ABSTRACT
Background: Maternal and fetal status are reflected in placenta. Toxemia of pregnancy exerts great impact on placenta and thereby fetal and maternal outcomes. Placenta reflects changes of toxemia and these changes are seen morphology as well as histology. Hence study of placenta gives information on the in-utero fetal condition.Methods: A total of 1000 placenta, 500 each from hypertensive and normotensive groups were included in this study conducted in Anatomy Department of SBKS Medical College and Research Centre, Vadodara. Histological evaluation of the samples taken was done under microscope.Results: Microscopic examination of the placenta revealed the presence of calcification, infarction, fibrinoid necrosis, villous hyalinization, syncytial knots and cytotrophoblastic cellular proliferation in both control and hypertension groups. In the present study, calcification was seen in 35.8% in the control group, while the same was seen in 53.8% patients in test group. Fibrinoid necrosis was seen in 48.8% patients in control group as against 69% patients in test group. Villous Hyalinization was seen in 7.40% and 21.4% patients in control and test groups respectively. On the other hand, syncytial knots were seen in 38% and 69% patients in control and test groups respectively. In test group, cytotrophoblastic cellular proliferation was seen in 69% patients while in control group, it was seen in 33.2% patients. Infarction was also seen in test (42.4%) and control (12.6%) groups.Conclusions: Hypertensive disorders of pregnancy have significant effect on the histology of placenta and also influences the fetal outcomes.
ABSTRACT
Biologics are highly sensitive large molecules with complex structure, difficult to characterize and reproduce, derived from living cells; used for treatment, diagnosis or prevention of disease. Examples are therapeutic hormones, vaccines, monoclonal antibodies etc. Biologicals are beneficial in the management of several health conditions which were once upon a time difficult to manage like cancer, multiple sclerosis, Alzheimer’s disease, rheumatoid arthritis, diabetes etc. Biosimilars are proteins that are similar to innovator biologics but not the same as they differ slightly in structure however with no clinically significant difference. Biosimilars are not the exact replicas of originator biologic and are therefore not generics. Biosimilars for their approval are not required to undergo intense clinical trials as innovator biologic but are required to produce data that demonstrates its similarity to an original biologic in terms of clinical efficacy and safety. However, manufactures of both the biologics and biosimilars are required to submit pharmacovigilance and risk management plans as part of their application. Marketing authorization for biosimilars was for the first time framed by EMA along with the guidelines for developing them. As biologics and biosimilars are derived proteins they have immunogenic potential and risk of adverse events which cautions their use. Pharmacovigilance is needed to ensure that adverse events are quickly detected, reported and attributed to the correct product and manufacturer. Regulations are implemented to improve identification and traceability of biologics. Automatic substitution should not be permitted for biologicals.