Onset and Recurrence Characteristics of Chinese Patients with Noncardiogenic Ischemic Stroke in Chinese Medicine Hospital / 中国结合医学杂志

OBJECTIVE@#To delineate the onset and recurrence characteristics of noncardiogenic ischemic stroke patients in China.@*METHODS@#A prospective, multicenter and registry study was carried out in 2,558 patients at 7 representative clinical sub-centers during November 3, 2016 to February 17, 2019. A questionnaire was used to collect information of patients regarding CM syndromes and constitutions and associated risk factors. Additionally, stroke recurrence was defined as a primary outcome indicator.@*RESULTS@#A total of 327 (12.78 %) patients endured recurrence events, 1,681 (65.72%) were men, and the average age was 63.33 ± 9.45 years. Totally 1,741 (68.06%) patients suffered first-ever ischemic stroke, 1,772 (69.27%) patients reported to have hypertension, and 1,640 (64.11%) of them reported dyslipidemia, 1,595 (62.35%) patients exhibited small-artery occlusion by The Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification. Specifically, 1,271 (49.69%) patients were considered as qi-deficient constitution, and 1,227 (47.97%) patients were determined as stagnant blood constitution. There were 1,303 (50.94%) patients diagnosed as blood stasis syndrome, 1,280 (50.04%) patients exhibited phlegm and dampness syndrome and 1,012 (39.56%) patients demonstrated qi deficiency syndrome. And 1,033 (40.38%) patients declared intracranial artery stenosis, and 478 (18.69%) patients reported carotid artery stenosis. The plaque in 1,508 (41.36%) patients were of mixed. Particularly, 41.09% of them demonstrated abnormal levels of glycated hemoglobin levels.@*CONCLUSIONS@#Recurrence in minor and small-artery stroke cannot be ignored. Hypertension, dyslipidemia, abnormal HbA1c, intracranial artery stenosis and carotid plaque were more common in stroke patients. Particularly, phlegm-dampness and blood stasis syndromes, as well as qi deficiency and blood stasis constitutions, were still the main manifestations of stroke. (Trial registration at ClinicalTrials.gov No. NCT03174535).

Clinical practice guideline for postmenopausal osteoporosis with traditional Chinese medicine / 中国中药杂志

The editorial group of the clinical practice guideline for postmenopausal osteoporosis(PMOP) with traditional Chinese medicine(TCM)(hereinafter referred to as "guideline") is composed of experts specialized in TCM orthopedics, TCM gynecology, clinical epidemiology, etc. The guideline was formulated through registration, collection and selection of clinical issues/outcome indicators, evidence retrieval and screening, preparation of systematic reviews, evaluation of evidence quality, formation of recommendations, drafting, and peer review. The syndromes and treatment of PMOP are elaborated in detail. Specifically, Liuwei Dihuang Pills and Zuogui Pills are recommended for PMOP with Yin deficiency in the liver and kidney, Qing'e Pills for PMOP with kidney deficiency and blood stasis, Yougui Pills and Jingui Shenqi Pills for PMOP with Yang deficiency in the spleen and kidney, and Er'xian Decoction for PMOP with Yin and Yang deficiency in the kidney. In addition, Duhuo Jisheng Decoction can be used to relieve pain. The commonly used Chinese patent medicines include Xianling Gubao Capsules, Qianggu Capsules, Jintiange Capsules, Gushukang Capsules, Hugu Capsules, Jinwu Gutong Capsules, and Guyuling Capsules. Acupuncture and moxibustion are also effective approaches for PMOP. The rehabilitation and daily management were carried out by exercise therapies such as Baduanjin(eight-section brocade), Wuqinxi(five-animal exercises), and Taijiquan(Tai Chi), Chinese medicine diet, health education, and fall prevention. The promotion and application of this guideline will facilitate the implementation of TCM prevention and treatment of PMOP, ensure the quality of life of PMOP patients, provide effective and safe TCM treatment measures for PMOP, and reduce the risk of fracture complications.

Post-marketing pharmaco-economics evaluation of Jinye Baidu Granules / 中国中药杂志

To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.

Expert consensus statement on Danshen Chuanxiongqin Injection in clinical practice / 中国中药杂志

Danshen Chuanxiongqin Injection is a commonly used medicine in cerebral infarction and coronary heart disease,which is recommended by many disease guidelines/consensus for cardiovascular and cerebrovascular diseases. However,there are irrational drug using in clinic,which affects the efficacy and brings safety risks. Based on clinical research evidence and expert experience,recommendations/consensus suggestion are determined through the nominal group method. The expert consensus recommends the indications,intervention time for treatment,route of drug administration,usage and dosage,course of treatment and introduces the safety in clinical application,which could provide reference for clinical use of Danshen Chuanxiongqin Injection.

Technical specifications for hospital-based intensive monitoring of post-marketing Chinese patent medicine / 中国中药杂志

In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.

Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica / 中国中药杂志

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions.

Study on mechanism of Drynariae Rhizoma in treating osteoporosis with integrative pharmacology perspective / 中国中药杂志

Drynariae Rhizoma has great significance in the clinical practice of osteoporosis treatment. Based on the perspective of integrative pharmacology, the study explored the mechanism of action of Drynariae Rhizoma in the treatment of osteoporosis. Six active components in Drynariae Rhizoma were obtained, mainly including glycosides and sterols. Taking the median of 2 times of "node connectivity" as the card value, the core node of the Chinese medicine target disease gene interaction network was selected. Based on this, three topological structural eigenvalues, such as "node connectivity" "node tightness" and "node connectivity" were calculated, thereby screening out four core targets of Drynariae Rhizoma treatment for osteoporosis, including thyroid parathyroid hormone 1 receptor (PTH1R), parathyroid hormone 2 receptor (PTH2R), calcitonin receptor gene (CALCR), and SPTBN1 gene (SPTBN1). Based on the gene ontology database GO and KEGG pathway database, the molecular function, intracellular localization, and biological reactions and pathways of proteins encoded by drug target genes were determined. Combined with enrichment calculation, it is predicted that osteoporosis may play a role in biosynthetic processes, such as circulatory system, nervous system, energy metabolism, prolactin signal pathway, GnRH signaling pathway, neurotrophic factor signaling pathway and other pathway. The conclusion of this study is certain with the existing research results, and the new target and new pathway could also be used as a theoretical basis for the further verification of osteoporosis.

Study design and implementation for population pharmacokinetics of Chinese medicine: An expert consensus / 中国结合医学杂志

Although many population pharmacokinetics (PPK) researches have been conducted on chemical drugs, few have been in the field of Chinese medicine (CM). Each ingredient in CMs possesses different pharmacokinetic characteristics, therefore, it is important to develop methods of PPK studies on them to identify the differences in CM drug safety and efficacy among the population subgroups and to conduct quantitative studies on the determinants of CM drug concentrations. To develop an expert consensus on study design and implementation for PPK of CM, in August 2013, 6 experts in the field of PPK, CMs pharmacology, and statistics discussed problems on the PPK research protocol of CMs, and a consensus was reached. The medicines with toxicity and narrow therapeutic windows and with wide range of target population or with frequent adverse reactions were selected. The compositions with definite therapeutic effects were selected as indices, and specific time points and sample sizes were designed according to standard PPK design methods. Target components were tested through various chromatography methods. Total quantity statistical moment analysis was used to estimate PPK parameters of each component and PPK models reflecting the trend of CMs (which assists in reasonable adjustments on clinical dosage). This consensus specifies the study design and implementation process of PPK. It provides guidance for the following: post-marketing clinical studies, in vivo investigations related to the metabolism in different populations, and development and clinical adjustment of dosages of CMs.

HIS-based analysis of clinical characteristics and combined treatment of Chinese and western medicine in diabetes deaths / 中国中药杂志

To understand the clinical characteristics and distribution of combined treatment of Chinese and western medicine in diabetes deaths, the hospitalization information of diabetes deaths from HIS system of 20 national 3A-grade general hospitals. Then the frequency statistics and association rules analysis were used to analyze the general information, complications, combined treatment, death time and other information of the patients died from diabetes. The results showed that most of the diabetes deaths were of middle aged and elderly people, more often in males than females. The complications with higher incidence included hypertension, pulmonary infection, coronary heart disease, cerebral infarction and renal inadequacy. In combined treatment rules, western medicines insulin, cefuroxime, furosemide, dopamine, nikethamide and sodium bicarbonate were used in combination at highest frequencies, followed by the combinations of traditional Chinese medicines panax notoginseng, radix bupleuri and western medicines, and the combinations between Chinese medicines had the lowest use frequency. Most of the diabetes deaths were of middle aged and elderly people, more often in males than females. They mainly died from 3 pm to 5 pm and from 5 pm to 7 pm. Therefore, the diabetes deaths often had complications of cardiovascular and cerebrovascular diseases, and early prevention shall be noted in clinics; the clinical treatment plan was basically in accordance with the guidelines for clinical treatment of diabetes; the drugs with promoting blood circulation to remove blood stasis and soothing liver-qi stagnation effects were the common Chinese medicines in treatment of diabetes.

Advantages of population pharmacokinetics and its application in the field of traditional Chinese medicine / 中国中药杂志

The accurate medical treatment is based on the information of the genome, which is the best treatment for the patients. Population pharmacokinetic study can be formulated according to the individual differences of patients to the dose, in the accurate medical model which has a unique advantage. At present, there are many problems such as adverse drug reaction in Chinese traditional medicine, and it is necessary to introduce a group of medicine on the basis of precise medical treatment. However, due to the different characteristics of traditional Chinese medicine and chemical medicine, it is necessary to combine the population pharmacokinetics, genetics and statistical methods to establish a research method which is in line with the characteristics of Chinese medicine. The key scientific problem is to make clear the active components of Chinese medicine metabolism of the drug metabolic enzyme gene, and pay attention to the analysis of the polymorphism of the overall role of drug metabolism enzymes in the human body. Clear key scientific issues and break through the bottleneck, so as to achieve the precise medical treatment, to international.

Construction and implementation of quality control index for clinical safety of Chinese medicine injection / 中国中药杂志

In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference.

Analysis of the allergic reaction types of Chinese medicine injection based on immunotoxicty / 中国中药杂志

The purpose of the study is to find the allergic reaction types and characteristics of Chinese medicine injection ( CMI). The authors monitored patients who used Shuxuetong injection, Dengzhan Xixin injection, Shenqi Fuzheng injection, Shenmai injection, Ciwujia injection, Shuxuening injection, Tanreqing injection, Reduning injection, a total of 150,000 cases were monitored. They used a nested case-control design to group the patients and obtained the serum samples from 14 allergic patients and 55 matched patients. They used enzyme-linked immunosorbent assay (ELISA) to detect serum C3, C4, IgE, IgG, MCT-P, and judge the allergic reaction types: Shuxuetong injection hypersensitivity (1 case), can not determine (1 case); Dengzhan Xixin injection hypersensitivity (1 case), hypersensitivity & anaphylactoid reaction (1 case), can not determine (1 case); Shenqi Fuzheng injection hypersensitivity (3 cases), can not determine (1 case); Shenmai injection anaphylactoid reaction (1 case); Ciwujia injection can not determine (1 case), Shuxuening injection can not determine (1 case), Tanreqing injection can not determine (1 case), Reduning injection can not determine (1 case). The results showed that the main type of allergic reaction of CMI was hypersensitivity, the type of allergic reaction was closely related to the varieties of CMI, the hypersensitivity and anaphylactoid reaction might occur in one patient at the same time which used Dengzhan Xixin injection.

Building safety evidence body of shuxuetong injection / 中国中药杂志

Evidence body is defined as an evidence complex incorporating the evidence obtained from various research methods and various resources. As one of common parenterally administered Chinese medicines, Shuxuetong's safety drew high concern from doctors. However, we only have grasped several but less systematic evidence on the safety of Shuxuetong. To build a safety evidence body of Shuxuetong injection. Review and evaluate the evidence related to the safety of Shuxuetong injection after accumulating, searching and classfying related literature. Accoeding to levels of evidence from high to low, the evidence related to the safety of Shuxuetong injection was classified as following: the evidence from a long-term, prospective, large-sample-size and intensive hospital monitoring study was the strongest; the evidence of hospital information system (HIS) data analysis; the evidence of spontaneous reporting system (SRS) data analysis; the evidence of adverse drugreactions (ADRs)/adverse drug events (ADEs) reported in systematic evaluation, ADRs case report, toxicological tests, pharmacological tests were weakest. Based on the evidence body, Shuxuetong Injection was proved to be safe, and its ADRs were mainly allergic reactions, and more often happened among the old patients.

Analysis of real-world use different treatment shuxuetong injection effects on liver and kidney function / 中国中药杂志

<p><b>OBJECTIVE</b>To understand the real world, the use of ultra- treatment Shuxuetong injection on liver and kidney functions are affected.</p><p><b>METHOD</b>The 18 hospitals of the country's HIS data sources from which to choose to use Shuxuetong injection, between the ages of 18 to 80 years, using Shuxuetong and the first seven days after discontinuation of at least 7 days has once aspartate aminotransferase or alanine aminotransferase, or creatinine or blood urea nitrogen were measured value as a research object, the number of days of medication is based on more than 14 days, divided into treatment group and the normal course of super-group to reach the normal range of physical and chemical indicators 200% of the upper limit is defined as abnormal. Using the propensity score method, balance the known confounding factors, differences in the occurrence of abnormal renal function and compared between the two groups.</p><p><b>RESULT</b>The treatment group and the normal course of super-group, resulting in alanine aminotransferase, aspartate aminotransferase, creatinine, urea nitrogen equally likely targets abnormal changes, no statistically significant difference.</p><p><b>CONCLUSION</b>Based on the available data did not find "super treatment using Shuxuetong damage the liver and kidney function" the situation, but the clinical disease lasts insist on the principle can not be arbitrarily extended treatment to prevent long-term medication.</p>

Shuxuetong injection-based on nested case-control study of blood through injection suspect allergic reaction influencing factors / 中国中药杂志

<p><b>OBJECTIVE</b>To understand the real world Shuxuetong injection suspicious allergic factors.</p><p><b>METHOD</b>National 18 hospitals of the hospital information system using Shuxuetong data, using design methods retrospective nested case-control, and contrast using Shuxuetong after the occurrence of allergic reactions in patients with non-allergic patients differences in age, gender, admission illness, allergies, etc.</p><p><b>RESULT</b>Based on available data, indicate suspicious allergies affect Shuxuetong factors may be hospitalized illness, solvent, single dose, concomitant medications.</p><p><b>CONCLUSION</b>When using Shuxuetong for critically ill patients should use caution and pay attention to solvents, dose, combination therapy of choice clinically. Conclusions of this study need further study to be verified.</p>

Analysis of traditional Chinese medicine syndrome, traditional Chinese medicine and western medicine in 84 697 patients with coronary heart disease based on big data / 中国中药杂志

In order to understand the clinical characteristics of patients with coronary heart disease (CHD) in real world and provide reference for clinical prevention and treatment, this study analyzed informations of patient with CHD in hospital information system. Data from 17 national hospitals were collected. Select patients with coronaryheart disease in diagnosis of the first place in 17 hospitals, general informations and traditional Chinese medicine (TCM) syndrome, complications, medicine were analyzed using frequency method and association rules. This study included 84 697 patients with CHD, the majority of men and in the elderly. The average age of patients was 71 years. The proportion of men to women was about 1. 45: 1. Hospital stay time ranged from 8 to 14 d. The most common total hospitalization cost distribution was 5 000-20 000 RMB. Young patients have a rising trend year by year. The death of patients increased with increasing age. Common complications were hypertension, diabetes, cerebral infarction and hyperlipidemia, 57.24 percent of the CHD patient complicated with hypertension, 21.94 percent patients complicated with diabetes. Among TCM syndrome types, Qi-Yin deficiency and qi deficiency blood stasis were the most common syndromes. Blood stasis was the highest syndrome elements, accounted for 79.97%, followed by Qi deficiency, phlegm, Yin deficiency, and so on. The most common western medicine was aspirin, followed with isosorbide dinitrate, clopidogrel. The most common used traditional Chinese medicine was danhong injection, followed by shuxuetong injection. Combined with removing blood stasis drugs has been more common at present clinical treatment, there were 43.46 percent of patients combined with anti-platelet western drug and injection of removing blood stasis.

Based on hospital information system data, analysis of effects of different doses of shenmai injection on renal function / 中国中药杂志

<p><b>OBJECTIVE</b>To assess whether the dosage of Shenmai injection influences renal function.</p><p><b>METHOD</b>Analysis of hospital information system (HIS) data from 18 national hospitals using Shenmai injections. Patients were aged between 18 to 80 years old. Blood analysis of creatinine and serum urea nitrogen was undertaken 7 days before and after exceeding the maximum recommended dose of 100 mL of Shenmai injection. Propensity score method was used to compare the differences between the two groups of renal function scores.</p><p><b>RESULT</b>The differences in abnormal changes in creatinine and serum urea nitrogen levels between the groups before and after exceeding the recommended dose was not statistically significant, but abnormal changes were detected.</p><p><b>CONCLUSION</b>Based on the available data we did not find that exceeding the recommended dose of Shenmai injection had a significantly deleterious effect on renal function. However, caution should be applied in its clinical use.</p>

Spontaneous reportintg system data based on shuxuetong injection adverse reactions signal warning analysis / 中国中药杂志

In this study, January 2009-December 2012 national adverse drug reaction monitoring center Shuxuetong the SRS data for the study, using the reporting rate ratio method and Bayesian belief propagation neural network Shuxuetong ADR warning signal, and balanced use of propensity score methods confounders. The results showed that chills as a possible warning signal. Tip clinical use Shuxuetong injection when, for the elderly, children, liver and kidney dysfunction are more prone to adverse reactions in patients with other special populations, the need to pay attention to the prevention of systemic allergic reactions, in particular the prevention shivering.

Expert consensus on population pharmacokinetics of Chinese medicine ( draft version for comments) / 中国中药杂志

In population pharmacokinetic (PPK) research of Chinese medicines with narrow therapeutic windows of toxicity, or when the target population is not homogeneous, or when there are frequent adverse reactions to parenterally administered Chinese medicine, select those that have a definite therapeutic effect, and in which the compositions of the toxic substances compositions are known, for study, and use complete PPK sampling design to take samples at specific time points. Use gas chromatography, HPLC, and LC-MS methods for the detection of target components. Finally, use total quantity statistical moment analysis, to account for each component of the PPK parameters. Thus, PPK model can reflect the overall trend of Chinese medicine, to provide the basis for reasonable clinical dosage adjustments.

Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments) / 中国中药杂志

Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.