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Pefloxacin plus metronidazole versus netilmicin plus metronidazole in the prevention of nosocomial infections during contaminated surgery. Surgical prophylaxis is widely used in contaminated surgery, especially colorectal surgery. In this clinical trial the efficacy of pefloxacin 800 mg i.v. slow infusion associated to metronidazole 500 mg i.v. 1-2 hours before surgery and then metronidazole alone after 6 and 12 hours versus netilmicin 200 mg i.m. associated to metronidazole 500 mg i.v. 1-2 hours before surgery and then both after 6 and 12 hours were evaluated in 97 patients suffering by colorectal surgery. Efficacy of prophylaxis in patients was evaluated in terms of appearance of post-surgical infections (abdominal, urinary, respiratory and wound infections). In pefloxacin + metronidazole group (53 patients), two cases of wound infections (3.8%) and three cases of respiratory infections (5.8%) were observed. In netilmicin + metronidazole group (44 patients), two cases of wound infections (4.9%), three cases of urinary infections (7%), three cases of respiratory infections (7.5%) and one case of intra-abdominal infection were observed. Our data confirmed that in colorectal surgery, the association pefloxacin, drug with microbiological and pharmacokinetics characteristics suitable for prophylaxis + metronidazole, active against anaerobes pathogens, prevents post-surgical infections as well as a reference association (netilmicin + metronidazole), with the advantage of a single administration.

Single-shot surgical prophylaxis is today used in all clean-contaminated surgery, because it is able to reduce the incidence of post-surgical infections. The aim of this clinical trial is to evaluate the efficacy of Pefloxacin 800 mg i.v. slow infusion in single administration 1-2 hours before surgery versus ceftriaxone 2 g i.v. 1-2 hours before surgery in 297 patients suffering from clean-contaminated surgery, especially biliary surgery and gastrectomy. Efficacy of prophylaxis in 259 patients, evaluable according to the protocol, was evaluated in terms of appearance of post-surgical infections (urinary, respiratory and wound infections). In the Pefloxacin group (128 patients), no cases of wound infections were observed, except one case of wound sterile secretion, without dehiscence, (0.81%), one case of urinary infection (0.81%) and three cases of respiratory infections (2.34%). In the ceftriaxone group (131 patients), three cases of wound sterile secretion without dehiscence (2.36%), one case of urinary infections (0.76%) and four cases of respiratory infections (3.05%) were observed. From this study we can conclude that single-shot surgical prophylaxis with pefloxacin, drug with microbiological and pharmacokinetics characteristics suitable for prophylaxis, is able to prevent postsurgical nosocomial infections as well as ceftriaxone, considered a reference drug largely used in this indication.

Four periods are recognizable in breast carcinoma treatment: the first period can be called as "era of the incurable disease". It begins at the arising of the mankind and lasts up to the end of the 19th century. During this period the disease was usually diagnosed in far advanced stage and any therapeutical attempt was unable to cure a significant percentage of patients. The second period begins with Halsted and ends in the late 60's. It should be considered as the "eve of the surgical treatment of the breast cancer". In these years an increasing number of patients was diagnosed in earlier, curable stage and about half of them was definitively cured. In the early 70's several multimodality treatments of breast cancer were proposed by different Cancer Centers worldwide. Usually a local treatment (surgery+radiotherapy) was adopted combined with a systemic treatment (chemotherapy or monotherapy), commonly in N+ patients. Such approach cured a further 25% of patients that the local treatment alone could not cure. Moreover conservative surgical procedures were extensively carried up. In the last ten years the increasing amount of clinical data leads us to adopt a tailored therapeutical plan for nearly every patient. Numerous subgroups of patients with different level of risk were identified (patients with inflammatory carcinoma, young women at high risk, elderly patients etc.). The early data show that some further advantages in survival rates, in cost saving policy and in cosmetic outcome can be achieved.

In 3088 patients submitted to various surgical procedures an open clinical trial was carried out to evaluate the rare of surgical wound infections (SWI). All of them were treated, before and after surgery, with a foam emulsion (Bioshield) considered, from a theoretical point of view, to be able decrease the bacterial contamination of the surgical wounds. The SWI rate was really low (congruent to 2.3%) and a favorable role played by Bioshield cannot be excluded, both minimizing the skin lesions of the surgeon's hands and reducing wound contamination by exogenous flora.

The bacterial infections constitute a serious problem for the surgeon: the choice of antibiotic drugs is really important and, as often as possible, should be guided by antibiotic sensitivity tests. In this study we used sulbactam-ampicillin (Unasyn) who is an antibiotic combination between sulbactam, inhibitor of beta lactam and ampicillin. The preliminary results were as follows: Unasyn was administered to 21 hospitalized selected patients, 16 women and 5 man, who had clinical signs of intraabdominal infection, wound infection and subphrenic abscess after digestive surgery. In these patients were isolated the following organisms: Staphylococcus epidermidis (8), Staphylococcus aureus (11), serratia (1), streptococcus (3), E. coli (3). The daily dosage of Unasyn was 3-12 g/die administered in three to four divided doses, and was determined by the severity of infection, the antibiotic susceptibility of the causative organism(s) and the condition of the patient. Each dose was given by slow i.v. infusion in 15-30 minutes. Our success rate was 100%, and neither systemic nor local side effects were recorded.

Since 1981 we monitored all the bacteria strains isolated from patients bearing a surgical infection and hospitalized in our department. We also tested the susceptibility of the isolated strains to different antibiotics. The observed results at three different intervals (1981, 1984, 1987-1988) reveal an increase in Gram+strains. Among the tested antibiotics Imipenem and Amikacin showed the highest antibacterial activity in recent years (1987-1988).

Surveillance and control of hospital infections are two particularly important aspects of the surgical ward, and great activity is necessary in the identification and the elimination of the risk factors whenever possible. Today the rational use of antibiotics, in both the prevention and treatment of infections, should be used to avoid or limit nosocomial infections, and it is as important as the use of disinfectants. Cefotetan has been studied in different surgical specialties in prophylaxis and treatment of postoperative infections for its particularly broad spectrum of activity, covering both aerobic and anaerobic organisms, and for the very low incidence of side-effects. In general surgery, Cefotetan has proved able to reduce not only the occurrence of surgical wound infections, but also that of postoperative infections of the genitourinary system.

An association of 5-fluoruracyl (or methotrexate) and cyclophosphamide was used in the treatment of 20 cases of hormone-resistant breast cancer. Five objective regressions were obtained. Mean survival here was 28.25 (S.D. 2.87) months, as opposed to 12.75 (S.D. 6.93) months in the remainder. Side-effects of various kinds were noted in 9 patients.

Fifty-three patients suffering from chronic arterial diseases of the lower limbs were treated with buflomedil, a vasoactive drug with vasodilating and hemorheological action on the microcirculation. The patients suffered from pain on walking or pain at rest; they were given 300 mg buflomedil orally twice a day for a period of about 2 months. The walking distance before pain onset was checked in all patients before and after the trial. Blood and plasma viscosity, haematocrit and fibrinogen and a Doppler velocimetry were also recorded. A significant improvement of the walking distance before pain onset was observed in nearly all patients, and in most patients the morphology of the velocity waves improved, too. No clear correlation between the positive clinical results and the hemorheological parameters studied could be observed.

The results obtained in 14 patients suffering from hormone-resistant metastatic breast cancer treated with the following association: methotrexate (5-fluorouracyl in case of methotrexate intolerance), cyclophosphamide, vinblastin administered i.v. once every 10-13 days, are reported. 4 objective regression (29%) were observed but survival did not very appreciably differing therapy. In 9 cases (65%) intolerance of various types was observed but in 8 these signs regressed in a short time and the therapy was resumed.

The results of 13 clinical trials were analysed in order to define the efficacy of ceftriaxone (Rocephin) when given alone and in a single daily dose in the treatment of postoperative infections. In a total of 306 evaluable patients, many of whom were suffering from severe infections, the global clinical success rate was about 90%. The drug was very well tolerated. Minor transient effects occurred only in a few patients. In 8 out of the 13 trials, ceftriaxone was compared with other standard antibiotics. In these comparative studies, the global clinical success rate with ceftriaxone (93.8%) was higher than with other drugs (81%). The microbiological response to ceftriaxone was extremely satisfactory for almost all pathogenes.

Changes in body weight (absolute and percent), overweight index, and body surface area were examined in 27 grossly obese subjects after jejunal-ileal by-pass. Curves were steeper and linear for 3-4 months and then flattened out for the remainder of the twelve-month period of observation. They were parallel to each other even when a division was made between patients weighing more and less than twice their ideal weight. This shows that if a person weighs more than 120 Kg his weight loss curve will depend on the time that has elapsed since surgery. It is virtually independent of the start value.

A comparison was made between 73 patients with colon-rectum neoplasia operated urgently due to occlusion and 85 electively operated in the absence of mechanical ileus. Six parameters were examined: 1) Duration of preoperative symptomatology; 2) Seriousness of preoperative symptomatology; 3) Extention of neoplasia at surgery; 4) Type of operation; 5) Postoperative mortality; 6) Long-term survival. It was found that obstruction often occurs within 5 months after the onset of symptoms and in cases where the tumour is still local (55%). It is attended by higher postoperative mortality (22%) and shorter survival (18 as opposed to 23 months).

To establish the effectiveness of adjuvant chemotherapy in patients with colon cancer after radical surgery, from 1980 to December 1983, 263 patients were randomized in a multicentric study to no further treatment (131 patients) or to a combination of fluorouracil (5-FU) (400 mg/m2 i.v., days 1-5) and lomustine (CCNU) (100 mg/m2 per os on day 5) every 6 weeks for 9 cycles (132 patients). The two groups were well balanced for age, sex, histology, tumor and nodal extent. Chemotherapy was not given to 30 of the 132 randomized patients, and of 98 treated patients only 38 completed the entire protocol. Analysis, as intention to treat, at 54 months did not show any significant difference between the two treatment groups in terms of relapse-free survival (surgery alone, 74.5%; surgery + adjuvant chemotherapy, 70.9%; p = 0.91). In contrast, a significant difference was observed in overall survival (surgery alone, 78.8%; surgery + adjuvant chemotherapy, 60.8%; p = 0.04). The sites of relapse were identical in the two treatment arms. In conclusion, from this study it appears that adjuvant chemotherapy with 5-FU and CCNU seems to have no efficacy in the cure rate of colon cancer patients.

The prophylactic activity of defibrotide, a new extractive antithrombotic-thrombolytic agent of mammalian origin, was assessed by detection of deep venous thrombosis (DVT) in patients who underwent general elective surgery. 120 patients (aged 25-85 years, mean 55.6) were randomly assigned to defibrotide (60 patients) or to placebo (60 patients). The two groups were homogeneous for age, sex and risk factors for DVT. The active drug was given intravenously 200 mg four times a day, starting the day before the operation and then for the following 7 days. To detect DVT, 125I-fibrinogen was used, by conventional methods. Defibrotide reduced the frequency of DVT to 4/60 (7%) from 16/60 (27%) in the placebo group. The difference was highly significant (p less than 0.01). Neither side effects nor anticoagulant activity were observed. On the basis of this evidence, defibrotide may be considered an effective and well-tolerated drug for prevention of DVT.

The results obtained in a series of 75 patients suffering from advanced cancer of the colon-rectum are examined. Survival of these patients is looked at as a function of the extent of surgical demolition, and as a function of postoperative chemotherapy. Demolition interventions were followed by much higher survival than was observed following palliative operations. At the same time, survival was higher in patients who underwent post-operative chemotherapy. The results therefore justify a more aggressive approach in advanced cancer of the colon-rectum.

Gastric carbonic anhydrase (CA) is believed to play an important role related to cytoprotection, and duodenogastric reflux of bile salts (BS) is suspected of having a causal role in many pathologic conditions. Thus, we decided to investigate the effect of free and conjugated BS on human and rat gastric CA activity. Cholate exerted the most potent inhibitory activity on both human (I50 = 2.24 mM) and rat (I50 = 1.68 mM) gastric CA, followed by glycochenodeoxycholate and taurocholate (I50 = 6.90 mM and 13.67 mM on rat gastric CA). Human and rat whole bile produced 10-90% and 20-40% inhibition of gastric CA of the same species. Since the concentrations of free and conjugated BS tested in this study can be found in the postgastrectomized stomach, our data suggest that inhibition of gastric CA might be one mechanism contributing to the gastric mucosa damage caused by BS refluxing into the stomach after gastric surgery.

Alkylating drugs, alkylating drugs + antimetabolites, and alkylating drugs + antimetabolites + Vinblastine were used to treat 62 patients. The results were assessed in terms of Karnofsky's classes and related to the following parameters: age, free interval, menopausal status, results of prior endocrine management, site of dominant metastases, length of survival. 44 failures (71%) and 18 objective responses (29%) were noted. A mean survival of 17.3 months was noted for the entire series. Subjects who failed to respond survived an average of 14 months, as opposed to 25.5 months for the responders. This difference was just significant. No relation could be shown between the results and the other parameters, whereas that between the results and the length of survival was highly significant. It is clear that the variables considered cannot be relied upon in predicting the outcome of chemotherapeutical management. If the latter is effective, however, survival will almost certainly be prolonged.

The results obtained in 26 patients suffering from metastatic cancer of the breast no longer sensitive to hormone treatment are reported. The patients were treated with ciclophosphamide (CTX) (500 mg i.v.) once a week and triethylenethiophosphamide (20-30 mg i.m.) (TSPA) every 4 weeks associated with cyclophosphamide as follows: CTX--CTX--CTX--CTX+TSPA. 9 objective regressions (34.6%) were observed. Those with objective regression lived 28 months on average (SD 23.45) and those without lived on average 11.41 months (SD 9.89). The difference is statistically significant. Side effects of various types were observed in 7 patients (27%).