Evolution of the registration regulations for proprietary Chinese medicines in China.

In this review, we provide a comprehensive overview on the registration of proprietary Chinese medicines (PCMs) in China over the past century by examining published literature and historical data. We will examine this evolving administrative practice for PCMs registration in China, which is divided to the following five stages: (1) initial measures (1915-1948); (2) early development (1949-1965); (3) provincial approval and trial implementation of the "approval number" system (1966-1984); (4) legislation and cleanup (1985-1999); and (5) centralized national approval (2000 until now), offering a panoramic view on the characteristics of PCMs registration management in China.

Evaluation of myelin basic protein levels with receiver operating characteristic curves for diagnosis of multiple sclerosis / 南方医科大学学报

<p><b>OBJECTIVE</b>To assess the value of cerebral spinal fluid (CSF) and serum myelin basic protein (MBP) levels in the diagnosis of multiple sclerosis (MS).</p><p><b>METHODS</b>Enzyme-linked immunosorbent assay was used to detect the CSF and serum levels of MBP in patients with MS (n=45), patients with Guillain-Barre syndrome (GBS) (n=36) and control subjects (control) (n=33). The sensitivity and specificity of MBP in CSF and serum in the diagnosis of MS were evaluated using the receiver-operating characteristic (ROC) curves.</p><p><b>RESULTS</b>The MBP levels in CSF and serum both increased significantly in MS group as compared with those in GBS (P<0.01) and control groups (P<0.01). The area under the curve (AUC) of the ROC curve of MBP in CSF was 0.853-/+0.037 for MS diagnosis, and with the optimal cut-off value of 0.87 pg/ml, CSF MBP showed a diagnostic sensitivity of 83.7% and specificity of 78.3%. The AUC of the ROC curve of serum MBP was 0.761-/+0.046, and the optimal cut-off value of 0.25 pg/ml resulted in a diagnostic sensitivity of 62.8% and specificity of 73.9%. No statistically significant difference was found between the two AUCs (P>0.05).</p><p><b>CONCLUSION</b>Evaluation of CSF and serum MBP levels allows accurate diagnosis of MS, and MBP level in the CSF has greater diagnostic sensitivity than serum MBP. The combination of both CSF and serum MBP levels may serve as a sensitive index for the diagnosis of MS.</p>

Clinical analysis of the risk factors of carotid atherosclerotic plaque formation / 中华神经医学杂志

Objective To analyze the risk factors for the formation of carotid atherosclerotic plaque. Methods The clinical data of 279 hospitalized patients undergoing carotid artery color Doppler ultrasonography between June 2005 and December 2006 were collected. Multiple regression of the common carotid intimal-medial thickness (IMT) was used to screen the potential risk factors of carotid plaque formation. The patients were divided into two groups according to the presence of carotid plaque, and binary logistic regression and univariate analysis were used to identify the risk factors. The carotid plaque score and index were compared between the subgroups with different risk factors. Results The common carotid IMT was subjected to influences by age (β=0.242, P=0.000), systolic blood pressure (SBP) (β=0.152, P=0.013) and the level of low-density lipoprotein (LDL) (β=0.115, P=0.048). Age (OR=1.087, P=0.000) and SBP (OR=1.036, P=0.000) were identified as the main factors that affected the formation of carotid plaque. In patients above 60 years old, the detection rate of carotid plaque was significantly higher than that in patients below 60 years (X2=58.379, P=0.000), and the rate was significantly higher in hypertensive patients than in the normotensive patients (X2=18.206, P=0.000). The carotid plaque score and index were significantly higher in patients over 60 years old than in those below 60 years (F=69.353, P=0.000;F=64.826, P=0.000, respectively), and also significantly higher in hypertensive patients than in the normohypertensive patients (F=4.866, P=0.028;F=6.927, P=0.009, respectively). Conclusion Age and SBP are the major risk factors of carotid atheroselerotie plaque formation, and LDL is a factor of lesser risk.