Interferon-gamma in the treatment of systemic sclerosis: a randomized controlled multicentre trial.

We report the results of a randomized controlled multicentre study on interferon-gamma (IFN-gamma) treatment of systemic sclerosis as determined by skin sclerosis, renal and other organ involvement, global assessment, subjective symptoms and quality of life. Forty-four patients were enrolled into the trial, 27 in the treatment group and 17 in the control group. All patients presented with type I or type II scleroderma. Twenty-nine patients (64%) finished the study. The mean duration of Raynaud's phenomenon and skin sclerosis was 15.3 and 10.8 years, respectively. The skin scores tended to improve in the treatment group (P > 0.05). Mouth aperture increased significantly from 38.5 to 47.7 mm in the treatment group (P < 0.001). Subanalysis of IFN-gamma treated patients with normalized skin sclerosis scores >/=1 showed significant improvement in both skin involvement and subjective symptoms (P < 0.05). Organ involvement improved in eight of 18 treatment patients and in three of 11 control patients. It worsened in three of 18 treatment patients and in four of 11 control patients. One control patient died due to cardiorespiratory failure during the study. No deterioration of renal function occurred during IFN-gamma treatment. There was a significant improvement in quality of life parameters in the control group but not in the treatment group. Plasma levels of neopterin increased significantly during IFN-gamma treatment but not in the control group, whereas N-terminal procollagen III peptide levels did not change in either group. There was a high frequency of mild to moderate influenza-like adverse events during IFN-gamma treatment. Only four of nine drop-out patients, however, experienced symptoms most probably associated with IFN-gamma treatment. We conclude that IFN-gamma therapy has mild beneficial effects on skin sclerosis and disease-associated symptoms in type I and II scleroderma. IFN-gamma treatment was associated with acceptable tolerability and did not induce major renal dysfunction in our patients.

Rapid diagnosis of Chlamydia trachomatis with a nucleic acid probe in male and female patients.

To evaluate a commercially available DNA hybridization test, the Gen-Probe Pace 2 assay (GP) was compared with the Chlamydiazyme (CZ) for the detection of Chlamydia trachomatis in urethral and endocervical specimens. Samples were collected from 300 persons, including 199 registered and 43 nonregistered female prostitutes, examined for screening purposes, as well as 22 male and 36 female symptomatic sexually transmitted disease (STD) patients. The overall prevalence of C. trachomatis was 7.3% in all persons examined with an infection rate of 20.9% in the nonregistered prostitutes, 2.5% in the registered prostitutes and 13.8% in the STD patients. The overall concordance of both diagnostic methods was 98.7% in all samples examined, 100% in male and 98.6% in female samples. Specimens with discordant results were further analyzed by a direct immunofluorescence test (MicroTrak) and by the probe competition assay (PCA). All samples only positive in the GP assay could be confirmed by the PCA while one result which was positive in the CZ could not be confirmed by any other test. The GP assay was superior to the CZ, when compared with true-positive and -negative results. The data demonstrate that the GP assay can be recommended as an alternative diagnostic technique to the CZ for Chlamydia diagnosis.

Comparison of DNA-probe test and culture for the detection of Neisseria gonorrhoeae in genital samples.

BACKGROUND AND OBJECTIVES: The nonisotopic DNA probe assay (PACE 2) was evaluated for the detection of Neisseria gonorrhoeae in urethral and endocervical specimens and compared quantitatively and qualitatively using recommended culture methods. GOAL OF THIS STUDY: To evaluate whether culture methods could be replaced by the DNA probe assay for the diagnosis of N. gonorrhoeae. STUDY DESIGN: A total of 502 men and women were studied, including 42 non-registered and 132 legally registered prostitutes and 115 male and 213 female STD patients. RESULTS: The overall concordance of culture and the PACE 2 assay was 98.4%. Of the tested persons, 9.6% were positive for N. gonorrhoeae by culture technique compared with 11.2% using the DNA probe assay. All samples that were positive in culture were positive in the Gen-Probe test. Of samples positive in Gen-Probe, 14.3% (8/56) were negative in culture. Three of these results were determined false-positives and five were true positives when evaluated by further analysis. The sensitivity and specificity were 90.6% and 100%, for the culture technique, and 100% and 99.3% for the DNA probe assay, respectively, when compared with true positive and negative results. CONCLUSION: The data indicate that the DNA probe assay serves as a suitable screening and diagnostic test for the diagnosis of N. gonorrhoeae in symptomatic and in asymptomatic men and women. When the performance of culture technique is not possible or unreliable, the DNA probe assay can be used for testing those at high risk for gonorrhea. In borderline cases with a low value of RLU, the DNA test should be confirmed to avoid false positive results, especially in women.