In this paper, the concepts of surrogate outcomes and intermediary outcomes, their correlation with the primary outcome, how to select surrogate outcomes and intermediary outcomes and the particular requirements for using surrogate outcomes in assessing TCM clinical efficacy were discussed and described. It is difficult to evaluate clinical efficacy objectively and thoroughly by means of a single surrogate outcome for reason of the global characteristics of TCM, therefore, to rationally select such intermediary outcomes as important clinical symptoms, combination of several syndromes, patients' subject feeling, patients' satisfaction for treatment and quality of life, should be beneficial for objectively evaluating the efficacy of TCM intervention approaches.
Drugs, Chinese Herbal ; therapeutic use ; Health Status Indicators ; Humans ; Medicine, Chinese Traditional ; Outcome Assessment (Health Care) ; methods ; Phytotherapy ; Treatment Outcome

HPS1-D, an active polysaccharide,was isolated and purified from Hedysarum polybotrys. HPS1-D was obtained after treated with Savage method and H2O2, and purified with DEAE-cellulose 52 and Sephadex G-100 gel filtration chromatography. Then physicochemical property analysis, GC, methylation, partial acid hydrolysis, and NMR method were used to study chemical structural of HPS1-D. The conformation was primarily analyzed with GPC-MALLS method and Congo red reaction. The anti-complementary activity of HPS1-D was evaluated with the hemolysis assay. HPS1-D was a heteropolysaccharide and consisted of D-glucose, L-arabinose, (7.2:1.3). HPS1-D proved to be a neutral sugar, with 1, 4-and 1, 4, 6-alpha-D-glucopyranosyl residues in backbone ,and 1, 5-and 1, 3, 5-alpha-L-arabinofuranosyl residues in branches. HPS1-D has a random coil state conformation with monodisperse mass distribution in 0.9% NaCl solution. And HPS1-D had triple-helix conformation in concentrate of NaOH solution. Anti-complementary activity of HPS1-D was closed to its positive control heparin.
Animals ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; Hemolysis ; drug effects ; Mice ; Plant Extracts ; chemistry ; pharmacology ; Polysaccharides ; chemistry ; pharmacology

Viewing from some TCM concepts and basic characteristics of health, assimilating the operationalization concerning thinking and procedure of modern scientific research, the pilot form of Health Scale of TCM--initial health scale of TCM (iHSTCM) based upon TCM theory was developed. From November 2002 to January 2003, the domain, facets and items of HSTCM were finally established by analyzing the data from a survey of 652 persons in Guangzhou City using iHSTCM. In conclusion, the HSTCM has its theoretical ratio-nality and is applicable. It could be further applied in TCM clinical practice.
Adolescent ; Adult ; Aged ; Diagnosis, Differential ; Female ; Health ; Health Promotion ; methods ; standards ; Health Status Indicators ; Humans ; Male ; Medicine, Chinese Traditional ; methods ; standards ; Middle Aged ; Surveys and Questionnaires

To develop a reverse dot blot assay for rapid detection of HBV genotypes.Specific oligonucleotides probes were desighed and immobilized on nylon membranes.The DNA sample to be tested was PCR-amplified with DIG labeling primers and then hybridized with the immobilized probes.This procedure for detecting HBV genotypes was simple,rapid and specificity.30 specimens in Chongqing area were collected and detected by this method,and results were evaluated using direct sequencing.Results showed that: This new method was applicable to precise detection HBV genotypes for specimen with copies up to 103,and the HBV genotyping results showed that genotype B was the predominant genotype in Chongqing area.

The analysis of the effective value obtained in clinical trails should take account of both sides of its size and precision, for its interpretation, the general principles of: accuracy, explicitness and quantification should be complied. Criteria such as relative risk (RR), relative risk reducing rate (RRR), absolute risk reducing rate (ARR) and number needed to treat (NNT) an important clinical event, etc. are commonly used in the primary outcomes interpretation, while the methods to express the effective size and precision of surrogate outcomes and intermediary outcomes are needed to be further studied. Many problems for give expression to the outcome of TCM clinical trail still remain to be solved.
Clinical Trials as Topic ; standards ; Data Interpretation, Statistical ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Outcome Assessment (Health Care) ; methods ; Phytotherapy ; Risk Assessment

OBJECTIVEIn order to scientifically reflect the real efficacy of TCM treatment and to preliminarily establish a definitely valid and reliable assessment system of stroke treatment, with multi-dimensional outcome assessment indexes, including efficacy evaluation system of conventional western medicine, syndrome evaluation criteria in TCM and quality of life assessment system.

METHODSAn integrative approach of cross-sectional survey and prospective follow-up was adopted. Two hundred and forty-five case-episodes of stroke patients were assessed by determining such parameters as nerve functional deficit scale, grading of total status of living ability, activity of daily living (ADL), TCM stroke criteria of diagnosing-treatment, TCM syndrome related symptoms/signs, Health Survey Questionnaire (Short form 36, SF-36), and index of quality of life (QOL), and their construction and relation were analyzed by such methods as multivariate relation, partial relation, linear regression, factor analysis, Cronbach's alpha coefficients, and the responsiveness estimation.

RESULTSThe multi-dimensional assessment system of stroke treatment, containing 57 indexes with clarified constructions and classification, was created, and its validity and reliability confirmed after assessement. Various degrees of relationship were found between different TCM Syndromes and different domains of QOL.

CONCLUSIONThe assessment system of stroke treatment preliminarily created has satisfied reliability and validity. It could be expected to reflect the real efficacy of TCM treatment more inclusive and accurate. TCM Syndrome indexes are considered to be the factor related to both domains of mental and physical health, particularly with the former, therefore, to improve the TCM Syndrome would imply improvement of the mental health, physical health and QOL of the patients.

Aged ; Cerebral Infarction ; drug therapy ; Cross-Sectional Studies ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Intracranial Hemorrhages ; drug therapy ; Male ; Middle Aged ; Outcome Assessment (Health Care) ; Phytotherapy ; Prospective Studies ; Quality of Life ; Stroke ; drug therapy ; Surveys and Questionnaires

Malignant cancer is the leading cause of death in man, exceeding cerebrovascular disease and heart disease. More than half of the total mortality due to malignant cancer is from lung, liver, intestinal and gastric cancer. Chemotherapy is one of the effective treatments for cancer. However, the great majority of Western anticancer medicines have considerable side effects. Herbal medicines offer many more advantages than synthesized compounds because they are made from purely natural compounds and have less adverse effects. However, the single administration methods used as standard in herbal medicine, and deficient drug targeting, severely limit their anticancer activity. Single-walled carbon nanotubes (SWNTs) can be used as drug carriers. They have been modified to form Chinese anticancer medicine-SWNT compounds which can specifically target tumors, thereby significantly increasing the therapeutic effectiveness of these medicines. Water-soluble SWNTs have high stability. As a drug carrier, SWNTs functional modification of the anticancer medicine may improve the targeting and killing of tumor cells. SWNTs have been attached to the Chinese antitumor medicines paclitaxel and plumbagin and have achieved excellent therapeutic effects. Furthermore, choosing the best administration methods such as internal iliac arterial infusion, intravesical infusion and embedment of a hypodermic chemotherapeutic pump, may also improve the anticancer effects of Chinese medicine.
Antineoplastic Agents ; pharmacology ; therapeutic use ; Cell Death ; drug effects ; Drug Carriers ; Drug Delivery Systems ; Drugs, Chinese Herbal ; therapeutic use ; Feasibility Studies ; Humans ; Nanotubes, Carbon ; chemistry ; Neoplasms ; drug therapy ; pathology

OBJECTIVETo decrease the incidence of inferior alveolar neurovascular bundle injury through location of mandibular canal by 3-dimensional (3-D) CT.

METHODS30 female cases with prominent mandibular angle underwent 3-D CT before operation. The 3-D images were used to measure the distances between upper points of lower teeth to the inferior border of the canal. Then the osteotomy was designed according to the canal position to avoid the inferior alveolar neurovascular bundle injury. The canal protection was observed intraoperatively and postoperatively.

RESULTSThe mandibular canal was protected very well in all 30 cases without any injury to the inferior alveolar neurovascular bundle.

CONCLUSIONSThe 3-D CT can accurately locate the mandibular canal to guide the design of the mandibular angle osteotomy for patients with prominent mandibular angle.

Adult ; Female ; Humans ; Imaging, Three-Dimensional ; Mandible ; diagnostic imaging ; innervation ; surgery ; Mandibular Nerve ; diagnostic imaging ; Neural Tube ; diagnostic imaging ; Tomography, X-Ray Computed

BACKGROUND: The age of patients with lumbar disc herniation tends to younger, and choosing which surgical method for young patients is a difficult in clinic. . OBJECTIVE: To investigate the curative efficacy and imaging characteristics of the dynamic stabilization using Bioflex System for young patients with single-level lumbar disc herniation. METHODS: Eighty patients diagnosed for single level lumbar disc herniation in Shenzhen Hospital of Chinese Medicine from October 2013 to November 2015 were randomly divided into experimental and control groups (n=40 per group). The patients in the experimental group underwent dynamic stabilization using Bioflex System, and the controls received percutaneous transthoracic discectomy. The Visual Analogue Scale and Japanese Orthopedic Association scores and Oswestry Disability Index were used to evaluate the clinical efficacy. The ventral and dorsal intervertebral disc height, distance between spinous processes, and the maximum height between intervertebral foramens were measured through digital radiography, CT and MRI examinations at baseline, 3, 6, and 12 months of follow-up. The operation time, intraoperative blood loss and complications were compared between groups. RESULTS AND CONCLUSION: (1) At 12 months postoperatively, the restoration of the ventral and dorsal intervertebral disc height, distance between spinous processes, and the maximum height between intervertebral foramens in the experimental group were significantly superior to those in the control group (P < 0.05). (2) The Visual Analogue Scale and Japanese Orthopedic Association scores and Oswestry Disability Index scores were significantly improved in both groups (P < 0.05); all above scores did not differ significantly between two groups at 3 and 6 months postoperatively (P >0.05); and all above scores in the experimental group were significantly superior to those in the control group at 12 months postoperatively (P < 0.05). (3) The operation time and intraoperative blood loss in the experimental group were significantly lower than those in the control group (P < 0.05). (4) There were no significant differences in the incidence of complications between two groups (P > 0.05). (5) These results show that although percutaneous transthoracic discectomy has advantages on the operation time and intraoperative blood loss; the two surgical methods show no significant differences in the early curative efficacy and complications. Besides, in terms of long-term efficacy, Bioflex System can significantly alleviate pain, restore intervertebral height, and prevent degeneration of the intervertebral disc and adjacent vertebrae.

BACKGROUND: Yaotu Granules have been proved to protect human nucleus pulposus cells and delay their degeneration. Notably, Yaotu Granules for lumbar disc herniation has achieved good clinical results.OBJECTIVE: To investigate the effect of the herbal compound formula Yaotu Granules on the Fas/FasL expression in a rabbit model of lumbar disc degeneration, and further elucidate the underling mechanism of preventing and treating lumbar disc degeneration.METHODS: Twenty New Zealand white rabbits were enrolled and the models of lumbar disc degeneration were established by minimally invasive puncture and rotation cutting, followed by randomized into normal saline, low-, middle-,and high-dose groups (n=5 per group). 10 mL of normal saline, 10, 20, and 40 mL of water decoction of Yaotu Granules were administered intragastrically into the normal saline, low-, middle-, and high-dose drug groups for 21 days, twice daily, respectively. Subsequently, the expression level of Fas/FasL in the rabbit nucleus pulposus cells in each group was detected.RESULTS AND CONCLUSION: The signal intensity of the rabbit lumbar disc on MRI was decreased, and ruptured annulus and posterior herniated disc were visible at 12 weeks after modeling. Masson staining showed that the nucleus pulposus cells arranged in disorder, and even ruptured. Additionally, safranin O staining found that the number of nucleus pulposus cells was decreased obviously. The order of the relative expression levels of Fas and FasL mRNA in the nucleus pulposus cells was as follows: normal saline group > low-dose drug group > middle-dose drug group > high-dose drug group (P < 0.05). These results suggest that Yaotu Granules delay the rabbit lumbar disc degeneration by downregulating the expression level of Fas/FasL.