Decreased bone mineral density and reproductive axis dysfunction: more than oestrogen.

Decreased bone mineral density (BMD) in oestrogendeficient states has long been thought to be a direct outcome of the reduction in oestrogen. In physiologic and many pathologic hypo-oestrogenic states, oestrogen supplementation improves BMD. However, the relationship between oestrogen replacement and BMD is less clear in the case of reproductive axis dysfunction secondary to decreased caloric intake or increased energy expenditure, such as in female athletes or anorexia nervosa. This decrease in oestrogen is associated with decreased BMD, but oestrogen replacement in these states fails to conclusively improve BMD. This suggests that the decrease in BMD in these states is not driven solely by low oestrogen. Cortisol and other markers of inflammation may play a role in BMD reduction but further research is needed. What is clear is that increased caloric consumption and restoration of menses and the reproductive axis are essential to improving BMD, while pharmacologic therapy, including oestrogen replacement through hormone therapy or contraceptives, does not provide conclusive benefit.

Absorbable subcuticular staples versus suture for caesarean section closure: a randomised clinical trial.

OBJECTIVE: To compare outcomes of efficiency, safety, patient, and surgeon satisfaction between absorbable subcuticular staples and subcuticular suture for caesarean section skin closure. DESIGN: A prospective, randomised, non-blinded, parallel-group trial. SETTING: Mayo Clinic Family Birth Center in Rochester, MN, USA. POPULATION: At least 18 years old and 24 weeks' gestation, undergoing caesarean section. Exclusion criteria were body mass index >50, chorioamnionitis, intrauterine fetal death, and multifetal gestation. METHODS: Patients were stratified by prior caesarean section, body mass index, and surgeon level and randomised to absorbable subcuticular staples or subcuticular suture. Electronic medical records and surveys were used. MAIN OUTCOME MEASURES: Primary outcomes were total operating time, from incision start to close. Secondary outcomes included subcuticular skin closure time, patient and surgeon satisfaction, percutaneous injuries, pain (analgesic use), cosmesis, and wound complications. RESULTS: Of 220 randomised patients, 206 were included in the final analysis (103 per group). Baseline characteristics were similar. The primary outcome of total operative time was not significantly different between groups [54.0 (44.9-63.6) versus 58.0 (50.4-68.2) minutes, P = 0.053]. The subcuticular staple group had shorter subcuticular skin closure time [median 2.6 (1.8-4.0) versus 8.5 (6.2-10.5) minutes, P < 0.001]. There were no differences in analgesic use, wound complications, cosmesis or patient satisfaction. One needlestick injury occurred with suture. Surgeons were more likely to recommend (97% versus 85%, P = 0.004) and use (98% versus 82%, P < 0.001) absorbable subcuticular staples. CONCLUSION: For caesarean section skin closure, absorbable subcuticular staples did not result in significantly different total operative times compared with sutures. Analgesic use, wound complications, and cosmesis were comparable. Patient and surgeon satisfaction were high with both methods. TWEETABLE ABSTRACT: Absorbable subcuticular staples associated with a similar total operative time compared with suture.

Stability of nitroglycerin tablets submitted by U.S. hospitals.

The stability of nitroglycerin tablets that had been stored in hospitals across the United States was studied. Through a voluntary FDA drug stability program, all hospital pharmacies in the United States were asked in October 1981 to complete a response card indicating information about nitroglycerin tablets they had in stock. Based on the responses, FDA selected 167 samples (representing three manufacturers and all available tablet strengths) from pharmacies that represented an adequate cross section of the country. The samples were analyzed for content uniformity, strength, identification, and disintegration; samples that left a residue on the screen of the tablet disintegration basket were tested for dissolution by three methods and compared with samples that did not leave a residue. All samples met USP requirements for content uniformity, strength, and disintegration. Six samples that showed unusual disintegration characteristics dissolved slowly by one or more methods; however, other samples also showed slow dissolution. Nitroglycerin tablets appear to be stable when stored under actual marketplace conditions. The USP disintegration test will not distinguish between rapidly and slowly dissolving tablets.

Decomposition of aminophylline in suppository formulations.

An aminophylline suppository product, when stored at room temperature, was found to be deficient in ethylenediamine content by the USP XIX assay and by a specific method for primary amines. The product also had a melting point that was considerably higher than body temperature. An accelerated decomposition experiment, conducted on normal suppositories of identical original composition, yielded a product refractory at steam bath temperatures and containing no ethylenediamine measurable by the USP assay. The suppositories from both the original sample and the decomposition experiment contained considerable amounts of a white material, which melted at similar to or approximately 150 degrees and which consisted of the diamide products formed by the reaction of ethylenediamine and the fatty acids present in coconut and palm kernel oils. The results, which confirmed the work of Cieszynski, showed that the ethylenediamine constituent of aminophylline can react with suppository base materials to produce insoluble amide decomposition products.