Considerations on intervention goal and efficacy evaluation of traditional Chinese medicine in the treatment of neurological diseases / 中国结合医学杂志

In the last several years, traditional Chinese medicine (TCM) has made much progress in the treatment of neurological diseases. The living space of TCM in neurological diseases lies in refractory diseases, aging and chronic diseases caused by multiple factors as well as sub-health state and chronic fatigue state. The effect model of TCM mainly consists of whole effect, self-organization, self-stable model, holographic effect and butterfly effect. The effective point of TCM in neurological diseases lies mainly in end-points and health-related events. Moreover, TCM has advantages in the evaluation of symptoms, syndrome and quality of life (QOL). Some key indexes should be included when evaluating the efficacy of TCM in neurological diseases. Meanwhile, the advantages of TCM such as end-points, health-related events and QOL should be highlighted. Multi-subject researching methods could be adopted to make a comprehensive evaluation of subjective and objective indexes. The clinical evidence on the TCM efficacy evaluation may come from RCTs, and other types of designs can also be considered.

Influence of Naomai II capsule on dynamic expression of protease-activated receptors-1 after acute intracerebral hemorrhage / 中国中药杂志

<p><b>OBJECTIVE</b>To study the dynamic expression of protease-activated receptor-1(PAR-1) after acute intracerebral hemorrhage (ICH) and the influence of Naomai capsule (NMC II) on the expression in rats.</p><p><b>METHOD</b>72 rats were randomly divided into 9 groups (n = 8 in each group). They were normal group, ICH model groups at 6, 24 h, 3, 7 d and NMC II groups at 6, 24 h, 3, 7 d. ICH models were induced by collagenase type VII-S. Immunohistochemical method was used to detect PAR-1 protein and RT-PCR technique was used to detect PAR-1mRNA in brain tissue around the haematoma at different groups.</p><p><b>RESULT</b>PAR-1 protein and mRNA were mild positive in normal group. In model groups, intensity of PAR-1 expression started to enhance at 6 h, and enhanced more at 24 h. PAR-1 expression reached the peak at 3 d and began to descend. At 7 d the decent was obvious. At 6, 24 h, 3, 7 d time point. The PAR-1 protein positive cell number and PAR-1 mRNA absorbance ratio in ICH model and NMC II groups were significantly higher than those in normal group (P < 0.05 or P < 0.01). The PAR-1 protein positive cell number and PAR-1mRNA absorbance ratio in NMC II group were significantly lower than those in ICH model group (P < 0.05 or P < 0.01).</p><p><b>CONCLUSION</b>After ICH, PAR-1 is continuously activated because of the simulation of thrombin. Function of thrombin after ICH maybe mediated by PAR-1; NMC II may inhibit the expression of PAR-1. This may be one of the main therapeutics mechanisms of NMC II.</p>

Observation of the effect of early fluid resuscitation on hepatic fatty degeneration in rats after severe scald / 中华烧伤杂志

<p><b>OBJECTIVE</b>To investigate the efficacy of early fluid resuscitation on hepatic steatosis in rats after severe scald.</p><p><b>METHODS</b>One hundred and forty-four Sprague-Dawley rats were enrolled in the study. In thirty-six rats skin of 30% TBSA was treated with cold water to serve as sham injury group. All other rats were inflicted with 30% full-thickness scald, and they were subdivided into 3 groups, i. e. scald group(S, without resuscitation), delayed resuscitation group ( DR, with Ringer's solution at 6 post-scald hour(PSH) ) and early resuscitation group( ER, with Ringer's solution immediately after scald). The hepatic tissues of the rats were harvested at 0.5, 1.0,2.0,3.0,7.0 post-scald hour( PSH) and on 21.0 PSD for the observation of pathological changes with light-microscope and transmission electron microscope. The serum contents of TC, TG, HDL, ALP were determined at the same time-points. Body weight of each rat was measured before blood sampling, and total liver weight after blood sampling. Liver weight/body weight ratio was recorded.</p><p><b>RESULTS</b>Compared with sham injury group, the fat denaturation degree of hepatic tissue in ER group was obviously less than that in S and DR group . The serum level of high density lipoprotein (TC) , triglyceride ( TG) , and alkaline phosphatase (ALP) after scald increased ranking as S > DR > ER, while the level of HDL decreased in that order. The liver weight/body weight ratio of the rats in DR group on 1.0 PSD was obviously elevated compared with that in ER group( P <0. 05) , and there exhibited significant difference of liver weight/body weight ratio between DR and ER groups on 7. 0 PSD ( P < 0. 01). The liver steatosis had obvious negative correlation with HDL content after scald( r = -0. 37, P <0.01) , but it had positive correlation with the ALP content( r = 0. 45, P <0. 01), TG content( r = 0. 25, P <0. 01) and liver weight/body weight ratio( r = 0. 440, P <0. 01). The remaining parameters showed no correlation with the liver steatosis.</p><p><b>CONCLUSION</b>Fluid resuscitation immediately after scald can ameliorate hepatic fatty degeneration, reduce its incidence, and beneficial to recovery of liver damage to a certain extent.</p>

Treatment of acute intracerebral hemorrhage with a comprehensive protocol of integrated Chinese and Western medicine / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the effect and safety of a comprehensive protocol of integrated Chinese and Western medicine (ICWM) in treating acute intracerebral hemorrhage (AICH).</p><p><b>METHODS</b>A multi-center, single blinded, random and control clinical trial was adopted with 404 patients with AICH, they were divided into the treatment group (199 cases) treated with ICWM protocol, and the control group (205 cases) treated with Western medicine plus placebo, and AICH related indexes were assessed after treatment.</p><p><b>RESULTS</b>Compared with the control group, the neurological deficit score (National Institute of Health Stroke Scale, NIHSS) determined on the 28th and the 90th day after treatment was ameliorated in the treatment group (P < 0.01). Moreover, the 90th day assessment showed that the mortality and severe disability rate was lower (BI < 75) (P <0.05), the complete rehabilitation and mild disability rate (BI > or = 95, P < 0.05), and the sociability rate (Functional Assessment Questionnaire, FAQ) were higher (P < 0.01) in the treatment group than those in the control group. The incidence of adverse reaction was 5.53%, manifested as non-infective diarrhea.</p><p><b>CONCLUSION</b>The ICWM protocol used in this study may improve neural function and quality of life of AICH patients, and reduce the mortality and severe disability rate in those after 90 days' treatment, with only non-infective diarrhea as the adverse reaction.</p>

A Meta-analysis in multi-center random controlled clinical trials / 中华流行病学杂志

<p><b>OBJECTIVE</b>To study the center effect discrepancy in the multi-center clinical trials.</p><p><b>METHODS</b>Two groups of data collected from the multi-center clinical trials were used. Data were processed by covariance analysis and Meta-analysis.</p><p><b>RESULTS</b>In the covariance analysis, the discrepancy of the center effect values indicated statistical significance. Through Meta-analysis on fixed effect model, the discrepancy in one heterogeneity test showed no statistical significance (P > 0.05) while the inter-group discrepancy of the merged effect values drawn from analysis based on fixed effect model having statistical significance (P < 0.05). In the random effect model, the discrepancy in one heterogeneity test showed statistical significance (P < 0.05) while the inter-group discrepancy of the merged effect values drawn from analysis based on random effect model having no statistical significance (P > 0.05).</p><p><b>CONCLUSIONS</b>Studies on multi-center random controlled clinical trials, when statistical significance was found in the interaction discrepancy between the inter-center and the center-group relation, the merged effect values should be compared and analyzed by an appropriate statistic model based on the heterogeneous test results from the Meta-analysis. However, if the result from covariance analysis and the one from Meta-analysis did not agree to each other, the results drawn from the Meta-analysis were reliable.</p>