The Optimal Hemostasis Duration After Tooth Extraction: A Randomized Controlled Trial.

Background There is a lack of evidence-based practice regarding the duration of pressure pack placement following tooth extraction. This study aimed to compare the incidence of post-extraction bleeding following 60 minutes versus 10 minutes of pressure pack placement. Methodology A randomized controlled trial was conducted at a tertiary care hospital and included patients requiring intra-alveolar tooth extractions. Patients were randomly allocated into the experimental group or control group by a permuted block randomization method. A blinded observer noted the incidence of post-extraction bleeding. Categorical variables were summarized as frequency and percentage. The chi-square test was used for intergroup statistical analysis. P-values <0.05 were considered statistically significant. Results There were 528 participants, 264 of whom were allocated to each group. The incidence of post-extraction bleeding was 8% and 6.8% in the experimental and control groups, respectively. On bivariate analysis, there was no statistically significant difference between the two groups (p = 0.618; relative risk with 95% confidence interval = 1.0). Conclusions In the majority of cases, hemostasis was achieved in 10 minutes. Therefore, removing the pressure pack after 10 minutes may be advised to ensure hemostasis and, ultimately, save chairside time.

Fasting Lipid Profile in Type 2 Diabetes- Necessity or Redundancy.

Diabetes mellitus is characterized not only by alteration in glucose insulin axis but marked features described as the diabetic dyslipidemia. The increased lipid level and total cholesterol synthesis during hyperglycemia may contribute to the acceleration of atherosclerosis in diabetes mellitus. Majority of guidelines currently recommend a fasting serum lipid for achieving consistency. It is also because majority of research has been performed using fasting lipids, it was assumed that making comparisons and analyzing risk would be less precise if using non-fasting tests. Fasting requirements are difficult for diabetics due to hypoglycemia and can reduce adherence with testing requests, delay results and place strain on testing facilities as a large influx of patients present for testing each morning. MATERIAL: 100 known cases of type-2 diabetes mellitus(as per ADA criteria) were selected after obtaining consent. EXCLUSION CRITERIA: Type 1 DM, pregnancy, CKD, CLD, Familial Dyslipidemias, hypothyroidism, hyperthyroidism, malignancies and Patients on Hypolipidemic drugs, beta blockers, thiazides, diuretics, corticosteroids. Lipid profile after 8 hours fasting and Lipid profile 2 hours after major meal was assessed. HDL-C was assessed by the direct assay method, and Friedewald's formula estimated LDL-C. OBSERVATION: Out of 100 cases, the majority i.e. 46% were from 61-70 years, 38% from 51-60 years, 8% from 41-50 years and 4% each from 30-40 years and above 70 years. Mean age of the study population was 59.98±9.84 years. 51% were females and 49% were males. Prevalence of dyslipidemia in our study was: elevated TC-16%, elevated TG-63%, elevated LDL-17%, elevated VLDL-63% and reduced HDL-96%. Total cholesterol value was elevated in 16% diabetic patients in fasting status and also in post prandial status. Mean total cholesterol value of diabetic patients in fasting status was 170.78±37.90 and in post prandial status was 168.32±31.79. Difference was statistically insignificant. Triglyceride value was elevated in 63% diabetic patients in fasting status and in 68% of diabetic patients in post prandial status. Mean triglyceride value of diabetic patients in fasting status was 181.24±70.89 and in post prandial status was 184.12±70.24. Difference was statistically insignificant. There no statistically significant difference between LDL, HDL and VLDL in fasting and postprandial states. CONCLUSION: There is very negligible difference in the mean values of fasting and postprandial lipid profile in our study. We would like to infer that Fasting lipid profile, which is usualy recomemded in view of consistency is neither covenient nor does it reflect the true biological state the person spends most of their time in.

Usefulness of Cat Score in Patients with Stable Copd and Acute Exacerbation of Copd and it's Co-Relation with PFT.

COPD was reported to be the 6th leading cause of death worldwide in the year 1990 and 4th in 2000. The CAT i.e. COPD Assessment Test was introduced in 2009 as an easy tool to assess health status impairment in COPD patients. The CAT evaluates severity that a patient experiences of many of the symptoms of COPD like breathlessness, cough, phlegm, etc. and is observed to be quite abnormal even in mild form of the disease. Hence it can be used as a simple tool to identify patients who are at increased risk of exacerbations. Material: All OPD and IPD patients coming to Navodaya Medical college Raichur, fulfilling the inclusion criteria i.e- Any patient with acute exacerbation of COPD diagnosed by clinical history and examination,any patient with Stable COPD and willing to participate were enrolled in the study. Patients with Interstitial Lung Diseases, Bronchial Asthma, History of Myocardial Infarction within 1 month, Chest or abdominal pain of any cause, oral or facial pain exacerbated by a mouthpiece, stress incontinence,dementia or confusional state, BMI > 25 kg/ m2 were excluded from the study. Sample size - Acute Exacerbation: Minimum 50 cases. Stable Disease: Minimum 50 cases. Appropriate statistical software, including but not restricted to MS Excel, SPSS ver. 20 were used for statistical analysis. Observation: The coefficient of correlation between CAT score and FEV1 (% predicted) in stable COPD cases is significant at 0.05 level of significance. The coefficient of correlation between CAT score and FEV1: FVC in stable COPD cases at 0.05 level of significance.The association between cases of Acute Exacerbation of COPD on Day 1 and Day 5 was significant between CAT scores, pulse rate, respiratory rate, FVC (%predicted) and FEV1 (%predicted) Conclusion: The CAT score provides a simple and reliable measure of overall COPD related health status for long term follow-up of an individual patient and their assessment. CAT score correlates well with PFT parameters in stable disease and during acute exacerbation. Hence it provides a reliable score of severity of the disease. In addition, the CAT score is cost effective, easy to use and is particularly useful for health settings where access to other objective measurements like spirometry is limited.

Substantial tumor regression in prostate cancer patient with extensive skeletal metastases upon Immunotherapy (APCEDEN): A case report.

RATIONALE: Prostate cancer along with colorectal and lung cancers accounts for 42% of cancer cases in men globally. It is the first cancer indication for which the use of active immunotherapy, Sipuleucel-T (Provenge) was granted by the FDA in 2010. This study presents a case of prostate carcinoma and the tumour remission observed after administration of a personalised Dendritic cell vaccine (APCEDEN). PATIENT CONCERNS: A 58 years old Caucasian male diagnosed with prostate carcinoma with GLEASON score 8. The patient had previously been diagnosed with Renal Cell Carcinoma (RCC) in 1996 and had undergone nephrectomy of the right kidney. PET CT scan revealed multiple intensely PSMA avid lesions noted in both lobes of the prostate gland with SUVmax -28.3 and the prostate gland measuring 3.2 × 3.2 cm displaying maximum dimensions. DIAGNOSIS: FNAC followed by PETCT confirmed CA Prostate and further supported by increased serum PSA level. INTERVENTIONS: The patient underwent personalised Dendritic Cell Immunotherapy APCEDEN regimen of six doses biweekly, in a time frame of 3 months were given both via intravenous and intradermal route. Six months post completion of APCEDEN, the patient was administered 6 booster shots for 6 months. OUTCOMES: Progressive remission of carcinoma was observed along with reduction in PSA and Testosterone levels. PET CT showed decline in PSMA avidity by 50% with SUVmax -14.0 and normal size and shape of prostate gland. LESSONS: Prostate carcinoma is the second most common cancer in men with majority of them exhibiting locally advanced disease. Apparently 20% to 30% of them are categorized as relapsed cases after various therapeutic interventions. Modulating immune system is an emerging therapy termed as Immunotherapy and potentiates the killing cancer cells via immune activation. Interestingly, prostate cancer is slow growing and it provides the scope and time to mount an anti-tumor response which makes it an attractive target for immunotherapy. This case study demonstrates the efficacy of APCEDEN Immunotherapy regimen resulting in a significant disease remission benefiting the patient.

Substantial remission of prostate adenocarcinoma with dendritic cell therapy APCEDEN® in combination with chemotherapy.

Of the most prevalent solid tumors with advanced disease, prostate and ovarian cancer and non-small cell lung carcinoma have the fewest therapeutic options. Herein, we report the case of a 63-year-old male with metastatic prostate adenocarcinoma showing substantial remission post-administration of personalized dendritic cell-based vaccine APCEDEN® in combination with chemotherapeutic drug Mitoxantrone. Therapeutic response displayed an interesting clinical correlation validated by PET scan images showing decreased fluorodeoxyglucose (FDG) avidity in the prostate gland, reduced skeletal metastases further established by the drop in serum Prostate Specific Antigen (PSA) levels and expression of immune assessment markers (IFN-γ, Tregs, neutrophil lymphocyte ratio and platelet lymphocyte ratio). This case demonstrates the potential efficacy of dendritic cell immunotherapy, showing a potent antitumor activity by enhancing the host immune responses, and improving quality of life.

Complete remission of rare adenocarcinoma of the oropharynx with APCEDEN® (dendritic cell-based vaccine): a case report.

APCEDEN ® is an autologous monocyte-derived dendritic cell-based immunotherapy. A 58-year-old man with adenocarcinoma of oropharynx shows complete remission after receiving APCEDEN ® in conjunction with Geftinib validated by reduction in size, whereas Gefitinib alone lead to disease progression.

A retrospective analysis comparing APCEDEN® dendritic cell immunotherapy with best supportive care in refractory cancer.

AIM: A retrospective survival benefit analysis of APCEDEN®, APAC BIOTECH Pvt Ltd 69, Jacranda Marg, DLF PHASE II, Gurugram, Haryana, India, an autologous dendritic cell-based product for management of refractory solid malignancies, was performed in comparison with a control group. METHODS: Subjects (retrospective data) whose survival data, geographical region, age, gender, ECOG performance status and stage of disease that could be matched with the treatment group were considered for analysis. RESULTS: The analysis suggests a significant survival benefit of 199 days for the APCEDEN therapy treatment group when compared with the control group (356 vs 157 days). The event-free survival time of APCEDEN therapy was 439 days in patients who demonstrated an objective response at first evaluation as per immune-related response criteria. CONCLUSION: APCEDEN demonstrated highly convincing survival benefits when compared with the control group.

Immune modulation by dendritic-cell-based cancer vaccines.

The interplay between host immunity and tumour cells has opened the possibility of targeting tumour cells by modulation of the human immune system. Cancer immunotherapy involves the treatment of a tumour by utilizing the recombinant human immune system components to target the pro-tumour microenvironment or by revitalizing the immune system with the ability to kill tumour cells by priming the immune cells with tumour antigens. In this review, current immunotherapy approaches to cancer with special focus on dendritic cell (DC)-based cancer vaccines are discussed. Some of the DC-based vaccines under clinical trials for various cancer types are highlighted. Establishing tumour immunity involves a plethora of immune components and pathways; hence, combining chemotherapy, radiation therapy and various arms of immunotherapy, after analysing the benefits of individual therapeutic agents, might be beneficial to the patient.

Open-label, multi-center, non-randomized, single-arm study to evaluate the safety and efficacy of dendritic cell immunotherapy in patients with refractory solid malignancies, on supportive care.

BACKGROUND AIMS: A phase II clinical trial of an autologous dendritic cell (DC) formulation for the management of refractory solid malignant tumors was conducted across six sites in India with an objective to study safety and efficacy. METHODS: A total of 51 patients with refractory cancer (either sex) with life expectancy ≥3 months, Eastern Cooperative Oncology Group score ≤2, available tumor tissue and adequate organ and bone marrow function were recruited. Monocytes obtained by leukapheresis, differentiated into DCs by cytokines and primed with autologous tumor lysate (fresh tissue biopsy or paraffin block). On the 8th day, mature DCs were analyzed for expression of CD40, CD80, CD83, CD86, DC205 and DC209. The treatment regime consisted of six doses (intravenous) over 14 weeks with 2 post-treatment follow-up visits, 6 weeks apart. Safety was assessed at all visits and responses were evaluated on days 58, 100 and 184 or at end of the study. RESULTS: A total of 38 patients were evaluated for safety and efficacy. One adverse event classified as possibly related was an episode of rigors or chills with mild pyrexia during one infusion. Objective response rate by Response Evaluation Criteria In Solid Tumors was 28.9% (11/38) and immune-related response criteria was 42.1% (16/38); 90% confidence interval for objective response rate was (17.2, 43.3) and (28.5, 56.7) by Response Evaluation Criteria In Solid Tumors and immune-related response criteria, respectively. The median time to treatment progression was >9 weeks. Median overall survival was 397 days. An increase in the expression of interferon-γ was not significant. CONCLUSIONS: Therapy was safe. The responses, time to treatment progression and survival are encouraging for patients with aggressive refractory disease.