| ObjectiveThis randomized controlled clinical trial intends to discuss the clinical curative effect of the treatment insomnia and evaluate objectively to its security of the herba Zinianmeifang.MethodsThe subjects were patients with insomnia. Case Source:The Chinese and Western medicine clinics meet the screening criteria of 64 cases of cases of insomnia. Western diagnostic criteria:Refer to "Guidelines for clinical research of Chinese medicine drug" in the diagnostic criteria on the development of insomnia. Patients sleep less than a day 4h, and sleeping pills is not valid; or sleeping pills to sleep 6h, but a slight fall asleep, easy to wake up more than a dream, waking mental state is poor, tired limbs Shenpi, lasting more than half of those. TCM syndrome criteria:the light of the 21st century curriculum materials TCM colleges and universities nationwide, "Chinese medical science" (People's Health Press 2002 1st Edition) "Insomnia" and syndrome type, as follows:stagnation of the fire certificate:main symptoms: insomnia, irritability, severe insomnia throughout the night. And second disease:chest hypochondriac pain, thirst hi drink and not eating, mouth pain, dry, red eyes and ringing in the ears, red yellow urine, or dizziness, headache, constipation. Tongue:Red tongue, yellow moss, or moss yellow dry. Pulse:a few strings, or string a few slip. Drugs:Health keel 9g, mother of pearl 9g, Caulis 9g, Zao Ren 12g, Schisandra 3g, white peony root 9g, habitat 9g. Random method, the proportion of eligible subjects were assigned to the 1:1 test group and control group, experimental group of 32 patients,14 males,18 females, Mei Fang On the second day taking the morning and evening services. The control group of 32 patients,18 men,14 women taking Estazolam 2mg, bedtime dosing. Observation:safety testing, TCM indicators, clinical symptoms, signs, Pittsburgh Sleep Quality Index (PSQI) score. Pittsburgh Sleep Quality Index (PSQI) rating scale were assessed and clinical efficacy. Establishment of a database with EPIDATA3.1 software, software for statistical analysis with SPSS17.0. Measurement data using t test between groups (variance arrhythmia using t'test or rank sum test), before and after their use of paired t test or Wilcoxon paired rank test. Classified information between the two groups were compared with x2 test, ranked data was used to compare groups Wilcoxon rank sum test.ResultsIn this study, randomized controlled clinical trial test methods, a total of 64 cases of qualified subjects. Experimental group of 32 patients; the control group of 32 patients; were outpatients. Check comparable groups:two groups of age, gender, disease duration, Pittsburgh Sleep Quality Index score, the severity of insomnia, compared with no significant difference. The two groups before treatment, difficulty falling asleep, sleep simple wake up, waking dreams, waking the spirit of poor, tired limbs Shenpi, irritability, anxiety, fatigue and other symptoms and signs of comparison, there was no significant difference. The two groups before treatment, irritable, night insomnia, chest tightness, hypochondriac pain, thirst hi drink and not eating, mouth pain, dry, red eyes and ringing in the ears, dizziness, headache, red yellow urine, constipation, etc. Chinese medicine clinical symptoms compared with no significant difference. Two groups of tongue, pulse comparison, the difference was not statistically significant. The comparability of baseline characteristics of patients in two groups of age, gender, disease duration, treatment before the Pittsburgh Sleep Quality Index scores and other indicators of comparison, the difference was not statistically significant, indicating that baseline characteristics of the two groups were comparable. Comparative efficacy:Two TCM syndromes difference was not statistically significant. Clinical recovery test group was 50.0%, effective rate of 31.2%, the effective rate was 12.5%, total effective rate was 93.7%; control group, the clinical cure rate was 43.7%, effective rate is 34.3%, the effective rate was 12.5%, total effective rate was 90.7%. Between the two groups, the difference was not statistically significant. Estazolam repeated applications easy to produce drug dependence, rebound insomnia after stopping the high incidence of hangover effect the next day and its impact on cognitive and psychomotor function of the damage, and taking a lot of time can cause poisoning, mainly on the central inhibition of nerve, the main symptoms of confusion, drowsiness, dizziness, vague language, ataxia and so on. In contrast, An Mei Fang drug safety. Improve the situation before and after treatment of insomnia (to improve a said:severity after treatment than before treatment an improvement of 2, said:severity after treatment than before treatment 2; improved three, said:After treatment, severity of disease compared with treatment before the lower 3; the same below.) difference was not statistically significant. After treatment, difficulty falling asleep, sleep simple wake up, wake up when the spirit of the poor, waking dreams, lost limbs and so tired Shenpi rate between the treatment group than the control group. After treatment, irritability, anxiety, fatigue, impatience and other disappearance rate between the treatment group than the control group. After treatment, all night insomnia, chest tightness, hypochondriac pain, thirst hi drink, do not think drinking, bitter mouth and dry disappearance rate between the treatment group than the control group. After treatment, red eyes, tinnitus, dizziness, headache, red yellow urine, constipation disappearance rate between the treatment group than the control group. PSQI assessment of each component: The two groups were compared before and after treatment of sleep time points: after the treatment group before treatment of sleep time integration, the difference was statistically significant (t=9.55, P=0.00). In the control group and the sleep time points before treatment, the difference was statistically significant (t=6.09, P=0.00). Time integration of the two groups before treatment of sleep the difference was not statistically significant. Comparable. After treatment, sleep time points, the difference was statistically significant (t=2.84, P=0.00). Sleep time points before and after treatment difference, the difference was statistically significant (t=3.05, P=0.00). After the treatment group and treatment time points before falling asleep, the difference was statistically significant (t=9.79, P= 0.00). In the control group and treatment time points before falling asleep, the difference was statistically significant (t=7.08, P=0.00). Sleep time integration of the two groups before treatment, the difference was not significant, comparable. Sleep time points after treatment, the difference was not statistically significant. Sleep time integration of the two groups before and after treatment the difference between the difference was not statistically significant. After treatment the experimental group between the function points the day before, the difference was statistically significant (t=8.62, P=0.00). After treatment control group, functional integration between the day before, the difference was statistically significant (t=5.97, P=0.00). Functional integration between the two groups the day before, the difference was not significant. Comparable. After treatment, daytime function points, the difference was statistically significant (t=2.26, P=0.02). Two points difference between daytime function before and after treatment, the difference was statistically significant (t=2.61, P=0.01). After the treatment group and integral sleep quality before treatment, the difference was statistically significant (t=9.94, P=0.00). In the control group and integral sleep quality before treatment, the difference was statistically significant (t=6.27, P=0.00). Points the two groups before treatment, sleep quality, the difference was not significant. Comparable. After treatment, sleep quality points, the difference was statistically significant (t=2.19, P=0.03). Two points difference between sleep quality before and after treatment, the difference was statistically significant (t=2.86, P=0.00). After the treatment group before treatment sleep efficiency and integration, the difference was statistically significant (t=9.82, P=0.00). The control group before treatment after treatment and integral sleep efficiency, the difference was statistically significant (t=7.76, P=0.00). Points the two groups before treatment, sleep efficiency, the difference was not significant. Comparable. After treatment, sleep efficiency points, the difference was not significant. Sleep efficiency before and after treatment in both groups points difference, the difference was not significant. After the treatment group and integral sleep disorders before treatment, the difference was statistically significant (t=6.05, P=0.00). In the control group and integral sleep disorders before treatment, the difference was statistically significant (t =2.75, P=0.00). Points the two groups before treatment, sleep disorders, the difference was not significant. Comparable. After treatment, sleep disorders points the difference was not statistically significant. Two points difference between sleep disorders before and after treatment, the difference was statistically significant (t=3.30, P=0.00). After 1 course of treatment, PSQI assessment of each component, differences between the two groups were compared before and after their statistical significance. Between groups known by the experimental group in the sleep time, daytime function, sleep quality, sleep disorders evaluation is better than the control group, similar to the other two groups of each component. Security testing:testing the treatment group had 32 cases before the blood test, treatment review, no exception. The treatment group had 32 cases before the urine testing, treatment review, no exception. Detected before the treatment group,32 cases of liver function (GPT), treatment review, no exception. Detected before the treatment group, 32 cases of renal function (BUN), treatment review, no exception. Detected before the treatment group 32 cases of ECG, treatment review, no exception. Control group,32 patients before treatment, blood was detected after treatment review, no exception. Control group,32 cases of pre-treatment urine testing, treatment review, no exception. Control group,32 patients tested before treatment, liver function (GPT), treatment review, no exception. Control group,32 patients tested before treatment, renal function (BUN), treatment review, no exception. Control group,32 patients tested before treatment, electrocardiogram, treatment review, no exception. Adverse events observed in both groups after treatment were no adverse reactions. Conclusions and InnovationThrough the above analysis of clinical research and documentation, you can draw the following conclusions:efficacy comparison:group treatment of insomnia a significant effect, can effectively improve the clinical efficacy and safety. However, traditional Chinese medicine syndromes between the two groups the difference was not statistically significant. Clinical recovery test group was 50.0%, effective rate of 31.2%, the effective rate was 12.5%, total effective rate was 93.7%; control group, the clinical cure rate was 43.7%, effective rate is 34.3%, the effective rate was 12.5%, total effective rate was 90.7%. Between the two groups, the difference was not statistically significant. Safety testing showed that treatment of blood, urine, stool, liver and kidney function, normal ECG, no abnormal changes after treatment, indicating that the treatment of clinical application security. For innovation in terms of:1. Applies traditional Chinese medicine treatment of insomnia has significant clinical efficacy in patients with improved sleep quality, shortened sleep time in patients, prolonged sleep time, improve sleep efficiency, sleep disturbances and improved ease the function of the day, in improving sleep time, alleviate sleep disorders, improve sleep quality and daytime function better than the control group. The method is safe, reliable, simple and effective features.2. Used in traditional Chinese medicine symptom scale questionnaire with the Pittsburgh Sleep Quality Index (PSQI) objective assessment of symptoms in detail, to avoid the subjective and to improve the accuracy and efficacy of the sample.3. Application Security Mei Fang, combined with modern detection index, the treatment of liver Qi stagnation in the assessment of insomnia to expect within the natural and prescription of traditional Chinese medicine Bianzheng under the Chinese government to develop new products, to achieve the best efficacy of treatment of insomnia.4. To increase the convenience of life, drug stability study by a large number of samples can be made safe Mei Fang decoction of the vacuum bag, or concentrated powder and tablets, used to increase the willingness of patients to improve the quality of life of patients...
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