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1.
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)
China , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Quality Control
2.
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)
Biomedical Research , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal , Ethical Review , Humans , Medicine, Chinese Traditional , Multicenter Studies as Topic , Pharmaceutical Preparations
3.
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)
China , Drugs, Chinese Herbal , Evidence-Based Medicine , Humans , Medicine, Chinese Traditional , Syndrome
4.
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)
Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Quality of Life , Research , Syndrome
5.
Article in Chinese | WPRIM | ID: wpr-905870

ABSTRACT

Objective:To evaluate the clinical efficacy and safety of Longmu Zhuanggu granule for the treatment of children recurrent respiratory infection due to lung-spleen Qi deficiency. Method:This multicenter stratified, block-randomized, double-blind, double-dummy, positive drug (pidotimod granule) parallel controlled, and non-inferiority trail intended to included 240 children patients and divided them into the experimental group (<italic>n</italic>=120) and the control group (<italic>n</italic>=120) at the ratio of 1∶1. Patients in both groups were treated for eight successive weeks and followed up for 12 months. The cure rates, numbers of respiratory infections, average courses of disease, curative effects of traditional Chinese medicine (TCM) syndrome, curative effects of individual symptoms, curative effects of immune indexes, and safety indexes between the two groups were observed and compared. Result:A total of 237 subjects were collected from 10 research centers, including 119 cases in the control group and 118 in the experimental group. There were 236 cases enrolled into the full analysis set (FAS), 210 into the per-protocol set (PPS), and 236 into the safety set (SS). The baseline data of the two groups were not significantly different from each other, indicating that they were comparable. The cure rates of the experimental group and control group were 75.21% (88/117) and 73.95%(88/119), respectively, with the 95% confidence interval (CI) of difference between the two groups being 1.26% (-9.85%,12.37%) for FAS and 3.81% (-6.28%,13.90%) for PPS. The 95% CI fell within the 10% non-inferiority margin, implying that non-infertility test of the cure rate in the treatment of endpoint disease was valid, and the conclusions of FAS and PPS analysis were consistent. There was no significant difference in the number or course of upper respiratory infection, bronchitis, and pneumonia. The difference in curative effects of TCM syndrome between the two groups after four weeks of treatment was not remarkable. After eight weeks of treatment, the total effective rate of the experimental group was 84.62%(99/117), statistically higher than 78.15%(93/119) of the control group(<italic>χ</italic><sup>2</sup>=-3.26,<italic>P</italic><0.05). There were no significant differences in the disappearance rates of individual symptoms between the two groups after four weeks of treatment. After eight weeks of treatment, the experimental group and control group exhibited the disappearance rates of 67.50%(54/80) and 47.37%(36/76) for shortness of breath and laziness to speak, 75.00%(54/72) and 53.33%(40/75) for poor appetite, 54.55%(60/110) and 37.84%(42/111) for hyperhidrosis, respectively, with obviously better outcomes observed in the experimental group (<italic>P</italic><0.05,<italic>P</italic><0.01). The inter-group comparison revealed significant differences in immune indexes after eight weeks of treatment. As demonstrated by comparison with the situations before treatment, IgA, IgG, IgM, and CD4 did not change significantly after treatment. Except for CD8 in the experimental group (<italic>P</italic><0.05), there was no significant difference in other immune indexes before and after treatment There was no significant difference in the incidence of adverse reactions. Conclusion:Longmu Zhuanggu granule is not inferior to pidomod granule in the treatment of children recurrent respiratory infection due to lung-spleen Qi deficiency, and it exhibits good safety, implying its promising clinical application value.

6.
Article in Chinese | WPRIM | ID: wpr-921818

ABSTRACT

Hypertension, a cardiovascular disease with main clinical manifestations of dizziness and elevated blood pressure, especially elevated arterial pressure, features high prevalence rate and low control rate, which affects patients' quality of life. Therefore, establishing a good animal model of hypertension is of great significance for its diagnosis and clinical prevention and treatment. Based on the clinical characteristics of hypertension in traditional Chinese and western medicine, this study summarized the advantages and disadvantages of current hypertension animal models: gene-related model, surgery-caused model, drug-induced model, and environment-induced model, and investigated the similarity to the clinical symptoms in traditional Chinese medicine and Western medicine. Among them, spontaneously hypertensive rats, models established with the surgical two-kidney one-clip, one-kidney one-clip, two-kidney two-clip, and abdominal aorta constriction methods, models induced with the drug deoxycorticosterone acetate, and models induced with the high-fat high-purine diet showed symptoms highly similar to the clinical manifestations. Then, the corresponding evaluation and improvement methods of hypertension animal models were proposed. This study provides suggestions for the establishment of hypertension animal model so that the symptoms are more similar to the clinical characteristics of hypertension in traditional Chinese and Western medicine, which is important for the clinical diagnosis and treatment of hypertension.


Subject(s)
Animals , Blood Pressure , China , Disease Models, Animal , Humans , Hypertension/drug therapy , Medicine, Chinese Traditional , Quality of Life , Rats
7.
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)
Drugs, Chinese Herbal/adverse effects , Humans , Medicine, Chinese Traditional , Prescriptions , Reproducibility of Results , Research
8.
Article in Chinese | WPRIM | ID: wpr-921657

ABSTRACT

Rheumatoid arthritis(RA) is an autoimmune disease involving multiple joints bilaterally with symmetrical polyarthritis as the main symptom. The high disability rate of this disease seriously affects the quality of life of patients and even threatens their lives. The establishment of a good animal model is of great significance for the diagnosis and clinical prevention of RA. Based on the clinical characteristics of RA in traditional Chinese and Western medicine, the common animal models of RA were summarized, including drug-induced, gene-related, and syndrome and disease combined models. Joint swelling, pain, redness, nodules, and joint deformity are the main criteria for model evaluation, which have certain differences from the clinical diagnostic criteria of RA. From the perspective of syndrome differentiation, the animal model combining syndrome and disease only simulates the syndrome of traditional Chinese medicine and has no direct causal relationship with the formation of RA. In this paper, we analyzed the advantages and disadvantages of animal models of RA and the coincidence degree of the models with the clinical characteristics and then put forward the corresponding recommendations for the evaluation and improvement of these models, aiming to make the animal models of RA closer to the clinical symptoms and play an important role in the clinical diagnosis and treatment of RA.


Subject(s)
Animals , Arthritis, Rheumatoid/drug therapy , China , Disease Models, Animal , Humans , Medicine, Chinese Traditional , Quality of Life
9.
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.

10.
Article in Chinese | WPRIM | ID: wpr-350163

ABSTRACT

Acute upper respiratory tract infection is the most common infectious disease in children's respiratory system. The pathogen to the main virus, can account for more than 90% of the primary upper respiratory tract infectio. However, there is no specific anti-viral drugs specifically for the disease, in addition to the existence of excessive, widespread use or even abuse of antibiotics.Long-term clinical practice has confirmed that Chinese medicine is safe and effective in treating acute upper respiratory tract infection in children. The author reviews the literatures of multiple databases, and analyzes the advantages of Chinese patent medicine in the treatment of acute upper respiratory tract infection in children from the perspective of clinical research and experimental basic research. It also puts forward the existing problems and possible research directions of Chinese patent medicine in the treatment of acute upper respiratory tract infection in children.

11.
Article in Chinese | WPRIM | ID: wpr-852817

ABSTRACT

Objective: To evaluate the clinical efficacy and safety of Fuganlin Oral Liquid in treatment of acute upper respiatory infection (AURI) in pratical application. Methods: A multi-centered observational study was conducted. Total 2124 patients were administrated with Fuganlin Oral Liquid for one week, and observed the cure rate and the occurrence rate of complications in different levels, and the safety was evaluated. Results: The total cure rate was 95.12%, and there was no significant difference on it among different dosage and diagnosis groups, while patients (younger than one year old) took Fuganlin Oral Liquid alone had higher cure rate. The occurrence rate of complications was 0.24%, and there was no statistical difference among different dosage, age, and diagnosis groups, while patient took Fuganlin Oral Liquid alone had lower rate than combination therapy. The rateS of adverse events and adverse reaction were 1.37% and 1.04%, there was statistical difference except in different dosage groups. Conclusion: Fuganlin Oral Liquid has high cure rate and low complication rate. It has a good clinical efficacy, especially in young age groups. The efficacy of Qi deficiency group and wind heat syndrome group, even the disease diagnosis group was similar. A few clinical adverse events and adverse reaction was founded, high dosage group was as safe as the low dosage group. Above all, Fuganlin Oral Liquid has widely applied prospect in clinical practice.

12.
Article in Chinese | WPRIM | ID: wpr-258411

ABSTRACT

To evaluate the efficacy and safety of Choudongning (CDN)capsule in children with Tourette's syndrome of spleen deficiency and phlegm accumulation through a randomized double-blind three-arm controlled phase Ⅲ study in 588 patients from 8 hospitals. The included patients were randomly divided into test group, positive control group and placebo group at the ratio of 3∶1∶1. Patients in the test group orally took CDN capsules and simulated Tiapridal tablets; the patients in positive control group took Tiapridal tablets and simulated CDN capsules; whereas the patients in placebo group orally took the simulated agents of the above two drugs. The treatment course was 6 weeks for three groups. The global grading rates, YGTSS scores and its factor scores, the degree of social function damage, as well as traditional Chinese medicine syndrome efficacy were evaluated as the outcome measures on efficacy. The AEs/ADRs, vital signs and laboratory testing were observed as outcome measures on safety. The total effective rate of YGTSS was 75.92% in the test group, 72.65% in the positive control group, and 37.29% in the placebo group. Non inferiority test stands between the test group and the positive control group, and they were superior to placebo group in efficacy with statistical difference. Significant difference had also been found among the 3 groups in YGTSS tics score, motor tics score, vocal tics, degree of social function damage and traditional Chinese medicine syndrome efficacy. During the study, there were 5 (1.42%)ADRs in the test group, 10 (8.55%)in the positive control group and 3 (2.54%)in the placebo group. The incidence of ADRs in the test group was lower than that in the positive control group, with statistical difference. It is clear to say that CDN capsule can effectively treat the Tourette's syndrome of spleen deficiency and phlegm accumulation. Its efficacy is not inferior to the commonly used Tiapridal tablets, with even less adverse reactions, so it has clinical application value.

13.
Article in Chinese | WPRIM | ID: wpr-853525

ABSTRACT

Objective: To evaluate the efficacy and safety of Qingfei Xiaoyan Pill (QXP) in the treatment of lung phlegm heat syndrome in children with acute bronchitis. Methods: Stratified random, open, parallel-group controlled, and multi-center clinical studies were applied. Totally 96 patients suffering from Xiao'er acute bronchitis were randomly divided into treatment group and the control group according to 2:1 ratio. The patients in treatment group were given QXP for application while the patients in control group were given Xiaoer Feire Kechuan Oral Liquid for application, 5 d in total. Results: The curative rates of treatment and control groups in disease efficacy were 76.92% and 50.00%, and the curative rates of both groups in traditional Chinese medicine syndrome effect were 78.85% and 60.76%. These of treatment group were better than those of control group, and there were significant differences between the two groups (P 0.05). Conclusion: QXP has a definite effect on lung phlegm heat syndrome in children with acute bronchitis with good safety and is better than Xiaoer Feire Kechuan Oral Liquid.

14.
Article in Chinese | WPRIM | ID: wpr-297392

ABSTRACT

<p><b>OBJECTIVE</b>To observe the efficacy and safety of Danlong Oral Liquid (DOL) combined Western medicine (WM) in treating mild-to-moderate bronchial asthma patients (heat wheezing syndrome) at acute onset.</p><p><b>METHODS</b>Totally 480 mild-to-moderate bronchial asthma patients (heat wheezing syndrome) at acute onset were randomly assigned to two groups in the ratio 3:1, the treatment group (360 cases) and the control group (120 cases). All patients received basic WM treatment. Patients in the treatment group took DOL, 10 mL each time, 3 times per day for 7 days in total, while those in the control group took Kechuanning Oral Liquid (KOL) , 10 mL each time, 3 times per day for 7 days in total. Efficacy for asthma symptoms, lung functions and scores of TCM syndrome and/or main symptoms were evaluated.</p><p><b>RESULTS</b>The percentage of clinical control and significant effectiveness of asthma symptoms in the treatment group was significantly higher than that of the control group (77.36% vs 56.07%, P < 0.01). The percentage of clinical control and significant effectiveness of lung functions in the treatment group was significantly higher than that of the control group (74.28% vs 50.00%, P < 0.01). The anterior-posterior difference in scores of TCM syndrome was significantly superior in the treatment group than in the control group (-11.26 ± 4.70 vs -9.21 ± 5.09, P < 0.01). The anterior-posterior difference in scores of main symptoms was significantly better in the treatment group than in the control group (-6.58 ± 3.08 vs -5.16 ± 3.45, P < 0.01). The incidence of adverse reactions was significantly lower in the treatment group than in the control group [1.73% (6/346 cases) vs 10.17% (12/118 cases) , P < 0.05].</p><p><b>CONCLUSION</b>DOL combined WM was superior to KOL in treating mild-to-moderate bronchial asthma patients (heat wheezing syndrome) at acute onset.</p>


Subject(s)
Anti-Asthmatic Agents , Therapeutic Uses , Asthma , Drug Therapy , Biomedical Research , Drug Therapy, Combination , Methods , Drugs, Chinese Herbal , Therapeutic Uses , Hot Temperature , Humans , Lung , Medicine, Chinese Traditional , Phytotherapy , Respiratory Sounds , Syndrome
15.
Article in Chinese | WPRIM | ID: wpr-297372

ABSTRACT

Based on collecting data at home and abroad, we combined clinical practice of scientific researches. We also summarized key points for design and evaluation of clinical studies in treating children's attention deficit hyperactivity disorder by Chinese medical new drugs from objective and design, selection of diagnostic criteria, recruitment and dropping-out of subjects, effectiveness evaluation, safety evaluation, drug combination, and quality control, and so on. We hope to provide reference for design and evaluation of clinical studies by Chinese medical new drugs.


Subject(s)
Attention Deficit Disorder with Hyperactivity , Drug Therapy , Biomedical Research , Child , Clinical Studies as Topic , Data Collection , Drugs, Chinese Herbal , Therapeutic Uses , Humans
16.
Article in Chinese | WPRIM | ID: wpr-312805

ABSTRACT

<p><b>OBJECTIVE</b>To assess the efficacy and safety of Xifeng Zhidong Tablet (XZT) in treating tic disorder children patients of internal disturbance of Gan-wind with phlegm syndrome (IDGWPS).</p><p><b>METHODS</b>A stratified randomized, double-blinded, parallel control of placebo, multi-center trial was conducted in 160 subjects from 5 hospitals in China. They were randomly assigned to 2 groups, the test group and the control group, 80 in each group. Those in the test group were treated with XZT, while those in the control group were treated with placebos. The therapeutic course was 4 weeks for all. The effectiveness indicators covered main indicators and secondary indicators. Yale global tic severity scale (YGTSS) was taken as the main indicators. The amelioration of social function impairment, efficacy, single index of Chinese medical syndromes, Chinese medical syndrome efficacy as well as disappearance rate of single Chinese medical symptoms were evaluated as secondary indicators. The safety indicators included clinical adverse events, vital signs, blood/urine/stool routines, renal and liver functions, and electrocardiogram (ECG).</p><p><b>RESULTS</b>As for main indicators, the score of YGTSS decreased from 22.10 +/- 6.38 to 11.34 +/- 6.58 in the test group, while it decreased from 22.65 +/- 6.70 to 16.82 +/- 6.53 in the control group, showing statistical difference when compared with the same group before treatment (P < 0.01). Besides, the decrement was more significant in the test group after treatment (P < 0.05). As for secondary indicators, the total effective rate was 83.54% in the test group and 34.18% in the controlled group, showing statistical difference between the two groups (P < 0.05). As for social function impairment, 20,38, 16, 3, 1 case(s) in the test group were ranked as normal, minimal, mild, moderate, obvious degree, while 1, 24, 45, 7, and 0 case(s) in the control group were ranked as normal, minimal, mild, moderate, obvious degree. Better effect was obtained in the test group (P < 0.05).As for Chinese medical syndrome efficacy, it was 87.34% in the test group and 64.56% in the control group (P < 0.05). As for single index of Chinese medical syndromes, the disappearance rate of motor tics, irritability, dreaminess, abnormal tongue proper,abnormal tongue fur, and abnormal tongue pulse condition was 78.67%, 34.72%, 62.26%, 34.62%, 58.97%, and 39.74%, respectively in the test group, while they were 34.67%, 13.11%, 21.82%, 15.58%, 25.97%, and 19.48%, respectively in the control group. Better results were shown in the test group (P < 0.05). Totally 5 adverse events occurred. The incidence of adverse events was 3.75% in the test group and 2.53% in the control group.</p><p><b>CONCLUSIONS</b>After 4 weeks of XZT treatment, the integral of YGTSS could be obviously reduced, the degree of social function impairment ameliorated, and Chinese medical syndromes improved. In addition, no adverse reaction occurred in this study.</p>


Subject(s)
Adolescent , Child , Child, Preschool , Double-Blind Method , Drugs, Chinese Herbal , Therapeutic Uses , Female , Humans , Male , Medicine, Chinese Traditional , Phytotherapy , Placebos , Tic Disorders , Diagnosis , Drug Therapy , Treatment Outcome
17.
Article in Chinese | WPRIM | ID: wpr-346487

ABSTRACT

We assessed and graded the evidence of relevant systematic reviews and randomized controlled trials, combined with our clinical study practice to identify eleven key elements as a focus for the clinical study of traditional Chinese medicine (TCM) new drugs on children's dermatitis and eczema: the primary purpose and design of the study, the inclusion and exclusion criteria of the study, the treatment, the trail procedure,the effectiveness and safety evaluation, and quality control, etc, as well. In addition, seven recommendations for the design of clinical study of TCM new drugs on children's dermatitis and eczema were provided.


Subject(s)
Child , Child, Preschool , Dermatitis , Drug Therapy , Drugs, Chinese Herbal , Therapeutic Uses , Eczema , Drug Therapy , Humans , Infant , Pediatrics , Randomized Controlled Trials as Topic
18.
Article in Chinese | WPRIM | ID: wpr-238570

ABSTRACT

Based on relevant research and development, the possibility of applying the reinforced urn processes (RUPs) statistical approach to traditional Chinese medicine(TCM) drugs safety research is discussed in this paper, primarily through theoretical discussion and simulations. Also introduced are work flows and the key points for the application of the RUPs approach. This potentially new approach has recently been applied to the target estimation of phase I human tolerance clinical trials. A traditional RUPs approach has also been widely applied in the precise point-estimation of allowable longest treatment courses, according to the particular safety outcomes of post-marketed TCM.


Subject(s)
Drug Therapy , Drugs, Chinese Herbal , Humans , Product Surveillance, Postmarketing , Regression Analysis , Treatment Outcome
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