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1.
Journal of Preventive Medicine ; (12): 794-798, 2022.
Article in Chinese | WPRIM | ID: wpr-936797

ABSTRACT

Objective@#To evaluate the effect of high-intensity interval somatosensory training combined with neuromuscular acupoint electrical stimulation on blood glucose and motor function among patients with type 2 diabetes mellitus (T2DM), so as to provide insights into prevention of daily life disability among T2DM patients.@*Methods@#T2DM patients treated in Zhejiang Hospital during the period from January 2019 to October 2021 were enrolled and randomly assigned into four groups. Patients in the K group received Kinect somatosensory interaction technology-assisted high-intensity interval training, patients in the N group received neuromuscular acupoint electrical stimulation, and patients in the KN group received high-intensity interval somatosensory training combined with neuromuscular acupoint electrical stimulation, while patients in the C group were given no interventions. The 2 h postprandial plasma glucose and glycated haemoglobin (HbA1c) levels were measured prior to interventions and 4 and 12 weeks post-interventions, and seven physical fitness tests were performed. The blood glucose levels and motor activity were compared among four groups using generalized estimating equations to evaluate the effectiveness of interventions.@*Results@#Totally 199 T2DM patients were enrolled, including 51 patients in the KN group, 49 patients in the K group, 52 patients in the N group and 47 patients in the C group. There were no significant differences in gender, age, course of disease, duration of daily exercises, waist-to-hip ratio, vital capacity or maximal oxygen uptake among the four groups prior to interventions (all P>0.05). There were time-group interaction effects in blood glucose and exercise parameters among the four groups post-interventions (all P>0.05), with the largest changes seen in the KN group. The HbA1c, 2 h postprandial plasma glucose, 2.4 m standing and detour test and back scratch test results reduced by 17.06%, 27.01%, 36.52% and 20.94% 12 weeks post-interventions as compared to those prior to interventions, while 2 min stepping test, 30 s sit-ups, 30 s loading and elbow flexion test, 6 min walking test and sit and reach test results increased by 18.85%, 34.69%, 15.41%, 7.22% and 112.37%, respectively.@*Conclusion@#High-intensity interval somatosensory training combined with neuromuscular acupoint electrical stimulation may improve the blood glucose and motor activity among patients with T2DM.

2.
Article in Chinese | WPRIM | ID: wpr-942344

ABSTRACT

To understand the development status and provide the basis for the construction and development of health technology assessment (HTA) institutions/organizations in China, this paper systematically reviewed the status of international HTA institutions/organizations and the HTA institutions/organizations in western developed countries and some Asian countries. This study was based on the results of the second round of global survey on HTA conducted by the World Health Organization (WHO) in 2020/2021. The websites of WHO, International HTA Database (INAHTA), international HTA institutions/organizations, and the HTA institutions/organizations in different countries were searched. After data extraction and classification, we summarized the status of 9 international HTA institutions/organizations (including Decide: Health Decision Hub, Health Technology Assessment International, HTAsiaLink, International Network of Agencies for Health Technology Assessment, European Network for Health Technology Assessment, Health Technology Assessment Network of the Americas, International Society for Pharmacoeconomics and Outcomes Research, Southern African Health Technology Assessment Society, International Information Network on New and Emerging Health Technologies), 11 HTA institutions/organizations in western developed countries and Asian countries (including Canada, France, Germany, the United Kingdom, Australia, the United States, Japan, Malaysia, South Korea, Singapore, and Thailand), and 6 HTA organizations/teams in China. The use of HTA varies greatly because of different medical and health systems among different countries, and thus the role of HTA in health decision-making varies among different countries. The international HTA institutions/organizations have greatly strengthened the communication between HTA institutions/organizations and the pharmaceutical industry and facilitated the promotion and practice of evidence-based health decision-making.

3.
Article in Chinese | WPRIM | ID: wpr-942343

ABSTRACT

This paper aims to systematically retrieve and summarize the clinical evidence on oral Chinese patent medicine in otorhinolaryngology by scoping review and analyze the distribution of the evidence, which is expected to serve as a reference for clinical practice and healthcare decision-making. Seven databases were searched (from inception to March 2022) for the clinical evidence of oral Chinese patent medicine in the prevention and treatment of otorhinolaryngologic diseases, and the distribution of the evidence was discussed. A total of 248 papers from core journals/SCI were included: 238 clinical studies (185 randomized controlled trials, 46 semi-/non-randomized controlled trials, 7 case series studies), 5 systematic reviews, 4 guidelines/expert consensuses, and 1 pharmacoeconomic study. The papers covered 26 oral Chinese patent medicines and 40 otorhinolaryngological diseases (5 ear diseases, 22 nose diseases, and 13 throat diseases). The majority of the clinical studies included 100-300 cases. The combination of Chinese patent medicine and western medicine is the common intervention in the experimental group. The outcomes were mainly “cure rate” and improvement of clinical symptoms. Common adverse events were nausea, vomiting, rash, headache, gastrointestinal discomfort, fatigue, etc. In summary, there is a lack of high-quality clinical evidence on oral Chinese patent medicine in otorhinolaryngology. In addition, the available studies have such problems as seldom use of recognized outcomes, low quality of clinical studies, and lack of pharmacoeconomic study. In future, efforts should be made to carry out more rigorous primary and secondary research and enhance the pharmacoeconomic evaluation, in a bid to explore the advantages of Chinese patent medicine in the treatment of otorhinolaryngologic diseases and promote the more rational allocation and application of health resources.

4.
Article in Chinese | WPRIM | ID: wpr-942342

ABSTRACT

ObjectiveTo evaluate the safety, efficacy, and economy of the four Chinese patent medicines (CPMs), including Simotang oral liquid, Liuwei Anxiao capsule, Baohe pill, and Jianwei Xiaoshi oral liquid in the treatment of functional dyspepsia (FD) by a rapid health technology assessment (RHTA), thus providing evidence support for clinical decision making. MethodChina National Knowledge Infrastructure (CNKI), WanFang Database, VIP Chinese Technology Periodical Database (VIP), China Biology Medicine disc (CBMdisc), PubMed, EMBASE, Cochrane Library, and Web of Science were searched by computer from inception to March 2022. After literature screening, data extraction, and quality evaluation, the descriptive analysis of the results combined with visual charts was performed. Nineteen studies were included, involving 18 randomized controlled trials (RCTs) and 1 Meta-analysis. Neither economic studies nor health technology assessment (HTA) reports were retrieved. ResultThe four CPMs were safe and effective in the treatment of FD, but economic research was lacking. Among them, Simotang oral liquid could be used for children with FD and FD caused by qi and food stagnation, liver and spleen disharmony, and liver and spleen stagnation. Liuwei Anxiao capsule could be used for adult patients with FD caused by food stagnation. Baohe pill could be used for the elderly with FD. Jianwei Xiaoshi oral liquid could be used for children with FD caused by spleen and stomach weakness. ConclusionThe four CPMs have their advantages in the treatment of FD. Among them, the clinical universality of Simotang oral liquid is higher. However, the quality of clinical evidence is generally low, and comparative analysis among drug dosage forms is lacking. In the future, it is necessary to improve, apply, and promote RHTA for rapid evidence production while carrying out a more standardized and scientific evidence-based demonstration of the comprehensive clinical efficacy of CPMs.

5.
Article in Chinese | WPRIM | ID: wpr-942341

ABSTRACT

The method of scoping review was used to systematically search and sort out the clinical research of oral Chinese patent medicines for ischemic stroke,to understand the scope of relevant research and the distribution of evidence. Three medical catalogs were manually searched to obtain the oral Chinese patent medicines used for ischemic stroke,and 7 databases were retrieved to obtain the clinical research including these oral Chinese patent medicines. Then the clinical evidence results were visualized by description combined with chart analysis. A total of 68 oral Chinese patent medicines were retrieved,and 1 392 articles were included,with 367 published in core journals, involving 35 oral Chinese patent medicines. The research types included randomized controlled trials,cohort studies,case series,case reports,secondary studies,adverse drug reaction reports,pharmacoeconomic evaluations,drug interactions,consensus or guidelines,non-randomized intervention studies and cross-sectional studies,of which randomized controlled trials had the largest number (283, 77.1%),followed by secondary studies and case series (25, 6.7% for each). Among the 283 randomized controlled trials,there were 159 clinical studies in the acute phase of ischemic stroke,65 in the non-acute phase,and 59 in the unclear phase. Ten intervention control types and 20 outcome index types were summarized. Among them, the composite outcome index and surrogate outcome index were used 217 times (76.7%) and 245 times (86.6%), respectively,followed by the degree of neurological impairment (three scales). Future clinical research of oral Chinese patent medicines for ischemic stroke should clarify the stage of the disease,and the research design should specify the advantages of oral Chinese patent medicines intervening in ischemic stroke. Furthermore, publicly-recognized positive controls should be employed,and important clinical outcome indexes should be selected.

6.
Article in Chinese | WPRIM | ID: wpr-942340

ABSTRACT

This study systematically and comprehensively sorted out the application status of Chinese patent medicines for the treatment of constipation in the clinic, to provide scientific evidence for future research directions and clinical drug use in this field. Based on the method of scoping review, the Chinese patent medicines for the treatment of constipation were retrieved from three drug lists to obtain the medicines that needed to be evaluated. A comprehensive and systematic search was carried out on the included studies on the treatment of constipation by Chinese patent medicines through eight Chinese and English databases, and the included studies were integrated and analyzed. The results were displayed in combination with charts. Thirty-four Chinese patent medicines and 118 studies were included in this study. According to the efficacies, Chinese patent medicines were divided into 4 categories, namely eliminating accumulation, purging fire, promoting Qi, and moistening bowels, involving 125 Chinese medicines. The overall attention of constipation research is on the rise. Marenwan (granules or soft capsules) gained the highest attention, with 42 studies, followed by Qirong Runchang oral liquid, with 21 studies, and Biantong tablets (capsules), with 19 studies. There are 10 studies on Congrong Tongbian oral liquid. Seventeen Chinese patent medicines had no corresponding clinical research. There were 8 study design types, and all drugs were mainly randomized controlled trials except Danggui Longhui pill. Among the intervention types, the comparison between Chinese patent medicines and western medicines was the most. The highest outcome indicators were efficacy, safety evaluation, and main symptoms or scores, and there was a lack of a unified core outcome indicator set. There were few studies on adverse reactions and the economy. Only 11.86% of the studies were funded. Clinically, Chinese patent medicines are widely used in the treatment of constipation, and the amount of related research shows an increasing trend. However, some Chinese patent medicines lack corresponding clinical evidence, and the published research has problems such as unrigorous design, ununified criteria for efficacy evaluation, lack of comprehensive evidence studies, and insufficient funds. It is hoped that more investment will be made in this field in the future, and more attention will be paid to drugs with relatively blank research and constipation syndromes with few treatments. Comprehensive evidence studies such as systematic reviews should be carried out actively. And the study design should be standardized to provide reliable evidence for the treatment of constipation with Chinese patent medicines.

7.
Article in Chinese | WPRIM | ID: wpr-942339

ABSTRACT

ObjectiveTo evaluate the methodological quality of traditional Chinese medicine (TCM) diagnosis and treatment guidelines/consensus of constipation with Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ)tool, and to study the attention situation of the included Chinese patent medicines in China's National Reimbursement Drug List in the guidelines/consensus. MethodThe data of CNKI,VIP,Wanfang Data,SinoMed,PubMed and Cochrane from the inception of the databases to October 2021 were searched to collect the TCM diagnosis and treatment guidelines/consensus of constipation. Then,the diagnosis and treatment standards and recommended Chinese patent medicines were extracted. Two researchers assessed the methodological quality of the guidelines/consensus with AGREE Ⅱ tool independently. The quality of reports was evaluated by Reporting Items for practice Guidelines in HealThcare (RIGHT) Statement. The recommended Chinese patent medicines in the guidelines/consensus were compared with those in the National Reimbursement Drug List. ResultEleven consensus and 2 guidelines were included,involving 794 experts. The scores of AGREE II were clarity of presentation(59.0%),scope and purpose(44.0%),stakeholder involvement(23.1%),rigor of development (12.1%),applicability (11.1%),and editorial independence (8.3%) from high to low. Five articles were recommended at B level(recommended after revision) and 8 articles were at C level (not recommended). The average scores of RIGHT Statement were as follows:basic information (93.59%),background (57.69%),evidence (18.46%),recommendations (20.88%),review and quality assurance (19.23%),funding,declaration and management of interests (0.00%), and other information (0.00%). The included guidelines/consensus recommended a total of 27 Chinese patent medicines,among which 20 were included in the National Reimbursement Drug List,with 4 species of Class A and 16 species of Class B, accounting for 74.1% of all recommended Chinese patent medicines. Ten purgative Chinese patent medicines in the National Reimbursement Drug List were recommended by the guidelines/consensus,accounting for 50% of all purgative drugs, and 8 were not recommended. There were prescriptions for purgation, for promoting digestion and removing food stagnation, for clearing heat and purging fire,and for warming the middle and dissipating cold,Tibetan medicine and Mongolian medicine. ConclusionBy the AGREE Ⅱ assessment,the methodological quality of the TCM diagnosis and treatment guidelines/consensus of constipation included in this study needed to be improved in the future. The report quality evaluated with RIGHT Statement was low. Most drugs included in the National Reimbursement Drug List were paid attention in the TCM diagnosis and treatment guidelines/consensus of constipation. Moreover,the drugs included in the National Reimbursement Drug List could basically fulfill the clinical needs reflexed from the guidelines/consensus recommendations. However, the reasons of some drugs failing to be included in the National Reimbursement Drug List needed to be studied in the future.

8.
Acta Pharmaceutica Sinica ; (12): 2811-2820, 2022.
Article in Chinese | WPRIM | ID: wpr-941510

ABSTRACT

Ultra-high performance liquid chromatography coupled with quadrupole/time-of-flight tandem mass spectrometry (UPLC-Q/TOF-MS/MS) has been used to detect the metabolites of schaftoside in plasma, bile, urine and feces of mice after oral administration. The study was approved by the Experimental Animal Ethics Committee from Xuzhou Medical University (No. XZMULL201612024). Compounds were identified by analyzing their high-resolution mass spectrometry data, mass spectra, and comparison with reference substances and the literatures. The parent compound and 29 metabolites were detected in the plasma, bile, urine and feces samples of mice. The main metabolic pathways of schaftoside in mice include deglycosylation/glycosylation, hydroxylation/dehydroxylation, hydrogenation, methylation, acetylation, sulfation, and glucuronidation. This study provides references for the material basis of schaftoside in vivo.

9.
Article in Chinese | WPRIM | ID: wpr-940713

ABSTRACT

The present study explored the effective approaches to realize the leading role of traditional Chinese medicine (TCM) in preventing diseases, the synergistic role in treating serious diseases, the core role in the rehabilitation of diseases and summarized the experience to provide feasible plans for the evaluation of other dominant diseases of TCM. To evaluate the effectiveness, safety, and economy of TCM in the treatment of ischemic stroke, encephalopathy project team of the China Center for Evidence-based Traditional Chinese Medicine(CCEBTCM) established an evaluation group to determine the work plan and complete the evaluation work. The concepts of the evaluation involved high-quality evidence, expert opinion survey, expert interview, and drug catalog. Under the guidance of clinical experts and methodologists, the evaluation work was completed in accordance with four steps, i.e., plan making, data collection and data extraction, evidence synthesis and evaluation, and report writing with the rapid review method. Through the review of TCM and western medicine experts, the advantage of TCM in the treatment of ischemic stroke was positioned in the convalescence period with the predominant effects of improving the neurological function defect and improving the daily living ability. In the convalescence period of stroke, TCM treatment could improve post-stroke motor dysfunction, post-stroke cognitive impairment, consciousness disorder, swallowing disorder, aphasia, constipation, urinary function, diplopia, etc., and the advantages of acupuncture, Chinese medicine, and traditional exercise were more prominent. In terms of safety, TCM treatment of ischemic stroke showed lower incidence of adverse reactions, fewer adverse events, and a milder degree of related symptoms. In terms of economic performance, the combined treatment of TCM and western medicine played a synergistic role and made the treatment cost more reasonable. Compared with conventional intervention, the integrated TCM and western medicine rehabilitation program showed more economic and social benefits.

10.
Article in Chinese | WPRIM | ID: wpr-940536

ABSTRACT

Evidence and value:impact on DEcisionMaking (EVIDEM) framework was developed by EVIDEM collaboration. Its core is the combination of multiple criteria decision analysis (MCDA) model and standardized health technology assessment (HTA) report, which aims to evaluate the overall value of medical interventions. It has been tested and implemented in the real-world evaluation environments. After more than 10 years of development, EVIDEM framework has been updated to version 10, and the relevant operation manuals have been published. More than 40 countries have joined the collaboration and more than 20 countries have carried out relevant studies. The framework is constructed with patients, population and sustainability as the overall goals, combing the evidence and value, forming a relatively complete decision-making framework system composed of 2 levels, 7 dimensions and 20 criteria. The two levels include normative universal criteria and contextual criteria. The normative universal criteria, namely EVIDEM core model, is the quantitative evaluation, consisting of 5 dimensions and 13 criteria. Contextual criteria, namely contextual tools, are qualitative evaluation, consisting of 2 dimensions and 7 criteria. The specific operation steps of EVIDEM framework include selecting and constructing criteria, assigning weights, integrating and evaluating evidence, quantitative and qualitative evaluation of value, comprehensive value estimation and ranking based on value estimation. EVIDEM framework is applicable to disease diagnosis, treatment, management and other fields. Its application scope includes medical insurance reimbursement, clinical practice decision-making, drug selection and so on, which can provide a method for more systematic, transparent and scientific healthcare decision-making. At present, the framework has been introduced into the field of traditional Chinese medicine and can provide a scientific and feasible evaluation tool and methodology system for the clinical comprehensive evaluation of Chinese patent medicine.

11.
Article in Chinese | WPRIM | ID: wpr-940467

ABSTRACT

Traditional Chinese medicine (TCM) health technology assessment (HTA) provides scientific information and decision-making basis for decision-makers at all levels to choose TCM health technology reasonably. However, it is still in its infancy. In the future, it is necessary to strengthen top-level design, improve cognition and attention, enhance talent training and cooperation, and speed up the development of evaluation criteria in line with the characteristics of TCM, so as to promote the development of HTA in TCM. Therefore, it is imperative to create a method system and tools suitable for TCM HTA. Evidence and value impact on decisionmaking (EVIDEM) framework is developed by EVIDEM collaboration. It combines evidence and value to form a relatively complete decision-making framework system, which can provide methodological support for medical insurance reimbursement, clinical practice decision-making, drug selection and so on. The introduction of EVIDEM framework into the field of TCM has methodological feasibility and practical operability, but it is still necessary to further integrate and optimize the TCM characteristics. On the basis of theoretical research, pilot studies are carried out with Chinese patent medicine as the breakthrough point, forming a preliminary framework and implementation path for the research of TCM HTA, in order to promote healthcare decision-making and achievement transformation.

12.
Article in Chinese | WPRIM | ID: wpr-940408

ABSTRACT

This study systematically evaluated the effectiveness and safety of Dingkundan combined with conventional western medicine in the treatment of female infertility. Four Chinese databases,three English databases, and two clinical trial registration platforms were retrieved from inception to April 2021. Two researchers independently carried out literature screening,data extraction,risk assessment of bias,and grading of evidence quality. RevMan 5.4.1 was used for data analysis. A total of 216 research articles were retrieved and 21 randomized controlled trials (RCTs) were included,involving 2 172 cases. The risks of bias in the included RCTs were high. As unraveled by Meta-analysis results, Dingkundan combined with western medicine for ovulation stimulation was superior to western medicine for ovulation stimulation alone in improving pregnancy rate and progesterone level [relative risk(RR)pregnancy rate=1.67,95% confidence interval(CI)(1.44,1.93);standardized mean difference (SMD)progesterone=1.21,95% CI(0.82,1.60)]. Dingkundan combined with western medicine for improving the endometrium was superior to western medicine for improving the endometrium alone in improving the pregnancy rate [RRpregnancy rate=1.35,95% CI(1.23,1.48)]. Dingkundan combined with clomiphene was more effective than clomiphene alone in regulating endometrial thickness and reducing follicle-stimulating hormone and estradiol levels [MDendometrial thickness=3.34,95% CI(3.27,3.41), MDfollicle-stimulating hormone=-0.42,95% CI(-0.65,-0.19), MDestradiol=-4.33,95% CI (-8.18,-0.48)]. Dingkundan combined with letrozole was superior to letrozole alone in increasing the follicle-stimulating hormone level and reducing the estradiol level [MD follicle-stimulating hormone=1.14,95% CI(0.49,1.78), MDestradiol =-33.65,95% CI(-59.13,-8.17)]. The single-study results showed that Dingkundan combined with conventional western medicine had certain advantages in regulating endometrial thickness,reducing follicle-stimulating hormone,luteinizing hormone,and estradiol levels,and increasing progesterone levels. The Grading of Recommendations, Assessment, Development, and Evaluation(GRADE)system was used for the evaluation of outcome indicators. The results showed that the quality of the evidence was graded moderate or low. Based on the existing evidence,Dingkundan combined with western medicine for infertility treatment had certain advantages in increasing the pregnancy rate, improving endometrial thickness, regulating hormone levels, and reducing adverse reactions. However,affected by the quality of the included trials,the results may have limitations,and high-quality RCTs are needed for verification in the future.

13.
Article in Chinese | WPRIM | ID: wpr-940407

ABSTRACT

To clarify the research progress and existing problems in the clinical research on oral Chinese patent medicine in the treatment of breast cancer. National drug catalogs and databases were searched for oral Chinese patent medicines against breast cancer. Chinese and English databases were searched for clinical trials on oral Chinese patent medicines in the treatment of breast cancer. The main functions,drug composition,literature basic characteristics,intervention measures, and outcome indicators of Chinese patent medicines were comprehensively analyzed and evaluated by a scoping review based on visual charts. In 68 Chinese patent medicines included,53% of them were potent in activating blood, resolving stasis, tonifying the kidney, and strengthening the spleen. In terms of frequency, the top drugs were Ligustri Lucidi Fructus, Astragali Radix, Moutan Cortex, Poria, and Olibanum,indicating the importance of the therapeutic principles of activating blood, resolving stasis, tonifying the kidney, and strengthening the spleen for breast cancer treatment. In 161 included clinical trials,70.71% of the intervention measures were Chinese patent medicine combined with chemotherapy. Literature studies mainly reported Xihuang pills and Huaier granules,which may be related to the combination of chemotherapy and the inclusion in the medical insurance. The outcome evaluation was mainly based on immune indexes,tumor markers,Karnofsky score,safety report and objective response rate,while the survival time and characteristic outcome indicators of traditional Chinese medicine (TCM) were insufficient. The application and research on oral Chinese patent medicine in the treatment of breast cancer have advanced in recent years,but most of the clinical research evidence is not robust,and the evaluation of outcome indicators is not standardized,which needs to be improved.

14.
Article in Chinese | WPRIM | ID: wpr-940406

ABSTRACT

This study aims to summarize the clinical research evidence on oral Chinese patent medicines for the treatment of influenza with the method of scoping review, and thus clarify the status quo and problems. Specifically, the target medicines were selected from related drug catalogues and diagnosis and treatment protocols, and the basic information of the medicines on the specifications was collected. Articles on these medicines were retrieved from Chinese and English databases for statistical analysis and visualization. Finally, 36 medicines and 87 articles were included. The main efficacy of the medicines is clearing heat and removing toxin, and the main components of the medicines are Lonicerae Japonicae Flos, Forsythiae Fructus, and Isatidis Radix. A total of 12 medicines can be used for the treatment of mumps and acute bronchitis in addition to influenza. Only 6 medicines have contraindications and adverse reactions labeled on the specifications. Papers on oral Chinese patent medicines in the treatment of influenza show an increasing trend, and the authors are from 25 provinces and cities in China. Among them, papers on Lianhuaqingwen preparations take up the largest proportion. The studies were mostly randomized controlled trials, non-randomized controlled trials, and retrospective research. A total of 13 studies were supported by national funding, and only 9 studies included more than 200 cases. The most frequently used method was the comparison of the intervention effect of Chinese patent medicines with western medicine, and the treatment course was generally 3-14 days. A total of 7 outcome indicators were used in the studies and the frequency was in the order of ① composite effective rate,② antipyretic effect, ③ symptom improvement, ④ safety indicator, ⑤ virological examination, ⑥ serum inflammatory factor, and ⑦ traditional Chinese medicine (TCM) syndrome score. The conclusions in the clinical studies show difference from the information in drug catalogues. The drug specifications are generally not standard. The available clinical studies have the limitations of small quantity, low in quality, and no demonstration of TCM advantages. In the future, it is necessary to optimize the specifications of Chinese patent medicines, enhance clinical research, further standardize the design of clinical research, and highlight the characteristics of Chinese patent medicines, thereby providing evidence to support the comprehensive clinical evaluation of oral Chinese patent medicines for influenza.

15.
Article in Chinese | WPRIM | ID: wpr-940405

ABSTRACT

To summarize the status quo of clinical evidence on oral Chinese patent medicine in the treatment of hyperlipidemia through scoping review and thereby provide a reference for clinical application and decision-making in health care. Proprietary Chinese medicines for the treatment of hyperlipidemia (dyslipidemia) were retrieved from relevant catalogs and then screened based on their instructions. Articles on the selected Chinese patent medicines were searched from Chinese and english electronic databases and screened according to the inclusion criteria, followed by data extraction and analysis. The results were described with text and graphs. ①A total of 32 Chinese patent medicines and 1 010 related articles were screened out. ②All the included Chinese patent medicines were made from Chinese medicinal materials, of which 5 were Chinese medicinal extracts,and the remaining 27 were pure Chinese medicinal preparations (the compositions of 1 prescription is confidential). ③As indicated in the instructions, all the 32 Chinese patent medicines can be used to treat hyperlipidemia with the main syndrome of combined phlegm and blood stasis, and the main effect of them is activating blood and resolving stasis. ④Among the 32 medicines, Xuezhikang tablets (Capsules) and Gypenosides Tablets have the lowest price. ⑤For the 328 key clinical studies, 248 were randomized controlled trials and 80 non-randomized controlled trials. ⑥As for the sample size, randomized controlled trials generally included 28-579 cases, and non-randomized controlled trials 24-152 cases. Clinical studies with more than 200 cases accounted for 9.3% (12/129). ⑦The most common method was the comparison of the intervention effect of Chinese patent medicine and western medicine (36.5%) and Atorvastatin Calcium Tablets was the preferred western medicine control. The observation duration was generally 56 days (8 weeks). ⑧In clinical practice, the absolute value of blood lipid decrease and (total) effective rate were often used to evaluate the efficacy, and the effective rate was generally determined based on Clinical Guidelines for New Chinese Medicines. The overall quality of clinical studies on oral Chinese patent medicines is uneven and there is a lack of high-quality clinical evidence. Moreover,there are the risks of unreasonable use and uneasy use of Chinese patent medicine.It is recommended that researchers on proprietary Chinese medicine should further broaden the research ideas,focus on the top-level design of the research plan, and standardize the research process,thereby provide high-quality research evidence for the clinical use of proprietary Chinese medicine. Moreover, more efforts should be made to establish a sound mechanism for information collection and feedback of proprietary Chinese medicine, so as to reduce the risk of uneasy use.We hope that in-depth investigation and discussion should be launched by price, economy, quality evaluation, and other departments headed by the supervision department to make the price of Chinese patent medicine reasonable and fair, thereby promoting the rational use of Chinese patent medicine.

16.
Article in Chinese | WPRIM | ID: wpr-940404

ABSTRACT

This scoping review aimed to summarize the application information and clinical studies of oral Chinese patent medicines. The oral Chinese patent medicines in treating lung cancer were screened out by searching pf the drug directory, related guidelines, and medical information websites. The data including functions, application, ingredients, and prices of these medicines were collected. Six public databases were searched with the time interval of establishment to August 22, 2021 for collection of the clinical studies of oral Chinese patent medicines in the treatment of lung cancer. The expert consensuses, systematic reviews, randomized controlled trials, non-randomized controlled trials, and non-controlled trials were selected for analysis. A total of 104 oral Chinese patent medicines were screened out, including 31 capsules, 16 granules, 20 oral liquids, 17 tablets, 17 pills, and 3 ointments, in which altogether 198 herbal medicines were involved. The single-dose prices of 2, 36, and 66 medicines were > CNY 100, CNY 10-100, and < CNY 10, respectively. There were 410 clinical studies associated with 48 oral Chinese patent medicines, which were published from 1986 to 2021. These publications included 1 expert consensus, 21 systematic reviews, 277 randomized controlled trials, 87 non-randomized controlled trials, and 24 non-controlled trials. In the clinical studies, the Chinese patent medicines were usually applied in combination with radiotherapy and chemotherapy. The evaluation of primary outcomes focused on 9 indicators including clinical efficacy, quality of life, and incidence of side effects. In conclusion, the oral Chinese patent medicines demonstrated significant advantages in the treatment of lung cancer, and the relevant clinical trials were increasing year by year, with multiple outcome indicators being evaluated. More comprehensive and standardized clinical studies need to be designed for oral Chinese patent medicines in treating lung cancer in the future.

17.
Article in Chinese | WPRIM | ID: wpr-939518

ABSTRACT

Based on the community research experience of heat-sensitive moxibustion, this study explained technical recommendations for pragmatic randomized controlled trials (pRCTs) of heat-sensitive moxibustion in community from 7 aspects: selection of community research sites, ethical approval and registration, patient recruitment, training of standard operating procedures, ensuring patient compliance, quality control of follow-up visits and patient safety, which aimed to reduce the difficulty of research execution and improve the quality of pRCTs implementation and follow-up visits of heat-sensitive moxibustion.


Subject(s)
Follow-Up Studies , Hot Temperature , Humans , Moxibustion/methods , Randomized Controlled Trials as Topic
18.
Article in Chinese | WPRIM | ID: wpr-928103

ABSTRACT

Adhering to Chinese culture and philosophy, the development of traditional Chinese medicine(TCM) should be cooperative and open. TCM should learn from the achievements of ancient and modern scientific and technological civilization in human history and promote cultural exchange. TCM advocates unity, harmony, and interaction, and keeps going in a new information and digital era with Big Science and Extensive Health. The disciplinary development of TCM should embrace inheritance and innovation, and explore the scientific research and transformation of clinical experience. The dual attributes of science and humanity of TCM should be followed. In terms of education, "reading classics, acquiring clinical experience, and consulting experienced tutors" cannot be ignored. Underpinned by Xiang-thinking, TCM development should highlight the originality and learn from the failures of excessive westernization in the past with an inclusive attitude to forge through disciplines to the leading position.


Subject(s)
Humans , Medicine, Chinese Traditional
19.
Article in Chinese | WPRIM | ID: wpr-927430

ABSTRACT

The existing problems in the outcomes of randomized controlled trials (RCTs) of acupuncture for vascular cognitive impairment (VCI) during recent five years are analyzed and suggestions are proposed. The RCTs of acupuncture for VCI were selected in PubMed, EMbase, Cochrane Library, Clinical Trials, CNKI database, Wanfang database, VIP database, SinoMed database and Chinese Clinical Trial Registry (ChiCTR) from January 1, 2015 to September 14, 2020. The outcomes were extracted and analyzed. As a result, 21 RCTs were included and the outcomes used were divided into 9 categories: clinical symptom/sign indexes, quality of life indexes, neuroimaging indexes, neuroelectrophysiology indexes, blood biochemical indexes, hemorheology indexes, TCM syndrome score indexes, clinical efficacy indexes, and safety indexes. Among them, the top three of the most used outcomes were clinical symptoms/signs indexes (21, 100.0%), clinical efficacy indexes (14, 66.7%) and quality of life indexes (12, 57.1%). In the RCTs of acupuncture for VCI, attention should be paid to distinguish the primary outcomes and secondary outcomes, adopt objective and standardized efficacy evaluation, and give consideration to report the outcomes of safety, health economic and TCM characteristic indexes.


Subject(s)
Acupuncture Therapy , Cognitive Dysfunction/therapy , Humans , Randomized Controlled Trials as Topic , Treatment Outcome
20.
Article in Chinese | WPRIM | ID: wpr-927343

ABSTRACT

OBJECTIVE@#To overview the methodological quality, report quality and evidence quality of the systematic review (SR) of acupuncture for vascular cognitive impairment ( VCI ).@*METHODS@#The SRs regarding acupuncture for VCI were searched in PubMed, Cochrane Library, EMbase, CNKI, SinoMed, Wanfang and VIP databases. The retrieval period was from the establishment of the database to September 24, 2020. The report quality, methodological quality and evidence quality of the included SRs were evaluated by PRISMA statement, the AMSTAR 2 tool and the GRADE system.@*RESULTS@#A total of 22 SRs were included, including 102 outcome indexes. The methodological quality was generally low, with low scores on items 2, 5, 7, 10, 14, 15 and 16. The report quality was good, with scores ranging from 19 points to 24.5 points. The problems of report quality were mainly reflected in the aspects of structural abstract, program and registration, other analysis and funding sources. The level of outcome indexes of SRs was mostly low or very low, and the main leading factor was limitation, followed by inconsistency and inaccuracy.@*CONCLUSION@#Acupuncture for VCI is supported by low quality evidence of evidence-based medicine, but the methodological quality and evidence body quality of relevant SRs are poor, and the standardization is needed to be improved.


Subject(s)
Acupuncture Therapy , Cognitive Dysfunction/therapy , Databases, Factual , Humans , Research Report , Systematic Reviews as Topic
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