OBJECTIVE:To obverse the efficacy and safety of Liuwei dihuang pill combined with TCM prescription acupoint application in the treatment of type 2 diabetic constipation. METHODS:120 patients with type 2 diabetic constipation were random-ly divided into control group(60 cases)and observation group(60 cases). All patients received controlling blood pressure and regu-lating blood lipids drugs,diet control combined with exercise,and fixed dose of Metformin hydrochloride tablet(0.5 g/times,2 times a day)and Acarbose tablet(100 mg/times,3 times a day);based on it,control group received 5 mg Mosapride citrate tablet, 3 times a day;observation group additionally received 8 Liuwei dihuang pills(3 times a day)combined with TCM prescription acu-point application (in double Tianshu Point,double Yongquan point,double Shenque Point and double Zusanli). 7 d was regarded as a treatment course,and it lasted 3 courses. Clinical efficacy,blood glucose [2 h postprandial glucose(2 h PG),blood glucose (FPG)],the clinical symptom indexes(defecation interval time,each defecation time,weekly defecation frequency)before and af-ter treatment,and the incidence of adverse reactions in 2 groups were observed. RESULTS:The total effective rate in observation group was significantly higher than in control group,and the difference was statistically significant (P<0.05). Before treatment, there were no significant differences in the 2 h PG,FPG,defecation interval time,each defecation time and weekly defecation fre-quency between 2 groups(P>0.05). After treatment,2 h PG and FPG in 2 groups were significantly lower than before,and obser-vation group was lower than control group;defecation interval time and each defecation time were significantly shorter than before, and observation group was shorter than control group;weekly defecation frequency was significantly higher than before,and obser-vation group was higher than control group,The differences were statistically significant (P<0.05). During treatment,6 patients showed adverse reactions in control group,and 5 in observation group,and there was no significant difference in the incidence of adverse reactions between 2 groups(P>0.05). CONCLUSIONS:Liuwei dihuang pill combined with TCM priscription acupoint ap-plication shows good efficacy in the treatment of type 2 diabetic constipation. It can effectively improve constipation,reduce defeca-tion interval time and each defecation time,increase weekly defecation frequency and have no influence on blood glucose control with small adverse reactions and high safety.

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

Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.
Biomedical Research ; Medicine, Chinese Traditional

There has been much difference between effectiveness and harm in evidence evaluation. Many evidence ranking or grading systems have been developed'by researchers in the world. However, no evidence ranking or grading systems are based on safety research reality. Those existing evidence ranking or grading systems are prone to evaluating effectiveness evidence not proper for harm evidence. It is necessary to develop a new system for harm evidence. We put forward to establishing the body of evidence for harm for postmarketing traditional Chinese medicine as required by our daily research work. We do hope such an ideal could be helpful and indicative for evidence evaluation for harm.
Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing

OBJECTIVETo Understand the characteristics of the common complications in the gastric malignant tumor inpatients in our country, the related traditional Chinese and western medicine combined usage.

METHODBy using the method of frequency analysis and correlation, analysis the diagnostic and Prescribing information in HIS database of 20 national first-class ternary general hospital inpatients.

RESULTThe most common coexistent disease are malignant tumor in other parts, benign tumor. The most common complications are serous cavity effusion, lung infection, abnormal liver function. In other parts malignant tumor, more than 50% with advanced gastric malignancy; in other parts benign tumor, 86.00% located in the digestive and Urinary system, in the complications, digestive system diseases accounted for 23.80%; further according to the association rules of data mining, and calculate the combination scheme of the most commonly used for acid suppression drugs in combination with the centralizer and eliminate pathogenic traditional Chinese medicine (TCM).

CONCLUSIONIn the real world, most of the gastric malignant tumor disorder crowd is in the advanced stage, with lymph nodes and other parts of the transfer; and at the same time to incorporate the spleen and kidney disease in TCM zang-fu organs dialectical, should notice the reach mark early intervention, achieve the purpose of cure not ill; acid suppression hemostatic drugs combined the centralizer and eliminate pathogenic the three medicine combined treatment of Chinese traditional medicine is relevant.

Asian Continental Ancestry Group ; Female ; Humans ; Inpatients ; Male ; Medicine, Chinese Traditional ; methods ; Stomach Neoplasms ; diagnosis ; drug therapy

This study aims to explore and analyze the condition of concurrent diseases and medicine use of traditional Chinese medicine (TCM) and western medicine among the patients with insomnia. One thousand and sxity seven cases of data from 20 national hospitals' hospital information system (HIS) databases were collected. The frequent concurrent diseases included hypertension (26.9%), brain blood supply insufficiency (24.93%), cerebral infarction (19.49%), blood lipoprotein disturbance (15.28%), coronary heart disease (14.15%), headache (10.68%), chronic gastritis (8.81%), type 2 diabetes mellitus (7.87%), depressive disorder (7.4%) and anxiety disorder (6.65%). The 10 most frequently-used western drugs included alprazolam (35.99%), aspirin (25.4%), olanzapine (24.18%), cinepazide (23.06%), flupentixol & melitracen (18.74%), zolpidem (18.37%), oxiracetam (15.65%), estazolam (15%), aniracetam (13.4%) and piracetam (13.31%). The 10 most frequently-used TCM included Shuxuening injection (16.4%), Shuxuetong injection (15.18%), extract of ginkgo biloba leaf (14.71%), gastrodin (12.46%), Dengzanxixin injection (11.34%), Xueshuantong (8.53%), Danhong injection (6.37%), compound liquorice tablet (5.81%), Sanqi Tongshu capsule (5.72%) and sowthistle-leaf ixeridium injection (5.34%). Among all combined uses, the most frequent western drug use was alprazolam and olanzapine, while combined use of hypnotic drug and Huoxuehuayu formula is the most frequent. This study concludes that the concurrent diseases mainly include cardio-cerebrovascular diseases, metabolic disorders and anxiety-depression disorders, with increasing tendency of diseases types by ages, especially for cardio-cerebrovascular diseases. The most frequently-used hypnotic is alprazolam in the insomnia patients, and it is worth being concerned about the off-label use of olanzapine as an antipsychotic for the treatment of insomnia However, due to the fact that all cases data are from the inpatients, these findings have some limitations.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Alprazolam ; therapeutic use ; Anti-Anxiety Agents ; therapeutic use ; Antipsychotic Agents ; therapeutic use ; Benzodiazepines ; therapeutic use ; Cerebral Infarction ; drug therapy ; epidemiology ; etiology ; Coronary Disease ; drug therapy ; epidemiology ; etiology ; Diabetes Mellitus, Type 2 ; drug therapy ; epidemiology ; etiology ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Headache ; drug therapy ; epidemiology ; etiology ; Humans ; Hypertension ; drug therapy ; epidemiology ; etiology ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Sleep Initiation and Maintenance Disorders ; complications ; drug therapy ; epidemiology ; Young Adult

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

To know the characteristics of Shuxuening injection used on cerebral infarction patients in clinical practice, 6 053 cases of Hospital information system (HIS) data from 20 hospitals were analyzed. Using the basic description method and association rules to analysis the data. By analysis the data we found that the average age of cerebral infarction patients who used Shuxuening injection is 67.96, 83.94% of patients were aged 46-80. The injection is administered intravenously,with most patients receiving a dosage of 15-20 mL per dose for between 1 and 14 days. It is always combined with aspirin (48.508%), cinepazide maleate injection (22.073%), atorvastatin calcium tablets (18.873%) in clinical practice. When it comes to two drug combinations, it always combined with cinepazide maleate injection and aspirin (8.178%), nicergoline capsules and aspirin (7.63%). Therefore, based on existing data, we give the conclusion that for the treatment of cerebral infarction Shuxuening injection is mainly used for older patients, and is often combination with similar pharmacological effects chemical drugs, which is complied with the guidelines. However, the wrong dose is still exist, doctors should realize the hiding risk.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anticoagulants ; therapeutic use ; Aspirin ; therapeutic use ; Atorvastatin Calcium ; Cerebral Infarction ; drug therapy ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Heptanoic Acids ; therapeutic use ; Humans ; Male ; Middle Aged ; Piperazines ; therapeutic use ; Pyrroles ; therapeutic use ; Young Adult

This research based on the analysis of spontaneous reporting system (SRS) data which the 9 601 case reports of Shuxuening injection adverse drug reactions (ADR) in national adverse drug reaction monitoring center during 2005-2012. Apply to the association rules to analysis of the relationship between Shuxuening injection's ADR and the characteristics of ADR reports were. We found that ADR commonly combination were "nausea + breath + chills + vomiting", "nausea + chills + vomiting + palpitations", and their confidence level were 100%. The ADR and the case reports information commonly combination were "itching, and glucose and sodium chloride Injection, and generally ADR report, and normal dosage", "palpitation, and glucose and sodium chloride injection, and normal dosage, and new report", "chills, and generally ADR report, and normal dosage, and 0.9% sodium chloride injection", and their confidence level were 100% too. The results showed that patients using Shuxuening injection occurred most of ADRs were systemic damage, skin and its accessories damage, digestive system damage, etc. And most of cases were generally and new reports, and patients with normal dosage. The ADR's occurred had little related with solvent. It is showed that the Shuxuening injection occurred of ADR mainly related to drug composition. So Shuxuening injection used in clinical need to closely observation, and focus on the ADR reaction, and to do a good job of drug risk management.
Adverse Drug Reaction Reporting Systems ; Drug-Related Side Effects and Adverse Reactions ; diagnosis ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Male

Objective To study the adjuvant effects of chitosan on Helicobacter pylori (H.pylori) vaccine.Methods A total of 20 adult mice were randomly divided into four groups.Mice in groups Ⅰ,Ⅱ,Ⅲ, and Ⅳ were orally immunized with PBS,H.pylori antigen alone,H.pylori antigen plus chitosan solution or H. pylori antigen plus chitosan particles,respectively.An ELISA was used to detect anti-H.pylori IgA in saliva and gastric mucosa ,interlukin(IL)-2,IL-4,IL-10 levels in gastric mucosa.Immunohistochemical method was used to detect secretory IgA in gastric mucosa.Results ①The levels of special anti-H.pylori IgA in saliva and gastric mucosa in the groups with chitosan as adjuvant were significantly higher than those in the group without adjuvants and control groups(P