OBJECTIVE: To compare the yield of cinnaldehydum from Cinnamomum cassia by TCM decoction machine or stainless steel pot at different decoction time, and to determine the appropriate decoction method of C. cassia. METHODS: The content of cinnaldehydum from C. cassia was determined by HPLC. T-test of data and results was conducted. RESULTS: At different decocting time, the yield of cinnaldehydum from C. cassia by TCM extraction machine was higher than by stainless steel pans (P

OBJECTIVE: To investigate the correlation of bone mineral density changes with vertebral deformation and clinical manifestations in patients with cervical spondylotic myelopathy.METHODS: A total of 42 cervical spondylotic myelopathy patients who received treatment at the Department of Sports Medicine,First Affiliated Hospital of Anhui Medical University from January to June 2009 were selected and randomly divided into the normal (n=20) and lower bone density (n=22) groups. The cervical lateral of the C_(3-8) spinal canal, sagittal diameter of vertebral body ratio, vertebral body deformation index in all cases was measured, and the clinical manifestations between two groups were compared.RESULTS: The cervical (C_3, C_4, C_5, C_6) sagittal diameter of vertebral body ratios of lower bone density group were significantly decreased than those of the normal group (P ＜ 0.05, or P ＜ 0.01), and the cervical (C_3, C_4, C_5, C_6)vertebral body deformation indexes of the two groups showed no significant difference (P ＞ 0.05); While the clinical manifestations (symptoms and physical signs) was significantly greater in the lower bone density group than the normal group (P ＜ 0.05).CONCLUSION: Cervical myelopathy can cause osteoporosis in patients with vertebral bone hyperplasia, spinal stenosis, in particular, the clinical manifestations are more obviously in lower bone density patients.

OBJECTIVE:To study the lifespan effect of ethyl acetate extract from Polygonum multiflora(EPM)on caenorhab-ditis elegans,and to investigate its anti-aging effect. METHODS:EPM low-concentration,medium-concentration and high- concen-tration groups(25,37.5,50 mg/L,calculated by crude drug)and blank group(0 mg/L)were established to investigate the effects of EPM on the lifespan of caenorhabditis elegans. EPM group(37.5 mg/L)and blank group(0 mg/L)were established to perform re-productive test,acute heat stress test and acute oxidative stress test of caenorhabditis elegans. The effects of EPM on reproductive capacity and pressure stress of caenorhabditis elegans were investigated. RESULTS:The lifespan test,average lifespan of cae-norhabditis elegans in EPM low-concentration,medium-concentration and high-concentration groups were prolonged significantly, compared to blank group(P<0.05 or P<0.01),especially in EPM medium-concentration group. In reproductive test,the number of offspring of caenorhabditis elegans in EPM group on the second and third day were increased significantly,compared to blank group (P<0.05). In acute heat stress test and acute oxidative stress test,average survival time of caenorhabditis elegans in EPM group was prolonged significantly(P<0.05). CONCLUSIONS:37.5 mg/L EPM can retard the aging process of caenorhabditis ele-gans and doesn’t damage the reproductive capacity.

OBJECTIVETo study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection.

METHODSet down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis.

RESULTStudy the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions.

CONCLUSIONThe central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

OBJECTIVETo study Danhong injection adverse reactions (ADR) incidence, nature and clinical performance, provide the basis for the clinical safety of drugs.

METHODMulti-center, a large sample of hospitals focused on monitoring method.

RESULTDanhong injection ADR for the rapid onset and ease the quick recovery, the rate was 0. 682% , the newly discovered ADR constipation, sweating, tinnitus, irritability, joint disease, erythema, venous pain, phlebitis, local numbness, pain, weakness, gastrointestinal ulcer bleeding, vasospasm, cyanosis.

CONCLUSIONDanhong injection adverse reactions are type A adverse reactions occasionally, centralized monitoring of hospital medicine injection method is to carry out post-marketing safety re-evaluation of appropriate methods.

OBJECTIVE: To provide reference for strengthening safe use and supervision of set prescription preparations containing toxic decoction pieces [called "Chinese patent medicine (CPM) containing toxicity" for short] in clinic. METHODS: The CPM containing toxicity in 2015 edition of Chinese Pharmacopoeia (part I) were summarized and analyzed to put forward the suggestion on improving safe use of them in clinic. RESULTS & CONCLUSIONS: A total of 474 CPM containing toxicity are included in 2015 edition of Chinese Pharmacopoeia (part I), accounting for 31. 75％ of set prescription preparations. There are 435 oral preparations (12 preparations both for oral and external use), 38 preparations for external use, one intramuscular injection, accounting for 91. 77％, 8. 02％, 0. 21％ of CPM containing toxicity, respectively. There are 318, 93, 32, 31 set prescription preparations containing 1, 2, 3 or more ingredients toxic decoction pieces, accounting for 67. 09％, 19. 62％, 6. 75％, 6. 54％, respectively. At present, basic research on CPM containing toxicity is weak; the information of the instructions is not perfect; guidance for clinical drug use is absent. It is suggested to strengthen basic research on CPM containing toxicity, develop drug use study among special population, improve rational use of Chinese patent medicine and strengthen post-marketing safety reevaluation so as to guarantee the safety of CPM containing toxicity use in clinic.

Objective To study the effects of Danggui-Chuanxiong herb pair medicine on vasoactive substances,adhesion factors,inflammatory factors,and VEGF-PI3K-AKT/NF-κB signaling pathways,in order to elucidate the mechanism of Danggui-Chuanxiong herb pair on the treatment of ischemic stroke(IS).Methods The oxygen glucose deprivation/reoxygenation(OGD/R)model of human umbilical vein endothelial cells(HUVEC)was constructed,and the cell viability was detected by cell proliferation kit(CCK-8 method)to explore the optimal modeling time of seven components;The release of lactate dehydrogenase(LDH)was detected by cytotoxicity kit;The expression of related cytokines was detected by enzyme-linked immunosorbent assay(ELISA);The mRNA expression of key proteins in the signaling pathway was detected by reverse transcription-polymerase chain reaction(RT-PCR).Results Reoxygenation after 6 h of oxygen-glucose deprivation of HUVEC is the best modeling time.High-dose chlorogenic acid group,ferulic acid group,senkyunolide H,low-dose and medium-dose butylidenephthalide group,medium-dose and high-dose senkyunolide A and ligustilide groups significantly decreased LDH leakage rate(P<0.05,P<0.01);The expression of IL-6 in the cells of the partial dose group of chlorogenic acid,caffeic acid,butenylphthalide,senkyunolide H and senkyunolide A was significantly increased,the expression of IL-1 in the cells of the partial dose group of chlorogenic acid,ferulic acid and senkyunolide A was significantly decreased,the expression of VEGF,ICAM-1 and VCAM-1 in the cells of the partial dose group of chlorogenic acid,ferulic acid and senkyunolide H was significantly decreased,the expression of NF-κB in the cells of the partial dose group of chlorogenic acid,ferulic acid,senkyunolide H and ligustilide was significantly decreased,the expression of PAI-1 in the cells of ferulic acid and senkyunolide H partial dose group decreased significantly(P<0.05,P<0.01);The mRNA relative expression levels of ERK,VEGF,NF-κB,VEGFR2 and MMP9 were significantly down-regulated in the cells of chlorogenic acid,ferulic acid,caffeic acid,butylidenephthalide and senkyunolide A partial dose group,while the mRNA relative expression levels of AKT were significantly up-regulated in the cells of senkyunolide H and senkyunolide A partial dose groups(P<0.05,P<0.01).Conclusion The medicinal components of Danggui-Chuanxiong herb pair may play a role in IS by inhibiting the mRNA expression of adhesion factor,inflammatory factor and key protein of VEGF-PI3K-AKT/NF-κB signaling pathway in HUVEC.

Objective In observational studies or non-randomized design,the researchers' ability to make causal inferences from data was hampered by confounding factors.This study used this method to analyze a group of observational medical data in order to instruct relevant medical personnel to carry out their own causal inference studies.Methods At present,the four main types of propensity scoring methods:matching,stratification,inverse probability weighting and covariate adjustment have been widely used in the study of causal inference.Propensity score method can theoretically eliminate the bias of the observable confounding factors,so that the treatments variables are close to the result of random assignment design,thus,it is estimated that the treatment factor has a causal effect on the outcome.Results Considering the advantages of the inverse probability weighting method over other methods,this paper summarizes the applicable conditions for the estimate of causal effect,particularly illustrates the use of a modern nonparametric statistical technology--Generalized Boosted Models (GBM) and its advantages and disadvantages.Conclusion When there is a lot of different types of confounding factors,and uncertain functional forms for their associations with treatment selection in linear,non-linear or interaction effect,and other issues,GBM propensity score weighting method can overcome the obstacles in the process of accurately estimating propensity score.

The main constituents of a typical medicinal herb,Polygonum muMflorum (Heshouwu in Chinese),that induces idiosyncratic liver injury remain unclear.Our previous work has shown that cotreatment with a nontoxic dose of lipopolysaccharide (LPS) and therapeutic dose of Heshouwu can induce liver injury in rats,whereas the solo treatment cannot induce observable injury.In the present work,using the constituent "knock-out" and "knock-in" strategy,we found that the ethyl acetate (EA) extract of Heshouwu displayed comparable idiosyncratic hepatotoxicity to the whole extract in LPS-treated rats.Results indicated a significant elevation of plasma alanine aminotransferase,aspartate aminotransferase,and liver histologic changes,whereas other separated fractions failed to induce liver injury.The mixture of EA extract with other separated fractions induced comparable idiosyncratic hepatotoxicity to the whole extract in LPS-treated rats.Chemical analysis further revealed that 2,3,5,4'-tetrahydroxy trans-stilbene-2-O-β-glucoside (trans-SG) and its cis-isomer were the two major compounds in EA extract.Furthermore,the isolated cis-,and not its trans-isomer,displayed comparable idiosyncratic hepatotoxicity to EA extract in LPS-treated rats.Higher contents of cis-SG were detected in Heshouwu liquor or preparations from actual liver intoxication patients associated with Heshouwu compared with general collected samples.In addition,plasma metabolomics analysis showed that cis-SG-disturbing enriched pathways remarkably differed from trans-SG ones in LPS-treated rats.All these results suggested that cis-SG was closely associated with the idiosyncratic hepatotoxicity of Heshouwu.Considering that the cis-trans isomerization of transSG was mediated by ultraviolet light or sunlight,our findings serve as reference for controlling photoisomerization in drug discovery and for the clinical use of Heshouwu and stilbene-related medications.

ObjectiveTo evaluate the clinical safety of Naoxintong （NXT） capsules after marketing， find out the potential risk factors of the drug as soon as possible， and reveal the incidence， nature， and clinical manifestations of the adverse events （ADE） and adverse reactions （ADR） of NXT capsules， so as to provide a basis for safe use of the drug in clinical practice. MethodA prospective， large-sample， multi-center observational cohort study was conducted to monitor all the 7 345 inpatients and outpatients orally taking NXT in 14 hospitals in China from January to December in 2018， with at least one follow-up. The demographic characteristics， disease type， NXT medication， ADR occurrence， characteristics， and prognosis of the patients were collected. SPSS 23.0 was used for single-factor and multivariate logistic regression to predict the influencing factors of ADR. ResultThe male and female patients accounted for similar proportions. There were 5 081 patients （79.40%） aged ≥60 years and 3 153 patients （49.27%） with body mass index （BMI） exceeding the normal standard. There were 344 （5.38%） patients with a history of allergy to medicines and food， 9 （0.14%） patients with a family history of allergy， and 52 （0.81%） patients with a history of allergic diseases. The ADRs associated with NXT occurred in 22 patients， with the incidence of 0.34%. The clinical manifestations of ADR appeared in 31 cases， involving 10 organs/systems， of which gastrointestinal system damage was the most common （17， 54.84%）. All ADRs were mild or moderate. Most ADRs （19， 86.36%） occurred within 4 weeks after administration. The patients with alleviated NXT-associated ADRs accounted for 81.82%. No indicators related to significant increases in ADR risks were found. ConclusionNXT is well tolerated in the general population. The hospital centralized monitoring for the clinical safety of oral Chinese patent drugs based on HIS data and Web tracking and follow-up system is an essential means for the post-market research on the safety of drugs.