Drug combination is extensive in the clinical real world,which is an important part and the inherent requirements of the post-marketing evaluation of traditional Chinese medicine (TCM). The key issues and technology include multi-domain and multi-disciplinary such as the rationality, efficacy and safety evaluation of combination drug starting from clinical real world, study on component in vivo and mechanism of combination drug, the risk/benefit assessment and cost-benefit evaluation of combination drug and so on. The topic has been studied as clinical demonstration on combination therapy of variety of diseases such as coronary heart disease, stroke, insomnia, depression, hepatitis, herpes zoster, psoriasis and ectopic pregnancy. Meanwhile, multi-disciplinary dynamic innovation alliance of clinical drug combination has been presented, which can promote the academic development and improving service ability and level of TCM.
Drug Combinations ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; methods

To systematically review the incidence rate of adverse drug reaction/event by Qingkailing injection. Such databases as the PubMed, EMbase, the Cochrane library, CNKI, VIP WanFang data and CBM were searched by computer from foundation to July 30, 2015. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and cross check data. Then, Meta-analysis was performed by using the R 3.2.0 software, subgroup sensitivity analysis was performed based on age, mode of medicine, observation time and research quality. Sixty-three studies involving 9,793 patients with Qingkailing injection were included, 367 cases of adverse reactions/events were reported in total. The incidence rate of adverse reaction in skin and mucosa group was 2% [95% CI (0.02; 0.03)]; the digestive system adverse reaction was 6% [95% CI(0.05; 0.07); the injection site adverse reaction was 4% [95% CI (0.02; 0.07)]. In the digestive system as the main types of adverse reactions/events, incidence of children and adults were 4.6% [0.021 1; 0.097 7] and 6.9% [0.053 5; 0.089 8], respectively. Adverse reactions to skin and mucous membrane damage as the main performance/event type, the observation time > 7 days and ≤ 7 days incidence of 3% [0.012 9; 0.068 3] and 1.9% [0.007 8; 0.046 1], respectively. Subgroup analysis showed that different types of adverse reactions, combination in the incidence of adverse reactions/events were higher than that of single drug, the difference was statistically significant (P < 0.05). This study suggested the influence factors of adverse reactions occur, and clinical rational drug use, such as combination, age and other fators, and the influence factors vary in different populations. Therefore, clinical doctors for children and the elderly use special care was required for a clear and open spirit injection, the implementation of individualized medication.
Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Incidence ; Infant ; Infant, Newborn ; Injections ; Male ; Middle Aged

From the hospital information system (HIS) of 20 national grade III-A general hospitals, 2 960 cases of herpes zoster as the research object, analyzes the relations between the general information, syndrome of traditional Chinese medicine (TCM), western medicine combined diseases, the relationship between the solar term and the incidence of herpes zoster, and the combined use of Chinese and western medicine. Among the patients with 46-65 year old has the highest percentage of diseased; admission to general outpatient clinic is the most; the most common medical payment is medicare; combined disease such as hypertension, diabetes and coronary heart disease is more common; early treatment effect of herpes zoster is better than the sequelae; summer and autumn solar term patients is hospitalized more, TCM syndrome is damp heat of liver fire; about drugs, western medicine is the most commonly used vitamin B1 and mecobalamin, traditional Chinese medicine is the most frequently used Danhong injection, combination therapy with promoting blood circulation drugs and neurotrophic drugs. Thus, herpes zoster, more common in elderly patients, with no obvious relationship between solar term, should be early diagnosis and early treatment, often with combination of Chinese traditional and western medicine treatment.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Herpes Zoster ; diagnosis ; drug therapy ; epidemiology ; Humans ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Thiamine ; therapeutic use ; Vitamin B 12 ; analogs & derivatives ; therapeutic use ; Young Adult

Objective To analyze the medical service pricing policy of 30 provinces and autonomous regions in China and recommend on problems and challenges, for reference of medical service pricing reform in the future.Methods Literature review and policy analysis were used for summary and performance appraisal of medical service pricing of China.Results Most of the areas surveyed followed the step-by-step approach to gradually adjust pricing, while a few areas completed it in a one-time adjustment manner.2015 witnessed most areas, up to 20 (66.67%), in price adjustment;their price adjustments focused on price reduction of large-scale medical equipment inspection fees and some medical tests.On the other hand, prices of diagnosis, nursing care, and treatment which are labor-intensive were increased.Conclusions Specifications of medical services are improving, yet there exist great gaps in the convergence of medical insurance.It is advisable to expedite the convergence of the new version specifications, to achieve value regression and dynamic price adjustment of medical services.

The paper is focused on the clinical applications of Tanreqing injection after listing, detecting and analyzing the related blood indicators of patients with allergic reactions based on prospective, multi-center, large sample, registration-type clinical safety monitoring nested case-control study (NCCS) to explore the possible mechanisms of allergic reaction of Tanreqing injection, 3 006 patients cases used with Tanreqing injection were monitored, including 3 cases of adverse reactions and 2 cases of allergic reactions. Each patient of allergic reactions, according to the ratio of 1:4 matches four cases of not adverse reactions as a control group of patients, while 5 healthy and 5 cases of volunteers into the healthy group. We examined the correlation detection of cases of allergic reactions among groups such as T-IgE, IgA, IgG, C3, C4, IFN-g, IL-2, IL-4, IL-6, IL-10. Allergic reactions of Tanreqing injection may be mediated by IgE as type I based on existing research data. This results and conclusions will promote the justifiability and safety of clinical applications.
Adolescent ; Adult ; Case-Control Studies ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Hypersensitivity ; diagnosis ; metabolism ; Interleukin-10 ; metabolism ; Interleukin-2 ; metabolism ; Interleukin-4 ; metabolism ; Interleukin-6 ; metabolism ; Male ; Prospective Studies ; Young Adult

This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.
Drug Combinations ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Injections ; Product Surveillance, Postmarketing ; Prospective Studies

This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction (ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1,000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety.
Case-Control Studies ; Drug Hypersensitivity ; etiology ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Injections ; Product Surveillance, Postmarketing ; Prospective Studies

The paper is to evaluate the efficacy and safety of Shenmai injection for chronic heart failure, retrieving the Pubmed, CBM, CNKI, Wanfang database and VIP database to comprehensively collect all types research report of Shenmai injection for chronic heart failure (CHF). Particularly wishing to point out, randomized controlled trials are include for the evaluation of effectiveness, which are statistically analyzed and evaluated by Rev-Man 5. 2. The current studies show that the improvement rate of NYHA classification of cardiac function of CHF patients and their related indexes figure such as LVEF, SV, CO, BNP, 6 min walking test value are all improved by the combination of Shenmai injection and foundation treatment. However, HR is almost no improvement. Meanwhile, serious ADR/AE of Shenmai injection for CHF isn't appear.
Drug Combinations ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Heart Failure ; drug therapy ; Humans

The two-dimensional model of cell culture is an important method in the study of testicular development and spermatogenesis but can not effectively mimic and regulate the testicular microenvironment and the whole process of spermatogenesis due to the lack of relevant cell factors and the disruption of a three-dimensional spatial structure. In the past 20 years, the development and optimization of the in vitro model such as testis organotypic culture and in vivo model such as testis transplantation achieved a transformation from two- to three-dimension. The maintenance and optimization of the testicular niche structure could mimic the testicular microenvironment and cell types including Leydig, Sertoli and germ cells, which showed similar biological behaviors to those in vivo. Besides, the cell suspension or tissue fragment floats in the gas-liquid interface so that the development of somatic and germ cells is well maintained in vitro whilst the feedback linkage between grafted testis tissue and hypothalamus-pituitary of the host rebuilt in the in vitro model provides an endocrinological basis for spermatogenesis, which serves as an effective methodology to better understand the organogenesis and development of the testis as well as testicular function regulation, advancing the concept of treatment of male infertility. Al- though each of the methods may have its limitations, the progress in the processing, freezing, thawing, and transplantation of cells and tissues will surely promote their clinical application and present their value in translational medicine.
Cell Culture Techniques ; Germ Cells ; physiology ; Humans ; Infertility, Male ; therapy ; Male ; Spermatogenesis ; physiology ; Testis ; growth & development

Objective:To explore the predictive value of a scoring model based on MRI images for diagnosing invasive placenta accreta and associated adverse clinical outcomes.Methods:This retrospective cohort study involved 260 patients delivered at Peking University Third Hospital from January 2015 to December 2018, who were suspected to be placenta accreta with two or more ultrasound image findings and underwent MRI examination. Placenta accreta was finally diagnosed and classified based on the intraoperative clinical findings or pathological examination. Adverse clinical outcomes were defined as intraoperative bleeding ≥1 500 ml and/or having hysterectomy. Quantitative and qualitative interpretation of five MRI signs were performed, including intraplacental low-intensity band on T2 weighted imaging, abnormal intraplacental vascularization, vascularization of uterovesical interface, uterine bulging and cervical involvement. Chi-square and t test were used for univariate analysis of the five MRI signs and the receiver operating characteristics (ROC) curve of each MRI sign for predicting invasive placenta accreta and adverse clinical outcomes were drawn. The predictive value was assigned as 1 when ≥ the cutoffs that matched to the maximum Yoden index values, and was assigned as 0 when below the cutoffs. A scoring model based on the five MRI signs was established, ROC curves of the model for predicting invasive placenta accreta and adverse clinical outcomes were drawn and the area under the curve (AUC), sensitivity, specificity and Youden index were calculated. Results:(1) Univariate analysis showed that all five MRI signs were significantly associated with invasive placenta accreta and adverse clinical outcomes. Except for cervical involvement, the other four signs had an AUC value of greater than 0.5 in predicting invasive placenta accreta and adverse clinical outcomes. (2) The predictive cut-off values of abnormal intraplacental vascularization image and intraplacental dark band area on T2 weighted imaging were 2.0 cm 2 and 0.6 cm 2, respectively, and were all 1.0 for the other three signs. The AUC value of MRI signs-based scoring model for predicting invasive placenta accreta was 0.863. When the score was ≥ 2 points, the diagnostic sensitivity was 0.836 and the specificity was 0.726. The scoring model predicted adverse clinical outcomes with an AUC of 0.841. When the score was ≥3 points, the predictive sensitivity was 0.707 and the specificity was 0.818. Conclusions:The scoring model based on MRI signs is of good value for the diagnosis of invasive placenta accreta and the prediction of adverse clinical outcomes.