Therapeutic potential and clinical efficacy of acid-resistant fungal lipase in the treatment of pancreatic steatorrhoea due to cystic fibrosis.

We investigated the therapeutic potential of an acid-resistant fungal lipase prepared from Aspergillus niger. We first demonstrated in vitro that it had a wide pH optimum of 2.5-5.5 and was resistant to pepsin and trypsin. We gave the enzyme or matching placebo in random order by mouth with a fatty meal to 10 adult patients with pancreatic steatorrhoea due to cystic fibrosis (CF) and sampled gastric contents for the following 2 h. Mean acid-resistant lipase activity was 330 nmol/ml/min free fatty acid released on placebo, compared with 896 nmol/ml/min on fungal lipase (p = 0.006 for area under the curve). We compared this lipase's clinical efficacy with that of two conventional pancreatin microsphere formulations in an open randomised crossover fat-balance study in 10 similar patients. Each preparation was given for 2 weeks, and a fat-balance study, using a faecal recovery marker, was performed on the final 3 days; a period without treatment was also included. The fungal lipase had no effect on faecal wet weight or on the coefficient of fat absorption (59.0% vs. 52.3%; NS) in comparison with placebo. The established enteric-coated microsphere preparation (Creon) produced a significant reduction in faecal wet weight and improvement in coefficient of fat absorption (81.4% vs. 52.3%; p less than 0.01) in comparison with placebo. The newer microsphere preparation (Pancrex M) was also effective, but perhaps less so than Creon; there were no significant differences between the two preparations.(ABSTRACT TRUNCATED AT 250 WORDS)

The effects of autoclaving on the physical properties and biological activity of parenteral heparin preparations.

Heparin ampoules have been autoclaved at 115 degrees C, 121 degrees C, 126 degrees C and 130 degrees C for time intervals up to 50 min and the biological potency and physicochemical integrity of the preparations assessed. The anticoagulant activity, determined with the APTT assay, did not change significantly for the autoclaved samples but a decrease was observed using the BP assay. Autoclaving was also associated with a depolymerization process, as confirmed by high performance liquid chromatography, and the formation of 'species' with an absorption in the UV spectrum. However, autoclaving had no detrimental effect on the integrity of the anionic sites on heparin. It is proposed that Maillard-type reactions are responsible for these observations and the results indicate that autoclaving could be used to sterilize parenteral heparin solutions.

Success of communication about renal transplantation between patient and doctor.

Four hundred patients in 12 renal units, half of them with attached transplant units, answered a questionnaire by post or in clinics about the successes and failures of the communication process that concerned their treatment by dialysis and transplantation. Eighty per cent wanted more information, whatever their mode of treatment, those with successful transplants being more satisfied with the information given than those with failed transplants (60% vs 35%). Patients with a failed transplant were more enthusiastic about a second transplant than those still waiting for their first (80% vs 70%). Answers still show some anxiety about transplantation in 20% of patients. Free comments not elicited by questions revealed lack of information about the major implications of transplantation and drugs used in treatment. It is suggested that written information must be backed up by personal enhancement of the stages a patient passes through. Patients' Associations provide a valuable way of giving information.