[Preoperative, neuropathic component in patients with back pain]. / Präoperative, neuropathische Komponente bei Rückenschmerzen.

BACKGROUND: The objectification of pain is essential for evaluation, treatment plan and follow-up; therefore, it is necessary to find reliable clinical parameters. OBJECTIVE: The goal of the study was the preoperative screening of a neuropathic component in patients with vertebral compression fracture (WKF), herniated disc (NPP) or spinal cord compression (SKS). MATERIAL AND METHODS: Depending on the preoperative condition on admittance, patients were classified into three groups: group 1 WKF, group 2 NPP and group 3 SKS. To characterize the pain we used the painDETECT questionnaire, the Oswestry questionnaire and further questionnaires. All patients were surgically treated according to the diagnosis, e.g. radiofrequency kyphoplasty, nucleotomy or spondylodesis. RESULTS: We evaluated the data from 139 patients (45% WKF, 34% NPP and 21% SKS). There were no differences in preoperative pain intensity (median ordinal scale 0-10) with a mean preoperative score of 7 for all groups. The total score of the painDETECT questionnaire showed significantly higher results in group 2 (median 18) and in group 3 (median 14) than in group 1 (median 9). There was even a significant difference between groups 2 and 3 (p = 0.03). The highest pain intensity was detected in group 1 with a median visual analog scale (VAS) of 71 mm. The total scores in the painDETECT questionnaire and the scores in the Oswestry questionnaire correlated in groups 2 and 3. CONCLUSION: The painDETECT questionnaire was shown to be a very suitable instrument for evaluating the neuropathic pain component in patients with dorsalgia. This could be very useful in planning further therapy.

Diagnosis of Neuropathic Components in Patients with Back Pain Before and After Surgery.

Background: The perception of back pain subjective is hard for physicians to measure. For this reason, questionnaires are an important instrument to evaluate the pain 1. The main point of this study was to verify differentiation of pain symptoms in patients with different pain mechanisms. The most important parameter was the PainDetect questionnaire, which can differentiate between nociceptive and neuropathic pain. Additional parameters were measured before and after surgery to characterise pain symptoms in detail. Material and Methods: We selected patients with diagnosed vertebral compression fracture, herniated disc or with spinal cord compression. To characterise the preoperative condition on admittance, we collected the data from the physical examination, as well as clinical data, including X-ray, CT and MRI. To characterise the pain, we used the painDetect questionnaire, the Oswestry Index questionnaire (ODI) and the visual analogue scale (VAS). Depending on the diagnosis, patients were treated by surgery (radiofrequency kyphoplasty, nucleotomy, spondylodesis). At 2 to 3 days and 6 months after surgery, we repeated the questionnaire and compared the results with those before the operation. Data on patient satisfaction and adverse events were also collected. Results: This study included 62 patients with vertebral compression fracture (group 1: VBF, 89 % female, mean age 71 years) and 77 patients with herniated disc or spinal cord compression (group 2: non-VBF, 55 % female, mean age 53 years). There was no difference between both groups in preoperative pain intensity (acute, maximum, average): median ordinal scale 0 to 10; group 1: 6, 8, 7; group 2: 6, 9, 7. The total score in the painDetect questionnaire differed significantly between the two groups (median group 1 = 9, group 2 = 17; effect size r = 0.5; p = 0.000). The existence of neuropathic pain was presumed (> 90 %) in 3 % of the patients in group 1 and in 13 % of patients it was not excluded. In contrast, in group 2 it was presumed (> 90 %) in 43 % of patients and in 30 % of patients it could not be excluded. Patients with vertebral compression fracture had greater pain intensity (VAS 71) than patients from group 2 (VAS 53). There was no difference in the total score of the Oswestry questionnaire between the two groups (56 % vs. 58 %). Pain intensity was significantly reduced in both groups after the operations. Six months postoperatively, pain intensity (median ordinal scale 0 to 10; acute, maximum, average) was 2, 5, 3 in group 1 and 2, 4, 2 in group 2. Moreover, the final scores of the painDetect questionnaires were significantly lower in both groups after the operations (4 in both groups). The median score of the ODI was reduced in both groups, with an effect size of 0.6. 98 % of the patients in group 1 and 94 % in group 2 were satisfied with the outcome of the operation. Conclusion: The preoperative pain characteristics of patients with vertebral compression fracture is different from those of patients with herniated disc or with spinal cord compression. 43 % of patients in group 2 exhibited a neuropathic pain component and in 30 % this could not be excluded. In contrast, in group 1 only 3 % of the patients exhibited a neuropathic pain component. Postoperatively, pain symptoms were significant reduced in both groups, so that the risk of chronic pain was considerably less.

[Clinical Trial to Test the iFuse Implant System® in Patients with Sacroiliac Joint Syndrome: One Year Results]. / Klinische Studie zur Prüfung des iFuse Implant Systems® bei Patienten mit Iliosakralgelenksyndrom: 1-Jahres-Ergebnisse.

Background: This study reports one year post-operative monitoring of the efficacy and safety of iFuse Implant System® in patients with sacroiliac joint syndrome. Material and Methods: After 6 months of inadequate conservative treatment, patients with properly proven ISG syndrome were selected for surgery. The iFuse implants had a triangular profile and coating of porous titanium plasma spray and were used in the minimally invasive procedures. The procedure was performed under general anaesthesia and fluoroscopic control. In each case, three implants were placed. Results: 24 patients (22 f; 92 %; 54.9 ± 14 years) participated in the study. The operations were performed in 11 patients (46 %) on the left and in 13 patients (54 %) on the right. The mean operative time was 42.4 minutes (95 % CI: 35.6-49.3). The reduction in pain intensity on the VAS scale was 58 ± 11 mm (68 ± 7 %). The Oswestry score showed a median decrease of 44 percentage points (57 %). After 12 months, 15 patients (63 %) reported that they were taking no more painkillers. Conclusion: The minimally invasive treatment of patients with sacroiliac joint syndrome using the iFuse Implant System leads to significant analgesic effects over the period of one year; it also contributes significantly to improving the functioning of the patient.

Clinical comparison of postoperative results of balloon kyphoplasty (BKP) versus radiofrequency-targeted vertebral augmentation (RF-TVA): a prospective clinical study.

INTRODUCTION: Osteoporotic vertebral fractures are a frequent occurrence in geriatric traumatology. Differences in the achievement of pain reduction and restoration of the height of the vertebral body after balloon kyphoplasty (BKP) or radiofrequency-targeted vertebral augmentation (RF-TVA) were to be tested on a randomized population. METHODS: A total of 80 patients (f = 59; m = 21) with osteoporotic fractures of vertebral bodies were assigned to the groups BKP (n = 44) or RF-TVA (n = 36). The clinical analyses were compared peri- and postoperatively in a prospective study with an additional follow-up examination after 1 year. RESULTS: The operations for BKP were bipedicular in all cases; for RF-TVA, a bipedicular access was required in only five cases (14 %) (p>0.0001). There were confirmed differences with respect to the amount of cement used (ml) between the two groups (BKP = 4.9 ± 1 vs. RFTVA= 3.4 ± 1; p<0.001). In the BKP group, the angle of kyphosis was reduced by an average of 1.65° and in the RF-TVA group by an average of 2.8° by the operation. The analysis of the maximum VAS data showed a clear postoperative reduction in the intensity of pain of approximately 4.5 cm in each of the groups with no discernible difference. After 12 months, the majority of patients in both groups (BKP = 61 % vs. RF-TVA = 83 %) reported being free of pain when at rest without a significant difference(p = 0.05). CONCLUSIONS: A certain superiority of RF-TVA with respect to pain relief, amount of cement required, savings of operating time and personnel, and greater safety with respect to cement leakage noted in this study are consistent with other published literature. The differences between the two methods in the frequency of subsequent postoperative fractures and the secondary loss of high restoration were encouraging regarding RF-TVA.

Benefits of a fixed-dose combination of bisoprolol and amlodipine in the treatment of hypertension in daily practice: results of more than 4000 patients.

OBJECTIVE: The study objective was assessing patient adherence to a fixed-dose combination (FDC) of bisoprolol and amlodipine in daily practice in patients who had been switched from the free to the fixed-dose combination prior to recruitment. MATERIAL AND METHODS: The non-investigational study was carried out in Poland. Patients over 18 years of age with essential hypertension were recruited if they had already been switched from a free combination to the FDC at least 4 weeks prior to recruitment. Exclusion criteria included pregnancy, lactation, any contraindication to the FDC, and other antihypertensive treatment. Adherence was measured by tablet count (tablets taken divided by tablets prescribed, times 100) and defined as follows: excellent >90%, good 76-90%, moderate 51-75%, bad ≤50%. Other patient data, clinical findings and laboratory values were recorded upon availability at study start, after 3 months (voluntary) and after 6 months. RESULTS: Data of 4288 patients (mean age: 59 years; gender: 50% each) were documented. The average daily doses of the FDC were 5.8 mg bisoprolol and 6.4 mg amlodipine. These doses differ only slightly from those of the free combination. After 3 months' treatment with the FDC, a dose increase was carried out in 113 patients for bisoprolol and in 126 for amlodipine. After 6 months of FDC treatment, 82% of the participants of the study showed excellent adherence and for a further 15% the adherence could be considered good. This strong adherence may have led to the observed reduction in systolic and diastolic blood pressure of 11% (Cohen's D efficient size 1.23). In addition, pulse pressure decreased from 58.8 mm to 52.2 mm. Also in diabetic patients (21% of the cohort), further reduction of systolic blood pressure values could be achieved (mean before 150 mm, after 133), wherein the initial differences compared to patients without diabetes had disappeared. The pulse rate also changed from 75 b/min to 68 b/min under the FDC. CONCLUSION: These study results clearly show that the FDC leads to excellent patient adherence and therefore may result in better blood pressure control. Blood pressure control is crucial in the risk reduction of cardiovascular events. The key limitation of this study is that the study design does not allow a direct comparison of patient adherence under the free and the fixed-dose combination.

Treatment options for vertebral fractures an overview of different philosophies and techniques for vertebral augmentation.

PURPOSE: For more than 30 years, minimally invasive surgical procedures have been available to stabilize the fractured vertebrae by cement augmentation leading to significant pain relief, a distinct improvement in quality of life and decreased mortality for patients suffering from osteoporotic vertebral compression fractures. This overview article is designed to provide information on the wide range of augmentation methods previously tested and clinically applied in surgery in an attempt to compile the clinically relevant information on safety and efficacy in the published literature. METHOD: Based on an extensive literature review on the topic of "vertebral fractures--surgical augmentation techniques" we summarized the results of published clinical trials and experimental testing which address clinically relevant questions. The selection of the publications in reference books and scientific journals covers the time period from the end of the 1970s until the present. RESULTS: The final selection of more than 50 publications with, in the opinion of the authors, clinically relevant data led to the following results, which can be of significance for clinical application. The prerequisites for the success of all augmentation methods include the earliest possible surgical intervention, optimal technical equipment and an experienced, interdisciplinary team, as well as thorough consideration of the situation of the individual patient. The selection of the material for vertebral augmentation depends on the surgical method. The material of choice remains polymethylmethacrylate (PMMA), and the best record of efficacy and safety is displayed by radiofrequency kyphoplasty with ultrahigh-viscosity cement. Regarding clinical efficacy and safety, there are many convincing documentations showing superiority of vertebroplasty and kyphoplasty in comparison with conservative therapeutic regimens. Initial results of clinical studies with additional implants indicate a trend toward further improvement in clinical success and suggest possible broader clinical possibilities of application. CONCLUSION: Modern, minimally invasive augmentation techniques represent a real alternative to conservative treatment of patients with vertebral fractures. Further technical and clinical development in this area should aim at optimizing procedural safety while continuing to achieve comparably good results to current methods. Minimizing damage to the remaining trabecular structures as well as to adjacent vertebral disks and vertebrae should be paramount of importance. SUMMARY: Options for the treatment of vertebral fractures: Reductions in bone density and pathological changes in bone structure are associated with an elevated risk of fractures, which can lead to decisive functional impairment, pain, and a host of further comorbidities. Vertebral augmentation can be considered as an alternative conservative treatment, in order to achieve immediate and lasting pain relief as well as improvement in functional impairment. To achieve greater safety, instrumentation for transpedicular access and incorporation of radiopacifiers in PMMA for vertebroplasty were developed in mid-eighties. Balloon kyphoplasty was introduced in the end nineties, and results of prospective, randomized clinical studies have confirmed the safety and efficacy; the destruction of the remaining native spongiosa structures during balloon expansion is viewed as a disadvantage of this method. The two step method of cavity creation followed by cement delivery known as kyphoplasty has been further refined and developed by and varied by technology/procedural developments. This includes most the radiofrequency kyphoplasty (DFINE Inc., San Jose, CA, USA), in which ultrahigh-viscosity cement is delivered at a controlled delivery rate, following producing a bone sparing size and side specific cavity which minimizes loss of spongiosa, allowing for mechanical stability upon interdigitation of cement into that remaining trabecular bone. This combination has been shown to preserve vertebral structures and reduces the risk of leakages. Finally, systems have been available in which cement augmentation of implants to enhance mechanical stability of the implants or the overall fracture is constructed by load sharing.

Report on a study of fires with smoke gas development : determination of blood cyanide levels, clinical signs and laboratory values in victims.

BACKGROUND: This is a report on an international non-interventional study of patients exposed to fires with smoke development in closed rooms. The objective of the study was to document clinical symptoms, relevant laboratory values and blood cyanide concentrations from fire victims in order to confirm or rule out presumptive correlations between the individual parameters. MATERIALS AND METHODS: The study was conducted in five European countries with patients being included if they presented with the characteristic clinical signs, such as soot deposits and altered neurological status. Venous blood samples were taken from victims prior to administration of an antidote in all cases and determination of cyanide concentration was performed in a central laboratory using high performance liquid chromatography. RESULTS: Data from 102 patients (62 % male, average age 49 years) were included in the evaluation with no blood samples being available for analysis from 2 patients. In 25 patients the blood cyanide concentration was below the limit of detection of 1.2 µmol/l. Cyanide levels between 1.2 and 10 µmol/l were measured in 54 patients, 7 patients had values between 10 and 20 µmol/l, 4 patients between 20 and 40 µmol/l while levels above 40 µmol/l were determined in 10 patients. The results of the study could not demonstrate that the cyanide level was influenced either by the interval between smoke exposure and blood sampling or the duration presence at the fire scene. The following clinical signs or laboratory values were recorded as relevant for increased and possibly toxic cyanide levels: respiratory arrest, dyspnea, resuscitation requirement, tracheal intubation, respiratory support measures, low Glasgow coma scale (GCS) score and respiratory frequency. A correlation between cyanide concentration and the total amount of soot deposits on the face and neck, in the oral cavity and in expectoration was confirmed. A correlation between cyanide and carboxyhemoglobin (COHb) levels in the blood of fire victims was also confirmed. CONCLUSIONS: As long as it is not possible to immediately determine the blood cyanide concentration in patients exposed to fire with smoke development, a decreased GCS score, soot deposits particularly in expectoration, dyspnea and convulsions are to be regarded as risk markers for intoxication. In their presence immediate administration of hydroxocobalamin as an antidote is recommended.

[Radiofrequency kyphoplasty - an innovative method for the treatment of vertebral compression fractures - comparison with conservative treatment]. / Radiofrequenz-Kyphoplastie - ein innovatives Verfahren zur Behandlung von vertebralen Kompressionsfrakturen - Vergleiche mit konservativer Behandlung.

OBJECTIVE: An evaluation of treatment protocols was used to expand the documentation of efficacy and safety of radiofrequency kyphoplasty (RFK). Additionally, a comparison of this new and innovative procedure with conservative treatment was carried out. PATIENTS, MATERIALS AND METHODS: Patients with painful osteoporotic vertebral fractures according to the common findings in an orthopaedic university hospital were included in the comparison study in which the indication for surgical intervention action according to the DVO guidelines was interdisciplinary confirmed. For the comparison group, patients with the same clinical and radiological findings were recruited who rejected a surgical intervention. For surgery, the StabiliT® Vertebral Augmentation System for a radiofrequency kyphoplasty by the company DFine was used. The cement was injected with a "multiplex controller". Thus, the results of the new method were compared to those of a group that was treated conservatively. RESULTS: The radiofrequency kyphoplasty (n = 114) resulted in an average decrease of VAS scores by almost 60 mm, which increased during the follow-up. Similarly, the Oswestry scores showed a marked improvement by 46 % points after 6 weeks. The mean increase in vertebral body height was 2.8 mm after radiofrequency kyphoplasty. In the conservatively treated group only very small changes compared to the initial findings were registered during the 6-week observation period. Accordingly, 33 of 67 patients decided after 6 weeks for surgery, which led to corresponding improvements (VAS, Oswestry, vertebral body height). Noteworthy is the low rate of cement leakage in the radiofrequency kyphoplasty group of 6 % (n = 7). CONCLUSIONS: Radiofrequency kyphoplasty offers a secure superiority over conservative treatment regarding clinical efficacy. In addition, the fractured vertebrae can be better targeted and erected, a longer processing time of the cement is ensured, a high interdigitation of the cement with the bone is guaranteed, the rate of cement leakage is low, the risk of radiation for the surgeon is minimised, and the operation time is shortened.

[PMMA augmentation of pedicle screws: results of a survey in Germany]. / PMMA-Augmentation von Pedikelschrauben: Ergebnisse einer Umfrage in Deutschland.

BACKGROUND: The anchorage of pedicle screws can be challenging in the osteoporotic spine. A promising technique are cement augumented pedicle screws. The goal of this study was to gain more information regarding application of pedicle screw augmentation in Germany. MATERIALS AND METHODS: Participants of the National German Spine Congress 2009 were invited to participate in an internet-based anonymous survey regarding application of pedicle screw augmentation. The questionnaire was related to different aspects of materials and procedures for pedicle screw augmentation. The frequency of answers was divided according to the specialty state of the surgeons: orthopaedic and trauma surgeons vs. neurosurgeons. The Mantel-Haenszel test was applied to evaluate the differences between the groups. RESULTS AND CONCLUSION: 69 (64 %) orthopaedic and trauma surgeons and 39 (36 %) neurosurgeons participated (n = 108). Nearly 80 % of the participants use cement-augmented pedicle screws in their daily practice. Almost 2/3 of the specialists apply cannulated screws or other special screws. The Expedium (Company) screws are particularly preferred. The insertion of screws is combined with kyphoplasty or vertebroplasty in 20 % of the cases. The balloon kyphoplasty was applied most commonly. There was no statistical difference between the surgeon groups regarding the different techniques. The main indications for pedicle screw augmentation were osteoporosis, intraoperative findings as well as loosening of screws, and revision. The most frequently observed complication is cement extravasation into the spinal canal (28 %). The cost issue is considered as being important but unknown to most of the participants. It can be assumed that the use of pedicle screws in Germany is well established in spine surgery, without as yet a standard technique being established.

[Kiva® VCF Treatment System - clinical study on the efficacy and patient safety of a new system for augmentation of vertebral compression fractures]. / Kiva® VCF Treatment System - klinische Studie zur Wirksamkeit und Patientensicherheit mit einem neuen System zur Augmentation von vertebralen Kompressionsfrakturen.

BACKGROUND: As a further alternative to previously used vertebral augmentation methods, the Kiva VCF Treatment System® was clinically investigated. MATERIAL AND METHODS: The pilot study included 24 patients (mean age 74 years, 34 vertebrae). RESULTS: During an operation period of 16.6 minutes on average 2.2 ± 1 mL of PMMA cement were injected. 87 % of patients were satisfied or very satisfied with this treatment. In 2 cases leakage of cement has been registered. The pain intensity was already reduced after 7 days to 69.5 mm (VAS scale 0-100). After 30 days, the difference from baseline was 76 mm. Significant improvements have also been shown in the Oswestry Score (functional ability), physical performance and mental well-being. CONCLUSION: On the basis of these results, the new augmentation can be described as being effective in the treatment of painful vertebral fractures.

[Comparative findings of balloon kyphoplasty in patients with vertebral fractures due to osteoporosis, metastases and myeloma]. / Vergleichende Befunderhebungen der Ballonkyphoplastie bei Patienten mit Wirbelkörperfrakturen infolge von Osteoporose, Metastasen und Myelomen.

OBJECTIVE: By evaluations of treatment protocols, the documentation of balloon kyphoplasty regarding efficacy, duration of action and safety should be expanded. In addition, the evaluations should help to clarify the differences in balloon kyphoplasty for patients with vertebral fractures concerning efficacy and safety in relation to the underlying diseases: osteoporosis, bone metastases or myeloma. MATERIAL AND METHODS: In order to reposition the endplates of the vertebrae a balloon was inserted after placement of the working channels. After removal of the balloon, the resulting caverns were filled with PMMA. The radiological and clinical follow-up examinations were carried out over a period of up to 3 years. The clinical and radiological findings before and after treatment at specified visits were transferred to a statistical programme and evaluated. RESULTS: The comparisons of the postoperative results according to the initial diagnosis (metastases: n = 222, osteoporosis: n = 122, myeloma: n = 122) demonstrated significant differences with respect to the cement leakage (14 %, 5 %, 7.5 %), but in all cases without any clinical relevance. The small differences related to the reduction in pain intensity (VAS > 50 mm in each group) after surgery were up to 12 months with no clinical significance. Also in the Oswestry score no differences between the 3 groups were registered. In the case of osteoporosis patients, due to the lower starting position a more significant increase of vertebral body height could be achieved by the kyphoplasty than in the comparison groups of patients with metastases or myeloma (∅ 3.1 mm vs. 0.4-0.5 mm; P < 0.001). Consequently, the kyphosis angle decreased in the osteoporotic group also more strongly than in the comparison groups. CONCLUSIONS: It is evident that the pain relief in the vast majority of cases started immediately after surgery. Additionally, a significant improvement in functioning (Oswestry score) was registered. Both clinical parameters - as far as they could be checked - showed a steady degree of improvement over a period of at least 3 years. This comparative analysis led to the conclusion that balloon kyphoplasty can be successfully applied indiscriminately in patients with vertebral fractures as a result of osteoporosis and also to fractures associated with bone metastases or with myeloma.

[Comparison of clinical and radiological data in the treatment of patients with osteoporotic vertebral compression fractures using radiofrequency kyphoplasty or balloon kyphoplasty]. / Vergleich klinischer und radiologischer Daten bei der Behandlung von Patienten mit osteoporotischen Wirbelkörper-Kompressionsfrakturen mit Radiofrequenz-Kyphoplastie oder mit Ballon-Kyphoplastie.

PURPOSE: Since the 1990s, balloon kyphoplasty has been proven as an effective method of treating patients with painful vertebral compression fractures (VCF). The radiofrequency kyphoplasty is an innovative procedure available since 2009, for which an ultra-high viscosity cement is used. For the statistical comparison of the two methods of augmentation, the clinical and radiological data of 2 larger patient groups were evaluated. MATERIALS AND METHODS: As part of the surgical treatment of patients with conservative therapy-resistant osteoporotic vertebral fractures, a prospective study of radiofrequency kyphoplasty (RFK) was performed between 2009 and September 2010. The treatment was minimally invasive using the StabiliT® Vertebral Augmentation System by DFine for which the StabiliT® multiplex controller, the articulating VertecoR® Midline Osteotome, and the radiofrequency-sensitive StabiliT® ER2 bone cement were applied. From the clinical aspect, measurement parameters for efficacy and safety were the course of pain intensity using a visual analogue scale (VAS: 0 to 100 mm) and the Oswestry disability score (0-100%). For the radiological outcome the increase in the middle and anterior parts of the treated vertebra and also the reduction of kyphosis after surgery and after 6 months were evaluated. Furthermore, the extent of cement extrusion and the duration of operation time were compared. There were 2 groups of patients chosen with the same indication, and with the same average VAS prior to treatment. For the balloon kyphoplasty (BKP) the Kyphon® technology was used. For the BKP group the same parameters as in the first group were evaluated (matched pairs). To compare the data statistically, parametric and non-parametric tests were applied. RESULTS: For the radiofrequency kyphoplasty group (RFK) 114 patients were recruited, and for the balloon kyphoplasty group (BKP) 114 appropriate patients were selected. In 48% of the RFK patients and in 44% of the BKP patients more than one vertebral body were treated (thoracic or lumbar). Prior to treatment 84 mm on the VAS were calculated in both groups. The decrease in VAS values (RFK vs. BKP) immediately after surgery was 58.8 vs. 54.7 mm (p = 0.02), and 73.0 vs. 58.9 mm after 6 months (p < 0.001). In both groups improvements in the Oswestry scores were registered after 6 months without a statistically significant difference. In both groups, the middle part of the vertebral bodies was increased by an average of 3.1 mm. RFK yielded a decrease in the average kyphosis angle of 4.4, the BKP resulted in about 3.8 degrees. Concerning cement leakage a key difference in favor of the radio frequency kyphoplasty was detected (6.1 % vs. 27.8%; p < 0.0001). For RFK a significant shorter duration of operation time was calculated (28.2 vs. 49.6 min; p < 0.001). CONCLUSIONS: The RFK has proven to be a clinically very effective procedure that does somewhat better than BKP in long-lasting pain relief. No differences could be detected regarding improvement of functioning and the mean restoration of mid- and anterior vertebral height. As far as the safety aspect is concerned the RFK offers the advantage of a statistically significant lower proportion of cement extrusion.

[Protective effects of ranitidine in ibuprofen gastroduodenopathy. An endoscopic controlled double blind study]. / Schutzwirkung von Ranitidin bei Ibuprofen-Gastroduodenopathie. Eine endoskopisch kontrollierte Doppelblindstudie an Probanden.

Protective Effect of Ranitidine in Ibuprofen Gastroduodenopathy/An endoscopically controlled double-blind study in healthy volunteers. In a randomized parallel double-blind study the gastroduodenal effects of 600 mg ibuprofen racemate (CAS 15687-27-1) tid in the presence of 150 mg ranitidine (CAS 66357-35-5, Sostril) bid or placebo was evaluated in 32 healthy volunteers undergoing upper gastrointestinal endoscopy. Drugs were taken during a period of 7 days. Endoscopic controls were performed at entry and repeated after 7 days of treatment. A damaging score was used to asses the lesions. At entry both groups showed comparable mucosal damages. The median values under ibuprofen/placebo were 1 (range 0-1) and under ibuprofen/ranitidine 1 (range 0-2). After 7 days of treatment the median lesions score increased under ibuprofen/placebo to 8 (range 1-20) whereas corresponding values in the ibuprofen/ranitidine group were constant at 1 (range 1-9). The differences between both groups were statistically significant (p < 0.05). Our data underline the protective effect of ranitidine 150 mg bid against ibuprofen both on the stomach as well as on the duodenum.

[Circadian dependency of ibuprofen gastropathy and the protective effect of ranitidine. An endoscopic, controlled double-blind pilot study]. / Tageszeitliche Abhängigkeit der Ibuprofen-Gastropathie und der Schutzwirkung von Ranitidin. Eine endoskopische, kontrollierte Doppelblind-Pilotstudie.

Circadian Dependency of Ibuprofen Gastropathy and Protective Effect of Ranitidine/An endoscopic, controlled double-blind pilot study. In a randomized parallel double-blind study, the gastric and duodenal effects of 600 mg S(+)-ibuprofen (CAS 15687-27-1) daily in the presence and absence of 300 mg ranitidine (CAS 66357-35-5) was evaluated in 20 healthy volunteers undergoing upper GI-endoscopy. Drugs were taken over a period of 7 days either at 8 a.m. (n = 10) or at 8 p.m. (n = 10). Endoscopic controls were performed at entry and repeated after 7 days of treatment. A damage score according to Lanza et al. was used. At entry both groups showed comparable mucosal damages. 8 a.m.-group: ibuprofen/placebo (stomach) 0.9 +/- 0.1 and 0.0 +/- 0.0 (duodenum); ibuprofen/ranitidine 0.8 +/- 0.1 (stomach) and 0.1 +/- 0.1 (duodenum). 8 p.m.-group: ibuprofen/placebo 0.9 +/- 0.1 (stomach) and 0.2 +/- 0.1 (duodenum); ibuprofen/ranitidine 0.9 +/- 0.1 (stomach) and 0.1 +/- 0.1 (duodenum). After 7 days of treatment the lesion score increased in the ibuprofen/placebo-group in the 8 a.m.-group to 3.2 +/- 1.2 (stomach) and to 0.7 +/- 0.5 (duodenum), and in the 8 p.m.-group to 8.4 +/- 1.9 (stomach) and to 2.9 +/- 1.2 (duodenum). The corresponding values in the ibuprofen/ranitidine-group were 1.8 +/- 0.8 (stomach) and 0.1 +/- 0.1 (duodenum) (8 a.m.-group) as well as 5.1 +/- 1.4 (stomach) and 0.1 +/- 0.1 (duodenum) (8 p.m.-group). The difference between the morning and the evening dose of ibuprofen as well as ranitidine protection reached statistical significance when the corresponding data were pooled (p < 0.05). Our data suggest that the gastrolesive effects of S(+)-ibuprofen are dependent of the time of drug ingestion; protection by ranitidine, however, was time-independent.

Cefuroxime axetil versus ofloxacin for short-term therapy of acute uncomplicated lower urinary tract infections in women.

In a multicentre study 163 women with acute lower urinary tract infection were treated orally with either 125 mg cefuroxime axetil or 100 mg ofloxacin twice daily for three days. Both antimicrobial agents were generally well tolerated. Four patients in the group treated with cefuroxime axetil and two in the group treated with ofloxacin experienced adverse events. Clinical cure and improvement were registered in 56 of 66 (84.8%) and 59 of 62 (95.2%) of the evaluable patients treated with cefuroxime axetil and ofloxacin, respectively. Seven to nine days after therapy, bacteriuria (CFU < 10(3)/ml) had been eliminated in 53 of 66 (80.3%) and 57 of 64 (89.1%) of the evaluable patients receiving cefuroxime axetil and ofloxacin, respectively. The results were not statistically significantly different (p > 0.1). Pathogens present at baseline were eliminated by up to an MIC of 16 mg/l of cefuroxime axetil, independent of susceptibility to this agent. There was no difference with regard to efficacy and tolerance between patients treated with cefuroxime axetil and those treated with ofloxacin. On the basis of the MICs of six antimicrobial agents (cefuroxime, ofloxacin, cefadroxil, ampicillin, trimethoprim with and without sulfamethoxazole) determined for the pathogens isolated prior to therapy, resistance rates were lowest for cefuroxime (2.2%) and ofloxacin (3.4%).

[Early evening administration of ranitidine in therapy of duodenal ulcer]. / Die frühabendliche Einnahme von Ranitidin in der Therapie des Ulcus duodeni.

In this randomized clinical study the effect of 300 mg ranitidine given either after an early evening meal (abt. 6 p.m.) (n = 136) or at bedtime (abt. 10 p.m.) (n = 145) was investigated in 279 patients with an acute duodenal ulcer (79 women, 200 men, age median 40 years). To provide a double blind design, patients of each therapy group were given a placebo tablet either at 10 p.m. or at 6 p.m. (double dummy technique). After 2 and 4 weeks of therapy, the healing rates for the early resp. late evening doses were 75.6% and 65.9% (p = 0.054) and 95.5% and 94.2%, respectively. The healing rates for patients with an ulcer diameter between 5 mm and 9.5 mm and with a case history of duodenal ulcer, however, were significantly higher for the early evening doses of 300 mg ranitidine (85 vs. 65%, p less than 0.01, and 75 vs. 60%, p less than 0.05). The study results indicate that an early (abt. 6 p.m.) as well as a late (abt. 10 p.m.) evening doses of 300 mg ranitidine have a comparable positive effect on the healing of an acute duodenal ulcer, with the early evening doses having advantages in special patient groups.

[Ranitidine in stomach ulcer. Controlled clinical trial of a comparison of administration after the evening meal or before bedtime]. / Ranitidin beim Ulcus ventriculi. Kontrollierte klinische Prüfung zum Vergleich der Einnahme nach dem Abendessen oder vor dem Schlafengehen.

In a randomized, double-blind comparative trial, 44 patients with gastric ulcer received one dose of ranitidine 300 mg following the evening meal (between 17.30 and 20.00 hours), and a placebo tablet just before retiring for the night (21.30 to 23.00 hours) (R-P group). In the comparative group, 43 patients received the same substances in the reverse order (P-R group). After four weeks' treatment, the endoscopic follow-up examinations revealed a 76% healing rate in the R-P group and a 63% healing rate in the P-R group. After six weeks, cumulative healing rates of 98% and 81%, respectively (p less than 0.05) were obtained, showing a better healing effect after early evening ingestion of ranitidine. The number of symptoms recorded at the start of treatment had, after four weeks of treatment, decreased considerably more following early-evening ingestion of ranitidine than after late-evening ingestion (p = 0.05). The results of this trial suggest that, in the treatment of gastric ulcers, the early-evening administration of ranitidine 300 mg is more effective than other modes of ingestion.

Results of a clinical and pharmacokinetic study of ceftazidime in patients with postoperative pneumonia on assisted ventilation.

Thirty-three patients who developed nosocomial pneumonia postoperatively were treated with ceftazidime, 4-6 g daily, over an average period of 7 days. Twenty-nine patients were evaluated; 13 (45%) patients were cured, five showed improvement, two relapsed, and one could not be assessed. X-rays of the chest showed no infiltrates in 17 out of the 29 cases (59%) after treatment. On the first day of treatment, ceftazidime concentrations in bronchial secretions of nine patients were estimated. The mean values of serum concentrations were: 15 min after infusion, 98 micrograms ml-1; 60 min, 63; 120 min, 44; 360 min, 20; 480 min, 13 micrograms ml-1. The mean values of the corresponding bronchial secretions were 2.9, 5.8, 10.2, 7.11 and 5.2 micrograms ml-1.

Comparative clinical trial of ceftazidime and imipenem/cilastatin in patients with severe nosocomial pneumonias and septicaemias.

The efficacy and safety of ceftazidime and imipenem in patients with severe infections was compared in a randomized multi-centre trial. Patients on assisted respiration with clinical signs of pneumonia or septicaemia who had been in hospital for at least 3 days were studied. Twenty-one patients were treated with ceftazidime, 24 with imipenem. The mean duration of treatment was 9 days in both groups. At the end of the trial 17 patients (81%) of the ceftazidime group and 16 patients (67%) in the imipenem group were clinically cured or showed marked improvement. The bacteriological results showed an eradication of the causative pathogens in 17 of 21 cases in the ceftazidime group and 13 of 19 in the imipenem group.

[Results of a double-blind study of diclofenac + vitamin B1, B6, B12 versus diclofenac in patients with acute pain of the lumbar vertebrae. A multicenter study]. / Ergebnisse einer Doppelblindprüfung Diclofenac + Vitamin B1, B6, B12 versus Diclofenac bei Patienten mit akuten Beschwerden im Lendenwirbelsäulenbereich. Eine Multicenterstudie.

Several clinical trials have shown that the duration of treatment of painful vertebral syndromes can be shortened by using a combination of vitamins B1, B6, B12 and diclofenac instead of diclofenac. In addition, a more efficient pain relief could be achieved by the combination therapy. In order to confirm these results, we compared the clinical efficacy of diclofenac (25 mg) and a combination preparation with diclofenac (25 mg) plus vitamins B1 (thiamine nitrate 50 mg), B6 (pyridoxine hydrochloride 50 mg) and B12 (cyanocobalamin 0.25 mg) in a multicentric randomized double-blind study including 418 patients. All patients received 3 x 2 capsules daily for a maximum of 2 weeks. In case of total pain relief, therapy should be discontinued after one week. Data of 376 patients could be evaluated. 53 out of 184 patients receiving the combination and 48 out of 192 patients treated with diclofenac alone could stop therapy due to sufficient pain relief after one week. The evaluation of the "Hoppe Pain Questionnaire" and the data concerning pain intensity also revealed better results for the combination preparation. The differences in favour of the B-vitamin-diclofenac-combination were statistically significant in patients with severe pain at the beginning of therapy. Considering undesirable side-effects (symptoms in 70 out of 418 patients) there were no significant differences between the two medications. This clinical trial provides further evidence that the combination therapy with diclofenac plus B-vitamins is more effective than diclofenac alone for the treatment of painful vertebral syndromes.