The amoxicillin-clavulanate combination (Augmentin) frequently induces gastric complaints and diarrhea by an unknown mechanism. The aim of this study was to assess the effects of two orally therapeutic regimens of amoxicillin-clavulanate on small bowel motility in human beings. Duodeno-jejunal manometric recordings were performed in six healthy subjects treated in a cross-over double-blind study with placebo; amoxicillinclavulanate, 1 g plus 250 mg per os every 12 h for 3 days; or amoxicillin-clavulanate, 1 g plus 250 mg per os every 12 h on day 3 only (1-day regimen). Recordings were all performed on day 3 during a diurnal fasting period, a fed state after a standard dinner, and a nocturnal fasting period. Amoxicillin-clavulanate did not affect the motility of the small intestine during the diurnal fast or the fed state. During the nocturnal fast, amoxicillin-clavulanate significantly increased the motility index of the nonpropagated contractions and tended to increase the duration and the amplitude of the propagated contractions. The same digestive motor effect was already observed on the first day of treatment (1-day regimen). This study demonstrates that the oral administration of a therapeutic regimen of amoxicillin-clavulanate is associated, in most cases, with the occurrence of small intestinal motor disturbances.The amoxicillin-clavulanate combination (Augmentin), one of the most widely used antibiotics, frequently induces gastrointestinal side effects, such as nausea, vomiting, cramping (prevalence, 3 to 6%), or diarrhea (prevalence, 4 to 15%) (3, 5). These prevalences are higher than those reported with other orally administrated beta-lactams (10). These effects are usually minor and transient, but they sometimes lead to interruption of the treatment (3). As for other broad-spectrum antibiotics, disturbances of the normal gastrointestinal microfiora are often incriminated, but there is no proof of this. The aim of this study was to test whether the oral administration of a therapeutic regimen of amoxicillin-clavulanate in healthy volunteers is accompanied by changes in small bowel motility, as reported previously for macrolide antibiotics (11). MATERIALS AND METHODSSubjects. Seven healthy male volunteers (ages, 22 to 28 years) were included in the study. No subject was taking any medication or had a history of gastrointestinal symptoms or surgery. The study was approved by the Ethical Committee of the Medical University of Rouen, and written informed consent was obtained from each subject.Recording system. As reported previously (4, 6), intraluminal pressures were recorded from four side holes cut into an assembly of four polyvinyl tubes (internal diameter, 0.8 mm). The sensors were located at 5, 15, 25, and 35 cm from a rubber stall containing 2 ml of mercury and fixed to the tip of the tube to facilitate positioning. Radiopaque marks were inserted in the catheters near the side holes and at the tip to facilitate the fluoroscopic control of the position to the assembly. The probe was advanced so that ...
A 60-year-old woman was diagnosed with PV in 1969 and successfully maintained in remission by repeated courses of busulfan alternating with phlebotomy. In 1990, hydroxyurea was given instead of busulfan. The patient had never smoked nor drunk any alcohol and had never been exposed to other toxic drugs or poisons.In May 1992, the patient became anemic, hydroxyurea was stopped. In September 1992, the hemoglobin (Hb) level was 11.1 g%, the leukocyte count was 48,600/mm3, and the platelet count was 518,000/mm3. Bone marrow biopsy showed myelofibrosis and a normal 46XX karyotype. Hydroxyurea was again started and further remission obtained. In April 1993, fatigue, dysphagia, dyspnea on exertion, and rapid weight loss occurred. Upon admission to Geneva University Hospital, the patient looked pale and was bedridden. No lymph nodes were palpable, but one 2-cm subcutaneous nodule in the scalp and another in the upper part of the thorax, also measuring 2 cm, were identified. The spleen was grossly enlarged to 21 cm. Laboratory investigations were as follows. Hemoglobin was 9.9 g% and leukocytes 15,000/mm3 with 90% neutrophils, 3% basophils, 4% monocytes, 2% lymphocytes, and 1% myelocytes; platelets were 398,000/ mm3. Asymptomatic hypercalcemia at 1.54 mmol/L (normal range = 1.06-1.26) was discovered, which returned to normal after infusion of 1,800 mg of clodronate.Fiberoptic esophagoscopy revealed an ulcerative lesion of the middle portion of the esophagus measuring 4 cm in length with a stenosis leaving an open passage inferior to 1 cm. Biopsies were taken, and the histology showed a well-differentiated squamous cell carcinoma. Cytology of the skin nodes gave a similar result. Thoracic and abdominal CT showed mediastinal and retroperitoneal metastatic lymph nodes as well as direct contiguous infiltration of both lungs and of the thoracic spine. Bronchoscopy was macroscopically normal, but tumor cells were found in the bronchial aspirate. Despite palliative external radiation therapy, the patient's condition rapidly declined, and she died with bilateral infectious pneumonia and overt progressive malignant disease 1 month later. Autopsy was not permitted.Patients with PV are at greater risk than the normal population of the development of a second malignancy. In a review of 431 PV patients treated with phlebotomy with or without CLB and 3zP over 11 years, a total of 51 nonhematological malignancies were reported, of which 20 were of gastrointestinal origin [l]. Patients treated with CLB had a 3-3.5 relative risk (RR) of developing a secondary malignancy compared to the population with PV that did not receive that drug. For patients treated with "P, the RR was 2.3-2.5, and the RR was not increased for patients treated with phlebotomy alone.Our patient was treated with another alkylating agent, busulfan, at a total cumulative dose of 950 mg, which has the same, if not greater, carcinogenic potential than CLB [2]. The patient also received several courses of hydroxyurea, which has never proved any carcinogenicity. In the abse...
Fourteen-membered macrolides are known to produce alterations in digestive tract motor activity; these include the induction of strong gastric contractions and a decrease in the motility of the small intestine. The aim of the study was to compare the effects of two different formulations of erythromycin ethylsuccinate (EE) on duodenojejunal motility. Compared with the more commonly used crystalline formulation of EE (CEE), the amorphous formulation (AEE) has previously been described to have greater bioavailability and to induce significantly fewer gastrointestinal side effects when given at therapeutic and what have been considered to be equivalent oral doses (i.e., CEE, 1,000 mg every 12 h; AEE, 500 mg every 12 h). In a crossover double-blind study, duodenojejunal manometric recordings were performed for 10 volunteers treated with placebo, CEE at 1,000 mg, or AEE at 500 mg. Recordings for each volunteer were obtained for a fed period after a standard dinner and then for a nocturnal fasting period. When compared with the placebo, CEE significantly decreased the motility index of the duodenum during the 30 min after the peak serum erythromycin concentrations, shortened the duration of the fed state, and had no effect during the fasting state. In contrast, AEE did not significantly modify any motility parameter. Because AEE produced significantly lower concentrations in serum than CEE, these results do not necessarily imply that the two formulations of EE act differently on the motility of the small intestine.
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