Biomedical subjects
Publications and source records attributed to B N Saxena.
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A study was undertaken to compare the effects of exposure to the toxic gas in pregnant women in Bhopal with pregnant women in a similar, unexposed area. A high incidence of spontaneous abortions (24.2%) in the pregnant women exposed to the toxic gas was observed as compared to those in the control area (5.6%). Other indices of adverse reproductive outcome, such as the rate of still birth and congenital malformation were not found to be different. The perinatal and neonatal mortalities were significantly higher in the affected area (6.9 and 6.1% respectively), as compared to the control area (5.0 and 4.5% respectively).
A study on the bioenvironmental control of malaria was launched in Bizadandi block (Mandla district, M.P.) in May 1986. Besides intervention, using environmental management methods and larvivorous fishes, weekly surveillance and chloroquine administration at 25 mg/kg body weight was practiced. Studies during 1987 revealed that a large number of P. falciparum cases did not respond to the standard anti-malarial treatment. Therefore, systematic 28 day in vivo studies were taken up on the follow-up of P. falciparum cases after administration of 3 day course of 25 mg/kg body weight as per the WHO procedure. Results revealed a high proportion of drug resistant cases belonging to RI (237), RII and RIII (182) category. In vivo studies on the sensitivity to metakelfin showed that some cases were resistant to this drug. There is an urgent need to eradicate this focus before it starts spreading to other areas.
The transfer of levonorgestrel (LNG) from the maternal plasma via breast milk to the infant was studied in 38 fully lactating and breast-feeding women at 4-6 weeks postpartum, for a duration of 28 days. These volunteers were provided with LNG contraceptive treatment delivered through three, different routes of drug delivery system: (i) intrauterine devices impregnated with LNG (LNG-IUD); (ii) subdermal implant (Norplant (R)-2); and (iii) minipills (LNG 30 micrograms daily). On the first day after either the LNG-IUD (n = 14 women) or Norplant (R)-2 (n = 14 women) insertion, the maternal blood and breast milk samples were collected at 2, 4 and 8 hourly intervals. This was followed by daily collection of these samples as well as infant's blood from days 2 to 4 and thereafter on days 7, 14 and 28. For infant's blood samples from LNG minipill users (n = 10 women), only a single 4-hour sample was collected on the first day and no samples were collected on days 3 and 4. The rest of the schedule for collection of maternal blood and breast milk as well as infant's blood samples were the same in minipill users as for the other two treatment groups. The study revealed a lower LNG percentage transfer from maternal sera to breast milk--11.8 +/- 2, 7 +/- 2 and 8 +/- 1 and relatively higher percentage LNG transfer from breast milk to infant's sera--75 +/- 17, 68 +/- 20 and 32 +/- 3, in LNG-IUD, Norplant (R)-2 and minipill users, respectively. Therefore, LNG contraceptive steroid is transferred into the infant's circulation, the biological significance of which remains to be established.
A single tablet of either of the three different types of oral contraceptive preparations, viz. "Gynovlar" containing 3000 micrograms norethisterone (NET) and 50 micrograms ethinyl estradiol (EE2) or "Ovral" containing 250 micrograms levonorgestrel (LNG) and 50 micrograms EE2, or a daily progestogen only type--"Minipill" containing 30 micrograms of LNG only, were administered to 40 normal lactating women on a random basis. The sampling schedule in all the three body fluids, i.e. the maternal sera, breast milk and the infant's sera, was kept in such a manner that the peak levels of the contraceptive steroids would be expected to be present in these fluids. The results of this study indicate that the transfer ratio of LNG or NET from the maternal sera to her breast milk was approximately 10% (6-34%) for Gynovlar, 9% (5-18%) for Ovral and 6% (2-34%) for Minipill. However, it was interesting to observe that whereas the transfer ratio of NET or LNG from breast milk to infant's sera was similar for combination pills--8% (3-23%) for Gynovlar and 12% (3-42%) for Ovral, it was significantly higher for progestogen only Minipills--38% (13-92%) for LNG. The precise reason for the higher transfer ratio of LNG from breast milk to infant's serum in Minipill users cannot be explained.
In a randomized clinical study, contraceptive efficacy and bleeding patterns were studied in a group of healthy, regularly menstruating, non-lactating women (n = 84) using two 4.4 cm covered silastic rods containing levonorgestrel, Norplant(R)-2, and compared with another group of women (n = 88) using six 3.4 cm capsules also containing levonorgestrel, Norplant(R). The silastic rods or capsules were placed subdermally in the medial aspect of the upper arm. No method failure was reported up to 24 months of use in this study with either of the device. The bleeding pattern was also similar for both devices as indicated by average episode length, number of bleeding runs and number of spotting days. The continuation rates with both devices were over 80 per 100 users at the end of 12 months and over 65 per 100 users at the end of 24 months. Discontinuations due to expulsion of the device, bleeding problems or personal reasons were few and similar for both devices. The results suggest that silastic-covered rods, Norplant(R)-2, which are comparatively easier to insert and remove and have similar clinical effect, could replace capsules, Norplant(R), as a long-term reversible subdermal contraceptive.
A study was conducted to compare the biological activity of the estrogenic component of the endogenous steroids in breast milk samples collected during various phases of lactation with those milk samples collected from women who were on estrogen therapy. The estrogenic biological activity in the milk sample was assessed by the immature mouse uterine weight gain assay. Milk samples collected during postpartum period from six different study groups, viz., control colostrum of 1-3 days and 4-6 days, transitional milk (10-20 days) and mature milk (1-3 months) were compared with colostrum and mature milk of women treated with Lynoral (ethinyl estradiol 0.1 mg) three times a day for three days. Estrogenic activity was observed only in animals injected with milk extracts of colostrum samples from both control and Lynoral-treated women; however, they were not significantly different from each other. Therefore it is not the exogenous estrogens, but the endogenous estrogen present in large quantities in the colostrum that is responsible for the biological activity.
Pharmacodynamic effect of levonorgestrel (LNG) present in small amounts in infant's circulation has not yet been studied adequately. In our present study, nine women were taking oral minipills (LNG 30 micrograms daily) and 10 were using subdermal implants, Norplant(R)-2, during early postpartum period from four weeks to 15 weeks. These were healthy lactating women in age group 20 to 35 yrs, who had full-term normal delivery of male infants. Daily 4-hour urine samples (from 8 AM to 12 noon) were collected from four weeks onwards to 15 weeks for estimations by radioimmunoassays of follicle stimulating hormone (FSH), luteinizing hormone (LH) and testosterone (T) levels. No significant differences (P greater than 0.05) were found between geometric means of the total area under curve at weekly intervals for FSH, LH and T hormones between the male infants from control group (n=10) when compared with oral minipill or Norplant(R)-2 users. These results are reassuring for future sexual growth and development of children who are exposed to contraceptive steroids during their infancy; however, they do require further confirmation by long-term epidemiological studies incorporating monitoring and surveillance of such children.
The potential for antifertility effect of two bioabsorable pellets, one containing norethisterone (NET) and the other containing levonorgestrel (LNG) fused with cholesterol, was studied in a group of healthy, menstruating but sterilised women. The pellets weighed approximately 30 mg and contain 85% steroid and 15% cholesterol. A single NET pellet was inserted in 4 subjects, out of which 2 were also studied for steroid pattern in blood. After reaching peak levels within 48 hours, the plasma NET levels declined gradually within a fortnight's time, and thereafter, ranged between 200 to 700 mg/ml up to 90 days post-insertion. After this period, occassional spurts of NET release were seen. Bleeding pattern was studied in 37 cycles; mid-luteal progesterone (P) estimation was done in 16 cycles, mid-cycle cervical mucus was studied in 27 cycles and post-coital test (PCT) in 7 cycles. Cycle length with pellet insertion was of 25 to 37 days duration except one cycle of 55 days duration. All cycles studied during the treatment were ovulatory (P greater than 5 ng/ml) and no consistent effect was observed on cervical mucus as well as on PCT. Thus, a single NET pellet does not seem to have a reliable contraceptive potential. A single LNG pellet was inserted in 8 subjects, and steroid patterns were studied in 6 women. Peak levels of LNG were reached within 24 hours of pellet insertion and the levels fell gradually in a week's time. Thereafter, LNG levels ranged between 100-400 pg/ml up to 8 months. In contrast to the observation with NET pellets, only one subject showed frequent spurts of LNG release until the 4th month of treatment. Bleeding pattern was studied in 90 cycles, P was estimated in 52 cycles, mid-cycle cervical mucus studied in 55 cycles and PCT done in 26 cycles. Breakthrough bleeding (BTB) occurred on 15 occasions, 11 episodes being in 2 subjects. Cycle length varied between 21 to 42 days. The LNG pellet did not exert a consistent effect either on ovulation inhibition or cervical mucus or PCT. In their present form, therefore, a single LNG pellet also does not appear to have a reliable contraceptive effect.
A longitudinal study in 60 women was undertaken to observe the changes, if any, in serum bile acids after taking oral combination pills containing either 50 or 30 microgram of ethinyl estradiol. The women were followed up to 12 months. Serum bile acids (cholyglycine conjugates) were estimated by radioimmunoassay. The combination contraceptives had no appreciable effect on serum bile acids.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
The value of luteinizing hormone (LH), progesterone (P) and oestradiol (E2) in serum as an index of ovulation and corpus luteum function was studied in blood samples collected at infrequent intervals during the menstrual cycle from 19 healthy Thai women. A serum P level of more than 3 ng/ml was detectable in 70 to 80 per cent samples obtained between days 20 and 25 and a P peak and/or E2 peak (greater than 150 pg/ml) were found at this time in 85 to 94 per cent of the cycles. In not more than 26 per cent of the cycles was an LH peak (greater than 150 ng/ml-LER-907) detected when all results were considered. A significant P and/or E2 peak on day 22 or 23 occurred in more than 78 per cent of 25 to 33 day cycles, whereas, the P and/or E2 peak was detectable in only 50 per cent of the cycles lasting less than 25 or more than 33 days. The postovulatory serum P levels were the ones most consistently raised in patients studied over several consecutive cycles.
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