Double-blind randomized controlled trial design is the most recognized scheme of therapeutic experimental design.On the assessment of the efficacy of traditional medicine, randomized controlled clinical trial design also has the same value.Only when using the research method towards epidemiology to perform the rigorous design on the clinical trial of traditional medicine and make the objective evaluation of its effect, can it get the real understanding and approval from modern medicine.When making the therapeutic clinical trial under the traditional medicine, due to the characteristics of the subject, therapeutic measures usually need to be changed so they cannot be standardized, and the modification may result in the share of multiple intervention components, which leads to the inaccurateness of results under the effect of confounding bias.According to the characteristics of traditional medicine, a new method was proposed for therapeutic clinical trial.Firstly do the randomization with the inclusion criteria made by the same symptom arise in a certain stage of disease, secondly adopt the standardized intervention measures for processing.Eventually confirm whether there is significant statistical difference.The symptom directing standardized interventions have provided the experimental design of the traditional medical clinical therapy with a feasible scheme, which can solve several problems existing in this design.

Objective To evaluate the efficacy of closed-loop coadministration of propofol and remifentanil guided by Narcotrend index (NI) in laparoscopic cholecystectomy.Methods Sixty American Society of Anesthesiologists physical status Ⅰ or Ⅱ patients of both sexes,aged 20-64 yr,with body mass index of 18-25 kg/m2,scheduled for elective laparoscopic cholecystectomy,were randomized into 2 groups (n =30 each):program regulation group (group P) and artificial regulation group (group A).After the initial target effect-site concentration of propofol was selected,the target effect-site concentration of remifentanil was determined according to the formula.In group A,the target effect-site concentrations of propofol (2-4 μg/ml) and remifentanil (3-4 ng/ml) were adjusted artificially according to anesthesiologists' experience every 5 min to maintain NI value at 26-46.Induction time,anesthesia induction and mean maintenance doses and the initial,highest and lowest target concentrations of propofol and remifentanil,mean NI value,percentage of time with NI between 26 and 46,emergence time,and development of fluctuation in heart rate or mean arterial pressure ＞ 20％ of the baseline value and intraoperative awareness were recorded.Results No intraoperative awareness was found in the two groups.Compared with group A,the induction time was significantly shortened,the induction dose and initial target concentration of remifentanil were increased,the mean maintenance dose and lowest target concentration of propofol and remifentanil were decreased,the percentage of time with NI between 26 and 46 was increased,and the emergence time was shortened (P＜0.05 or 0.01),and no significant change was found in the induction dose and initial target concentration of propofol,the highest target concentrations of propofol and remifentanil,mean NI value,or incidence of fluctuation in heart rate or mean arterial pressure ＞ 20％ of the baseline value in group P (P＞ 0.05).Conclusion For laparoscopic cholecystectomy,NI-guided closed-loop coadministration of propofol and remifentanil produces safe and effective anesthesia,and the efficacy of precise administration is superior to that of artificially regulated target-controlled infusion.

Due to the characteristics of the complicated and critical deseases, therapeutic measures in the TCM clinical trials need to be multiple rather than single indexes. It is the flexibility and principle reflection of treatment based on syndrome differentiation. The advantage is more suitable for severe and complex diseases, but the adverse effect is mis-understood by the confounding bias. According to the characteristics of traditional medicine, a new method was proposed for the complicated and critical deseases. Firstly, the randomization with the inclusion criteria was made by the same symptom in a certain stage of disease; and secondly, the comprehensive intervention measures were adopted of processing; Eventually, the statistical difference was calculated. The symptom directed comprehensive interventions have provided the experimental design of the TCM therapeutic clinical trials.

OBJECTIVE: To explore the expression of perforin and granzyme-B in peripheral blood lymphocyte (PBL) in patients with prostate cancer (PCa) and the clinical significance. METHODS: The expressions of perforin and granzyme-B in PBL were detected by fluorescence quantitative reverse transcription polymerase chain reaction. The results of perforin and granzyme-B expression were compared among patients with PCa (n=60), patients with BPH (benign prostatic hyperplasia, n=40) and healthy controls (n=20). RESULTS: Th e expressions of perforin and granzyme-B in patients with PCa were significantly lower than that in patients with BPH or that in the healthy controls (P<0.05), respectively. Furthermore, in PCa patients with low pathological grade, the expressions of perforin and granzyme-B in PBL was statistically higher than that in patients with high pathological grade (P<0.05). The expressions of perforin and granzyme-B in PCa patients at high clinical stage was statistically lower than that in PCa patients at low clinical stage (P<0.05). CONCLUSION The results of this study suggest that development and progression of PCa might be associated with poor immune status of patients.
Case-Control Studies ; Granzymes ; metabolism ; Humans ; Lymphocytes ; enzymology ; Male ; Perforin ; metabolism ; Prostatic Hyperplasia ; Prostatic Neoplasms ; immunology

We reviewed and analyzed the clinical data for a patient with metastatic castration-resistant prostate cancer (mCRPC) from September, 2009 to December, 2014. After the treatment with abiraterone, patient's performance status improved, pain relieved, total prostate specific antigen (tPSA) and free prostate specific antigen (fPSA) markedly decreased. tPSA or fPSA fluctuated between 
30 and 50 ng/mL or between 10 and 20 ng/mL. MRI showed the left peripheral zone reduced. MRI and bone single photon emission computed tomography (SPECT) scan showed no new metastasis. These results indicated that application of abiraterone for patient with mCRPC not only decreased prostate specific antigen (PSA) levels and tumor volume, but also blocked bone metastasis progression and enhanced pain relief.
Androstenes ; therapeutic use ; Bone Neoplasms ; drug therapy ; secondary ; Disease Progression ; Humans ; Male ; Prostate-Specific Antigen ; blood ; Prostatic Neoplasms, Castration-Resistant ; drug therapy ; pathology