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Biomedical subjects

G Rohr

Publications and source records attributed to G Rohr.

At least 19 recordsLinked to original sources

Relationship of seminal plasma interleukin (IL) -8 and IL-6 with semen quality.

The concentration of interleukin (IL) -8 and IL-6 was determined in seminal plasma (SP) samples from 137 randomly chosen subfertile males to evaluate the relationship with other potential parameters of subclinical infection/inflammation such as seminal leukocytes, and with semen quality in a prospective study. All patients were asymptomatic for genital tract infection. A comprehensive semen evaluation included sperm analysis, sperm migration testing, antisperm antibody screening, immunocytochemical round cell differentiation to determine seminal leukocytes counts and the leukocyte ratio, complement fraction C(3) (C(3c)) determination, and semen cultures, in aliquots of the same ejaculates. The SP concentration of IL-8 was inversely related to semen quality, e.g. to the total number of motile spermatozoa or to the outcome of the sperm migration test (motile sperm harvested after a swim-up procedure). IL-8 concentrations were significantly correlated with leukocyte counts per ml (P < 0.0001) and per ejaculate (P < 0.0001), and with the leukocyte ratio (P < 0.001). All leukocytospermic samples had high IL-8 concentrations (< or =2 ng/ml). The SP concentration of IL-6 was much lower, but was significantly correlated with IL-8 (P < 0.0001). Both IL-8 and IL-6 were significantly related with the C(3c). No association of interleukin concentrations with the bacterial colonization of semen samples was found. The results indicate a marked relationship of some pro-inflammatory cytokines with semen quality. The significant association with seminal leukocytes and other potential inflammation markers suggests that IL-8 might be used as sensitive marker for silent male genital tract infection.

Adult↗

Herpes simplex virus infection of the uterine cervix--relationship with a cervical factor?

OBJECTIVE: To determine the prevalence of genital herpes simplex virus (HSV) in women of reproductive age and to evaluate a potential relation of asymptomatic HSV shedding with a cervical factor. DESIGN: Prospective study. SETTING: Outpatient infertility clinic of a university hospital. PATIENT(S): Randomly chosen asymptomatic women (n = 1,262) with a median age of 30 years. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Prevalence of cervical HSV, cervical index parameters, and other variables of CM quality, including CM penetrability in vivo and in vitro. RESULT(S): The prevalence of HSV infection of the uterine cervix was 5.2% (identified with cell culture). There was a tendency toward increased viscosity of the CM in HSV-positive women, but no significant relation with the other variables of CM quality (amount, spinnbarkeit, ferning, cervical appearance, and cellularity of the CM), or with the summarized Insler score or the cervical index according to World Health Organization guidelines. Postcoital testing and the in vitro penetration test, using either partners' or donors' semen, showed that the penetrability of the CM did not differ significantly between women with and without cervical HSV shedding. Asymptomatic cervical HSV infection was not significantly associated with bacterial colonization of the lower genital tract, with leukocyte counts in cervical secretions, with the pH of the CM or the vaginal fluid, or with antisperm antibodies in the CM. CONCLUSION(S): The results suggest that in asymptomatic women under controlled endocrine conditions, cervical HSV infection is not a significant cause of impaired quality and penetrability of the CM.

Adult↗

Objective assessment of the contribution of each diagnostic test and of the ordering sequence in jaundice caused by pancreatobiliary carcinoma.

BACKGROUND: Computer-assisted diagnostic systems are not substantially more accurate than the clinician in the differential diagnosis of jaundice but may help in optimal selection and sequencing of tests. The present study aimed to assess with an electronic diagnostic tool the pattern of ordering tests and the diagnostic contribution and related financial cost of each test in jaundiced patients with pancreatobiliary carcinoma, in an effort to make the clinician's diagnostic behaviour more efficient and economical. METHODS: Clinical and diagnostic test data were prospectively gathered from 356 jaundiced patients with pancreatobiliary carcinoma and entered in a Bayesian diagnostic programme. The test results were added to the existing diagnostic evidence, and the programme calculated the diagnostic contribution of each test. RESULTS: A total of 1804 diagnostic tests were ordered. Quantitative assessment of the diagnostic contribution of each test showed that percutaneous transhepatic cholangiography and computed tomography were associated with the highest provision of information. The most cost-effective tests were ultrasonography and liver function tests. CONCLUSIONS: It is possible to determine objectively the diagnostic contribution of each test in establishing the diagnosis of pancreatobiliary carcinoma. The observed physician behaviour in ordering the various diagnostic tests might be improved with regard to its efficacy and its cost-effectiveness profile.

Bayes Theorem↗

Antimicrobial activity of human cervical mucus.

The antibacterial activity of human cervical mucus (CM) was examined on standardized microbial colonized agar plates (agar diffusion test). In parallel, the lysozyme content of CM was determined by means of a turbidimetric test system in aliquots of the same CM specimens. Suspensions of living lyophilized Micrococcus lysedeikticus were used as bacterial substrate. Testing was performed in a total of 133 CM samples, obtained at mid-cycle from sexually active women from unselected infertile couples with a median age of 30 (range 21-42) years. All mucus specimens showed considerable antibacterial activity with clearly visible circular inhibition zones around the CM-filled holes in the colonized agar plates. Related to the effect of hen's egg white (HEW)-lysozyme on the same plates, the median activity of the CM specimens in the agar diffusion test was equivalent to 33.0 (range 6.4-391.4) microg/ml HEW-lysozyme. However, there was a wide inter-individual range of antibacterial effects of cervical secretions. The cervical index did not significantly influence the outcome of either test. The pH of the endocervical CM also was not correlated with the antibacterial effect. Sexual activity leading to the presence of spermatozoa in CM considerably increased its antibacterial effect. The activity was markedly higher in samples obtained within hours after intercourse compared with those taken after sexual abstinence of >/=5 days (P < 0.05). In microbially colonized CM specimens compared to sterile CM, all obtained under hormonally standardized conditions, the antibacterial activity in the agar plate test was significantly lower (P < 0.05). The results of this pilot study demonstrate the considerable antibacterial activity of human CM.

Adult↗

Antisperm antibodies and microorganisms in genital secretions--a clinically significant relationship?

In asymptomatic infertility patients, no significant relationship was found between the presence of antisperm antibodies (ASA) in serum and in semen samples (IgG and/or IgA ASA), differentiated with the mixed antiglobulin reaction (MAR), and the microbial colonization of ejaculates covering a broad spectrum of microorganisms. Likewise, there was no significant association of ASA with microbial findings in patients' female partners, who also presented without symptoms of genital tract infection and were screened at the same time. Furthermore, ASA in semen (IgG and IgA) were not significantly related to several potential markers of subclinical male sexual gland infection or inflammation (leukocytes, PMN elastase, albumin, C3c) evaluated in aliquots of the same ejaculates used for immunological testing.

Adult↗

[General practitioners' choice of treatment for young women with metrorrhagia as evaluated by vignettes].

A consensus conference on menstrual disorders concluded that a discrepancy exists between the large number of curettages performed annually on fertile women and the actual findings of cancer of the endometrium in this group of patients. Based on three written simulated consultations (vignettes) with 42-year-old women with metrorrhagia but without increased risk of cancer a decision analysis was performed among 695 general practitioners in Denmark and the Faroe Islands. The first choice of treatment was curettage in 43% of the responders. It was found that a large proportion of doctors decided on curettage when the patient had developed anaemia. The choice of curettage was associated with the doctors' assessment of need to exclude cancer of the endometrium, while doctors who gave high priority to non-invasive treatment and cessation of bleeding were less likely to refer for curettage. A larger proportion of male than female doctors chose curettage as primary treatment.

Adult↗

Chlamydial serology in 1303 asymptomatic subfertile couples.

The clinical significance of antichlamydial antibodies (Chlam Ab) was determined in a total of 1303 subfertile couples consulting for infertility investigation and treatment. Median age of the women was 30 (range 22-44) years and of the men 33 (range 21-53) years. The median duration of infertility was 4 (range 1-21) years. All patients were asymptomatic for genital tract infection. A comprehensive infertility investigation included examination of the endocrine, cervical, and tubal factor, and semen analysis, antisperm antibody (ASA) testing, sperm-mucus interaction testing in vitro using a standardized protocol, and post-coital testing (PCT). Screening for Chlam IgG Ab was performed in serum of both partners, obtained at the same time. Simultaneous microbial cultures in genital secretions of both partners included a broad spectrum of potentially pathogenic bacteria. Elevated titres of Chlam IgG Ab as seromarker for previous infection were found in 20.8% of all women, and in 12.6% of men. Chlam Ab were significantly more frequent in partners of seropositive patients (in 51.8% of women with a Chlam Ab positive partner, compared to 15.8% of the other women). Microbial screening outcome was not significantly related to results of chlamydial serology in both partners. In women, elevated titres of Chlam Ab were significantly associated with a tubal factor, but were not related to reduced quality of the endocervical mucus (CM), including the in-vitro penetrability of the CM (using partners' or donors' spermatozoa). In males, Chlam Ab were not significantly related to the outcome of semen analysis, including screening for ASA (IgG and/or IgA) in semen, and several parameters of sperm functional capacity. After exclusion of couples with tubal disease, subsequent male fertility did not significantly differ in males with or without Chlam Ab. The results suggest that during basic infertility investigation, positive chlamydial serology as an easy screening procedure indicates a higher risk for a tubal infertility factor. However, in asymptomatic patients, Chlam IgG Ab in serum are not associated with a cervical factor or with the male factor, using several determinants for evaluation of semen quality including subsequent fertilizing capacity.

Adult↗

Sperm morphology assessment using strict criteria and male fertility under in-vivo conditions of conception.

The clinical significance of sperm morphology assessment according to very strict criteria was determined using semen samples of randomly chosen males from couples not submitted to assist procreation techniques, with a median duration of infertility of 4 years (range 1-17; n = 89). The relationships of sperm morphological properties to the results of standard sperm analysis, including the differentiation of round cells in semen by monoclonal antibodies and semen cultures, the testing of sperm functional capacity in vitro with the standardized sperm-cervical mucus penetration test (SCMPT) and the subsequent pregnancy rate under in-vivo conditions of conception, were evaluated in a prospective study. The quick staining method (DiffQuick(R) stain) for sperm morphology proved to be practical and suitable for routine use. The percentage of normal forms according to strict criteria ranged from 1 to 36%, with a median of 12%. Morphological findings were not markedly related to the medical history, but significant relationships between standard parameters of sperm analysis, in particular the sperm count, the progressive motility and standard sperm morphology, were found. The percentage of normal forms was not significantly associated with the microbial colonization of semen samples but was negatively related to high leukocyte rates. Semen samples with a higher percentage of normal spermatozoa (shown, for example, for >4,> 7 or >=14% normal) were significantly more frequent in cases of an adequate SCMPT. The subsequent pregnancy rate within an observation period of 12 months was 20.2%. The pregnancy rate under in-vivo conditions was significantly higher when semen samples had a better sperm morphology, with significant differences for thresholds at 4, 7 and 14% of strictly normal forms. Although sperm morphology is only one among a multiplicity of factors determining fertility, the results suggest that the evaluation of sperm morphology using strict criteria provides valuable information during basic infertility investigations.

Adult↗

The Acridine Orange test: a clinically relevant screening method for sperm quality during infertility investigation?

To determine the clinical usefulness of Acridine Orange (AO) staining of spermatozoa as a screening test for the evaluation of semen quality during basic infertility investigation, semen smears from 103 randomly chosen males of subfertile couples were examined. The median duration of infertility was 4.5 years (range 1-15) and the median age was 33 years (range 21-43). The outcome of AO staining ranged from 5 to 81%, with a median of 24%, green fluorescent spermatozoa. Results were not significantly related to the parameters of semen analysis (sperm count, motility, standard morphology, viability, pH and volume, as well as fructose concentration and number of found cells) or to local sperm antibody testing and semen cultures. Fluorescence after AO staining was also not related to sperm functional capacity (evaluated using sperm-mucus interaction tests in vitro and in vivo), or the medical history of the patient. No significant differences in the AO test outcome were seen in patients with explained and unexplained infertility, or with regard to subsequent fertility [with a median value of 21% (range 5-46) green fluorescence in the fertile group, compared with a median value of 28% (range 9-81) green fluorescence in the other men]. The results of this prospective study indicate that under the usual conditions of conception, the AO test is not clinically useful as a screening procedure to determine semen quality during basic infertility investigation.

Acridine Orange↗

Antibodies to chlamydia trachomatis in semen and relationship with parameters of male fertility.

To screen for infection with Chlamydia trachomatis in semen samples from asymptomatic men in couples consulting for infertility and to determine the relationship of seminal chlamydial antibodies with clinically relevant parameters of male fertility, 197 randomly chosen patients were enrolled in a prospective study. The median duration of infertility was 4 years (range 1-18). Screening for C. trachomatis and chlamydial antibodies of the immunoglobulin (Ig) A and IgG classes were performed in ejaculates and, in parallel, endocervical material from the partners of the patients and serum samples from both partners were evaluated. A comprehensive examination of semen quality included sperm analyses, semen cultures, local antisperm antibody (ASA) testing, the determination of potential infection markers, and sperm-cervical mucus interaction testing in vitro (SCMPT) and in vivo (post-coital testing). Chlamydial IgA antibodies were found in the semen samples of 18.8% (37/197) of the patients, while chlamydial IgG antibodies were found in 8.1% (16/197) of the patients. Screening for C. trachomatis was negative in all semen and cervical specimens. Only 5.5% of men remembered a past genital infection. Chlamydia antibodies (IgA/Ig/G) in semen were significantly correlated with chlamydia IgG antibodies in serum samples (P < 0.001). No marked relationship was found between the presence of seminal chlamydial antibodies and the major parameters of sperm analysis, semen cultures, local ASA and sperm penetration testing as an indicator of functional capacity. Seminal chlamydial antibodies were not significantly associated with potential infection or inflammation markers in aliquots of the same ejaculates. However, a significant relationship of chlamydial antibodies in patients' semen with past genital infections of their female partners was found with clinical relevance for a tubal infertility factor. The results indicate that in asymptomatic patients the presence of chlamydial antibody IgA or IgG in semen is not associated with reduced semen quality, potential seminal infection markers or impaired functional capacity as important determinants of male fertility; however, seminal chlamydial antibodies suggesting a previous sexually transmitted disease are significantly related to a tubal infertility factor of female partners.

Adult↗

Induction of immunoresponse by subclinical male genital tract infection?

OBJECTIVE: To determine the relationship of subclinical infection or inflammation of the male genital tract, as evaluated with seminal markers, with local antisperm antibodies as potential parameter of immunoresponse. PATIENTS: One hundred ninety-one randomly chosen males of subfertile couples who were asymptomatic in terms of genital tract infection. SETTING: Outpatient Infertility Clinic of the University of Heidelberg, Germany. MAIN OUTCOME MEASURES: Determination of leukocytes rates in semen using an immunocytochemical method for differentiation of round cells and measurement of polymorphonuclear (PMN) granulocyte elastase concentration in seminal plasma in addition to semen cultures as screening for subclinical infection of the male genital tract. Determination of local antisperm antibodies (Ab) with the mixed antiglobulin reaction ([MAR] immunoglobulin [Ig] G and IgA) in aliquots of the same ejaculates. RESULTS: Leukocyte rates of the round cells ranged from 0% to 93%, leukocytospermia was found in 6.8%. This was not related significantly to the presence of local antisperm antibodies of the IgG or IgA class. There was also no significant association of antisperm Ab with the concentration of PMN granulocyte elastase in seminal plasma and the outcome of semen cultures. CONCLUSIONS: The results of this prospective study suggest that when the rate or number of leukocytes or the concentration of PMN elastase in semen are taken as markers for subclinical infection or inflammation of the male genital tract, this is not associated significantly with the production of local antisperm Ab of the IgG or IgA class as indicator of immunoreaction.

Adult↗

Morphologic distribution of transforming growth factor alpha in the gastrointestinal tract--its presence in neuroendocrine cell type of the colon mucosa.

Among the growth factor proteins of the epidermal growth factor (EGF)-family especially the transforming growth factor alpha (TGF-alpha) and EGF can be detected in the mucosa of the gastrointestinal tract. In this study, immunohistochemistry on 15 different human tissue probes of gastrointestinal and colonic mucosa was carried out to visualize possible deposits for TGF-alpha in the mucosa and to compare different compartments of the upper and lower gastrointestinal epithelium. Most interestingly, in the colon there is a strong TGF-alpha-like immunoreactivity in neuroendocrine cells as evidenced by double labeling experiments with common neuroendocrine markers and by immunoelectron microscopy. In the upper gastrointestinal epithelium, however, all neuroendocrine cell types are negative for TGF-alpha, but parietal cells of the gastric corpus epithelium show strong cytoplasmic immunostaining for TGF-alpha. The neuroendocrine cells of the colon-harboring TGF-alpha-like immunoreactivity in their neurosecretory granules belong morphologically to the so-called L-cell type. Along with the well-known presence of EGF-receptor in the mucosa of the gastrointestinum, TGF-alpha, which is very likely to be released by this neuroendocrine cell type of the colon, acts in a paracrine mode. These findings represent the first morphologic indication that in the colonic epithelium growth regulation is under neuroendocrine control.

Colon↗

Clinical relevance of sperm morphology assessment using strict criteria and relationship with sperm-mucus interaction in vivo and in vitro.

OBJECTIVE: To determine the relationship of the differentiated morphological pattern of semen samples according to strict criteria and sperm-mucus interaction in vivo and in vitro. PATIENTS: One hundred sixty-three randomly chosen couples with long-standing infertility (median duration of infertility 4 years, range 1 to 19 years). SETTING: Outpatient clinic of the fertility unit at the Women's University Hospital of the University of Heidelberg, Heidelberg, Germany. MAIN OUTCOME MEASURES: Sperm morphology assessment using strict criteria (Tygerberg or Norfolk classification) parallel to standard methods of sperm analysis: Evaluation of the cervical factor of patients' female partners, including a microbial screening of genital secretions of both partners; Examination of sperm migration ability in vivo under hormonally controlled conditions for the cervical mucus (CM) quality and in vitro with the crossed sperm-CM penetration test performed with CM of patients' partners, as well as with CM and spermatozoa of donors; Determination of the selection capacity of CM with regard to sperm morphology by means of a biological model; Prospective analysis of the differentiated morphological pattern with respect to couples' subsequent fertility within 6 months. RESULTS: Using stict criteria, amorphous sperm heads were the most frequently found sperm anomaly (severely amorphous forms: median, 28%; range, 4% to 62%). The morphology index offered a median of 45% (range, 7% to 80%). Results correlated significantly with routine sperm analysis, including standard morphology. The morphological pattern differed significantly in samples offering adequate or inadequate ability to penetrate CM in the standardized sperm-CM penetration test or in the postcoital test, with the percent of severely amorphous heads as the most important parameter. Neck and tail defects did not play an important role. During passage of mucus columns in vitro, the rate of pathological spermatozoal forms was reduced significantly, from a median of 65% to a median of 38%. Better functional capacity of spermatozoa with normal head morphology also was reflected by a significantly higher pregnancy rate under natural conditions of conception. CONCLUSIONS: Sperm morphological properties, determined with strict criteria, are important factors for sperm ability to penetrate the mucus barrier at the uterine cervix before reaching the site of fertilization, but sperm morphology is only one among other parameters determining the complex phenomenon of sperm-mucus interaction.

Adult↗

Anaerobes in ejaculates of subfertile men.

The clinical significance of micro-organisms in semen samples of asymptomatic subfertile patients is a matter of constant debate. Usually little attention is paid to anaerobic bacteria as they are sensitive to transportation and culturing, and differentiation is difficult, costly and time-consuming. In the present study, special screening was carried out for anaerobes in ejaculates in addition to the routine microbial cultures of genital secretions of both partners. In addition to standard semen analysis and evaluation of sperm ability to penetrate cervical mucus (CM) in vivo (post-coital testing) and in vitro using a standardized test system, semen samples from 126 randomly chosen males of couples with a median duration of infertility of 4 years were examined for colonization with anaerobic bacteria. All couples were without clinical signs or symptoms of genital tract infection. The special care taken for anaerobic growth in semen samples gave a high rate of positive cultures and showed that nearly all ejaculates (99%) were colonized with anaerobic micro-organisms, and potentially pathogenic species were found in 71% of men. This rate was more than four times higher than that obtained with routine cultures and standard transportation (16%). Anaerobic bacterial growth of > or = 10(6) colony forming units (CFU)/ml was seen in 42% (total range 10(3)-10(8) CFU/ ml). In addition, aerobic growth was found in 96% (> or = 10(6) CFU/ml in 21%), potentially pathogenic species in 61% of semen specimens. There were no marked differences in the prevalence of anaerobic micro-organisms in patients with reduced or normal sperm count, motility or morphology. Nor was there any significant difference in anaerobic colonization between samples with impaired or good ability to penetrate CM of female partners (in vivo or in vitro), or the CM of fertile donors in the in-vitro sperm-cervical mucus penetration test (SCMPT) in this asymptomatic group of patients. There was no clear association between microbial colonization and subsequent fertility in vivo within an observation period of 6 months. The results of this study suggest that anaerobic bacteria are often not detected when routine methods for microbial evaluation are used. This should be considered during assisted reproduction and in patients with symptoms of genital tract infection and should lead to further studies in infertile patients where subclinical infection or inflammation is indicated by specific markers in semen samples.

Adult↗

Screening for subclinical inflammation in ejaculates.

OBJECTIVE: To determine the clinical significance of albumin determination in ejaculates by means of an easy office test to screen semen samples for subclinical infection-inflammation. PATIENTS: One hundred fifty-nine randomly chosen males of couples with longstanding infertility (median duration of infertility 4 years (range 1 to 19 years) without clinical signs or symptoms of genital tract infection. SETTING: Outpatient Infertility Clinic of the University of Heidelberg, Germany. MAIN OUTCOME MEASURES: Screening of ejaculates for subclinical infection-inflammation by means of a ready-to-use kit for semiquantitative detection of albumin in addition to determination of leukocytes rates by means of monoclonal antibodies for differentiation of round cells and measurement of granulocyte elastase concentration in semen samples. Evaluation of sperm quality by means of standard sperm analysis including determination of local antisperm antibodies with the mixed antiglobulin reaction, evaluation of sperm functional capacity in vitro with the standardized sperm-cervical mucus (CM) penetration test, and semen cultures. All tests were performed from aliquots of the same ejaculates. RESULTS: Screening of semen samples for elevated albumin with the modified paper strips proved to be very easy, quick, and suitable for routine use. Positive results were not related markedly to medical history and outcome of clinical examination as well as to standard parameters of sperm analysis and were not influenced by local antisperm antibodies of the immunoglobulin (Ig)G and/or IgA class and microbial colonization. However, albumin-positive semen samples were significantly less frequent in case of very good outcome of the sperm-CM penetration test. A significant relationship was found with high rates of leukocytes of the round cells in semen samples (total range 0% to 96%) and the concentration of granulocyte elastase (total range 1 to 880 micrograms/L). CONCLUSIONS: The results of this prospective study suggest that the determination of albumin in semen samples with ready-to-use test kits might be a valuable additional marker for subclinical infection-inflammation of the male genital tract and therefore suitable for screening during infertility investigation.

Adult↗

NMR spectroscopy in andrology: research uses and possible clinical applications.

Research uses and possible clinical applications of NMR spectroscopy are considered. By monitoring extracts of testes using 31P-NMR spectroscopy, detailed analysis of high-energy phosphates, or pathways such as phospholipid biosynthesis or glycolysis, is possible. By using in-vivo 31P NMR spectroscopy of testes in animal experiments it has proved possible to discriminate non-invasively between experimentally impaired and control testes. It has been demonstrated in several human studies that discrimination between normal testes and those with impaired spermatogenesis and obstruction is possible by non-invasive NMR spectroscopy. In studies of semen, seminal plasma or spermatozoa, NMR spectroscopy is of high experimental value for analysis of sample composition, the kinetics of metabolites or the structure of single components, but clinical applications have not yet been clearly defined.

Animals↗

Immunological aspects of subfertility.

No significant relationship between semen quality [determined by standard sperm analysis and sperm-cervical mucus (CM) interaction testing in vivo and in vitro] and the presence of antisperm antibodies (ASA) [determined using three different methods] in serum samples of males and/or females of subfertile partnerships was found. These circulating ASA were not associated with reduced fertility in prospective studies. On the other hand, ASA in semen, particularly those of the IgA class, significantly impaired the ability of spermatozoa to penetrate CM and the fertility prognosis of the couple. ASA in CM must also be considered as a severe infertility factor but are a very rare cause of poor mucus quality.

Adult↗

Treatment of hypertensive emergency. Comparison of a new dosage form of the calcium antagonist nitrendipine with nifedipine capsules.

OBJECTIVE: To present the efficacy and tolerability of a new oral dosage form of the calcium antagonist nitrendipine compared to nifedipine capsules in patients with hypertensive emergency. DESIGN: Multicenter randomized double blind clinical study. SETTING: 23 study centres (hospitals) in Germany. PATIENTS: 161 patients between 20 and 70 years with acutely elevated blood pressure (systolic 200-250 mmHg, diastolic between 110-140 mmHg) with and without concomitant clinical symptoms. INTERVENTIONS: Double blind treatment with 10 mg nifedipine or 5 mg nitrendipine. Nifedipine was administered as capsules, nitrendipine was given from a small plastic tube (vial), containing 1 ml alcoholic solution. Every patient received in addition to the test medication a placebo corresponding to the other product. Patients with insufficient treatment after 45 min were given either an additional capsule of 10 mg nifedipine or a further vial containing 5 mg nitrendipine according to their group and maintaining the double dummy procedure. MEASUREMENTS AND RESULTS: Blood pressure and heart rate were measured repeatedly during 4 h, before and 90 min after beginning of the treatment a 12 channel resting ECG was recorded. At 45 min after administration the blood pressure had fallen significantly from 216.0/117.4 mmHg to 170.0/93.3 mmHg under nifedipine and from 216.9/117.3 mmHg to 177.4/94.4 mmHg under nitrendipine. 61.6% of the nifedipine patients and 58.8% of the nitrendipine patients had already reached blood pressure values < 180/100 mmHg after 45 min and in both groups 83% of these patients were still in this limit at the end of the observation period after 4 h. Tolerability was very good in both groups. CONCLUSION: The new dosage form of nitrendipine (vial with 1 ml of alcoholic solution) represents an alternative in the treatment of hypertensive emergency.

Administration, Oral↗