PERBEDAAN KADAR UREUM DAN KREATININ PADA ST-ELEVATION MYOCARD INFARCTION (STEMI) DAN NON ST ELEVATION MYOCARD INFARCTION (N-STEMI)

Latar belakang: Infark Miokard Akut (IMA) menyebabkan penurunan curah jantung dan aliran darah menuju ginjal sehingga dapat mengakibatkan fungsi ginjal menurun yang dapat dilihat dari kenaikan ureum dan kreatinin. Kenaikan ureum dan kreatinin dapat sebagai petanda laboratorium untuk membedakan antara ST-elevation  myocard infartion (STEMI) dengan non ST elevation myocard infarction (NSTEMI) sehingga mempercepat penanganan dan menurunkan kasus kematian IMA. Tujuan penelitian ini untuk mengetahui apakah terdapat perbedaan kadar ureum dan kreatinin antara pasien STEMI dengan NSTEMI.Metode: Desain penelitian belah lintang, data sekunder diambil dari rekam medik dari bulan Januari - September 2017 di RSUP Dr. Kariadi. Jumlah sampel 80 pasien, digolongkan dua kelompok yaitu STEMI dan NSTEMI berdasarkan pemeriksaan EKG dan enzim jantung (troponin dan CKMB). Kadar ureum dan kreatinin serum diperiksa dengan alat ADVIA 1800. Data dianalisis dengan program statistik SPSS v.15 menggunakan uji beda mann whitney.Hasil: Ada perbedaan bermakna kadar ureum dan kreatinin antara STEMI dan NSTEMI (p=0,010 dan p=0,003). Hal ini dikarenakan kerusakan otot jantung menyebabkan penurunan curah jantung yang menuju ginjal lebih tinggi pada kasus STEMI dibandingkan NSTEMI.Simpulan: Simpulan: Kadar Ureum dan kreatinin lebih tinggi bermakna pada STEMI. Peningkatan kadar ureum dan kreatinin perlu diperhatikan pada kasus infark miokard. Kata Kunci: Ureum, kreatinin, Infark Miokard Akut, STEMI, NSTEM

Safety and efficacy of dendritic cell vaccine for COVID-19 prevention after 1-Year follow-up: phase I and II clinical trial final result

IntroductionInterim analysis of phase I and phase II clinical trials of personalized vaccines made from autologous monocyte-derived dendritic cells (DCs) incubated with S-protein of SARS-CoV-2 show that this vaccine is safe and well tolerated. Our previous report also indicates that this vaccine can induce specific T-cell and B cell responses against SARS-CoV-2. Herein, we report the final analysis after 1 year of follow-up regarding its safety and efficacy in subjects of phase I and phase II clinical trials.MethodsAdult subjects (>18 years old) were given autologous DCs derived from peripheral blood monocytes, which were incubated with the S-protein of SARS-CoV-2. The primary outcome is safety in phase I clinical trials. Meanwhile, optimal antigen dosage is determined in phase II clinical trials. Corona Virus Disease 2019 (COVID-19) and Non-COVID-19 adverse events (AEs) were observed for 1 year.ResultsA total of 28 subjects in the phase I clinical trial were randomly assigned to nine groups based on antigen and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) dosage. In the phase II clinical trial, 145 subjects were randomly grouped into three groups based on antigen dosage. During the 1-year follow-up period, 35.71% of subjects in phase I and 16.54% in phase II had non-COVID AEs. No subjects in phase I experienced moderate–severe COVID-19. Meanwhile, 4.31% of subjects in phase II had moderate–severe COVID-19. There is no difference in both COVID and non-COVID-19 AEs between groups.ConclusionsAfter 1 year of follow-up, this vaccine is proven safe and effective for preventing COVID-19. A phase III clinical trial involving more subjects should be conducted to establish its efficacy and see other possible side effects

Diagnostic Value of Vascular Endothelial Growth Factor C (VEGF-C) and CA 15-3 in Breast Cancer

ABSTRACT Background: expression of VEGF-C and CA 15-3 may be useful to differentiate between malignant and benign breast tumour because VEGF-C plays a role in promoting angiogenesis and lymphangiogenesis in malignant processes and CA 15-3 is the soluble form of transmembrane protein MUC1, a tumour marker which shows higher expression in breast cancer.Objective: to determine the diagnostic value of VEGF-C and CA 15-3 as tumour markers in patients with breast cancer.Methods: this diagnostic study recruited 76 patients that underwent surgical biopsy procedures at Dr. Kariadi and Pantiwilasa Citarum Hospitals Semarang. The VEGF-C and CA 15-3 levels in blood specimens taken before surgical biopsy procedure was determined using ELISA method. An ROC curve and AUC were used to establish the cut-off points and diagnostic value. Pathology examination results from the biopsy specimens were used as the gold standard.Results: the cut-off value for VEGF-C and CA 15-3 were 989.50 pg/mL and 74.00 U/mL. Sensitivity for VEGF-C, CA 15-3 and VEGF-C+CA 15-3 were 76.6%, 64.1% and 89.1%. Specificity for VEGF-C, CA 15-3 and VEGF-C+CA 15-3 were 75.0%, 75.0% and 50.0%. The AUC for VEGF-C, CA 15-3 and VEGF-C+CA 15-3 was 0.831 (95% CI = 0.727-0.934), 0.742 (95% CI = 0.628-0.856) and 0.840 (95% CI = 0.742-0.938).Conclusion: VEGF-C in combination with CA 15-3 is the best diagnostic parameter for breast cancer and has the best accuracy as a tumour marker for breast cancer

Hubungan Kadar HbA1c dan Rasio TG/HDL dengan Cystatin-C Serum pada Pasien Diabetes Melitus Tipe 2

Latar belakang: Diabetes melitus (DM)  tipe 2 dapat menyebabkan komplikasi salah satunya nefropati. Kontrol glikemik yang dinilai dengan HbA1c dan dislipidemia yang dinilai dengan rasio trigliserida/high density lipoprotein (TG/HDL) diduga berhubungan dengan komplikasi nefropati. Cystatin C merupakan petanda yang dapat menilai kerusakan fungsi ginjal dini. Hubungan kadar HbA1c dan rasio TG/HDL dengan Cystatin C pada pasien DM tipe 2 belum diketahui dengan jelas. Tujuan: Mengetahui hubungan antara kadar HbA1c dan rasio TG/HDL dengan Cystatin C pada pasien diabetes melitus tipe 2. Metode: Penelitian observasional analitik dengan pendekatan belah lintang dilakukan pada bulan April - Juni 2019 melibatkan 34 pasien DM tipe 2 di Puskesmas Karang Ayu yang memenuhi kriteria inklusi dan ekslusi. Pemeriksaan kadar HbA1c menggunakan metode HPLC, rasio TG/HDL dihitung dengan perbandingan TG dengan HDL yang diperiksa menggunakan alat kimia klinik otomatis, kadar Cystatin C menggunakan metode ELISA. Uji statistik menggunakan korelasi Spearman. p < 0,05 dianggap signifikan.  Hasil: Rerata±SD kadar HbA1c adalah 8,21±1,65. Median (minimum-maksimum) rasio TG/HDL dan Cystatin C berturut-turut adalah 3,65(1,3–9,7), 0,72(0,46 – 1,22) mg/L. Korelasi HbA1c dengan Cystatin C dan rasio TG/HDL dengan Cystatin C berturut-turut adalah (r = 0,505; p = 0,002) dan (r = 0,471; p = 0,005). Simpulan: Terdapat hubungan positif sedang bermakna antara kadar HbA1c dengan Cystatin C  dan rasio TG/HDL dengan Cystatin C pada pasien diabetes melitus tipe 2. Kata kunci: HbA1c, rasio TG/HDL, Cystatin C, DM.   The correlation of HbA1c and TG/HDL ratio with serum cystatin C in type 2 diabetes patients   Background: Type 2 diabetes mellitus (DM) can cause chronic complications such as nephropathy. Glycemic control assessed with HbA1c and dyslipidemia assessed by the tryglyceride/high density lipoprotein (TG / HDL) ratio is thought to be associated with complications of nephropathy. Cystatin C is a marker that can assess early kidney function damage. Relationship between HbA1c levels and TG / HDL ratio with Cystatin C in type 2 DM patients is not clearly known. Objective: to investigate the correlation of HbA1c and TG/HDL ratio with Cystatin C  in acute type 2 diabetes mellitus patients. Methods: Analytic observational study with cross sectional approach was conducted in April-June 2019 involving 34 type 2 diabetes mellitus patients at the Karang Ayu Puskesmas who were screened according to the inclusion and exclusion criteria. The level of HbA1c were measured by the HPLC method, TG/HDL ratio was measured by automatic chemistry analyzer and Cystatin C was measured by ELISA method. Statistical analysis used Spearman Correlation Test. p <0.05 was considered significant. Results: The mean ± SD HbA1c level was 8.21 ± 1.65. The median (minimum-maximum) ratio of TG / HDL and Cystatin C were 3.65 (1.3–9.7), 0.72 (0.46 - 1.22) mg / L, respectively. Correlation of HbA1c with Cystatin C and the ratio of TG / HDL with Cystatin C respectively (r = 0.505; p = 0.002) and (r = 0.471; p = 0.005). Conclusions: There are significant moderate positive correlation between HbA1c with  Cystatin C and TG/HDL ratio with Cystatin C in type 2 diabetes mellitus patients. Keywords : HbA1c, TG/HDL ratio, Cystatin C, Type 2 Diabetes mellitus

A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a world-wide pandemic. Internationally, because of availability, accessibility, and distribution issues, there is a need for additional vaccines. This study aimed to: establish the feasibility of personal dendritic cell vaccines to the SARS-CoV-2 spike protein, establish the safety of a single subcutaneous vaccine injection, and determine the antigen-specific immune response following vaccination. In Phase 1, 31 subjects were assigned to one of nine formulations of autologous dendritic cells and lymphocytes (DCL) incubated with 0.10, 0.33, or 1.0 µg of recombinant SARS-CoV-2 spike protein, and admixed with saline or 250 or 500 µg of granulocyte-macrophage colony-stimulating factor (GM-CSF) prior to injection, then assessed for safety and humoral response. In Phase 2, 145 subjects were randomized to one of three formulations defined by incubation with the same three quantities of spike protein without GM-CSF, then assessed for safety and cellular response. Vaccines were successfully manufactured for every subject at point-of-care. Approximately 46.4% of subjects had a grade 1 adverse event (AE); 6.5% had a grade 2 AE. Among 169 evaluable subjects, there were no acute allergic, grade 3 or 4, or serious AE. In Phase 1, anti-receptor binding domain antibodies were increased in 70% of subjects on day-28. In Phase 2, in the 127 subjects who did not have high levels of gamma interferon-producing cells at baseline, 94.4% had increased by day 14 and 96.8% by day 28. Point-of-care personal vaccine manufacturing was feasible. Further development of such subject-specific vaccines is warranted