Background: Liposomal cisplatin is a new formulation developed to reduce the systemic toxicity of cisplatin while simultaneously improving the targeting of the drug to the primary tumor and to metastases by increasing circulation time in the body fluids and tissues. The primary objectives were to determine nephrotoxicity, gastrointestinal side-effects, peripheral neuropathy and hematological toxicity and secondary objectives were to determine the response rate, time to tumor progression (TTP) and survival.Patients and methods: Two hundred and thirty-six chemotherapy-naive patients with inoperable non-small-cell lung cancer were randomly allocated to receive either 200 mg/m2 of liposomal cisplatin and 135 mg/m2 paclitaxel (arm A) or 75 mg/m2 cisplatin and 135 mg/m2 paclitaxel (arm B), once every 2 weeks on an outpatient basis. Two hundred and twenty-nine patients were assessable for toxicity, response rate and survival. Nine treatment cycles were planned.Results: Arm A patients showed statistically significant lower nephrotoxicity, grade 3 and 4 leucopenia, grade 2 and 3 neuropathy, nausea, vomiting and fatigue. There was no significant difference in median and overall survival and TTP between the two arms; median survival was 9 and 10 months in arms A and B, respectively, and TTP was 6.5 and 6 months in arms A and B, respectively.Conclusions: Liposomal cisplatin in combination with paclitaxel has been shown to be much less toxic than the original cisplatin combined with paclitaxel. Nephrotoxicity in particular was negligible after liposomal cisplatin administration. TTP and survival were similar in both treatment arms.
Post-prandial serum bile acid concentrations were measured in 200 Maltese dogs in an attempt to identify those with subclinical portosystemic shunts. Five of these were later shown to have hepatic pathology or abnormal liver function. In the other 195 Maltese, bile acid concentrations ranged from 1 to 362 mumol.L-1 (mean +/- SD, 70 +/- 50 mumol.L-1; median, 65.0 mumol.L-1). Of these, 79% were above the reference range (0 to 31 mumol.L-1) established from 23 mixed-breed control dogs. It was therefore not possible to determine the prevalence of subclinical portosystemic shunts on the basis of bile acid determinations. Further investigation of liver function was performed to investigate why bile acid concentrations were increased in these dogs. Rectal ammonia tolerance tests were normal in 102 of 106 Maltese tested and liver samples (11 dogs) and plasma biochemistry profiles (9 dogs) demonstrated no significant hepatic disease or dysfunction. Of 2 Maltese with hyperammonaemia after administration of ammonium chloride, one had a large congenital portosystemic shunt that was confirmed at surgery. In the other there were no macroscopic portosystemic communications, but a liver biopsy showed histological changes consistent with microscopic portovascular dysplasia. Total serum bile acid concentrations were consistently lower when assessed by high-performance liquid chromatography than by an enzymatic spectrophotometric method. This discrepancy was substantially larger in Maltese than in control dogs, suggesting the presence of an additional reacting substance in the serum of Maltese dogs.
R Re es sp pi ir ra at to or ry y m mu us sc cl le e s st tr re en ng gt th h d du ur ri in ng g c co on nt ti in nu uo ou us s a am mb bu ul la at to or ry y p pe er ri it to on ne ea al l d di ia al ly ys si is s ( (C CA AP PD D) ) N Maximum pressures, spirometry and lung volumes were measured before dialysis, 4 h after the administration of 2 l of dialysate into the peritoneal cavity, and just after the next drainage. In addition, biochemical indices (urea, creatinine, sodium, potassium, calcium and phosphorus) and haematological indices (haemoglobin (Hb) and haematocrit (Hct)) were measured once before the treatment.The results showed that mean PImax and PEmax were normal, with a very wide range between patients, before CAPD. However, seven patients (27%) showed a PImax of <75% predicted (pred) and eight (31%) a PEmax <75% pred. Maximal pressures decreased significantly during CAPD and increased again after the drainage of fluid. Similarly, lung volumes were within the normal range before and decreased significantly during CAPD. The forced expiratory volume in one second to forced vital capacity (FEV 1 /FVC) ratio did not change.We conclude that respiratory muscle strength was preserved in the majority of the patients with chronic renal failure treated with CAPD. During CAPD, lung volumes and respiratory muscle function were decreased, demonstrating an effect of the abdominal cavity on the mechanics of the respiratory system. However, the decrease in the maximum pressures was less than 20%, indicating that CAPD is a safe procedure in patients without pre-existing pulmonary disease or uraemic pulmonary complications. Respiratory muscle strength increased immediately after the drainage of fluid.
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