A message from the President of IIDSOG-USA.
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Bacterial Infections↗
Biomedical subjects
W J Ledger
Publications and source records attributed to W J Ledger.
Vulvovaginal candidiasis: epidemiologic, diagnostic, and therapeutic considerations.
Although it is the second most common vaginal infection in North America, vulvovaginal candidiasis is a non-notifiable disease and has been excluded from the ranks of sexually transmitted diseases. Not surprisingly, vulvovaginal candidiasis has received scant attention by public health authorities, funding agencies, and researchers. Epidemiologic data on risk factors and pathogenic mechanisms remain inadequately studied. Most important, standards of care, including diagnosis and therapy, remain undefined. A conference was held in April 1996 to define and summarize what is known and supported by scientific data in the areas of epidemiology, diagnosis, and treatment of vulvovaginal candidiasis; but, more important, the conference aimed at defining what is not known, poorly studied, and controversial. Guidelines for the treatment and diagnosis of the different forms of vulvovaginal candidiasis are suggested.
Antifungal Agents↗
Biodegradable norethindrone (NET:cholesterol) contraceptive implants: phase II-A: a clinical study in women.
Safety, contraceptive efficacy and biodegradability of subdermal norethindrone (NET)-cholesterol implants (Anuelle) were investigated in 19 healthy, sexually active women. Mean serum NET levels in women with four and five pellets, containing 174 mg and 266.5 mg NET, showed a "burst-effect" of 3.17 and 3.71 ng/ml, respectively, within 24 h post implantation. Subsequently, for the four- and five-pellet groups, respectively, the levels declined from 0.75 to 0.40 ng/ml and 1.05 to 0.61 ng/ml during the months 12-15, from 0.40 to 0.11 ng/ml and 0.61 to 0.25 ng/ml up to month 36. The serum NET levels were undetectable at 36 months and beyond, indicating complete biodegradability of NET pellets. Serum E2 levels remained within normal limits (> 50 pg/ml), whereas serum P indicated anovulatory cycles in 78% of the four-pellet group and 99% of the five-pellet group. FSH and LH levels were subnormal and acyclic. Plasma lipids showed reduced total and LDL cholesterol and triglycerides. HDL cholesterol remained unchanged. Drug-related adverse effects were essentially limited to irregular bleeding. There were no pregnancies in either group.
Adolescent↗
Contraceptive efficacy of norethindrone encapsulated in injectable biodegradable poly-dl-lactide-co-glycolide microspheres (NET-90): phase III clinical study.
Safety, contraceptive efficacy, and acceptability of norethindrone, encapsulated in biodegradable poly-dl-lactide-co-glycolide injectable microspheres (NET-90), was evaluated for 12 months in one hundred women. Fifty-one volunteers received 65 mg, and 49 received 100 mg of NET-90, at three month intervals, intramuscularly in the gluteal region. The mean NET levels at 3-month intervals for the 65 and 100 mg groups were, respectively, 0.32 +/- 0.16 ng/ml and 0.49 +/- 0.25 ng/ml. No local or systemic side-effects were observed in either group. Body weight, blood pressure, and laboratory parameters, namely hemoglobin, hematocrit, lipid profile, sequential multichannel autoanalyzer computer profiles (SMAC), as well as PAP smear, remained within normal limits throughout the study in both groups. There was no pregnancy in the 65 mg group; however, one volunteer became pregnant in the 100 mg group. In the 65 mg group, 52.9% of menstrual cycles were normal, 34.5% were amenorrheic, and 12.6% showed prolonged bleeding. In the 100 mg group, 40.6% of the cycles were normal, 52.3% were amenorrheic, and 7.1% had episodes of prolonged bleeding. A total of 40.3% and 36.6% of the cycles showed increased spotting in the 65 and 100 mg group, respectively. Our observations indicate that NET-90 microsphere injectables can provide a safe, efficacious, and acceptable method of contraception.
Adult↗
Labor induction with intravaginal misoprostol in term premature rupture of membranes: a randomized study.
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Abortifacient Agents, Nonsteroidal↗
A triphasic oral contraceptive pill, CTR-05: clinical efficacy and safety.
OBJECTIVE: The primary objective of this study was to compare the safety, contraceptive efficacy, and menstrual cycle patterns in women using triphasic oral contraceptive pills, namely CTR-05, containing 50/100/150 micrograms desogestrel and 35/30/30 micrograms ethinylestradiol, and Orthonovum777 containing 500/750/1000 micrograms norethindrone and 35/35/35 micrograms ethinylestradiol. METHOD: Forty-six female volunteers, satisfying the selection criteria, were evaluated for six cycles, in an open-label, randomized study. Volunteers using CTR-05 were studied for 13 additional cycles for efficacy and safety. RESULTS: No serious adverse effects were observed in either group. The incidences of other drug-related adverse effects, such as headache and nausea, were transient in both groups. CTR-05 did not lower levels of high density lipoprotein (HDL) cholesterol. This may be attributed to the lower androgenicity of its progestin component, desogestrel. No pregnancies were reported in either group. Clinical and laboratory parameters remained within normal limits in both groups. In the CTR-05 group, the lower dose of ethinylestradiol did not affect the safety, efficacy and acceptability of the product. CONCLUSION: Desogestrel, with little estrogenic activity and only minimal androgenic activity, leads to lipoprotein changes, resulting in a favorable cardiovascular profile, as well as minimal androgen-related effects, such as hirsutism and acne.
Adult↗
Genital ulcer disease in women infected with human immunodeficiency virus.
OBJECTIVE: The purpose of this study was to determine the prevalence and microbiologic characteristics of genital ulcer disease in a population of human immunodeficiency virus-infected women. STUDY DESIGN: A retrospective cohort study was performed in university-affiliated, hospital-based women's human immunodeficiency virus clinics. A total of 307 women with human immunodeficiency virus infection were followed up during 20 months. There were no interventions. Age, race, CD4+ cell counts, bacteriologic and virologic analyses in cases of ulcers, serologic testing for syphilis, and histopathologic examination in selected cases (n = 6). RESULTS: Among 307 women followed up over a 20-month period, 43 ulcers were detected with a prevalence of 14%. Among the ulcer cases the average absolute CD4+ lymphocyte number was 210/mm3. Diagnostic evaluation yielded no proven etiologic agent in 26 (60%) of the cases. Twelve of the 43 cases (28%) were positive for herpes simplex-2. Five cases (12%) yielded unusual or mixed bacteriologic types. No cases were attributable to primary syphilis infection. One case each of an ulcer infected with cytomegalovirus, Chlamydia trachomatis, and Gardnerella vaginalis, as well as three unusual presentations of herpetic ulcers, is analyzed in detail. CONCLUSION: These cases exemplify the often dramatic presentation of human immunodeficiency virus-related genital ulcers and the clinical complexity of both diagnosis and management. The frequent lack of an infectious or neoplastic cause in human immunodeficiency virus-infected women with genital ulcer disease suggests that human immunodeficiency virus may play a local role in causation or exacerbation. Biopsies of atypical genital ulcers should be considered to aid diagnosis. Further studies are needed to elucidate the pathogenesis of genital ulcer disease in human immunodeficiency virus-infected women.
AIDS-Related Opportunistic Infections↗
Proliferative response to conserved epitopes of the Chlamydia trachomatis and human 60-kilodalton heat-shock proteins by lymphocytes from women with salpingitis.
OBJECTIVE: Our objective was to determine whether an upper genital tract Chlamydia trachomatis infection sensitizes lymphocytes to heat-shock protein epitopes expressed in both the human and chlamydial 60 kd heat-shock protein. STUDY DESIGN: Peripheral blood mononuclear cells were isolated from women with or without a prior documented salpingitis and tested for their ability to proliferate in response to the recombinant C. trachomatis heat-shock protein and to five synthetic peptides corresponding to conserved epitopes expressed in both the human and chlamydial heat-shock proteins. RESULTS: Among 22 healthy women with no history of chlamydial infections or salpingitis and 10 women seen for complaints other than a C. trachomatis infection, none had positive lymphocyte responses to any of the peptides and only one responded to the chlamydial heat-shock protein. Among nine women with a single episode of salpingitis none responded to the chlamydial heat-shock protein and one exhibited a positive lymphocyte response to a single peptide. This woman was also positive for C. trachomatis in the cervix. In contrast, among the 10 women with two or more episodes of salpingitis four (40%) had proliferation in response to the chlamydial heat-shock protein and five (50%) had positive lymphocyte responses to one of the peptides; two of these women also had C. trachomatis detected in their cervices. CONCLUSION: In women with a history of C. trachomatis upper genital tract infections, infection with C. trachomatis or other microorganisms can induce a lymphocyte proliferative response to the chlamydial 60 kd heat-shock protein and to epitopes present in the human heat-shock protein.
Adult↗
Comparison of three regimens recommended by the Centers for Disease Control and Prevention for the treatment of women hospitalized with acute pelvic inflammatory disease.
This six-center, prospective, open-label clinical trial compared the efficacy and safety of three regimens recommended by the Centers for Disease Control and Prevention (CDC) for the treatment of women hospitalized for acute pelvic inflammatory disease (PID). The study focused on the response to inpatient therapy, not on long-term prevention of sequelae. A severity score was used for objective comparison of the degree of illness before and after therapy. Women were randomly assigned (in a 1:1:1 ratio) to treatment with cefoxitin plus doxycycline, clindamycin plus gentamicin, or cefotetan plus doxycycline. Two hundred seventy-five (94.2%) of 292 evaluable women required no alteration in therapeutic regimen. The three regimens produced almost identical cure rates. No serious adverse clinical or laboratory events were observed. In short, the three regimens recommended by the CDC for inpatient therapy of acute PID were similarly effective and safe.
Acute Disease↗
Historical review of the treatment of bacterial vaginosis.
The review of the treatment of bacterial vaginosis parallels the history of this syndrome. Before the syndrome was defined, treatment was local and nonspecific. Gardner and Dukes defined nonspecific vaginitis in 1955 as an infection caused by Haemophilus vaginalis. Therapy was directed toward this aerobic "pathogen" and included oral tetracycline and a triple sulfa vaginal cream. Subsequent studies indicated success with this regimen as well as with ampicillin, a drug with good aerobic activity. Since 1977, studies have shown the importance of anaerobes in this clinical syndrome. Both metronidazole and clindamycin have been found to have clinical success. The clinical definition of the disease makes evaluation of treatment difficult, because it includes women without symptoms.
Anti-Infective Agents↗
Detection of Chlamydia trachomatis by the polymerase chain reaction in the cervices of women with acute salpingitis.
OBJECTIVE: Our objective was to determine whether an increased prevalence of Chlamydia trachomatis could be detected by the polymerase chain reaction as opposed to culture in the cervices of women with acute salpingitis. STUDY DESIGN: Endocervical samples from 15 women with laparoscopy-verified acute salpingitis and 20 women seeking medical help for conditions other than pelvic pain were tested for Chlamydia trachomatis with the polymerase chain reaction. The oligonucleotide primer pairs used were specific for a 144 bp region of the major outer membrane protein that contained a single EcoRI endonuclease cleavage site. The detection of a 144 bp band that was cleaved by EcoRI to a 103 bp band denoted a Chlamydia trachomatis-positive sample. Cervical samples were cultured for Chlamydia trachomatis with the use of McCoy cells. The lymphocyte proliferative response to Chlamydia trachomatis elementary bodies was also determined. RESULTS: Nine of the 15 women (60%) with salpingitis had positive results when tested with the polymerase chain reaction for cervical Chlamydia trachomatis. Only two of these women (13%), both of whom had positive results when tested with the polymerase chain reaction, had cultures that were positive for Chlamydia trachomatis (p < 0.02). Among the 20 other women, only two patients with cervicitis had positive cultures for Chlamydia. Those women plus two women with unexplained recurrent abortions had positive polymerase chain reaction test results for Chlamydia trachomatis. A lymphocyte proliferative response to Chlamydia trachomatis was detected in five of eight women with salpingitis, as well as three of the other four patients, all of whom had positive polymerase chain reaction test results; lymphocytes from the remaining women were unresponsive. Follow-up cervical samples were obtained 4 to 6 months after treatment from six of the patients with salpingitis who had positive polymerase chain reaction test results; at that time five had negative polymerase chain reaction test results for Chlamydia trachomatis. CONCLUSION: The polymerase chain reaction appeared to be more sensitive and more rapid than culture in detecting Chlamydia trachomatis in the cervices of women with acute salpingitis. This assay may be of value for the early diagnosis of chlamydial infections.
Acute Disease↗
Detection of Chlamydia trachomatis in semen by the polymerase chain reaction in male members of infertile couples.
OBJECTIVE: Our objective was to evaluate the presence of asymptomatic Chlamydia trachomatis infection by means of the polymerase chain reaction in male members of couples with previously undiagnosed infertility. STUDY DESIGN: Twenty-eight infertile-couples who had negative cultures or negative results when tested by deoxyribonucleic acid probe for Chlamydia trachomatis in semen and cervical samples were studied. Semen samples were tested for Chlamydia trachomatis by means of the polymerase chain reaction. Sera from both partners were diluted 1:128 and tested for immunoglobulin M antibodies to Chlamydia. Sera and ejaculated sperm were evaluated for the presence of antisperm antibodies. Semen analyses were also performed. RESULTS: Chlamydia trachomatis was identified in semen from 11 (39.3%) of the male partners. Its detection correlated with the presence in the ejaculate of motile sperm containing antisperm antibodies (p < 0.01). Either antisperm immunoglobulin G, immunoglobulin A, or both were located on sperm only from 5 (45.5%) of the 11 men whose results were positive when tested for Chlamydia trachomatis. Similarly, immunoglobulin G or immunoglobulin A antibodies to sperm were only detected in 5 (45.5%) of the spouses of men with Chlamydia in semen. Immunoglobulin M antibody to Chlamydia trachomatis was identified in only one of the men. However, antichlamydial immunoglobulin M antibodies were present in sera from 6 (54.5%) female partners of men with seminal Chlamydia trachomatis but in none of the other 17 women (p < 0.01). CONCLUSION: Although undetected by culture of deoxyribonucleic acid probe of semen samples, Chlamydia trachomatis was nevertheless identified in semen of some symptom-free men by the polymerase chain reaction. This is probably a result of the increased sensitivity of the polymerase chain reaction to detect Chlamydia trachomatis. The increased prevalence of an autoimmune response to sperm in men with this organism in their semen suggests that a subclinical chlamydial infection may activate an immune response to sperm. A similar association between Chlamydia trachomatis in semen and circulating antisperm antibodies in female partners indicates that Chlamydia may also induce an immune response to sperm in women. Infertility in these couples may be the result of a direct inflammatory response in the cervix or endometrium to repeated Chlamydia exposure or of the ability of Chlamydia to evoke an immune response to spermatozoa.
Adult↗
Cell-mediated immune response to the recombinant 57-kDa heat-shock protein of Chlamydia trachomatis in women with salpingitis.
Peripheral blood mononuclear cells (PBMC) from 9 of 18 women with laparoscopy-verified salpingitis proliferated in response to recombinant Chlamydia trachomatis 57-kDa heat shock protein (hsp). In contrast, PBMC from 0 of 10 women with cervicitis, 1 of 5 women with recurrent abortions, and 3 (7.1%) of 42 healthy reproductive-age women were responsive to hsp (P < .001). After passage of the hsp through an endotoxin-removing column, PBMC from 6 of 14 additional women with salpingitis were responsive to hsp, while those from 10 controls, including the 3 previously positive women, were negative. PBMC from all patients responsive to the chlamydial hsp were unresponsive to Mycobacterium bovis 65-kDa hsp. PBMC from 6 of the 15 women with a positive hsp-induced lymphocyte response were unresponsive to C. trachomatis elementary bodies. Induction of a cell-mediated immune response to the chlamydial 57-kDa hsp is a common feature of an upper genital tract infection but does not appear to be limited to women with apparent chlamydial infections.
Adult↗
New directions in the diagnosis and treatment of pelvic inflammatory disease.
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Chlamydia Infections↗
Treatment of preterm labor with the beta-adrenergic agonist ritodrine.
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Female↗
Antibodies to Chlamydia trachomatis in sera of women with recurrent spontaneous abortions.
OBJECTIVE: The relationship between high-titer immunoglobulin G antibodies to Chlamydia trachomatis and recurrent spontaneous abortions was evaluated. STUDY DESIGN: Sera from the female partners of 258 couples with unexplained infertility, no history of chlamydial infection, and negative cervical cultures were diluted 1:128 and tested for immunoglobulin G antibodies to Chlamydia trachomatis. A subset of patients was also tested for antibodies to cytomegalovirus, cardiolipin, nuclear antigens, lactoferrin, and spermatozoa. RESULTS: Seven (41%) of 17 women with three abortions and 6 (60%) of 10 women with four abortions had chlamydial antibodies as opposed to 20 (13.5%) of 148 with no abortions, 6 (12.8%) of 47 with one abortion, and 4 (12.1%) of 33 with two abortions (p < 0.01). The incidence of > or = 3 spontaneous abortions was 31.8% among women with high-titer chlamydial antibodies and 7.5% among women who had seronegative results (p < 0.001). There was no relation between any of the other antibodies and > or = 3 abortions or antibodies to Chlamydia trachomatis. CONCLUSION: High-titer immunoglobulin G antibody to Chlamydia trachomatis was associated with recurrent spontaneous abortions. The mechanism may involve reactivation of a latent chlamydial infection, endometrial damage from a past chlamydial infection, or an immune response to an epitope shared by a chlamydial and a fetal antigen.
Abortion, Habitual↗
Evaluation of new anti-infective drugs for surgical prophylaxis. Infectious Diseases Society of America and the Food and Drug Administration.
It has been established by substantial research that antimicrobial prophylaxis for various surgical procedures can reduce the risk of postoperative morbidity and mortality. When the incidence of infectious complications is high, the reduction with prophylaxis is most dramatic. However, even for many "clean" procedures (vascular procedures, total joint replacement), the small reduction in potentially calamitous complications justifies the use of prophylaxis. Many issues of detail remain unanswered: timing and duration of administration of antimicrobial drug; type of drug; use of topical anti-infective agents as ancillary measures; and choices for high-risk individuals and others ordinarily excluded from clinical trials. An approach to the conduct of clinical trials of anti-infective drugs for surgical prophylaxis is provided. Both general guidelines and specific recommendations for total hip replacement, colorectal operations, appendectomy, and transurethral resection of the prostate are included.
Anti-Infective Agents↗
In vivo tumor necrosis factor production in women with salpingitis.
Immune mediated mechanisms might contribute to damage of the fallopian tube in instances of salpingitis. Using a filter paper technique to obtain samples during the surgical procedure, we examined fluids from the reproductive tract organs of seven women with salpingitis and five controls, for evidence of tumor necrosis factor (TNF). TNF, produced principally by macrophages, is a substantial mediator of inflammatory responses. In three women culture-positive for Chlamydia trachomatis, TNF was identified only in those fallopian tubes with visual evidence of disease. Fluids obtained from morphologically normal tubes, as well as from the ovaries and uterus, were negative. In three women with negative fallopian tube cultures but visual evidence of salpingitis, TNF was also identified in fluids from damaged, but not from normal, tubes. Ovarian and uterine fluids of the women were also TNF positive. The last patient, also culture-negative, had TNF only in one affected tube. All five patients in the control group had negative findings at all genital tract sites. Only one patient had TNF in her serum. Thus, localized cell-mediated immune system activation, identified by TNF production, appears to be a typical component of salpingitis.
Bacteria↗