Reduction of ischaemic rest pain in advanced peripheral arterial occlusive disease. A double blind placebo controlled trial with iloprost.

Severe pain at rest is a major symptom of advanced peripheral arterial occlusive disease (PAOD). Preliminary studies of treatment with iloprost, a prostacyclin analogue, showed encouraging results in patients with ischaemic rest pain. Therefore a randomized, placebo-controlled multicentre study was undertaken in 113 patients admitted to hospital with rest pain of at least 2 weeks duration caused by severe PAOD. The patients were randomly assigned to receive 2-week placebo or iloprost infusions for 6 hours per day at a dose of 0.5-0.2 ng/kg/min in addition to conventional care. Demographic data and arteriographic findings were similar in the two groups. Eleven patients withdrew from the study before completion and 102 patients could be included in the final analysis. Significantly more patients in the iloprost group (62.5% of 48) than in the placebo group (42.6% of 54) had complete relief of pain without analgesic therapy during at least five consecutive days at the end of the treatment period (p less than 0.05, chi 2-test). Facial flush, headache and nausea were the most common side effects during iloprost infusion. Serious adverse reactions did not occur. Thus, a 2-week iloprost infusion was shown to be safe and effective as a treatment for ischaemic rest pain caused by PAOD.

The geriatric patient in surgery. Experience with patients over the age of 85 years.

Between 1982 and 1989 hospitalized treatment was applied to 615 patients aged between 85 and 101 years. The average age was 88.8 years. Operations were performed on 406 of them (66.1%). The surgical lethality amounted 16.5%. The lethality in conjunction with emergency operation was as high as 30.8% or as low as 10.7% in the context of elective operations. X-ray findings recorded from heart and lung as well as ECG provided reliable criteria for assessment of the surgical risk.

["INTENSIV"--organization and structure of a knowledge-based PC system for the intensive care unit]. / "INTENSIV"--Aufbau und Struktur des wissensbasierten PC-Systems für die Intensivstation.

A computer program for use on an intensive care unit (ICU) has been developed. The program INTENSIV is a knowledge-based system with integrated conventional basic functions. Besides managing all patient-related data, the program processes all laboratory data, clinical observations and measured data. Deviations from the norm and disturbances in patient balances are recognized by the system; under consideration of contraindications such as antagonistic or synergistic drug interactions, the system makes recommendations for basic therapy regimens as well as necessary corrections according to changes in the regular course of an illness. Aside from disturbance analysis and therapy planning, the computer can portray and document the entire course of therapy and the patient's progress as seen in ICU charts, including fluid and electrolyte balances and graphic parameter curves.

[Experiences with early postoperative enteral tube feeding]. / Erfahrungen mit der frühen postoperativen enteralen Sondenernährung.

Over a period of 2 years 234 patients scheduled for major intraabdominal surgery were fed postoperatively via fine needle jejunostomy catheter. Nutrition ensued directly after surgery. Mean period of nutrition was 7.8 +/- 1.5 days. Care of the catheter was simple and secure. Compatibility with formula nutrition was good. Pertaining to catheter related complications, 25 patients presented diarrhoea, which was generally tolerable. Occasionally, flatulence and nausea occurred. In one patient, catheter nourishment had to be discontinued because of diarrhoea. One further discontinuation occurred due to postoperative non-catheter-related ileus. Clinical postoperative progress and laboratory findings showed no negative results relating to this form of nutrition.

Conversion operation Billroth II into Billroth I with jejunal interposition.

First, under consideration of the erroneous operative often techniques often found in patients with B II gastrectomy, all functional complaints of these patients should prompt the consultant to recommend conversion surgery. Secondly, all recurrent ulcerations, whether peptic or anastomositis, represent an indication for conversion surgery. Last but not least reconstruction of normal nutrition passage in an important indication for surgery in patients with B II gastrectomy, restoring near physiologic passage circumstances. Particularly grave in its consequences is the gastric stump carcinoma with its fateful and irrevocable course for patients with B II gastrectomy if regular gastroscopic and laboratory follow-up inspection do not take place (regardless of questionable operation indication). We recall a tragic case of a woman with B II gastrectomy who refused conversion surgery despite histologic verification of metaplasia, who died of gastric stump carcinoma a year later.

[Surgical diseases in advanced age]. / Chirurgische Erkrankungen im hohen Lebensalter.

Between 1982 and 1989 hospitalized treatment was applied to 615 patients aged between 85 and 101 years. The average age was 88.8 years. Operations were performed on 406 of them (66.1%). The surgical lethality amounted 16.5%. The lethality in conjunction with emergency operation was as high as 30.8% or as low as 10.7% in the context of elective operations. X-ray findings recorded from heart and lung as well as ECG provided reliable criteria for assessment of the surgical risk.

[Surgery in advanced age]. / Chirurgie im hohen Lebensalter.

Between 1982 and 1990 724 patients aged between 85 and 102 years were hospitalized (average age: 88.7 years). Operations were performed on 482 of them (66.6%). The surgical mortality amounted to 16.8%. The mortality in conjunction with emergency operation was as high as 28.2%, or as low as 11.4% in the context of elective operations. X-ray findings recorded from heart and lung, and ECG provided reliable criteria for assessment of the surgical risk.

[The elderly surgical patient. Experiences with patients over 85]. / Der alte chirurgische Patient. Erfahrungen mit Patienten über 85 Jahre.

Hospitalised treatment was applied to 326 patients aged between 85 and 101 years, between 1982 and 1987. Operations were performed on 215 of them. The surgical lethality amounted to 16.3 per cent, though lethality in conjunction with emergency operations was as high as 23.9 per cent or as low as 11.8 per cent in the context of elective operations. X-ray findings recorded from heart and lung as well as ECG provided reliable criteria for assessment of the surgical risk.

[Iloprost, a stable prostacyclin derivative, in stage 4 arterial occlusive disease. A placebo-controlled multicenter study]. / Iloprost, ein stabiles Prostacyclinderivat, bei arterieller Verschlusskrankheit im Stadium IV. Eine placebo-kontrollierte Multizenterstudie.

The effectiveness of iloprost, a prostacyclin derivative, was assessed in a placebo-controlled multicentre trial on 101 patients with chronic arterial disease, stage IV. All patients were on a basic local treatment, 53 randomly being assigned to the iloprost group, 48 to the placebo one. Both groups received identical saline infusions, one with the other without iloprost. Infusions were given on 28 consecutive days, iloprost being added at a dose of up to 2 ng/kg.min over six hours. At the end of the treatment period, 32 of 52 patients (61.5%) of the iloprost group and eight of the 47 in the placebo group (17%) had partial or complete healing of ulcers (P less than 0.05), the treatment effect persisting in both groups for a mean duration of at least one year. Iloprost was well tolerated, once individual dosages had been appropriately adjusted. Facial flushes, headache and nausea were the most common side effects. Heart rate and blood-pressure variations did not differ between the two groups.

Double-blind randomised placebo-controlled phase III study of an E. coli extract plus 5-fluorouracil versus 5-fluorouracil in patients with advanced colorectal cancer.

The primary aim of this study was to evaluate the toxicity (mucositis, diarrhea and leucopenia) of a therapy with 5-fluorouracil (CAS 51-21-8; 5-FU) plus an E. coli extract (LC-Extract, Laves coli extract, Colibiogen inject, cell-free soluble fraction from lysed E. coli, Laves strain) in comparison with 5-FU plus placebo. Secondary endpoints included general toxicity, response rate according to WHO, survival time and quality of life. 164 patients with advanced colorectal cancer were enrolled in this randomised, placebo-controlled, double-blind, multicenter phase III study. The treatment consisted of 0.167 ml/kg/d LC-Extract or placebo followed by 500-750 mg/m2/d 5-FU on five consecutive days, repeated every three weeks for up to six treatment cycles. 158 (77 verum, 81 placebo) patients were evaluable for toxicity, 144 (72 verum, 72 placebo) evaluable for response. The therapy with LC-Extract was well tolerated. Adverse events that occurred during the study were mainly judged as 5-FU- or tumor-related. Toxicity from treatment with 600 mg/m2/d 5-FU in both treatment groups was very low. After treatment with 750 mg/m2/d 5-FU patients in the placebo-group experienced a higher CTC toxicity than in the LC-Extract groups. Remission rate and survival time showed a slight trend in favour of LC-Extract. These results suggest a positive benefit-risk ratio of the additional application of LC-Extract to 5-FU in the treatment of advanced colorectal cancer especially for administration of high doses of 5-FU.

[General problems in long-surviving experimental animals following complete heart replacement]. / Allgemeine Problematik bei langüberlebenden Versuchstieren nach Totalersatz der Herzens.

Total heart replacement was performed in 7 calves. All animals were alive at 3 weeks, and four survived more than 2 months up to 121 days. Failure of the pumping equipment was responsible for death in each case. At autopsy increase both in size of the right atrium and of liver weight and evidence of thromboembolism were regular findings.