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Randomized, double-blind, comparative study of dexrabeprazole 10 mg versus rabeprazole 20 mg in the treatment of gastroesophageal reflux disease

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World Journal of Gastroenterology 2007年第30期13卷 4100-4102页

作者： Vikas pai Nitin pai pai clinic Pune Abhinav Apts 778/B-1 Shivajinagar Pune 411005 India

AIM：TO compare the efficacy and safety of dexrabe-prazole 10 mg versus rabeprazole 20 mg in the treatment of gastroesophageal reflux disease （GERD）.METHODS： This was a randomized, double-blind clinical study. Fifty patients with GERD were randomly assigned to receive dexrabeprazole 10 mg or rabeprazole 20 mg once daily. Efficacy was assessed by evaluating improvement in visual analog scale （VAS） scores of heart-burn and regurgitation and safety was assessed by recording incidence of any adverse drug reactions. Laboratory investigations and upper gastro-intestinal endoscopy was conducted at baseline and after 28 d of therapy.RESULTS： A total of 50 patients （n = 25 in dexrabeprazole group and rabeprazole group each） completed the study. There were no significant differences in the baseline characteristics between the two groups. The VAS score （mean 4. SD） of heartburn and regurgitation in dexrabeprazole （64.8±5.1 and 64 ± 8.1, respectively） and rabeprazole （64.4 ± 8.7 and 57.6 ± 9.7, respectively） groups significantly reduced （P 〈 0.0001） to 30 ± 11.5, 24 ± 10 and 32 ± 9.5, 29.2±11.9, respectively on d 28. A significantly higher （P = 0.002） proportion of patients showed ≥ 50% improvement in regurgitation with dexrabeprazole 10 mg （96%） compared to rabeprazole 20 mg （60%）. Onset of symptom improvement was significantly earlier with dexrabeprazole than with rabeprazole （1.8 ± 0.8 d vs 2.6 ± 1.4 d; P 〈0.05）. The incidences of esophagitis in the dexrabeprazole group and rabeprazole group before therapy were 84% and 92%, respectively （P = 0.38）. The incidence of improvement/healing of esophagitis after therapy was more （P = 0,036） in the dexrabeprazole group （95.2%） compared to the rabeprazole group （65.2%）. No adverse drug reaction was seen in either group.CONCLUSION： In the treatment of GERD, efficacy of dexrabeprazole 10 mg is better than rabeprazole 20 mg, with regards to improvement/healing of endoscopic lesions and relief from symptoms of regurgitation.

关键词： Dexrabeprazole/R(+) rabeprazole Gastroesophageal reflux disease Efficacy Safety

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Comparative clinical trial of S-pantoprazole versus racemic pantoprazole in the treatment of gastro-esophageal reflux disease

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World Journal of Gastroenterology 2006年第37期12卷 6017-6020页

作者： Vikas G pai Nitin V pai Hemant P Thacker Jaisingh K Shinde Vijay P Mandora Subhash S Erram pai clinic Pune India Thacker’s clinic Sukh Sagar 4th Floor NS Patkar Marg Mumbai India Surya Hospital Pune India Inlaks & Budhrani Hospital Pune India Sharada clinic Karad India

AIM: To compare the effi cacy and tolerability of S-pan- toprazole (20 mg once a day) versus racemic Panto- prazole (40 mg once a day) in the treatment of gastro- esophageal reflux disease (GERD). METHODS: This multi-centre, randomized, double-blind clinical trial consisted of 369 patients of either sex suf- fering from GERD. Patients were randomly assigned to receive either one tablet (20 mg) of S-pantoprazole once a day (test group) or 40 mg racemic pantoprazole once a day (reference group) for 28 d. Patients were evaluated for reduction in baseline on d 0, GERD symptom score on d 14 and 28, occurrence of any adverse effect during the course of therapy. Gastrointestinal (GI) endoscopy was performed in 54 patients enrolled at one of the study centers at baseline and on d 28. RESULTS: Signifi cant reduction in the scores (mean and median) for heart burn (P < 0.0001), acid regurgitation (P < 0.0001), bloating (P < 0.0001), nausea (P < 0.0001) and dysphagia (P < 0.001) was achieved in both groups on d 14 with further reduction on continuing the therapy till 28 d. There was a statistically signifi cant difference in the proportion of patients showing improvement in acid regurgitation and bloating on d 14 and 28 (P = 0.004 for acid regurgitation; P = 0.03 for bloating) and heart burn on d 28 (P = 0.01) between the two groups, with a higher proportion in the test group than in the refer- ence group. Absolute risk reductions for heartburn/acid regurgitation/bloating were approximately 15% on d 14 and 10% on d 28. The relative risk reductions were 26%-33% on d 14 and 15% on d 28. GI endoscopy showed no signifi cant difference in healing of esophagitis (P = 1) and gastric erosions (P = 0.27) between the two groups. None of the patients in either group reported any adverse effect during the course of ***: In GERD, S-pantoprazole (20 mg) is more effective than racemic pantoprazole (40 mg) in improving symptoms of heartburn, acid regurgitation, bloating and equa

关键词： Gastro-esophageal reflux disease Pantoprazole Efficacy Tolerability

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Efficacy and Safety of PDM011011 Capsules as Compared to Metformin in Subjects with Type-2 Diabetes Mellitus: An Open-Label, Randomized, Active-Controlled, Multicentric, Phase III Study

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Journal of Diabetes Mellitus 2016年第1期6卷 38-48页

作者： Ashish C. Suthar Vikas G. pai Yogesh Kadam Aniruddha Tongaonkar Shailaja Kale Atul B. Deshpande Sharat Kolke Snehal Tanna Shrikant V. Deshpande Purvi Chawla Debjit Biswas Somesh Sharma Piramal Enterprises Limited Mumbai India pai clinic and Diagnostic Center Pune India Poona Diabetes Centre Pune India Tongaonkar Hospital Pune India Orange Diabetes clinical Research Unit Pune India Ethika clinical Research Centre Prakruti Hospital Thane India Kolkes clinic Mumbai India clinic De Care Thane India Ashirwad Hospital and Medical Research Centre Thane India

Context: Bitter melon (Momoradica charantia) is one of the well-known plants used for lowering blood glucose since antiquity. Aims: To compare the efficacy and safety of PDM011011 capsule (1200 mg/day) with Metformin (1000 mg/day) in a 15 weeks study using mean change in fasting plasma glucose (FPG) and Hb1Ac% in subjects with type 2 diabetes mellitus (T2DM). Settings and Design: This is an open-label, randomized, active-controlled, multicentric, phase III study. Methods and Material: A total of 123 eligible patients were randomized in 2:1 ratio in PDM011011 and Metformin arm. Total 83 subjects received PDM011011 capsule (1200 mg/day) and 40 subjects received Metformin (1000 mg/day) in their respective arms for 15 weeks. Subjects were analyzed for FPG and Hb1Ac% at baseline and during treatment visits (Visit 3 to Visit 7). Safety assessments were carried out. Results: In this study, the significant reduction in mean FPG level was observed after treatment with PDM011011 capsule and Metformin in T2DM patients. The mean change from baseline to week 15 in FPG was 14.52 mg/dL (95% CI: 6.36, 22.67) in the PDM011011-treated subjects and 28.34 mg/dL (95% CI: 21.35, 35.32) in the Metformin-treated subjects. At week 15, the mean change from baseline in HbA1c levels was 0.27% (95% CI: 0.06, 0.47) in the PDM011011 arm and 0.62% (95% CI: 0.40, 0.83) in the Metformin arm. Conclusion: PDM011011 capsule (1200 mg/day) exhibited the modest efficacy and safety as compared to Metformin (1000 mg/day) in type 2 diabetes patients.

关键词： Momoradica charantia Glycebal Diabetes mellitus Anti-Diabetic

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Small Interfering RNA-mediated Caveolin-1 Knockout on Plasminogen Activator Inhibitor-1 Expression in Insulin-stimulated Human Vascular Endothelial Cells

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Acta Biochimica et Biophysica Sinica 2007年第3期39卷 224-233页

作者： Huiling YANG~(1,3#) Shuya HE~(2,3#) Zhihua QUAN Weixia PENG~1 Bin YAN~1 Jianghua LIU~1 Fang WEN~1 Renxian CAO~1 Yangyan XU~3 Gebo WEN~1 Weixin HU~2 1 Institute of clinic Medicine,the First Affiliated Hospital of Nanhua University,Hengyang 421001,China 2 Research Institute of Biochemistry and Molecular Biology.Central South University Changsha 421001,China 3 Institute of Pharmacology and Pharmacy,Nanhua University,Hengyang 421001,China Institute of clinic Medicine the First Affiliated Hospital of Nanhua UniversityHengyang 421001 China Institute of Pharmacology and Pharmacy Nanhua UniversityHengyang 421001 China Research Institute of Biochemistry and Molecular Biology Central South UniversityChangsha 421001 China

Using human vascular endothelial cells（ECV304）as the target,we studied the effect ofcaveolin（CAV）-1 in the course of insulin-stimulated expression of plasminogen activator inhibitor（PAl）-*** appropriate single-stranded oligonucleotides representing the RNAi CAV- 1 gene were analyzed by *** annealing to generate double-stranded oligonucleotides（ds oligo）,it was cloned into thepENTR/U6 entry vector containing RNA polymerase Ⅲ expression element by T4 DNA *** shorthairpin（shRNA）sequences transferred from the pENTR/U6 entry were cloned into the pLenti6/BLOCK-iT-DEST vector with an LR recombination *** identification by sequencing,we successfully con-structed the CAV-1 RNAi lentiviral expression system using Gateway *** efficiency wasassayed by real-time reverse transcription-polymerase chain reaction,immunofluorescence staining and ***304 cells were cultured in the medium containing different concentrations of insulin(1×10-9to1×10-7M)with the CAV-1 gene silenced or *** expression level and subcellular localization of pai-1 andCAV-1 were compared using reverse transcription-polymerase chain reaction,immunofluorescence stainingand Western blot *** results showed that the potent inhibition of CAV-1 expression could reach 85%,and it was specific to the CAV-1-derived shRNA,not the S 100A13-derived *** was no dramaticdifference in pai-1 expression between the RNAi+and RNAi-ECV304 cells incubated with physiologicalinsulin,but pai-1 protein did accumulate under the cell *** the concentration of insulin increased,the expression of pai-1 was up-regulated,whereas the expression of CAV-1 ***,pai-1 clearly augmented after CAV-1 *** results indicated that hyperinsulinism could promotepai-1 expression by inhibiting CAV-1,and stabilizing or up-regulating CAV-1 expression in endothelial cellsmight reduce complications of the great vessels and capillary vessels i

关键词： caveolin-1 plasminogen activator inhibitor-1 gene silencing insulin

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Towards the optimization of management of hepatocellular carcinoma

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Frontiers of Medicine 2011年第3期5卷 271-276页

作者： Xi Feng Madhava pai Malkhaz Mizandari Tinatin Chikovani Duncan Spalding Long Jiao Nagy Habib Division of Surgery Department of Surgery and CancerImperial College LondonLondon W120NNUK Tbilisi 1st Hospital University clinic High Technology Medical CenterTbilisi 0144Georgia

Hepatocellular carcinoma(HCC)is the fifth most common neoplasm in the world,closely correlated with viral hepatitis and liver *** vast majority of HCC patients present at a late stage and are unsuitable for surgery due to limited liver functional *** can involve major vessels or hilar structures,necessitating major liver resection and/or rendering liver resection unfeasible.A series of new technologies have been developed to optimise HCC *** cell therapy improves impaired liver functional reserve prior to liver *** radiofrequency ablation recanalises the portal vein invaded by tumour thrombus and endobiliary radiofrequency ablation restores and extends biliary patency of the bile duct invaded by *** radiofrequency assisted liver resection minimizes blood loss and avoids liver warm ischemia,while increasing parenchymal *** benefits combined maximize the safety of liver resection.

关键词： management hepatocellular carcinoma(HCC) radiofrequency(RF)ablation laparoscopic liver resection stem cell intravascular RF ablation endobiliary RF ablation

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Pegylated interferon alfa-2b plus ribavirin for treatment of chronic hepatitis C

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World Journal of Hepatology 2014年第7期6卷 520-526页

作者： PN Rao Abraham Koshy Jacob Philip Narayanan Premaletha Joy Varghese Krishnasamy Narayanasamy Samir Mohindra Nitin Vikas pai Manoj Kumar Agarwal Ashokna Konar Hasmukh B Vora Department of Gastroenterology Asian Institute of Gastroenterology Hyderabad 500082 India Department of Hepatology Lakeshore Hospital Kochi 682040 India Department of Gastroenterology Cosmopolitan Hospital Thiruvananthapuram 695004 India Department of Gastroenterology Medical College Thiruvananthapuram 695011 India Department of Hepatology Global Hospitals and Health City Chennai 600100 India Department of Hepatology GGHand MMC Chennai 600003 India Department of Gastroenterology SGPGIMS Lucknow 226014 India Department of Gastroenterology Pai Clinic and Diagnostic Center Pune 411005 India Department of Gastroenterology Belle Vue Clinic Kolkata 700017 India Department of Gastroenterology PeerlessHospital and B.K. Roy Research Center Kolkata 700094 India Department of Gastroenterology Alka Hospital Ahmedabad 380019 India

AIM: To study the safety and efficacy of pegylated interferon alfa-2b, indigenously developed in India, plus ribavirin in treatment of hepatitis C virus(HCV). METHODS: One-hundred HCV patients were enrolled in an open-label, multicenter trial. Patients were treated with pegylated interferon alfa-2b 1.5 μg/kg per week subcutaneously plus oral ribavirin 800 mg/d for patients with genotypes 2 and 3 for 24 wk. The same dose of peginterferon plus weight-based ribavirin(800 mg/d for ≤ 65 kg; 1000 mg/d for > 65-85 kg; 1200 mg/d for > 85-105 kg; 1400 mg/d for > 105 kg body weight) was administered for 48 wk for patients with genotypes 1 and 4. Serological and biochemical responses of patients were ***: Eighty-two patients(35 in genotypes 1 and 4 and 47 in 2 and 3), completed the study. In genotype 1, 25.9% of patients achieved rapid virologic response(RVR): while the figures were 74.1% for early virologic response(EVR) and 44.4% for sustained virologic response(SVR). For genotypes 2 and 3, all patients bar one belonged to genotype 3, and of those, 71.4%, 87.5%, and 64.3% achieved RVR, EVR, and SVR, respectively. In genotype 4, 58.8%, 88.2%, and 52.9% of patients achieved RVR, EVR, and SVR, respectively. The majority of patients attained normal levels of alanine aminotransferase by 4-12 wk of therapy. Most patients showed a good tolerance for the treatment, although mild-to-moderate adverse events were exhibited; only two patients discontinued the study medication due to serious adverse events(SAEs). Eleven SAEs were observed in nine patients; however, only four SAEs were related to study ***: Peginterferon alfa-2b, which was developed in India, in combination with ribavirin, is a safe and effective drug in the treatment of HCV.

关键词： Hepatitis C virus Genotype Peginterferon alfa-2b Ribavirin Treatment

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Fast track anesthesia for liver transplantation: Review of the current practice

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World Journal of Hepatology 2015年第20期7卷 2303-2308页

作者： Stephen Aniskevich Sher-Lu pai Department of Anes- thesiology Division of Hepatobiliary and Abdominal Organ Transplant Mayo Clinic Florida

Historically,patients undergoing liver transplantation were left intubated and extubated in the intensive care unit(ICU)after a period of *** of this practice argued that these patients were critically ill andneed time to be properly optimized from a physiological and pain standpoint prior to ***,there has been a growing movement toward early extubation in transplant centers *** fueled by research into early extubation following cardiac surgery,extubation in the operating room or soon after arrival to the ICU,has been shown to be safe with proper patient ***,as experience at determining appropriate candidates has improved,some institutions have developed systems to allow select patients to bypass the ICU entirely and be admitted to the surgical ward after *** discuss the history of early extubation and the arguments in favor and against fast track *** also described our practice of fast track anesthesia at Mayo clinic Florida,in which,we extubate approximately 60%of our patients in the operating room and send them to the surgical ward after a period of time in the post anesthesia recovery unit.

关键词： Liver transplant Fast track anesthesia Early extub

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有或无冠状动脉疾病的患者中可溶性E-选择素、P-选择素及细胞间黏附分子-1的日间改变

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世界核心医学期刊文摘（心脏病学分册） 2005年第3期1卷 24-25页

作者： Osmancik P. Kvasnicka J. Widimsky P. Tarnok A. 王亭忠 3rd Internal-Cardiology clinic 3rd Faculty of Medicine Univ. Hospital Kralovske Vinohrady Srobarova 50 CZ-10034 Prague Czech Republic Dr.

Background: The more frequent onset of acute coronary syndromes (ACS) in the morning has been known for a long time. Diurnal changes of fibrinolysis such as lower activity of tissue plasminogen activator and higher activity of plasminogen activator inhibitor-1(pai-1) in the morning has been demonstrated previously and correspond with the manifestation of ACS. Less is known about the diurnal variation of soluble adhesion molecules asmarkers of endothelial or platelet activity in patientswith coronary artery disease(CAD). Patients and Methods: 80 patients with a history of myocardial infarction and/or chest pain with positive exercise testing admitted for elective coronary angiographywere studied. 10 had normal findings on coronary angiography(control group), 70 patients had at least one or more stenoses ≥50%of the diameter of an epicardial vessel. None of the patients suffered from acute inflammation, connective or tumor disease. Blood samples were drawn at 7:00 a.m. and at 7:00 p.m. at rest and plasma concentration of soluble P-selectin(sP-selectin), E-selectin (sEselectin), intercellular adhesion molecule-1 (sICAM-1) and acute-phase proteins were measured by ELISA. Results: In both groups, no diurnal variation was found in sE-selectin and sICAM-1. sPselectin levels were significantly higher in the evening(CAD group: 149.8±54.5 vs. 172.2±68.8 ng/ml, p< 0.001; control: 148.7±75.5 vs. 187.5±96.3 ng/ml, p=0.001,Wilcoxon test). Conclusion: We have demonstrated diurnal variation of sP-selectin in patients with CAD. We conclude that high sP-selectin values in the evening represent the shed forms of the morning membrane-bound P-selectin.

关键词：选择素 P-选择素无冠状动脉细胞间黏附分子结缔组织疾病外膜血管血小板活性运动试验胸痛纤溶酶原激活剂

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