Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.
China ; Clinical Trials as Topic ; standards ; Drug Evaluation ; Drug Therapy ; standards ; trends ; Drugs, Chinese Herbal ; standards ; therapeutic use ; Humans ; Quality Control ; Research

To investigate the relationship between gene p1 7 0 expression of human gastric carcino- ma tissues and histological types of the gastric carcinoma . 80 human gastric carcinoma tissues were taken from endoscopies and postoperations , and detected the p1 70 gene expression by peroxidase immuno- chemical stain method(Kit from US) . According to depth of yellow to brown stain on tumor cell mem- brane and/or cytoplasm ,if no colour stain indicated no p170 gene expression rif 70% stained 3+. The positive rate of p170 gene overexpression in gas- tric carcinoma tisaues by endoscopic . and postoperation were 66 % and 7 1% respectively. These histopathological types of gastric carcinomas with p 1 70 expression rate were 83% ( 5/6 ) in early carcino- mas ; 76% (26/34) in tubular adenocarcinomas ;64% (14/22) of undifferetiated adenocarcinomas ; 62% (5/ 8 ) in mucinous adenocarcinomas and 50% (2/4) in signet rign-form carcinomas. This study showed that p 1 70 gene overexpression gresented in human gastric carcinoma tissues and significantly in the group with metastatic lymph nodes. We considered that p 1 70 gene might be a new tumor marker for detection of gastric carcinoma.

Adult ; Female ; Health Knowledge, Attitudes, Practice ; Health Promotion ; Humans ; Lead ; Male ; Middle Aged ; Occupational Exposure ; prevention & control ; Occupational Health ; Occupational Health Services ; Stearates ; Young Adult

Administration, Inhalation ; Adrenal Cortex Hormones ; pharmacology ; Asthma ; drug therapy ; metabolism ; Child ; Child, Preschool ; Drug Interactions ; Drug-Related Side Effects and Adverse Reactions ; Female ; Humans ; Male ; Theophylline ; pharmacokinetics ; pharmacology ; Treatment Outcome

Objective:To investigate the expression of peripheral blood CD54,CD106,CD62p in patients with multi-infarct dementia.Methods:The levels of serum CD54,CD106,CD62P of 82 patients with multi-infarct dementia were measured with ELISA,and were compared with 23 normal controls.Results:The levels of serum CD54,CD106,CD62p in patients with multi-infarct dementia(CD54:469?76.33 ng/ml,CD106:1 103.3?98.96 ng/ml,CD62p:18.22?8.90 ng/ml) were higher than those in normal controls(CD54:196?45.91 ng/ml,CD106:601.0?76.30 ng/ml,CD62p:6.70?3.30 ng/ml). There were significant difference between the two groups.The levels of serum CD54,CD106,CD62p were positively correlated with the degree of dmentia.Conclusion:CD54,CD106,CD62p are closely related to the development of MID and play an important role in pathlogical procedure of cerebral damage after MID.The levels of CD54,CD106,CD62p in patients with MID implies the degree of their neurological function deficit scores and might be an important indicator to observe the changes of disease.

Objective To retrospectively analyze adverse drug reaction ( ADR ) of Yuxingcao ( Houttuyniae Herba ) preparations, thus provide reference for post-market re-evaluation of traditional Chinese medicine injections. Methods The ADR from Chinese ADR spontaneous reporting system database from 2006 to 2008 were analyzed by descriptive statistic method. Results A total of 2 282 reports on ADR induced by Yuxingcao preparations were concluded in this study, and 98.07% ADR of the total cases ( 2 238 case ) were due to vein injection. The main ADR were anaphylactic reactions which injure multiple systems and organs.The most frequent symptoms were respiratory system damage, such as expiratory dyspnea (with the incidence rate of 27.25%).Skin and mucous membrane were the secondly susceptible (with the incidence rate of 21.35%).The ratio of serious ADR in the total case was 13.50% (308 case), rate of allergic shock was 8.37% (191 case), and 22 cases were dead. Conclusion By strengthening the ADR reporting and monitoring, the risk of traditional Chinese medicine injection could be controlled.Safety re-evaluation should be performed to overall enhance safety, effectiveness and quality control of these kinds of medicine.

Objective To observe the clinical efficacy of surround electroacupuncture in relieving pain after operation for mixed hemorrhoids. Method Seventy-two patients with mixed hemorrhoids were randomized into a treatment group and a control group, 36 cases in each group. The two groups both received the corresponding interventions once in 15 min after the operation: the treatment group received electroacupuncture treatment, and the control group was only placed in a simulated environment of electroacupuncture but without receivimg any needling treatment. The pain intensity was evaluated by using Verbal Rating Scale (VRS), Wong-Baker Faces Pain Rating Scale, and Visual Analogue Scale (VAS) at 11 different time points after the treatment: once every 1 h in 8 h after the treatment, once at the first defecation, once respectively 24 h and 48 h after the treatment. The data were statistically analyzed afterwards. Result At 3 h and 4 h after the treatment and at the first defecation after the treatment, the VRS scores of the treatment group were significantly lower than that of the control group (P<0.05); respectively at 4 h, 5 h, 6 h, 7 h, and 8 h after the treatment and at the first defecation, the Wong-Baker scores of the treatment group were significantly lower than that of the control group (P<0.05); respectively at 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, and 8 h after the treatment, at the first defecation, as well as at 24 h after the treatment, the VAS scores of the treatment group were significantly lower than that of the control group (P<0.05); it indicates that the pain intensity of the treatment group should be lower than that of the control group at the above time points, and the analgesic effect in the treatment group lasts a longer time, running a lower risk of losing effectiveness compared to the control group (P<0.05). Conclusion Real-time acupuncture treatment after the operation is significantly effective in relieving pain after operation for hemorrhoids.

Objective To evaluate the clinical effect of acupuncture combined with estazolam for the treatment of primary insomnia with heart and spleen deficiency type. Methods Seventy qualified patients were randomized into treatment group and control group, 35 in each group. Both groups received oral use of estazolam before bed time for 6 continuous weeks, and acupuncture group was additionally given acupuncture for regulating governor vessel and tranquilizing spirit on acupoints of Baihui(GV20), Yintang(GV29), Shenting(GV25), Anmian (EX-HN22), Shenmen(H7), Sanyinjiao(SP6), 3 times a week and lasting for 6 continuous weeks. The sleep state of the patients was estimated according to Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS) and Athens Insomnia Scale(AIS) before treatment, on the third and the sixth week of treatment, and one month after the completion of treatment. Results (1) Five cases in the treatment group and 3 cases in the control group were dropped out for not completing the treatment timely. In the end , 30 cases in the treatment group and 32 cases in the control group finished the trial. (2) The total effective rate in the treatment group was up to 90.0%, and was 71.9% in control group, the difference being significant(P<0.01).(3) Compared to the control group, the scores of PSQI, ESS and AIS were much decreased in treatment group on the third and the sixth week of treatment , and one month after treatment(P<0 . 05 or P<0 . 01). Conclusion Acupuncture for regulating governor vessel and tranquilizing mind combined with oral use of estazolam exerts certain therapeutic effect for the treatment of heart and spleen deficiency type insomnia, and the effect was superior to that of estazolam alone.

AIM:To optimize total flavone of herba epimediumon microporosity osmotic pump tablets by boxbehnken design-response surface methodology. METHODS:Osmotic agent (lactose),dosage of plastificator (dibutyl phthalate),and coating weight gain were selected as key factors of influencing total flavone delivery. Total flavones cumulatiive yield in 12 h and fitting approximation was regarded as the response. Design Expert method useful for the modeling and analysis was to optimize the response. RESULTS:Response surface surface obtained repre-sented maximum one which conformed to the zero-order delivery rate equation. CONCLUSION:Optimal excipient formulation of total epimedium flavone microporosity osmotic pump tablet consists of 0. 18 g of lactose,0. 26 ratio of dibutyl phthalate to acetyl celulose and 7. 7% of coating weight gain.

Objective To systematically review the efficacy of hydromorphone hydrochloride injection for treatment of chronic pain.Methods Web of Science Proceedings and PubMed were searched for clinical trials involving the efficacy of hydromorphone for treatment of chronic pain, with no language or time limit.Evaluation indexes included visual analogue scale (VAS) score and the rate of pain control or relief.The studies were screened independently, and the data were extracted by two researchers.Meta-analysis was conducted using the Stata 10 software.Results Eleven studies involving 452 patients were included in our meta-analysis.VAS score was significantly decreased after treatment compared with that before treatment.For the patients with cancer pain, VAS score was significantly decreased after treatment with hydromorphone hydrochoride injection, and the rate of pain control or relief was increased when compared with the other opioid analgesics.Conclusion Hydromorphone hydrochloride injection can treat chronic pain, and it may provide better therapeutic effect than the other opioid analgesics for the patients with cancer pain.