Impact of transient decrease in mixed venous oxygen saturation on prognosis in off-pump coronary artery bypass surgery: a retrospective cohort study / 대한마취과학회지

Background@#The prognostic consequences of transient hemodynamic deterioration due to cardiac displacement, which is most severe during left circumflex artery (LCX) grafting in off-pump coronary artery bypass surgery (OPCAB) are unknown. This study aimed to investigate the association between mixed venous oxygen saturation (SvO2) 24 h, cerebrovascular accident, and acute kidney injury. @*Results@#Among 1,071 patients, the composite of morbidity endpoints occurred in 303 (28%) patients. SvO2 < 60% during LCX grafting was significantly associated with the composite of morbidity (OR: 2.72, 95% CI [1.60, 4.61], P < 0.001) along with advanced age, chronic kidney disease, ratio of early mitral inflow velocity to mitral annular early diastolic velocity, and EuroSCORE II. Other major hemodynamic variables including the cardiac index were not associated with the outcome. Additional regression analysis revealed pre-operative anemia as a predictor of SvO2 < 60% during LCX grafting (OR: 2.09, 95% CI [1.33, 3.29], P = 0.001). @*Conclusions@#A decrease in SvO2 < 60%, albeit confined to the period of cardiac displacement, was associated with a 2.7-fold increased risk of detrimental outcomes after OPCAB, implying the prognostic importance of this transient deterioration in oxygen supply-demand balance.

Hemodynamic management during off-pump coronary artery bypass surgery: a narrative review of proper targets for safe execution and troubleshooting / 대한마취과학회지

Off-pump coronary surgery requires mechanical cardiac displacement, which results in bi-ventricular systolic and diastolic dysfunction. Although transient, subsequent hemodynamic deterioration can be associated with poor prognosis and, in extreme cases, emergency conversion to on-pump surgery, which is associated with high morbidity and mortality. Thus, appropriate decision-making regarding whether the surgery can be proceeded based on objective hemodynamic targets is essential before coronary arteriotomy. For adequate hemodynamic management, avoiding myocardial oxygen supply-demand imbalance, which includes maintaining mean arterial pressure above 70 mmHg and preventing an increase in oxygen demand beyond the patient’s coronary reserve, must be prioritized. Maintaining mixed venous oxygen saturation above 60%, which reflects the lower limit of adequate global oxygen supply-demand balance, is also essential. Above all, severe mechanical cardiac displacement incurring compressive syndromes, which cannot be overcome by adjusting major determinants of cardiac output, should be avoided. An uncompromising form of cardiac constraint can be ruled out as long as the central venous pressure is not equal to or greater than the pulmonary artery diastolic (or occlusion) pressure, as this would reflect tamponade physiology. In addition, transesophageal echocardiography should be conducted to rule out mechanical cardiac displacement-induced ventricular interdependence, dyskinesia, severe mitral regurgitation, and left ventricular outflow tract obstruction with or without systolic motion of the anterior leaflet of the mitral valve, which cannot be tolerated during grafting. Finally, the ascending aorta should be carefully inspected for gas bubbles to prevent hemodynamic collapse caused by a massive gas embolism obstructing the right coronary ostium.

Transcatheter Aortic Valve Replacement versus Sutureless Aortic Valve Replacement:A Single Center Retrospective Cohort Study

Purpose@#This study sought to compare clinical outcomes between transcatheter aortic valve replacement (TAVR) and sutureless aortic valve replacement (SU-AVR). @*Materials and Methods@#In total, 320 patients with symptomatic severe aortic stenosis who underwent TAVR (n=254) or SU-AVR (n=66) at Severance Cardiovascular Hospital between July 2011 and September 2019 were included for analysis. Propensity score matching and inverse probability weighted adjustment were performed to adjust for confounding baseline characteristics. Outcomes defined by the Valve Academic Research Consortium-2 in 62 patients pairs were compared. @*Results@#Device success (79.0% vs. 79.0%, p>0.999) and 30-day mortality (4.8% vs. 0.0%, p=0.244) did not differ between the TAVR and SU-AVR groups. The TAVR group developed more frequent mild or moderate paravalvular leakage (59.7% vs. 8.1%, p<0.001), whereas SU-AVR was associated with higher rates of major or life-threatening bleeding (9.7% vs. 22.6%, p=0.040), acute kidney injury (8.1% vs. 21.0%, p=0.041), and new-onset atrial fibrillation (4.8% vs. 32.3%. p<0.001) at 30 days, along with longer stays in the intensive care unit (ICU) (1.9±1.6 days vs. 5.9±9.2 days, p=0.009) and hospital (7.1±7.9 days vs. 13.1±8.8 days, p<0.001). The TAVR group showed a trend towards a higher 1-year all-cause mortality, compared with the SU-AVR group (7.0% vs 1.7%, p=0.149). Cardiovascular mortality, however, did not differ significantly (1.6% vs 1.7%, p=0.960). @*Conclusion@#TAVR achieved a similar 1-year survival rate free from cardiovascular mortality as SU-AVR and was associated with a lower incidence of complications, except for paravalvular leakage, and shorter stays in the ICU and hospital.

Transcatheter Aortic Valve Replacement versus Sutureless Aortic Valve Replacement:A Single Center Retrospective Cohort Study

Purpose@#This study sought to compare clinical outcomes between transcatheter aortic valve replacement (TAVR) and sutureless aortic valve replacement (SU-AVR). @*Materials and Methods@#In total, 320 patients with symptomatic severe aortic stenosis who underwent TAVR (n=254) or SU-AVR (n=66) at Severance Cardiovascular Hospital between July 2011 and September 2019 were included for analysis. Propensity score matching and inverse probability weighted adjustment were performed to adjust for confounding baseline characteristics. Outcomes defined by the Valve Academic Research Consortium-2 in 62 patients pairs were compared. @*Results@#Device success (79.0% vs. 79.0%, p>0.999) and 30-day mortality (4.8% vs. 0.0%, p=0.244) did not differ between the TAVR and SU-AVR groups. The TAVR group developed more frequent mild or moderate paravalvular leakage (59.7% vs. 8.1%, p<0.001), whereas SU-AVR was associated with higher rates of major or life-threatening bleeding (9.7% vs. 22.6%, p=0.040), acute kidney injury (8.1% vs. 21.0%, p=0.041), and new-onset atrial fibrillation (4.8% vs. 32.3%. p<0.001) at 30 days, along with longer stays in the intensive care unit (ICU) (1.9±1.6 days vs. 5.9±9.2 days, p=0.009) and hospital (7.1±7.9 days vs. 13.1±8.8 days, p<0.001). The TAVR group showed a trend towards a higher 1-year all-cause mortality, compared with the SU-AVR group (7.0% vs 1.7%, p=0.149). Cardiovascular mortality, however, did not differ significantly (1.6% vs 1.7%, p=0.960). @*Conclusion@#TAVR achieved a similar 1-year survival rate free from cardiovascular mortality as SU-AVR and was associated with a lower incidence of complications, except for paravalvular leakage, and shorter stays in the ICU and hospital.

Monitored Anesthesia Care for Cardiovascular Interventions

The interventional cardiology is growing and evolving. Many complex procedures are now performed outside the operating room to manage cardiovascular pathologies which had been traditionally treated with cardiac surgery. Appropriate sedation strategy is crucial for improved patient comfort and successful procedure while ensuring safety. Sedation for cardiovascular intervention is frequently challenging, especially in critically-ill, high-risk patients. This review addresses pre-procedure evaluation and preparation of patients, proper monitoring, commonly used sedatives and analgesics, and considerations for specific procedures. Appropriate depth of sedation and analgesia should be balanced with patient, procedural and institutional factors. Understanding of the pharmacology of sedatives/analgesics, vigilant monitoring, ability and proper preparation for management of potential complications may improve outcomes in patients undergoing sedation for cardiovascular procedures.

Perioperative management of patients receiving non-vitamin K antagonist oral anticoagulants: up-to-date recommendations

Indications of non-vitamin K antagonist oral anticoagulants (NOACs), consisting of two types: direct thrombin inhibitor (dabigatran) and direct factor Xa inhibitor (rivaroxaban, apixaban, and edoxaban), have expanded over the last few years. Accordingly, increasing number of patients presenting for surgery are being exposed to NOACs, despite the fact that NOACs are inevitably related to increased perioperative bleeding risk. This review article contains recent clinical evidence-based up-to-date recommendations to help set up a multidisciplinary management strategy to provide a safe perioperative milieu for patients receiving NOACs. In brief, despite the paucity of related clinical evidence, several key recommendations can be drawn based on the emerging clinical evidence, expert consensus, and predictable pharmacological properties of NOACs. In elective surgeries, it seems safe to perform high-bleeding risk surgeries 2 days after cessation of NOAC, regardless of the type of NOAC. Neuraxial anesthesia should be performed 3 days after cessation of NOACs. In both instances, dabigatran needs to be discontinued for an additional 1 or 2 days, depending on the decrease in renal function. NOACs do not require a preoperative heparin bridge therapy. Emergent or urgent surgeries should preferably be delayed for at least 12 h from the last NOAC intake (better if > 24 h). If surgery cannot be delayed, consider using specific reversal agents, which are idarucizumab for dabigatran and andexanet alfa for rivaroxaban, apixaban, and edoxaban. If these specific reversal agents are not available, consider using prothrombin complex concentrates.

Monitored Anesthesia Care for Cardiovascular Interventions

The interventional cardiology is growing and evolving. Many complex procedures are now performed outside the operating room to manage cardiovascular pathologies which had been traditionally treated with cardiac surgery. Appropriate sedation strategy is crucial for improved patient comfort and successful procedure while ensuring safety. Sedation for cardiovascular intervention is frequently challenging, especially in critically-ill, high-risk patients. This review addresses pre-procedure evaluation and preparation of patients, proper monitoring, commonly used sedatives and analgesics, and considerations for specific procedures. Appropriate depth of sedation and analgesia should be balanced with patient, procedural and institutional factors. Understanding of the pharmacology of sedatives/analgesics, vigilant monitoring, ability and proper preparation for management of potential complications may improve outcomes in patients undergoing sedation for cardiovascular procedures.

Anesthetic considerations for a patient with situs inversus totalis undergoing cardiac surgery: A case report

A 58-year-old male patient with situs inversus totalis, a rare congenital malformation characterized by all asymmetric organs being formed as the mirror images of their normal morphologies, underwent mitral valve repair due to mitral valve prolapse. This case was reported to suggest that anesthesiologists should thoroughly understand the anatomy of these types of patients before providing cardiac anesthesia that often requires advanced monitoring and rely on their accurate interpretation. Accordingly, a few key points will be discussed with emphasis on reversing lead placement during electrocardiogram monitoring, using the left internal jugular vein for pulmonary artery catheterization, and firmly comprehending mirror image heart morphology to better conduct transesophageal echocardiography.

Dual antiplatelet therapy and non-cardiac surgery: evolving issues and anesthetic implications / 대한마취과학회지

Dual antiplatelet therapy (DAPT) consisting of aspirin plus a P2Y₁₂ inhibitor (clopidogrel, prasugrel, or ticagrelor) is imperative for the treatment of acute coronary syndrome, particularly during the re-endothelialization period after percutaneous coronary intervention (PCI). When patients undergo surgery during this period, the consequences of stent thrombosis are far more serious than those of bleeding complications, except in cases of intracranial surgery. The recommendations for perioperative DAPT have changed with emerging evidence regarding the improved efficacy of non-first-generation drug (everolimus, zotarolimus)-eluting stents (DES). The mandatory interval of 1 year for elective surgery after DES implantation was shortened to 6 months (3 months if surgery cannot be further delayed). After this period, it is generally recommended that the P2Y₁₂ inhibitor be stopped for the amount of time necessary for platelet function recovery (clopidogrel 5–7 days, prasugrel 7–10 days, ticagrelor 3–5 days), and that aspirin be continued during the perioperative period. In emergent or urgent surgeries that cannot be delayed beyond the recommended period after PCI, proceeding to surgery with continued DAPT should be considered. For intracranial procedures or other selected surgeries in which increased bleeding risk may also be fatal, cessation of DAPT (possibly with continuation or minimized interruption [3–4 days] of aspirin) with bridge therapy using short-acting, reversible intravenous antiplatelet agents such as cangrelor (P2Y₁₂ inhibitor) or glycoprotein IIb/IIIa inhibitors (tirofiban, eptifibatide) may be contemplated. Such a critical decision should be individually tailored based on consensus among the anesthesiologist, cardiologist, surgeon, and patient to minimize both ischemic and bleeding risks.

Effects of Age on Esophageal Motility: Use of High-resolution Esophageal Impedance Manometry

BACKGROUND/AIMS: Disturbances of esophageal motility have been reported to be more frequent the aged population. However, the physiology of disturbances in esophageal motility during aging is unclear. The aim of this study was to evaluate the effects of age on esophageal motility using high-resolution esophageal impedance manometry (HRIM). METHODS: Esophageal motor function of 268 subjects were measured using HRIM in 3 age groups, 65 years (Group C, n = 62). Lower esophageal sphincter (LES) and upper esophageal sphincter (UES) pressures, integrated relaxation pressure, distal contractile integral, contractile front velocity, distal latency, and pressures and duration of contraction on 4 positions along the esophagus, and complete bolus transit were measured. RESULTS: Basal UES pressure was lower in Group C (P < 0.001) but there was no significant difference in the LES pressure among groups. Contractile duration on position 3 (10 cm from proximal LES high pressure zone) was longer in Group C (P = 0.001), and the contractile amplitude on position 4 (5 cm from proximal LES high pressure zone) was lower in Group C (P = 0.005). Distal contractile integral was lower in Group C (P = 0.037). Contractile front velocity (P = 0.015) and the onset velocity (P = 0.040) was lower in Group C. There was no significant difference in impedance values. CONCLUSIONS: The decrease of UES pressure, distal esophageal motility, and peristaltic velocity might be related with esophageal symptoms in the aged population.

The Effect of H₂ Receptor Antagonist in Acid Inhibition and Its Clinical Efficacy / 대한소화기학회지

The first histamine H₂ receptor antagonists (H₂RAs) were developed in the early 1970s. They played a dominant role in treating peptic ulcer disease and gastroesophageal reflux disease (GERD). H₂RAs block the production of acid by H⁺, K⁺-ATPase at the parietal cells and produce gastric luminal anacidity for varying periods. H₂RAs are highly selective, and they do not affect H₁ receptors. Moreover, they are not anticholinergic agents. Sequential development of H₂RAs, proton pump inhibitors (PPIs), and discovery of Helicobacter pylori infection changed the paradigm of peptic ulcer disease with marked decrease of morbidity and mortality. PPIs are known to be the most effective drugs that are currently available for suppressing gastric acid secretion. Many studies have shown its superiority over H₂RAs as a treatment for acid-related disorders, such as peptic ulcer disease, GERD, and Zollinger-Ellison syndrome. However, other studies have reported that PPIs may not be able to render stomach achlorhydric and have identified a phenomenon of increasing gastric acidity at night in individuals receiving a PPI twice daily. These nocturnal acid breakthrough episodes can be eliminated with an addition of H₂RAs at night. The effectiveness of nighttime dose of H₂RA suggests a major role of histamine in nocturnal acid secretion. H₂RAs reduce secretion of gastric acid, and each H₂RA also has specific effects. For instance, nizitidine alleviates not only symptoms of GERD, but also provokes gastric emptying, resulting in clinical symptom improvement of functional dyspepsia. The aim of this paper was to review the characteristics and role of H₂RAs and assess the future strategy and treatment of upper gastrointestinal disease, including acid related disorders.

Current clinical application of dexmedetomidine for sedation and anesthesia

Many sedatives are used clinically and include benzodiazepines, barbiturates, antihistamines, propofol, and alpha-2-agonist. Benzodiazepines activate GABA neuronal receptors in the brain and present sedating, hypnotic, anxiolytic, amnestic, and anticonvulsant effects, but low analgesic effects. Propofol induce sedative, anxiolytic, and amnestic effects but no analgesic effects. However, risks such as cardiopulmonary instability and hypotension must be considered during administration. Dexmedetomidine is a high selective alpha-2 agonist and has many advantages as a sedative. Patients under dexmedetomidine sedation awaken easily and are more likely to be cooperative. Risk of respiratory depression and cardiopulmonary instability is low as well. Additionally, dexmedetomidine decreases amount of analgesic needed during and after surgery, presenting analgesic effects. Dexmedetomidine also decreases risk of delirium. However, bradycardia may occur and biphasic effects on blood pressure may be observed during beginning of administration. Because of lengthy symptom onset and offset time, physicians should carefully control administration at the beginning and end of dexmedetomidine administration. The purpose of this review is to evaluate the efficacy and availability of dexmedetomidine in various clinical fields including sedation for critically ill patients, regional anesthesia, monitored anesthesia care for some invasive procedures, stabilization of heart in cardiac surgery or endoscopic procedures.

Current clinical application of dexmedetomidine for sedation and anesthesia

Many sedatives are used clinically and include benzodiazepines, barbiturates, antihistamines, propofol, and alpha-2-agonist. Benzodiazepines activate GABA neuronal receptors in the brain and present sedating, hypnotic, anxiolytic, amnestic, and anticonvulsant effects, but low analgesic effects. Propofol induce sedative, anxiolytic, and amnestic effects but no analgesic effects. However, risks such as cardiopulmonary instability and hypotension must be considered during administration. Dexmedetomidine is a high selective alpha-2 agonist and has many advantages as a sedative. Patients under dexmedetomidine sedation awaken easily and are more likely to be cooperative. Risk of respiratory depression and cardiopulmonary instability is low as well. Additionally, dexmedetomidine decreases amount of analgesic needed during and after surgery, presenting analgesic effects. Dexmedetomidine also decreases risk of delirium. However, bradycardia may occur and biphasic effects on blood pressure may be observed during beginning of administration. Because of lengthy symptom onset and offset time, physicians should carefully control administration at the beginning and end of dexmedetomidine administration. The purpose of this review is to evaluate the efficacy and availability of dexmedetomidine in various clinical fields including sedation for critically ill patients, regional anesthesia, monitored anesthesia care for some invasive procedures, stabilization of heart in cardiac surgery or endoscopic procedures.

PMK-S005 Alleviates Age-Related Gastric Acid Secretion, Inflammation, and Oxidative Status in the Rat Stomach

BACKGROUND/AIMS: The aim of this study was to evaluate the effect of the synthetic S-allyl-l-cysteine (SAC) PMK-S005 on gastric acid secretion, inflammation, and antioxidant enzymes in aging rats. METHODS: The rats were divided into four groups at 31 weeks of age and were continuously fed a diet containing a vehicle control, PMK-S005 (5 or 10 mg/kg), or lansoprazole (5 mg/kg). Gastric acid secretion and connective tissue thickness of the lamina propria were evaluated at 74 weeks and 2 years of age. Tumor necrosis factor (TNF)-α, interleukin (IL)-1β, and COX-2 levels were measured by using enzyme-linked immunosorbent assays (ELISAs) or Western blot assays. Levels of antioxidant enzymes, including heme oxyganase 1 (HO-1) and NAD(P)H:quinone oxidoreductase 1 (NQO-1), were also measured. RESULTS: As the rats aged, gastric acid secretion significantly decreased, and the connective tissue of the lamina propria increased. However, 74-week-old rats in the PMK-S005 group exhibited greater levels of gastric acid secretion than those of the control and lansoprazole groups. The increase of TNF-α, IL-1β, and COX-2 expression in 74-week and 2-year-old control rats were inhibited by PMK-S005. In addition, the decrease in HO-1 and NQO-1 protein expression that occurred with aging was inhibited by PMK-S005 in the 74-week-old rats. CONCLUSIONS: These results suggest that PMK-S005 has therapeutic potential as an antiaging agent to ameliorate age-related gastric acid secretion, inflammation, and oxidative stress in the stomach.

Nonsteroidal Anti-inflammatory Drug and Aspirin-induced Peptic Ulcer Disease / 대한소화기학회지

Despite decreasing Helicobacter pylori prevalence, the prevalence of peptic ulcer disease is increasing in the aged population, mainly due to increasing use of NSAIDs to manage pain and inflammation. In addition, low dose aspirin is employed as an anti-coagulant for those who have suffered or are at high risk of ischemic stroke and cardiovascular disease. However, NSAIDs and aspirin are injurious to mucosa of stomach and duodenum. NSAID-induced inhibition of mucosal prostaglandin synthesis is thought to be a major mechanism of gastrointestinal mucosal injury. The proportion of elderly has increased rapidly in Korea, with the proportion over 65 years old expected to be 24.3% in 2030. In this higher-risk population, the strategy to reduce the incidence of NSAID-related peptic ulcers and complications such as bleeding, obstruction and perforation is very important. Proton pump inhibitors (PPIs) with cyclooxygenase-2 inhibitor can be used for reducing the risk of NSAID-related ulcers and upper gastrointestinal (GI) complications. However, continuous use of PPI has several problems. In addition, NSAID-related problems in the lower GI tract have increased, in contrast to the decrease of NSAID-related upper GI disease. The aim of this review is to provide an evidence-based knowledge regarding the mechanism, complications of treatment, and prevention strategies for NSAID- or aspirin-related peptic ulcer disease in Korea.

Persistent Left Superior Vena Cava Detected Incidentally after Pulmonary Artery Catheterization / 대한구급학회지

We present a case of pulmonary artery catheter (PAC) placement through the right internal jugular vein, bridging vein and coronary sinus in a patient with previously unrecognized persistent left superior vena cava (LSVC) and diminutive right superior vena cava. A 61-year-old male patient was scheduled for mitral valve repair for regurgitation. Preoperative transthoracic echocardiography revealed dilated coronary sinus, but no further evaluations were performed. During advancement of the PAC, right ventricular and pulmonary arterial pressure tracing was observed at 50 and 60 cm, respectively. Transesophageal echocardiography ruled out intracardiac knotting and revealed the presence of the PAC in the LSVC, entering the right ventricle from the coronary sinus. Diminutive right superior vena cava was observed after sternotomy. The PAC was left in place for 2 days postoperatively without any complications. This case emphasizes that the possibility of LSVC and associated anomalies should always be ruled out in patients with dilated coronary sinus.

Persistent Left Superior Vena Cava Detected Incidentally after Pulmonary Artery Catheterization / 대한중환자의학회지

We present a case of pulmonary artery catheter (PAC) placement through the right internal jugular vein, bridging vein and coronary sinus in a patient with previously unrecognized persistent left superior vena cava (LSVC) and diminutive right superior vena cava. A 61-year-old male patient was scheduled for mitral valve repair for regurgitation. Preoperative transthoracic echocardiography revealed dilated coronary sinus, but no further evaluations were performed. During advancement of the PAC, right ventricular and pulmonary arterial pressure tracing was observed at 50 and 60 cm, respectively. Transesophageal echocardiography ruled out intracardiac knotting and revealed the presence of the PAC in the LSVC, entering the right ventricle from the coronary sinus. Diminutive right superior vena cava was observed after sternotomy. The PAC was left in place for 2 days postoperatively without any complications. This case emphasizes that the possibility of LSVC and associated anomalies should always be ruled out in patients with dilated coronary sinus.

Efficacy of Goal-Directed Therapy Using Bioreactance Cardiac Output Monitoring after Valvular Heart Surgery

PURPOSE: We compared the efficacy of postoperative hemodynamic goal-directed therapy (GDT) using a pulmonary artery catheter (PAC) and bioreactance-based noninvasive cardiac output monitoring (NICOM) in patients with atrial fibrillation undergoing valvular heart surgery. MATERIALS AND METHODS: Fifty eight patients were randomized into two groups of GDT with common goals to maintain a mean arterial pressure of 60-80 mm Hg and cardiac index > or =2 L/min/m2: the PAC group (n=29), based on pulmonary capillary wedge pressure, and the NICOM group (n=29), based on changes in stroke volume index after passive leg raising. The primary efficacy variable was length of hospital stay. Secondary efficacy variables included resource utilization including vasopressor and inotropic requirement, fluid balance, and major morbidity endpoints. RESULTS: Patient characteristics and operative data were similar between the groups, except that significantly more patients underwent double valve replacement in the NICOM group. The lengths of hospital stay were not different between the two groups (12.2+/-4.8 days vs. 10.8+/-4.0 days, p=0.239). Numbers of patients requiring epinephrine (5 vs. 0, p=0.019) and ventilator care >24 h (6 vs. 1, p=0.044) were significantly higher in the PAC group. The PAC group also required significantly larger amounts of colloid (1652+/-519 mL vs. 11430+/-463 mL, p=0.004). CONCLUSION: NICOM-based postoperative hemodynamic GDT showed promising results in patients with atrial fibrillation undergoing valvular heart surgery in terms of resource utilization.

Efficacy and Safety of New Prokinetic Agent Benachio Q Solution(R) in Patients with Postprandial Distress Syndrome Subtype in Functional Dyspepsia: A Single-center, Randomized, Double-blind, Placebo-controlled Pilot Study / 대한소화기학회지

BACKGROUND/AIMS: Functional dyspepsia (FD) is a gastrointestinal disorder in which the patient suffers from chronic abdominal symptoms despite the absence of organic disease. Benachio Q solution (soln.)(R) is a new prokinetic herbal medicine. The aim of the present study is to determine the efficacy and safety of Benachio Q soln.(R) in patients with postprandial distress syndrome (PDS) subtype in FD. METHODS: A single-center, randomized, double-blind, placebo-controlled pilot study was performed in 20 patients with PDS. Patients were assigned to receive either Benachio Q soln.(R) or placebo three times a day. After 4 weeks of treatment, the data on response rates, symptoms severity of PDS and gastric emptying time were analyzed to evaluate its efficacy. Adverse events, laboratory tests and vital sign were analyzed to assess its safety. RESULTS: Nine patients were assigned to Benachio group and 10 patients to placebo group. The response rate after 4 weeks was 44.4% and 20.0% in Benachio and placebo group, respectively (p=0.350). The response rate during the first week in Benachio group was better compared to that of placebo group with marginal difference (33.3% vs. 0.0%, p=0.087). Changes of severity score in early satiety on second and third week were -1.8+/-0.6, -1.9+/-0.4 and -1.3+/-0.5, -1.4+/-0.6 in Benachio and placebo group, respectively (p=0.059 vs. p=0.033). No adverse event was observed. CONCLUSIONS: The new herbal drug, Benachio Q soln.(R) seems to improve the symptoms of PDS subtype in FD and could be used safely. Further larger trial is needed in the future.

Adequate Dextran Sodium Sulfate-induced Colitis Model in Mice and Effective Outcome Measurement Method

BACKGROUND: Dextran sodium sulfate (DSS)-induced colitis mouse model is used for research of inflammatory bowel disease. The aim of this study was to establish the adequate conditions for DSS mice model, and to find useful tool to measure inflammation. METHODS: The 2.5% DSS was administered to six male C57BL/6 mice and 4% DSS to eight mice at 5 or 9 weeks of age. Each group was consisted of 6 mice with control group in which vehicle was administered instead of DSS. The mice were sacrificed on the 7th day after DSS or vehicle administration. Body weight, diarrhea, and hematochezia were recorded daily. Disease activity index (DAI) score which was composed of body weight change, diarrhea, and hematochezia was measured every day. Colon length was measured after sacrifice and colon mucosal level of interleukin 1 beta (IL-1beta) was measured by ELISA assay. Histological score was compared between ascending and descending colon in the DSS group. RESULTS: Colon length of five- and nine-week DSS group was significantly shorter than each control group but there was no statistical significance depending on DSS concentration or age. DAI score of 4% DSS group in nine-week was significantly higher than that five-week (P = 0.012) but there was no difference between 2.5% and 4% DSS group. The level of IL-1beta in DSS mice was much higher than control group (P < 0.01), but there was no difference among several DSS groups. The histological score was higher in the descending colon than in the ascending colon but there was no statistical difference between each pair of DSS groups. CONCLUSIONS: The 4% DSS mice in nine-week was adequate for DSS-induced colitis model. DAI score was useful tool and descending colon was more appropriate site for histological evaluation of colitis than ascending colon.