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1.
Article in Chinese | WPRIM | ID: wpr-970494

ABSTRACT

Pharmaceutical products need to ensure the effectiveness, safety and quality controllability through scientific supervision, and as the broad masses of the people are full of new expectations for the supply of high-quality traditional Chinese medicine products, the reform and innovation of traditional Chinese medicine regulatory policies are also facing new opportunities and new challenges. National Medical Products Administration, National Administration of Traditional Chinese Medicine and other relevant departments have implemented the requirements of the Party Central Committee and the State Council, vigorously promoted the reform of the regulatory system in line with the characteristics of traditional Chinese medicine, introduced a series of innovative policies, and achieved phased results. Including the new registration classification standards in line with the characteristics of traditional Chinese medicine, encouraging the development of classical formulas and hospital preparations, encouraging the research and development of symptomatic Chinese medicines, and gra-dually improving the "three-combined " evidence system. However, in the face of the development problems of traditional Chinese medicine in the new era, it is still necessary to improve the scientific supervision system, further optimize the management measures for the registration of traditional Chinese medicines based on classical formulas, accelerate the improvement of the standard system for traditional Chinese medicine formula granules, and form management measures to encourage and support the secondary development of traditional Chinese medicines. In terms of scientific supervision of traditional Chinese medicine, it is necessary to follow the characteristics and development laws of traditional Chinese medicine itself, comprehensively consider the characteristics of epochal, scientific and systematic in regulatory policies, and serve the inheritance and innovative development of traditional Chinese medicine with scientific supervision.


Subject(s)
Humans , Medicine, Chinese Traditional , Drugs, Chinese Herbal/therapeutic use , Pharmaceutical Preparations , Reference Standards
2.
Article in Chinese | WPRIM | ID: wpr-928192

ABSTRACT

This study aims to systematically evaluate the effect of oral Chinese patent medicines on hypertension with network Meta-analysis. Randomized controlled trials on the treatment of hypertension with oral Chinese patent medicine combined with conventional western medicine were retrieved from China National Knowledge Infrastructure(CNKI), Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library(from establishment of the database to August 2021). Two researchers independently screened the articles, extracted the data, and evaluated article quality. Then R 4.1.0 was employed for data analysis. Finally, 195 eligible articles were screened out, involving 22 546 patients and 18 oral Chinese patent medicines. The results of the network Meta-analysis are as follows. In terms of reducing systolic blood pressure(SBP) and diastolic blood pressure(DBP), Xuesaitong, Qiangli Dingxuan Tablets, Songling Xuemaikang Capsules combined with conventional western medicine are superior. In improving blood lipids, the overall effects of Xinmaitong Capsules, Compound Xueshuantong Capsules, Ginkgo Folium preparations, Yindan Xinnaotong Soft Capsules, and Naoxintong Capsules combined with conventional western medicine are outstanding. In terms of regulating endothelial function, Yindan Xinnaotong Soft Capsules, Xinmaitong Capsules, Zhenju Jiangya Tablets, Compound Danshen Dripping Pills, Xuesaitong with conventional western medicine have certain advantages. As for the safety, the incidence of adverse reactions of conventional western medicine combined with oral Chinese patent medicines is lower than that of conventional western medicine alone. In summary, compared with conventional western medicine alone, the 18 oral Chinese patent medicines combined with conventional western medicine in the treatment of hypertension show advantages in improving blood pressure, blood lipids, and endothelial function. Among them, Xuesaitong, Qiangli Dingxuan Tablets, and Songling Xuemaikang Capsules may be the best oral Chinese patent medicines for lowering blood pressure. The conclusion needs to be further verified by more high-quality studies.


Subject(s)
Humans , Antihypertensive Agents , Capsules , Drugs, Chinese Herbal/adverse effects , Hypertension/drug therapy , Network Meta-Analysis , Nonprescription Drugs
3.
Chinese Acupuncture & Moxibustion ; (12): 1216-1220, 2021.
Article in Chinese | WPRIM | ID: wpr-921035

ABSTRACT

OBJECTIVE@#To compare the effect of moxibustion combined with basic treatment and simple basic treatment on the clinical symptoms, renal function and hypercoagulable state in patients with idiopathic membranous nephropathy (IMN) of low to medium risk with spleen-kidney deficiency and blood stasis.@*METHODS@#A total of 60 patients with IMN of low to medium risk with spleen-kidney deficiency and blood stasis were randomized into an observation group (30 cases, 2 cases dropped off) and a control group (30 cases, 1 case dropped off). In the control group, the conventional basic treatment of anti-hypertension, regulating blood lipid and anti-coagulation was adopted. On the basis of the control group, moxibustion was applied at Shenshu (BL 23), Pishu (BL 20), Guanyuan (CV 4), Zusanli (ST 36) and Sanyinjiao (SP 6) in the observation group, once a day, 5 days a week continuously with 2 day interval. The treatment of 6 months was required in the both groups. Before treatment and 3 and 6 months into treatment, the total TCM syndrome score, the renal function indexes (24-hour urinary protein quantity [UTP], albumin [ALB], urea nitrogen [BUN] and creatinine [Scr]), the blood coagulation indexes (fibrinogen [FIB], D-Dimer [D-D], p-selection and von Willebrand factor [vWF]), total cholesterol (TC) and triacylglycerol (TG) levels were observed, and the therapeutic efficacy was evaluated on 3 and 6 months into treatment in the two groups.@*RESULTS@#The effective rates of 3 and 6 months into treatment were 78.6% (22/28) and 89.3% (25/28) in the observation group, which were higher than 62.1% (18/29) and 75.9% (22/29) in the control group respectively (@*CONCLUSION@#Moxibustion combined with basic treatment can effectively improve the clinical symptoms, renal function and renal microcirculation in patients with idiopathic membranous nephropathy of low to medium risk with spleen-kidney deficiency and blood stasis, the therapeutic effect is superior to the simple basic treatment.


Subject(s)
Humans , Acupuncture Points , Acupuncture Therapy , Glomerulonephritis, Membranous , Kidney/physiology , Moxibustion , Spleen
4.
Article in Chinese | WPRIM | ID: wpr-906335

ABSTRACT

Objective:To observe the clinical efficacy as well as anti-inflammatory and anti-fibrosis mechanism of Yishen Tongluo decoction in the treatment of chronic glomerulonephritis (CGN) with spleen and kidney Qi deficiency and blood stasis syndrome. Method:According to the random number table method, one hundred and twenty patients were divided into control group (60 cases) and observation group (60 cases). The two groups were given oral valsartan capsules, 160 mg/time, 1 time/day, and dipyridamole tablets orally, 50 mg/time, 3 times/day. Patients in control group additionally took Wubi Shanyao pills orally, 9 g/time, 2 times/day, while patients in observation group additionally took Yishen Tongluo decoction orally, 1 dose/day. Both groups were treated continuously for four months. Before and after treatment, 24 h urine total protein (24 h UTP), creatinine (SCr), urea nitrogen (BUN), serum cystatin C (CysC), tumor necrosis factor-<italic>α</italic> (TNF-<italic>α</italic>), interleukin-6 (IL-6), IL-17, interferon-<italic>γ</italic> (IFN-<italic>γ</italic>), transforming growth factor-<italic>β</italic><sub>1</sub> (TGF-<italic>β</italic><sub>1</sub>), connective tissue growth factor (CTGF), matrix metalloproteinase-9 (MMP-9), tissue inhibitor of metalloproteinases (TMP-1) and hypoxia inducible factor-1<italic>α </italic>(HIF-1<italic>α</italic>) levels were detected in both groups. The scores of spleen and kidney Qi deficiency and blood stasis syndrome were graded. Urine protein, and urine red blood cells (urinary RBC) were monitored. Result:The 24 h UTP, SCr, BUN and CysC levels of the observation group were lower than those of the control group (<italic>P</italic><0.01). The score of spleen and kidney Qi deficiency and blood stasis syndrome in the observation group was lower than that in the control group (<italic>P</italic><0.01). The levels of TNF-<italic>α</italic>, IL-6, IL-17 and IFN-<italic>γ </italic>in the observation group were lower than those in the control group (<italic>P</italic><0.01). The levels of TGF-<italic>β</italic><sub>1</sub>, CTGF, TMP-1 and HIF-1<italic>α</italic> in the observation group were lower than those in the control group (<italic>P</italic><0.01). While MMP-9 level was higher than that in control group (<italic>P</italic><0.01). The clinical effective rate was 88.33% (53/60) in the observation group, higher than 73.33% (44/60) in the control group (<inline-formula><alternatives><mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:msup><mml:mrow><mml:mi>χ</mml:mi></mml:mrow><mml:mrow><mml:mn mathvariant="normal">2</mml:mn></mml:mrow></mml:msup></mml:math><graphic specific-use="big" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/155A9E27-C0C9-44b4-96FF-AF947372054E-M002.jpg"><?fx-imagestate width="3.30200005" height="3.64066648"?></graphic><graphic specific-use="small" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/155A9E27-C0C9-44b4-96FF-AF947372054E-M002c.jpg"><?fx-imagestate width="3.30200005" height="3.64066648"?></graphic></alternatives></inline-formula>=4.356, <italic>P</italic><0.05). Conclusion:On the basis of conventional Western medicine treatment, Yishen Tongluo decoction in the treatment of CGN patients with spleen and kidney Qi deficiency and blood stasis syndrome can reduce proteinuria, and improve traditional Chinese medicine (TCM) syndromes, with anti-inflammatory and anti-kidney fibrosis effects. Thereby, it plays a role in protecting renal function and delaying the malignant progression of renal function, with high clinical efficacy and value of clinical use.

5.
Article in Chinese | WPRIM | ID: wpr-879029

ABSTRACT

To systemically evaluate the efficacy and safety of Maxing Shigan Decoction in the treatment of community acquired pneumonia(CAP) and provide a reference for the treatment of CAP. Databases of CNKI, Wanfang, VIP, SinoMed, EMbase, Cochrane Library, Web of Science and PubMed were searched(from inception to May 30, 2020) to screen the randomized controlled trials(RCTs) of Maxing Shigan Decoction in treating CAP. Two authors independently screened and selected relevant literature and extracted data based on the inclusion and exclusion criteria. Any disagreement or differences was resolved through discussion. The bias risk assessment tool recommended by Cochrane handbook was used to evaluate the quality of the included studies, and RevMan 5.3 software was used for data analysis. Seventeen RCTs were finally included, involving 1 309 patients. Meta-analysis showed that Maxing Shigan Decoction combined with conventional Western medicine treatment could improve clinical efficacy in patients with CAP more effectively as compared with conventional Western medicine treatment alone, mainly in terms of anti-inflammatory effects, a decrease in C-reactive protein(CRP) content(MD=-6.01, 95%CI[-10.95,-1.06], P=0.02)and white blood cell(WBC) count, a decrease in procalcitonin(PCT) level(MD=-0.74, 95%CI[-0.77,-0.71], P<0.000 1), and shortened recovery time of cough and fever. Maxing Shigan Decoction has certain curative effect on CAP, but there are problems in the methodology of included studies. High-quality stu-dies are still needed for further verification.


Subject(s)
Humans , Community-Acquired Infections/drug therapy , Cough , Drugs, Chinese Herbal , Pneumonia/drug therapy , Randomized Controlled Trials as Topic , Treatment Outcome
6.
Article in Chinese | WPRIM | ID: wpr-879163

ABSTRACT

To systematically evaluate the clinical efficacy and safety of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy. China National Knowledge Infrastructure(CNKI), Wanfang, VIP, PubMed, EMbase, Cochrane Library, Ovid and Web of Science databases were searched by computer to retrieve the randomized controlled trials(RCTs) of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy from the establishment of databases to July 2020. After two researchers performed data retrieval, data extraction, and risk assessment of bias, they used RevMan 5.3 software for Meta-analysis. A total of 10 RCTs were included, with a total of 979 patients. Meta-analysis results showed that in terms of interventricular septal thickness(MD=-0.70, 95%CI[-1.15,-0.24], P=0.003), left ventricular posterior wall thickness(MD=-0.81, 95%CI[-1.41,-0.21], P=0.008), left ventricular mass index(MD=-8.75, 95%CI[-17.40,-0.10], P=0.05), systolic blood pressure(MD=-8.97, 95%CI[-13.46,-4.48], P<0.000 1), diastolic blood pressure(MD=-5.87, 95%CI[-8.39,-3.34], P<0.000 01) and left ventricular end-diastolic diameter(MD=-1.73, 95%CI[-2.38,-1.08], P<0.000 01), Compound Danshen Dripping Pills combined with conventional antihypertensive drugs was superior to conventional antihypertensive drugs. In terms of left ventricular ejection fraction(MD=0.41, 95%CI[-0.74, 1.55], P=0.49), there was no statistical difference in treatment between the two groups. Because of the small amount of literatures included in the safety aspect, it is impossible to give an accurate conclusion. The GRADE score showed that the level of evidence was low and extremely low. The results show that the Compound Danshen Dripping Pills combined with conventional antihypertensive drugs may effectively improve the clinical efficacy for hypertensive ventricular hypertrophy, and the safety needs to be further explored. Due to the low quality of the included literatures, more high-quality RCTs are needed for verification.


Subject(s)
Humans , Antihypertensive Agents/adverse effects , China , Drugs, Chinese Herbal/adverse effects , Hypertrophy, Left Ventricular/drug therapy , Stroke Volume , Treatment Outcome , Ventricular Function, Left
7.
Zhongguo Zhong Yao Za Zhi ; 45(18): 4500-4509, 2020 Sep.
Article in Chinese | MEDLINE | ID: mdl-33164381

ABSTRACT

Network Meta-analysis has been widely applied in the field of traditional Chinese medicine(TCM) due to its unique advantages. This study aimed to conduct a visual analysis on the state of the application network Meta-analysis in the field of traditional Chinese medicine. Databases of CNKI and Web of Science were retrieved to identify the qualified literatures and then screen out their titles and abstracts. Institutions, authors, cited references, and keywords were analyzed using the information visualization analysis software CiteSpace. Finally, 79 English and 186 Chinese articles were included. The results indicated that the literatures were mainly published in Chinese, and the number of articles was increased rapidly since 2015. Cooperation between institutions and authors were mainly concentrated inside the institutions. The most important four institutions were four universities who attached more importance to evidence-based medical education and academic exploration. The keywords beside the method of network Meta-analysis could be summarized into three types: the main interventions in traditional Chinese medicine(Chinese herbal injection, herb medicine, acupuncture, etc.), disease types(cancer, circulatory system disease, bone joint disease, urinary system disease, etc.) and the outcome of interests(efficacy, safety, symptom, survive, mortality, etc.), which reflected the current research hotspots to certain extent. In addition, the most cited articles were methodology articles, including the introduction of methodology and the guides of application software, suggesting that the exploration of methodological articles will be extremely concerned.


Subject(s)
Acupuncture Therapy , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Network Meta-Analysis , Publications , Research Design
8.
Article in Chinese | WPRIM | ID: wpr-828023

ABSTRACT

Coronavirus disease 2019(COVID-19) is a newly emerged and highly contagious respiratory disease. Traditional Chinese medicine(TCM) has both systematism theory knowledge and clinical practical value in the prevention and treatment of COVID-19. Therefore, it was particularly important to examine the effect of TCM in the prevention and treatment of COVID-19. The patents of TCM might reflect the latest progression of scientific research. We aimed to provide reference for the prevention and treatment of COVID-19 by extracting and analyzing the TCM patents from the Patent Information Sharing Platform of COVID-19. The antiviral TCM patents were screened and exported from the Patent Information Sharing Platform. VOSviewer 1.6.14 was used to visualize and analyze the network of TCM in these patents. There were total 292 TCM patents, including 52 patents for etiological treatment and 240 patents for symptomatic treatment. Thirty-two provinces and 1 076 inventors were involved, mainly from Beijing, Guangdong and Jiangsu. Overall, there were 356 TCMs, 71 single prescriptions, and 221 compound prescriptions. The patents for treatment of coronavirus mainly focused on the treatment of coronavirus, while the patents for symptomatic treatment mainly focuses on the improvement of respiratory symptoms, such as fever and cough. There were 14 highly frequently used TCMs, including Glycyrrhizae Radix et Rhizoma, Scutellariae Radix, Lonicerae Japonicae Flos, Forsythiae Fructus, Isatidis Radix, Astragali Radix, Menthae Haplocalycis Herba, Gypsum Fibrosum, Houttuyniae Herba, Isatidis Folium, Rhei Radix et Rhizoma, Gardeniae Fructus, Platycodonis Radix, Armeniacae Semen Amarum. The analyzed results of the TCM patents from the patent information sharing platform of COVID-19 were consistent with the Guideline of Diagnosis and Treatment of COVID-19(7th edition), and the combination of TCM in each cluster may also provide future directions for drug compatibility.


Subject(s)
Humans , Beijing , Betacoronavirus , Coronavirus Infections , Drug Therapy , Drugs, Chinese Herbal , Information Dissemination , Medicine, Chinese Traditional , Pandemics , Pneumonia, Viral , Drug Therapy
9.
Article in Chinese | WPRIM | ID: wpr-773146

ABSTRACT

To assess the clinical efficacy of Yiqi Huoxue Chinese patent medicine for coronary heart disease with angina pectoris by using network Meta-analysis method. The relative randomized controlled trials( RCTs) of Yiqi Huoxue Chinese patent medicine for coronary heart disease with angina pectoris were retrieved from China National Knowledge Infrastructure( CNKI),Wan Fang,VIP and Chinese Biomedical Literature Database( CBM) in July 2018. Two researchers independently completed the literature screening,data extraction and quality evaluation according to the pre-determined inclusion and exclusion criteria,and the results were cross-checked.The data were analyzed by Win Bugs,and STATA software was used for plotting. Finally,114 RCTs were included,involving 7 Yiqi Huoxue Chinese patent medicines and 11 775 patients. Network Meta-analysis showed that the total effective rate for improvement in AP symptoms had 7 direct comparisons and 21 indirect comparisons,8 of which were statistically significant. The ECG improvement had 7 direct comparisons and 21 indirect comparisons,7 of which were statistically significant. In terms of the total effective rate of improvement in AP symptoms,the order of efficacy was as follows: Shensong Yangxin Capsules > Shexiang Baoxin Pills > Qishen Yiqi Dropping Pills > Tongxinluo Capsules > Wenxin Granules > Qishen Capsules > Naoxintong Capsules. In terms of ECG improvement,the order of efficacy was as follows: Shexiang Baoxin Pills > Tongxinluo Capsules > Naoxintong Capsules > Qishen Yiqi Dropping Pills> Wenxin Granules > Shensong Yangxin Capsules > Qishen Capsules. The results showed that Shensong Yangxin Capsules and Shexiang Baoxin Pills had certain advantages in the treatment of coronary heart disease with angina pectoris. Due to the small sample size,more studies were required to further verify the evidences.


Subject(s)
Humans , Angina Pectoris , Drug Therapy , China , Coronary Disease , Drug Therapy , Drugs, Chinese Herbal , Therapeutic Uses , Network Meta-Analysis , Nonprescription Drugs , Randomized Controlled Trials as Topic
10.
Article in Chinese | WPRIM | ID: wpr-773282

ABSTRACT

To systematically review the efficacy and safety of Tongmai Yangxin Pills in treatment for angina pectoris of coronary heart disease. CNKI, WanFang, VIP, SinoMed, PubMed, EMbase and the Cochrane Library databases were retrieved online to collect randomized controlled trials(RCTs) of Tongmai Yangxin Pills for angina pectoris of coronary heart disease since the establishment to November 2018. Two investigators screened out literatures independently, extracted data and assessed the risk of bias of included studies. The risk assessment of included references was made according to criteria recommended by Cochrane Handbook 5.3. Meta-analysis was then performed by RevMan 5.3 software. A total of 9 RCTs were included. The results of Meta-analysis showed that compared with the single application of chemotherapy, the combined administration with Tongmai Yangxin Pills and Western medicine could significantly improve the clinical efficacy of angina(RR=1.22, 95%CI[1.13, 1.31]), the improvement rate of electrocardiogram(RR=1.31, 95%CI[1.21, 1.42]), and the clinical efficacy of traditional Chinese medicine(TCM) syndrome(RR=1.17, 95%CI[1.02, 1.35]). Only one study reported adverse events, while 5 studies reported no adverse event. According to current evidences, in the treatment of angina pectoris of coronary heart disease, Tongmai Yangxin Pills has a better clinical efficacy in the treatment of angina pectoris of coronary heart disease in terms of the improvement rate of electrocardiogram and the clinical efficacy of TCM syndrome. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.


Subject(s)
Humans , Angina Pectoris , Drug Therapy , Coronary Disease , Drug Therapy , Drugs, Chinese Herbal , Therapeutic Uses , Electrocardiography , Medicine, Chinese Traditional , Randomized Controlled Trials as Topic
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