Long-term benefits of EPs® 7630 in patients with acute sinusitis: a real-world cohort study.

Background: We evaluated whether EPs® 7630 prescription in patients with acute sinusitis (AS) is associated with less frequent recurrence of AS, occurrence of chronic sinusitis or nasal polyps, or fewer antibiotic prescriptions. Methods: This retrospective cohort study used electronic medical records from the IQVIA Disease Analyzer database. Associations between initial therapy [EPs® 7630, antibiotics, intranasal corticosteroid (INCS), or corticosteroid-free nasal spray within 3 days of AS diagnosis] and AS recurrence, incidence of chronic sinusitis or nasal polyps or rate of antibiotic prescription were studied using multivariable Cox or logistic regression models, adjusting for sex, age, insurance status, month of diagnosis, and comorbidity. Results: A total of 216,360 patients were analyzed. INCS prescription was associated with a higher risk of recurrent AS (HR: 1.40; 95% CI: 1.01-1.92) and a higher incidence of chronic sinusitis or nasal polyp diagnosis (HR: 1.39; 95% CI: 1.01-1.92) compared to EPs® 7630. Initial antibiotic therapy was significantly associated with higher risk of new antibiotic prescription in the period of 31-365 days after the index date compared to EPs® 7630 (OR: 2.20; 95% CI: 1.66-2.92). Conclusion: EPs® 7630 prescription is associated with long-term benefits in AS patients. EPs® 7630 can help to reduce inappropriate antibiotic use and might reduce the risk of chronic sinusitis or nasal polyps.

Lymphocyte-predominant and classical Hodgkin's lymphoma: a comprehensive analysis from the German Hodgkin Study Group.

PURPOSE: Lymphocyte-predominant Hodgkin's lymphoma (LPHL) is rare and differs in histologic and clinical presentation from classical Hodgkin's lymphoma (cHL). To shed more light on the prognosis and outcome of LPHL, we reviewed all LPHL patients registered in the German Hodgkin Study Group (GHSG) database, comparing patient characteristics and treatment outcome with cHL patients. PATIENTS AND METHODS: We analyzed retrospectively 8,298 HL patients treated within the GHSG trials HD4 to HD12, of whom 394 had LPHL and 7,904 had cHL. RESULTS: Complete remission and unconfirmed complete remission after first-line treatment was achieved in 91.6% v 85.9% of patients in early favorable stages, 85.7% v 83.3% of patients in early unfavorable stages, and 76.8% v 77.8% of patients in advanced stages of LPHL compared with cHL, respectively. Tumor control (freedom from treatment failure [FFTF]) for LPHL and cHL patients at a median observation of 50 months was 88% and 82% (P = .0093) and overall survival (OS) was 96% and 92%, respectively (P = .0166). In LPHL patients, negative prognostic factors were advanced stage (P = .0092), Hb less than 10.5 g/dL (P = .0171), and lymphopenia (P = .010) for FFTF. Age >or= 45 years (P = .0125), advanced stage (P = .0153), and Hb less than 10.5 g/dL (P = .0014) were negative prognostic factors for OS. CONCLUSION: The better prognosis of LPHL as compared with cHL might allow different treatment strategies, particularly for early-stage LPHL patients.

Fertility in male patients with advanced Hodgkin lymphoma treated with BEACOPP: a report of the German Hodgkin Study Group (GHSG).

To date, there is little information on the impact of more aggressive treatment regimen such as BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) on the fertility of male patients with Hodgkin lymphoma (HL). We evaluated the impact of BEACOPP regimen on fertility status in 38 male patients with advanced-stage HL enrolled into trials of the German Hodgkin Study Group (GHSG). Before treatment, 6 (23%) patients had normozoospermia and 20 (77%) patients had dysspermia. After treatment, 34 (89%) patients had azoospermia, 4 (11%) had other dysspermia, and no patients had normozoospermia. There was no difference in azoospermia rate between patients treated with BEACOPP baseline and those given BEACOPP escalated (93% vs 87%, respectively; P > .999). After treatment, most of patients (93%) had abnormal values of follicle-stimulating hormone, whereas the number of patients with abnormal levels of testosterone and luteinizing hormone was less pronounced-57% and 21%, respectively. In univariate analysis, none of the evaluated risk factors (ie, age, clinical stage, elevated erythrocyte sedimentation rate, B symptoms, large mediastinal mass, extranodal disease, and 3 or more lymph nodes) was statistically significant. Male patients with HL are at high risk of infertility after treatment with BEACOPP.

Evaluation of Eustachian tube function by sonotubometry: results and reliability of 8 kHz signals in normal subjects.

Sonotubometry allows an assessment of the Eustachian tube (ET) function under physiological conditions. The reliability of the application of an 8 kHz pure-tone signal was investigated. In 40 normal subjects (80 ears) sonotubometric studies were performed with a custom-made device. ET opening was provoked by swallowing, yawning and Valsalva manoeuvre. An opening was detected in all patients but not in all manoeuvres. Four characteristic sonotubogram types were found. Most common was the spike-type (60%). The double-peak and the plateau-shaped curves occurred in 17% each. The finding of an descendant curve was rare (5%). Of 623 measurements, only in 55% manouvres a positive sonotubometric result was found despite the fact that the patients reported an opening in all cases. The median opening time in dry swallowing, liquid swallowing, yawning and Valsalva was found to be 486, 355, 1,263 and 1,250 ms. A median sound increase of 16.0, 13.8, 15.0 and 15.0 dB was recorded for these manoeuvres. There was a statistic significant difference (P < 0.02) between the increase in sound intensity of liquid and dry swallowing. There was also a statistic significant difference found for the duration of the forced manoeuvres Valsalva and yawning as compared to dry and liquid swallowing (P < 0.0001). The use of an 8 kHz pure-tone signal showed a limited sensitivity for the detection of ET openings. This is mainly due to noise pollution, but also because of an altered positioning and/or dislocation of the probes and compression of the nostrils. The application of an 8 kHz signal is therefore not reliable enough for the use in practice. Further technical refinements and the use of alternative signals are necessary for a broader clinical application.

Rituximab added to an intensified salvage chemotherapy program followed by autologous stem cell transplantation improved the outcome in relapsed and refractory aggressive non-Hodgkin lymphoma.

We investigated the addition of rituximab to an intensified salvage program followed by a myeloablative course with autologous stem cell transplantation (ASCT) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL). Patients with relapsed or progressive aggressive NHL were treated with two cycles of conventional salvage chemotherapy (DHAP) followed by high-dose sequential chemotherapy (cyclophosphamide, methotrexate with vincristine and etoposide) and a final myeloablative course (BEAM) with ASCT. Rituximab (375 mg/m(2)) was administered at each treatment cycle. This cohort was compared with a historical control group of patients treated with the same chemotherapy but without rituximab. Patients from both groups were matched by duration of first remission and lactate dehydrogenase serum levels. Forty-five patients were treated with chemotherapy and 22 with immunochemotherapy. The overall response rates (ORR) at the final evaluation were 63% for the immunochemotherapy group and 42% for the chemotherapy group (p = 0.330). In the historical controlled analysis freedom from second failure (FF2F) at 2 years in the immunochemotherapy group was 57% and overall survival (OS) was 77%. FF2F in the chemotherapy group was 18% (p = 0.0051) and OS was 37% (p = 0.0051). In the matched-pair analysis, FF2F was 58% in the immunochemotherapy group compared to 16% in the chemotherapy group (p = 0.0517); OS was 74 vs 33%, respectively (p = 0.0424). The toxicity was tolerable and comparable in both groups. The addition of rituximab to an intensified salvage chemotherapy regimen seems to improve the prognosis. However, only prospective randomized trial can offer sufficient data of the value of rituximab in relapsed and refractory aggressive NHL.

Blond hair removal using ELOS systems.

OBJECTIVE: The aim of this study was to test blond hair removal using the ELOS system, which is optical energy and radio-frequency combined. METHODS: Seventeen patients with blond hair were randomly selected from the Department of Lasertherapy, Medical Centre Maastricht, The Netherlands. The mean age of the patients was 57.4 years. The mean energy used per patient was 23.2 J/cm2 and the mean radio-frequency was 18.6 J/cm2. RESULTS: A mean hair reduction of 57.4% was obtained with a mean of 8.5 treatments. There was a trend found between hair removal and the number of treatments. No correlation was found between the percentage of hair removal and age. Furthermore, there was no correlation between hair removal and the device's technical data. No major side effects were observed postoperatively. CONCLUSIONS: This study showed that ELOS can effectively be used for blond hair reduction.

Erectile function after non-nerve-sparing radical prostatectomy: fact or fiction?

OBJECTIVE: To evaluate the potency in patients after radical perineal prostatectomy with wide excision of both neurovascular bundles. MATERIAL AND METHODS: In this prospective study, a quality-of-life questionnaire was completed by 128 patients at the preoperative stage, and 6 and 12 months postoperatively. Ten questions concerning the patient's sexuality were included on the pre- and both postoperative questionnaires. In addition, 6 patients who recorded some erectile function were sent a separate questionnaire containing eight more detailed questions. RESULTS: Preoperatively, 74/128 (57.8%) patients reported erections sufficient for sexual intercourse, and of these 74, 6 (8.1%) described having spontaneous erections 1 year postoperatively. These spontaneous erections occurred 1-5 times per week. The reply to the separate mailing made clear that the reported erections were insufficient for intercourse. CONCLUSIONS: Patients undergoing standardized radical prostatectomy with wide excision of the neurovascular bundle have a very small chance of spontaneous erections sufficient for intercourse postoperatively.

Role of hematotoxicity and sex in patients with Hodgkin's lymphoma: an analysis from the German Hodgkin Study Group.

PURPOSE: Several scores have described sex as a prognostic factor in patients with Hodgkin's lymphoma (HL). However, little is known how sex-specific factors influence treatment outcome. We systematically investigated sex differences with regard to pretreatment characteristics and therapy-related variables, and examined their influence on the outcome of HL patients. PATIENTS AND METHODS: This analysis comprises 4,626 HL patients of all prognostic risk groups who were enrolled onto the multicenter studies HD4 to HD9 of the German Hodgkin Study Group. At 5.5 years, 2,050 female and 2,576 male patients were analyzed. RESULTS: Male and female patients had similar prognostic factors. There was more acute chemotherapy-related hematotoxicity in women, especially more severe leucopenia (WHO grade 3/4, 69.9% female and 55.2% male; P < .0001). Importantly, this did not translate into more infections. Female patients had similar response rates but fewer relapses and deaths, leading to a significantly better freedom from treatment failure (FFTF; at 66 months, 81% female [95% CI, 79% to 82%] and 74% male [95% CI, 72% to 76%]). Severe leucopenia during chemotherapy was strongly associated with better FFTF, both for males and females. In addition, when only those patients who developed severe leucopenia within the first two cycles of chemotherapy were included, the factor maintained its protective role. CONCLUSION: The protective role of severe leucopenia suggests the testing of a more individualized therapy. In future trials, this therapy may be tailored in a response-adapted manner depending on the individual toxicity profile within the first cycles.

Secondary amenorrhea after Hodgkin's lymphoma is influenced by age at treatment, stage of disease, chemotherapy regimen, and the use of oral contraceptives during therapy: a report from the German Hodgkin's Lymphoma Study Group.

PURPOSE: Long-term survivors of successfully treated Hodgkin's lymphoma (HL) are at risk for late complications. Among these, infertility for female patients is of major importance. The subject of this analysis is to evaluate the menstrual status after HL therapy. PATIENTS AND METHODS: From 1994 to 1998, the German Hodgkin's Lymphoma Study Group conducted clinical trials for early-, intermediate-, and advanced-stage HL (trials HD7 to HD9) involving a total of 3,186 patients. A survey was carried out to evaluate the menstrual status after therapy. The following factors were assessed concerning their influence on amenorrhea: age, treatment, stage, and the use of oral contraceptives during chemotherapy. RESULTS: A total of 405 women aged younger than 40 years answered the study questions. After a median follow-up of 3.2 years, 51.4% of the women receiving eight cycles of dose-escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) had continuous amenorrhea. Amenorrhea was significantly more frequent after dose-escalated BEACOPP compared with doxorubicin, bleomycin, vinblastine, and dacarbazine; cyclophosphamide, vincristine, procarbazine, prednisone, doxorubicin, bleomycin, vinblastine, and dacarbazine; or standard BEACOPP (P = .0066). Amenorrhea after therapy was most pronounced in women with advanced-stage HL (P < .0001), in women older than 30 years at treatment (P = .0065), and in women who did not take oral contraceptives during chemotherapy (P = .0002). CONCLUSION: Most women who are treated for advanced-stage HL experience amenorrhea after therapy. Amenorrhea is significantly more frequent in women with advanced-stage HL receiving eight cycles of dose-escalated BEACOPP and in women older than 30 years at first treatment. Furthermore, the data show a statistical association between the use of oral contraceptives and return of menstrual cycle, which is subject to further investigation.

Lymphocyte-predominant and classical Hodgkin's lymphoma--comparison of outcomes.

INTRODUCTION: Lymphocyte predominant Hodgkin's lymphoma (LPHL) differs in histological and clinical presentation from classical Hodgkin's lymphoma (cHL). Treatment of LPHL patients using standard Hodgkin's lymphoma (HL) protocols leads to complete remission (CR) in more than 95% of patients. However, differences in terms of relapse rates, survival and freedom from treatment failure (FFTF) between LPHL and cHL patients were suggested by a recent intergroup analysis. To obtain a more comprehensive picture, we reviewed all LPHL-cases registered in the GHSG database and compared patient characteristics and treatment outcome with cHL patients. PATIENTS AND METHODS: We retrospectively analyzed 8298 HL patients treated within the GHSG trials (HD4-HD12): 394 LPHL patients and 7904 cHL patients. From 394 LPHL patients 63% were in early stage, 16% in intermediate and 21% in advanced stage of disease. Of the 7904 cHL patients analyzed, 22% were in early, 39% in intermediate and 39% in advanced stages. About 9% of LPHL patients had B symptoms compared to 40% in cHL patients. RESULTS: About 91% LPHL vs. 86% cHL patients in early stages, 86% vs. 83% in intermediate and 79% vs. 75% in advanced stages reached CR/CRu. Additional analysis for LPHL IA patients showed 98% CR/CRu after extended field, 100% after involved field (IF) and 98% CR/CRu after combined modality treatment. About 0.3% LPHL patients developed progressive disease (PD) compared to 3.7% cHL patients. The relapse rate of LPHL patients was very similar to cHL (8.1% vs. 7.9%). There were 2.5% secondary malignancies in LPHL and 3.7% in cHL patients. About 4.3% LPHL patients and 8.8% cHL patients died. The FFTF rates for LPHL and cHL patients at a median observation of 41 or 48 months were 92% and 84%, respectively. The OS for LPHL and cHL patients was 96% and 92%, respectively. CONCLUSION: The cHL patients present more frequently with advanced stages and B symptoms compared to LPHL patients. There was no difference in treatment outcome in terms of CR/CRu, PD and mortality between LPHL and HL. Surprisingly, there were also no differences in patients with relapse.

Efficacy of unilateral nerve sparing in radical perineal prostatectomy.

AIM: We determine the efficacy of unilateral nerve-sparing radical perineal prostatectomy in preserving the sexual function. PATIENTS AND METHODS: Ninety-two patients with histologically confirmed unilateral prostate cancer were scheduled for contralateral nerve preservation. The perioperative morbidity was assessed using the patients' chart reviews. Postoperative health-related quality of life, urinary continence, and potency were evaluated prospectively with questionnaires provided before surgery and then after 6, 12, and 24 months. RESULTS: Unilateral nerve preservation was performed in 88 of the 92 patients. Due to extensive scarring or prostatic size, the procedure was terminated as regular radical prostatectomy in 4 other patients. The perioperative complication rate was low and of minor significance, except in 1 patient who experienced a significant myoglobulinuria due to a prolonged procedure. Blood transfusions were necessary in 5 (5.4%) patients. Ureteral reimplantation was performed in 1 patient because of ureteral stricture. Positive surgical margins were present in 12 (18%) of 67 pT2 patients and in 8 (35%) of 23 pT3 patients. A proportion of 48% (15/31) of the patients followed for more than 24 months and who had a good erectile function prior to surgery reported unassisted sexual intercourse. However, only 4 of these patients were completely satisfied with all aspects of sexual performance, as asked in a short version of the International Index of Erectile Function questionnaire. CONCLUSIONS: Unilateral nerve-sparing radical perineal prostatectomy is technically feasible and yields excellent results in terms of potency preservation for prostates <60 ml. However, the quality of erections is decreased, even in patients with erections sufficient for intercourse. Hence, appropriate sexual counseling in conjunction with medical therapy should be offered to all patients.

Fecal incontinence after radical perineal prostatectomy: a prospective study.

OBJECTIVES: To assess, in a prospective study, the incidence of fecal incontinence after radical perineal prostatectomy. METHODS: Bowel symptoms were evaluated with questionnaires mailed to 132 patients preoperatively and 6 months postoperatively, and annually thereafter. All patients had undergone extrafascial perineal prostatectomy for Stage cT1-cT3N0M0 prostate cancer. The data of 116 patients (88%), who answered at least the preoperative and 12-month questionnaires, were analyzed. Reduced sensibility, reduced discrimination, urgency, or stool smearing were symptoms indicative of fecal incontinence. Patients with one symptom of fecal incontinence were evaluated further with a structured telephone interview. RESULTS: Daily stool smearing was reported preoperatively by 4% of the patients. Two symptoms related to fecal incontinence were present preoperatively in 6% of the patients. At 12 months postoperatively, 15 patients (13%) reported at least two symptoms of fecal incontinence. The structured telephone interview revealed that 6 of these 15 patients had symptoms of fecal incontinence that were related to the perineal prostatectomy; 9 patients had newly developed symptoms not related to surgery or symptoms due to tumor recurrence or radiotherapy. Patients with the presence of at least one symptom of fecal incontinence before surgery had an almost fourfold increased risk of developing at least two symptoms of fecal incontinence postoperatively compared with patients without any symptom of fecal incontinence. CONCLUSIONS: Significant fecal incontinence after radical extrafascial perineal prostatectomy is a rare event. The results of questionnaires should be supplemented by additional interviews to obviate wrong interpretations.

Photodynamic therapy: new treatment for therapy-resistant plantar warts.

BACKGROUND: Plantar wart treatment remains a challenging one. Various treatment modalities have been previously used and are still in current use. The problem remains in the degree of response to these treatments and the side effects associated with them. OBJECTIVE: The aim of this study was to test a new treatment modality for therapy-resistant plantar warts. METHODS: Thirty-one patients with 48 plantar warts were randomly selected from the Department of Laser Therapy, Medical Centre Maastricht, The Netherlands. The mean age of the patients was 29 years (range 6-74 years). The mean incubation time was 6.8 hours, and the mean treatment time was 18.7 minutes per wart. Each wart was treated an average of 2.3 times, with a median fluence of 100 cm2. RESULTS: Forty-two of 48 (88%) warts showed a complete response. A trend was found between total clearance and size of the warts, age of the patient, and the mean treatment time. No significant side effects were seen postoperatively. CONCLUSION: This study showed that recalcitrant plantar warts were successfully treated with no significant side effects; however, the user needs sufficient experience for this new effective treatment application.

Permanent 125I-seed brachytherapy or radical prostatectomy: a prospective comparison considering oncological and quality of life results.

OBJECTIVE: To assess the quality of life in patients with prostate cancer after permanent brachytherapy (BT) or radical perineal prostatectomy (RP). PATIENTS AND METHODS: The American Brachytherapy Society recommends the permanent implantation of radioactive seeds as a monotherapy for patients with T1-T2aN0M0 prostate cancer and a prostate-specific antigen (PSA) level of < or = 10 ng/mL, a Gleason score of <7 and a prostate volume of <60 mL. Using these criteria, 132 patients with low-risk prostate cancer were selected; 52 had BT with 125I-seed implantation, 38 had RP with unilateral nerve-sparing (RP + NS) and 42 extended RP (RP group). Only patients with unilateral tumour on biopsy were considered. Before therapy and 6, 12 and 24 months afterward, patients completed questionnaires to assess perceived health and function. PSA relapse was diagnosed with a PSA of >0.1 ng/mL for patients in the RP groups, and three consecutive PSA increases for those after BT. RESULTS: Extraprostatic tumours were found in 18% of specimens taken during RP, and bilateral tumours in 63% of patients. After a mean follow-up of 27 months, there was PSA relapse in two of the 80 patients in the RP and RP + NS groups, and six of the 52 patients in the BT group; a significant difference, with a hazard ratio of 5.2. The acute morbidity was low in all groups. At 1 year, more than two incontinence pads were used by 5% of patients after RP and by 4% after BT. Similarly, at 1 year 15% of patients after RP and 13% after BT were bothered by urinary incontinence. Newly-developed fecal soiling was reported by 4%, 5% and 11% of the RP, RP + NS and BT groups respectively; none of the patients after RP and 4% after BT were bothered by this symptom. The duration and stiffness of erection was assessed after 1 year and reported to be equal or slightly decreased by a third after RP + NS and 38% after BT. Taking a 5-10 point difference as clinically relevant, role, emotional and social functioning were improved considerably after RP + NS than after BT, but sexual activity was impaired significantly after RP + NS than after BT. CONCLUSIONS: Both therapies showed typical acute and late morbidity; the most bothersome late symptoms were urinary incontinence for patients after RP and fecal soiling after BT. Sexual function was impaired significantly in patients who were potent before RP + NS, whereas after BT men reported only a minor change in sexual performance at 1 year. Tumour control after a median follow-up of 27 months was better after RP but biochemical recurrence may still occur after > or = 5 years; therefore the present results are not mature enough and there were too few patients to provide a more definitive statement. As approximately 18% of patients considered to be appropriate candidates for BT had tumours extending beyond the prostate capsule or invading the seminal vesicles, nomograms are needed for more accurate information before therapy.

Hair reduction using intense pulsed light source.

BACKGROUND: Long-term hair removal in hirsute women remains a challenging issue. Various laser and laser-like devices are currently in use for hair removal, but little is known about the permanence of their results. This study deals with the permanence of hair removal using the intense pulsed light source (IPLS). OBJECTIVE: To test the effectiveness in long-term hair reduction. METHODS: Seventy female hirsute patients were selected in the Department of Laser Therapy at the Medical Center, Maastricht, the Netherlands. The average age of the mostly dark-haired patients of various skin types (Fitzpatrick I to V) was 41 years. They were subjected to a mean of 8 treatments (range of 2 to 23) followed for a mean period of 27.3 months. RESULTS: Using the IPLS, 87% hair removal was achieved, whereby the number of treatments correlated with the amount of hair lost. No correlation was found between hair removal and patient-related or technical data. Minimal side effects occurred in 10% of the patients. CONCLUSION: The IPLS system with its broad range of technical variables is effective in achieving long-term hair removal.

Ninety percent permanent hair reduction in transsexual patients.

Transsexualism as a condition requires hair removal. Twenty-five male-to-female transsexual patients were included in this study on epilation using the Intense Pulsed Light Source (IPLS). Patients received a varying number of treatments, depending on their response. A mean hair clearance rate of 90% was achieved in the studied patients. The average number of treatments per patient was nine. A negative correlation was found between hair removal and the age of the patient. Hair removal was also found to be more effective when the patients had not used any needle epilation. No difference in hair removal was found between transsexual patients, who were hormonal, and those who were not. Follow-up lasted an average of 44 months. This study proved that the IPLS has the potential to be effective, permanent, and painless especially in younger patients who have not used any mechanical methods for epilation before photoepilation.

Insufficient tissue ablation by rotational atherectomy leads to worse long-term results in comparison with balloon angioplasty alone for the treatment of diffuse in-stent restenosis: insights from the intravascular ultrasound substudy of the ARTIST randomized multicenter trial.

The ARTIST trial demonstrated a worse outcome for patients with in-stent restenosis (ISR) treated with rotational atherectomy (RA) and adjunctive balloon angioplasty (PTCA) as compared to PTCA alone. This intravascular ultrasound (IVUS) substudy compares effects of lumen enlargement and examines reasons for failure of RA in this setting. IVUS (n = 56) was performed after each interventional step and at follow-up. Volumetric lumen gain measured 79 +/- 68 mm(3) after PTCA (13 +/- 4 atm) as compared to 44 +/- 26 mm(3) after RA and adjunctive PTCA (7 +/- 3 atm; P < 0.0001). RA itself enlarged lumen by only 19 +/- 17 mm(3) and stent volume was 47% smaller as compared to high-pressure PTCA. Low-pressure strategy after RA did not prevent tissue growth during follow-up (19 +/- 25 vs. 36 +/- 38 mm(3); RA vs. PTCA; P = 0.09). Consequently, net lumen gain after PTCA was 82% higher compared to RA (46 +/- 54 vs. 25 +/- 24 mm(3); P = 0.09). Further stent expansion is the key mechanism to achieve luminal gain by PTCA of ISR. Neointimal ablation by RA has only minor effects. Low-pressure PTCA does not prevent recurrent tissue growth and failed for treatment of ISR due to insufficient stent expansion.

Analysis of the reliability of manual and automated immunohistochemical staining procedures. A pilot study.

OBJECTIVE: To study the variation in the number of stained cells and staining intensity comparing 2 immunostainers and manual staining for estrogen receptor (ER) expression in breast carcinoma. STUDY DESIGN: In 5 cases, 15 consecutive paraffin sections were investigated after simultaneous immunohistochemical ER staining. The slides were evaluated using a CM-2 TV image analysis system (Hund, Wetzlar, Germany). One viewing field, identified around a histologic structure present on all 15 sections, was analyzed. The percentage of immunoreactive cells (PP), mean grey values of the immunopositive (GVpos.) and immunonegative nuclei (GVneg.), and immunohistochemical staining intensity (SI, defined as GVneg.-GVpos.) were calculated. RESULTS: The mean PP values were higher for immunostainers A (70.2%) and B (53.8%) than for manual staining (40.8%). The results were significantly different comparing the 2 immunostainers (P = .0143) or immunostainer A and manual staining (P < .0001). Also, the mean SI values were higher for immunostainers A (24.5 +/- 2.8% [CV]) and B (18.5 +/- 31.1%) than for manual staining (10.8 +/- 33.8%). These differences revealed statistical significance comparing the immunostainers with manual staining (.0001 < P = .0048). CONCLUSION: Our results underline the higher staining quality using immunostainers in comparison with manual staining.

Cytokine concentrations in the amniotic fluid during parturition at term: correlation to lower uterine segment values and to labor.

BACKGROUND: In previous studies a significant increase in interleukin (IL)-6 and IL-8 concentrations in the lower uterine segment parallel to cervical dilatation at term could be found, however only a weak correlation to duration of labor was detected. This study compares amniotic fluid concentrations of interleukin (IL)-6 and IL-8 with those in the lower uterine segment, and the duration of labor. METHODS: Amniotic fluid and lower uterine segment specimens were obtained from 29 patients during cesarean section at term. The patients were divided into groups according to cervical dilatation (< 2 cm, 2-3.9 cm, 4-6 cm, > 6 cm) and to labor (0 h, > 0-12 h, > 12 h). Interleukin-6 and IL-8 concentrations were determined by enzyme immunoassay. RESULTS: Amniotic fluid IL-6 already increased at 2-3.9 cm (p = 0.02), while the steepest increase in IL-8 was observed at > 6 cm (p = 0.003). No correlation with lower uterine segment values was observed for either of the cytokines. However, the amniotic fluid IL-6 concentration correlated with labor (p = 0.0008). CONCLUSION: The increase in the concentration of IL-6 in the amniotic fluid earlier than its increase in the lower uterine segment supports the hypothesis that IL-6 plays a crucial role for the promotion of labor in the first place, and afterwards for the biochemical degradation processes in the lower uterine segment. The fact that the greatest increase in IL-8 concentration occurs only at > 6 cm indicates that this chemotactic cytokine has only minor significance in the initiation of parturition by its concentration in the amniotic fluid.

Chorioamnionitis: elevated interleukin-6 and interleukin-8 concentrations in the lower uterine segment.

AIMS: To determine interleukin (IL)-6 and IL-8 concentrations in the lower uterine segment in patients with chorioamnionitis compared to those without. METHODS: Biopsy specimens from the lower uterine segment of 33 patients with chorioamnionitis were matched to specimens of 33 patients without. The biopsies had been taken during cesarean section. The concentrations of IL-6 and IL-8 in protein extracts of these specimens were determined by enzyme linked immunosorbent assays. RESULTS: Compared to the controls patients with chorioamnionitis showed significantly lower gestational age and higher parity, and were more likely to receive fenoterol or betamethasone. In the chorioamnionitis group the median IL-6 concentrations were higher than in the controls (61.5 and 19.4 pg/mg protein, respectively [p < 0.01]). The same applies to the median IL-8 concentrations (162.3 and 13.4 pg/mg protein, respectively [p < 0.001]). CONCLUSIONS: To our knowledge this is the first study which could clearly demonstrate significantly increased IL-6 and IL-8 levels in the lower uterine segment of patients with chorioamnionitis. Increased concentrations of pro-inflammatory cytokines may play a pivotal role in cervical softening and dilatation during chorioamniotic infection.