Optimization of Traditional Chinese Medicine (TCM) clinical trials as philosophy, process and method, is extremely necessary and can be applied in different levels. Optimization of TCM clinical trials should follow some principles and procedures, and be executed in two ways. Optimization of treatment plan should be supported by the research basis and literature experience, and be perfected by research group and experts argumentation. Optimization of design plan is modified and accomplished by expert discussion and repeated consulting multi-disciplinary experts. Specific research objective, exact target population definition, proper design plan selection, valid calculation of sample size, precise and appropriate main outcome measures, data management system, medical ethics and statistical analysis are the focuses.

The principle of TCM diagnosis standard is communicational convenience, and the international universal standard recommended by WHO should also be paid attention to. When there’s no corresponding standard, inferior standard is available, but self made standard is generally not accepted. It’s suggested to apply the same standard for one program. The standards include international standard, regional standard, domestic standard, industrial standard, provincial standard and enterprise standard, the hierarchies and levels of these standards reduce successively. It’s thought that medical standard consists of international standard (issued by WHO or set by international academic conference), domestic standard (set by government authorities, national academic organization and conference), diagnosis standard set by provincial academic organization and textbook standard by universities and colleges. A lot of literature network database, as well as ICD-10, therapy guide, professional periodicals, professional society website, and books could be used for searching. TCM clinical trials also cover syndrome diagnosis standard. The conclusion standard and exclusion standard setting and influence of improper standard setting is also discussed in this article.

TCM clinical investigators should attach importance to buildup of research basis in order to ensure the feasibility and normalization of clinical regimen,definite curative effect of treatment regimen and enhance consistency among different researchers and repeatability of clinical regimen.Syndrome,therapeutic method and prescription should be consistent,the addition or subtraction of the medicinal or the dosage should be reasonable.Reduce the use of rare or invaluable medicinal to avoid the restrictions of herb resource,drug cost and animal protection.When transforming decoction to capsule,granule,dripping pill and compound granule,the preliminary test in clinic to recur the curative effect of the decoction is necessary.The application of a single medicinal,the single target area of a medicinal or active ingredient of a single medicinal in a prescription should be based on the preliminary work experience.Meanwhile the county-level producing area of the processed medicinal should be explicit,in order to ensure the quality and efficacy of the processed medicinal.This article also discussed the key point of treatment regimen optimization of acupuncture and massage.

Start with common problems in the quality control process of TCM clinical research,we summarize the problems in protocol execution,CRF fill-in,ICF signature,medication management,EDC management,lab examination and AE report; meanwhile we analyze the reasons and put forward the countermeasures for the optimization of TCM quality control.

OBJECTIVE:To observe therapeutic efficacy and safety of tobramycin dexamethasone in the treatment of meibo-mian gland dysfunction(MGD). METHODS:108 MGD patients were randomly divided into control group(53 cases)and observa-tion group(55 cases). Control group was given eyelid cleaning with conventional physical cleaning method,at the same time,giv-en Doxycycline hydrochloride tablets 0.1 g orally after meal,twice a day. Based on control group,observation group was addition-ally given Tobramycin and dexamethasone eye ointment with length of 1.0-1.5 cm,smearing into conjunctival sac,4 times a day. Treatment courses of 2 groups lasted for 4 weeks. Clinical efficacies of 2 groups were observed as well as eyelid observation score, symptom score,the levels of IL-6 and TNF-α,the occurrence of ADR before and after treatment. RESULTS:The total response rate of observation group was significantly higher than that of control group(89.1% vs. 77.4%),with statistical significance(P<0.05). Before treatment,there was no statistical significance in eyelid observation score,symptom score,the levels of IL-6 and TNF-α between 2 groups(P>0.05). After treatment,eyelid observation score of 2 groups were significantly higher than before treatment,and the observation group was significantly higher than the control group;symptom score and the levels of IL-6 and TNF-α in 2 groups were significantly lower than before treatment,and the observation group was significantly lower than the con-trol group,with statistical significance(P<0.05).There was no statistical significance in the incidence of ADR between 2 groups (P>0.05). CONCLUSIONS:Based on routine treatment,tobramycin dexamethasone shows significant therapeutic efficacy for MGD,and can improve clinical symptoms significantly but does not increase the occurrence of ADR.

Acupuncture Therapy ; Adult ; Female ; Humans ; Psoriasis ; therapy

Conducting quality monitoring to multi-center clinical research is an effective measure of quality control.This study explored the optimization of some key links of quality monitoring of TCM clinical research,i.e.optimization of CRA appointment,optimization of monitoring preparation,optimization of monitoring items,and optimization of monitoring feedback.For monitoring items,this study emphasized on research progress,protocol compliance,original data conservation,medication management,validity,CRF fill-in,informed consent singing and acquisition,EDC,traceability of lab examination,(severe) adverse event reporting in detail,thus providing the theoretical support for quality monitoring improvement of TCM clinical research.

Abstract: Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine (TCM), we elaborated the implementation process and demands of quality control measures of each level, including quality control, monitoring, auditing, and inspection. On the basis of joint inspection experience of 41 projects of the "Prevention and Treatment of Difficult and Complicated Diseases of TCM" plan of the "11th Five-year National Key Technology R&D Program", we analyzed the ensuring effect of 4-level quality control system and joint inspection model, and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model. Finally we investigated what should be revised in the quality control system and joint inspection model, thus providing the theoretical support for quality inspection improvement of TCM clinical research.

Objective To evaluate and compare the clinical outcomes of concurrent chemoradiotherapy with different radiation doses for esophageal carcinoma. Methods 78 cases of esophageal carcinoma receiving primary definitive treatment in our department between May 1 , 2005 to June 31 2007 were analyzed retrospectively. The patients with esophageal carcinoma were divided into high- ( > 50 Gy, median dose of 64 Gy) and low-dose (50 Gy) groups according to their prescription doses (n = 35, 43, respectively). Chemotherapy regimen consisted of cisplatin (75 mg/m2, d1) and 5-FU (500 ~ 600 mg/m2, D2 ~ 5) starting at days 1, 28, 49 and 70 after the beginning of radiotherapy with 2 ~ 4 cycles. The two groups were compared in terms of the early treatment outcomes, the side effects and survival rates. Results The 1,3 and 5-year survival rates for the high and low dose groups were 71.4%, 34.3%, 25.7%and 76.7%, 41.9%, 30.2%, respectively. The median survival time was 19 and 22 months respectively without statistical difference. The high dose group was more likely to have higher incidence rate of grade Ⅲ to Ⅳ myelosuppression in spite of the statistical difference. The high dose group had significantly higher incidence of esophagitis than did the low dose group (P=0.040). Conclusion For esophageal carcinoma with only indications of concurrent chemoradiotherapy, te low dose radiation (50 Gy) has comparable outcomes and less side effects compared with the high dose radiation (>50 Gy).

AIM: To observe pathomorphological changes in cerebral cortex and hippocampus in the mouse with synthetic vascular dementia. METHODS: The synthetic vascular dementia model was produced in the mouse. Animals were killed 7 d, 15 d, and 30 d after the operation, brain tissues were removed and embedded in paraffin. Section of 8?m thickness were stained with hematoxylin-eosin(HE) and Nissl methods, and observed with light microscope. RESULTS: The cerebral cortex in the mouse became thinner on the seventh day, karyopyknosis in partial nervous cells was formed, the number of local neurons was reduced, sieve structure was observed, and glial cells proliferated, with the similar results 15 d and 30 d after operation. Model mouses hippocampal cells in CA 1 area were reduced and almost disappeared 30 d after operation. At the same time, glial cells were abundantly proliferated, tubercles were formed. Cells in CA 2, CA 3 area were also reduced and hippocampal sclerosis occurred. CONCLUSION: Delayed necrosis of hippocampal pyramidal cells may be the pathological basis of ischemia cerebral vascular dementia.