Lumbar Transforaminal Injection of Steroids versus Platelet-Rich Plasma for Prolapse Lumbar Intervertebral Disc with Radiculopathy: A Randomized Double-Blind Controlled Pilot Study

Anuj Gupta,Harvinder Singh Chhabra,Vishwajeet Singh,Daram Nagarjuna 대한척추외과학회 2024 Asian Spine Journal Vol.18 No.1

Study Design: Double-blind randomized controlled pilot study. Purpose: The purpose of this study was to compare outcomes of steroids with autologous platelet-rich plasma (PRP) administered by lumbar transforaminal injection (LTI) in patients with lumbar radiculopathy. Overview of Literature: Degenerative disc disease of the lumbar spine is one of the most common conditions managed by spine surgeons in routine practice. Once conservative management fails, LTI is diagnostic and often therapeutic. Steroids are the gold standard drug used for LTI but have limitations and side effects. Methods: In this single-center double-blind randomized controlled pilot study, 46 patients were recruited and randomized by the lottery method. The Visual Analog Scale (VAS) for leg pain, modified Oswestry Disability Index (mODI), and Short-Form 12 (SF-12) were assessed at 1 week, 3 weeks, 6 weeks, 6 months, and 1 year. Results: Both groups were comparable in terms of demographics, preprocedure VAS scores, mODI, and SF-12 scores (p=0.52). At the 1-week follow-up, the steroid group had significantly better improvement than the PRP group (p=0.0001). At the 3-week follow-up, both groups showed comparable outcomes; however, the PRP group had better symptom improvement. At 6 weeks and 6 months, the PRP group had better outcomes (VAS, p<0.0001; ODI, p=0.02; SF-12, p=0.002). Moreover, 17 and 16 patients in the steroid and PRP groups underwent repeat LTI with steroids or surgery because of pain recurrence during follow-up. At 1 year, no difference in outcomes was observed. Conclusions: PRP may be a useful alternative to steroids for LTI in lumbar radiculopathy. Although improvement was delayed and 1-year outcomes were comparable, the 6-week and 6-month outcomes were better with PRP than with LTI. Multiple PRP injections may be beneficial because of its autologous nature. However, further studies with a larger number of participants, longer follow-up, and repeat LTIs are warranted to draw definite conclusions.

Study of oxygen reduction reaction on binuclear-phthalocyanine with Fe-Fe, Co-Co, and Fe-Co dual-atom-active sites using density functional theory

Anuj Kumar,Dipak Kumar Das,Raj Kishore Sharma,Manickam Selvaraj,Mohammed A. Assiri,Saira Ajmal,Guoxin Zhang,Ram K. Gupta,Ghulam Yasin 한국공업화학회 2023 Journal of Industrial and Engineering Chemistry Vol.123 No.-

Although the N4-macrocyclic ligands have been used to develop single-atom catalysts (SACs), their utilizationfor the construction of dual-atom catalysts (DACs) for electrocatalytic oxygen reduction reaction(ORR) is poorly investigated. Herein, a binuclear phthalocyanine (bN-Pc) was explored as a theoreticalmodel for the construction of FeFe-bN-Pc, CoCo-bN-Pc, and FeCo-bN-Pc dual-atom-site configurationsand their ORR activity along with mechanisms were investigated systematically in alkaline media, usingdensity functional theory (DFT) calculations. The results indicated that the dual-atom-bN-Pc models, havingclose proximity between adjacent metals, invited individual O-atom of O2 for coordination on bothsites, forming a cis-bridged-O2 adduct. The Gibbs free energy studies showed that the decompositionof O2 on dual-atom sites was the rate-determining step, and the Fe-Co-bN-Pc had a lower energy barrier(0.591 eV) for this step as compared to Fe-Fe-bN-Pc (0.641 eV) and Co-Co-bN-Pc (0.692 eV), which justifiesits stronger ORR performance. The synergistic effect of Fe-Co collaboration, the close proximity ofFe-Co, and the significant e- donation from the 3d-orbital of active sites into the *orbital of O2 can beattributed to this decrease in limiting the potential for the rate-determining step on Fe-Co-bN-Pc. Forfuture ORR electrocatalysts, this work offers a scientific and engineering perspective on the constructionof dual-atom active sites employing molecular moieties.

Bioprocess Challenges in Purification of Therapeutic Protein Charge Variants

Tarun Gupta,Anuj Kumar,Sriram Seshadri 한국생물공학회 2023 Biotechnology and Bioprocess Engineering Vol.28 No.4

Biopharmaceuticals are complex therapeutic protein molecules produced in living cells and have been a major driving force for drug development in the pharmaceutical sector in recent years. Monoclonal antibodies (mAbs) are biological macromolecules used for treating life-threatening and rare illnesses. mAbs with post-translation alterations can be observed during the assessment of charge variants. Controlling the charge variant profile of therapeutic protein is a regulatory requirement to confirm that the macromolecule complies with the quality parameters to ensure patient safety. Unfortunately, manufacturing these biopharmaceuticals is very expensive. However, the emergence of biosimilars has reduced developmental cost across the biopharmaceutical industry. The advent of biosimilars has constrained the development of more efficient downstream bioprocesses that are mainly considered the bottleneck of the manufacturing process. This review focuses on the existing methods for charge variants separation and process optimization and indicates new approaches for future developments. It also provides a comprehensive summary for the biological community about the impact of charge variants.

Early pharmacokinetic evaluation of anti-tubercular treatment as a good indicator of treatment success in pulmonary tuberculosis patients on a retreatment regimen

Mohan Anant,Bhatnagar Anuj,Gupta Tarang,Ujjalkumar Das,Kanswal Sunita,Velpandian Thirumurthy,Guleria Randeep,Singh Urvashi B. 한국약제학회 2022 Journal of Pharmaceutical Investigation Vol.52 No.4

Purpose Patients with pulmonary tuberculosis (PTB) who fail therapy or develop a relapse are initiated on a retreatment regimen. These patients are at high risk for adverse outcomes. This study aimed to assess the relationship between plasma levels of anti-tubercular drugs and therapy outcome in patients on retreatment. Methods Pharmacokinetics of retreatment regimen drugs [isoniazid (INH), rifampicin (RIF), pyrazinamide (PZA), ethambutol (EMB), and streptomycin (STM)] were compared between cured and not-cured patients using liquid chromatographytandem mass spectrometry (LC-MS/MS) in 134 patients with PTB on a retreatment regimen. Results Of 134 patients, 108 were cured, 17 developed multi-drug resistant TB (MDR-TB), and 9 remained smear-positive after completion of the retreatment (8 months). Two-hour plasma levels ( C2hr) at Day 0 were lower in ‘not cured’ subjects than ‘cured’ subjects and reflected the drug levels achieved later in the duration of retreatment. Notably, in the 26 ‘not cured’ subjects, C2hr plasma levels after the first dose at Day 0 were significantly low (INH: 0.86 vs. 2.94 mg/L, p ≤ 0.002, RIF: 0.56 vs. 2.55 mg/L, p ≤ 0.003, PZA: 1.85 vs. 26.58 mg/L, p ≤ 0.001 and EMB: 0.72 vs. 1.53 mg/L, p ≤ 0.010). Conclusion Therapeutic failure in patients with PTB on a retreatment regimen is associated with lower plasma drug levels. Therapeutic drug monitoring would prove useful for obtaining a favorable clinical outcome. C2hr levels on Day 0 reflected drug levels achieved later and could be a good predictor of patient outcome.

Model-Based Blind System Identification Approach to Estimation of Central Aortic Blood Pressure Waveform From Noninvasive Diametric Circulatory Signals

Ghasemi, Zahra,Kim, Chang-Sei,Ginsberg, Eric,Gupta, Anuj,Hahn, Jin-Oh ASME International 2017 Journal of dynamic systems, measurement, and contr Vol.139 No.6

Surgical Outcomes of Transpedicular Decompression with or without Global Reconstruction in Thoracic/Thoracolumbar Pott’s Spine: A 7-Year Institutional Retrospective Study

Kalidindi Kalyan Kumar Varma,Bansal Kuldeep,Biswas Gourab,Gupta Anuj,Vishwakarma Gayatri,Tandon Vikas,Chhabra Harvinder Singh 대한척추외과학회 2022 Asian Spine Journal Vol.16 No.2

Study Design: Retrospective case-control study. Purpose: This study aimed to analyze the radiological and clinical outcomes of transpedicular decompression in spinal tuberculosis (or Pott’s spine) with and without anterior reconstruction using polyetheretherketone (PEEK) or mesh cage. Overview of Literature: The outcomes of transpedicular decompression with and without global reconstruction in Pott’s spine are insufficiently investigated. Additionally, the use of PEEK cages in Pott’s spine has remained unestablished. Methods: Using the hospital records and imaging database obtained from January 2014 to January 2020, this study retrospectively analyzed patients who underwent surgery for Pott’s spine and met the eligibility criteria. Results: This study included 230 patients with a mean±standard deviation age of 47.7±18.1 years (109 males, 121 females). The Visual Analog Scale score, Oswestry Disability Index, and Cobb angle were significantly improved in these patients (p<0.001). Patients who underwent anterior reconstruction had a greater correction in Cobb angle postoperatively (p=0.042) but also had a greater blood loss (p=0.04). During the follow-up, they experienced a significant loss of correction compared with those who only underwent transpedicular decompression (p=0.026). Nevertheless, patients who underwent anterior reconstruction using mesh/PEEK cages showed no significance difference in the clinical or radiological outcomes. Conclusions: Transpedicular decompression used in the surgical management of Pott’s spine showed favorable clinical and radiological outcomes. The additional use of anterior reconstruction obtained equivalent clinical outcomes but resulted in excessive blood loss. Meanwhile, the use of mesh/PEEK cage for anterior reconstruction did not affect the clinical and radiological outcomes.

Weekly cisplatin or gemcitabine concomitant with radiation in the management of locally advanced carcinoma cervix: results from an observational study

Arun K Verma,Ashok Kumar Arya,Milind Kumar,Anuj Kumar,Sweety Gupta,DN Sharma,GK Rath 대한부인종양학회 2009 Journal of Gynecologic Oncology Vol.20 No.4

Objective: The use of non-platinum drugs in concurrent chemoradiation in carcinoma cervix has not been well explored and hence a two arm study was planned to compare the outcome of concomitant cisplatin or gemcitabine in locally advanced carcinoma cervix. Methods: Thirty six patients were evaluated in this study for response rates and complications. These patients were divided into two arms, sixteen patients in the cisplatin arm and twenty patients in the gemcitabine arm. Cisplatin and gemcitabine were given as i.v. infusion at doses of 40 mg/㎡ and 150 mg/㎡ respectively for five weeks concomitant with radiotherapy. All patients had received pelvic radiotherapy to a dose of 50 Gy/25 fraction/5 weeks by four field box technique followed by high-dose-rate brachytherapy (3 sessions, each of 7.5 Gy to point A). Results: Median follow up was of 10.4 months (range, 3 to 36 months) and 10.9 months (range, 2 to 49 months) in the cisplatin and gemcitabine arms, respectively. At first follow up, 68.8% in the cisplatin arm and 70% in the gemcitabine arm had achieved complete response (p=0.93). Similar response rates were noted in different stages in both arms. None of the patients except one developed grade 4 toxicity. Similar toxicity profiles were observed in both arms. Local disease control, distant disease free survival and overall survival was 68.8% vs. 70%, 93.8% vs. 85%, 68.8% vs. 60% in the cisplatin and gemcitabine arms, respectively. Conclusion: Weekly gemcitabine had similar disease control and tolerable toxicity profile with cisplatin. Gemcitabine may be used as an alternative to cisplatin in patients with compromised renal function. Objective: The use of non-platinum drugs in concurrent chemoradiation in carcinoma cervix has not been well explored and hence a two arm study was planned to compare the outcome of concomitant cisplatin or gemcitabine in locally advanced carcinoma cervix. Methods: Thirty six patients were evaluated in this study for response rates and complications. These patients were divided into two arms, sixteen patients in the cisplatin arm and twenty patients in the gemcitabine arm. Cisplatin and gemcitabine were given as i.v. infusion at doses of 40 mg/㎡ and 150 mg/㎡ respectively for five weeks concomitant with radiotherapy. All patients had received pelvic radiotherapy to a dose of 50 Gy/25 fraction/5 weeks by four field box technique followed by high-dose-rate brachytherapy (3 sessions, each of 7.5 Gy to point A). Results: Median follow up was of 10.4 months (range, 3 to 36 months) and 10.9 months (range, 2 to 49 months) in the cisplatin and gemcitabine arms, respectively. At first follow up, 68.8% in the cisplatin arm and 70% in the gemcitabine arm had achieved complete response (p=0.93). Similar response rates were noted in different stages in both arms. None of the patients except one developed grade 4 toxicity. Similar toxicity profiles were observed in both arms. Local disease control, distant disease free survival and overall survival was 68.8% vs. 70%, 93.8% vs. 85%, 68.8% vs. 60% in the cisplatin and gemcitabine arms, respectively. Conclusion: Weekly gemcitabine had similar disease control and tolerable toxicity profile with cisplatin. Gemcitabine may be used as an alternative to cisplatin in patients with compromised renal function.