatremia is very likely the cause of exaggerated thirst and weight gain in patients on hemodialysis. Potassium depletion may cause thirst in animals, but this condition is extremely rare in patients on maintenance hemodialysis, who often accumulate it. In these patients it is, therefore, unlikely that potassium depletion is a dipsogenic factor. Increasing serum urea levels exert an evident dipsogenic effect in anephric rats and urea, when infused into normal volunteers, stimulates thirst. The extracellular urea levels in the interdialytic period are certainly higher than the intracellular ones, as a consequence of its continuous accumulation, and this creates an osmotic gradient with a dipsogenic effect. When this gradient is reversed, following hemodialysis (which removes first the extracellular urea), the dipsogenic effect disappears.(ABSTRACT TRUNCATED AT 250 WORDS)

Diabetes mellitus is a chronic metabolic condition characterized by persistent hyperglycaemia with resultant morbidity and mortality related to its microvascular and macrovascular complications. In addition diabetes is also associated with several musculoskeletal disorders of the hand, that can be debilitating. There is increased incidence of these abnormalities in patients with type 1 and type 2 diabetes compared with the general population, related to disease duration but not to the age or sex. Typical diabetes associated hand condition include the palmar flexor tenosynovitis, Dupuytren's contracture, syndrome of limited joint mobility, carpal tunnel syndrome, Charcot arthropathy and reflex sympathetic dystrophy. Maintaining good glycaemic control by exercise, diet and drugs improves or prevents the development of these hand rheumatic condition. In this brief report we review the rational therapeutic approach to these disorders.

The obstetric and prenatal outcome in post-menopausal women of advanced age in an oocyte donation programme is described in this paper, the oldest being aged 63 years. A total of 2729 candidates were visited up to November 2000. Only 1150 (42%) were accepted, with 1579 being rejected during a rigorous selection procedure. Several excluding clinical conditions were noted, including hypertension of varying severity, cardiovascular disease, smoking, dysfunctions of the hepatic, thyroid and renal systems and diabetes. Overall, 489 (38%) clinical pregnancies were established in 1288 recipient cycles, with 390 healthy babies delivered out of 363 pregnancies (28%), while 126 (25.7%) were lost. In all, 327 (90%) of the pregnancies reached full term, with 36 involving premature deliveries, 24 involving multiple gestation, 21 sets of twins, three sets of triplets (0.9%) and no quadruplets. Antenatal complications arising in 86 patients (23.6% of deliveries) included 33 preterm deliveries, 43 cases of gestational hypertension, four cases of pre-eclampsia, three cases of gestational diabetes and three of abruptio placentae. A total of 272 (75%) of all deliveries were by Caesarean section. Neonatal complications included two cases of growth retardation. There were no neonatal or maternal deaths. The 63-year-old woman reached full term pregnancy in July 1994, with delivery by Caesarean section of a boy in good health. Proper screening for risks has enabled this treatment to be given to a preselected group of patients.

The aim of this study was to examine the safety and the efficiency of a 'non-contact' UV laser to assist hatching through zona opening of human embryos. Between January and November 1995 we performed zona drilling for assisted hatching using a new laser system (PALM UV Laser microbeam), operating in a 'non-contact' mode to create a hole in the zona pellucida of human embryos. In a randomized study, laser zona opening was applied on embryos from two groups of patients with repeated in-vitro fertilization (IVF) failures (two to four attempts): group A was composed of 107 patients who received mixed embryos (216 laser-treated and 223 not treated) and group B of 72 patients who received 218 laser-treated embryos only. Both groups were compared with a control group of 98 patients whose embryos were not laser treated (n = 407) (group C). The mean ages of all groups (38.1, 38.2 and 37.8 years respectively) and the number of IVF attempts (two to four attempts) were similar. The resulting clinical pregnancies were 39 (36.4%) in group A, 32 (44.4%) in group B and 19 (19.3%) in group C. The implantation rates/embryo were 9.3% in A, 16% in B and 5.1% in the control group. In total, 17 normal babies have been delivered (10 in group A and seven in group B). These results show that laser zona drilling increased the pregnancy and implantation rates in all the treated patients. The increase was slight but significant in patients of group A (P0.01 and P0.02), it was even higher in the patients of group B (P0.05).

Twenty-three chronic uremic patients on maintenance hemodialysis and suffering from severe pruritus were treated with activated powdered charcoal (6 g daily p.o.). In 10 patients pruritus disappeared completely, and in 10 other patients a partial effect was observed. The favorable results persisted for several weeks after discontinuation of the treatment. Only 3 cases were totally unresponsive. No relevant undesirable side effects were observed with the exception of 1 case who showed treatment intolerance. It is concluded that activated charcoal per os is a safe, effective, and low-cost therapy for patients with uremic pruritus, but its mechanism of action is unknown.

In spite of the demonstration that the Al of the antacids is absorbed in the gastrointestinal tract (1, 2, 3, 4) and that its retention may cause severe adverse effects in patients with chronic renal failure (CRF) (5, 6, 7, 8), the Al-containing phosphate binders continue to be widely used to correct hyperphosphatemia.

A low-protein, low-phosphorus diet supplemented with essential amino acids and keto analogues was given to 12 rats, starting from the 90th day after subtotal nephrectomy. The purpose was to assess its effect on the residual renal function and on the nutritional status in rats with already established severe renal failure. Ten control rats in the same conditions, following a standard diet supplying normal amounts of protein and phosphorus were also studied. The supplemented diet exerted a well-evident protection of residual renal function and structure: lower rate of decline of creatinine clearance, lower mortality, significant decrease of proteinuria and almost total absence of histological signs of activity. The nutritional status was also well protected by the dietary therapy: increase of body weight, normal values of total serum protein, and low-constant values of urea appearance. In the control rats body weight decreased, total serum protein was lower than normal and the values of urea appearance were increasing simultaneously with a decreasing food intake and body weight.

The results are described of a combined nutritional (supplemented diet) and dialytic (once a week hemodialysis) therapy, employed in 17 selected chronic uremics for a mean period of 18.2 months/patient. The clinical findings, blood chemical abnormalities and changes of renal function were examined and compared with those of patients on the standard thrice-a-week dialysis schedule and free diet. The clinical findings were not significantly different in the two groups. The residual renal function of patients on combined therapy declined faster than in patients on conservative treatment, but at a slower rate than in those on thrice-a-week dialysis. The time averages of serum urea, methylguanidine and phosphate concentrations and their postdialytic rebounds were lower in the patients on combined therapy than in those on thrice-a-week dialysis, whereas the time averages of the serum creatinine concentration were higher, and those of serum bicarbonate and serum oxalate were not significantly different in the two groups. It is concluded that this combined therapy is a valid alternative to the conventional thrice-a-week hemodialysis and free diet for selected patients and for periods of time whose duration is conditioned by the rate of decline of the residual renal function.