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C Chastang

Publications and source records attributed to C Chastang.

At least 37 records · Page 2Linked to original sources

White blood cell count: a prognostic factor and possible subset indicator of optimal treatment with low-dose adjuvant interferon in primary melanoma.

AlphaIFN has recently been recognized as an adjuvant therapy to surgery in melanoma patients. A major issue is to select patients who will benefit from this therapy and to avoid toxicity in those who will not respond. The aim of this exploratory analysis was to identify the predictive factors of response to alphaIFN. The French cooperative group has recently shown that adjuvant therapy of melanoma patients with low-dose alphaIFN provides a benefit on disease-free interval (DFI). Using this database, predictors of DFI were investigated using Cox models and treatment-covariate interactions were sought. Gender, age, Breslow thickness, and baseline WBC count, given an alphaIFN-WBC interaction, were independent predictors of DFI. Baseline WBC count was the only variable for which there was an interaction with alphaIFN, whatever the Breslow: patients with low WBC count (<6.8 x 10(9)/liter = median) did not benefit from alphaIFN (HR=1.27 (95%CI: 0.84-1.91); P = 0.26) whereas the DFI of patients with high WBC was prolonged (P = 0.0001) with a hazard ratio of 0.50 (95% confidence interval, 0.35-0.71). The estimated values of WBC count for which IFN was significantly superior to no-treatment were those > or = 7.2 x 10(9)/liter. The baseline WBC count was correlated to baseline neutrophils but not to Breslow thickness or to time since last melanoma surgery. AlphaIFN prolonged DFI in patients with a high WBC count but not in those with a low WBC count. The results of this exploratory analysis, if confirmed by other studies, may help to identify patients who are most likely to benefit from alphaIFN.

Age Factors↗

The addition of cisplatin to cyclophosphamide-doxorubicin-etoposide combination chemotherapy in the treatment of patients with small cell lung carcinoma: A randomized study of 457 patients. "Petites Cellules" Group.

BACKGROUND: To assess whether the addition of cisplatin (100 mg/m(2) administered intravenously on Day 1) to CDE (cyclophosphamide [1000 mg/m(2) on Day 1], doxorubicin [45 mg/m(2) on Day 1], and etoposide [150 mg/m(2) on Days 1 and 2] combination is useful in the treatment of patients with small cell lung carcinoma (SCLC). METHODS: In a multicenter clinical trial, 457 patients were randomized from May 1988 to March 1993 to receive either CDE (n = 228) or cisplatin-CDE (PCDE, n = 229) chemotherapy every 4 weeks for 6 cycles. As patients with limited SCLC were included in a concomitant trial assessing thoracic radiotherapy, the current study mainly included patients with extensive stage (79%) or limited stage disease and a contraindication for thoracic radiotherapy. RESULTS: The objective response rate was higher in the cisplatin-CDE group (72%) than in the CDE group (53%) (P = 0.0001). The median overall survival was similar for the groups that received CDE (266 days) and PCDE (271 days) (P = 0.93, log rank test). A higher fatal neutropenia rate was observed in the PCDE group (n = 23) than in the CDE group (n = 4) (P < 0.001, log rank test), mainly for patients with extensive disease (n = 26; P = 0.015, log rank test). CONCLUSIONS: The addition of cisplatin to a CDE regimen is toxic to patients with extensive SCLC and does not improve overall survival. The PCDE combination must be avoided for patients with extensive SCLC; CDE or cisplatin-etoposide combinations remain standard chemotherapy for these patients. The PCDE combination associated with granulocyte-colony stimulating factors could only be assessed in patients with good prognoses.

Aged↗

A randomized clinical trial comparing concurrent and alternating thoracic irradiation for patients with limited small cell lung carcinoma. "Petites Cellules" Group.

BACKGROUND: Although thoracic radiotherapy is considered to be useful for the treatment of patients with small cell lung carcinoma (SCLC), its optimal administration schedule is still controversial. METHODS: In a multicenter clinical trial, 164 patients with limited SCLC (of whom 156 were eligible for the study) were randomized to receive either concurrent thoracic irradiation, initiated immediately after the second cycle of chemotherapy (Days 30-64) at a dose of 50 grays in 20 fractions, or alternating thoracic irradiation, scheduled in 3 courses between the second, third, fourth, and fifth cycles of chemotherapy with a 7-day rest period after and before chemotherapy at a dose of 20 grays in 8 fractions (Days 36-47 and Days 64-75) and then 15 grays in 6 fractions (Days 92-101). The same chemotherapy regimen (cyclophosphamide-doxorubicin or vindesine-etoposide) was administered every 4 weeks in both groups. RESULTS: Concurrent radiotherapy-induced lung toxicity led to early termination of this trial when a significant difference was observed (6 cases vs. 1, P = 0.05, 2-sided log rank test). Objective response rates were 89% in the 82 patients of the concurrent radiotherapy group and 95% in the 74 patients of the alternating radiotherapy group. Median survival periods were 13.5 and 14.0 months, respectively, with no significant difference between the two survival distributions (P = 0.15, 2-sided log rank test). Toxic deaths due to bone marrow hypoplasia were similar in both groups (3 vs. 2), but mortality due to lung toxicity (pulmonary fibrosis) was more frequent with concurrent radiotherapy (6 patients) than with alternating radiotherapy (1 patient) in long term analysis (P = 0.05, 2-sided log rank test). CONCLUSIONS: Although no statistically significant overall survival difference was observed between the two radiation therapy schedules, the better tolerance of the alternating schedule justifies the choice of this schedule with this chemotherapy regimen, although it may not be applicable to other chemotherapy regimens.

Antineoplastic Combined Chemotherapy Protocols↗

A randomized comparison of all transretinoic acid (ATRA) followed by chemotherapy and ATRA plus chemotherapy and the role of maintenance therapy in newly diagnosed acute promyelocytic leukemia. The European APL Group.

All transretinoic acid (ATRA) followed by daunorubicin (DNR)-AraC chemotherapy (CT) has improved the outcome of acute promyelocytic leukemia (APL) by comparison to CT alone. In a randomized trial, (1) we compared 2 induction schedules (ATRA followed by CT [ATRA-->CT] and ATRA plus CT [ATRA+CT, with CT added on day 3 of ATRA treatment]) and (2) we assessed the role of maintenance treatment. Four hundred thirteen patients </=75 years of age and with newly diagnosed APL were included. Induction treatment was stratified on white blood cell (WBC) count and age: patients </=65 years of age and with an initial WBC count of </=5,000/microL (n = 208) were randomized between ATRA-->CT and ATRA+CT (initially randomized patients); patients with a WBC count greater than (high WBC count group, n = 163) and patients 66 to 75 years of age with a WBC count greater than 5,000/microL (elderly group, n = 42) were not initially randomized and received ATRA+CT from day 1 and ATRA -->CT, respectively. All patients achieving CR received 2 additional DNR-AraC courses (only 1 in patients 66 to 75 years of age) and were then randomized for maintenance between no treatment, intermittent ATRA (15 days every 3 months) for 2 years, continuous low-dose CT (6 mercaptopurine + methotrexate) for 2 years, or both, using a 2-by-2 factorial design. Overall, 381 (92%) of the patients achieved complete remission (CR), 31 (7%) suffered an early death, and only 1 patient had leukemic resistance. ATRA syndrome occurred in 64 patients (15%) and was fatal in 5 cases. The CR rate was similar in all induction treatment groups. Event-free survival (EFS) was significantly lower in the high WBC group (P =.0002) and close to significance in the elderly group (P =.086) as compared with initially randomized patients. Relapse at 2 years was estimated at 6% in the ATRA+CT group, versus 16% in the ATRA-->CT group (P =.04, relative risk [RR] =.41). EFS at 2 years was estimated at 84% in the ATRA+CT group, versus 77% in the ATRA-->CT group (P =.1, RR =.62). Two hundred eighty-nine patients were randomized for maintenance. The 2-year relapse rate was 11% in patients randomized to continuous maintenance CT and 27% in patients randomized to no CT (P =.0002) and 13% in patients randomized to intermittent ATRA and 25% in patients randomized to no ATRA (P =.02). An additive effect of continuous maintenance CT and intermittent ATRA was seen, and only 6 of the 74 patients who received both maintenance treatments had relapsed. Overall survival was improved in patients who received maintenance CT (P =.01), and there was a trend for better survival in patients who received maintenance ATRA (P =.22). Our findings strongly suggest that early addition of chemotherapy to ATRA and maintenance therapy combining continuous CT and intermittent ATRA can reduce the incidence of relapse in APL. This effect already translates into significantly better survival for maintenance treatment with continuous CT.

Adolescent↗

A controlled study of postoperative radiotherapy for patients with completely resected nonsmall cell lung carcinoma. Groupe d'Etude et de Traitement des Cancers Bronchiques.

BACKGROUND: Postoperative radiotherapy is commonly used to treat patients with completely resected nonsmall cell lung carcinoma, but its effect on overall survival has not been established. METHODS: After undergoing complete surgical resection, 728 patients with non-small cell lung carcinoma (221 Stage I, 180 Stage II, and 327 Stage III) were randomized to receive either postoperative radiotherapy at a total dose of 60 gray or observation only . The main end point was overall survival. RESULTS: At the reference date, 218 of 355 patients in the control group had died and 262 of 373 in the radiotherapy group had died. Five-year overall survival was 43% for the control group and 30% for the radiotherapy group (P = 0.002, log rank test; relative risk [RR]: 1.33; 95% confidence interval [CI]: 1.11-1.59). This result was not modified by adjustment for potential prognostic factors. The excess mortality rate for the radiotherapy group was due to an excess of intercurrent deaths (P = 0.0001; RR: 3.47; the 5-year intercurrent death rate was 8% for the control group and 31% for the radiotherapy group). Radiotherapy had no significant effect on local recurrence (RR: 0.85; 95% CI: 0.64-1.14) and no effect on metastasis (RR: 1.06; 95% CI: 0.85-1.31). The rate of non-cancer-related death increased with the dose per fraction delivered.

Aged↗

Factors associated with outcome after cord blood transplantation in children with acute leukemia. Eurocord-Cord Blood Transplant Group.

We have analyzed factors influencing the outcome of 102 children with acute leukemia given a cord blood transplantation (CBT) and reported to the Eurocord Registry. Seventy patients with acute lymphoblastic and 32 with acute myeloid leukemia were given either a related (n = 42) or an unrelated (n = 60) CBT. Children given CBT during first or second complete remission were considered as belonging to the good-risk group (n = 66), whereas those who received a transplant in a more advanced stage of disease were assigned to the poor-risk group (n = 36). In the related group (RCBT), 12 of 42 patients received transplantation from an HLA-disparate donor, whereas in the unrelated group (UCBT) 54 of 60 received an HLA mismatched CBT. Kaplan-Meier estimates for neutrophil recovery at day 60 were 84% +/- 7% in RCBT and 79 +/- 6% in UCBT (P =.16). In multivariate analysis, the most important factor influencing neutrophil engraftment in UCBT was a nucleated cell dose infused greater than 3.7 x 10(7)/kg (P =.05, relative risk [RR] of 1.85, 95% confidence interval [CI]: 0.98-3.4). The incidence of grade II through IV acute graft-versus-host disease was 41% +/- 8% in the RCBT group and 37% +/- 6% in the UCBT group (P =.59). Kaplan-Meier estimates of 2-year event-free survival (EFS) after RCBT or UCBT were 39% +/- 8% and 30% +/- 7%, respectively (P =.19). In multivariate analysis, the most important factor influencing EFS was disease status at time of transplantation: good-risk patients had a 2-year EFS of 49% +/- 7% as compared to 8% +/- 5% in patients with more advanced disease (P =.0003, RR: 0.40, 95% CI: 0.24 to 0. 65). This was a consequence of both an increased 1-year transplant related mortality and a higher 2-year relapse rate in the poor-risk group (65% +/- 9% and 77% +/- 14%, respectively), as compared with good risk patients (34% +/- 6% and 31% +/- 9%, respectively). These data confirm that allogeneic CBT from either a related or an unrelated donor is a feasible procedure able to cure a significant proportion of children with acute leukemia, especially if transplanted in a favorable phase of disease.

Acute Disease↗

Effect of autologous platelet concentrate in surgery for idiopathic macular hole: results of a multicenter, double-masked, randomized trial. Platelets in Macular Hole Surgery Group.

OBJECTIVE: To evaluate prospectively the efficacy and safety of autologous platelet concentrate (APC) as an adjuvant in surgery for idiopathic macular hole. DESIGN: Multicenter, double-masked, randomized clinical trial. SETTING: Four university-based ophthalmology clinics. PARTICIPANTS: One hundred ten patients with stage 3 or 4 idiopathic full-thickness macular holes of less than 3 years' duration were randomized (53 eyes to the platelet group and 57 eyes to the control group). INTERVENTIONS: Standardized macular hole surgery versus surgery combined with injection of an APC. In all cases, the procedure consisted of three-port pars plana vitrectomy, posterior hyaloid separation, and nonexpansile fluid-gas exchange. After the fluid-gas exchange, patients were randomized to receive either injection of an APC or no adjunctive treatment. After surgery, patients were positioned face down for 12 days. Platelet counts showed that the concentrates contained a mean of 96.106 platelets (range, 82-102). MAIN OUTCOME MEASURES: Anatomic and functional evaluations were performed at 1, 3, and 6 months after surgery in a double-masked fashion by an independent observer. The main outcome was reapposition of the edge of the macular hole 1 month after surgery. Secondary outcomes were anatomic status at 3 and 6 months, changes in Early Treatment Diabetic Retinopathy Study score, and complications. RESULTS: One month after surgery, the anatomic success rate in the platelet group was 52 of 53 (98%; 95% confidence interval, 0.90-1.00) versus 47 of 57 (82%; 95% confidence interval, 0.70-0.91) in the control group (P = 0.009, Fisher's exact test; relative risk, 0.11; 95% confidence interval, 0.01-0.81). Visual acuity was not significantly different between the two groups at any timepoint. There were no complications specifically attributable to the platelet injection. CONCLUSION: Injection of APC improved significantly the anatomic success rate of surgery for idiopathic macular holes of less than 3 years' duration, but postoperative visual acuity of the platelet group was not statistically different from the control group.

Aged↗

A new prognostic classification for predicting survival in patients with hepatocellular carcinoma. Groupe d'Etude et de Traitement du Carcinome Hépatocellulaire.

BACKGROUND/AIMS: In patients with hepatocellular carcinoma, prediction of survival is difficult. The aim of this prospective study was to provide a simple classification for predicting survival of patients with hepatocellular carcinoma, based on a multivariable Cox model. METHODS: Seven hundred and sixty-one patients who presented with hepatocellular carcinoma from 24 Western medical centers were enrolled over a 30-month period. Patients were randomly assigned to either a training sample (n=506, with 418 deaths) from which a classification system was established, or a test sample (n=255, with 200 deaths) for validating its prognostic significance. RESULTS: Five prognostic factors were selected at the 0.0001 level: Karnofsky index <80% (relative risk of death=2.2, 95% confidence interval: 1.7-2.7), serum bilirubin >50 micromol/l (relative risk=2.1, 95% confidence interval: 1.7-2.6), serum alkaline phosphatase at least twice the upper limit of normal range (relative risk=1.6, 95% confidence interval: 1.3-2.0), serum alpha-fetoprotein >35 microg/l (relative risk=1.7, 95% confidence interval: 1.4-2.1), and ultrasonographic portal obstruction (relative risk=1.3, 95% confidence interval: 1.1-1.7). Three risk groups with different 1-year survival rates (72%, 34%, 7%) were derived, and independently validated in the test sample (79%, 31%, 4%). CONCLUSION: This classification could be useful in the assessment of prognosis from homogeneous groups of patients with respect to their expected outcome.

Adult↗

Assessing smallest detectable change over time in continuous structural outcome measures: application to radiological change in knee osteoarthritis.

Interpreting changes in continuous structural outcome measures is a common problem in clinical research and in daily practice. We propose a method for estimating whether difference observed between two successive measures in an individual constitutes a statistically relevant change or a change induced by variability. This statistically relevant change is based on an analysis of reproducibility. The continuous structural outcome measure investigated as an example was joint space width (JSW) measurement on standard X-rays, which is known to be the primary end-point for assessing structural osteoarthritis progression. The results of the present study demonstrate that cutoffs are closely dependent on all sources of variabilities in JSW measurement such as joint positioning, radiographic procedure, and the measurement process itself. Therefore, we suggest to determine cutoffs for each study using a representative sample of the population studied and using the procedures and methods of measurement of the specific study. This approach may easily be extended to other continuous structural outcome measures.

Aged↗

A short induction regimen of interferon-alpha is not effective for treatment of relapse in chronic hepatitis C: a randomized trial. For the multicentre GER-CYT-01 group.

The aim of this work was to assess the effect of a high-dose (10 million units, MU) short-duration (14 weeks) interferon-alpha2b (IFN-alpha2b) regimen in relapsers compared with the standard IFN regimen of 3 MU three times weekly (t.i.w.) for 6 months. Fifty-eight non-cirrhotic patients (who had relapsed after previous treatment with IFN) with chronic hepatitis were randomized: 29 to the high-dose, short-duration regimen and 29 to the standard regimen. By the end of IFN therapy, in the high-dose, short-duration group alanine aminotransferase (ALT) normalization was observed in 23 (79%) of 29 patients, and undetectable hepatitis C virus (HCV) RNA in eight (28%) vs 25 (86%) and 11 (38%) of the 29 patients in the standard group, respectively (P = NS). At the end of the 72-week follow-up, in the high-dose, short-duration group a sustained ALT normalization was observed in two (7%) patients, and undetectable HCV RNA in 0 (0%) vs five (17%) and four (14%) patients in the standard group (P = NS). There was less fibrosis improvement in the high-dose, short-duration group (two of 26 patients, 8%) than in the standard group (eight of 25 patients, 32%) (P = 0.04). Tolerance to IFN was good and similar in the two groups. In conclusion, in IFN relapsers, high-dose, short-duration treatment with IFN-alpha has no advantage when compared to a 6-month treatment with 3 MU IFN t.i.w.

Adult↗

Survival and prognostic factors of invasive aspergillosis after allogeneic bone marrow transplantation.

To determine prognostic factors for survival in bone marrow transplant recipients with invasive aspergillosis (IA), we retrospectively reviewed 27 IA cases observed in our bone marrow transplantation unit between January 1994 and October 1994. On 30 September 1997, six patients were alive and disease-free. The median survival after IA diagnosis was 36 days. Of eight variables found to be related to survival according to the univariate analysis, graft-versus-host disease (GVHD) status at IA diagnosis (P = .0008) and the cumulative prednisolone dose taken during the week preceding IA diagnosis (CPDlw) (P < .0001) were selected by a backward stepwise Cox regression model. A three-stage classification was established: CPD1w of < or =7 mg/kg (3 of 8 patients died; 60-day survival rate, 88%), CPD1w of >7 mg/kg and no GVHD (9 of 10 patients died; 60-day survival rate, 20%), and CPD1w of >7 mg/kg and active acute grade 2 or more or extensive chronic GVHD (9 of 9 patients died; 30-day survival rate, 0) (P < .0001).

Adolescent↗

A double-blind, randomized study assessing the equivalence of valacyclovir 1000 mg once daily versus 500 mg twice daily in the episodic treatment of recurrent genital herpes. Genival Study Group.

Valaciclovir is a prodrug of acyclovir with more favourable bioavailability. Twice daily oral administration of valacyclovir is recommended in patients with genital herpes. A double-blind, randomized, controlled, multicriteria equivalence trial was conducted to determine whether od treatment with valacyclovir 1000 mg is as effective as bd treatment with 500 mg in patients with recurrent genital herpes. A total of 922 immunocompetent outpatients were treated with either regimen for 5 days; treatment was self-initiated at the first symptoms of the next recurrence. The principal outcome measures were the percentage of lesions healed at day 6, time to healing, time to cessation of pain, discomfort or itching, the percentage of abortive episodes and safety. Equivalence was assessed by comparison of 80% confidence limits for each measure; the two regimens were regarded as equivalent if the lower confidence limit was higher than a pre-determined equivalence limit calculated to show a maximum 10% inferiority of valacyclovir 1000 mg od against valaciclovir 500 mg bd. Intention-to-treat analysis showed that the two treatments were equivalent for each outcome measure. Hence, it is concluded that valacyclovir 1000 mg od is as effective as 500 mg bd. as self-initiated therapy in patients with recurrent genital herpes.

Acyclovir↗

Impact of guidelines to alter antitetanus prophylaxis practices and reduce costs in the emergency department.

The objective of this study was to assess the impact of an intervention to modify antitetanus prophylaxis of open wounds. This prospective, before-and-after study was conducted in an emergency department of a large metropolitan hospital. Consecutive patients with open wounds were managed according to the World Health Organization (WHO) guidelines before an intervention, then according to new guidelines afterwards. Locally developed guidelines were introduced and backed up by a teaching program, with emphasis on reducing unwarranted human tetanus immunoglobulins and costs. Serum tetanus antitoxins level was measured in postintervention patients mainly to verify the soundness of the intervention, eventually to complete patients' protection during follow-up, and to derive more reliable recommendations for the future. Main outcome measures included the number of treatments conforming to each set of guidelines, the rate of tetanus immunoglobulin prescriptions, and the cost of each strategy. Two groups of 389 and 459 patients were included. Treatment conforming to guidelines increased from 60% to 79%, undertreatment decreased from 31% to 19%, and overtreatment decreased from 9% to 2% (P < 0.001). Tetanus immunoglobulin prescriptions decreased from 23% to 1% (P < 0.001). On the basis of antitoxins level, 60% of 367 postintervention patients were correctly treated, 29% were overtreated, and 11% were undertreated. Nevertheless, with the WHO guidelines, only 49% would have been correctly treated, 39% would have been overtreated (29% with immunoglobulins), and 12% would have been undertreated (P < 0.001). Costs decreased from $32 to $24 per patient. New guidelines resulted in improved tetanus prophylaxis at reduced costs in an emergency department. Because they rely on immunization history, however, guidelines currently in use are misleading. More reliable recommendations, including a test for tetanus antibody status in some cases, are needed.

Adult↗

Predictive factors for failure of isotretinoin treatment in acne patients: results from a cohort of 237 patients.

BACKGROUND: The efficacy of oral isotretinoin in acne has been established, though the role of the mean daily dose (MDD) is still unclear. OBJECTIVE: To determine the predictive factors of resistance to oral isotretinoin and the role of the MDD of isotretinoin on relapse of acne while taking into account patient characteristics and the total cumulative dose (TCD). METHODS: Two hundred and thirty-seven patients treated with oral isotretinoin for the first time were enrolled by a single dermatologist. Patients with closed comedonal acne and with hyperandrogenism received adequate therapy prior to isotretinoin. RESULTS: Closed comedonal acne was the only predictive factor of resistance to isotretinoin with an adjusted OR = 2.7 (95% CI: 1.0-7.3). The estimated rates of relapse at 1, 3 and 5 years were 14, 40 and 48%, respectively. Age and grade of facial acne were the only predictive factors for relapse with adjusted relative risks of 0.6 (95% CI: 0.4-0.8) for age >/= 20 and 1.5 (95% CI: 1.0-2.2) for grade > 3. CONCLUSION: MDD, TCD, closed comedonal acne and hyperandrogenism that have been adequately treated prior to isotretinoin treatment had no prognostic value for relapse.

Acne Vulgaris↗

A prospective study of the influence of HIV status on the seroreversion of serological tests for syphilis.

UNLABELLED: The evolution of serological tests for syphilis (STSs) after therapy in HIV+ patients is a major point of controversy, with possible seroreactivation and illicit seroreversion in these patients. The aim of our study was to evaluate the long-term outcome of STSs in a cohort of HIV+ male homosexuals with a history of treated syphilis as compared with HIV- controls. PATIENTS AND METHODS: Sixty-nine HIV+ male homosexuals with a documented history of treated syphilis and positive baseline treponemal tests were prospectively studied between 1986 and 1993. A medical examination, HIV staging, CD4+ cell count, VDRL, FTA-Abs tests and TPHA were performed every 6 months. Controls consisted of 49 HIV- patients with similar inclusion criteria over the same period. Comparisons between subgroups were based on chi(2) and Kruskal-Wallis tests. Analysis of negativation of the STS used the failure data methods (Kaplan-Meier, log-rank and Cox's model). RESULTS: Patients had a mean age of 38 years, a baseline CD4+ cell count of 578/mm(3), elapsed time since last syphilis of 7.5 years and a median follow-up of 4.3 years. Controls had a mean age of 42 years, elapsed time since last syphilis of 5.3 years and a median follow-up of 4.7 years. Time to seroreversion was shorter in HIV+ patients for TPHA (p = 0.009, log-rank test) and FTA-Abs test (p = 0.001, log-rank test), even after adjustment for stage of syphilis, age and time since the last episode of syphilis. The decrease in VDRL titres was not different between the 2 groups (p = 0.053, log-rank test). Seroreversion of the TPHA, FTA-Abs test and VDRL test was not significantly related to stage of syphilis, time elapsed since the last episode of syphilis, age or history of STDs in both groups. Seroreversion of the TPHA and VDRL test was not related to baseline CD4+ cell count. However, seroreversion of the FTA-Abs test was related to a low baseline CD4+ cell count (p = 0. 003). In HIV+ patients, a significant decrease in titres was noticed for TPHA, FTA-Abs test and VDRL test over time, but this time effect remained only for TPHA titres after adjustment for the CD4+ cell count. CONCLUSION: TPHA may serorevert in HIV+ patients. Thus, a non-reactive TPHA does not exclude a past syphilis infection in such patients. Evolution of the VDRL test after therapy is regular in HIV+ patients. The VDRL test remains adequate for controlling the efficacy of treatment in these patients.

Adult↗

A randomized study assessing the systematic search for maxillary sinusitis in nasotracheally mechanically ventilated patients. Influence of nosocomial maxillary sinusitis on the occurrence of ventilator-associated pneumonia.

The objective of this randomized study was to compare the occurrence of nosocomial pneumonia in nasotracheally intubated patients who were randomly allocated either to a systematic search of sinusitis by CT scan (study group) or not (control group). A total of 399 patients were included: 272 male and 127 female; mean age, 61 +/- 17 yr; SAPS: 12.6 +/- 4.9. The study group consisted of 199 patients and the control group consisted of 200. In the study group, sinus CT scans were performed in case of fever at Days 4 and 8 and then every 7 d. Nosocomial sinusitis was defined as follows: fever of >/= 38 degrees C, radiographic (sinusal air-fluid level or opacification on CT scan) signs, and presence of purulent aspirate from the involved sinus puncture with >/= 10(3) cfu/ml. Patients with sinusitis received sinus lavage and intravenously administered antibiotics. In the study group, 80 patients experienced nosocomial sinusitis. In the control group, no patient was treated for a sinusitis. Ventilator-associated bronchopneumonia (VAP) was observed in 88 patients: 37 in the study group (1 mo Kaplan-Meier estimate, 34%) versus 51 in the control group (1 mo Kaplan-Meier estimate, 47%); (p = 0.02, log-rank test; relative risk [RR] = 0.61; 95% confidence interval [CI], 0.40 to 0.93). Two months overall mortality was estimated at 36% in the study group versus 46% in the control group (p = 0.03, log-rank test; RR = 0.71; 95% CI, 0.52 to 0.97). We conclude that the occurrence of VAP in patients undergoing prolonged mechanical ventilation via a nasotracheal intubation can be prevented by the systematic search and treatment of nosocomial sinusitis. The effect on mortality should be confirmed.

Cross Infection↗

Efficacy and safety of an oral fixed low-dose perindopril 2 MG/indapamide 0.625 MG combination: a randomized, double-blind, placebo-controlled study in elderly patients with mild to moderate hypertension.

The efficacy and safety of 12 weeks treatment with an oral fixed low-dose perindopril 2 mg + indapamide 0.625 mg (Per/Ind) combination in elderly and very elderly patients (65-85 years) with mild to moderate systolic and diastolic hypertension (SDH) or isolated systolic hypertension (ISH) were investigated vs placebo. This trial was a multinational randomized double-blind study with doubling of active drug dosage in nonresponders. Intention to treat analysis was performed in 383 patients (age 72.4 years; ISH 32%). 58.5% remained on their initial dosage. Per/Ind decreased supine diastolic and systolic blood pressure (sDBP/sSBP) by 13.2+/-8.0 mm Hg and 22.5+/-13.9 mm Hg (P <.0001) versus placebo -7.3+/-9.0 mm Hg and -12.3+/-15.2 mm Hg, respectively. In ISH (n = 123), Per/Ind decreased sSBP by 23.0+/-11.8 mm Hg (P <.0001). Overall response and normotension rates was 81.3% with Per/Ind (P <.0001). Adverse event rates (including hypokalemia) were similarly low in both groups. Analysis in the over-75 year subgroup showed similar safety and efficacy results. Fixed low-dose Per/Ind is a safe and effective treatment of hypertension including isolated systolic hypertension in the elderly.

Administration, Oral↗

Relevance in the emergency department of a decisional algorithm for outpatient care of women with acute pyelonephritis.

The outcome of three types of management for patients with acute pyelonephritis, in an emergency department is assessed. This was carried out by a prospective enrolment of patients with acute pyelonephritis. Through a decisional algorithm, doctors were encouraged to discharge female patients under 60 years with acute uncomplicated pyelonephritis, either directly from the emergency ward or after a short stay in the observation unit. All received a single intravenous dose of pefloxacin, after urine and blood cultures were obtained; before discharge a normal ultrasonography of the abdomen and the pelvis was required. Conversely, hospitalization was advised for patients who did not fit the criteria of uncomplicated pyelonephritis. Only females with positive urine cultures qualified. Of 83 patients enrolled, 70 were females with positive urine cultures, 60 of whom had uncomplicated pyelonephritis. At 3 weeks, two of 70 patients were lost to follow-up. In the remaining 68, favourable outcome was observed in 98% of 48 patients discharged from the observation unit (95% CI: [94%; 100%]), 90% of 10 discharged from the emergency ward (95% CI: [73%; 100%]) and 70% of 10 hospitalized (95% CI: [50%; 93%]). A decisional algorithm was useful in determining that over 85% of women who present to our emergency department with pyelonephritis have an uncomplicated form and may be safely treated as outpatients, if necessary after a brief stay in the observation unit. Prospective controlled trials are needed to determine duration of antimicrobial therapy, length of follow-up and finally, to compare tolerance and cost-effectiveness of outpatient vs. inpatient care of acute uncomplicated pyelonephritis.

Acute Disease↗