Case of Esophageal Actinomycosis Occurred after Endoscopic Mucosal Resection for Subepithelial Tumor / 대한소화기학회지

Esophageal actinomycosis is a rare, chronic granulomatous disease caused by Actinomyces species. Endoscopy and biopsy are essential for making a diagnosis. This paper reports a case of esophageal actinomycosis that developed after an endoscopic mucosal resection (EMR) for a subepithelial tumor (SET). A 74-year-old male patient had a 3 cm flat, smooth elevation in the esophagus without symptoms. The SET was partially resected, and histology revealed “nonspecific degenerated mesenchymal tissue”. Three months later, the patient exhibited a persistently large ulceration at the EMR site, and a biopsy revealed actinomycosis. CT of the chest and abdomen revealed no abnormal findings. Ampicillin treatment was administered for six months, and the ulceration on the esophageal SET improved.

Endoscopic Ultrasonography-guided Gastrojejunostomy for Patients with Gastric Outlet Obstruction and Pyloric Metal Stent Dysfunction / 대한소화기학회지

A 52-year-old woman with a gastric outlet obstruction (GOO) caused by pyloric cancer underwent pyloric endoscopic self-expandable metal stent (SEMS) insertion. She presented with abdominal distension 40 days later. The SEMS was dysfunctional, and endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) was performed using an endoscopic nasobiliary drainage tube. A 16 mm×31 mm Niti-S ™ HOT SPAXUS™ (TaeWoong Medical, Gimpo, Korea) was inserted successfully between the stomach and the adjacent jejunum. After the procedure, the patient had a good oral intake for more than seven months. GOO is a mechanical obstructive condition caused by various benign and malignant conditions. Traditionally, surgical GJ and SEMS insertion have been used to treat GOOs. EUS-GJ is a feasible treatment option for patients with GOO and a pyloric metal stent dysfunction.

Genomic landscape of advanced endometrial cancer analyzed by targeted next-generation sequencing and the cancer genome atlas (TCGA) dataset / 부인종양

Objective@#Recent studies have detailed the genomic landscape of endometrial cancer (EC); however, no study has focused on genetic alterations in advanced EC. We performed genomic profiling of patients with advanced EC using targeted next-generation sequencing (NGS). @*Methods@#Archival tissue samples from 21 patients diagnosed with stage III and IV EC were obtained and subjected to NGS. Our data and the cancer genome atlas dataset were combined, and somatic mutation patterns were analyzed and compared according to the stage and histological type. Additionally, survival effects of specific mutated genes were analyzed. @*Results@#Somatic mutation patterns of 38 genes were identified in 263 EC samples, and the most commonly mutated genes were PTEN and PIK3CA. PTEN was the most common in endometrioid histology, while PPP2R1A was the most commonly mutated gene in serous histology. The mutation rates of PPP2R1A and TP53 were significantly higher in advanced EC sample than in stage I samples (22.5% vs. 4.3% [p<0.001] and 8.4% vs. 1.4% [p=0.021], respectively). Survival analysis of the total population and endometrioid subgroup revealed that patients with PPP2R1A mutations had significantly shorter survival than did those without mutations (p=0.005 and p<0.001, respectively). @*Conclusion@#PPP2R1A mutations might have a role in dismal prognosis of advanced EC.

Updated clinical guideline for human papillomavirus vaccine: the Korean Society of Gynecologic Oncology guidelines / 부인종양

Since the human papillomavirus (HPV) vaccine guidelines were developed by the Korean Society of Gynecologic Oncology (KSGO) in 2011, 2016, and 2019, several recent studies on the efficacy and safety of HPV vaccines in middle-aged women and men have been reported. Furthermore, there has been an ongoing debate regarding the efficacy of the HPV vaccine in women with prior HPV infection or who have undergone conization for cervical intraepithelial neoplasia (CIN). We searched and reviewed studies on the efficacy and safety of the HPV vaccine in middle-aged women and men and the efficacy of the HPV vaccine in patients infected with HPV and those who underwent conization for CIN. The KSGO updated their guidelines based on the results of the studies included in this review.

Predictive Factors for Differentiating Gastrointestinal Stromal Tumors from Leiomyomas Based on Endoscopic Ultrasonography Findings in Patients with Gastric Subepithelial Tumors: A Multicenter Retrospective Study

Background/Aims@#The utility of endoscopic ultrasonography (EUS) for differentiating gastrointestinal stromal tumors (GISTs) and leiomyomas of the stomach is not well known. We aimed to evaluate the ability of EUS for differentiating gastric GISTs and leiomyomas. @*Methods@#We retrospectively reviewed the medical records of patients with histopathologically proven GISTs (n=274) and leiomyomas (n=87). In two consensus meetings, the inter-observer variability in the EUS image analysis was reduced. Using logistic regression analyses, we selected predictive factors and constructed a predictive model and nomogram for differentiating GISTs from leiomyomas. A receiver operating characteristic (ROC) curve analysis was performed to measure the discrimination performance in the development and internal validation sets. @*Results@#Multivariate analysis identified heterogeneity (odds ratio [OR], 9.48), non-cardia (OR, 19.11), and older age (OR, 1.06) as independent predictors of GISTs. The areas under the ROC curve of the predictive model using age, sex, and four EUS factors (homogeneity, location, anechoic spaces, and dimpling or ulcer) were 0.916 (sensitivity, 0.908; specificity, 0.793) and 0.904 (sensitivity, 0.908; specificity, 0.782) in the development and internal validation sets, respectively. @*Conclusions@#The predictive model and nomogram using age, sex and homogeneity, tumor location, presence of anechoic spaces, and presence of dimpling or ulcer on EUS may facilitate differentiation between GISTs and leiomyomas.

Cannulation of the Portal Vein during Endoscopic Retrograde Cholangiopancreatography in a Patient with Choledocholithiasis / 대한소화기학회지

Cannulation of the portal vein is a rare complication of ERCP. This paper reports a case of portal vein catheterization during ERCP in a patient with choledocholithiasis. A 62-year-old man was admitted to the Presbyterian Medical Center with right upper quadrant pain and jaundice. ERCP was performed under the suspicion of obstructive jaundice caused by a radiolucent stone. Bile duct cannulation using a pull-type papillotome was attempted, but it failed. After needle-knife fistulotomy, wire-guided cannulation was performed successfully, and 10 mL contrast was injected. On the other hand, the fluoroscopy image showed that the contrast medium disappeared very quickly. Pure blood was collected when the catheter was aspirated to identify the bile reflux, indicating possible cannulation of the portal vein. The procedure was terminated immediately and abdominal computed tomography showed air in the portal vein. One day after, a follow-up CT scan showed no air in the portal vein. The patient underwent repeated ERCP, and the common bile duct was cannulated. In most cases, isolated portal vein cannulation does not result in severe morbidity. However, it is important to aware of this rare complication so that no further invasive procedure is performed on the patient.

Pregnancy Outcomes Following Laparoscopic and Open Surgery in Pelvis during Pregnancy: a Nationwide Population-based Study in Korea

Background@#Non-obstetric surgery during pregnancy is associated with adverse obstetric and fetal outcomes. The aim of this study was to investigate the risk of adverse pregnancy outcomes for women who underwent non-obstetric pelvic surgery during pregnancy compared with that of women that did not undergo surgery. @*Methods@#Study data from women who gave birth in Korea were collected from the Korea National Health Insurance claims database between 2006 and 2016. We identified pregnant women who underwent abdominal non-obstetric pelvic surgery by laparoscopy or laparotomy from the database. Pregnancy outcomes including preterm birth, low birth weight (LBW), cesarean section (C/S), gestational hypertension, gestational diabetes, and postpartum hemorrhage were identified. The adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for the pregnancy outcomes were estimated by multivariate regression models. @*Results@#Data from 4,439,778 women were collected for this study. From 2006–2016, 9,417 women from the initial cohort underwent non-obstetric pelvic surgery (adnexal mass resection, appendectomy) during pregnancy. Multivariate logistic regression analysis indicated that preterm birth (HR, 2.01; 95% CI, 1.81–2.23), LBW (HR, 1.62; 95% CI, 1.46– 1.79), C/S (HR, 1.13; 95% CI, 1.08–1.18), and gestational hypertension (HR, 1.35; 95% CI, 1.18–1.55) were significantly more frequent in women who underwent non-obstetric surgery during pregnancy compared to pregnant women who did not undergo surgery. When the laparoscopic and laparotomy groups were compared for risk of fetal outcomes, the risk of LBW was significantly decreased in laparoscopic adnexal resection during pregnancy compared to laparotomy (odds ratio, 0.62; 95% CI, 0.40–0.95). @*Conclusion@#Non-obstetric pelvic surgery during pregnancy was associated with a higher risk of preterm birth, LBW, gestational hypertension, placenta previa, placental abruption, and C/S. Although the benefits and safety of laparoscopy during pregnancy appear similar to those of laparotomy in regard to pregnancy outcomes, laparoscopic adnexal mass resection was associated with a lower risk of LBW.

Effect of Sarcopenia and Body Shape on Cardiovascular Disease According to Obesity Phenotypes

BackgroundThis study aimed to assess the effects of sarcopenia and A Body Shape Index (ABSI) on cardiovascular disease (CVD) risk according to obesity phenotypes.MethodsWe used data from the National Health and Nutrition Examination Survey 1999 to 2012. A total of 25,270 adults were included and classified into the following groups: metabolically healthy normal weight (MHNW), metabolically healthy overweight/obese (MHO), metabolically unhealthy normal weight (MUNW), and metabolically unhealthy overweight/obese (MUO). Sarcopenia was defined as the appendicular skeletal mass index ResultsThe MHNW participants with sarcopenia had higher risk for CVD than those without sarcopenia (OR, 2.69; 95% confidence interval [CI], 1.56 to 4.64). In the analysis with MHNW participants without sarcopenia as a reference, the participants with sarcopenia showed a higher OR for CVD than those without sarcopenia in both MHO (OR in participants without sarcopenia, 3.31; 95% CI, 1.94 to 5.64) (OR in participants with sarcopenia, 8.59; 95% CI, 2.63 to 28.04) and MUO participants (OR in participants without sarcopenia, 5.11; 95% CI, 3.21 to 8.15) (OR in participants with sarcopenia, 8.12; 95% CI, 4.04 to 16.32). Participants within the second and third tertiles of ABSI had higher ORs for CVDs than the counterpart of obesity phenotypes within the first tertile.ConclusionThese results suggest that clinical approaches that consider muscle and body shape are required.

Performance and Diagnostic Accuracy of Human Papillomavirus Testing on Self-Collected Urine and Vaginal Samples in a Referral Population / Journal of the Korean Cancer Association, 대한암학회지

Purpose@#The study aimed to evaluate the diagnostic accuracy of polymerase chain reaction ‒based high-risk human papillomavirus (HPV) assays on self-collected vaginal and urine samples for detection of precancerous cervical lesions in referral population. @*Materials and Methods@#Women referred for colposcopy following abnormal cytology, were included this study. A total of 314 matched urine, vaginal, and cervical samples were collected. All samples were tested for HPV DNA using the RealTime HR-S HPV and Anyplex II HPV 28 assays. Primary endpoints were sensitivity for cervical intraepithelial neoplasia (CIN) 2+/CIN3+ and specificity for

Cannulation of the Portal Vein during Endoscopic Retrograde Cholangiopancreatography in a Patient with Choledocholithiasis / 대한소화기학회지

Cannulation of the portal vein is a rare complication of ERCP. This paper reports a case of portal vein catheterization during ERCP in a patient with choledocholithiasis. A 62-year-old man was admitted to the Presbyterian Medical Center with right upper quadrant pain and jaundice. ERCP was performed under the suspicion of obstructive jaundice caused by a radiolucent stone. Bile duct cannulation using a pull-type papillotome was attempted, but it failed. After needle-knife fistulotomy, wire-guided cannulation was performed successfully, and 10 mL contrast was injected. On the other hand, the fluoroscopy image showed that the contrast medium disappeared very quickly. Pure blood was collected when the catheter was aspirated to identify the bile reflux, indicating possible cannulation of the portal vein. The procedure was terminated immediately and abdominal computed tomography showed air in the portal vein. One day after, a follow-up CT scan showed no air in the portal vein. The patient underwent repeated ERCP, and the common bile duct was cannulated. In most cases, isolated portal vein cannulation does not result in severe morbidity. However, it is important to aware of this rare complication so that no further invasive procedure is performed on the patient.

Pregnancy Outcomes Following Laparoscopic and Open Surgery in Pelvis during Pregnancy: a Nationwide Population-based Study in Korea

Background@#Non-obstetric surgery during pregnancy is associated with adverse obstetric and fetal outcomes. The aim of this study was to investigate the risk of adverse pregnancy outcomes for women who underwent non-obstetric pelvic surgery during pregnancy compared with that of women that did not undergo surgery. @*Methods@#Study data from women who gave birth in Korea were collected from the Korea National Health Insurance claims database between 2006 and 2016. We identified pregnant women who underwent abdominal non-obstetric pelvic surgery by laparoscopy or laparotomy from the database. Pregnancy outcomes including preterm birth, low birth weight (LBW), cesarean section (C/S), gestational hypertension, gestational diabetes, and postpartum hemorrhage were identified. The adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for the pregnancy outcomes were estimated by multivariate regression models. @*Results@#Data from 4,439,778 women were collected for this study. From 2006–2016, 9,417 women from the initial cohort underwent non-obstetric pelvic surgery (adnexal mass resection, appendectomy) during pregnancy. Multivariate logistic regression analysis indicated that preterm birth (HR, 2.01; 95% CI, 1.81–2.23), LBW (HR, 1.62; 95% CI, 1.46– 1.79), C/S (HR, 1.13; 95% CI, 1.08–1.18), and gestational hypertension (HR, 1.35; 95% CI, 1.18–1.55) were significantly more frequent in women who underwent non-obstetric surgery during pregnancy compared to pregnant women who did not undergo surgery. When the laparoscopic and laparotomy groups were compared for risk of fetal outcomes, the risk of LBW was significantly decreased in laparoscopic adnexal resection during pregnancy compared to laparotomy (odds ratio, 0.62; 95% CI, 0.40–0.95). @*Conclusion@#Non-obstetric pelvic surgery during pregnancy was associated with a higher risk of preterm birth, LBW, gestational hypertension, placenta previa, placental abruption, and C/S. Although the benefits and safety of laparoscopy during pregnancy appear similar to those of laparotomy in regard to pregnancy outcomes, laparoscopic adnexal mass resection was associated with a lower risk of LBW.

Effect of Sarcopenia and Body Shape on Cardiovascular Disease According to Obesity Phenotypes

BackgroundThis study aimed to assess the effects of sarcopenia and A Body Shape Index (ABSI) on cardiovascular disease (CVD) risk according to obesity phenotypes.MethodsWe used data from the National Health and Nutrition Examination Survey 1999 to 2012. A total of 25,270 adults were included and classified into the following groups: metabolically healthy normal weight (MHNW), metabolically healthy overweight/obese (MHO), metabolically unhealthy normal weight (MUNW), and metabolically unhealthy overweight/obese (MUO). Sarcopenia was defined as the appendicular skeletal mass index ResultsThe MHNW participants with sarcopenia had higher risk for CVD than those without sarcopenia (OR, 2.69; 95% confidence interval [CI], 1.56 to 4.64). In the analysis with MHNW participants without sarcopenia as a reference, the participants with sarcopenia showed a higher OR for CVD than those without sarcopenia in both MHO (OR in participants without sarcopenia, 3.31; 95% CI, 1.94 to 5.64) (OR in participants with sarcopenia, 8.59; 95% CI, 2.63 to 28.04) and MUO participants (OR in participants without sarcopenia, 5.11; 95% CI, 3.21 to 8.15) (OR in participants with sarcopenia, 8.12; 95% CI, 4.04 to 16.32). Participants within the second and third tertiles of ABSI had higher ORs for CVDs than the counterpart of obesity phenotypes within the first tertile.ConclusionThese results suggest that clinical approaches that consider muscle and body shape are required.

Performance and Diagnostic Accuracy of Human Papillomavirus Testing on Self-Collected Urine and Vaginal Samples in a Referral Population / Journal of the Korean Cancer Association, 대한암학회지

Purpose@#The study aimed to evaluate the diagnostic accuracy of polymerase chain reaction ‒based high-risk human papillomavirus (HPV) assays on self-collected vaginal and urine samples for detection of precancerous cervical lesions in referral population. @*Materials and Methods@#Women referred for colposcopy following abnormal cytology, were included this study. A total of 314 matched urine, vaginal, and cervical samples were collected. All samples were tested for HPV DNA using the RealTime HR-S HPV and Anyplex II HPV 28 assays. Primary endpoints were sensitivity for cervical intraepithelial neoplasia (CIN) 2+/CIN3+ and specificity for

Eosinophilic fasciitis: A case report with a brief literature review

Eosinophilic fasciitis (EF) is a scleroderma-like immune-allergic disorder of unknown etiology and pathogenesis. This rare disease is characterized by the progressive induration of the skin and soft tissue, and peripheral eosinophilia. Here, we report a case of EF. A 21-year-old female was referred due to edema in the upper and lower extremities for 1 month. Laboratory results were unremarkable except for severe eosinophilia. Parasite infestation, venous thrombosis, and cardiac and renal problems were excluded. Magnetic resonance imaging of both the lower extremities revealed symmetrical thickening and contrast enhancement of crural fascia with adjacent subcutaneous fat infiltration. A full-thickness biopsy at the lower extremity showed infiltration of the fascia by eosinophils, plasma cells, and lymphocytes with marked edema. Thus, this patient was confirmed to have EF and she was treated with systemic corticosteroids, resulting in a remarkable improvement in both edema and eosinophilia.

Effect of Sarcopenia and Body Shape on Cardiovascular Disease According to Obesity Phenotypes

Background@#This study aimed to assess the effects of sarcopenia and A Body Shape Index (ABSI) on cardiovascular disease (CVD) risk according to obesity phenotypes. @*Methods@#We used data from the National Health and Nutrition Examination Survey 1999 to 2012. A total of 25,270 adults were included and classified into the following groups: metabolically healthy normal weight (MHNW), metabolically healthy overweight/obese (MHO), metabolically unhealthy normal weight (MUNW), and metabolically unhealthy overweight/obese (MUO). Sarcopenia was defined as the appendicular skeletal mass index <7 kg/m2 in men and <5.5 kg/m2 in women. A multivariate logistic regression analysis was performed to evaluate the odds ratio (OR) of sarcopenia and ABSI for CVD events according to the obesity phenotype. @*Results@#The MHNW participants with sarcopenia had higher risk for CVD than those without sarcopenia (OR, 2.69; 95% confidence interval [CI], 1.56 to 4.64). In the analysis with MHNW participants without sarcopenia as a reference, the participants with sarcopenia showed a higher OR for CVD than those without sarcopenia in both MHO (OR in participants without sarcopenia, 3.31; 95% CI, 1.94 to 5.64) (OR in participants with sarcopenia, 8.59; 95% CI, 2.63 to 28.04) and MUO participants (OR in participants without sarcopenia, 5.11; 95% CI, 3.21 to 8.15) (OR in participants with sarcopenia, 8.12; 95% CI, 4.04 to 16.32). Participants within the second and third tertiles of ABSI had higher ORs for CVDs than the counterpart of obesity phenotypes within the first tertile. @*Conclusion@#These results suggest that clinical approaches that consider muscle and body shape are required.

Risk factors for type-specific persistence of high-risk human papillomavirus and residual/recurrent cervical intraepithelial neoplasia after surgical treatment

Objective@#This study aimed to investigate the clinicopathologic risk factors for type-specific persistence of high-risk human papillomavirus (hrHPV) and residual/recurrent cervical intraepithelial neoplasia (CIN) after surgical treatment. @*Methods@#Patients with CIN-2/3 who underwent conization or loop electrosurgical excision procedure (LEEP) at Korea University Hospital were enrolled. All patients underwent hrHPV testing and genotyping before conization or LEEP followed by both hrHPV genotyping and cytology. The significance of associations between patient characteristics and persistence of infection were assessed by multivariate logistic regression analyses. @*Results@#Among 398 women with pathologically confirmed CIN-2/3, 154 (38.7%) patients showed hrHPV persistence after surgical treatment. In multivariate analysis, high preoperative hrHPV load (P<0.05; odds ratio [OR], 2.063), presence of CIN-2 at treatment (P<0.01; OR, 2.732), and multiple hrHPV infections (P<0.001; OR, 4.752) were associated with hrHPV persistence. HPV 53 was the most likely to persist after treatment (24/43, 55.8%). The risk of residual/recurrent CIN-2/3 was higher in persistent infection with HPV 16 than other types (P<0.05). Menopause (P<0.001; OR, 3.969), preoperative and postoperative hrHPV load (P<0.05; OR, 2.430; P<0.05; OR, 5.351), and infection with multiple hrHPV types (P<0.05; OR, 2.345) were significantly related to residual/recurrent CIN following surgical treatment. @*Conclusion@#HPV load before treatment and infection with multiple hrHPV types were predictors of postoperative hrHPV persistence. HPV 53 was the type most likely to persist, but HPV 16 was the type that was most closely associated with residual/recurrent CIN-2/3.

Risk factors for type-specific persistence of high-risk human papillomavirus and residual/recurrent cervical intraepithelial neoplasia after surgical treatment

Objective@#This study aimed to investigate the clinicopathologic risk factors for type-specific persistence of high-risk human papillomavirus (hrHPV) and residual/recurrent cervical intraepithelial neoplasia (CIN) after surgical treatment. @*Methods@#Patients with CIN-2/3 who underwent conization or loop electrosurgical excision procedure (LEEP) at Korea University Hospital were enrolled. All patients underwent hrHPV testing and genotyping before conization or LEEP followed by both hrHPV genotyping and cytology. The significance of associations between patient characteristics and persistence of infection were assessed by multivariate logistic regression analyses. @*Results@#Among 398 women with pathologically confirmed CIN-2/3, 154 (38.7%) patients showed hrHPV persistence after surgical treatment. In multivariate analysis, high preoperative hrHPV load (P<0.05; odds ratio [OR], 2.063), presence of CIN-2 at treatment (P<0.01; OR, 2.732), and multiple hrHPV infections (P<0.001; OR, 4.752) were associated with hrHPV persistence. HPV 53 was the most likely to persist after treatment (24/43, 55.8%). The risk of residual/recurrent CIN-2/3 was higher in persistent infection with HPV 16 than other types (P<0.05). Menopause (P<0.001; OR, 3.969), preoperative and postoperative hrHPV load (P<0.05; OR, 2.430; P<0.05; OR, 5.351), and infection with multiple hrHPV types (P<0.05; OR, 2.345) were significantly related to residual/recurrent CIN following surgical treatment. @*Conclusion@#HPV load before treatment and infection with multiple hrHPV types were predictors of postoperative hrHPV persistence. HPV 53 was the type most likely to persist, but HPV 16 was the type that was most closely associated with residual/recurrent CIN-2/3.

Effects of hormone therapy on recurrence in endometrial cancer survivors: a nationwide study using the Korean Health Insurance Review and Assessment Service database / 부인종양

OBJECTIVE: The aim of this study was to verify the effects of hormone therapy (HT) on recurrence in endometrial cancer (EC) survivors using the Korean Health Insurance Review and Assessment Service (HIRA) database. METHODS: Using the HIRA claims database, we identified all Korean women who were newly diagnosed with EC and underwent surgical staging between 2010 and 2013. Patient characteristics such as age, HT exposure, lymphadenectomy, and adjuvant therapy were evaluated. Cox proportional hazards models were used to estimate the adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for the recurrence of EC. RESULTS: The mean follow-up time of all 5,667 eligible patients was 47.5 months. Of these, 847 (14.9%) received HT. Recurrence was seen in 446 (7.8%) patients. Univariate analysis revealed an increased recurrence rate in patients older than 50 years (HR=2.05; 95% CI=1.62–2.63), patients with high-risk EC (HR=24.51; 95% CI=18.63–32.35), and patients who underwent lymphadenectomy (HR=1.52; 95% CI=1.21–2.03), and a reduced recurrence rate in patients who received HT (HR=0.62; 95% CI=0.46–0.83). Multivariate analysis confirmed the significant increase in recurrence in patients older than 50 years (HR=1.47; 95% CI=1.14–1.89) and in patients with high-risk EC (HR=23.90; 95% CI=18.12–31.51). HT did not increase the recurrence rate of EC (HR=0.81; 95% CI=0.31–2.10). CONCLUSION: This study demonstrates that HT does not increase disease recurrence in EC survivors, despite lack of data that could affect the outcome.

Efficacy and Safety of AlbisD Compared With Omeprazole 20 mg in Patients With Non-erosive Reflux Disease: A Randomized, Open-label, Active-controlled, Pilot Study

BACKGROUND/AIMS: Proton pump inhibitors (PPIs) are frequently used to treat non-erosive reflux disease (NERD), but their effect is limited. It is not known whether a potential alternative, AlbisD, containing ranitidine hydrochloride, sucralfate hydrate, and tripotassium dicitrato bismuthate, is effective and safe in treating NERD. The aim of the study is to evaluate the efficacy and safety of AlbisD compared with omperazole in patients with NERD. METHODS: This was a multicenter, randomized, open-label, parallel-group, non-inferiority comparative study. A total of 126 patients with NERD were randomly allocated to either AlbisD twice daily or omeprazole 20 mg once daily for 4 weeks from February 2016 to August 2016. The study patients had histories of heartburn or regurgitation of moderate severity (> score 2) and a frequency of at least 2 episodes per week, and had no mucosal breaks of the esophagus on endoscopy. The primary efficacy variable was complete cure of heartburn at week 4. Secondary efficacy variables evaluating symptoms of heartburn and acid reflux as well as safety profiles were compared in the 2 groups at week 2 and 4 after treatment. RESULTS: A total of 113 patients completed the study (57 and 56 in AlbisD and omeprazole groups, respectively). The proportion of patients with complete cure of heartburn at week 4 was not significantly different between the AlbisD and omeprazole groups (35.1% vs 32.1% respectively, P = 0.740). There were no significant differences between the 2 groups in the any secondary variables including proportions of days without heartburn or acid reflux over 4 weeks (including daytime and nighttime). Adverse events were similarly reported in the 2 groups (7 [12.3%] vs 6 [10.7%]), and there were no serious adverse events. CONCLUSIONS: The efficacy and safety of AlibsD in treating NERD patients are not inferior to those of omeprazole. Therefore, AlbisD can be an alternative to PPIs for NERD.

Programmed death-1 (PD-1) expression in cervical intraepithelial neoplasia and its relationship with recurrence after conization / 부인종양

OBJECTIVE: Impaired local cellular immunity contributes to persistent human papillomavirus (HPV) infection and development of cervical intraepithelial neoplasia (CIN). Programmed death-1 (PD-1) and its ligands PD-ligand-1 (L1) and PD-L2 are negative regulators of T cell activity in various cancers, but few studies exist. The aim of this study was to determine the clinicopathologic and immunologic parameters (PD-1, PD-L1, and PD-L2) related to the persistence/recurrence of CIN after conization. METHODS: Medical records of 652 patients diagnosed with CIN and underwent conization were reviewed. The associations between clinicopathologic parameters (e.g., age, parity, initial HPV load, etc.) and persistence/recurrence of CIN were analyzed. Expression of PD-1, PD-L1, and PD-L2 was assessed on 100 conization specimens by immunohistochemistry (IHC) in women matched for propensity-score (50 with persistence/recurrence and 50 without). RESULTS: Initial HPV load (>1,000 relative light unit) and positive margin were shown to be significantly associated with CIN persistence/recurrence (p=0.012 and p < 0.001, respectively). Multivariate analysis showed that margin status was an independent predictor of persistence/recurrence (hazard ratio=8.86; 95% confidence interval=1.67–16.81; p < 0.001). On IHC analysis, none of the patients expressed PD-L1. PD-1+ T cells were observed in 25 of 100 patients. Also, PD-1+ T cells were significantly correlated with increasing grade of CIN (p=0.031). In addition, patients with persistence/recurrence had increased expression of PD-1 compared with those without (36% vs. 14%, respectively; p=0.020). Although PD-L2 expression did not differ between 2 groups, it was significantly higher in patients with high-grade CIN compared to low-grade (34.7% vs. 12%, respectively; p=0.041). CONCLUSION: Positive surgical margin and expression of PD-1+ T cells were associated with CIN persistence/recurrence after conization.