Evaluation of mental state in a clinical trial of MARS for patients with acute hepatic encephalopathy: comparison of two scales

摘要: It is important to assess the severity of hepatic encephalopathy (HE) and quantitate improvement in HE after therapeutic interventions a reliable reproducible manner. The lack well standardized method measurement has led use different techniques by clinical investigators, making comparison between studies problematic. Although this issue had been noted more than 2 decades ago,1, it still unresolved reflected diversity end-points methods used assessment acute trials over last 15 years, e.g. West Haven criteria, Glasgow coma scale, PSE index with arterial or venous ammonia, EEG) (Table 1). Also conditions have classified as chronic (not reviewed here). problem how should be assessed, together considerable terms define settings, prompted gathering panel international experts reach consensus. Table 1. Clinical treatment episodic (precipitated spontaneous) years. SMT: standard medical treatment Author Year Type patients Therapy studied Primary End-point Measurement HE Kramer, 200115 Stage II III Cirrhosis Sorbent dialysis + SMT vs only Sensory evoked potentials Clinical staging (West Haven), sensory potentials automated EEG Laccetti, 200016 Stage III-IV Cirrhosis Flumazenil placebo SMT Clin ical improvement Glasgow scale Barbaro, 199816 Stage IVa Cirrho sis Flumazenil lactulose lactulose Clinical EEG. EEG modified scale (Pappas Jones), including: verbal ability, eye-opening, pupillary light reflex, corneal spontaneous eye movements, oculocephalic motor response, respiration pattern Barbaro, 199818 Stage III-IVa EEG EEG abilitiy, pattern Gyr, 199614 Stage I-III (Lactulose permitted both groups) Clinical improvement Own adapted score, EEG Van der Rijt, 199519 HE staged EEG (clinical stage varied from 0 IV) Acute liver disease Flumazenil placebo Clinical EEG Clinical asses sed own classi ficatio n: I: > inverted sleep pattern, disturbed memory, impaired serial 7’s, slowness speech, flapping tremor; II: lethargy, time disorientation, asterixi s; III: state that subject stimulated repetitively open eyes execute commands, place person disorientation; IV: coma. EEG Cadranel, 199520 Stage II-IV grading classification: euphoria/depression, mild confusion, slowness, disordered rhythm; drowsiness, inappropriate behaviour, accentuation grade I; stupor, patient sleeps most but rousable, incoherent marked confu sion; IVa: coma, coordinated response pain; IVb: hyperextension pronosupination pain stimuli; IVc: no V: clinica l decerebration. EEG Pomier-Layrargues, 199421 Stage IV improvement Modified eyeopening, light, reflexes, pattern. EEG Blanc, 199422 Acute Cirrhosis Lactulose neomycin placebo PSE index PSE Index (mental number conection test, EEG, asterixis ammonia) Strauss, 199223 Acute stages I-IV Cirrhosis Neomycin improvement Clinical criteria (I reference explanation. Sushma, 199224 Acute sodium benzoate Clinical improvement Mental (WH), asterixis, psychometric tests, potentials Vilstrup, 199025 Acute Cirrhosis BCAA iv glucose scale Klotz, 198926 Stage improvement Coma status evaluated reactions reflexes stimuli (no further explanation reference) Uribe, 198727 Acute (stage Cirrhosis Lactitol lactose enemas nonacidifying enemas PSE index: mental NCT, fasting ammonia. Morgan, 198713 Acute lactulose PSE NCT-A, ammonia