AIMTo determine Danshensu in urine and study its pharmacokinetics in human.

METHODSA solid phase extraction-HPLC method was used for determination of Danshensu in urine of human. HPLC separation is performed on a Shim-pack CLC-ODS column (150 mm x 6.0 mm ID, 5 microns) with a mobile phase composed of acetonitrile -0.01 mol.L-1 KH2PO4 (adjusted to pH 2.8 with phosphoric acid). The flow rate was 1.0 mL.min-1 and the UV detector was set at 280 nm. The linear range of Danshensu was 0.2-50 mg.L-1 (r = 0.9999), and its limit of detection was 1.5 ng. The mean recovery was 99.4% (RSD = 2.9%).

RESULTSThe pharmacokinetics of Danshensu after p.o. administration of two kinds of pharmaceutical preparations containing Danshen (with 20 mg of Danshensu) were investigated in 6 healthy human volunteers by determining the Danshensu in urine samples. The elimination half lives (T1/2) of Danshensu after p.o. administration of compound granule preparation A and decoction of Danshen were (0.92 +/- 0.16) h and (0.94 +/- 0.21) h, respectively. Their excretions of Danshensu in urine were (6.2 +/- 2.8)% and (14 +/- 4)% of the dose in 8 hours, respectively.

CONCLUSIONUnder normal doses, Danshensu can be eliminated from kidney. There is no evident difference on elimination half lives of Danshensu after p.o. administration of the two doses, but the excretions of Danshensu by urine after p.o. administration of compound granule preparation A were lower than that of decoction of Danshen.

Adult ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; isolation & purification ; pharmacokinetics ; Humans ; Lactates ; pharmacokinetics ; urine ; Male ; Plants, Medicinal ; chemistry ; Salvia miltiorrhiza ; chemistry

To identify the structure of three related substances in potassium sodium dehydroandrographolide succinate (PSDS), an HPLC preparation method was used to separate the impurities. These main impurities were identified using LC-ESI/TOFMS, LC-ESI/MSn, NMR, UV and IR. One of the main impurities was a hydrolyzed and oxidized product of PSDS, which has not been reported previouely. The other two impurities were hydrolyzed products of PSDS after losing different succinic acids. The results indicate that PSDS can be easily hydrolyzed and oxidized. It should be stored at cool and dry places.
Andrographis ; chemistry ; Antiviral Agents ; chemistry ; isolation & purification ; Chromatography, High Pressure Liquid ; Diterpenes ; chemistry ; isolation & purification ; Drug Contamination ; Drugs, Chinese Herbal ; chemistry ; isolation & purification ; Molecular Structure ; Plants, Medicinal ; chemistry ; Spectrometry, Mass, Electrospray Ionization ; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

Objective To evaluate the clinical efficacy and safety of memantine combined with olanzapine in treating Alzheimer's disease patients with behavioral and psychological symptoms of dementia (BPSD).Methods One hundred and seventy-six cases of Alzheimer's disease with BPSD were randomly divided into treatment group (n =87) and control group (n =89).The control group received oral administration of memantine 5-20 mg qd.The treatment group was given oral administration of olanzapine 2.5-10 mg qn on the basis of control group.The treatment course was two weeks.Both groups were treated for 6 courses.Clinical efficacy,neuropsychiatric inventory scale (NPI),activities of daily living (ADL) score,and the incidence of adverse drug reactions were compared between the two groups.Results After treatment,the total efficiency of the treatment group and the control group were 90.70％ (78/86 cases)and 75.29％ (64/85 cases) respectively,and the statistically significant difference was shown between the two groups (P＜0.01).Before treatment and at week 2,4,8,12,NPI-1 in the treatment group and were(25.18 ±4.17) (23.02 ± 3.98),(20.51 ± 3.65),(17.85 ± 3.08),(16.56 ± 2.95);NPI-2 were (46.86 ± 4.65) (45.78 ± 4.62),(43.53 ± 4.24),(40.53 ± 4.31),(38.91 ± 4.27);ADL were (44.34 ± 4.59),(44.25 ± 4.53) (42.85 ±4.01),(40.30 ± 3.98),(39.21 ± 3.48).NPI-1 in the control group were(25.27 ±4.23) (24.67 ±4.12),(23.68 ± 3.98),(21.36 ± 3.57),(19.92 ± 3.24);NPI-2 were (46.56 ± 4.72) (46.31 ± 4.51),(45.82 ± 4.42),(43.21 ± 4.37),(42.74 ± 4.33);ADL were (43.62 ± 4.61),(43.36 ± 4.49) (43.08 ±4.25),(42.18 ±4.31),(41.27 ±4.29).Statistical significant differences were found in NPI-1,NPI-2 and ADL between the two groups at week 2,4,8(P ＜0.01).The adverse drug reactions in the treatment group were hypersomnia,weight gain,dry mouth and constipation;and dizziness,sleeplessness,headache,nausea in the control group.The incidence of adverse drug reactions in treatment and control groups were 8.14％ (7/86 cases) and 7.06％ (6/85 cases),without statistically significant difference (P ＞ 0.05).Conclusion Memantine combined with olanzapine achieves better efficacy than memantine alone in treating patients with Alzheimer's disease and BPSD.

OBJECTIVETo understand HBV serotypes and genotypes epidemiology in a northern city and a southern city in China.

METHODSUsing polymerase chain reaction (PCR) and direct sequencing of HBV DNA PCR products, the serotypes and genotypes of HBV in 530 from HBsAg positive samples. The enrolled patients were from Harbin, a northern city and Lianjiang, a southern city in China.

RESULTSComparison of the serotypes and genotypes of HBV between Harbin and Lianjiang showed that adrq+ was the most predominant hepatitis B virus serotype in both Harbin and Lianjiang (87.2% and 73.5%,respectively), adw2 was the next (12.0% and 25.7%, respectively); genotype C was the most frequent in Harbin and Lianjiang (87.8% and 73.2%, respectively), and genotype B was the next (12.2% and 26.1%, respectively) only 1 patient was infected by genotype D, and 1 patient was found to be co-infected by genotype B and C in Lianjiang.

CONCLUSIONThe results suggest that the percentage of HBV serotypes and genotypes between Harbin and Lianjiang was significantly different (P less than 0.001), but the main HBV serotype and genotype of the two cities were similar.

China ; DNA, Viral ; genetics ; Genotype ; Hepatitis B Surface Antigens ; blood ; Hepatitis B virus ; classification ; genetics ; Humans ; Polymerase Chain Reaction ; Serotyping

Objective To explore the changes of functional connectivity of the prefrontal cortex in chronic heroin addicts under resting-state functional MRI (fMRI). Methods Resting fMRI examination was performed on 13 chronic heroin addicts and 14 healthy volunteers. After pre-processing the resting-state fMRI data, the prefrontal cortex was selected as the seed region, with which a whole-brain voxel temporal correlation in Iow frequency fMRI fluctuations was analyzed and the changes of functional connectivity of the prefrontal lobe in both chronic heroin addicts and healthy volunteers were calculated with SPM5 software. Results Compared with that in the control group, the functional connectivity between the left prefrontal cortex and the left hippocampus, right anterior cingulate, left middle frontal gyrus, right middle frontal gyrus, right precuneus in the heroin addiction group was significantly decreased. The functional connectivity between the right prefrontal cortex and the left orbital frontal cortex, left middle frontal gyrus in thc heroin addiction group was also significantly decreased as compared with that in the control group. Conclusion Functional connectivity of prefrontal cortex in chronic heroin addicts decreases, indicating that the prefrontal cortex may be involved in the maintenance of heroin addiction and relapse after withdrawal.

Objective To study the changes of amplitude of low-frequency fluctuation (ALFF) in blood oxygenation level dependent functional MRI (BOLD-fMPI) in non-lesional epilepsy (NLE),and discuss its underlying neurophysiological mechanism. Methods The BOLD-fMRI data of 16 patients with NLE and 15 normal volunteers were analyzed by ALFF. The amplitude of the blood oxygenation level dependent activation of the resting state brain was investigated. The brain structures showing increased and decreased ALFF in NLE patients were demonstrated by comparing to normal subjects with 2-sample t-test with threshold of P＜0.05. Results As compared with those in normal subjects,the regions showing increased ALFF in NLE patients were distributed in the right temporal lobe (Montreal Neurological Institute [MNI] coordinates:x=15,y=90,z=21),medial frontal lobe (MNI coordinates:0,24,-24),ventral anterior cingulated (MNI coordinates:-12,30,27) and right cerebellar hemisphere (MNI coordinates:-51,-57,-4); while the regions showing decreased ALFF covered the areas of the left cerebellar hemisphere (MNI coordinates:-48,-15,39),posterior cingulum gyrus (MNI coordinates:60,-21,33) and precuneus (MNI coordinates:-6,-54,66). Conclusion NLE patients show abnormal brain functional organization in resting state; the increased ALFF is considered to be the facilitation such as epileptic activity generation and propagation,while the decreased ALFF might be considered as the functional inhibition in these regions.

Objective To apply a COMSOL-based finite element analysis method to investigating the electric field effects produced by the human lower limb musculoskeletal system under the synergistic effects of stress field and electromagnetic field.Methods Firstly,a 3D human body model was constructed by Maxon Cinema 4D R21 software,and then imported into COMSOL 6.1 software in STL format.Secondly,an electromagnetic field intervention and stress loading model for the left lower limb of the human body was designed and constructed,in which 15 Hz quasi-pulse group current signals were used for electromagnetic field excitation and the stress field was realized by applying a vibration load with an average compressive force of about 90 N/cm2 to the left foot of the human body.Finally,the electromagnetic properties of human tissue were simulated by numerical simulation,and then the effects of stress field or elecromagnetic field or combined stress field and electromagnetic field on human bioelectric field were compared.Results Simulation results showed that the electric field intensity peaked at the leg joints under both electromagnetic and stress fields acting alone or synergistically,the bioelectric field intensity generated by the human body was related to the distance from the exogenous excitation loading location,and the electric field generated under synergistic action was equivalent to the linear superposition of the bioelectric field in the tissue induced by the electromagnetic field and the stress field acting alone.Conclusion Data supplement is provided for predicting bioelectric field changes within the musculoskeletal tissue,and theoretical foundation is laid for the development and application of multi-physics field synergistic intervention therapy for treating the disorders of the lower limb musculos-keletal system.[Chinese Medical Equipment Journal,2024,45(9):21-26]

OBJECTIVE: To study the association of different stages of histological chorioamnionitis (HCA) with the incidence rate and severity of respiratory distress syndrome (RDS) in preterm infants. METHODS: Related data were collected from the infants and their mothers who were treated in the Neonatal Intensive Care Unit of Qingdao Women and Children's Hospital, Qingdao University, from January 2018 to June 2020. According to the presence or absence of HCA and its stage, the infants were divided into four groups: control ( RESULTS: Compared with the control and late-stage HCA groups, the early-stage HCA group had a significantly lower incidence rate of placental abruption and a significantly higher rate of prenatal use of antibiotics ( CONCLUSIONS Early-, middle-, and late-stage HCA can reduce the incidence rate of RDS in preterm infants. HCA stage may not be correlated with RDS severity in preterm infants, which needs to be verified by further research.
Birth Weight ; Child ; Chorioamnionitis/epidemiology* ; Female ; Gestational Age ; Humans ; Infant ; Infant, Newborn ; Infant, Premature ; Pregnancy ; Respiratory Distress Syndrome, Newborn/etiology*

Applying Chinese medicine (CM) is an important strategy for malignant tumor treatment in China. One of the significant characteristics of CM is to treat diseases based on syndrome differentiation. For Western medicine, it is of important clinical significance to formulate guidelines for the diagnosis and treatment of cancer patients based on the characteristics of disease differentiation. In Chinese clinical practice, the combination of disease differentiation and syndrome differentiation is an important feature for cancer treatment in the past. Currently, molecular profiling and genomic analysis-based precision medicine optimizes the anticancer drug design and holds the greatest success in treating cancer patients. Therefore, we want to know which populations of cancer patients can benefit more from CM treatment if the theory of precision medicine is applied to CM clinical practice. So, we developed a novel diagnostic and therapeutic strategy "disease-syndrome differentiation-genomic profiling-prescriptions" for cancer patients by CM syndrome differentiation and precision medicine. As a result, this strategy has greatly enhanced the anti-tumor efficacy of CM and improved clinical outcomes for cancer patients with some gene mutations. Our idea will hopefully establish a novel approach for the inheritance and innovation of CM.
Antineoplastic Agents ; Drugs, Chinese Herbal/therapeutic use* ; Humans ; Medicine, Chinese Traditional ; Neoplasms/therapy* ; Precision Medicine ; Syndrome

Objective: To understand the current situation regarding pediatric off-label use of drugs recommendations in Chinese clinical practice guidelines and to make recommendations for standardized reporting format regarding off-label use of drugs for children. Methods: This cross-sectional study was carried out by systematically searching the databases for Chinese guideline consensus articles published in journals between 2018 and 2020 and extracting recommendations regarding off-label use of drugs from those articles. The essential characteristics of the included guidelines, the ranking of off-label drug types, the order of drug information, the type of off-label drug use, and the percentage of citation studies on which the recommendations were based were analyzed. Results: Among 108 studies that included Chinese off-label guidelines and consensus, 364 recommendations on pediatric off-label use of drugs were included. The Chinese Medical Association published the most, 48 out of the 108 studies (44.4%), and of those 14 studies (13.0%) were on infectious and parasitic diseases. Of the 364 recommendations on off-label use of drugs, the most commonly addressed drugs were 16 recommendations (4.4%) for cyclosporine A, 11 recommendations (3.0%) for methotrexate , and 11 recommendations (3.0%) for fentanyl. The most commonly addressed drug categories were as follows: 68 recommendations (18.6%) were immune system drugs, 66 recommendations (18.1%) were anti-infectives, and 56 recommendations (15.4%) were oncology drugs. The most commonly addressed drug information accounts were as follows: 364 recommendations (100.0%) were indications, 204 recommendations (56.0%) were dosages, and 198 recommendations (54.4%) were the route of administration. Based on the instructions approved by the Chinese Food and Drug Administration, the main forms of the off-label drug were as follows: 175 recommendations (48.1%) were unapproved indications, 127 recommendations (34.9%) were unapproved populations, and 72 recommendations (19.8%) were unapproved ages. Only 129 recommendations (35.4%) were cited, mainly including clinical guidelines (48 studies, 23.4%), reviews (22 studies, 10.7%), and pediatric randomized controlled trials (22 studies, 10.7%). Conclusions: Off-label use of drugs is commonly recommended in pediatric guidelines and consensus documents written by Chinese authors. However, the reporting of the recommendations varies widely, and the quality of the supporting evidence is poor.
Child ; China ; Consensus ; Cross-Sectional Studies ; Humans ; Off-Label Use ; Pharmaceutical Preparations