1.Quantification of 17-desacetyl norgestimate in human plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and its application to bioequivalence study
Saxena Ashish ; Gupta Kumar Arun ; Kumar Praveen V. ; Nainar Sundaramoorthi M. ; Bob Manoj ; Kasibhatta Ravisekhar
Journal of Pharmaceutical Analysis 2015;(2):93-100
A rapid and sensitive ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) method was developed and validated for the estimation of 17-desacetyl norgestimate in human plasma using solid-phase extraction technique. 17-desacetyl norgestimate D6 was used as the internal standard. Simple gradient chromatographic conditions and mass spectrometric detection enabled accurate and precise measurement of 17-desacetyl norgestimate at sub-picogram levels. The proposed method was validated for a linear range of 20–5000 pg/mL with a correlation coefficient Z 0.9988. The intra-run and inter-run precision and accuracy were within 10%. The overall recoveries for 17-desacetyl norgestimate and 17-desacetyl norgestimate D6 were 96.30%and 93.90%, respectively. The total run time was 4.5 min. The developed method was applied for the determination of the pharmacokinetic parameters of 17-desacetyl norgestimate following a single oral administration of a norgestimate and ethinyl estradiol 0.250 mg/0.035 mg tablets in 35 healthy female volunteers.
2.Role of Peroral Endoscopic Myotomy in Advanced Achalasia Cardia With Sigmoid and/or Megaesophagus: A Systematic Review and Metanalysis
Harshal S MANDAVDHARE ; Praveen KUMAR M ; Jayendra SHUKLA ; Antriksh KUMAR ; Vishal SHARMA
Journal of Neurogastroenterology and Motility 2022;28(1):15-27
Background/Aims:
Sigmoid esophagus and/or megaesophagus are considered as an advanced stage in the natural history of achalasia cardia. The role of peroral endoscopic myotomy (POEM) in these subset of patients is emerging. We performed a systematic review and metanalysis to study the efficacy of POEM in advanced achalasia cardia with sigmoid and megaesophagus.
Methods:
A literature search in PubMed and Embase was done from inception till August 3, 2021 to look for studies reporting exclusively on the role of POEM in advanced achalasia cardia with sigmoid and/or megaesophagus. The random effect method with inverse variance approach was used for the computation of pooled prevalence. For 2 groups’ analysis of continuous outcome standardized mean difference was used as the summary measure.
Results:
Eleven studies with 428 patients were included for analysis. The pooled technical and clinical success was 98.27% (95% CI, 96.19-99.22; I 2 = 0%) and 89.38% (95% CI, 84.49-92.86; I 2 = 26%) and on subgroup analysis into sigmoid and megaesophagus it was (98.06% [95% CI, 95.41-99.19; I 2 = 0%], 98.47% [95% CI, 92.72-99.69; I 2 = 0%] and 87.92% [95% CI, 80.68-92.70; I 2 = 37%], 88.36% [95% CI, 62.62-97.17; I 2 = 77%]) respectively. The clinical success at < 1 year and 1-3 year follow-up was 89.37% (95% CI, 82.82-93.61; I 2 = 0%) and 88.66% (95% CI, 81.65-91.22; I 2 = 46%) respectively. There was a significant reduction in the post-POEM scores with standardized mean difference for Eckardt score (4.81), for integrated relaxation pressure at 4 seconds (1.93), and for lower esophageal sphincter pressure (2.06).
Conclusions
POEM is an effective modality of treatment even in the subset of patients of advanced achalasia cardia with sigmoid and megae sophagus.
3.Clinical presentation of COVID-19 in patients with inflammatory bowel disease: a systematic review and meta-analysis
Anupam K. SINGH ; Anuraag JENA ; Praveen KUMAR-M ; Daya Krishna JHA ; Vishal SHARMA
Intestinal Research 2022;20(1):134-143
Background/Aims:
Coronavirus disease 2019 (COVID-19) is recognized to have variable clinical manifestations. The clinical presentation of patients with inflammatory bowel disease (IBD) having COVID-19 is unclear.
Methods:
We identified articles reporting about the clinical presentation of COVID-19 in those with underlying IBD from PubMed and Embase. The studies, irrespective of design or language, were included. The overall pooled frequency of various symptoms was estimated. Joanna Briggs Institute Critical appraisal checklist was used to assess the quality of studies.
Results:
Eleven studies, including 1,325 patients, were included in the pooled analysis. The pooled estimates for clinical presentation were; fever: 67.53% (95% confidence interval [CI], 45.38–83.88), cough: 59.58% (95% CI, 45.01–72.63), diarrhea: 27.26% (95% CI, 19.51–36.69), running nose: 27% (95% CI, 15.26–43.19) and dyspnea: 25.29% (95% CI, 18.52–33.52). The pooled prevalence rates for abdominal pain, nausea and vomiting were 13.08% (95% CI, 9.24–18.19), 10.08% (95% CI, 5.84–16.85) and 8.80% (95% CI, 4.43–16.70) per 100 population, respectively.
Conclusions
The clinical presentation of COVID-19 in IBD patients is similar to the general population.