Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn`s Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study

( Chen Wang Chang ),( Shu Chen Wei ),( Jen Wei Chou ),( Tzu Chi Hsu ),( Chiao Hsiung Chuang ),( Ching Pin Lin ),( Wen Hung Hsu ),( Hsu Heng Yen ),( Jen Kou Lin ),( Yi Jen Fang ),( Horng Yuan Wang ),( 대한장연구학회 2014 Intestinal Research Vol.12 No.4

Background/Aims: Only moderate to severe Crohn`s Disease (CD) patients without a satisfactory conventional therapy effect are eligible to get reimbursement from the National Health Insurance of Taiwan for using adalimumab. These are more stringent criteria than in many Western countries and Japan and Korea. We aim to explore the efficacy of using adalimumab in CD patients under such stringent criteria. Methods: A retrospective analysis was conducted in nine medical centers in Taiwan and we collected the results of CD patients receiving adalimumab from Sep 2009 to Mar 2014. The clinical characteristics, response measured by CDAI (Crohn`s Disease Activity Index), adverse events and survival status were recorded and analyzed. CR-70, CR-100, and CR-150 were defined as attaining a CDAI decrease of 70, 100 or 150 points compared with baseline. Results: A total of 103 CD patient records were used in this study. Sixty percent of these patients received combination therapy of adalimumab together with immunomodulators. CR-70 was 68.7%, 74.5% and 88.4% after week 4, 8 and 12 of treatment, respectively. The steroid-free rate, complications and survival were 47.6%, 9.7% and 99% of patients, respectively. In considering the mucosal healing, only 25% patients achieve mucosal healing after treatment for 6 to12 months. Surgery was still needed in 16.5% of patients. Combination treatment of adalimumab with immunomodulators further decreased the level of CDAI at week 8 when compared with the monotherapy. Conclusions: Even under the stringent criteria for using adalimumab, the response rate was comparable to those without stringent criteria. (Intest Res 2014;12:287-292)

Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis

( Chen-hua Liu ),( Chi-yi Chen ),( Wei-wen Su ),( Chun-jen Liu ),( Ching-chu Lo ),( Ke-jhang Huang ),( Jyh-jou Chen ),( Kuo-chih Tseng ),( Chi-yang Chang ),( Cheng-yuan Peng ),( Yu-lueng Shih ),( Chia 대한간학회 2021 Clinical and Molecular Hepatology(대한간학회지) Vol.27 No.4

Background/Aims: Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited. Methods: We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR₁₂) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. The safety profiles were reported. Results: The SVR₁₂ rates in the EP, modified EP and PP were 89.7% (95% confidence interval [CI], 82.5-94.2%), 94.1% (95% CI, 87.8-97.3%), and 100% (95% CI, 96.2-100%). Number of patients who failed to achieve SVR₁₂ were attributed to virologic failures. The SVR₁₂ rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs). Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR₁₂, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 4.13; 95% CI, 1.16-14.71; P=0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate declines than patients with CKD stage 2 (-0.42 mL/min/1.73 ㎡/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 ㎡/month; P<0.001). Conclusions: SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis. (Clin Mol Hepatol 2021;27:575-588)

A retrospective analysis of 20-year data of the surgical management of ulcerative colitis patients in Taiwan: a study of Taiwan Society of Inflammatory Bowel Disease

( Chun-chi Lin ),( Shu-chen Wei ),( Been-ren Lin ),( Wen-sy-tsai ),( Jinn-shiun Chen ),( Tzu-chi Hsu ),( Wei-chen Lin ),( Tien-yu Huang ),( Te-hsin Chao ),( Hung-hsin Lin ),( Jau-min Wong ),( Jen-kou 대한장연구학회 2016 Intestinal Research Vol.14 No.3

Background/Aims: With the recent progress in medical treatment, surgery still plays a necessary and important role in treating ulcerative colitis (UC) patients. In this study, we analyzed the surgical results and outcomes of UC in Taiwan in the recent 20 years, via a multi-center study through the collaboration of Taiwan Society of IBD. Methods: A retrospective analysis of surgery data of UC patients from January 1, 1995, through December 31, 2014, in 6 Taiwan major medical centers was conducted. The patients’ demographic data, indications for surgery, and outcome details were recorded and analyzed. Results: The data of 87 UC patients who received surgical treatment were recorded. The median post-operative follow-up duration was 51.1 months and ranged from 0.4 to 300 months. The mean age at UC diagnosis was 45.3±16.0 years and that at operation was 48.5±15.2 years. The 3 leading indications for surgical intervention were uncontrolled bleeding (16.1%), perforation (13.8%), and intractability (12.6%). In total, 27.6% of surgeries were performed in an emergency setting. Total or subtotal colectomy with rectal preservation (41.4%) was the most common operation. There were 6 mortalities, all due to sepsis. Emergency operation and low pre-operative albumin level were significantly associated with poor survival (P =0.013 and 0.034, respectively). Conclusions: In the past 20 years, there was no significant change in the indications for surgery in UC patients. Emergency surgeries and low pre-operative albumin level were associated with poor survival. Therefore, an optimal timing of elective surgery for people with poorly controlled UC is paramount.

The long-term anatomical and visual effect of intravitreal triamcinolone injection during vitrectomy for the treatment of idiopathic macular epiretinal membrane

Lai, Chi-Chun,Wang, Nan-Kai,Wu, Wei-Chi,Yeung, Ling,Hwang, Yih-Shiou,Chen, Kuan-Jen,Chen, Tun-Lu,Chuang, Lan-Hsin Informa Healthcare 2011 Cutaneous and ocular toxicology Vol.30 No.4

<P><I>Purpose</I>: To compare the long-term anatomical and visual outcomes of patients with idiopathic epiretinal membrane (ERM) removed by vitrectomy and membrane peeling with or without the use of intravitreal injection of triamcinolone acetonide (IVTA).</P><P><I>Methods</I>: A retrospective chart review was performed. Subjects who underwent vitrectomy and who were followed over 12 months were included. The study included two groups of patients. In group 1 (71 eyes), the patients underwent vitrectomy and membrane peeling without the use of IVTA. In group 2 (27 eyes), 2 mg of IVTA was given at the end of the surgery. The main outcome measures were best-corrected visual acuity (BCVA), central foveal thickness (CFT) determined by optical coherence tomography (OCT), the number of cataract surgeries, and the use of anti-glaucomatous drugs during the follow-up period.</P><P><I>Results</I>: This study included 98 eyes with ERM from 98 patients. There was no significant difference between the two groups with respect to age, gender, pre- and postoperative lens status, BCVA, CFT, or length of the follow-up period. The mean age for all of the patients was 62.45 ± 10.01 (mean ± SD) years, and the mean follow-up length was 20.58 ± 9.64 (mean ± SD) months. In all cases, the mean best-corrected logarithm of minimum angle of resolution (logMAR) acuity improved from a preoperative value of 0.91 ± 0.32 [Snellen equivalent (SE), 0.16 ± 0.14] to a postoperative value of 0.46 ± 0.36 (SE, 0.46 ± 0.29) (<I>P</I> < 0.0001). The CFT was reduced from a preoperative value of 473.46 ± 96.91 μm to a postoperative value of 302.44 ± 69.80 μm (<I>P</I> < 0.0001). Six patients (22.2%) in group 2 required anti-glaucomatous drugs to control intraocular pressure (IOP) during the follow-up period, and three patients (4.2%) in group 1 required drugs to control IOP (<I>P</I> == 0.012).</P><P><I>Conclusions</I>: The postoperative visual outcomes for patients with idiopathic ERM were favorable, but CFT did not return to a normal level, even in eyes in which 2 mg IVTA was used. The IVTA use after ERM removal produced no significant benefits during long-term follow-up, but IVTA did increase the risk of increased IOP.</P>

Enhanced x-ray irradiation-induced cancer cell damage by gold nanoparticles treated by a new synthesis method of polyethylene glycol modification

Liu, Chi-Jen,Wang, Chang-Hai,Chien, Chia-Chi,Yang, Tsung-Yeh,Chen, Shin-Tai,Leng, Wei-Hua,Lee, Cheng-Feng,Lee, Kuen-Ho,Hwu, Y,Lee, Yao-Chang,Cheng, Chia-Liang,Yang, Chung-Shi,Chen, Y J,Je, J H,Margari IOP Pub 2008 Nanotechnology Vol.19 No.29

<P>We explored a very interesting gold nanoparticle system—pegylated gold in colloidal solution—and analyzed its uptake by mice colorectal adenocarcinoma CT26 tumor cells and the impact on the cell’s response to x-ray irradiation. We found that exposure to polyethylene glycol (PEG) modified (‘pegylated’) 4.7 ± 2.6 nm gold nanoparticles synthesized by a novel synchrotron-based method enhances the response of CT26 cells to x-ray irradiation. Transmission electron microscopy (TEM) and confocal microscopy revealed that substantial amounts of such nanoparticles are taken up and absorbed by the cells and this conclusion is supported by quantitative induced coupled plasma (ICP) results. Standard tests indicated that the internalized particles are highly biocompatible but strongly enhance the cell damage induced by x-ray irradiation. Synchrotron radiation Fourier transform infrared (SR-FTIR) spectromicroscopy analyzed the chemical aspects of this phenomenon: the appearance of C = O stretching bond spectral features could be used as a marker for cell damage and confirmed the enhancement of the radiation-induced toxicity for cells.</P>

Management of Crohn`s disease in Taiwan: consensus guideline of the Taiwan Society of Inflammatory Bowel Disease

( Shu-Chen Wei ),( Ting-An Chang ),( Te-Hsin Chao ),( Jinn-Shiun Chen ),( Jen-Wei Chou ),( Yenn-Hwei Chou ),( Chiao-Hsiung Chuang ),( Wen-Hung Hsu ),( Tien-Yu Huang ),( Tzu-Chi Hsu ),( Chun-Chi Lin ) 대한장연구학회 2017 Intestinal Research Vol.15 No.3

Crohn`s disease (CD) is a chronic relapsing and remitting inflammatory disease of the gastrointestinal tract. CD is rare in Taiwan and other Asian countries, but its prevalence and incidence have been steadily increasing. A steering committee was established by the Taiwan Society of Inflammatory Bowel Disease to formulate statements on the diagnosis and management of CD taking into account currently available evidence and the expert opinion of the committee. Thorough clinical, endoscopic, and histological assessments are required for accurate diagnosis of CD. Computed tomography and magnetic resonance imaging are complementary to endoscopic evaluation for disease staging and detecting complications. The goals of CD management are to induce and maintain remission, reduce the risk of complications, and improve quality of life. Corticosteroids are the mainstay for inducing re-mission. Immunomodulating and biologic therapies should be used to maintain remission. Patients should be evaluated for hepatitis B virus and tuberculosis infection prior to treatment and receive regular surveillance for cancer. These consensus statements are based on current local evidence with consideration of factors, and could be serve as concise and practical guidelines for supporting clinicians in the management of patients with CD in Taiwan. (Intest Res 2017;15:285-310)

Management of ulcerative colitis in Taiwan: consensus guideline of the Taiwan Society of Inflammatory Bowel Disease

( Shu-Chen Wei ),( Ting-An Chang ),( Te-Hsin Chao ),( Jinn-Shiun Chen ),( Jen-Wei Chou ),( Yenn-Hwei Chou ),( Chiao-Hsiung Chuang ),( Wen-Hung Hsu ),( Tien-Yu Huang ),( Tzu-Chi Hsu ),( Chun-Chi Lin ) 대한장연구학회 2017 Intestinal Research Vol.15 No.3

Ulcerative colitis (UC) is an inflammatory bowel disease characterized by chronic mucosal inflammation of the colon, and the prevalence and incidence of UC have been steadily increasing in Taiwan. A steering committee was established by the Taiwan Society of Inflammatory Bowel Disease to formulate statements on the diagnosis and management of UC taking into account currently available evidence and the expert opinion of the committee. Accurate diagnosis of UC requires thorough clinical, endoscopic, and histological assessment and careful exclusion of differential diagnoses, particularly infectious colitis. The goals of UC therapy are to induce and maintain remission, reduce the risk of complications, and improve quality of life. As outlined in the recommended treatment algorithm, choice of treatment is dictated by severity, extent, and course of disease. Patients should be evaluated for hepatitis B virus and tuberculosis infection prior to immunosuppressive treatment, especially with steroids and biologic agents, and should be regularly monitored for reactivation of latent infection. These consensus statements are also based on current local evidence with consideration of factors, and could be serve as concise and practical guidelines for supporting clinicians in the management of UC in Taiwan. (Intest Res 2017;15:266-284)

Prognostic Factors in Adult Patients with Solid Cancers and Bone Marrow Metastases

Hung, Yu-Shin,Chou, Wen-Chi,Chen, Tai-Di,Chen, Tse-Ching,Wang, Po-Nan,Chang, Hung,Hsu, Hung-Chih,Shen, Wen-Chi,Cheng, Wei-Hong,Chen, Jen-Shi Asian Pacific Journal of Cancer Prevention 2014 Asian Pacific journal of cancer prevention Vol.15 No.1

Background: Solid cancers with bone marrow metastases are rare but lethal. This study aimed to identify clinical factors predictive of survival in adult patients with solid cancers and bone marrow metastases. Methods: A total of 83 patients were enrolled consecutively between January 1, 2000 and December 31, 2012. Bone marrow metastases were confirmed by biopsies. Patient clinical features and laboratory data were analyzed for associations. Results: The median age of the patients was 54 years (range, 23-88 years), and 58% were male. The 3 most common primary tumor locations were the stomach (32 patients, 39%), prostate (16 patients, 19%), and lungs (12 patients, 15%). The median overall survival was 49 days (range, 3-1423 days). Patients with Eastern Cooperative Oncology Group performance status 1, cancers of prostate origin, platelet counts over 50,000/ml, and undergoing antitumor therapies had a significantly better prognosis in the multivariate analysis. The median survival times were 173 and 33 days for patients with 2-3 more favorable parameters (n=24) and those with 0-1 (n=69), respectively (hazard ratio 0.30; 95% CI 0.17-0.52, p<0.001). Conclusions: Solid cancers with bone marrow metastases are dismal and incurable diseases. Understanding prognostic factors to these diseases helps medical personnel to provide appropriate treatments and better inform patients about outcomes. Antitumor therapies may improve outcomes in selected patient cohorts.

Ledipasvir/Sofosbuvir for 12 Weeks Is Safe and Effective in CHC and CHB Coinfection Patients: A Phase 3 Study in Taiwan

( Chun-Jen Liu ),( Wan-Long Chuang ),( I-Shyan Sheen ),( Horng-Yuan Wang ),( Chi-Yi Chen ),( Kuo-Chih Tseng ),( Ting-Tsung Chang ),( Benede tta Massetto ),( Jenny Yang ),( Gregory Camus ),( Fangqiu Zh 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

Aims: Patients co-infected with HCV and HBV have more rapid progression and worse outcomes than mono-infected patients. Taiwan has among the highest prevalence of chronic HCV/HBV coinfection in Southeast Asia. This study evaluated the safety and efficacy of an all-oral treatment with ledipasvir(LDV)/sofosbuvir(SOF) for 12 weeks in chronic HCV and HBV coinfection. Methods: Patients with or without compensated cirrhosis chronic HCV GT1/GT2 and HBV (HBsAg+) treatment naïve were enrolled into open-label, receiving LDV 90 mg/SOF 400 mg(QD) for 12 weeks. The primary efficacy endpoint is SVR12. HBV DNA was monitored at all study visits and it will be monitored for 2 years post-treatment. Results: A total of 111 patients (68[61%] with GT1 and 43[39%] with GT2) were enrolled and treated. The majority were female(62%), treatment naive(67%), and non-cirrhotic(85%), with a mean age of 55 years and mean BMI of 24.5kg/m2. All but one was HBeAg negative. Mean baseline HBV DNA was 2.1 log10IU/mL. SVR4 was 100%(111/111). The mean change in HBV DNA ranged from -0.06 log10IU/mL at week 1 to +0.49 log10IU/mL at follow-up visit 4; HBV DNA kinetics are shown in Fig 1. 60(54%) patients had an increase in HBV DNA> 10 x BL or became HBV DNA > LLOQ. No patients had ALT ≥ 2 X baseline. No patients discontinued treatment due to adverse events (AEs). Three patients had serious AEs(optic neuritis, post procedural bleeding and duodenal ulcer bleeding; none was considered drug related). Conclusions: In chronic HCV/HBV infection patients, LDV/SOF for 12 weeks resulted in an SVR4 rate of 100%. Although most patients had an increase in HBV DNA during treatment, this was not associated with ALT elevations ≥2 X baseline, and no patients started HBV therapy to date. This all-oral, interferon-free regimen was well tolerated, supporting its potential as a treatment option for HCV/HBV co-infected patients.

Ideal Topographic Simulations for Null Measurement Data

Yan-Jen Su,Chi-Hong Tung,Leh-Rong Chang,Jin-Liang Chen,Calvin Chang 한국정밀공학회 2008 International Journal of Precision Engineering and Vol.9 No.4

A method is described for ideally reconstructing the profile from a surface profiling measurement containing a reasonable amount of null measurement data. The proposed method can conjecture lost information and rectify irregular data that result due to bad measuring environments. signal transmission noise. or instrument-induced errors. The method adopts the concept 0/ computer graphics and consists of several processing steps. First, a search for valid data in the neighborhood of the null data is performed. The valid data are then grouped and their contours are extracted. By analyzing these contours, a bounding box can be obtained and the general distribution of the entire area encompassing the valid and null data is determined. Finally, em ideal surface model is overlaid onto the measurement results based on the bounding box, generating a complete reconstruction of the calculations. A surface-profiling task on a liquid crystal display photo spacer is used to verify the proposed method. The results are compared to those obtained through the use of a scanning electron microscope to demonstrate the accuracy of the proposed method.