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1.
Zhongguo Zhong Yao Za Zhi ; (24): 256-264, 2023.
Article in Chinese | WPRIM | ID: wpr-970521

ABSTRACT

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.


Subject(s)
Medicine, Chinese Traditional , Nonprescription Drugs , Consensus , China , Reference Standards , Drugs, Chinese Herbal
2.
Zhongguo Zhong Yao Za Zhi ; (24): 1402-1406, 2023.
Article in Chinese | WPRIM | ID: wpr-970610

ABSTRACT

Ethnic medicine has a rich history of application. Because of the large number of ethnic groups, wide geographical distribution, and unique medical systems in China, the research on the human use experience(HUE) of ethnic medicine should combine the characteristics of ethnic medicine, be based on practical experience, and respect folk practice and tradition. The clinical positioning of ethnic medicine should consider three factors, i.e., population region, dominant diseases, and clinical demand. We should consider the development of traditional preparations that meet the needs of ethnic regions and encourage the development of new drugs that can be popularized and used nationwide for the dominant diseases of ethnic medicines. Attention should be paid to the problems such as a large number of customary articles or substitutes of ethnic medicinal materials, the phenomena of foreign bodies with the same name and different names for the same substance, the different standards of medicinal materials, and the poor processing standards. The name, processing method, source, medicinal parts, and dosage of ethnic medicinal materials or decoction pieces should be determined, and resources should be carefully evaluated to ensure the safety of medicinal resources and ecology. The preparation of ethnic medicine is mostly in the form of pills, powder, ointment, etc., with simple processing technology. The problems of low-quality stan-dards of some preparations, different prescriptions with the same name, and inconsistent processing technology should be overcome, and the process route and main process parameters should be clarified to lay the foundation for the subsequent empirical research on HUE. In the collection and analysis of the HUE data of ethnic medicine, the core guiding ideology of "patient-centered" should be established, and the experience data of patients should be collected. The problems of weak links existing in the inheritance of ethnic medicine should be solved, and flexible and diverse methods should be adopted. Meanwhile, on the premise of complying with the requirements of the principles of medical ethics, we should respect the religion, culture, and customs of ethnic areas to obtain the key HUE information of ethnic medicine. On the basis of the patient preference information and differences in regional disease epidemiology, population characteristics, and medical practice, whether the HUE conclusions of ethnic medicine can be extrapolated to patients outside the region is evaluated from the aspects of clinical benefits, risk tolerance, risk acceptance, etc. The HUE research on ethnic medicine is carried out in a clear way to guide the research and development of new ethnic medicines.


Subject(s)
Humans , Medicine, Chinese Traditional , China , Reference Standards , Technology , Drugs, Chinese Herbal/therapeutic use
3.
Zhongguo Zhong Yao Za Zhi ; (24): 562-568, 2022.
Article in Chinese | WPRIM | ID: wpr-928001

ABSTRACT

The development of traditional Chinese medicine(TCM) has always been highly valued and supported since 1949. However, Chinese medicine industry still faces great challenges in view of the current status of the industry and registration and approval of new products in recent years. Related policies also directly influence the development of the industry. The latest version of the Provisions for Drug Registration and Requirement on Registration Classification and Application Information of Traditional Chinese Medicines have been put into practice since 2020. Registration classification is the core content of the Chinese medicine registration management system, as it is closely related to the research, development, and registration of Chinese medicine and the innovative development of the industry. This article aims to systematically review the historical evolution of the category of Chinese medicine registration and analyze the current status and problems, which is expected to provide a reference for the formulation of supporting documents according to related laws and regulations.


Subject(s)
Drug Industry , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Policy
4.
Zhongguo Zhong Yao Za Zhi ; (24): 1120-1125, 2022.
Article in Chinese | WPRIM | ID: wpr-928032

ABSTRACT

Since the implementation of drug registration in China, the classification of Chinese medicine has greatly met the needs of public health and effectively guided the transformation, inheritance, and innovation of research achievements on traditional Chinese medicine(TCM). In the past 30 years, the development of new Chinese medicine has followed the registration transformation model of " one prescription for single drug". This model refers to the R&D and registration system of modern drugs, and approximates to the " law-abiding" medication method in TCM clinic, while it rarely reflects the sequential therapy of syndrome differentiation and comprehensive treatment with multiple measures. In 2017, Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices released by the General Office of the CPC Central Committee and the General Office of the State Council pointed out that it is necessary to " establish and improve the registration and technical evaluation system in line with the characteristics of Chinese medicine, and handle the relationship between the traditional advantages of Chinese medicine and the requirements of modern drug research". Therefore, based on the development law and characteristics of TCM, clinical thinking should be highlighted in the current technical requirements and registration system of research and development of Chinese medicine. Based on the current situation of registration supervision of Chinese medicine and the modern drug research in China, the present study analyzed limitations and deficiency of " one prescription for single drug" in the research and development of Chinese medicine. Additionally, a new type of " series prescriptions" was proposed, which was consistent with clinical thinking and clinical reality. This study is expected to contribute to the independent innovation and high-quality development of the TCM industry.


Subject(s)
China , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Prescriptions , Public Health
5.
Journal of Integrative Medicine ; (12): 226-231, 2021.
Article in English | WPRIM | ID: wpr-881014

ABSTRACT

OBJECTIVE@#To observe the early interventions of traditional Chinese Medicine (TCM) on the conversion time of nucleic acid in patients with coronavirus disease 2019 (COVID-19), and find possible underlying mechanisms of action.@*METHODS@#A retrospective cohort study was conducted on 300 confirmed COVID-19 patients who were treated with TCM, at a designated hospital in China. The patients were categorized into three groups: TCM1, TCM2 and TCM3, who respectively received TCM interventions within 7, 8-14, and greater than 15 days of hospitalization. Different indicators such as the conversion time of pharyngeal swab nucleic acid, the conversion time of fecal nucleic acid, length of hospital stay, and inflammatory markers (leukocyte count, and lymphocyte count and percentage) were analyzed to observe the impact of early TCM interventions on these groups.@*RESULTS@#The median conversion times of pharyngeal swab nucleic acid in the three groups were 5.5, 7 and 16 d (P < 0.001), with TCM1 and TCM2 being statistically different from TCM3 (P < 0.01). TCM1 (P < 0.05) and TCM3 (P < 0.01) were statistically different from TCM2. The median conversion times of fecal nucleic acid in the three groups were 7, 9 and 17 d (P < 0.001). Conversion times of fecal nucleic acid in TCM1 were statistically different from TCM3 and TCM2 (P < 0.01). The median lengths of hospital stay in the three groups were 13, 16 and 21 d (P < 0.001). TCM1 and TCM2 were statistically different from TCM3 (P < 0.01); TCM1 and TCM3 were statistically different from TCM2 (P < 0.01). Both leucocyte and lymphocyte counts increased gradually with an increase in the length of hospital stay in TCM1 group patients, with a statistically significant difference observed at each time point in the group (P < 0.001). Statistically significant differences in lymphocyte count and percentage in TCM2 (P < 0.001), and in leucocyte count (P = 0.043) and lymphocyte count (P = 0.038) in TCM3 were observed. The comparison among the three groups showed a statistically significant difference in lymphocyte percentage on the third day of admission (P = 0.044).@*CONCLUSION@#In this study, it was observed that in COVID-19 patients treated with a combination of Chinese and Western medicines, TCM intervention earlier in the hospital stay correlated with faster conversion time of pharyngeal swab and fecal nucleic acid, as well as shorter length of hospital stay, thus helping promote faster recovery of the patient. The underlying mechanism of action may be related to improving inflammation in patients with COVID-19.


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , COVID-19/drug therapy , Length of Stay , Medicine, Chinese Traditional , Retrospective Studies , SARS-CoV-2
6.
Zhongguo Zhong Yao Za Zhi ; (24): 5987-5991, 2021.
Article in Chinese | WPRIM | ID: wpr-921721

ABSTRACT

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.


Subject(s)
Humans , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Prescriptions , Reproducibility of Results , Research
7.
Zhongguo Zhong Yao Za Zhi ; (24): 1681-1685, 2021.
Article in Chinese | WPRIM | ID: wpr-879078

ABSTRACT

Collecting and summarizing human use experience(HUE) data, forming high-quality data and evidences that can be used for evaluation are the key links of HUE research on traditional Chinese medicine(TCM). The collection, collation and summary of human experience data were discussed in this paper. It is pointed out that the collection of HUE should be focus on the source of prescription of new traditional Chinese medicines, and be summarized based on dialectical thinking, experience in medication, characte-ristics of prescription and clinical application. The collected contents include prescription, process, clinical location and applicable population, efficacy data and safety data, etc. The methods include interview, clinical data summary and data mining. When the data formed based on HUE information is used as drug registration information, it is necessary to ensure that the data source is legal and compliant, and the ownership of intellectual property is clear.Data sources should meet the requirements of medical ethics. To avoid conflict of interest, data analysis should be conducted by an independent third party. It is necessary to develop the quality control measures of HUE data to ensure the data traceability, integrity, consistency and accuracy, and avoid data bias.The data of HUE should include the key data such as accurate clinical location and applicable population, recognized clinical efficacy and safety.After the formation of HUE, the statistical analysis plan of empirical data of human use should be formulated. Through strict data processing, statistical analysis and clinical interpretation, HUE can be produced for evaluation.


Subject(s)
Humans , Data Collection , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Prescriptions , Quality Control
8.
Zhongguo Zhong Yao Za Zhi ; (24): 1686-1690, 2021.
Article in Chinese | WPRIM | ID: wpr-879079

ABSTRACT

This article proposes that the research and development of new Chinese medicines should be based on the clinical values of traditional Chinese medicine(TCM), and expounds the multiple clinical values of new Chinese medicines such as therapeutic effects, adjuvant treatment effects, improvement of disease symptoms, improvement of quality of life, prevention of diseases, etc., so as to broaden the clinical indications of new Chinese medicines. It is pointed out that the clinical value of TCM determines the clinical efficacy evaluation method of new Chinese medicines, so as to construct a clinical evaluation system of new Chinese medicines with the characteristics of TCM. It is proposed that the clinical value of new Chinese medicines should be found under the guidance of TCM theo-ry and clinical practice, and the theoretical innovation of TCM should be emphasized. There is no difference in the clinical value of drugs, and the key is to meet the clinical needs of patients. The research and development of new Chinese medicines ignores the theoretical guidance of Chinese medicine, and relying solely on animal experiment data may lead to failure of clinical trials. Different from the individualized treatment of TCM clinical syndrome differentiation, summarizing the core pathogenesis of TCM is the basis for the development of new Chinese medicines. It is necessary to summarize the pathogenesis of the disease under the guidance of TCM theory and encourage the application of modern medical methods to clarify the diagnosis of the disease. In view of the characteristics of new Chinese medicine research and development, it is proposed that the supporting role of human experience should be emphasized, and the technical points of clinical trials of new syndrome-type Chinese medicines should be explained.The use of objective indicators for syndrome evaluation, the selection of appropriate scales, and the formulation of reasonable treatment courses are advocated. During the research and development of new Chinese medicines, it is not only necessary to pay attention to modern medical safety indicators, but also to observe the evolution of TCM syndromes and specific TCM symptoms.


Subject(s)
Humans , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Quality of Life , Research , Syndrome
9.
Zhongguo Zhong Yao Za Zhi ; (24): 1691-1695, 2021.
Article in Chinese | WPRIM | ID: wpr-879080

ABSTRACT

The relevant laws and regulations of drug clinical trials were introduced in this paper. It is pointed out that with drug re-gulatory laws and technological advances, clinical trials have become an important link in the development of new drugs of traditional Chinese medicines(TCM). Clinical trials of new drugs of TCM must comply with the requirement of "Good Clinical Practice for Trial on Medicinal Products". In view of the particularities of clinical trials of new drugs of TCM, China has established an ethical review system for clinical research in TCM and carried out ethical review and certification of TCM research. In order to guide the development of clinical trials of new drugs of TCM, relevant departments have promulgated a series of guidelines for clinical trials of it, and established a new review system and technical requirements for clinical trials. Since 1983, the "national clinical pharmacology base" has been established. At present, there are 96 drug clinical trial institutions and 32 phase I clinical research wards in TCM hospitals, which can meet the development of clinical trials of new drugs of TCM. In the long-term practice, the technical team has continued to grow and develop, the research experience and technical strength have been significantly improved, and a large number of experts have become the backbone of clinical research in Chinese medicine. It is pointed out that we should attach importance to risk and benefit assessment, human experience, select scientific, objective and appropriate effectiveness indexes, evaluate the efficacy of TCM syndromes, and encourage the use of electronic methods in clinical research of new drugs of TCM. Based on the analysis of clinical trials of TCM in recent five years, it is pointed out that the active degree of clinical trials of new drugs of TCM is not high, the innovation ability of it is insufficient and the ability and enthusiasm of all aspects need to be improved. It is of great significance to carry out clinical trials of new traditional Chinese medicines to upgrade the TCM industry and produce high-level evidence-based medicine evidences. The high quality development of TCM can be promoted by strengthening clinical trials of new drugs of TCM.


Subject(s)
Humans , China , Drugs, Chinese Herbal , Evidence-Based Medicine , Medicine, Chinese Traditional , Syndrome
10.
Zhongguo Zhong Yao Za Zhi ; (24): 1696-1700, 2021.
Article in Chinese | WPRIM | ID: wpr-879081

ABSTRACT

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.


Subject(s)
Humans , Biomedical Research , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal , Ethical Review , Medicine, Chinese Traditional , Multicenter Studies as Topic , Pharmaceutical Preparations
11.
Zhongguo Zhong Yao Za Zhi ; (24): 1701-1705, 2021.
Article in Chinese | WPRIM | ID: wpr-879082

ABSTRACT

Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.


Subject(s)
Humans , China , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Quality Control
12.
Article in Chinese | WPRIM | ID: wpr-921925

ABSTRACT

OBJECTIVE@#To observe the effect of Qiang Jin exercises on the muscle strength and activity of lumbar spine in patients with lumbar disc herniation.@*METHODS@#From March 2016 to September 2017, at the Department of Orthopaedics, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, a total of 110 subjects were enrolled, and 98 eligible subjects were screened. The subjects were randomized by stratified randomization and divided into experimental group and control group, 49 cases in each group, 25 males and 24 females in the experimental group, 25 males and 24 females in the control group. The experimental group exercised with Qiang Jin exercises, one time each morning and evening, each time10 sets were made;the control group used classic rehabilitation training, training twice a week, and three months was a course of treatment. After 12 weeks of training, the muscle strength and activity of the lumbar spine were evaluated and compared with the muscle strength and activity of the lumbar spine before training.@*RESULTS@#The experimental group and the control group had different muscle strength and activity of the lumbar spine before and after treatment (@*CONCLUSION@#Qiang Jin exercises can effectively improve the muscle strength and activity of the lumbar spine and improve the daily living ability of patients.


Subject(s)
Female , Humans , Male , China , Intervertebral Disc Degeneration , Intervertebral Disc Displacement , Lumbar Vertebrae , Lumbosacral Region , Treatment Outcome
13.
Article in Chinese | WPRIM | ID: wpr-792973

ABSTRACT

OBJECTIVE@#To compare the degeneration of lumbosacral multifidus muscle in patients with lumbar disc herniation.@*METHODS@#Magnetic Resonance Spectroscopy was performed on the multifidus muscle of 35 healthy volunteers and 35 patients with unilateral L lumbar disc herniation. There were 20 males and 15 females in each group, aged from 25 to 55 years old. In healthy volunteers, the mean age was (35.66±8.73) years old and the BMI was (21.85±1.94) kg/m; in the patients, the mean age was (36.09±7.70) years old, the BMI was (21.50±1.78) kg/m, the VAS score was (4.40±0.88) points, the course of disease was (11.2±7.14) months. The proportion of fat in the L lumbosacral multifidus muscle and the proportion of fat-suppressed cross-sectional area were observed by MRI, the differences of the observation indexes of the two groups were compared through data analysis.@*RESULTS@#In healthy volunteers, the proportion of fat on the left side of the multifidus muscle was (0.169± 0.035)%, the proportion of fat removal cross-sectional area on the left side of the multifidus muscle was (0.699±0.070)%, the proportion of fat on the right side of the multifidus muscle was (0.168±0.031)%, and the proportion of fat removal cross-sectional area on the right side of the multifidus muscle was (0.712±0.056)%, there was no significant difference between the two sides (>0.05). In patients, the proportion of fat on the healthy side of multifidus muscles was (0.173±0.021)%, the proportion of fat removal cross-sectional area on the healthy side of multifidus muscles was (0.695±0.054)%, the proportion of fat on the affected side of the multifidus muscle was (0.228±0.027)%, and the proportion of fat removal cross-sectional area on the affected side of the multifidus muscle was (0.629±0.048)%, the differences of the above indexes on both sides were statistically significant (0.05).@*CONCLUSION@#There is degeneration of lumbosacral multifidus muscle on the affected side of patients with unilateral L intervertebral disc herniation, featuring multifidus muscular atrophy and fat infiltration.

14.
Article in Chinese | WPRIM | ID: wpr-828273

ABSTRACT

OBJECTIVE@#To compare the degeneration of lumbosacral multifidus muscle in patients with lumbar disc herniation.@*METHODS@#Thirty-five healthy volunteers and 35 patients with unilateral L lumbar disc herniation from December 2015 to September 2017 were recruited. There were 20 males and 15 females in each group, aged from 25 to 55 years old. In healthy volunteers group, the mean age was (35.66±8.73) years old and the BMI was (21.85±1.94) kg /m. In patients with lumbar disc herniation, the mean age was (36.09±7.70) years old, the BMI was (21.50±1.78) kg /m, the VAS score was 4.40±0.88, the course of disease was (11.20±7.14) months. Surface electromyography analysis was performed on the multifidus muscle of the two groups. The average myoelectric amplitude of the multifidus muscle in the two groups were compared.@*RESULTS@#The average myoelectric amplitude of the multifidus muscle of healthy volunteers was (48.84±7.77) µV on the left and (49.13±7.86) µV on the right. There was no significant difference between the two sides (>0.05). The average myoelectric amplitude of multifidus muscle in patients with lumbar disc herniation was(48.82±8.14) µV on the healthy side and (42.81±7.00) µV on the affected side, and the difference was statistically significant between two sides(0.05). There was significant difference in the average myoelectric amplitude of multifidus muscle between the affected side of lumbar disc herniation and on the left of healthy volunteers, and also between the affected side of lumbar disc herniation and on the right of healthy volunteers(<0.05).@*CONCLUSION@#Patients with chronic lumbar disc herniation have an imbalance in myoelectric activity, and the muscle strength of the multifidus muscle on the affected side is significantly reduced.


Subject(s)
Adult , Female , Humans , Male , Middle Aged , Electromyography , Intervertebral Disc Degeneration , Diagnostic Imaging , Intervertebral Disc Displacement , Lumbar Vertebrae , Paraspinal Muscles
15.
Article in Chinese | WPRIM | ID: wpr-259847

ABSTRACT

<p><b>OBJECTIVE</b>To study effects of strengthening exercise with strong tendon on the lumbosacral multifidus muscle.</p><p><b>METHODS</b>Among 30 healthy volunteers, there were 21 males and 9 females, with an average age of(31.30±6.48) years old(ranged, 25 to 55 years old). The mean BMI was (21.70±1.95) kg/m²(ranged, 18.1 to 24.9 kg/m²). The ultrasonic image was used to analyze the thickness of lumbosacral multifidus(LM) under the follow conditions: supine position, and supine position with leg lifting 30°, 60°, 90°; seat and hip flexion, flexion to limit position, front to limit position with both hands climbing and strengthening the kidneys and the waist.</p><p><b>RESULTS</b>The average lumbosacral multifidus thickness was (16.867±2.460) mm, (19.010±2.510) mm, (22.477±2.220) mm, and(27.593±2.370) mm respectively in supine position with leg lifting 0°, 30°, 60°, 90°. There were statistical differences(=423.619,<0.05). The average lumbosacral multifidus thickness was (25.810±2.440) mm, (15.677±2.130) mm, and (15.533±2.110) mm respectively in seat and hip flexion, flexion to limit, front to limit positions with both hands climbing and strengthening the kidneys and the waist. There were statistical differences(=597.789,<0.05).</p><p><b>CONCLUSIONS</b>When healthy volunteers in Shi's Orthopedics strengthen muscle exercises training, multifidus thickness is increased with the increasing of leg degree, reduced with the increasing of the flexion degree. It can change the stretching state of multifidus muscle by a specific training, so as to achieve the purpose of training the multifidus muscle.</p>

16.
Zhongguo Zhong Yao Za Zhi ; (24): 6-9, 2017.
Article in Chinese | WPRIM | ID: wpr-231001

ABSTRACT

Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.

17.
Article in Chinese | WPRIM | ID: wpr-324659

ABSTRACT

<p><b>OBJECTIVE</b>To analyze the relationship between position of head, cervical curvature type and associated cervical balance parameters in a neutral looking-forward posture.</p><p><b>METHODS</b>Cervical lateral X-rays of 60 patients with cervical spondylosis were selected from January to December 2015. There were 22 males and 38 females with an average age of (35.5±10.9) years old. The measured parameters included cervical curvature type, McGregor slope, C2 lower end plate slope, T1 slope, center of gravity to C7 sagittal vertical offset (CG-C7 SVA), and C2 to C7 sagittal vertical offset (C2-C7 SVA). The parameters were analyzed using Spearman correlation.</p><p><b>RESULTS</b>The cervical curvature type was significantly correlated with C2 lower endplate slope, C0-C2 angle (total degree of C2 lower endplate slope plus McGregor slope), CG-C7 SVA and T1 slope (<0.05), but it was not significantly correlated McGregor slope (>0.05). C2 lower endplate slope and C2-C7 SVA (r=0.87) were significantly (<0.05) correlated with CG-C7 SVA (<0.05).</p><p><b>CONCLUSIONS</b>There was certain some relationship among position of head, cervical curvature type and associated cervical balance parameters in a neutral looking-forward posture. The center of gravity of the head would backwards shift following faced upward. A position of extension with posterior-shifting of the head would suggest that it may be accompanied with a relatively normal lordosis of the cervical spine. Some patients with abnormal curvature showed slightly bended head in the natural posture. Health education toward these people would be meaningful to restore the balance of their neck.</p>

18.
Article in Chinese | WPRIM | ID: wpr-230372

ABSTRACT

<p><b>OBJECTIVE</b>To explore the effect of articulatio atlantoepistrophica sublaxation on the pathogenesis of cervical spondylosis, and provide a thread for diagnosis and treatment of cervical spondylosis with manipulation.</p><p><b>METHODS</b>There were two groups in the study, which were non cervical spondylosis group and cervical spondylosis group. There were 333 patients in cervical spondylosis group, included 119 males and 214 females with the mean age of(48.11±12.21) years old. The patients were recruited from clinic service of orthopaedics in Shuguang Hospital between March 2006 and December 2008. There were 73 subjects in non cervical spondylosis group, included 18 males and 55 females with the mean of(45.99±11.47) years old. The subjects were recruited from undergraduate students, postgraduate, advanced study persons, and community personnel. The position relation of the atlanto axial joint was observed by cervical X rays with opening position, and the incidence rate of articulatio atlantoepistrophica sublaxation was compared between two groups, and their clinical characteristics were analyzed.</p><p><b>RESULTS</b>The incidence of articulatio atlantoepistrophica sublaxation in cervical spondylosis group was 81.38%(271/333)and was more than non cervical spondylosis group(<0.01). Furthermore, the pattern of the articulatio atlantoepistrophica sublaxation in cervical spondylosis group was complicated and diversified, which was 50.55% (137/271)with single moving sublaxation, 7.01%(19/271) with revolving sublaxation, 42.44%(115/271) with single moving and revolving sublaxation.</p><p><b>CONCLUSIONS</b>The articulatio atlantoepistrophica sublaxation may be a X ray diagnostic indication to the cervical spondylosis, which should be grouping studied in clinic. It will provide guidance for the diagnosis and treatment of cervical spondylosis.</p>

19.
Article in Chinese | WPRIM | ID: wpr-230419

ABSTRACT

As a common disease in clinical, the treatment of lumbar disc herniation (LDH) focused on local intervertebral disc, such as surgery and other interventional therapy treatment, but postoperative complications and recurrence rate has been a difficult problem in the field of profession. With the development of spine biomechanics and anatomy, researches on lumbar herniation also increased. Researchers discovered that the incidence and prognosis of LDH were inseparable with local muscle and soft tissue. As the deep paraspinal muscles, multifidus muscle plays an important role to make lumbar stability. Its abnormal function could reduce the stable of lumbar spine, and the chronic lumbar disease could also lead to multifidus muscle atrophy.


Subject(s)
Animals , Humans , Intervertebral Disc Displacement , General Surgery , Lumbosacral Region , General Surgery , Paraspinal Muscles
20.
Article in Chinese | WPRIM | ID: wpr-255220

ABSTRACT

<p><b>OBJECTIVE</b>To develop a Chinese version of Vertigo Symptom Scale (VSS-C) and to examine its reliability and validity.</p><p><b>METHODS</b>The VSS was translated into Chinese and developed a Chinese version VSS (VSS-C) with the consent of the author. The VSS-C scale was tested in 52 subjects with cervical spondylosis of vertebral artery type (CSA group) and 21 healthy subjects (control group). In CSA group VSS-C scale and SF-36 scale investigation was performed for 2 times with 1 week interval, after receiving 1-week orthopedic rehabilitation the patients were evaluated with the VSS-C and SF-36 scale; while subjects in control group received the investigation twice in two weeks. The reliability of the scale was evaluated with Cronbach's alpha method and the correlation between SF-36 scale and the VSS-C were also evaluated for the validity.</p><p><b>RESULTS</b>The internal consistency of VSS-C was good with Cronbach's alpha of 0.886. Test-retest reliability was also very good with an intraclass correlation coefficient (ICC) between two time points, being 0.970 for VSS-C, 0.965 for VSS-AA and 0.992 for the VSS-VER. Regarding concurrent validity, significant low correlation was found between the VSS-AA and VSS-VER (r=0.379, P<0.05). Significant expected correlation was detected between the VSS-C and SF-36 (r>0.5, P<0.05) . The independent-samples t test results (t=6.261, P<0.01) of the CSA group and the control group showed that the VSS-C was able to distinguish healthy people from CSA patients. The paired-samples t test results (t=5.513, P<0.01) showed that VSS-C reflected the improvement of patients after treatment of Chinese massage manipulation.</p><p><b>CONCLUSION</b>The Chinese version of VSS has a high comprehensibility, internal consistency and validity, and it can be a useful instrument for evaluation of patients with cervical spondylosis of vertebral artery type in China.</p>


Subject(s)
Humans , China , Language , Reproducibility of Results , Surveys and Questionnaires , Vertigo , Diagnosis
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