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Efficacy and Safety of Tinefcon^® Tablets in Subjects with Plaque Psoriasis: An Open Label, Non-Comparative, Multicenter, Phase IV Trial

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Journal of Cosmetics, Dermatological Sciences and Applications 2016年第2期6卷 55-66页

作者： Somesh Sharma Kailash Bhatia Meetesh Agarwal Sandesh Gupta Leelavathi Budamakuntla Sudhakar Grandhi Vinod Titarmare Sushil Pande Ranjan Rawal Aruna Samarth Rizwan Haq Vikrant Saoji D. V. S. Pratap L. M. Kansal D. G. Saple Shatrughan Sahay Parag Kalyani Puneet goyal Sharmila Patil A. J. Kanwar Bhavesh Swarnakar Sujay Kulkarni Abhijeet Morde Hitesh Khandagale Yogesh Dound Nitin Jadhav Sanjeev Hegde Murlidhara Padigaru Ashish C. Suthar Piramal Enterprises Limited Mumbai India Bhatia Skin Center Bima Nagar Indore India Agrawal Path LAB Vijaynagar Indore India Skin & Laser Center Krishna Nagar New Delhi India Diabetes and Shirdi Skin Care Centre Karnataka India Medipoint Hospitals Pvt. Ltd. Pentagon Research Pvt. Ltd. Pune India Skin Care Clinic Nagpur India NKP Salve Institute and Lata Mangeshkar Hospital Nagpur India Department of Dermatology Sheth VS General Hospital Ahmedabad India Sai Skin Care Clinic Hyderabad India Radiance Skin Care Clinic Nagpur India Dr. Vikrant Saoji’s Clinic Ramdaspeth Nagpur India Durgabai Deshmukh Hospital & Research Center Hyderabad India Kansal Cosmetic & Skin Care Clinic Jaipur India Dr. Saple’s Clinic Dadar (East) Mumbai India Sri Skin Care & Laser Clinic Lucknow UP India Ruby Hall Clinic Pune India Renova Skin & Laser Clinic Sector-9 Mansarovar Jaipur India Dr. D. Y. Patil Medical College and Hospital Nerul Navi Mumbai India Department of Dermatology Venerology & Leprology Postgraduate Institute of Medical Education and Research Chandigarh India Swarnakar Superspeciality Centre Indore India Clinical Research and Development Piramal Enterprises Limited Mumbai India

Importance: This post-marketing surveillance study was conducted to evaluate real-world information about the efficacy and safety of oral Tinefcon? tablets (Sphaeranthus indicus based) in plaque psoriasis patients. Materials and Methods: Patients aged at least 18 years and older with clinical diagnosis of plaque psoriasis, were enrolled in this open label, non-comparative, multicenter trial. All eligible subjects received four 700 mg Tinefcon? tablets/day for 12 weeks. The primary outcome measure was percent change in Psoriasis Area Severity Index (PASI) score from baseline to week 12. The secondary outcome measures were Physician Global Assessment (PGA), Nail Psoriasis Severity Index (NAPSI), Psoriatic Arthritis Evaluation and Gene Expression Profiling and Immunohistochemistry. Results: After completion of Tinefcon? treatment at 12 weeks, more than half of subjects (52%) achieved PASI 50 response;PASI 75 response was attained in 68 (23%) subjects and PASI 90 response in 22 (7%) subjects. Five subjects with severe psoriasis achieved PASI 90 without receiving any concomitant medication. Reduction in severity as assessed by PGA was observed in more than half of patients with moderate disease. Histopathological evaluation revealed that epidermal thickness was considerably reduced in 66% of subjects. The expression of inflammatory marker S100A9 protein was(meaningfully reduced in 60% patients with non-significant reduction of Keratin 10 protein expression. Gene expression analysis showed increase down regulation of SERPINB4;PI3 and KRT16 genes after a 12-week treatment period in subjects with higher PASI scores. Conclusion: Oral Tinefcon? tablets showed good efficacy and had a favorable safety profile in plaque psoriasis patients.

关键词： Psoriasis Tinefcon® Tablet Sphaeranthus indicus

耐药性胃轻瘫患者经口或PEG安置电极的一过性胃电刺激

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世界核心医学期刊文摘（胃肠病学分册） 2005年第8期1卷 36-36页

作者： Ayinala S Batista O goyal A T. Abell 陈云茹 Division of Digestive Dis eases Univ. of Mississippi Medical Center2500 N. State St. Jackson MS 39216 United States.Dr

Background: Gastric electrical stimulation (GES) has been shown to be efficaci ous for drug refractory gastroparesis, but GES requires surgery. Placement of te mporary GES electrodes endoscopically (ENDOstim) or via a PEG (PEGstim) is feasi ble,thereby allowing rapid assessment and comparison of temporary use (TEMP) wit h permanent (PERM) ***: Twenty consecutive patients with gastro paresis had TEMP electrodes placed (6 ENDOstim, 14 PEGstim). TEMP alone and TEMP vs. PERM placement of GES devices in 13 of 20 patients were compared via the fo llowing: average vomiting frequency score (VFS), total symptom score, days to sy mptom improvement, electrode impedance, and gastric emptying ***: For p atients receiving TEMP, GES demonstrated a rapid, significant, and sustained imp rovement in VFS, results similar to those for PERM. Conclusions: Both ENDO and P EG placement of GES electrodes are safe and effective in patients with gastropar esis, with outcomes that correspond to those achieved with permanent GES implant ation.

关键词：胃轻瘫 PEG 经口胃电症状改善时间胃排空

MRI扩散成像在肾炎性病变中的价值:与肾细胞癌的鉴别

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国际医学放射学杂志 2013年第2期 191-191页

作者： A. goyal R. Sharma A.S. Bhalla S. Gamanagatti A. Seth 赵芳 Department of Radiodiagnosis All India Institute of Medical Sciences Ansari Nagar New Delhi 110029India

目的评价肾炎性病变的扩散特征,以及表面扩散系数(ADC)值是否可用于与肾细胞癌(RCC)的鉴别诊断。方法 88例病人行多层CT(MDCT)、MRI和扩散加权(DW)MRI(b值为0、500s/mm2)观察肾局灶病变特征。回顾性评价15例患有20处炎性病变和33例患有3... 详细信息

目的评价肾炎性病变的扩散特征,以及表面扩散系数(ADC)值是否可用于与肾细胞癌(RCC)的鉴别诊断。方法 88例病人行多层CT(MDCT)、MRI和扩散加权(DW)MRI(b值为0、500s/mm2)观察肾局灶病变特征。回顾性评价15例患有20处炎性病变和33例患有36处RCC的病人。对比其DW影像,绘出受试者操作特征(ROC)曲线评估ADC值。结果所有炎性病变及91.7%RCC表现为扩散受限。脓肿液性密度区的DW影像表现为扩散明显受限,而RCC的囊性部分却表现为扩散不受限。脓肿及RCC的ADC值(分别为1.12×10-3mm2/s,1.56×10-3mm2/s)明显低于正常肾实质(2.34×10-3mm2/s),其差异有统计学意义(P<0.0001)。区分炎性病变与RCC方面,ADC取值1.41×10-3mm2/s时,ROC分析具有高敏感度(100%)和特异度(78.1%)。结论脓肿及RCC均表现为扩散受限,前者程度更大,取决于液体成分。因此,ADC值可以对不确定的肾脏病灶提供额外的特征信息。要点①RCC和炎性病变都表现为MRI扩散受限。②扩散受限不是恶性病变特有征象,相反,炎性病变受限更多。③脓肿液体成分表现为显著扩散受限;RCC囊性成分表现为不受限。④ADC值和扩散受限的方式可以为不确定病变提供更多的特征信息。⑤DWMRI可以避免静脉内注射对比剂,这对肾功能不全的病人很有价值。

关键词：扩散加权MRI 肾炎性病变肾脓肿肾细胞癌不确定的肾脏病变

颈动脉内膜中层厚度是Takayasu动脉炎病变活动性的指标

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世界核心医学期刊文摘（心脏病学分册） 2006年第8期2卷 56-56页

作者： Seth S. goyal N. K. Jagia P. 吴晓燕(译) 孙凯(校) Department of Cardiology Cardiothoracic Center All India Institute of Medical Sciences New Delhi - 110029 India 不详

Background: Assessment of disease activity in patients with Takayasu’s arteritis(TA) is difficult due to absence of definitive tests. Presence of carotid intima-medial thickening has been suggested as a possible marker of inflammation and disease activity. Methods: We evaluated common carotid artery carotid intima-medial thickness(CCA-IMT) in 56 common carotid arteries(CCAs) in 28 healthy controls and 74 CCAs in 37 patients of *** correlated these findings with the presence of activity as assessed by the National Institutes of Health(NIH) cri- teria. Results: CCA-IMT was increased(>0.8 mm) in 59% of the patients with TA. In patients with disease activity, the CCA-IMT was more than in those without activity(1.5± 0.16 vs. 0.9± 0.2 mm, P< 0.005). This is presumably because of ongoing inflammation causing abnormal thickening. Even among patients without active disease, CCA-IMT was more than in controls(0.9± 0.2 vs. 0.6± 0.1 mm, P< 0.05) possibly due to a milder degree of inflammation or healing with fibrosis. All patients with angiographic carotid obstruction had increased CCA-IMT irrespective of whether they were active or not. However, in patients with angiographically normal carotid arteries, CCA-IMT was increased only among the patients who were active(1.4± 0.2 vs. 0.7± 0.04, P< 0.05). Abnormal CCA-IMT as marker of disease activity had a sensitivity of 82% and specificity of 60% . On excluding patients with increased CCA-IMT who had angiographic carotid stenosis(because the increase in CCA-IMT cannot be attributed entirely to activity alone in these patients), the specificity increased to 70% . Conclusion: Increased CCA-IMT is a reliable marker of active disease, especially in the absence of angiographically visible carotid disease.

关键词：颈动脉内膜中层厚度 Takayasu动脉炎病变活动性美国国立卫生研究院疾病活动性血管造影正常对照活动期

淡紫色青霉菌引起皮肤型透明丝孢霉病:3例病例报道和文献回顾

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世界核心医学期刊文摘（皮肤病学分册） 2005年第2期1卷 39-39页

作者： Hall V.C. goyal S. Davis M.D.P. Walsh J.S. 崔荣 Department of Dermatology Mayo Clinic 4500 San Pablo Road Jacksonville FL 32224 United States Dr.

Cutaneous infectionwith Paecilomyces lilacinus is encountered worldwide, with most infections occurring either iatrogenically or in immunocompromisedhosts. We report three cases of cutaneous hyalohyphomycosis caused by P. lilacinus, one of which occurred in an immunocompetent individual. In addition, we review the 17 cases previously reported in the literature. Although this infection can be difficult to treat, most cases are not fatal. Most cases responded well to systemic azole antifungal agents, either alone or in association with surgical excision of the lesion. Paecilomyces species are saprophytic fungi found in soil and decaying organic matter. Infection in humans is rare, but when it occurs treatment is often difficult. We report three cases of cutaneous hyalohyphomycosis caused by P. lilacinus and reviewthe 17 previously reported cases in which the clinical history and response to therapy were described.

关键词：透明丝孢霉病青霉文献回顾皮肤型类感染淡紫色抗真菌剂霉菌感染免疫缺陷者免疫活性

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新型皮肤替代品修复复杂性巨大脐疝

世界核心医学期刊文摘（儿科学分册） 2006年第9期2卷 32-32页

作者： Almond S.L. goyal A. Jesudason E.C. P.D. Losty 王经纬 Institute of Child Health Alder Hey Children's HospitalL12 2AP LiverpoolUnited Kingdom

Giant exomphalos can be successfully managed using conservative or surgical techniques. However,if treatment is complicated by sepsis,early skin cover of the defect becomes necessary. Options include split skin grafting,but in the presence of ongoing infection the risk of graft failure is high and limited skin is available for regrafting. We describe the novel use of a skin substitute (Integra Artificial Skin,Integra Life Sciences Corporation,Plainsboro,NJ) as an alternative to primary grafting in the management of infected giant exomphalos.

关键词：皮肤替代品再次移植皮肤移植人造皮肤皮瓣移植脓毒症备选方案缺损区外科手术

急性缺血性脑卒中血管内治疗流程和时间及其对治疗效果的影响分析:SWIFT PRIME随机对照试验的结果

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国际医学放射学杂志 2016年第4期 442-442页

作者： M.goyal A.P.Jadhav A.Bonafe H.Diener V.M.Pereira E.Levy 戴群瑶 Departments of Radiology and Clinical Neuro-sciences University of Calgary

摘要目的研究急性缺血性脑卒中病人Solitaire支架机械取栓作为急性缺血性梗死(AIS)血管内主要治疗(SWIFT PRIME)试验中功能独立性和再灌注时间的关系,一组病人进行联合血管内治疗和静脉组织纤溶酶原激活物(t PA)治疗,另外一组进行单纯t... 详细信息

摘要目的研究急性缺血性脑卒中病人Solitaire支架机械取栓作为急性缺血性梗死(AIS)血管内主要治疗(SWIFT PRIME)试验中功能独立性和再灌注时间的关系,一组病人进行联合血管内治疗和静脉组织纤溶酶原激活物(t PA)治疗,另外一组进行单纯t PA治疗。研究影响不连续步骤间隔时间的变量。材料与方法分析SWIFT PRIME试验的

关键词：急性缺血性脑卒中再灌注血管内

脑卒中III期介入治疗临床试验中基线CT血管成像所见血栓闭塞点的再通和临床结果

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国际医学放射学杂志 2014年第6期 588-588页

作者： A.M.Demchuk M.goyal S.D.Yeatts J.Carrozzella L.D.Foster E.Qazi 张扬 Calgary Stroke Program Dept of Clinical Neurosciences and RadiologyHotchkiss Brain InstUniv of Calg.ary1403 29 St NWRoom 112CalgaryABCanada T2N 2T9

摘要目的使用基线CT(CT)血管成像分析影像表现和脑卒中Ⅲ期介入治疗中临床终点来确定将从血管内卒中治疗中获益的病人。材料与方法主要临床终点为90 d二分改

关键词：血管成像 III 基线脑卒中介入治疗 CT

肝局灶性病变经皮介入的光分子成像前瞻性试验

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国际医学放射学杂志 2015年第3期 276-276页

作者： R.A.Sheth R.S.Arellano R.N.Uppot A.E.Samir L.goyal A.X.Zhu 施益洁 Departments of Radiology Massachusetts General Hospital149 13th St Room 2301Charlestown MA 02129

目的为证明光分子成像(OMI)可临床转化应用于肝局灶性病变经皮介入定位。材料与方法本前瞻性、单中心试验符合HIPAA,获伦理审查委员会批准。入选者为怀疑

关键词：肝局灶性病变分子成像经皮