This paper described the drafting background,including the process and division of labour,of the general guidelines of clinical trials on new drugs of TCM (hereinafter called the guideline) published by China Food and Drug Administration (CDFA) in 2015.The paper mainly introduced the key content and outstanding characteristics of the guideline.The guideline indicated that purpose and target of the clinical trials on the new drugs of TCM should be in accordance with clinical practice and bring clinical benefits to the patients.Besides,the guideline stipulated that the risk/benefit assessment was requisite before marketing a new drug,emphasizing the importance of adequate exploratory clinical trials,scientificalness of the disignation of the endpoints of clinical efficacy,and the significance of the quality control of clinical trials.The specific requirements for the safety evaluation of the heart,liver and kidney was raised and a request for the preparation of the placebo formulated in the guideline.At the same time,the existing problems and the future development of the guideline are discussed in this paper.

Objective To observe the effects of modified Shenmaiyin on arrhythmia in CHD. Methods A total of 180 patients were randomly recruited into a control group (80 cases) and a treatment group (100 cases). Both groups were treated with conventional western medicines. On this basis, the treatment group was treated with modified Shenmaiyin. The conditions of myocardial ischemia and arrhythmia were observed for both groups. Results The total effective rate of ischemia and arrhythmia were 50.00% and 80.00% in the treatment group, constrating to 32.50% and 60.00% in the control group, showing statistical difference (P＜0.05). Conclusion Modified Shenmaiyin had sound effects in improving ischemia and arrhythmia.

Chronic low back pain is a common type of pain which is related to the dysfunction of low back muscles. In recent years, the pressure biofeedback has been widely used for the assessment and treatment of chronic low back pain. This paper reviewed the reliability and validity of pressure biofeedback unit in the evaluation of lumbar and abdominal muscles activity, as well as its application on the rehabil-itation of chronic low back pain, which mainly related to the assessment and treatment of lumbar muscle activity and lumbar spine stability.

Objective To study the relation between alcohol-induced osteonecrosis of femoral head (AIONFH) related with high morbidity TCM constitution type with CYP2C8 gene polymorphisms.Methods Totally 152 Han nationality NONFH cases from Feburary 2014 to September 2015 from outpatient and the inpatient departments in Gansu Province Hospital of TCM were collected. 50 AIONFH cases were set as medical case group; meanwhile, 45 healthy volunteers were enrolled as control group. Database for medical materials of all patients and volunteers was established. TCM distribution for AIONFH patients was determined. Solution DNA extraction kit was used to extract DNA, and detect the concentration and purity of DNA. The target gene was amplified by PCR and the target gene was amplified by gel electrophoresis. The length of the fragment was confirmed to conduct target gene sequencing. With the results of sequencing and gel electrophoresis, the relation of AIONFH with CYP2C8 gene polymorphism in AIONFH patients with phlegm-dampness syndrome and the control group.ResultsThe CYP2C8 gene loci rs17110453 gene polymorphism was not statistically significant between the two groups (χ2=0.253,P>0.05). There was no significant difference in allele between the two groups (χ2=0.077,P>0.05). The risk of disease in CC genotype was 1.37 times higher than the AA genotype (95%CI: 0.339-5.540), without statistical significance (P>0.05). There was no significant difference in genotype and allele distribution between AIONFH patients with phlegm-dampness and non-phlegm-dampness and the control group (P>0.05).Conclusion CYP2C8 gene loci rs17110453 gene polymorphism A/C mutation has no obvious relation with AIONFH risk. There is no clear relationship between CYP2C8 gene loci rs17110453 gene polymorphism with AIONFH.

Objective To study the correlation between nontraumatic osteonecrosis of femoral head (NONFH) and ApoA1 polymorphism of blood stasis type.Methods Totally 93 cases of NONFH were selected as the case group, and 83 healthy volunteers were randomly selected as the control group. With TCM constitution questionnaire survey, the case group was screened out 32 cases of blood stasis NONFH type and 61 cases of non blood stasis NONFH type. In the case group and control group, the subjects took blood samples 2 mL, extracted DNA for PCR amplification, PCR products for DNA sequencing. G994T PAF-AH and rs9658282 gene NOS1 site polymorphism were detected for tatistical analysis.Results -75G/A gene AA ApoA1 genotype (OR: 2.578; 95%CI: 1.174-5.663;P=0.018) and A allele (OR: 1.726; 95%CI: 1.121-2.658;P=0.013) may be one of the risk factors of NONFH.Conclusion -75G/A gene ApoA1 may be related to the pathogenesis of NONFH. There was no correlation between the ApoA1 gene polymorphism of -75G/A gene and the pathogenesis of blood stasis NONFH. There was no correlation between the ApoA1 gene polymorphism of +83C/T gene and the pathogenesis of blood stasis NONFH.

Objectives: Online grocery shopping has gained traction with the digital transformation of retail. This study constructs a behavioral model combining values, attitudes, and reasons for behavior—specifically, facilitators and resistance—to provide a more novel discussion and further understand the relative influences of the various factors affecting continuance intention in online grocery shopping. Methods: Data were collected through an online questionnaire from consumers who had engaged in online grocery shopping during the past month in Seoul, Korea. All collected data were analyzed using descriptive analysis, and model validation was performed using partial least squares structural equation modeling. Results: Continuance intention is primarily driven by facilitative factors (compatibility, relative advantage, and ubiquity). Attitude can also positively influence continuance intention. Although resistance factors (price, tradition, and risk) do not significantly affect continuance intention, they negatively affect attitude. Values significantly influence consumers’ reasoning processes but not their attitude. Conclusions These findings explain the key influences on consumers’ online grocery shopping behavior in Seoul and provide additional discussion and literature on consumer behavior and market management. To expand the online grocery market, consumers should be made aware of the potential benefits of the online channel; the barriers they encounter should be reduced. This will help sustain online grocery shopping behavior. Furthermore, its positive impact on attitude will further strengthen consumers’ continuance intention.

Uyghur medicine has not yet had the clinical research guidelines consistent with Uyghur medicine theory for its new medicine. In this research, retrospective multi-center study on medical records of Uyghur medicine diagnosis and treatment program of stable angina was conducted. Data about demography, diagnostics, therapeutics, efficacy evaluation, and nursing were collated and analyzed. Uyghur medicine syndrome diagnosis indicators and their contribution to stable angina were identified, and Uyghur medicine syndrome differentiation criteria were established. Uyghur medicine established its primary and secondary disease syndrome and its symptoms quantization table entries for the syndrome elements of Uyghur medicine syndrome differentiation criteria. Then combined with symptoms of angina and ECG changes, nitroglycerin stop and decrement rate, evaluation criteria for the efficacy of disease symptom combination were established. On this basis, in accordance with the technical requirements of the national new medicine evaluation, the study developed clinical research guidelines for the treatment of stable angina with new Uyghur medicine.

The multi-central clinical records retrospective survey for psoriasis vulgaris was carried out by collecting related information such as demographic, diagnostics, therapeutics, efficacy evaluation, nursing data, and so on. The Uygur medical differentiation classification standard about psoriasis vulgaris was established and it was divided into four types:abnormal Khan Hilit type, abnormal Sapra Hilit type, abnormal saltness Balgham Hilit type, and abnormal Sawda Hilit type, according to main symptom and secondary symptom feature. The disease efficacy evaluation standard was established based on score of surface area and severity of skin injury combining with the changes of main symptom and secondary symptoms. On the basis, guidelines for clinical research of new drugs of Uygur medicine used in the treatment of psoriasis vulgaris were formulated in accordance with the technical requirements and procedure of national center for drug evaluation.

Retrospective multi-center study on medical records of Uyghur medicine diagnosis and treatment program of eczema was done. Demography, diagnostics, therapeutics, efficacy evaluation and nursing data and other information were collated and analyzed. With analysis and summary of the primary and the secondary symptoms, eczema was divided into four types:blood corruption type (Ofunetlengen Kan Tiplik), blue colored yellow bile type (Zenggereng Sapra Tiplik), abnormal black bile type (Hayri Tabii Savda Hilitlik), and salty phlegm type (Shor Belgem Hilitlik). Uyghur Medicine syndrome differentiation and efficacy evaluation criteria were established. Skin itching, lesion shape, and lesion area integral of patients were scored before and after the treatment, respectively. According to the improvement in symptoms of Uyghur medicine syndrome and life quality of patients, and the internal environment change, evaluation criteria for the efficacy of disease symptom combination were established. On this basis, in accordance with the technical requirements of the national new medicine assessment technology, the study developed clinical research guidelines for the treatment of eczema with new Uyghur medicine.

In this study, retrospective multi-center study on medical records of Uyghur medicine diagnosis and treatment program of osteoporosis was done and demographic, diagnostic, therapeutic, efficacy evaluation and nursing data and other information were collected. The main and secondary disease manifestations of osteoporosis were analyzed inductively. Osteoporosis was divided into 2 types in Uyghur medicine field, which were abnormal Savda type and abnormal Balgham type. Uighur medicine syndrome type standards of osteoporosis were established. Treatment efficacy was evaluated according to bone pain, bone density, life quality, and improvement of clinical symptoms and Uyghur medical symptoms. On this basis, in accordance with the technical requirements of the national drug review, the study developed clinical research guidelines for the treatment of osteoporosis with new Uyghur medicine (draft).