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P Martus

Publications and source records attributed to P Martus.

At least 91 records · Page 5Linked to original sources
PubMed1999

Esophageal achalasia: intrasphincteric injection of botulinum toxin A versus balloon dilation.

BACKGROUND AND STUDY AIMS: In patients with esophageal achalasia, pneumatic dilation is the treatment of choice, but it bears the risk of perforation in about 4% of cases. A new nonsurgical method, intrasphincteric injection of botulinum toxin A, has shown promising initial results, and we thus undertook this study to compare the long-term outcome of these two methods. PATIENTS AND METHODS: In a prospective randomized study, 24 patients with definitive esophageal achalasia were divided into two equal groups and underwent either balloon dilation or injection of botulinum toxin (20 U injected into each of the four quadrants in the lower esophageal sphincter). The outcome was assessed on the basis of a symptom score documented before treatment and at regular intervals for two and a half years thereafter. Complications associated with the two techniques were also documented. RESULTS: No relevant complication occurred in either of the treatment groups. Initially, dilation was successful in 10 of 12 patients (83%), and botulinum toxin injection in 9 of 12 patients (75%). The symptom scores showed no significant differences between the two groups before and one month after treatment. Over the two and a half year follow-up, however, all nine successfully treated patients in the botulinum toxin group experienced recurrence of symptoms, but only four of the ten patients (40%) in the dilation group. CONCLUSIONS: The two treatment methods initially had equal success rates, but in the long term the effect of the botulinum toxin injection was statistically significantly shorter than that of balloon dilation. As fewer risks are associated with the injection treatment, studies should be undertaken either to identify patient subgroups in whom botulinum toxin can be effective long-term or to test substances with longer-lasting effects.

Adolescent↗
PubMed1999

Quantification of blood--aqueous barrier breakdown after trabeculectomy: pseudoexfoliation versus primary open-angle glaucoma.

PURPOSE: Impairment of the blood-aqueous barrier in unoperated eyes with pseudoexfoliation syndrome has been demonstrated by fluorescein angiography, fluorophotometry, measurement of aqueous flare, and determination of aqueous protein. We performed noninvasive quantification of aqueous flare using the laser flare-cell meter to compare blood-aqueous barrier breakdown after trabeculectomy in eyes with primary open-angle glaucoma (POAG) and in eyes with pseudoexfoliative glaucoma (PEX). METHODS: Twenty eyes with PEX and 20 eyes with POAG were included in the study. Trabeculectomy was performed by two surgeons according to a standard trabeculectomy technique. Intra- and postoperative treatments were identical in both groups. Aqueous flare was quantitatively determined using the laser flare-cell meter FC-1000 (Kowa, Tokyo, Japan) before and 3, 5, 7, and 9 days after trabeculectomy. Absolute flare and difference between post- and preoperative flare values were statistically analyzed using the Mann-Whitney U-Test for independent samples. RESULTS: Before surgery, aqueous flare values were significantly higher in PEX than in POAG. On days 3, 5, 7 and 9 after surgery, flare values were significantly higher in eyes with PEX than in eyes with POAG. Absolute differences between post- and preoperative flare values also were significantly higher in eyes with PEX, but this was not true for percentage values. CONCLUSION: These results show that substantial blood-aqueous barrier breakdown occurs in eyes with PEX after trabeculectomy. These alterations may contribute to early or late complications of trabeculectomy and indicate the need for close postoperative follow-up evaluation in eyes with PEX.

Aged↗
PubMed1999

Polarimetric measurement of retinal nerve fiber layer thickness in glaucoma diagnosis.

PURPOSE: To evaluate reliability and diagnostic value of polarimetric measurements of the retinal nerve fiber layer (RNFL) thickness in the diagnosis of glaucoma. METHODS: The study included 81 eyes with perimetric glaucoma with glaucomatous changes of the optic disc and visual field defects; 52 eyes with preperimetric glaucoma with glaucomatous optic disc abnormalities and normal achromatic visual fields; and 70 normal eyes. For determination of reliability, four examiners repeated polarimetric measurements five times in ten normal subjects. RESULTS: The polarimetric variables were significantly correlated with increasing mean visual field defect and decreasing neuroretinal rim area. In correlation analyses with visual field defects, correlation coefficients were highest for the variable "superior/nasal ratio" and "the Number," a variable calculated by the neural network of the device. In correlations with neuroretinal rim area, correlation coefficients were highest for measurements of the inferior nerve fiber layer thickness. The preperimetric glaucoma group and the control group differed significantly in the variables "superior/nasal ratio" and "the Number" and, to a smaller degree, in the variables "superior/temporal ratio" and "superior/inferior ratio." The Number variable had a sensitivity of 82% and 58% at a predefined specificity of 80% in separating perimetric glaucoma patients and preperimetric glaucoma patients, respectively, from control subjects. Reproducibility of the polarimetric measurements ranged between 70% and 89%. CONCLUSION: Polarimetric measurements of the RNFL thickness can detect glaucomatous optic nerve damage in patients with visual field loss, and in some patients with preperimetric glaucomatous optic nerve damage. Considering the fast performance, easy handling, and low maintenance costs, RNFL polarimetry may be helpful in glaucoma diagnosis.

Adult↗
PubMed1998

Efficacy of radiochemotherapy with platin derivatives compared to radiotherapy alone in organ-sparing treatment of bladder cancer.

PURPOSE: Presently, for muscle-invasive bladder cancer, radical cystectomy is considered to be the standard treatment. Bladder preservation, in the interest of quality of life, is secondary to the primary treatment goal of curing the patient. We present a 14-year multivariate analysis of prognostic factors influencing survival and bladder preservation after transurethral resection of the bladder (TURB) and radiotherapy (RT) +/- chemotherapy. METHODS AND MATERIALS: From May 1982 to May 1996, sequential cohorts of 333 patients with bladder cancer (mean age: 66 years) were treated by either RT alone (128 patients), or with platin-based concomitant radiochemotherapy (RCT, 205 patients) after TURB. Patients (282) with muscle-invasive or T1 high-risk cancers (Grade III, residual tumor after TURB, multifocality, tumor diameter > 5 cm, associated Tis or Ta, multiple recurrences or lymph node metastases), who received a minimal target dose of 45 Gy were selected for analysis (med. follow-up = 7.5 years): after October 1985, 115 patients received cisplatin (25 mg/m2) and 69 patients carboplatin (65 mg/m2) before every treatment fraction (1.8 Gy) on Days 1-5 and 29-33 of conventional fractionated RT. RESULTS: Complete remission rate was 20% (55 of 282 patients) after radical TURB, 57% (56 of 98) after TURB plus postoperative RT, and 80% (145 of 181 patients) after TURB plus RCT (85% after concomitant cisplatin and 70% after RCT plus carboplatin). These differences were significant in multivariate analysis (p = 0.003-0.05). The strongest impact on initial response had T-category (p < 0.0001) and R-status after TURB (p < 0.0003). Cause-specific survival (CSS) was 59 and 43% after 5 and 10 years; 79% of patients survived with preserved bladder. Five-year CSS after RT, RCT-Cis, and RCT-Carbo was 40, 64, and 54%, 10-year CSS 31, 48, and 27%, respectively (p = 0.04-0.045, univariate). R-status after TURB was the only independent prognostic factor for survival and bladder preservation. For relapsed patients after cystectomy, the 5- and 10-year CSS were 40 and 33%. CONCLUSIONS: TURB followed by RT/RCT is an alternative treatment option to primary cystectomy for patients with muscle-invading bladder cancer. Compared to historic controls, the addition of cisplatin or carboplatin leads to significantly more complete remissions and better survival. Survival rates are similar to those achieved by primary cystectomy and possibly even better for selected subjects, such as patients with T3b and T4 tumors. Cystectomy should be restricted to only those patients who fail after RCT.

Adult↗
PubMed1998

[The age correction of survival probabilities in cancer studies].

PURPOSE: Survival of elder oncological patients may depend on the tumor disease, on reasons not related to the underlying disease or simply on patient's age. Therefore patient' age has to be taken into account if the objective of an oncological study is the disease-related survival. Basically, there are 3 different approaches: multivariate statistical modelling, estimation of disease-related survival after censoring of cases with cause of death not due to the tumor disease, and consideration of demographical data in the general population. PATIENTS AND METHODS: Our paper deals with the age correction using the data from the 1986/88 census in Germany. We have written a computer program based on SPSSWIN, which allows an automated age correction. Using clinical data of radiotherapy after surgical therapy of bladder cancer, we illustrate the method. RESULTS: The estimated 5-year-survival using the age correction was--dependent on patient's age in the sample--10% up to 15% higher than the uncorrected rate. In the whole sample of 333 unselected patients, 5-year-survival was corrected from 47% to 59%. In the normal population adjusted for age- and sex-distribution, the expected survival rate was 80%. CONCLUSIONS: The age correction has substantial influence on survival analysis of male patients elder than 60 years and female patients elder than 70 years. It should therefore be used in oncological studies investigating long-term survival of patients in these age-groups.

Adult↗
PubMed1998

Radiotherapy alone or radiochemotherapy with platin derivatives following transurethral resection of the bladder. Organ preservation and survival after treatment of bladder cancer.

PURPOSE: Multivariate analysis of prognostic factors influencing survival and bladder preservation after radiochemotherapy for bladder cancer following transurethral resection of the bladder (TURB). PATIENTS AND METHODS: At the University Hospital of Erlangen 333 patients with bladder cancer were treated with either radiotherapy alone (RT, n = 128) or platin based radiochemotherapy (RCT, n = 205) after TURB between 5/1982 and 5/1996. Two-hundred and eighty-two curative patients, with either muscle invasive or T1-high risk cancer, were analyzed. Median age was 66 years, median follow-up is 7.5 years. Uni- and multivariate analysis was performed for age, grade, R-status after initial TURB, T-category and treatment modality relevant to the endpoints initial response, survival and bladder preservation. RESULTS: Treatment related mortality was below 1%. Complete remissions were achieved at 57%, 70%, and 85% after RT or RCT with carboplatin or cisplatin. This difference was multivariately significant. Further significant prognostic factors were pT-category and R-status. For all patients survival was 59% and 43% after 5 and 10 years. 79% of survivors could keep their own bladder. Five-year survival rates after RT alone, RCT with carboplatin or cisplatin were 47%, 57%, and 69%, respectively. This was univariately significant. The only multivariately significant factor for survival and bladder preservation was the R-status after initial TURB. CONCLUSIONS: Treatment of bladder cancer by TURB and RT/RCT is an alternative to primary cystectomy. The addition of chemotherapy leads to significantly more complete remissions and better survival. Initial TURB is recommended to be as radical as possible.

Adult↗
PubMed1998

Aqueous flare in retinitis pigmentosa.

BACKGROUND: The purpose of this study was to quantify blood-ocular barrier impairment by measuring aqueous flare in retinitis pigmentosa (RP) and to search for clinical correlations. METHODS: Forty-nine patients (94 eyes) with RP and 85 normal controls were examined. Aqueous flare was quantified with the noninvasive laser flare-cell meter (FC-1000, Kowa, Japan). Degrees of cystoid macular edema (CME), vitreous pigment dusting (VPD), intraretinal migration of retinal pigment epithelium, and waxy pallor of the optic nerve head were determined semiquantitatively by biomicroscopy. Data were analyzed using the t-test the Mann-Whitney U-test, the chi-squared test and regression analysis by taking into account the dependency of data from two eyes of the same patients. RESULTS: Aqueous flare (photon counts/ms) was significantly higher in RP (mean 10.11 +/- 3.53) than in normals (3.89 +/- 0.94; P < 0.001). Clinically significant CME was present in 26% of eyes with RP, being significantly more frequent in autosomal dominant RP (11 of 16 eyes, 69%) than in other variants (17%; P < 0.005). Multivariate analysis revealed that CME was most strongly associated with flare values (r = 0.84), P < 0.01), whereas--after adjusting for CME--correlations between aqueous flare and other clinical findings did not reach significance. CONCLUSION: RP eyes show increased aqueous flare values, indicating impairment of blood-occur barriers. This appears to be associated with CME and with autosomal dominant RP.

Adolescent↗
PubMed1998

Quantification of aqueous melanin granules in primary pigment dispersion syndrome.

PURPOSE: Aqueous melanin granules are essential in the pathogenesis of pigment dispersion syndrome and pigmentary glaucoma. We quantified aqueous melanin granules with the laser flare-cell meter in patients with pigment dispersion syndrome, assessed the measurement reproducibility, and correlated the numbers with clinical findings. METHODS: Aqueous melanin granules were counted by means of the cell count mode of the laser flare-cell meter (KOWA FC-1000; Kowa, Tokyo, Japan) in 42 eyes of 21 patients with primary pigment dispersion syndrome under three conditions (undilated pupils, dilated pupils, after exercise). The reproducibility of the measurements was determined with the intraclass correlation coefficient. A control group of 40 age- and sex-matched eyes was also examined after pupillary dilation. The results were correlated with biomicroscopic findings in eyes with pigment dispersion syndrome (retrocorneal Krukenberg spindle, iris transillumination, pigmentation of trabecular meshwork). RESULTS: Numerous aqueous melanin granules were detected in eyes with pigment dispersion syndrome (mean, 2.9 +/- 3.7 granules/0.075 mm3) but only small numbers were counted in normal eyes (0.2 +/- 0.3, P < .001). Medical pupil dilation caused an additional increase of aqueous melanin granules in pigment dispersion syndrome (6.3 +/- 5.3, P < .001), but not undilated exercise (climbing stairs) (2.9 +/- 3.7, P > .5). The reproducibility of the measurements was very high (intraclass coefficient >0.92). The number of melanin granules correlated with the degree of Krukenberg spindle (r = .61, P = .004) and with iris transillumination (r = .69, P = .001). CONCLUSIONS: Quantification of aqueous melanin granules yields reproducible results and shows increased numbers in pigment dispersion syndrome, especially after pupillary dilation. Aqueous melanin granule quantification may be useful for evaluating eyes with pigment dispersion syndrome and for assessing treatment effects.

Adult↗
PubMed1998

[Design and preliminary results of the Erlanger non-high-risk penetrating-keratoplasty study].

PURPOSE: The purpose of this prospective study is to examine the non-high-risk penetrating keratoplasty clinically, tyndallometrically and immunological-serologically in order to learn more about the pathogenesis, early symptoms and therapy monitoring of corneal graft rejection. PATIENTS AND METHODS: Since february 1997, patients undergoing non-high-risk-PK have been enrolled in this prospective study. Examinations are done preoperatively and in well-defined postoperative gates (6 weeks, 3 months, 6 months, etc.) and include clinical assessments, corneal topography, laser-tyndallometry, corneal endothelial cell count and corneal pachymetry. Preoperatively as well as at each postoperative examination, 10 ml serum and perioperatively corneoscleral donor tissue are collected and frozen (-80 degrees C) to allow immunological and serological examinations in case of graft rejection later. A relational data base (MS Access) guarantees complete and homognous standardized clinical and serological data. We randomised our patients with respect to duration of topical steroid therapy in standard situations (short-time vs. long-time) as well as for systemic steroid therapy (bolus group vs. tapering group) in case of a graft rejection in 2 treatment groups. RESULTS: Up to March 1998, 99 patients have been enrolled in this prospective study. Our report includes the first consecutive 55 patients (25 female, 30 male, recipient age 56.9 +/- 19.4 years, donor age 57.0 +/- 19.9 years). Up to now (follow-up 2.5 +/- 2.1, maximum of 7.3 months) we did not observe immunologic graft rejections. In one patient a primary graft failure occurred. Laser tyndallometry showed a reduction of blood-aqueous barrier breakdown from 6 weeks postoperatively (9.3 +/- 5.7 photon counts/msec) to 3 months postoperatively (6.8 +/- 3.5 photon counts/msec). CONCLUSION: This prospective randomized clinical and immunological study after non-high-risk-PK is supposed to give more information about pathogenesis, early symptoms and therapy monitoring of graft rejection after elective PK. The concept and design of this study are described. Preliminary data may give significant results in a few years.

Adult↗
PubMed1998

Histamine and cutaneous nociception: histamine-induced responses in patients with atopic eczema, psoriasis and urticaria.

Having observed altered itch and flare reactions after histamine application in patients with atopic eczema, we tried to determine these reactions in patients with urticaria and psoriasis. We investigated 16 healthy non-atopic subjects, 16 atopics in an eczema-free interval, 16 with acute atopic eczema, 16 with urticaria and 16 with psoriasis. Histamine was iontophoretically applied. The resulting sensations were rated on a visual analogue scale. Flare areas were measured 6 min after stimulation. Itch ratings of urticaria and psoriasis patients did not differ significantly from controls, whereas both atopic groups, regardless of acute or symptom-free state, reported significantly reduced intensity of itching. Flares were significantly diminished in all subjects with acute skin disease (psoriasis, urticaria and atopic eczema), regardless of diagnosis. However, flares were "normal" in symptom-free atopics and were not significantly different from controls. In conclusion, all "acute" patients showed a diminished axon-reflex function, possibly due to a downregulation of C-fiber responsiveness to histamine or an increased turnover rate of inflammatory mediators. Both atopic groups reported weaker itching, suggesting altered central nervous processing of itch.

Acute Disease↗
PubMed1998

Update on reversal of left ventricular hypertrophy in essential hypertension (a meta-analysis of all randomized double-blind studies until December 1996).

OBJECTIVE: To provide an update on the ability of different antihypertensive drugs to reduce left ventricular hypertrophy in essential hypertension. DATA SOURCES: Relevant medical databases including MEDLINE, BIOSIS PREVIEWS, EMBASE, and SCISEARCH as well as review articles to December 1996. STUDY SELECTION: Meta-analysis of all published articles including only double-blind, randomized, controlled clinical studies with parallel-group design. DATA EXTRACTION: Literature search and data extraction according to a prefixed scheme performed independently by two investigators. The primary parameter was reduction of left ventricular mass by antihypertensive therapy with placebo, diuretics, beta-blockers, calcium channel blockers, or ACE-inhibitors. DATA SYNTHESIS: Fifty studies published till the end of December 1996 were identified. They comprised a total of 1715 patients in 13 placebo (n=165, age: 50+/-3 years) and 89 active treatment arms (n=1550, age: 56+/-10 years) respectively. Overall, for active treatment left ventricular mass index was the more reduced the greater the decrease in systolic blood pressure, (r=0.27; P<0.05), the longer the duration of therapy (r=0.36; P<0.001), and the higher the pretreatment value of left ventricular mass index (r= 0.53; P<0.001). Left ventricular mass index was decreased by 12% with ACE-inhibitors (95% CI: 9.0-14.5%), by 11% with calcium channel blockers (95% CI: 7.8-13.7%), by 5% with beta-blockers (95% CI: 1.2-7.3%) and by 8% with diuretics (95% CI: 3.9-11.1%) (overall P<0.01). Subsequent tests revealed that ACE-inhibitors and calcium channel blockers were more effective than beta-blockers in reducing left ventricular mass index (P<0.05). Similar differences between drug classes were found with regard to effect on left ventricular wall thickness (P<0.05). CONCLUSIONS: Decrease in systolic blood pressure, duration of antihypertensive therapy, degree of pretreatment left ventricular hypertrophy and antihypertensive drug class determined the reduction of left ventricular hypertrophy. ACE-inhibitors and calcium channel blockers were more potent in reducing left ventricular mass than beta-blockers, with diuretics in the intermediate range.

Adrenergic beta-Antagonists↗
PubMed1998

Controlled clinical laboratory comparison of two supplemented aerobic and anaerobic media used in automated blood culture systems to detect bloodstream infections.

A 20-ml blood sample was collected from adult patients with suspected bloodstream infections and distributed equally into the four volume-controlled bottles of a blood culture set consisting of aerobic and anaerobic BACTEC Plus/F bottles and aerobic and anaerobic BacT/Alert FAN bottles. All bottles were incubated in their respective instruments for a standard 5-day protocol or until the instruments signalled positivity. Samples in all bottles with negative results by these instruments were terminally subcultured. A total of 8,390 blood culture sets were obtained during the study period, of which 4,402 (52.5%) met the study criteria. Of these, 946 (21.5%) were positive either by instrument signal or by additional terminal subculture of all negative bottles and yielded growth of microorganisms. Five hundred eighty-nine (13.4%) blood culture sets were considered to have recovered 663 clinically significant organisms. When both the BACTEC and the BacT/Alert systems were used, 465 positive sets were detected; BACTEC alone detected 52 positive sets and BacT/Alert alone detected 72 (P = 0.09). No differences were found between the two systems in microbial recovery rate from blood cultures obtained from patients on antibiotic therapy. Significantly more members of the family Enterobacteriaceae (P < 0.01) were detected from patients without antimicrobial therapy by BacT/Alert than by BACTEC. The false-negative rates were 0.20% for BACTEC and 0.32% for BacT/Alert. A significantly higher false-positive rate was found for BACTEC (P < 0.0001). Both systems were comparable for the time to detection of microorganisms. However, gram-positive bacteria were detected faster by BACTEC and Enterobacteriaceae were detected faster on average by BacT/Alert. We concluded that both systems are comparable in their abilities to recover aerobic and anaerobic organisms from blood cultures and a terminal subculture might not be necessary for either of the two systems. The increased positivity rate when using an anaerobic bottle in a two-bottle blood culture set is due to the additional blood volume rather than to the use of an anaerobic medium.

Adult↗
PubMed1998

[Disposable protection for flexible gastroenterologic endoscopy: prospective comparative evaluation of a new gastroscopy system (Endosheath) compared to the standard fiberglass gastroscope].

The reprocessing of flexible gastrointestinal endoscopes is time-consuming and expensive. Endoscopically transmitted infections due to insufficient disinfection are already of clinical importance. A new developed prototype of a flexible, fiberoptic gastroscope was tested in a prospective open randomized trial to evaluate the function. reprocessing and hygienical safety of this disposable, sheathed endoscopic system and was compared with a standard gastroscope. This new endoscopical system utilizes a disposable sheath to cover and protect all working surfaces of the endoscope from contamination. A prospective, randomized trial was performed in our unit to compare the disposable gastroscope (G-F100) with a standard-gastroscope of the newest Generation (GIF-Q 30). Visual analog rating scales were used to record evaluations of endoscope performance and reprocessing by endoscopists and reprocessing personnel. We recorded the time of reprocessing, the time to perform the procedures, depth of insertion, total instrument downtime and any problems which occurred during the procedure. Microbiological swabs were taken from each endoscope. 40 procedures (20 standard, 20 sheathed) were performed. The sheathed gastroscope 8.9 min versus 7.1 min. The overall instrument downtime was significantly shortened by the endosheath (9.8 min versus 47.5 min with the standard gastroscope). The disposable gastroscope-system permits an increase of procedure-frequency up to a factor of 2.9. The standard gastroscope was preferred by the endoscopists and the reprocessing personnel. No microbiological contaminations of the sheathed or the standard gastroscopes could be demonstrated, and no leak of the sheaths was recorded after gastroscopy. The disposable gastroscope has important advantages of decreased instrument turn-around time and potentially increased staff and patient safety.

Gastroscopes↗
PubMed1998

A multivariate sensory model in glaucoma diagnosis.

PURPOSE: To evaluate whether the combination of two psychophysical and two electrophysiological procedures improves diagnostic validity compared with single procedures. METHODS: In a clinical study, 73 patients with glaucoma from the University Eye Hospital in Erlangen and 122 healthy control subjects from the university staff, ranging in age from 19 to 62 years, underwent measurement of temporal contrast sensitivity using a full-field flicker test, spatiotemporal contrast sensitivity, blue-on-yellow visual evoked potential (VEP), and a black-and-white, pattern-reversal electroretinogram. Diagnostic reference criteria included applanation tonometry, optic disc morphometry, and automated perimetry. Sensitivity was determined univariately with a fixed specificity of 80% and in a multivariate approach using logistic regression analysis. The classification rate was estimated using the leaving-one-out method. The correlation with intraocular pressure, visual field defects, and optic nerve defects was determined. RESULTS: Contrast sensitivity measurements and the blue-on-yellow pattern-onset VEP showed comparable sensitivity (85%, 84%, and 85%) with 80% specificity, and a pattern-reversal electroretinogram showed lower sensitivity (64%). The first three methods contributed independent information to a diagnostic score. This score improved sensitivity to 94%, with a specificity of 89%. All procedures moderately correlated with the neuroretinal rim area of the optic disc (r=0.32-0.46). The psychophysical tests showed a higher correlation with visual field defects (r > 0.5) than the electrophysiological tests (r < 0.3). CONCLUSIONS: The multivariate approach substantially increased the diagnostic validity compared with single procedures. This was probably because the diagnostic procedures under investigation tested different aspects of visual function.

Adult↗
PubMed1997

Prevention of heterotopic ossification about the hip: final results of two randomized trials in 410 patients using either preoperative or postoperative radiation therapy.

PURPOSE: Experimental and clinical data support effectiveness of perioperative radiotherapy to prevent heterotopic ossification after hip surgery or trauma. Since 1987, two prospectively randomized trials were performed in patients with high-risk factors to develop heterotopic ossification: the first (HOP 1) to assess the prophylactic efficacy of postoperative low vs. medium dose radiotherapy, and the second (HOP 2) to assess the prophylactic efficacy of pre vs. postoperative radiotherapy. METHODS AND MATERIAL: 410 patients with high risk to develop heterotopic ossifications about the hip following hip surgery were recruited. Between June 1987 and June 1992, 249 patients were randomized in HOP 1 to postoperative "low dose" (5 x 2 Gy; total: 10 Gy) or "medium dose" (5 x 3.5 Gy; total: 17.5 Gy) radiotherapy. Between July 1992 and December 1995, 161 patients were randomized in HOP 2 to either 1 x 7 Gy preoperatively (< or = 4 h before surgery) or 5 x 3.5 Gy (total: 17.5 Gy) postoperatively (< or = 96 h after surgery). With exception of age and type of implant (cemented vs. uncemented prosthesis) all confounding patient variables (gender, prior surgery) and predisposing risk factors were similarly distributed between both trials and treatment arms. Portals encompassed the periacetabular and intertrochanteric soft tissues. Radiographs were obtained prior and immediately after surgery and at least 6 months after surgery to assess the extent of ectopic bone formation about the hip. Modified Brooker grading was used to score the extent of heterotopic ossification. Harris scoring was applied to evaluate the functional hip status. If the scores decreased from immediate post or preoperative status, respectively, to the last follow-up, radiological or functional failures were assumed. RESULTS: Effective prophylaxis was achieved in 227 (91%) hips of HOP 1 and in 142 (88%) of HOP 2. In HOP 1, 15 (11%) radiological failures were observed in the low-dose group compared to 7 (6%) in the medium dose group (p > 0.05). In HOP 2, 4 (5%) radiological failures were observed in the postoperative and 11 (19%) in the preoperative group (p < 0.05). Subgroup analysis of the preoperative group revealed that the highest failure rate occurred in patients with prophylactic radiotherapy prior to removal of ipsilateral Brooker Grade III and IV ossification (39%) (p < 0.001), while all other patients in the preoperative group had a failure rate that was comparable to postoperative treatment groups. In multivariate logistic regression analysis the number of high-risk factors for development of heterotopic ossification (p = 0.03) and the time to RT initiation (p = 0.05) were independent prognostic factors in the HOP 1 study. For the HOP 2 study, the multivariate logistic regression analysis revealed the number of high-risk factors for development of heterotopic ossification (p = 0.003), the preoperative HO grade (p = 0.001) and the RT dose concept (p = 0.05) as independent prognostic factors. Other factors including type of implant (cemented vs. uncemented) did not affect the prophylactic efficacy of radiotherapy. There were no increased intra- and postoperative complications seen in the preoperative group, and no long-term complications were observed in both HOP studies. For functional failures (decrease of Harris score) no statistically prognostic factors were found. There were less functional failures in HOP 1 (18 = 7%) than in HOP 2 (23 = 14%, but this difference was not statistically significant. Only patients with high Brooker Grade III and IV at last FU achieved a lower Harris score than those with low Brooker Grade 0, I and II (p < 0.05). CONCLUSION: With the exception of a small subgroup of patients with ipsilateral high Brooker Grade III and IV, pre- and postoperative radiotherapy are equally effective to prevent heterotopic ossification about the hip after hip surgery and total hip arthroplasty. Fractionated medium dose radiotherapy resulted in the low

Adult↗
PubMed1997

[The acute toxicity of the simultaneous radiochemotherapy of rectal carcinoma].

AIM: We retrospectively examined the acute toxicity of (neo-)adjuvant combined treatment for rectal cancer in an attempt to evaluate potential factors that influence the severity of toxic side effects. PATIENTS AND METHOD: Between 1987 and 1995, 120 patients with rectal cancer (73 patients with primary tumor, 47 with recurrent disease) received chemoradiation for rectal cancer. Fifty-six patients received preoperative chemoradiation, 64 patients were treated postoperatively. Radiation was given by 4-field box technique with 6 to 10 MV-photons. Daily fraction size was 1.8 Gy, total dose 50.4 Gy (range: 41.4 to 56 Gy) +/- 5.4 Gy (range: 3.6 to 19.8 Gy) local boost in selected cases, specified to the ICRU reference point. During the first and fifth week of radiation 5-FU at a dose of 1000 m2/d for 120 hours was administered by continuous infusion. Toxicity was recorded following (modified) WHO-criteria. RESULTS: Acute grade 3 toxicity occurred mainly as diarrhea (33%), perineal skin reaction (37%), and leukopenia (10%). Extension of the treatment volume including paraaortic lymph nodes (L3) led to a significant increase of grade 3-diarrhea (68% vs. 25%, p = 0.0003) and grade 3-leukopenia (18% vs. 8%, p = 0.03). After abdominoperineal resection less patients suffered from grade 3-diarrhea (8% vs. 47% after sphincter preserving procedures, p = 0.0006), whereas severe perineal erythema occurred more frequently (56% vs. 29%, p = 0.02). Women had significantly more toxic side effects (grade 3-diarrhea: 39% vs. 16% in men, p = 0.04; grade 2 to 3-nausea/emesis: 21% vs. 8% in men, p = 0.018; grade 2 to 3-leukopenia 53% vs. 31% in men, p = 0.02). After preoperative chemoradiation a significant reduction of grade 3-diarrhea (11% vs 29%, p = 0.03) and grade 3-erythema (16% vs. 41%, p = 0.04) was noted. CONCLUSION: Treatment volume, type of surgery, sex and sequence of treatment modalities are the most important factors that influence the severity of toxic side effects. Individual adjustment of 5-FU dosage by monitoring its systemic clearance (which is lower in women) could help to avoid toxic side effects. The reduced acute toxicity of the preoperative approach provides a further argument in favor of the neoadjuvant chemoradiation for rectal cancer.

Acute Disease↗
PubMed1997

[Epicondylopathia humeri. The indication for, technic and clinical results of radiotherapy].

BACKGROUND: The efficacy of radiotherapy for degenerative-inflammatory disorders is well known, but so far long-term observations and reliable assessment of symptoms according to objective criteria and scores for validation are still missing. PATIENTS AND METHOD: From 1986 to 1991, 104 patients with refractory epicondylopathia humeri were irradiated. 85 patients or 93 elbows (due to double-sided symptoms) were documented in long-term follow-up according to objective criteria. All patients had received intensive therapy. Pain symptoms were quantified in "categories" and "grades" prior to and 6 weeks after radiotherapy and at last follow-up. In addition, the elbow score of Morrey et al. [36] was used for long-term evaluation. The onset of pain symptoms was acute in 41 and chronic in 52 cases. The mean symptom duration prior to radiotherapy was 16 months. Pain was mostly triggered off during professional (46) or sportive activities (23) or spontaneously (11). Fifty-one patients were severely disabled in professional or sportive activities. The involved elbow(s) received 2 radiotherapy series of 6 x 1 Gy (total 12 Gy) with 3 fractions per week; the second radiotherapy series was started 6 weeks after the first series. Mean follow-up was 4 +/- 2 (1 to 8) years. RESULTS: Forty-three patients (50 elbows) achieved "complete pain relief (CR)" in all pain categories: 59% elbows with pain at strain had "complete pain relief", 79% with pain at night, 84% with permanent pain, 80% with pain at rest and 81% with pain at initiation or morning stiffness. Nineteen elbows gained "major pain relief (PR)", i.e. had minor symptoms (maximum grade 1) in all categories. Thus, a total of 69 (74%) elbows responded to radiotherapy. Seventeen patients (19 elbows) were operated because of persistent symptoms or dissatisfaction in long-term follow-up; 7 of those became completely free of symptoms. The Morrey-Score improved by a mean of 18 points from 78 prior to radiotherapy to 96 points at last follow-up. According to the Morrey-Score only 2 patients became worse in long-term follow-up. Two parameters indicated a negative prognosis in multivariate analysis: long symptom duration prior to radiotherapy and immobilisation with plaster (p < 0.05). CONCLUSIONS: Radiotherapy for refractory epicondylopathia humeri is highly effective. Long symptom duration and long-term immobilisation by plaster are negative prognostic factors for treatment outcome. Due to the low side effects and treatment costs, radiotherapy is a good therapeutic option in comparison to conventional treatment methods and surgery in the chronic stage of epicondylopathia humeri.

Acute Disease↗