Biomedical subjects

M P Dain

Publications and source records attributed to M P Dain.

4 recordsLinked to original sources

PubMed1992

Clinical evaluation of a new triphasic oral contraceptive: norgestimate and ethinyl estradiol.

The safety and efficacy of the triphasic oral contraceptive agent containing norgestimate and ethinyl estradiol were evaluated in a 12-month study of 661 women. Excellent contraceptive efficacy was achieved, with two pregnancies ascribed to product failure in a total of 6,511 treatment cycles. The life-table predicted pregnancy rate was 0.57 per 100 woman-years of use. The overall and theoretical Pearl indexes were 0.55 and 0.37, respectively. Good cycle control was maintained in patterns similar to those noted in previous studies. The incidence of dysmenorrhea and premenstrual syndrome was sharply reduced. Side effects reported were typical of those associated with use of low-dose oral contraceptive agents. Acceptability was high compared with agents used previously by the subjects. Total cholesterol did not change but high-density lipoprotein cholesterol was significantly elevated at 3 and 12 months. There were no clinically significant changes in the parameters of hematology or blood chemistry tested.

Adolescent↗

PubMed1992

A comparison study of lipid and androgen metabolism with triphasic oral contraceptive formulations containing norgestimate or levonorgestrel.

The effects of norgestimate triphasic (Ortho Tri-Cyclen, Tri-Ciles) and levonorgestrel triphasic (Triphasi) formulations on lipid and androgen metabolism were assessed in a study of 66 healthy women treated through six menstrual cycles. Levels of the following were measured: cholesterol and its subfractions, triglycerides, carrier lipoproteins, estradiol, testosterone, and sex hormone binding globulin (SHBG). Comparison of baseline values with values after 3 and 6 months of treatment indicated that both regimens influenced lipid and androgen metabolism. There was a statistically significant between-regimen difference in levels of high-density lipoprotein, which were favorably increased with norgestimate triphasic but reduced with levonorgestrel triphasic. Related data on SHBG showed that plasma levels of this marker of estrogen/androgen balance were increased significantly more in the norgestimate triphasic group, providing additional evidence of low androgenicity. Both regimens inhibited follicular growth to the same extent, as evidenced by low mean levels of estradiol in all on-therapy cycles; and both decreased free testosterone. Side effects in both groups were minor and characteristic of those observed with low-dose oral contraceptive agents. The results of the study support the reported safety and positive effects of norgestimate on lipid and androgen metabolism, in comparison with a levonorgestrel-containing combined oral contraceptive.

Adolescent↗

PubMed1989

Alipase versus nonenteric-coated enzymes in pancreatic insufficiency. A french multicenter crossover comparative study.

Pancreatic enzymes (PE) are prepared as pH-sensitive enteric coated microspheres [Pancrease, Alipase in France (P)], to prevent gastric inactivation of orally administered enzymes. The efficacy and tolerability of P were compared to those of Eurobiol (E) (PE lacking enteric coating) in patients with exocrine pancreatic insufficiency (PI) via an open crossover study conducted at 16 centers in France. Pancreatic insufficiency was diagnosed in patients with signs of chronic pancreatitis who showed steatorrhea (fecal fat excretion greater than 8.0 g/24 h). The dosage of P was 9 capsules/d and that of E, 3 vials/d. Stools were collected for 3 consecutive days at each of the following periods: after 10 d without any PE, and after 21 d of P and E administration. Results were analyzed statistically by the method of Hills and Armitage. Chronic pancreatitis was alcohol-induced in 33 of 35 patients (94%) who entered the study. The group that received P before E (n = 20) was comparable to the group that received E before P (n = 15) in patient and disease characteristics. Eight of 35 patients failed to complete the study for the following reasons: adverse reactions 2 cases, lost to followup 4 cases, dropped out of study 2 cases. The degree of steatorrhea was similar after P and E. However, symptomatic improvement was noted far more frequently with P than with E. Moreover, patients preferred P to E because of drug taste (p less than 10(-4] and ease of drug administration (p less than 10(-3). Drug safety was comparable in the two groups of patients.

Adolescent↗

PubMed1988

Efficacy of pancrease: crossover comparative study versus eurobiol in cystic fibrosis.

An open crossover study in patients with documented cystic fibrosis (CF) compared the efficacy and acceptability of Pancrease (Cilag, PC), consisting of pH-sensitive, enteric-coated microspheres, with those of Eurobiol, consisting of lyophilized total pancreas. Eleven patients, age 6-17 years, were hospitalized for study. A hypercaloric, normal fat diet as well as previous antibiotic, vitamin, and other CF therapy were maintained during the 2-week study period. During the first study week, eight patients were given four divided doses of either Pancrease, 8 capsules daily, and two patients were given Eurobiol, 2 bottles daily. One patient received six Pancrease capsules or 1.5 bottles of Eurobiol daily. Patients were switched to the alternate drug for the second study week. Stools were collected for analysis over the final 3 days of each week. Steatorrhea (mean +/- 1 SD) with Pancrease was 11.8 +/- 6.6 g/24 h and with Eurobiol was 17.9 +/- 11.7 g/24 h. The coefficient of lipid absorption was 74.1 +/- 13.3% for Pancrease and 58.6 +/- 22.5% for Eurobiol (p less than 0.02). The decrease in steatorrhea and increase in lipid absorption with Pancrease compared to Eurobiol were 33.9% and 26.5%, respectively. All patients considered the acceptability of Pancrease superior to that of Eurobiol. No adverse effects were seen with either drug.

Adolescent↗