| Objective:This topic plans through clinical research, obserwation Qing gan Granule to nonalcoholic fatty liber disease (Type of hot damp and blood stasis) clinical effectiveness and safety, this paper discusses the treatment nonalcoholic simple fatty liver (Type of hot damp and blood stasis) inteinsic and stasis mechanism of action, and those lay a foundation for further study. To alleviate patient pain and improve the clinical efficacy is of great significance.Methords:1. Cases of selected objects(1) The informed consent certificates signed(2) The age 18-65 male or female(3) TCM syndrome differentiation Type of hot damp and blood stasisperson(4)Western medicine clinical diagnosis accord nonalcoholic fatty liber disease(5)ALT less than 1.5 times the normal cap (6) Fasting blood glucose≤7.0 mmol/L(7) Not used nearly 1 month treatment of nonalcoholic fatty liver disease of other drugsEvery accords with the above hospital patients or outpatient cases are intended to be incorporated into clinical trials2. Cases of exclusion(1) The drug sex liver damage, merger autoimmune a, b, and c, hepatitis e, etc.;(2) The merger heart, brain, kidney, lung, endocrine, blood, metabolism and gastrointestinal serious the original disease, or mental patients;(3) Creatinine (Cr) greater than the upper limit of normal persons;(4) Use drug dieters;(5) Alcoholics and drug addicts;(6) Pregnant women, lactation women or short-term prepare pregnancies and application estrogen contraceptive person;(7) Allergic constitution and to a variety of drugs and this prescription composition allergy;(8) In critical condition, it is difficult to stuff the efficacy and safety of new clients making definitive; (9) patients do not willing partner.3. All patients department in March 2010-2010 Chinese medicine hospital in Hubei Province in December out-patient and hospitalization in patients with liver disease, a total of 40 cases, according to admission order, the principles of a randomized double-blind, divided into two groups, one experimental group of 20 patients in the control group of 20 patients.4. Test group:Liver grain, boiled water, a sack, three times daily. Control group:Liver particle simulation of agent, boiled water, a bag, three times daily.Treatment:24 weeks5. Combined medication requirements:(1) During the trial in all cases except vitamins and essential drugs to drugs used in symptomatic treatment, but can not be combined with other treatment of non-alcoholic fatty liver disease drug, lipid-lowering drugs, reducing enzyme effective drugs and a variety of diseases affecting the Chinese and Western medicine.(2) The other drugs used during the tests as required, dosage and record drug usage.(3) Disease place must continue merger taking drugs or other treatment, must record its types (or other treatment name), dosage, use frequency and time etc, so as to summarize, to analyze and report.(4) Resulting in merger medication if that can not correctly judge its efficacy and safety, according to eliminate cases processing.6. Safety observationPhysician self-report or by observation of the subjects to evaluate the clinical safety of the situation, in the course of treatment before and after treatment were blood, urine, liver and kidney function will be normal and indicators measured, and the ECG.7. After 24 weeks of treatment by competent medical review of various scales, from the statistics unit of the primary efficacy endpoint of the final evaluation at the same time FAS, PP analysis, comparing before and after treatment, the total effective cure rate.8 Efficacy evaluation standard 8.1 Intelligent efficacy evaluation standardReference to "guidelines for new drug clinical research of Chinese medicine" to develop.8.2 Therapeutic effect evaluation syndromesAccording to the "People's Republic of China issued by the ministry of new drug of TCM clinical research guiding principle " relevant part adopts the following formula:syndromes curative effect index (N)= [(before treatment integral-after treatment, the integral) /before treatment integral]×100%, expressed as a percentage.8.3 Safety evaluation standardsLevel 1:Security, without any adverse reaction.Level 2:Comparison of safety, side effects, if any, does notrequire any treatment can continue to administration.Level 3:There are security problems, and moderate adverse reactions to drug treatment can do.Level 4:Test aborted due to adverse events.Results:1. This test has included the 40 patients with idiopathic nonalcoholic fatty lier disease (Type of hot damp and blood stasis) patients, a total of 39 patients finish the experiment.2. Two groups of improve liver and spleen CT value after the comparison:treatment, two groups compared with before treatment, the treatment group liver/spleen CT ratio has obviously improved (P< 0.05), two groups of liver/spleen CT ratio between change is a statistically significant (P< 0.05).3. Two groups of lower triglyceride (TG), total cholesterol (TC) comparison:treatment group than before treatment TG has obviously improved function (P< 0.05), and TC improve does not play a significant role; Comparison between the two groups was statistically significant TG improve (P< 0.05), TC comparison was statistically significant (P> 0.05). Before and after the treatment group TC, TG were no statistically significant comparison.4. Two groups of clinical symptoms (TCM) in comparison:the two groups compared to the situation in patients with clinical symptoms disappeared, the index between the two groups showed no significant difference.5. Adverse reactions and side effects:treatment group and control group has not occurred in clinical trials to test during drug related adverse reactions. Three groups of laboratory results (three conventional, electrocardiogram, liver and kidney function) before and after therapy and treatment does not appear in the process of abnormal changes associated with therapy.Conclusion:This clinical trials take randomized, double-blind, placebo controlled study method, parallel research shows, qinggan particle groups compared with placebo, and with no adverse reaction, for clinical treatment nonalcoholic simple fatty liver (Type of hot damp and blood stasis) effective and safe drug. |
PDF Full Text Request