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Biomedical subjects

J M Wheeler

Publications and source records attributed to J M Wheeler.

At least 19 recordsLinked to original sources
PubMed1992

Postoperative hyponatremic encephalopathy in menstruant women.

OBJECTIVES: To determine factors associated with the development of encephalopathy and with its clinical course in patients with postoperative hyponatremia. SETTING: Consultation and referral services of two university medical centers and community hospitals. DESIGN: Case-control study (risk factors for encephalopathy) and cohort study (clinical course among patients with encephalopathy). PATIENTS: Case patients included 65 adults with postoperative hyponatremic encephalopathy; controls included 674 adult patients who had postoperative hyponatremia without encephalopathy and who were selected from 76,678 consecutive adult surgical inpatients. MEASUREMENTS: Age, gender, menstrual status, neurologic symptoms, time to development and degree of hyponatremia, arterial blood gas determinations, serum chemistries, morbidity and mortality. RESULTS: Case patients included 40 women (62%) and 25 men (38%) (P > 0.05); controls included 367 women (54%) and 307 men (46%) (P > 0.1). Of the 34 case patients who developed permanent brain damage or died, 33 (97%) were women (P < 0.001). Among the women with brain damage, 25 (76%) were menstruant (P < 0.001). The relative risk for death or permanent brain damage from hyponatremic encephalopathy in women compared with men was 28 (95% Cl, 5 to 141) and in menstruant women compared with postmenopausal women, 26 (Cl, 11 to 62). Arterial PO2 at diagnosis was significantly lower in female than in male case patients (34 +/- 5 compared with 91 +/- 3 mm Hg; P < 0.001). Further, of the 38 case patients who had respiratory arrest before the diagnosis of hyponatremic encephalopathy, 36 (95%) were women. Extent of or time to development of hyponatremia did not correlate with subsequent brain damage (P > 0.1). CONCLUSIONS: Women and men are equally likely to develop hyponatremia and hyponatremic encephalopathy after surgery. However, when hyponatremic encephalopathy develops, menstruant women are about 25 times more likely to die or have permanent brain damage compared with either men or postmenopausal women.

Adult↗
PubMed1992

Depot leuprolide versus danazol in treatment of women with symptomatic endometriosis. I. Efficacy results.

OBJECTIVE: We aimed to assess the efficacy of depot leuprolide versus danazol in the treatment of endometriosis. STUDY DESIGN: A double-blind randomized trial of 270 patients from 22 centers compared the pretreatment and posttreatment laparoscopic extent of endometriosis. Pretreatment and posttreatment endometriosis symptoms and signs were assessed with standardized methods. RESULTS: When compared with danazol, leuprolide depot caused a more rapid and profound suppression of estradiol. Leuprolide depot and danazol were similarly efficacious in decreasing the extent of endometriosis, as well as the pain and tenderness associated with endometriosis. CONCLUSION: Depot leuprolide is an effective alternative to danazol in decreasing the extent of endometriosis and endometriosis-related pain.

Adolescent↗
PubMed1992

Coagulation profile in severe preeclampsia.

One hundred women with severe preeclampsia or chronic hypertension with superimposed preeclampsia were seen during a 2-year period. We sought to determine whether a normal platelet count assures that no other clinically significant clotting abnormalities are present, and what level of thrombocytopenia predicts a risk of abnormalities in other coagulation indices. Fifty women had platelet counts below 150,000/microL, of whom 13 had a fibrinogen level below 300 mg/dL and two had a prolonged prothrombin time (PT) or partial thromboplastin time (PTT). The admission platelet count was an excellent predictor of subsequent thrombocytopenia (r = 0.829, P less than .001). No subject had an abnormal fibrinogen level or prolonged PT or PTT in the absence of thrombocytopenia. When monitoring intrapartum coagulation indices in preeclampsia, one can safely follow only the platelet count at admission and subsequently, reserving PT and PTT and fibrinogen levels for those cases complicated by counts less than 100,000/microL.

Adult↗
PubMed1991

The use of an amniotic membrane graft to prevent postoperative adhesions.

Grafts of trypsin-treated, gamma-irradiated human amniotic membranes were used to cover injured uterine horns of nulliparous female rabbits to prevent adhesions. In this study, the gradual integration of the membranes into the serosal layer of the uterus, together with marked neovascularization, was observed. By the 30th postoperative day, the grafts had been completely integrated, with little evidence of rejection and no evidence of infection at the graft sites. Of 30 uterine horns treated with membrane grafts, only 4 (13.4%) showed any adhesion formation at or among the graft sites. All of the 24 untreated controls showed adhesion formation at the site of injury. Furthermore, whatever adhesions were found in membrane-treated horns could be graded as thin and filmy, accounting for less than 10% of the surface area of the graft, whereas the controls showed dense, thick adhesions covering 50% to 100% of the injured areas. We conclude that these specially prepared amniotic membranes are safe and effective in dramatically reducing postoperative adhesion formation in this animal model.

Animals↗
PubMed1991

Role of phase IV trials in determining the safety and efficacy of oral contraceptives. Guidelines for evaluation.

The continued evaluation of a new drug after it reaches the general marketplace is of ever-increasing concern for pharmaceutical manufacturers and regulatory agencies. This interest in performance after the drug has come to market has spawned a new type of research, "postmarketing surveillance," or phase IV research. Often when a new drug comes to market, a phase IV trial is implemented to reevaluate the results of previously performed controlled clinical trials. While the primary strength of a phase IV trial is that it gathers a large amount of prospective data on many patients in a short time, this type of study is limited in design as compared to the rigorous, randomized clinical trial required to "prove" efficacy. This paper offers the obstetrician-gynecologist and clinical epidemiologist a 10-point checklist to employ when evaluating phase IV trials involving an oral contraceptive.

Clinical Trials as Topic↗
PubMed1991

Incidence of breakthrough bleeding during oral contraceptive therapy.

A phase IV, open-label, multicenter survey of 983 obstetrician-gynecologists was conducted to evaluate the incidence of intermenstrual bleeding in 6,382 women receiving a low-dose monophasic oral contraceptive, ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) over a six-month period. Most patients (75%) did not experience intermenstrual bleeding during therapy. Follow-up questionnaires were sent to the physicians of the 1,526 women reporting breakthrough bleeding or spotting; 1,027 follow-up questionnaires (67%) were returned. The questionnaires revealed that approximately one-fifth of the patients were placed on EDA 1 mg with EE 35 micrograms to regulate preexisting bleeding; of them, 71% reported an improvement, 13% reported worsening, and 16% reported no change in their cycle regularity. Most breakthrough bleeding or spotting (91%) occurred in the first three months of therapy in women with preexisting irregular bleeding as well as in those using the oral contraceptive solely for birth control. Although a fair proportion of women experienced intermenstrual bleeding, very few (5.1%) discontinued therapy because of it. Thus, the study demonstrated that the incidence of breakthrough bleeding and spotting appears to be within or below the range reported for other monophasic and multiphasic oral contraceptives. Further, in agreement with previously published reports, the data suggest that cycle control will improve after three months of oral contraceptive use.

Contraceptives, Oral, Hormonal↗
PubMed1991

Complexion changes in oral contraceptive users. Results from a phase IV multicenter trial evaluating the safety and efficacy of ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms.

An open-label, phase IV, multicenter survey of obstetrician-gynecologists was conducted to evaluate the efficacy and safety of a low-dose monophasic oral contraceptive, ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms. Surveys from 983 community-based physicians reported on 6,382 women. Most patients did not experience "clinically noticeable complexion changes" (5,695/6,382, or 89.2%). Of the 687 patients with complexion changes, nearly three-fourths reported an improvement (501/687, or 72.9%). A follow-up questionnaire was sent to 127 respondents (18.6%) who reported worsening of the complexion; 70% of the questionnaires were returned. Most complexion worsening was of slight degree (63%), reported by the patient and not the physician (84% vs. 16%), and experienced during the first two to three months (84%). Although the literature includes many references to skin condition "improvement" on oral contraceptives, this report of a descriptive study gives clinicians as estimate of the incidence and severity of complexion changes in actual use.

Contraceptives, Oral, Hormonal↗
PubMed1991

Incidence of ovarian cyst formation in women taking ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms.

A total of 7,759 women were treated with ethynodiol diacetate, 1 mg, with ethinyl estradiol, 35 micrograms (EDA 1 mg with EE 35 micrograms) in a field study involving 983 obstetrician-gynecologists evaluating the incidence of ovarian cyst formation. Six thousand three hundred eighty-two patients were evaluable; 1,377 could not be evaluated because of failure to meet inclusion criteria or inconsistent or incomplete data collection. Cysts were detected in 80 patients at the time of the final visit. Follow-up questionnaires were received on 61% of patients and confirmed the presence of 12 newly formed ovarian cysts in patients taking EDA 1 mg with EE 35 micrograms. Only three women required an operation for ovarian cysts; two women had functional ovarian cysts (one follicular and one luteal), and one had a neoplastic cyst (cystadenoma). Thus, the incidence of ovarian cyst formation requiring surgical intervention was 0.05% in women taking EDA 1 mg with EE 35 micrograms.

Adult↗
PubMed1990

Outcome of twin-twin transfusion diagnosed before 28 weeks of gestation.

To develop prognostic indicators for those patients diagnosed with twin-twin transfusion before 28 weeks' gestation, we conducted a retrospective analysis of all cases diagnosed at Baylor College of Medicine from January 1985 through April 1989. Twenty-seven cases of twin-twin transfusion were diagnosed by ultrasound; the criteria for diagnosis were polyhydramnios in one amniotic cavity and oligohydramnios in the other cavity. The mean (+/- SD) age at diagnosis was 21.9 +/- 2.9 weeks and the mean age at delivery was 26.8 +/- 4.9 weeks. Gestational age at diagnosis was similar in survivors and non-survivors (21.7 +/- 3.7 versus 22.2 +/- 2.8 weeks; P = .35); however, surviving infants were delivered later in gestation (31.9 +/- 3.5 versus 25.9 +/- 3.4 weeks; P = .000008). The overall survival rate was 21%. Fetal hydrops correlated with poor survival. Amniocentesis for decompression and tocolysis failed to decrease perinatal mortality.

Adult↗
PubMed1990

Statistical methods in evaluating endometriosis studies.

There is no shortage of statistical methods available for use in presenting the results of endometriosis research. Those that are currently in widest use have underlying statistical assumptions that may not be met by our study populations. Those methods that are more robust and compensate more for defects in satisfying these underlying assumptions are computer-based and much less "friendly" to physician and patient alike in terms of comprehensibility. Statisticians, with little appreciation for clinical practice, cannot answer these questions alone. Research is needed by clinician scientists comparing the validity of these methods of analysis.

Biometry↗
PubMed1989

The surgical management of endometriosis.

Surgical treatment is an important option in treatment of all stages of endometriosis. Surgical options of operative laparoscopy, lasers, laparotomy technique, and perioperative medical treatment are discussed in the contexts of both published literature and the authors' clinical experience.

Endometriosis↗
PubMed1989

Epidemiology of endometriosis-associated infertility.

To explain the great discrepancy between the prevalence estimates for endometriosis in the literature, a series of operations was studied from a combined patient population derived from a 21-physician collaborative. The reported discrepancy appears to have to do more with operative indications and technique than with an actual increase in the prevalence of endometriosis over time. The least-biased estimate for the overall prevalence of endometriosis in reproductive-age women is about 10% on the basis of a study of women operated on for symptoms other than those associated with endometriosis. Accepted criteria for causality applied to the endometriosis literature failed to demonstrate an association between endometriosis and infertility.

Endometriosis↗
PubMed1988

Office hysteroscopy.

Several forces are acting on hysteroscopic surgeons to promote the 100-year-old practice of office hysteroscopy. It remains the surgeon's responsibility to triage patients properly to the office or hospital, and it is hoped that the principles discussed herein are helpful in that thinking. Office hysteroscopy implies more adaptability in the surgeon than in the surgeon's instruments. The indications, contraindications, and technique of office hysteroscopy do not differ significantly from those of hysteroscopy in the hospital on an awake patient. With current economic forces, instrumentation, and surgeon interest and training, office hysteroscopy will probably grow in popularity over the next several years.

Ambulatory Surgical Procedures↗