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PubMed2002

Isoflavones from red clover (Promensil) significantly reduce menopausal hot flush symptoms compared with placebo.

OBJECTIVES: To investigate the effectiveness and safety of a red clover isoflavone dietary supplement (Promensil, Novogen Ltd., Australia) versus placebo on the change in hot flush frequency in postmenopausal women. METHODS: In this randomized, double blind, placebo-controlled trial 30 women with more than 12 months amenorrhoea and experiencing more than five flushes per day were enrolled. All received single blind placebo tablets for 4 weeks and were subsequently randomized to either placebo or 80 mg isoflavones for a further 12 weeks. Efficacy was measured by the decrease in number of hot flushes per day and changes in Greene Climacteric Scale Score. RESULTS: During the first 4 weeks of placebo the frequency of hot flushes decreased by 16%. During the subsequent double blind phase, a further, statistically significant decrease of 44% was seen in isoflavones group (P<0.01), whereas no further reduction occurred within the placebo group. The Greene score decreased in the active group by 13% and remained unchanged in the placebo group. CONCLUSION: In this study, treatment with 80 mg isoflavones (Promensil) per day resulted in a significant reduction in hot flushes from baseline. At the end of the study there was a significant decrease in hot flushes of 44% between the active and placebo group, demonstrating the effectiveness of Promensil in the management of hot flushes.

Aged↗
PubMed2003

Cimicifuga racemosa for the treatment of hot flushes in women surviving breast cancer.

OBJECTIVES: To examine the effect of Cimicifuga racemosa (CR BNO 1055) on hot flushes caused by tamoxifen adjuvant therapy in young premenopausal breast cancer survivors. This treatment presents an off-label use of CR BNO 1055. METHODS: Between May 1999 and December 2001, we accrued 136 breast cancer survivors aged 35-52 years. After treatment with segmental or total mastectomy, radiation therapy and adjuvant chemotherapy, participants were in open-label randomly assigned (1-2) to receive tamoxifen 20 mg per day orally (usual-care group; n=46) or tamoxifen (same dose and posology) plus CR BNO 1055 (Menofem/Klimadynon, corresponding to 20 mg of herbal drug; intervention group n=90). Duration of treatment was 5 years for tamoxifen, according to international standards for adjuvant therapies, and 12 months for CR BNO 1055. Follow-up included clinical assessment every 2 months; the primary endpoint was to record the number and intensity of hot flushes. RESULTS: Comparing patients assigned to usual-care group with those assigned to intervention group, the number and severity of hot flushes were reduced after intervention. Almost half of the patients of the intervention group were free of hot flushes, while severe hot flushes were reported by 24.4% of patients of intervention group and 73.9% of the usual-care group (P<0.01). CONCLUSIONS: Hot flushes were the most frequent adverse reaction to tamoxifen adjuvant therapy in breast cancer survivors. The combined administration of tamoxifen plus CR BNO 1055 for a period of 12 months allowed satisfactory reduction in the number and severity of hot flushes.

Administration, Oral↗
PubMed2003

Mapping of quantitative trait loci controlling timing of bud flush in Salix.

Dormancy release is an important phenological stage, which determines plant growth and survival in northern temperate regions. Spring bud flushing was studied in a Salix pedigree (n=82) derived from a cross between the male hybrid clone "Björn" (Salix viminalis x Salix schwerinii) and the female clone "78183" (Salix viminalis). The timing of bud flush was recorded outdoors in two consecutive years (1998, 1999) and indoor in the spring of 1998. Timing of bud flush was found to be under moderately strong genetic control (clonal mean heritabilities ranging from 0.43 to 0.72). Phenotypic correlations between height growth and bud flushing were negative but non-significant (r=0.1-0.3). Using a Salix linkage map composed of 325 AFLP and 38 RFLP markers, six quantitative trait loci (QTLs) and three unmapped marker loci associated with timing of bud flush were detected. Four QTLs were detected in the field experiment while two QTLs and three unmapped marker loci were identified in the indoor experiment. One QTL associated with indoor bud flushing coincided with one of the QTL detected from the field data. Individual QTL explained 6-16% of the phenotypic variance [corrected]. None of the bud flush QTLs coincided with QTLs controlling height growth identified previously in the same pedigree.

Adaptation, Physiological↗
PubMed2005

Is there a benefit from routine follicular flushing for oocyte retrieval?

The object of this study was to determine the optimum number of follicular flushing for a maximum number of oocytes to be retrieved. This was a prospective study, based at a private in vitro fertilization centre (Brentwood Fertility Centre, The Essex Nuffield Hospital, Brentwood, Essex UK). Patients attending the IVF centre for assisted reproductive technology were studied. We counted the number of oocytes obtained with each flushing after primary aspiration of the follicle. Some 40% of the oocytes were retrieved with primary aspiration without follicular flushing, while up to 82% of oocytes were retrieved with two flushes and 97% of oocytes were retrieved in up to four flushes. Only 3% of the remaining oocytes were retrieved with 5th and 6th flush. The optimum number of follicular flushing was four times, in order to achieve maximum number of oocytes without compromising the duration of retrieval and number of oocytes retrieved.

Adult↗
PubMed1990

Non-surgical flushing of the uterus for pre-embryo recovery: possible clinical applications.

Growing interest in preimplantation genetic diagnosis has indicated uterine flushing as one method for obtaining human preimplantation embryos. To date, our institution has performed non-surgical uterine flushing to donate the recovered embryos to infertile recipients. We performed 127 flushings in 127 cycles using a modified urinary bladder catheter. Using the donors' natural cycles, a single ovum was recuperated in 37 out of 88 flushings. In 17 flushings, clomiphene citrate was given to the donors and 14 ova were found in nine positive recoveries. Human menopausal gonadotrophins were administered to the donors in 22 flushings and 22 ova were located in 14 positive recoveries. In total, 22 blastocysts, 11 morulae and 13 pre-embryos at the 2- to 16-cell stages were found. When transferred, these embryos gave rise to 18 clinical pregnancies in the recipients (40.9% of the transfers; 14.1% of the flushings). In comparison with natural cycles, superovulation of donors did not significantly increase the recipients' pregnancy rate. At present, non-surgical recovery of uterine pre-embryos does not seem to carry much potential as a tool for infertility treatment, or for genetic diagnosis. This is because currently available alternative methods are more successful.

Blastocyst↗
PubMed1982

Comparison of glucose, fructose, ascorbic acid and glucosephosphate isomerase enzymatic activity in uterine flushings from nonpregnant and pregnant gilts and pony mares.

In Experiment 1, 40 gilts and 30 pony mares were used to characterize changes in glucose, fructose, ascorbic acid and glucosephosphate isomerase (GPI) enzymatic activity in uterine flushings collected either during the estrous cycle or early pregnancy. Total recoverable glucose was greater (P less than 0.01) in uterine flushings from pregnant gilts, but pregnancy status had no effect on total recoverable glucose in pony mare uterine flushings. Fructose was undetectable in uterine flushings from nonpregnant gilts and pony mares and pregnant gilts and pony mares prior to Day 14, but occurred in increasing amounts between Days 14 and 18 or 20 of pregnancy. In Experiment 2, it was demonstrated that the porcine conceptus is the primary source, if not the sole source of fructose. Total recoverable ascorbic acid in uterine flushings was not affected by pregnancy in gilts, but was greater (P less than 0.01) in pregnant versus nonpregnant pony mares. In both species, total recoverable ascorbic acid was affected (P less than 0.01) by day of the estrous cycle and pregnancy. The GPI enzyme allows for the interconversion of glucose-6-PO4 and fructose-6-PO4. GPI total and specific activities were greater (P less than 0.01) for pregnant than nonpregnant gilts and pony mares. The periods of greatest GPI activity were temporally associated with elevated estrogens of either ovarian or blastocyst origin. Results from Experiment 3 indicated a marked increase (P less than 0.01) in GPI activity in uterine flushings from gilts treated with estradiol valerate. Results of this study indicate that glucose (gilt only), fructose, ascorbic acid and GPI activity are increased in uterine flushings of gilts and pony mares during early pregnancy. The increase in these constituents may reflect increased carbohydrate metabolism in ways which are uniquely beneficial to conceptus development in ungulates.

Animals↗
PubMed2004

Retrograde air embolization during routine radial artery catheter flushing in adult cardiac surgical patients: an ultrasound study.

BACKGROUND: Rapid flushing of radial artery catheters may result in retrograde embolization of air into the cerebral circulation. This study examined the incidence of central air embolization during and after flushing of an arterial pressure monitoring system. METHODS: One hundred adult patients undergoing cardiac surgical procedures were enrolled in this study. Ten ml of saline and blood were withdrawn into a syringe in the arterial flushing-sampling pressure system and then readministered to the patient through a 20-gauge radial artery catheter over 3-12 s. The right carotid artery, left carotid artery, and aortic arch were visualized using ultrasound imaging techniques during three manual flushes of the system. The left and right common carotid arteries were examined for the presence of macrobubbles or microbubbles using a linear array ultrasound transducer. The aortic arch was imaged using transesophageal echocardiography to detect retrograde air emboli. The severity of air embolization was quantified using a modification of an established grading system. RESULTS: A total of 298 ultrasound studies in 100 patients were recorded and analyzed after radial artery catheter flushing. Two aortic arch images were not obtained because of an inability to place the probe. Most clinicians (54%) returned flush solution to patients at near-maximal injection rates (2-3 ml per second). No air emboli (macrobubbles or microbubbles) were detected in the carotid arteries or aortic arch of any subject. CONCLUSION: Retrograde air embolization is a rare event after routine radial artery catheter flushing in adult patients with stable hemodynamic conditions.

Aged↗
PubMed2002

Significant increase of activated partial thromboplastin time by heparinization of the radial artery catheter flush solution with a closed arterial catheter system.

OBJECTIVE: Evaluate whether the use of a heparinized flush for an arterial catheter with a closed-loop blood sampling system leads to erroneous coagulation studies. DESIGN: Prospective study. SETTING: Twenty-two-bed surgical adult intensive care unit in a university hospital. PATIENTS: Sixty patients, 30 in each phase of the study. INTERVENTIONS: Phase 1: coagulation studies on a blood sample from a venous puncture and an arterial blood sample from an arterial catheter with heparinized flush. Phase 2: the same protocol but the arterial catheter was flushed with saline. MEASUREMENTS: Activated partial thromboplastin time, fibrinogen, percentage of prothrombin time, and international normalized ratio of prothrombin time on the venous and arterial samples. MAIN RESULTS: Activated partial thromboplastin time in the arterial blood samples taken from an arterial catheter with heparinized flush was significantly prolonged compared with the venous controls. This was not the case in blood samples from an arterial catheter with saline flush. The magnitude of this difference found by the Bland and Altman analysis was clinically significant. In 23.3% of the patients in phase 1, there was a difference of >50% between the arterial and venous sampled activated partial thromboplastin time, compared with 0% of the patients in phase 2 (p =.018). There was no difference between the venous and the arterial blood samples for the non-heparin-sensitive coagulation studies in both phases of the study. An explanation for these findings could be that there was release of heparin bound to the arterial catheter into the blood sample. CONCLUSION: A heparinized flush solution for the arterial catheter, when used together with a closed-loop blood sampling system, leads to erroneous results of heparin-sensitive coagulation studies. Heparin-sensitive coagulation studies, therefore, should not be analyzed on blood samples from such a system if a heparinized flush solution is used.

Anticoagulants↗
PubMed1983

Studies of renal preservation using a rat kidney transplant model. Evaluation of citrate flushing.

Rat kidneys were flushed with isotonic citrate solution, hypertonic citrate solution, or Collins's C2 solution, and were stored hypothermically for 24 hr before transplantation into another rat of the same inbred colony. The number of animals surviving for one month was greatest with isotonic-citrate-flushed kidneys (82%), and least with Collins's C2 solution (27%). Functional and morphological damage after transplantation was consistently greater in Collins's-flushed grafts, as compared with citrate-flushed grafts. Best results were attained with the isotonic-citrate flushed grafts. Seven days after contralateral nephrectomy all surviving animals had elevated serum creatinine and urea concentrations, along with decreased creatinine clearance, and they had secreted large volumes of dilute urine. Renal function was best in animals with isotonic-citrate-flushed grafts. After one month, significant improvement in urine osmolality, creatinine clearance, and serum creatinine had occurred only in the rats with citrate-flushed grafts. There were no significant differences between the citrate groups. All surviving rats had some residual renal cortical damage, but severe interstitial nephritis (greater than 30%) was much less frequent in the citrate groups.

Animals↗
PubMed1994

Obviation of prereperfusion rinsing and decrease in preservation/reperfusion injury in liver transplantation by portal blood flushing.

Liver allografts are traditionally rinsed with cold lactated Ringer's (LR) prereperfusion to clear K(+)-rich preservation solution from the hepatic vasculature. LR has been shown, however, to be injurious to the graft. By restoring portal blood flow without rinsing and discarding the initial blood traversing the liver (PB flush), we sought to eliminate rinsing without inducing hyperkalemia. Between August 1988 and December 1992, 481 OLTx were performed in 412 pts. Four rinsing methods were used sequentially: group 1 (157 pts)--low-flow-rate cold LR rinse (500 ml, 100 ml/min via standard i.v. tubing at 100 cm H2O [LFLR]) during lower caval anastomosis; Group 2 (120 pts)--LFLR as in group 1, at reperfusion, 500 ml PB flush via IVC catheter; group 3 (66 pts)--high-flow-rate LR rinse (500 ml, 1 L/min using large-bore tubing with 100 cm H2O rinsing pressure [HFLR]), PB flush as in group 2; Group 4 (62 pts)--no LR rinse; PB flush as in groups 2 and 3. Poor early graft function (PEGF) was defined as peak ALT or AST > 2500 U or PT > 16 sec (on POD 2); PEGF causing re-OLTx or death within 14 days was called primary nonfunction (PNF). Group 1 and Group 3 had high PEGF rates. Group 4 had significantly less PEGF than Group 1, with a trend toward a significant difference from Group 3. In Group 1, 3 pts. had intraoperative hyperkalemic cardiac arrest; this did not occur when PB flush was performed. PB flush without prior rinsing optimizes graft function without risk of hyperkalemia. LR rinse, alone or followed by PB flush, is unnecessary and may be deleterious.

Adolescent↗
PubMed1997

Randomized controlled trial to evaluate flush and reperfusion techniques in liver transplantation.

To determine the impact of different flush and reperfusion techniques on postreperfusion syndrome (PRS) and postoperative graft function, 100 transplants were randomly assigned into four groups as follows: group 1 (n=31), portal vein flush, no vena caval venting; group 2 (n=21), hepatic arterial flush, no vena caval venting; group 3 (n=29), portal vein flush with vena caval venting; and group 4 (n=19), hepatic artery flush with vena caval venting. Donor and recipient characteristics were similar. Extensive intraoperative and postoperative monitoring was performed and measurements were documented immediately before reperfusion and at 1, 5, 15, and 30 min after reperfusion. PRS was defined by three criteria: mean arterial pressure (MAP) <60 mmHg at 1 min after reperfusion, MAP <60 mmHg at 5 min after reperfusion, and a decrease of 30% or more for the MAP percent area under the curve during the initial 5 min after reperfusion (%AUC). Using these definitions, the overall incidence of PRS was 21%, 8%, and 43%, respectively. Group 1 was the most hemodynamically stable; the incidence of PRS in group 1 was 2/31 (7%) at 1 min and 8/31 (25%) using %AUC criteria compared with 7/21 (33%) at 1 min and 12/21 (57%) using %AUC criteria for group 2 (P<0.05). The patients in groups 3 and 4 (vena caval venting) demonstrated smaller percentage increases in serum potassium levels (as determined by %AUC; 4.3+/-6.8 and 0.3+/-5.4, vs. 15.1+/-8.1 for group 1 and 22.9+/-8.2 for group 2). The difference between group 4 and group 2 was statistically significant (P<0.05). The increases in serum potassium did not translate into increased cardiac or hemodynamic instability. Combining all data obtained over the first 30 min after reperfusion, there was no statistically significant difference in hemodynamic or biochemical changes noted among the four groups. Postoperative liver function was similar among the four groups. We conclude that portal vein flush without vena caval venting provided a lower incidence of PRS than any other technique. Vena caval venting decreased the release of potassium into the circulation. Postoperative graft function was not significantly affected by flush and reperfusion techniques.

Adult↗
PubMedDate not supplied

How often should peripheral intravenous catheters in ambulatory patients be flushed?

Ambulatory intravenous (IV) treatment is frequently prescribed to be administered every 24 hours. Institutional protocols commonly recommend flushing catheters every 8 hours. The authors sought to identify whether flushing more than once every 24 hours conferred any benefit. A retrospective review compared complication rates of different catheter flushing intervals for patients receiving IV therapy. This study investigated 111 courses of treatment for 63 patients. In 43% of the patients (48/111), complications were identified during the treatment period. Complications were less common with flushing every 24 hours (39/99, 39.4%) than with more frequent flushing (9/12, 75%) (P = .021). Indwelling peripheral IV catheters flushed once every 24 hours appear to have lower complication rates than those flushed 2 or 3 times a day.

Ambulatory Care↗
PubMed2005

Impacts of co-solvent flushing on microbial populations capable of degrading trichloroethylene.

With increased application of co-solvent flushing technologies for removal of nonaqueous phase liquids from groundwater aquifers, concern over the effects of the solvent on native microorganisms and their ability to degrade residual contaminant has also arisen. This study assessed the impact of ethanol flushing on the numbers and activity potentials of trichloroethylene (TCE)-degrading microbial populations present in aquifer soils taken immediately after and 2 years after ethanol flushing of a former dry cleaners site. Polymerase chain reaction analysis revealed soluble methane monooxygenase genes in methanotrophic enrichments, and 16S rRNA analysis identified Methylocystis parvus with 98% similarity, further indicating the presence of a type II methanotroph. Dissimilatory sulfite reductase genes in sulfate-reducing enrichments prepared were also observed. Ethanol flushing was simulated in columns packed with uncontaminated soils from the dry cleaners site that were dosed with TCE at concentrations observed in the field; after flushing, the columns were subjected to a continuous flow of 500 pore volumes of groundwater per week. Total acridine orange direct cell counts of the flushed and nonflushed soils decreased over the 15-week testing period, but after 5 weeks, the flushed soils maintained higher cell counts than the nonflushed soils. Inhibition of methanogenesis by sulfate reduction was observed in all column soils, as was increasing removal of total methane by soils incubated under methanotrophic conditions. These results showed that impacts of ethanol were not as severe as anticipated and imply that ethanol may mitigate the toxicity of TCE to the microorganisms.

Bacteria↗
PubMed1992

A change in flushing protocols of central venous catheters.

Oncology nurses working with hematology patients at the Tom Baker Cancer Centre questioned the need for twice daily flushings of central venous catheters. The nurses speculated that weekly flushings would be more convenient for patients, maintain patency, reduce risk of infections, and save the costs of supplies and nursing time. In 1986, the nurses, in collaboration with physicians, introduced a weekly flushing protocol for outpatients attending the clinic. The staff noted that no difference in rates of infection or patency appeared to result from this change in protocol. In an effort to provide empirical data in support of this fundamental shift in nursing protocols, the nurses initiated a study to examine infection rates and patency related to weekly flushing procedures. The study involved 82 patients with 89 catheter insertions. Overall infection rates were 19.1% or 0.15 per 100 catheter days. These rates were 0.25 per 100 catheter days for patients undergoing bone marrow transplant (BMT) and 0.07 per 100 catheter days in patients not undergoing BMT. Reduced patency occurred in only 13.5% of catheters studied, requiring a change in flushing protocol. When compared with published complication rates, these findings support the use of a weekly flushing protocol. As a result, staff and patients continue to use the weekly flushing protocol with greater confidence.

Adult↗
PubMed1985

Improving Euro-Collins flushing solution's ability to protect kidneys from normothermic ischemia.

In this investigation, we describe a modification of Euro-Collins flushing solution which enables this solution to be effective in preventing normothermic postischemic acute renal failure. The left kidneys of Sprague-Dawley rats were briefly flushed in situ by vascular perfusion with Euro-Collins solution and the renal pedicle clamped to render the kidney ischemic and hold the flushing solution in the kidney. Following 1 h of in situ normothermic ischemia, the pedicle clamp was removed and a contralateral nephrectomy of the right kidney performed. In two other groups of rats the same experimental protocol was followed using Euro-Collins solution in which the dextrose in this solution was replaced with a similar osmolal contribution of either sucrose (64 g/l) or mannitol (35 g/l). Rats with kidneys flushed with the standard Euro-Collins solution containing dextrose (n = 24) exhibited significantly higher postischemic daily serum creatinine levels, a greater degree of tubular necrosis, and a higher mortality (75, versus 31%) than unflushed ischemic controls (n = 22). Rats with kidneys flushed with Euro-Collins, containing either sucrose (n = 25) or mannitol (n = 22) in place of dextrose, all survived, exhibited only focal tubular damage as observed by electron microscopy, and most returned to normal serum creatinine levels within 72 h following ischemia. These findings, together with other reports that mannitol- and sucrose-based flushing solutions provide excellent protection during prolonged cold ischemia, strongly argue for the substitution of sucrose, mannitol or other similar protective impermeant agents for dextrose in flushing solutions such as Euro-Collins.

Acute Kidney Injury↗
PubMed1981

Association of waking episodes with menopausal hot flushes.

To examine the possible relationship between the occurrence of menopausal hot flushes and waking episodes, a study was conducted of nine postmenopausal women with severe hot flushes and five asymptomatic premenopausal women. Measurement of simultaneous changes of finger temperature and skin resistance over the sternum was used as an objective marker of hot flushes. During cumulative sleep 47 objectively measured hot flushes occurred, and 45 were associated with a waking episode measured by polygraphic techniques. In eight of nine subjects, a significant correlation was observed between the occurrence of hot flushes and waking episodes. A similar association was not observed in premenopausal subjects. Estrogen administered to symptomatic patients resulted in significant reductions of both hot flushes and waking episodes. These data suggest the menopausal flushes are associated with a chronic sleep disturbance, and both can be improved by estrogen therapy.

Age Factors↗
PubMed1997

Retrograde flush and cold storage for twenty-two to twenty-five hours lung preservation with and without prostaglandin E1.

BACKGROUND: Our previous study showed that retrograde flush through the left atrium is better than antegrade flush in 6-hour lung preservation. Whether it is feasible in long-term lung preservation is not clear. Several studies suggested that prostaglandin E1 may not be necessary in retrograde flush because of the low vascular resistance on the venous side. This study evaluates the effects of retrograde flush and prostaglandin E1 in 24-hour lung preservation. METHODS: Canine donor lungs were retrograde flushed with University of Wisconsin solution. Group A (n = 7) was pretreated with prostaglandin E1. No prostaglandin E1 was used in group B (n = 7). After flush and cold storage at 4 degrees C for 22 to 25 hours, left lung allotransplantation was performed. Measurements were taken before transplantation (baseline), and at 10, 30, 60, and 120 minutes after transplantation while the right pulmonary artery was occluded. RESULTS: After 120 minutes of reperfusion, the oxygen tension and carbon dioxide tension were 643 +/- 24 and 37 +/- 3 mm Hg in group A and 600 +/- 29 and 37 +/- 3 mm Hg in group B, respectively (p = NS). Pulmonary artery pressure (group A vs group B) was 20 +/- 1 versus 28 +/- 2 mm Hg (p < 0.01); right atrium pressure: 4 +/- 1 versus 8 +/- 1 mm Hg (p < 0.01); left pulmonary vascular resistance: 1109 +/- 51 versus 1525 +/- 133 dyne.sec.cm-5 (p < 0.05); airway resistance: 22 +/- 1 versus 24 +/- 1 cm H2O/L/sec (p = NS); lung dynamic compliance: 30 +/- 1 versus 26 +/- 1 cc/cm (p < 0.05) respectively. As compared with the baseline (19 +/- 1), airway resistance was significantly increased after 2 hours of reperfusion in group B (p < 0.05). Electron microscopy revealed that type I pneumocytes, capillary endothelial cells, and epithelial cells of bronchi were well preserved and the contents of lamellar bodies of type II pneumocyte were reduced. CONCLUSIONS: Canine lung was well preserved by retrograde flush and cold storage with University of Wisconsin solution after 24 hours preservation. Pretreatment of prostaglandin E1 is helpful in reducing pulmonary vascular resistance and airway resistance and improving lung dynamic compliance.

Adenosine↗
PubMed1992

Acipimox-induced facial skin flush: frequency, thermographic evaluation and relationship to plasma acipimox level.

Facial skin flush is the most frequent adverse effect induced by acipimox (ACX), a nicotinic acid analogue used in the management of hyperlipidaemia. The aims of the study were to evaluate the frequency, magnitude and reproducibility of the ACX flush in previously unexposed healthy subjects and to assess any possible relationship with the dose and plasma level of ACX. Seventy four healthy subjects received, on two different mornings, ACX 250 mg and placebo (P), according to a single blind, randomized, cross-over design; 33 had a clear flush after ACX and not after P.25 of those subjects were retested on five different mornings, with P, and with ACX 31.2, 62.5, 125.0, 250.0 mg, according to a double blind, randomized, cross-over design. Any increase in the local skin temperature was recorded by a thermocouple fixed to the left check. Subjective and objective assessment of the flush were strongly correlated with thermographic recordings. They indicated that a 120 min flush occurred after doses of ACX greater than 62.5 mg. In 12 of the 25 subjects, 6 with the highest and 6 with the lowest thermographic recordings, plasma ACX levels were determined. Subjects with different thermographic records had superimposable plasma ACX levels after all doses of ACX. Only the 6 subjects with the highest skin temperatures showed a significant relationship between the thermographic record and the plasma ACX. The data indicate that flush is a frequent, reproducible and dose-related adverse effect of ACX.

Adult↗