Effectiveness of Cimetidine as Adjuvant Therapy in the Treatment of Acute-Extrinsic Atopic Dermatitis: A Double-Blind Randomized Controlled Trial.

INTRODUCTION: Acute extrinsic atopic dermatitis (AD) requires long-term treatment. Cimetidine could be used as an adjuvant therapy for acute-extrinsic AD due to immunomodulatory effects. This study aims to assess the effectiveness of cimetidine as an adjuvant to standard treatment in acute extrinsic AD. METHODS: This is a double-blind randomized controlled trial involving 26 AD patients aged 12-60 years from 2017 to 2020. Effectiveness of cimetidine was assessed by comparing SCORing Atopic Dermatitis (SCORAD) and objective SCORAD changes in both groups at week 2, 4, 6, and 8. Serum levels of immunoglobulin E (IgE), interferon (IFN)-γ, interleukin (IL)-12, and IL-4 were also documented. RESULTS: Significant differences were observed in SCORAD changes at week 2, 4, 6, and 8 (p = 0.004; p = 0.001; p < 0.001; and p < 0.001 respectively), objective SCORAD changes at week 2, 4, 6, and 8 (p = 0.004, p = 0.001, p < 0.001, and p < 0.001 respectively), and IgE level changes at week 8 (p = 0.002) between the two groups. However, there were no significant changes in IFN-γ, IL-12, and IL-4 levels between the two groups. CONCLUSION: Cimetidine is a safe and effective adjuvant therapy for acute-extrinsic AD. TRIAL REGISTRATION: NCT04018131.

A Clinical Trial on Biological Half Life of Bioactive Protein from Lumbricus rubellus, DLBS1033 in Healthy Volunteers.

BACKGROUND: DLBS1033 is a bioactive protein fraction extracted from Lumbricus rubellus, with fibrinogenolytic, fibrinolytic and anti-aggregation activities reported in an in vitro study. Plasma half-life is an important parameter to calculate its dose. This study was conducted to evaluate the biological half-life of DLBS1033 by measuring serial plasmin-antiplasmin (PAP) complex. PAP complex is a stable and inactive compound as a result of fibrinolysis process. METHODS: this was an open-label clinical trial in healthy adult subjects. Subjects were divided into two groups to receive single dose drugs (received 3 x 490 mg) or repeated administration until steady state conditions (3 x 490 mg/day for 3 days). Blood samples for PAP complex measurement were collected at time 0 (before drug administration for single dose group), then at 0.5, 1, 1.5, 2, 3, 6, 8, 10, 12, and 24 hours after drug administration. Safety parameters used in this study were creatinine, prothrombin time (PT), activated partial thromboplastin time (aPTT), SGOT, and SGPT. RESULTS: the biological half-life of DLBS1033 was calculated based on the mean of PAP complex concentration on each time sampling. In single dose group, the highest mean of PAP complex concentration was reached before drug administration. Our result showed that the activity of DLBS1033 could not be determined after single dose administration. In steady state condition, the PAP complex concentration increase in 2 hours after last drug administration. The biological half-life of DLBS1033 was 8.6 hours. There were no significant safety findings on all laboratory parameters and no serious adverse events. CONCLUSION: it is concluded that the fibrinolytic effects of DLBS1033 can be measured in steady state condition. The biological half-life of DLBS1033 in steady state condition was 8.6 hours. There were no serious adverse events on two groups of subjects.

Correlation Between Vitreous Advanced Glycation End Products, and D-dimer with Blood HbA1c Levels in Proliferative Diabetic Retinopathy.

BACKGROUND: proliferative diabetic retinopathy (DR) is an advanced form of DR that eventually could lead to blindness. Levels of vitreous advanced glycation end products (AGEs) and D-dimer may reflect the pathological changes in the retina, but only few studies have assessed their correlation with blood hemoglobin A1C (HbA1c) levels. This study aimed to find the association between blood HbA1c levels with vitreous AGEs and D-dimer levels in patients with proliferative DR. METHODS: an analytical cross-sectional study was performed in subjects with proliferative DR who underwent vitrectomy. Subjects were divided into 2 subgroups, i.e. uncontrolled (HbA1c >7%) and controlled (HbA1c <7%) groups. Vitreous AGEs and D-dimer levels were assessed; the levels were compared between uncontrolled and controlled hyperglycemic patients. Statistic correlation tests were also performed for evaluating blood HbA1c, vitreous AGEs, and D-dimer levels. RESULTS: a total of 47 patients were enrolled in this study and 32 (68.1%) of them were women. Median vitreous AGEs level was 11.0 (3.0 - 48.0) µg/mL; whereas median vitreous D-dimers level was 5,446.0 (44.0 - 37,394.0 ) ng/mL. The median vitreous AGEs levels was significantly higher in patients with uncontrolled vs. controlled hyperglycemia (14.0 vs. 4.0 mg/mL; p<0.001). There was a significant positive correlation with moderate strength between blood HbA1c level and vitreous AGEs level (r=0.524; r2=0.130; p=0.0001). Blood HbA1c level could be used to predict vitreous AGEs level by using the following calculation: vitreous AGEs = -1.442+ (1.740xblood HbA1c). Vitreous D-dimer levels were not significantly different between uncontrolled and controlled hyperglycemia (median 4607.5 vs. 5701.6 ng/mL; p = 0.458). There was a positive significant correlation between blood HbA1c and vitreous D-dimer levels (r = 0.342; p = 0.019); however the correlation was weak. Vitreous AGEs level had a positive significant correlation with vitreous D-dimer levels (r = 0.292; p = 0.046) and the correlation strength was also weak. CONCLUSION: median vitreous AGEs levels were significantly higher in proliferative DR patients with uncontrolled than those with controlled hyperglycemia. Blood HbA1c level can be used to assess vitreous AGEs level in patients with proliferative DR by using the following calculation: vitreous AGEs = -1.442+(1.740 x HbA1c). However, the blood HbA1c level can not be used to predict vitreous D-dimer level in patients with proliferative DR.

The correlation between coagulation test and albumin with antithrombin III in Dengue hemorrhagic fever.

AIM: To analyse the correlation between coagulation tests (PT APTT fibrinogen, D-dimer) and albumin with AT-II in DHF as well to find the formula to calculate AT-III with the parameter of coagulation tests and albumin. METHODS: A descriptive-correlative cross sectional study was conducted to 49 patients with DHF consisted of DHF I(17), DHF (19), DHF III (6) and DHF IV (7). The diagnosis of DHF is based on WHO criteria 1997. The laboratory examinations were coagulation tests (PT, APT, fibrinogen and D-dimer), antithrombin III and albumin, performed when the fever subside and the platelets reached the lowest count(4(th) - 6(th) day). RESULTS: A significant correlation was found between PT and AT-III (r= -0.631; p=0.000), between D-dimer and AT-III (r= -0.337; p=0.021) and between albumin and AT-III (r= 0.291; p-0.045). In multiple linier regression analysis(backward), AT-III can be calculated with the formula, accuracy 68.3%. CONCLUSIONS: PT and D-dimer were correlated negatively with AT-III, however albumin was correlated positively with AT-III. PT, D-dimer and AT-III were correlated with the grading severity of the DHF. In this study, AT-III can be calculated with the formula, accuracy 68.3%.