Side Effects, Interactions, Warning, Dosage & Uses. SIDE EFFECTSThe following adverse events are based on the experience of 5. Am. Bisome and 2. B deoxycholate) and 9. Am. Bisome and 4. B deoxycholate) in Study 9. Am. Bisome and amphotericin B were infused over two hours. The incidence of common adverse events (incidence of 1. Am. Bisome compared to amphotericin B deoxycholate, regardless of relationship to study drug, is shown in the following table: Empirical Therapy Study 9. Common Adverse Events Adverse Event by Body System Am. Bisomen=3. 43% Amphotericin B n=3. Body as a Whole Abdominal pain 1. Asthenia 1. 3. 1 1. Back pain 1. 2 7. Blood product transfusion react. Chills 4. 7. 5 7. Infection 1. 1. 1 9. Pain 1. 4 1. 2. 8 Sepsis 1. Cardiovascular System Chest pain 1. Hypertension 7. 9 1. Hypotension 1. 4.
Tachycardia 1. 3. Digestive System Diarrhea 3. Gastrointestinal hemorrhage 9. Nausea 3. 9. 7 3. MINI-REVIEW MICROBIOLOGY. The use of standard methodology for determination of antifungal activity of natural products against medical yeasts Candida sp and. Vomiting 3. 1. 8 4. Metabolic and Nutritional Disorders Alkaline phosphatase increased 2. ![]() ALT (SGPT) increased 1. AST (SCOT) increased 1. Bilirubinemia 1. 8. BUN increased 2. 1 3. Creatinine increased 2. Edema 1. 4. 3 1. 4. Hyperglycemia 2. 3 2. Hypematremia 4. 1 1. Hypervolemia 1. 2. Hypocalcemia 1. 8. Hypokalemia 4. 2. Hypomagnesemia 2. Peripheral edema 1. Nervous System Anxiety 1. Confusion 1. 1. 4 1. Headache 1. 9. 8 2. Insomnia 1. 7. 2 1. Respiratory System Cough increased 1. Dyspnea 2. 3 2. 9. Epistaxis 1. 4. 9 2. Hypoxia 7. 6 1. 4. Lung disorder 1. 7. Pleural effusion 1. Rhinitis 1. 1. 1 1. Skin and Appendages Pruritus 1. Rash 2. 4. 8 2. 4. Sweating 7 1. 0. 8. Urogenital System Hematuria 1. Am. Bisome was well tolerated. Am. Bisome had a lower incidence of chills, hypertension, hypotension, tachycardia, hypoxia, hypokalemia, and various events related to decreased kidney function as compared to amphotericin B deoxycholate. In pediatric patients (1. Am. Bisome compared to amphotericin B deoxycholate had a lower incidence of hypokalemia (3. Similar trends, although with a somewhat lower incidence, were observed in open- label, randomized Study 1. Am. Bisome and 6. B deoxycholate). Pediatric patients appear to have more tolerance than older individuals for the nephrotoxic effects of amphotericin B deoxycholate. The following adverse events are based on the experience of 2. Am. Bisome 3 mg/kg, 8. Am. Bisome 5 mg/kg and 7. B lipid complex 5 mg/kg in Study 9. Am. Bisome and amphotericin B lipid complex were infused over two hours. The incidence of adverse events occurring in more than 1. Empirical Therapy Study 9. Common Adverse Events Adverse Event by Body System Am. Bisome. 3 mg/kg/day n=8. Am. Bisome. 5 mg/kg/day n=8. Amphotericin B Lipid Complex 5 mg/kg/day n=7. Body as a Whole Abdominal pain 1. Asthenia 8. 2 6. 2 1. Chills/rigors 4. 0 4. Sepsis 1. 2. 9 7. Transfusion reaction 1. Cardiovascular System Chest pain 8. Hypertension 1. 0. Hypotension 1. 0. Tachycardia 9. 4 1. Digestive System Diarrhea 1. Nausea 2. 5. 9 2. Vomiting 2. 2. 4 2. Metabolic and Nutritional Disorders Alkaline phosphatase increased 7. Bilirubinemia 1. 6. BUN increased 2. 0 1. Creatinine increased 2. Edema 1. 2. 9 1. 2. Hyperglycemia 8. 2 8. Hypervolemia 8. 2 1. Hypocalcemia 1. 0. Hypokalemia 3. 7. Hypomagnesemia 1. Liver function tests abnormal 1. Nervous System Anxiety 1. Confusion 1. 2. 9 8. Headache 9. 4 1. 7. Respiratory System Dyspnea 1. Epistaxis 1. 0. 6 8. Hypoxia 7. 1 6. 2 2. Lung disorder 1. 4. Skin and Appendages Rash 2. The following adverse events are based on the experience of 2. Am. Bisome 3 mg/kg, 9. Am. Bisome 6 mg/kg and 8. B deoxycholate 0. Study 9. 4- 0- 0. HIV positive patients. The incidence of adverse events occurring in more than 1. Cryptococcal Meningitis Therapy Study 9. Common Adverse Events Adverse Event by Body System Am. Bisome 3 mg/kg/day n=8. Am. Bisome 6 mg/kg/day n=9. Amphotericin B 0. Body as a Whole Abdominal pain 7 7. Infection 1. 2. 8 1. Procedural Complication 8. Cardiovascular System Phlebitis 9. Digestive System Anorexia 1. Constipation 1. 5. Diarrhea 1. 0. 5 1. Nausea 1. 6. 3 2. Vomiting 1. 0. 5 2. Hemic and Lymphatic System Anemia 2. Leukopenia 1. 5. 1 1. Thrombocytopenia 5. Metabolic and Nutritional Disorders Bilirubinemia 0 8. BUN increased 9. 3 7. Creatinine increased 1. Hyperglycemia 9. 3 1. Hypocalcemia 1. 2. Hypokalemia 3. 1. Hypomagnesemia 2. Hyponatremia 1. 1. Liver Function Tests Abnormal 1. Nervous System Dizziness 7 8. Insomnia 2. 2. 1 1. Respiratory System Cough Increased 8. Skin and Appendages Rash 4. Infusion Related Reactions In Study 9. Day 1). Am. Bisome- treated patients had a lower incidence of infusion related. Day 1 as compared to amphotericin B deoxycholate- treated patients. The incidence of infusion related reactions on Day 1 in pediatric and adult. Incidence of Day 1 Infusion Related Reactions (IRR) By Patient. Age Pediatric Patients( ≤ 1. Adult Patients( > 1 6 years of age) Am. Bisome Amphotericin B Am. Bisome Amphotericin B Total number of patients receiving at least one dose of study drug 4. Patients with fever†Increase ≥ 1. C 6(1. 3%) 2. 2 (4. Patients with chills/rigors 4 (8%) 2. Patients with nausea 4 (8%) 4 (9%) 3. Patients with vomiting 2 (4%) 7(1. Patients with other reactions 1. Day 1 body temperature increased above the temperature taken within. Cardiorespiratory events, except for vasodilatation (flushing), during all study drug infusions were more frequent in amphotericin B- treated patients as summarized in the following table: Incidence of Infusion Related Cardiorespiratory Events Event Am. Bisomen=3. 43 Amphotericin Bn=3. Hypotension 1. 2 (3. Tachycardia 8 (2. Hypertension 8 (2. Vasodilatation 1. Dyspnea 1. 6 (4. 7%) 2. Hyperventilation 4(1. Hypoxia 1 (0. 3%) 2. The percentage of patients who received drugs either for the treatment or prevention of infusion related reactions (e. Am. Bisome- treated patients compared with amphotericin B deoxycholate- treated patients. In the empirical therapy study 9. Day 1, where no premedication was administered, the overall incidence of infusion related events of chills/rigors was significantly lower for patients administered Am. Bisome compared with amphotericin B lipid complex. Fever, chills/rigors and hypoxia were significantly lower for each Am. Bisome group compared with the amphotericin B lipid complex group. The infusion related event hypoxia was reported for 1. B lipid complex- treated patients compared with 0% of patients administered 3 mg/kg per day Am. Bisome and 1. 2% of patients treated with 5 mg/kg per day Am. Bisome. Incidence of Day 1 Infusion Related Reactions (IRR) Chills/Rigors Empirical Therapy Study 9. Am. Bisome Amphotericin B lipid complex 5 mg/kg/day 3 mg/kg/day 5 mg/kg/day BOTH Total number of patients 8. Patients with Chills/Rigors (Day. Patients with other notable reactions: Fever ( > 1 . C increase. in temperature) Nausea 2. Vomiting 9(1. 0. 6%) 7 (8. Hypertension 5 (5. Tachycardia 4 (4. Dyspnea 2 (2. 4%) 8 (9. Hypoxia 4 (4. 7%) 8 (9. Day 1 body temperature increased above the temperature taken within 1. Patients were not administered premedications to prevent infusion related reactions. Day 1 study drug infusion. In Study 9. 4- 0- 0. Am. Bisome and amphotericin B deoxycholate as initial therapy for cryptococcal meningitis, premedications to prevent infusion related reactions were permitted. Am. Bisome treated patients had a lower incidence of fever, chill/rigors and respiratory adverse events as summarized in the following table: Incidence of Infusion- Related Reactions Study 9. Am. Bisome 3 mg/kg Am. Bisome 6 mg/kg Amphotericin B Total number of patients receiving at least one dose of study drug 8. Patients with fever increase of > 1 °C 6 (7%) 8 (9%) 2. Patients with chills/rigors 5 (6%) 8 (9%) 4. Patients with nausea 1. Patients with vomiting 1. Respiratory adverse events 0 1 (1%) 8 (9%)There have been a few reports of flushing, back pain with or without chest tightness, and chest pain associated with Am. Bisome administration; on occasion this has been severe. Where these symptoms were noted, the reaction developed within a few minutes after the start of infusion and disappeared rapidly when the infusion was stopped. The symptoms do not occur with every dose and usually do not recur on subsequent administrations when the infusion rate is slowed. Toxicity and Discontinuation of Dosing. In Study 9. 4- 0- 0. Am. Bisome group compared with the amphotericin B group. ELISA : Principle, Procedure, Types, Applications and Animation. Enzyme Linked Immunosorbent Assay (ELISA) is a very sensitive immunochemical technique which is used to access the presence of specific protein (antigen or antibody) in the given sample and it’s quantification. It is also called solid- phase enzyme immunoassay as it employs an enzyme linked antigen or antibody as a marker for the detection of specific protein. An enzyme conjugated with an antibody reacts with a colorless substrate to generate a colored reaction product. A number of enzymes have been employed for ELISA, including alkaline phosphatase, horseradish peroxidase, and B- galactosidase. Principle of ELISAELISA is a plate- based assay technique. Along with the enzyme- labelling of antigens or antibodies, the technique involves following three principles in combination which make it one of the most specific and sensitive than other immunoassays to detect the biological molecule: An immune reaction i. Enzymatic chemical reaction i. Signal detection and Quantification i. General Procedure of ELISATypes of ELISAA number of variations of ELISA have been developed, allowing qualitative detection or quantitative measurement of either antigen or antibody. Indirect ELISAThe indirect ELISA detects the presence of antibody in a sample. The antigen for which the sample must be analyzed is adhered to the wells of the microtiter plate. The primary antibody present in the sample bind specifically to the antigen after addition of sample. The solution is washed to remove unbound antibodies and then enzyme conjugated secondary antibodies are added. The substrate for enzyme is added to quantify the primary antibody through a color change. The concentration of primary antibody present in the serum directly correlates with the intensity of the color. Advantages. A wide variety of labeled secondary antibodies are available commercially. Versatile because many primary antibodies can be made in one species and the same labeled secondary antibody can be used for detection. Maximum immunoreactivity of the primary antibody is retained because it is not labeled. Sensitivity is increased because each primary antibody contains several epitopes that can be bound by the labeled secondary antibody, allowing for signal amplification. Disadvantages. Cross- reactivity might occur with the secondary antibody, resulting in nonspecific signal. An extra incubation step is required in the procedure. Sandwich ELISAThe sandwich ELISA is used to identify a specific sample antigen. The wells of microtiter plate are coated with the antibodies. Non- specific binding sites are blocked using bovine serum albumin. The antigen containing sample is applied to the wells. A specific primary antibody is then added after washing. This sandwiches the antigen. Enzyme linked secondary antibody is added that binds primary antibody. Unbound antibody- enzyme conjugates are washed off. The substrate for enzyme is introduced to quantify the antigens. Advantages. High specificity because the antigen/analyte is specifically captured and detected. Suitable for complex (or crude/impure) samples as the antigen does not require purification prior to measurement. Flexible and sensitive, both direct or indirect detection methods can be used. Competitive ELISAThis type of ELISA depends on the competitive reaction between the sample antigen and antigen bound to the wells of microtiter plate with the primary antibody. First, the primary antibody is incubated with the sample. This results in the formation of Ag- Ab complex which are then added to the wells that have been coated with the same antigens. After an incubation, unbound antibodies are washed off. The more antigen in the sample, more primary antibody will bind to the sample antigen. Therefore there will be smaller amount of primary antibody available to bind to the antigen coated on well. Secondary antibody conjugated to an enzyme is added, followed by a substrate to elicit a chromogenic signal. Concentration of color is inversely proportional to the amount of antigen present in the sample. Advantages. It is highly sensitive even when the specific detecting antibody is present in relatively small amounts. ELISA Data Interpretation. The ELISA assay yields three different types of data output: Quantitative: ELISA data can be interpreted in comparison to a standard curve (a serial dilution of a known, purified antigen) in order to precisely calculate the concentrations of antigen in various samples. Qualitative: ELISAs can also be used to achieve a yes or no answer indicating whether a particular antigen is present in a sample, as compared to a blank well containing no antigen or an unrelated control antigen. Semi- Quantitative: ELISAs can be used to compare the relative levels of antigen in assay samples, since the intensity of signal will vary directly with antigen concentration.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. Archives
November 2017
Categories |