Tolvaptan in Chinese cirrhotic patients with ascites: A randomized, placebo-controlled phase 2 trial.

OBJECTIVE: To evaluate tolvaptan as a novel therapeutic option for Chinese patients with liver cirrhosis-associated ascites in a phase 2 clinical trial. METHODS: This randomized, double-blind, placebo-controlled, multicenter trial was conducted in patients with insufficient responses to combination therapies of an oral loop diuretic and an aldosterone antagonist. Reduction in body weight and abdominal circumference, increase in 24-h cumulative urine volume and improvement in serum sodium level from baseline to the end of treatment in the tolvaptan groups (15 mg/day or 30 mg/day orally) were compared with those in the placebo group. Drug safety was also assessed. RESULTS: Sixty-two patients were allocated to the placebo group, 56 to the tolvaptan 15-mg group and 63 to the tolvaptan 30-mg group. Their mean changes in body weight were -0.5 ± 1.6 kg, -2.1 ± 2.0 kg and -1.9 ± 2.0 kg, respectively. Body weight reductions in both tolvaptan groups were significantly greater than that in the placebo group (difference -1.6, 95% confidence interval [CI] -2.5 to -0.8, and difference -1.4, 95% CI, -2.2 to -0.7, both P < 0.0001). The administration of tolvaptan also significantly reduced the abdominal circumference, increased 24-h cumulative urine volume and serum sodium level compared with placebo. The most common adverse events in the tolvaptan groups were constipation, diarrhea, dry mouth and thirst, with no severe adverse events observed. CONCLUSION: Tolvaptan at 15 mg/day significantly reduced the body weight and abdominal circumference in patients with liver cirrhosis-associated ascites, which needs to be confirmed in a phase 3 trial.

Prevalence of eye diseases and causes of visual impairment in school-aged children in Western China.

BACKGROUND: The present study investigated the prevalence of refractive error, visual impairment, and eye diseases in school-aged children in western China. METHODS: The survey was done in a representative county (Yongchuan District, Chongqing Municipality) of western China. Cluster random sampling was used to select children aged 6 to 15 years. We conducted door-to-door surveys and eye examinations including optometry, stereoscopic vision test, eye position and eye movement, slit lamp examination of the anterior segment, retinoscopy, and fundus examination after cycloplegia with 1% cyclopentolate. RESULTS: Among 3469 children, data were available for 3079 (88.76%). The prevalences of eye diseases were, in descending order, refractive error (20.69%; 637/3079), conjunctivitis (11.76%; 362/3079), amblyopia (1.88%; 58/3079), color vision defect (0.52%; 16/3079), keratitis (0.36%; 11/3079), strabismus (0.29%; 9/3079), cataract (0.23%; 7/3079), pathologic myopia (0.19%; 6/3079), and ocular trauma (0.13%; 4/3079). The prevalence of corneal leucoma, corneal staphyloma, optic neuropathy, macular degeneration, and myelinated nerve fibers was 0.03% (1/3079) for each. The prevalence of visual impairment was 7.70% (237/3079), and the major causes of visual impairment were uncorrected refractive error (86.08%; 204/237), amblyopia (9.70%; 23/237), pathologic myopia (1.27%; 3/237), congenital cataract (0.42%; 1/237), and others (2.11%; 5/237). CONCLUSIONS: Among school-aged children in a less developed area of western China, refractive error was the most prevalent eye disorder, and uncorrected refractive error was the main cause of visual impairment.

Refractive status and prevalence of refractive errors in suburban school-age children.

OBJECTIVE: This study investigated the distribution pattern of refractive status and prevalence of refractive errors in school-age children in Western China to determine the possible environmental factors. METHODS: A random sampling strategy in geographically defined clusters was used to identify children aged 6-15 years in Yongchuan, a socio-economically representative area in Western China. We carried out a door-to-door survey and actual eye examinations, including visual acuity measurements, stereopsis examination, anterior segment and eyeball movements, fundus examinations, and cycloplegic retinoscopy with 1% cyclopentolate. RESULTS: A total of 3469 children living in 2552 households were selected, and 3070 were examined. The distributions of refractive status were positively-skewed for 6-8-year-olds, and negatively-skewed for 9-12 and 13-15-year-olds. The prevalence of hyperopia (≥+2.00 D spherical equivalent [SE]), myopia (≤-0.50 D SE), and astigmatism (≥1.00 diopter of cylinder [DC]) were 3.26%, 13.75%, and 3.75%, respectively. As children's ages increased, the prevalence rate of hyperopia decreased (P<0.001) and that of myopia increased significantly (P<0.001). Children in academically challenging schools had a higher risk of myopia (P<0.001) and astigmatism (≥1.00DC, P =0.04) than those in regular schools. CONCLUSION: The distribution of refractive status changes gradually from positively-skewed to negatively-skewed distributions as age increases, with 9-year-old being the critical age for the changes. Environmental factors and study intensity influence the occurrence and development of myopia.

[Combined slower plasma exchange and continuous veno-venous hemofiltration with a parallel circuit in the treatment of chronic severe viral hepatitis B patients.].

OBJECTIVE: To explore the clinical effects of combined slower plasma exchange (PE) and continuous veno-venous hemofiltration (CVVH) with a parallel circuit in the treatment of chronic severe viral hepatitis B patients. METHODS: 104 patients with chronic severe viral hepatitis B were divided into three groups: 44 patients were treated with a parallel circuit of combined slower plasma exchange and continuous veno-venous hemofiltration (group A), 30 patients were treated with plasma exchange (group B), and 30 patients received routine treatment (group C). Efficacy of treatment and survival rate in three groups were investigated. The levels of cytokine, plasma sodium concentration and pH value were examined before and after artificial liver support system treatment. RESULTS: In group A, 7 of 9 patients in coma regained normal consciousness, 6 of 9 patients with hepatorenal syndrome restored renal function, hyponatremia was improved, the balance of pH value was corrected, tumor necrosis factor (TNF)-alpha level was decreased, and the total survival rate was 56.82%. In group B, 2 of 7 patients in coma regained normal consciousness, 1 of 5 patients with hepatorenal syndrome restored renal function. Hyponatremia, pH value and TNF-alpha level were not changed; the total survival rate was 33.33%. Both IL-1 and IL-6 levels were significantly decreased after treatment in group A. IL-10 level was increased in both group A and group B. In group C, 1 of 6 patients regained normal consciousness from coma, none of them restored renal function, and the total survival rate was 16.67%. CONCLUSIONS: Combined slower PE and CVVH with a parallel circuit is a new, safe and effective non-biological artificial liver in the treatment for chronic severe viral hepatitis B patients.

[Combined non-biological artificial liver in treatment of late stage chronic severe hepatitis].

OBJECTIVE: To explore the clinical effects of combined non-biological artificial liver in the treatment of late stage chronic severe hepatitis and especially to observe their effects on hepatic encephalopathy, hepatorenal syndrome and disturbance of electrolytes. METHODS: 103 chronic severe hepatitis patients were treated with the same medical measures, including plasma exchange. Among them, 63 patients were also treated with combinations of non-biological artificial liver (treatment group), and the other 40 patients served as controls (control group). The efficacy of the treatments and survival rates of the two groups were compared. RESULTS: In the treatment group, the rate of regaining normal consciousness was 72.7%, the rate of electrolyte disorder being rectified was 89.5%, the rate of restoring renal function was 66.7% and the total survival rate was 47.6%. In comparison, in the control group the rate of regaining normal consciousness was 16.7%, the rate of electrolyte disorder being rectified was 42.3%, none of their renal functions were restored and the total survival rate was 22.5%. The differences between the two groups were significant (chi2=6.56, P less than 0.05). CONCLUSION: With other medical treatment, combined non-biological artificial liver can improve the survival rate of severe hepatitis patients.

[Clinical research of plasma exchange with continuous veno-venous hemofiltration in treating mid- and late-stage chronic severe viral hepatitis B patients].

OBJECTIVE: To evaluate the clinical efficacy and study the mechanism of combining plasma exchange and continuous veno-venous hemofiltration in treating patients with chronic severe viral hepatitis B in their mid- and late stages. METHODS: 94 patients suffering from chronic severe viral hepatitis B were divided into three groups. 29 patients were treated with plasma exchange plus continuous veno-venous hemofiltration (group A). 31 patients were treated with plasma exchange alone (group B). 34 patients received routine treatment (group C). The efficacy of treatment and survival rate of the three groups was investigated. Before and after artificial liver support system treatment the levels of cytokine were examined. RESULTS: In group A, hyponatremia improved, the levels of interleukin 8 (IL-8) obviously decreased, the level of IL-10 increased, 5 of the 10 patients in coma regained normal consciousness (50.0%) and their survival rate was 48.3%. In group B, hyponatremia did not change, the level of IL-8 and IL-10 did not change. 2 of 11 patients in coma regained normal consciousness (18.2%) while survival rate was 22.6%. In group C, 1 of 11 patients in coma regained normal consciousness (9.1%) while survival rate was 20.6%. CONCLUSIONS: It shows that plasma exchange with continuous veno-venous hemofiltration in treating patients with mid- and late stage chronic severe viral hepatitis B can increase the survival rate. IL-8 can be significantly removed, IL-10 significantly increased. This combined therapy is easy to practice, and should be used as an artificial liver support system.