| Objectives: To evaluate the effectivity and security of NAC injection to Chronic hepatitis B (including early stage of severe hepatitis).Methods: This is a multi-centre, double blind and randomization clinical trial with parallel control which was approved by SDA and sanctioned by The Second AfFilated Hospital of Chongqing University of Medical Sciences, and carried out according to the rule of GCP. All patients were random divided into the NAC treatment group and placebogroup.The patients in NAC group were treated with NAC injection, once a day with 40ml (that is 8 microgram) for 45 days. The index of observation included symptom, biochemistry parameter of liver. The effectivity was determined according to the 2000-revision edition of "Guideline of Clinical application of New Drug".Results: 144 case including 93 Chronic hepatitis B and 51 chronic severe hepatitis were selected and divided into group A and group B. Each group consisted of 72 patients without difference of demology and disease characterization. 30 days after treatment, The patients in group A were improved much better with deceased total bilirubin and direct bilirubin in the serum. Before and 30 days after treatment, the T-bil and D-bil were 401.7+ 149.2, 221.8+ 77.0 and 160.1 + 160.6, 87.8+77.9, and the decreasing rate were 61.8+25.3% and 62.4+ 24.0% respectively. The PTA was increased. The value were 43.5+11.3%, 59.8+ 20.2%, and the increasing rate was 34.8+36.0%. ALT and AST were 221.1 + 267.2, 47.6+ 26.4 and the decreasing rate were 50.2+43.8%, 35.9+52.8% respectively. The patients in group B were improved to some extent. Before and 30 days after treatment, the T-bil and D-bil were 384.1 +134.0, 217.7 + 82.6, and 216.3+199.9, 124.0+112.6, and the decreasing rate were 42.1 + 50.0% and 41.2 + 52.5 %. The PTA were 43.5 + 12.0 and 56.5 + 19.9, increased by 24.4 + 41.0%. The ALT and AST in the serum were decreased to some extent, which were 225.7+ 285.2 and 74.4 + 59.9 of ALT, 214.2+ 197.4 and 105.9 + 75.4 of AST, and the decreasing ratewere 29.5 + 63.7% and 18.6 + 59.4%. The treatment effect for bilirubin, transaminase and PTA showed remarkable difference between two groups. 45 days after treatment, patients in group A improved much more better than those of group B with deceased total bilirubin and direct bilirubin in the serum, the T-bil and D-bil were 124.2+184.1 68.6 + 91.5, and the rate of decrease were 72.1+28% and 73.1+28.2% respectively. The PTA was increased. The value were 63.9+21.4% , and the rate of increase was 43.5+41.5%. ALT and AST were 52.5 + 70.3, 68.9+ 83.3 and the rate of decrease were 50.9 + 44.8%> 38.7 + 64.0% respectively. The patients in group B were improved to some extent. 45 days after treatment, the T-bil and D-bil were 144.1 +177.0, and 78.7 + 88.2, and the decreasing rate were 59.7 + 47.4% and 57.6+55.0 %. The PTA were 59.1+22.8%, increased by 29.9 + 50.6%. The ALT and AST in the serum were decreased to some extent, which were 59.9+ 58.0 of ALT, 84.9 + 65.3 of AST, and the decrease rate were 44.3 + 73.3% and 35.5 + 52.5%. The effect of bilirubin transaminase and PTA showed remarkable difference between two groups. The total curative effecacy of group A after 30-day treatment was 89.6% (with significant effecacy 44.8%, effecacy 44.8% and inefficacy 10.4%), and group B was 69.8% (with significant effecacy 24.5%, effecacy 45.3% and inefficacy 30.2%). 45 days after treatment the total curative efficacy of group A was 90.6%(with significant effecacy 62.3%, effecacy 28.3% and inefficacy 9.4%), and group B was 84.8% (with significant effecacy 34.8%, effecacy 50.0% and inefficacy 15.2%).Conclusion: The general methods with addition of NAC to treatment chronic hepatitis and early stage of severe hepatitis excelled the single treatment methods in the aspect of reducing bilirubin in the serum, increasing PTA, and decreasing enzyme in the serum. NAC showed no adverse effect even after long medication. Patients may show nausea, nervous when treated with faster speed of injection and which could improv...
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