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Objective To investigate the effect and mechanism of pomalidomide(POM)on airway inflammation and mucus hypersecretion in rats with chronic obstructive pulmonary disease(COPD).Methods Thirty-six SD rats were randomly divided into control group,model group and POM group,with 12 in each group,half male and half female.The COPD model was established by smoke exposure combined with Klebsiella pneumoniae infection in model group and POM group.The rats in POM group were treated with POM(0.5 mg/kg,once a day for 1 week).The lung function,lung tissue pathology,the proportion of inflammatory cells in bronchoalveolar lavage fluid(BALF)and the levels of serum inflammatory factors tumor necrosis factor-α(TNF-α),interleukin(IL)-1β,IL-6 and IL-13 were observed and detected in each group.AB-PAS staining and immunohistochemistry were used to analyze the proliferation of goblet cells and the secretion of mucin(MUC)5AC and MUC5B in airway epithelium of rats.The expression levels of TNF-α receptor 1(TNFR1),IκB kinase(IKK),phosphorylated IKK(p-IKK)and P65 protein in lung tissue were detected by Western blotting.Results Compared with control group,model group showed significant decreased of tidal volume(TV),minute ventilation(MV),forced expiratory vital capacity(FVC),0.1s forced expiratory volume(FEV0.1)and 0.3 s forced expiratory volume(FEV0.3)(P<0.05),increased of the mean linear intercept(MLI)of the alveoli(P<0.01),decreased of the mean alveolar number(MAN)(P<0.01),increased of the proportion of neutrophils and lymphocytes in BALF sediment(P<0.05),and decreased of the proportion of macrophages in BALF sediment(P<0.01);increased of the levels of serum inflammatory factors TNF-α,IL-1β,IL-13 and IL-6(P<0.05),the proportion of goblet cells in airway epithelium(P<0.01),the secretion of MUC5AC and MUC5B in lung tissue(P<0.01),the content of TNFR1 and the ratio of p-IKK/IKK(P<0.01),the content of P65 in nucleus(P<0.01);and decreased of the content of P65 in cytoplasm(P<0.05).Compared with model group,after one week of POM treatment,POM group showed significant improved of the TV,MV,FVC,FEV0.1,FEV0.3,MLI and MAN of rats(P<0.05);decreased of the proportion of neutrophils and lymphocytes in BALF(P<0.05);increased of the proportion of macrophages(P<0.01);decreased of the levels of serum TNF-α,IL-1β,IL-6 and IL-13(P<0.05),the proportion of goblet cells in airway(P<0.01),the secretion of MUC5AC and MUC5B(P<0.01),and the expression of TNFR1,P-IKK and P65(nucleus)(P<0.05);and increased of the level of P65(cytoplasm)(P<0.01).Conclusions POM can improve airway inflammation and mucus hypersecretion in COPD rats,which may be achieved by inhibiting TNF-α/NF-κB signaling pathway.
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The basic constituent elements of ancient acupuncture prescriptions and moxibustion prescriptions for migraine and headache are extracted and summarized. The frequency and proportion of each element are counted and its characteristics are analyzed. The basic constituent elements of ancient acupuncture and moxibustion prescriptions includes five aspects: disease symptoms (main symptoms, concurrent symptoms, etiology and pathogenesis), disease type, acupuncture and moxibustion site (acupoint name, site name, meridian name), manipulation method (acupuncture method, reinforcing and reducing method, blood pricking method, moxibustion method) and curative effect. Acupuncture and moxibustion prescriptions are essential for recording the disease symptoms, while the acupuncture and moxibustion site and manipulation methods are the two core elements of ancient acupuncture and moxibustion prescriptions, which are also the premise to ensure that acupuncture and moxibustion prescriptions have good reference value.
Subject(s)
Humans , Moxibustion , Acupuncture Therapy , Meridians , Acupuncture Points , Headache/therapy , Migraine Disorders/therapyABSTRACT
In 2020, the prevalence of abnormal spinal curvature among 54 079 students in Shandong Province was 1.54%. The multivariate logistic regression model analysis showed that, compared with those in primary school, economically underdeveloped areas, and non-residential schools, students in middle and high schools, economically average areas, and residential schools had a higher risk of abnormal spinal curvature, with OR (95%CI) values of 2.029 (1.662-2.476), 2.746 (2.208-3.416), 2.237 (1.740-2.875) and 2.057 (1.705-2.483), respectively. Compared with those in economically underdeveloped areas, who were underweight, who had seat adjustments≤1 time per academic year, and who had physical education classes≤1 per week, students in economically developed areas, who were normal weight, overweight, and obese, who had seat adjustments≥2 times per academic year, and who had physical education classes 2-3 or≥4 per week, had a lower risk of abnormal spinal curvature, with OR (95%CI) values of 0.690 (0.521-0.915), 0.722 (0.546-0.955), 0.535 (0.389-0.735), 0.383 (0.274-0.535), 0.835 (0.711-0.980), 0.561 (0.474-0.663) and 0.491 (0.315-0.766), respectively.
Subject(s)
Humans , Risk Factors , Prevalence , Spinal Curvatures , Schools , StudentsABSTRACT
In 2020, the prevalence of abnormal spinal curvature among 54 079 students in Shandong Province was 1.54%. The multivariate logistic regression model analysis showed that, compared with those in primary school, economically underdeveloped areas, and non-residential schools, students in middle and high schools, economically average areas, and residential schools had a higher risk of abnormal spinal curvature, with OR (95%CI) values of 2.029 (1.662-2.476), 2.746 (2.208-3.416), 2.237 (1.740-2.875) and 2.057 (1.705-2.483), respectively. Compared with those in economically underdeveloped areas, who were underweight, who had seat adjustments≤1 time per academic year, and who had physical education classes≤1 per week, students in economically developed areas, who were normal weight, overweight, and obese, who had seat adjustments≥2 times per academic year, and who had physical education classes 2-3 or≥4 per week, had a lower risk of abnormal spinal curvature, with OR (95%CI) values of 0.690 (0.521-0.915), 0.722 (0.546-0.955), 0.535 (0.389-0.735), 0.383 (0.274-0.535), 0.835 (0.711-0.980), 0.561 (0.474-0.663) and 0.491 (0.315-0.766), respectively.
Subject(s)
Humans , Risk Factors , Prevalence , Spinal Curvatures , Schools , StudentsABSTRACT
The paper reviews systematically the main ancient medical books with the origin literature included on acupuncture prescription. It is found that the origin literature with acupuncture prescription in successive dynasties mainly focuses on Qin-Han and Jin-Yuan Dynasties. In Jin, Tang and Song Dynasties, as well as Ming and Qing Dynasties, the literature mainly records the experience of medical masters in the previous dynasties. By taking "headache" and "retention of urine" as examples, the origins on the literature of clinical acupuncture prescription are explored, the distribution rules and characteristics are summarized. Moreover, the evidences and evaluation method of quality grading were explored on the ancient books with the origin literature of acupuncture prescription involved.
Subject(s)
Acupuncture , Acupuncture Therapy , Books , China , History, Ancient , Medicine, Chinese Traditional , PrescriptionsABSTRACT
Objective:To observe clinical efficacy of Lung-toxin dispelling formula No.1 treating patients of corona virus disease 2019(COVID-19) type severe/type extremely severe, and summarize experiences of diagnosis and treatment. Method:Collected and analyzed clinical informations of patients of COVID-19 type severe/type extremely severe, treated with Lung-toxin dispelling formula No.1, who were hospitalized in central hospital in Zhumadian and the first affiliated hospital of Henan university of traditional Chinese medicine from 31st January to 27th February. Result:All patients had positive epidemiological history, major symptoms were fever, cough, tachypnea, weakness and sore heavy muscles, combined with bad appetite and diarrhea. The median age was 59, median time from onset to getting worse was 9 days, ground glass opacity, lamellar, nodular high density shadow were mostly displayed in both lungs, lesions progressedfaster. After treatment with Lung-toxin dispelling formula No.1 combined with western medicine, the median time of PCR-NAD-test from positive to negative was 16 days, the median hospitalization days were 20 days, all patients were cured and discharged. Conclusion:Lung-toxin dispelling formula No.1 had certain clinical efficiency in treating patients of COVID-19 type severe/type extremely severe, further large sample clinical verification is needed.
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To sort out and summarize the evaluationmethods on the efficacy by acupuncture and moxibustion in ancient literature. The evaluation methods by ancient medical experts could be divided into two categories: one is according to the change of patient's conditions before and after treatment, including the subjective symptoms, the information getting from the four examination methods in TCM; the other is according to the characteristics of different interventions. For example, evaluating acupuncture by the "arrival of
Subject(s)
Humans , Acupuncture , Acupuncture Points , Acupuncture Therapy/history , Bloodletting , History, Ancient , Medicine, Chinese Traditional , MoxibustionABSTRACT
OBJECTIVE@#To evaluate the effect of comprehensive therapy based on Chinese medicine (CM) patterns on self-efficacy and satisfaction with its effectiveness in patients with chronic obstructive pulmonary disease (COPD).@*METHODS@#A total of 216 patients were randomly divided into the trial group (n =108) and the control group (n=108) based on the stratified and block randomization design. Patients in the trial group were treated with conventional Western medicine combined with Bufei Jianpi Granules (), Bufei Yishen Granules (), and Yiqi Zishen Granules () according to the CM patterns respectively, and patients in the control group were treated with conventional Western medicine. The COPD Self-Efficacy Scale (CSES) and the Effectiveness Satisfaction Questionnaire for COPD (ESQ-COPD) were employed in a 6-month treatment and in further 6 month follow-up visit.@*RESULTS@#Among the 216 patients, 191 patients (97 in the trial group and 94 in the control group) fully completed the study. After 12-month treatment and follow-up, the mean scores of the trial group all continued to increase over time, which were significantly higher than those of the control group (P <0.05), and the improvement in the following trial group domain: negative affect domain (12.13%), intense emotional arousal domain (12.21%), physical exertion domain (11.72%), weather/environmental domain (13.77%), behavioral risk domain (7.67%) and total score (10.65%). The trial group also exhibited significantly higher mean scores in the ESQ-COPD (P <0.05) and the improvement in the following domain: capacity for life and work domain (30.59%), clinical symptoms domain (53.52%), effect of therapy domain (35.95%), convenience of therapy domain (35.54%), and whole effect domain (52.47%).@*CONCLUSIONS@#Bufei Jianpi Granules, Bufei Yishen Granules and Yiqi Zishen Granules can improve the self-efficacy and satisfaction of COPD patients.
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Objective To explore the role of P-glycoprotein(P-gp)on cellular uptake and metabolism in the transmembrane transport of quercitrin.Methods Caco-2 cell monolayer and P-gp inhibitor Cyclosporin A(CysA)were used in the study.Quercitrin, quercetin,isorhamnetin and tamarixetin were determined by LC-MS to study cellular uptake and metabolism of quercitrin on Caco-2 cells.Results Uptake of quercitrin by Caco-2 cells:in different concentration groups of quercitrin coincubating with and without Cy?sA,intracellular accumulation presented the following characteristics:the amount of quercitrin first rose,reached the peak in 60 min and then declined to a steady-state in 120 min.And meanwhile there were significant differences between the two different processing groups incubating with and without CysA(P<0.05);quercetin was detected in all groups(3.0,9.0 and 27.0 mg/L).But in the higher concentration groups incubating with and without CysA,the intracellular quercetin presented a characteristics similar to its original glycosides and showed a significant difference(P<0.05),while the other groups showed no concentration-and time-dependence.At the same time,isorhamnetin and tamarixetin were detected in two higher concentration groups incubating with and without CysA, which showed the trend similar to the original glycosides but no significant difference was obtained between the two processing groups(P>0.05).Isorhamnetin and tamarixetin were not detected in the low and middle concentration groups.Transmembrane transport:on the basal lateral of all groups,the content of the quercitrin in 150 min incubation time showed a trend of continuous rise,and there was no significant difference between the two processing groups.Quercetin,isorhamnetin and tamarixetin were not detected.Conclu?sion Intact quercitrin could be absorbed into the Caco-2 cells and transported across the Caco-2 cell monolayer,and suffered a series of further metabolism in the Caco-2 cells and the basal side of Caco-2 cell monolayer,leading to different characteristics between intra?cellular accumulation and transmembrane transport.P-gp reduces the transmembrane transport of quercitrin by its efflux function,but did not involved in quercitrin metabolism.
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<p><b>OBJECTIVE</b>To summarize and analyze neonatal screening results for congenital hypothyroidism (CH) in parts of Yunnan Province, China.</p><p><b>METHODS</b>A total of 236 218 newborns (121 463 males and 114 755 females) who were born in Zhaotong City, Qujing City, Lijiang City, and Diqing Tibetan Autonomous Prefecture of Yunnan Province, China, between July 2012 and April 2014 were screened for CH. The original blood smear was re-tested if the thyroid stimulating hormone (TSH) level in heel blood was ≥8 μIU/L in the initial screening. The newborns with positive TSH results were called back for further diagnosis by measuring blood TSH and free thyroxine (FT4) levels.</p><p><b>RESULTS</b>Among 236 218 newborns, the pass rate of blood smears, re-acquisition rate of unqualified blood smears, and recall rate of suspected cases were 96.67%, 81.75%, and 73.02%, respectively. Sixty-six cases of CH were confirmed, among which 36 were male infants and 30 were female infants (P>0.05). The incidence rate of CH was 1/3 579, which was significantly lower than the national average rate (1/2 034; P<0.01). The gestational age of CH newborns was mostly between 37 to 42 weeks, and only 3% were born at a gestational age of >42 weeks. Most of the CH newborns had normal birth weight. The CH newborns with a body length of <50 cm accounted for 32%.</p><p><b>CONCLUSIONS</b>The incidence of CH in Yunnan Province is lower than the national average. There are no specific clinical features in CH newborns. The neonatal screening in Yunnan Province needs further improvement.</p>
Subject(s)
Female , Humans , Infant, Newborn , Male , China , Epidemiology , Congenital Hypothyroidism , Blood , Epidemiology , Neonatal Screening , Thyrotropin , BloodABSTRACT
<p><b>OBJECTIVE</b>To develop and validate a specific patient reported outcome (PRO) for chronic obstructive pulmonary disease (COPD) patients (COPD-PRO) at a set of standardized procedures.</p><p><b>METHODS</b>Literature analysis, interview and group discussion were performed to draft an initial model of COPD-PRO. Thereafter, 65 clinicians and experts throughout China reviewed the draft scale. Then cognitive debriefing interviews with 40 patients were conducted to assess respondent comprehension of the scale. After that, the revised scale was validated through pre-testing and field-testing. Finally, the psychometric properties of the COPD-PRO were evaluated by indicators such as validity, reliability and responsiveness based on the data from 230 patients.</p><p><b>RESULTS</b>The COPD-PRO contained 17 items in 3 domains: amelioration of clinical symptoms, satisfaction of health condition and satisfaction of treatment effect. The Cronbach's α, Split-half coefficient and test-retest coefficient were 0.806, 0.744, 0.703, respectively; the correlation coefficients between domains and overall scale were 0.835-0.963; 5 factors were extracted according to the conceptual model. The differences of the scale scores before and after treatment were statistically significant (P=0.000).</p><p><b>CONCLUSIONS</b>The COPDPRO has good validity, reliability and responsiveness. The COPD-PRO could provide patients' response to the treatments and then evaluate the effect of treatment in a standardized way.</p>
Subject(s)
Female , Humans , Male , Middle Aged , Demography , Factor Analysis, Statistical , Medicine, Chinese Traditional , Patient Outcome Assessment , Psychometrics , Pulmonary Disease, Chronic Obstructive , Therapeutics , Reproducibility of Results , Surveys and Questionnaires , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>To investigate the clinical symptoms and features of interictal epileptiform discharges (IED) on electroencephalogram (EEG) in children with spastic hemiplegic cerebral palsy (CP) and to analyze the risk factors for IED.</p><p><b>METHODS</b>Eighty-three children with spastic hemiplegic CP were recruited, and their clinical data, results of video-electroencephalogram, imaging findings, and cognitive levels were collected. The influencing factors for IED were determined by multiple logistic regression analysis.</p><p><b>RESULTS</b>The incidence of epilepsy was 13% in children with spastic hemiplegic CP; 34% of these cases had IED. The incidence of epilepsy in children with IED (32%) was significantly higher than that in those without IED (4%) (P<0.01). The incidence of IED in children with complications and brain cortex impairment increased significantly (P<0.01). The incidence of IED varied significantly between patients with different cognitive levels (P<0.01). Brain cortex impairment (OR=11.521) and low cognitive level (OR=2.238)were risk factors for IED in children with spastic hemiplegic CP (P<0.05).</p><p><b>CONCLUSIONS</b>Spastic hemiplegic CP is often found with IED on EEG, and the incidence of epilepsy is higher in children with IED than in those without IED. Brain cortex impairment and low cognitive level have predictive values for IED in children with spastic hemiplegic CP.</p>
Subject(s)
Child , Child, Preschool , Female , Humans , Infant , Male , Cerebral Cortex , Cerebral Palsy , Electroencephalography , Epilepsy , Epidemiology , Hemiplegia , Incidence , Risk FactorsABSTRACT
ZHU Lian is the founder of international communication of acupuncture-moxibustion after establishment of New China. This article discussed ZHU Lian's great deal of pioneering work and historic contributions from the aspects of acupuncture-moxibustion treatments for foreign people, international training and communication, and the international influence of Xin Zhenjiu Xue. Our research showed that ZHU Lian's early work didn't only enlarge acupuncture's worldwide influence and spreading pace, especially in Soviet Union, India and Korea, but also accumulated precious experiences for each subject of Chinese medicine attending into international medical care and academic communication in the future.
Subject(s)
Humans , Acupuncture , Education , History , Acupuncture Therapy , History , Asia , China , Europe , History, 20th Century , Internationality , Moxibustion , History , MethodsABSTRACT
The research methods, such as philology of medicine history and comparison between tradition and modern and so on were adopted in this article to study the acupuncture-moxibustion development after western medicine spreading to the East in Japan and its main transition under the impact of western medicine. The results showed that from Meiji to Showa period, under the influence of western medicine, the transition of Japanese acupuncture-moxibustion mainly embodied in following three aspects, incuinng acupuncture works absorbing western medicine knowledge, applying experiment measures to explore acupuncture principle and launching acupuncture teaching in accordance with Europe and America academy educational pattern. The changes on acupuncture works, teaching materials and methods of researching and teaching have triggered the transition and transformation of Japanese acupuncture-moxibustion from tradition to modern.
Subject(s)
Humans , Acupuncture Therapy , History , History of Medicine , History, 19th Century , History, 20th Century , History, 21st Century , Japan , Medicine , Medicine in Literature , Moxibustion , HistoryABSTRACT
With new acupuncture and moxibustion as the study object, based on the basic composition of acupuncture-moxibustion theory, from 3 aspects of meridian-acupoint theory, acupuncture-moxibustion method theory and acupuncture-moxibustion treatment theory, under the background of western medicine, ZHU Lian's different opinions on theory and method of acupuncture and moxibustion were discussed. It was believed by ZHU Lian that the distribution of 14-meridians was approximately identical to that of nerves, so with modern neuroanatomy knowledge to understand the meaning of acupoint; the acupuncture function could be explained from the angle of neurophysiology. Clinical diagnosis and treatment method could be established by modern classification methods of diseases. ZHU Lian's cognition that was different from traditional theory and method of acupuncture and moxibustion was combined with updated physiology and anatomy knowledge at that time, and was involved with Pavlov's advanced nerve theory, so she firstly put forward the opinion that acupuncture therapy can't work without the involvement of cerebral cortex.
Subject(s)
Humans , Acupuncture Points , Acupuncture Therapy , History , Psychology , Books , History , China , History, 20th Century , History, 21st Century , Knowledge , Medicine , Moxibustion , History , PsychologyABSTRACT
<p><b>BACKGROUND</b>Chronic obstructive pulmonary disease (COPD) is a major public health problem worldwide. Pulmonary rehabilitation (PR) is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China.</p><p><b>METHODS AND DESIGN</b>A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline (month 0) and after the study period (month 3).</p><p><b>DISCUSSION</b>It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD.</p><p><b>TRIAL REGISTRATION</b>This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.</p>
Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Breathing Exercises , China , Lung , Pulmonary Disease, Chronic Obstructive , Psychology , Rehabilitation , Therapeutics , Research DesignABSTRACT
<p><b>OBJECTIVE</b>To evaluate the efficacy of Bufei Yishen Granule BFYSG) combined with Shufei Tie acupoint sticking therapy on quality of life of patients with stable chronic obstructive pulmonary disease (COPD).</p><p><b>METHODS</b>A multi-center, double-blinded, double-dummy and randomized controlled method was adopted in this trial. A total of 244 patients were randomly assigned to a trial group and a control group according to the random number, each with 122 patients; treatment allocation occurred when the participants met the inclusion criteria and signed the informed consent form. In the trial group, patients were treated with BFYSG combined with "Shufei Tie" acupoint sticking therapy and sustained-release theophylline dummy, and in the control group patients were treated with oral sustained-release theophylline and BFYSG dummy combined with "Shufei Tie" acupoint sticking therapy dummy. The therapeutic course for two groups was 4 months and the follow-up was 6 months. The frequency and duration of acute exacerbation calculated by adding up each frequency and duration of acute exacerbation in treatment and follow-up time respectively, the quality of life measured by the World Health Organization Quality of Life (WHOQOL)-BREF scale and adult COPD quality of life (COPD-QOL) scale were observed.</p><p><b>RESULTS</b>Among the 244 enrolled patients, 234 were screened for full analysis set (FAS); 221 were screened for per-protocol analysis set (PPS). After 4-month treatment and 6-month follow-up there were differences between the trial group and the control group in frequency of acute exacerbation (FAS: P=0.013; PPS: P=0.046); duration of acute exacerbation (FAS: P=0.005; PPS: P=0.006); scores of physiological, psychological and environment aspects of the WHOQOL-BREF questionnaire (FAS: P=0.002, P=0.006, P=0.000; PPS: P=0.00, P=0.001, P=0.000); scores of daily living ability, social activity, depression symptoms aspects of the COPD-QOL questionnaire (FAS: P=0.000, P=0.000, P=0.006; PPS: P=0.002, P=0.001, P=0.001).</p><p><b>CONCLUSION</b>BFYSG combined with acupoint sticking therapy could improve the quality of life of patients with stable COPD.</p>
Subject(s)
Adult , Aged , Female , Humans , Male , Acupuncture Points , Anxiety , Psychology , Combined Modality Therapy , Depression , Psychology , Disease Progression , Drugs, Chinese Herbal , Therapeutic Uses , Pulmonary Disease, Chronic Obstructive , Drug Therapy , Psychology , Quality of Life , Surveys and Questionnaires , Treatment OutcomeABSTRACT
The regulations on basic clinical use of parenterally administered Chinese medicine, issued jointly in 2008, by the ministry of health (MOH), China food and drug administration (SFDA) and the state administration of traditional Chinese medicine (SATCM). Integrating actual clinical practice, these presented doctors and nurses with detailed specifications for the safe use of parenterally administered Chinese medicine. The regulations emphasize the use of Chinese medicine pattern differentiation, use in strict accordance with instructions, and they prohibit use combined with other medicines. The emphasis of the regulations are practicality and operability, and provide meaningful guidance to doctors and nurses for the rational and safe use of parenterally administered Chinese medicine, to reduce adverse reactions/adverse events caused by improper use.
Subject(s)
Humans , China , Drug Therapy , Reference Standards , Drugs, Chinese Herbal , Reference Standards , Guidelines as Topic , Infusions, ParenteralABSTRACT
It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.
Subject(s)
Humans , China , Epidemiology , Drug Monitoring , Reference Standards , Drug-Related Side Effects and Adverse Reactions , Epidemiology , Drugs, Chinese Herbal , Reference Standards , Hospital Information Systems , Product Surveillance, Postmarketing , Methods , Reference StandardsABSTRACT
To obtain the optimal preparation technology of Fang-bing nasal inhalant from components of traditional Chinese medicine by central composite design, with an apparatus containing nasal inhalant that simulated the expiration and inspiration of nose, the dissolution in vitro of different optimized inhalant samples designed through central composite design were investigated. The accumulative release of linalool, borneol, menthol was detected with GC. Response surface methodology was used to optimize the conditions of preparation technology by establishing multiple linear regression and second-order quadratic models. Then, deviation was carried out through comparing the observed and predicted values. It was showed that the coefficient of correlation of second-order quadratic model was high. The related coefficient reached 0.999 3, 0.998 0, 0.944 9, separately. The optimum conditions of preparation technology were as following: 84.39% of alcohol concentration, the weight of starch 1.45 g and the weight of carmellose sodium (CMC-Na for short) 1.22 g. The deviations between observed and predicated values showed -0.36%, 1.52%, 2.40%, separately. In this experiment, the established model can describe the good relation between factors and indexes from preparation technology of Fang-bing nasal inhalant and the outcome of prediction is well. This optimal Fang-bing nasal inhalant was used to study its in vivo effect on model rats deprived from sleep and showed sedative and sleep aiding, which will bring an instruction on inhalants of components from traditional Chinese medicine.