1.Evaluation of GRADE Clinical Research Evidence of Chinese Patent Medicine Combined with Western Medicine in Treatment of Hypertension with Dyslipidemia
Jiaheng WANG ; Yukun LI ; Liangyu CUI ; Yilan ZHENG ; Zhiwei ZHAO ; Cong REN ; Tianyue JING ; Tong YIN ; Liying WANG ; Xuejie HAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(10):95-105
ObjectiveTo evaluate the effect of antihypertensive and lipid-regulating Chinese patent medicine combined with conventional Western medicine in the treatment of hypertension with dyslipidemia. To carry out the evidence synthesis of clinical research and provide evidence-based evidence support for clinical decision-making. MethodThe databases including China National Knowledge Infrastructure (CNKI),Wanfang Data Knowledge Service Platform (WF),VIP,SinoMed,Embase,PubMed,Web of Science (WOS),and the Cochrane Library were searched for randomized controlled trials (RCT) of all listed Chinese patent medicines in the treatment of hypertension with dyslipidemia from the establishment of the databases to April 15,2023. The literature was screened and extracted,and the risk of bias tool 2.0 (RoB2) was used to assess the quality and risk of bias of the methodology. Revman 5.4.1 software was used to analyze the outcome indicators. Grading of Recommendations Assessment,Development and Evaluation (GRADE) was applied to assess the quality of evidence formed by clinical research data. The inclusion and recommendation of Chinese patent medicines in the National Drug Catalogue for Basic Medical Insurance,Work-related Injury Insurance and Maternity Insurance (2022) and domestic guidelines and consensus were searched to form a bubble chart. ResultA total of 15 studies were included. The evaluation of the methodological quality of each study showed that the risk of bias stemmed from the lack of blinding and allocation concealment,and low sample size. The comprehensive analysis of clinical studies showed that Dengzhan Shengmai capsules combined with rosuvastatin and amlodipine besylate,Yindan Xinnaotong capsules combined with simvastatin and levamlodipine tablets,Xiaoshuan Tongluo capsules combined with nifedipine controlled release tablets and pravastatin sodium tablets,Xinshubao capsules combined with atorvastatin calcium tablets and irbesartan,Wenyading capsules combined with enalapril,and Jiangzhining tablets combined with conventional Western medicines were all superior to conventional Western medicines used in the control group in improving systolic blood pressure (SBP),diastolic blood pressure (DBP),cholesterol (TC),triglyceride (TG),low density lipoprotein cholesterol (LDL-C),and high density lipoprotein cholesterol (HDL-C). There was no significant difference in the incidence of adverse reactions between the two groups. The GRADE evaluation of the main outcome indicators showed that the evidence quality of SBP and incidence of adverse reactions was graded as B,that of DBP as C,and that of total TC,TG,LDL-C,and HDL-C as D. The evaluation of Chinese patent medicines covered by medical insurance and recommended by guidelines and consensus showed that Yindan Xinnaotong soft capsules,Dengzhan Shengmai capsules and Xiaoshuan Tongluo capsules belonged to class B drugs of medical insurance,and were recommended for 7,6 and 3 times in the guidelines and consensus,respectively. ConclusionCompared with simple medicine treatment,Chinese patent medicine combined with conventional Western medicine has more advantages in improving blood pressure and blood lipid,and shows higher safety. Among them,Yindan Xinnaotong soft capsules,Dengzhan Shengmai capsules and Xiaoshuan Tongluo capsules have stronger clinical applicability and economy. All the trials included in this article adhered to the principle of randomization and reported the outcome measures. However,the quality of evidence in related clinical studies was low. In terms of trial design,large-sample,multi-center,blinded randomized controlled trials based on the consolidated standards of reporting trials (CONSORT) statement are still needed for comprehensive trial designs and reporting,to further improve the GRADE quality evaluation and guideline formulation under the guidance of evidence-based medicine,so as to provide higher quality evidence-based research evidence for clinical decision-making.
2.GRADE Clinical Study Evidence Evaluation and Expert Consensus on Antihypertensive Chinese Patent Medicines Combined with Western Medicines for Treatment of Hypertension
Liangyu CUI ; Yukun LI ; Tianyue JING ; Yu WANG ; Cong REN ; Tong YIN ; Zhiwei ZHAO ; Jiaheng WANG ; Chenge SUN ; Dasheng LIU ; Zhizheng XING ; Xuejie HAN ; Liying WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(10):106-115
ObjectiveTo evaluate the quality of research and evidence related to antihypertensive Chinese patent medicines combined with western medicines for the treatment of hypertension, synthesize and update the evidence, form expert consensus, and provide evidence for clinical decision-making. MethodThe databases of China National Knowledge Infrastructure (CNKI), WanFang Data Knowledge Service Platform (WanFang), Vip Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Service System (Sinomed), National Library of Medicine (PubMed), Cochrane Library, Web of Science, and US Clinical Trials Registry were searched for randomized controlled trials of antihypertensive Chinese medicine combined with western medicine for the treatment of hypertension from database construction to July 31, 2022. The quality of the literature was evaluated using the bias risk assessment tool in Cochrane Handbook 6.3. Evidence synthesis of main outcome indicators was performed using R software. The Grading of Recommendations Assessment, Development, and Evaluation profiler (GRADEprofiler) 3.6 was employed to evaluate the quality of evidence. Expert consensus was formed based on the Delphi method after two rounds of voting. Result64 pieces of literature were included, and the results of literature quality evaluation and risk of bias showed that 70.31% (45/64) of the studies indicated some risks, and 29.69% (19/64) indicated high risks. Compared with conventional western medicines, the combination of Chinese patent medicines with western medicines can significantly lower systolic pressure (SBP) and diastolic pressure (DBP), increase the effective rate of antihypertensive, reduce the incidence of adverse reactions, endothelin-1, and traditional Chinese medicine syndrome scores. Egger's test showed that Songling Xuemaikang capsules reduced SBP and DBP. Tianma Gouteng granules reduced SBP and DBP and increased the effective rate of antihypertensive, and Xinmaitong capsules reduced SBP and increased the effective rate of antihypertensive, without significant publication bias. Songling Xuemaikang capsules increased the effective rate of antihypertensive, and Xinmaitong capsules decreased DBP, with significant publication bias. The results of the GRADE evidence quality evaluation showed that most evidence was at grades B and C. Finally, four strong recommendations and 14 weak recommendations were formed. ConclusionCompared with conventional western medicines for the treatment of hypertension, antihypertensive Chinese patent medicines combined with western medicines have advantages in reducing blood pressure and improving drug use safety, but they are mostly weak recommendations in terms of efficacy, and more high-quality evidence is needed.
3.Clinical Evidence Mapping of Chinese Patent Medicines Combined with Western Medicine in Treatment of Hypertension
Yukun LI ; Liangyu CUI ; Zhiwei ZHAO ; Cong REN ; Tong YIN ; Yu WANG ; Liying WANG ; Xuejie HAN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(10):116-123
ObjectiveTo systematically collect, analyze, and evaluate the randomized controlled trials (RCT) of Chinese patent medicine combined with western medicine in the treatment of hypertension, map the evidence, and provide reference for the future clinical research and formulation of guidelines and policies. MethodThe relevant articles were retrieved from China Biology Medicine disc, China National Knowledge Infrastructure (CNKI), VIP, Wanfang Data, PubMed, Embase, and Cochrane Library with the time interval from inception to December 31, 2022. The RCT of Chinese patent medicines combined with western medicine in the treatment of hypertension were included. The research characteristics and methodological quality were analyzed and evaluated. ResultA total of 330 RCTs of treating hypertension with Chinese patent medicines combined with Western medicine were included in this study, all of which were published in Chinese. These RCTs involved 88 Chinese patent medicines and 37 788 patients, and 46% of RCT had the sample size ≥100 patients. Eighty-seven percent of RCT showed the study period within 3 months. All the interventions in the RCTs were Chinese patent medicine + western medicine vs western medicine. Among the evaluation indicators, blood pressure, response rate, TCM syndrome score, endothelial cell function, and safety were mainly concerned. In terms of methodological quality, most articles did not mention the generation of random sequences, allocation concealment, or blinding method. The blinding evaluation of outcomes showed low risks of bias, and there was insufficient information to judge whether there was selective bias or other bias. ConclusionThere were many Chinese patent medicines used in combination with western medicine in the treatment of hypertension, and they were mainly taken orally. The existing RCT had problems such as small sample size, unclear clinical value positioning, imperfect design failing to reflect the value of Chinese patent medicines, unreasonable measurement indicators, and non-standard measurement methods. Future research should solve the above problems, improve the research quality, value, and authenticity, and enhance the reliability and extension of evidence.
4.Investigation on the Improvement of Adverse Reactions of Paclitaxel by Nanoparticle Albumin-bound Paclitaxel and Its Clinical Status
Xunan LI ; Liying QIU ; Jian YIN ; Jing HU
Chinese Journal of Modern Applied Pharmacy 2024;41(7):962-967
OBJECTIVE
To investigate the clinical incidence and severity of adverse reactions related to nano-albumin-bound paclitaxel(Nab-P) and traditional solvent-based paclitaxel chemotherapy, and analyze the improvement of adverse reactions of paclitaxel treatment by nano-albumin delivery system.
METHODS
A hospital information system was used to retrospectively investigate 326 cancer patients received Nab-P chemotherapy and 303 paclitaxel chemotherapy patients who were diagnosed in the Department of Oncology of the Affiliated Hospital of Jiangnan University from July 2019 to December 2021. The information of the adverse reactions related to Nab-P and paclitaxel treatment was extracted from the electronic medical records and nursing record sheets, to explore the effect and clinical status of the nano albumin drug delivery system to improve the adverse reactions of chemotherapy.
RESULTS
Nab-P and paclitaxel-related adverse reactions such as nausea, vomiting, allergic reactions, myelosuppression, liver injury, paresthesias, phlebitis and others were significantly different in incidence and severity(P<0.05). The incidence and severity of Nab-P-related myelosuppression was higher than that of paclitaxel, while the incidence and severity of all other adverse reactions treated with Nab-P were lower.
CONCLUSION
Except for myelosuppression, Nab-P-related adverse reactions are significantly lower than traditional paclitaxel. Therefor, for patients undergoing Nab-P chemotherapy, more attention should be paid to the occurrence of myelosuppression.
5.The Research Status and Thinking of Objectification of Diagnosis by Integrating Prior Knowledge and Information Technology
Chenge SUN ; Yukun LI ; Zhiwei ZHAO ; Linshuang WANG ; Liangyu CUI ; Tong YIN ; Liying WANG ; Xuejie HAN ; Dasheng LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(6):1654-1659
In order to solve the problem of strong subjectivity and difficulty in quantification,clinical objectification mainly adopts the techniques of image processing,computer vision and machine learning.The acquisition and processing of prior knowledge is a key link in the objectification of inspection,as well as an important elaboration of the quantification of subjective judgment and macro performance in objectification research.However,there is still a lack of in-depth summary and parametric processing of prior knowledge.Based on the analysis of the current research status of objectification of inspection,this paper uses data mining technology to summarize the experience of TCM inspection.Moreover,the observation information can be transformed into quantifiable digital features through natural language processing and representation learning.Meanwhile,the application of deep learning can realize automatic diagnosis and analysis of observation images to improve accuracy and efficiency,and promote the process of TCM modernization.
6.Compound Danshen Dripping Pill inhibits hypercholesterolemia/atherosclerosis-induced heart failure in ApoE and LDLR dual deficient mice via multiple mechanisms.
Yanfang YANG ; Ke FENG ; Liying YUAN ; Yuxin LIU ; Mengying ZHANG ; Kaimin GUO ; Zequn YIN ; Wenjia WANG ; Shuiping ZHOU ; He SUN ; Kaijing YAN ; Xijun YAN ; Xuerui WANG ; Yajun DUAN ; Yunhui HU ; Jihong HAN
Acta Pharmaceutica Sinica B 2023;13(3):1036-1052
Heart failure is the leading cause of death worldwide. Compound Danshen Dripping Pill (CDDP) or CDDP combined with simvastatin has been widely used to treat patients with myocardial infarction and other cardiovascular diseases in China. However, the effect of CDDP on hypercholesterolemia/atherosclerosis-induced heart failure is unknown. We constructed a new model of heart failure induced by hypercholesterolemia/atherosclerosis in apolipoprotein E (ApoE) and LDL receptor (LDLR) dual deficient (ApoE-/-LDLR-/-) mice and investigated the effect of CDDP or CDDP plus a low dose of simvastatin on the heart failure. CDDP or CDDP plus a low dose of simvastatin inhibited heart injury by multiple actions including anti-myocardial dysfunction and anti-fibrosis. Mechanistically, both Wnt and lysine-specific demethylase 4A (KDM4A) pathways were significantly activated in mice with heart injury. Conversely, CDDP or CDDP plus a low dose of simvastatin inhibited Wnt pathway by markedly up-regulating expression of Wnt inhibitors. While the anti-inflammation and anti-oxidative stress by CDDP were achieved by inhibiting KDM4A expression and activity. In addition, CDDP attenuated simvastatin-induced myolysis in skeletal muscle. Taken together, our study suggests that CDDP or CDDP plus a low dose of simvastatin can be an effective therapy to reduce hypercholesterolemia/atherosclerosis-induced heart failure.
7.Progress in Diagnosis and Treatment of Proteus Syndrome
Yuehan YIN ; Liying SUN ; Wen TIAN
JOURNAL OF RARE DISEASES 2023;2(4):626-632
Proteus syndrome is a rare congenital hamartomatous syndrome characterized by the asymmetric and disproportionate overgrowth of limbs, emergence of connective tissue nevi, epidermal nevi, ysregulated adipose tissue, and vascular malformations. The Proteus syndrome is caused by mosaicism of somatic activating mutation in the AKT1 gene which locates at chromosome 14q32.3. This syndrome is extremely rare, making it difficult to diagnose. The most commonly used diagnostic criteria are too complicated to be used in clinical practice. Surgery can partially alleviate the clinical symptoms of overgrowth, but it can't inhibit the progression of the disease. This article summarizes the diagnostic criteria, treatment principles, and perioperative managements for Proteus syndrome in the world. The article proposes the highly suspected morphological manifestations of Proteus syndrome was based on clinical experiences of the author.The article emphasizes using genetic detection of pathological tissue as the gold standard for diagnosis, and suggests targeted therapy as the optimal treatment for Proteus syndrome.
8.Differential diagnosis of benign and malignant breast lesions using quantitative synthetic magnetic resonance imaging.
Liying ZHANG ; Xin ZHAO ; Xing YIN
Journal of Southern Medical University 2022;42(4):457-462
OBJECTIVE:
To investigate the value of quantitative synthetic magnetic resonance imaging (SyMRI) in distinguishing between benign and malignant breast lesions.
METHODS:
We retrospectively collected data of preoperative conventional MRI and multi-dynamic multi-echo sequences from 95 patients with breast lesions showing mass-type enhancement on DCE-MRI, including 27 patients with benign lesions and 68 with malignant lesions. The MRI features of the lesions (shape, margin, internal enhancement pattern, time-signal intensity curve, and T2WI signal) were analyzed, and for each lesion, SyMRI-generated quantitative parameters including T1 and T2 relaxation time and proton density (PD) were measured before and after enhancement and recorded as T1p, T2p, PDp and T1e, T2e, and PDe, respectively. The relative change rate of each parameter was calculated. Logistic regression and all-subset regression analyses were performed for variable selection to construct diagnostic models of the breast lesions, and receiver-operating characteristic (ROC) analysis was used to assess the performance of each model for differentiation of benign and malignant lesions.
RESULTS:
There were significant differences in the MRI features between benign and malignant lesions (P < 0.05). All the SyMRI-generated quantitative parameters, with the exception of T2e and Pdp, showed significant differences between benign and malignant lesions (P < 0.05). Among the constructed diagnostic models, the model based on all the DCE-MRI features combined with SyMRI parameters T2p and T1e (DCE-MRI+T2p+T1e) showed the best performance in the differential diagnosis malignant breast masses with an AUC of 0.995 (95% CI: 0.983-1.000).
CONCLUSION
Quantitative SyMRI can be used for differential diagnosis of benign and malignant breast lesions.
Breast/diagnostic imaging*
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Breast Neoplasms/diagnostic imaging*
;
Contrast Media
;
Diagnosis, Differential
;
Female
;
Humans
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Magnetic Resonance Imaging/methods*
;
ROC Curve
;
Retrospective Studies
9.Relapse risk analysis in anti-aquaporin 4-IgG positive neuromyelitis optica spectrum disorders patients treated with immunosuppressant
Hexiang YIN ; Yao ZHANG ; Wenjun WANG ; Yan XU ; Bin PENG ; Liying CUI
Chinese Journal of Neurology 2022;55(4):306-311
Objective:To investigate the relapse risk factors of anti-aquaporin 4 (AQP4)-IgG positive neuromyelitis optica spectrum disorders (NMOSD) patients treated with immunosuppressant.Methods:Data (from January 2011 to June 2021) of AQP4-IgG positive NMOSD patients treated with immunosuppressant for longer than 5 years from MSNMObase, a hospital-based electronic registry for multiple sclerosis and related disorders in Peking Union Medical College Hospital, were collected. Clinical features and risk factor differences between patients with and without relapse under the immunosuppressive therapy were analyzed.Results:One hundred and twelve patients with AQP4-IgG positive NMOSD were included, 105 (93.8%) of which were female. The disease onset age was (34.9±11.3) years, 13(11.6%) had an older disease onset age than 50 years (late onset), and the disease duration was 8.1 (6.6, 11.4) years. Sixty-four (57.1%) patients had relapse, and the proportion of late onset patients was significantly lower in relapse group than in non-relapse group [4/64(6.3%) vs 9/48(18.8%), χ2=4.18, P=0.041]. Compared with those without relapse, both the annualized relapse rate (ARR) before treatment [1.07 (0.36, 2.25) vs 0.34 (0, 1.11), Z=2.92, P=0.003] and the proportion of patients with relapse before treatment [54/64(84.4%) vs 33/48(68.8%), χ2=3.86, P=0.049] were significantly higher for patients in relapse group. Multivariate Logistic regression analysis revealed the relapse risk of late-onset patients was lower than that of early-onset patients ( HR=0.26, 95% CI 0.10-0.73, P=0.010) and patients with higher ARR before treatment showed a higher risk of relapse under the immunosuppressive therapy ( HR=1.55,95% CI 1.26-1.91, P<0.001). Conclusion:AQP4-IgG positive NMOSD patients with younger disease onset age than 50 years or with frequent relapses before treatment had a higher relapse risk under the immunosuppressive therapy, and they may need highly effective treatments.
10.Anti-inflammation and Regulation of HIF-1α/VEGF of 3 Kinds of Borneolum in Prevention and Treatment of AMI Model Rats
Liying WANG ; Jian WANG ; Yamei FAN ; Jiajun WANG ; Yin FU ; Xianjuan YANG ; Daoyin GONG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(19):61-72
ObjectiveTo investigate the possible mechanism of different doses of L-Borneolum,Borneolum,and Borneolum Syntheticum in the electrophysiology,anti-inflammation,and regulation of hypoxia inducible factor-1α (HIF-1α)/vascular endothelial growth factor (VEGF) cardiovascular protection of the experimental acute myocardial infarction (AMI) rats. MethodSD male adult rats were randomly divided into thirteen groups according to their body weight,namely the sham operation group,the model group,the solvent model group,the nitroglycerin group,the Borneolum high,medium,and low-dose (0.6,0.3, 0.15 g·kg-1) groups,the L-Borneolum high,medium,and low-dose (0.2,0.1, 0.05 g·kg-1) groups,and the Borneolum Syntheticum high,medium,and low-dose (0.2,0.1, 0.05 g·kg-1) groups,with 10 rats in each group. Rats were given 10 mL·kg-1 by gavage for 3 d of pre-administration. Thirty minutes after the last administration,the left anterior descending coronary artery (LAD) was ligated to induce the model,and the successful rat model was continuously treated for 3 d. BL-420N biosystem was used to analyze the electrocardiogram (ECG) and heart rate variability (HRV) before and after modeling and after 3 d of treatment. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to determine the mRNA expressions of interleukin-1β (IL-1β) and interleukin-6 (IL-6) in the myocardial tissue Western blot and immunohistochemistry were used to determine the protein expression levels of VEGF receptor 1 (VEGFR1),HIF-1α,and CD34. ResultCompared with the sham operation group,the model group significantly increased the heart rate,ECG ST wave,T wave,QRS duration,QTC interval,and Q wave on the day of modeling and after 3 d of treatment,and significantly changed HRV and T wave (P<0.05,P<0.01). As compared with the solvent model group,on the day of modeling,the heart rate of the L-Borneolum medium and low-dose groups and the Borneolum groups,the ST wave of the L-Borneolum groups,the Borneolum high and medium-dose groups,and the Borneolum Syntheticum high-dose group,HRV parameters of the L-Borneolum groups,the Borneolum medium and low-dose groups,and the Borneolum Syntheticum high-dose group,LF/HF of the L-Borneolum high and medium-dose group,the Borneolum low-dose group,and the Borneolum Syntheticum groups,T wave of the L-Borneolum high-dose group,the Borneolum Syntheticum high-dose group,and Borneolum medium-dose group,QTC interval of the L-Borneolum medium and low-dose groups and the Borneolum high and medium-dose groups,and QRS duration of the L-Borneolum high and low-dose groups,the Borneolum high and low-dose groups,and the Borneolum Syntheticum groups were significantly reduced or shortened (P<0.05,P<0.01). After 3 d of treatment,the heart rate of the L-Borneolum groups,the Borneolum high and medium-dose groups,and the Borneolum Syntheticum medium-dose group,ST wave of the L-Borneolum group,the Borneolum high and medium-dose groups,and the Borneolum Syntheticum high-dose group,OTC interval,ORS duration,and Q wave of the L-Borneolum high-dose group,the Borneolum high-dose group,and the Borneolum Syntheticum high and medium-dose groups,QRS duration of the L-Borneolum medium-dose group,QTC interval of the Borneolum medium-dose group,and Q wave of the Borneolum Syntheticum low-dose group were all significantly reduced or shortened(P<0.01). The mRNA expressions of IL-1β and IL-6 in the L-Borneolum medium and low-dose groups,the Borneolum medium and low-dose groups,and the Borneolum Syntheticum high and medium-dose groups were significantly down-regulated(P<0.01),and LF/HF in the L-Borneolum high and medium-dose groups,the Borneolum high and medium-dose groups,and the Borneolum Syntheticum high and low-dose groups were significantly reduced (P<0.05,P<0.01). HRV in the L-Borneolum high-dose group,the Borneolum groups,and the Borneolum Syntheticum high and low-dose groups,and T wave in the Borneolum high and medium-dose groups and the Borneolum Syntheticum high-dose group were increased significantly. The protein expressions of HIF-1α,VEGFR1,and CD34 in the L-Borneolum medium and low-dose groups,the Borneolum low-dose group,and the Borneolum Syntheticum high-dose group were significantly up-regulated,as well as those of VEGFR1 and CD34 in the Borneolum medium-dose group (P<0.05,P<0.01). ConclusionThe 3 kinds of Borneolum improves the heart rate,heart rate variability,and electrocardiogram of AMI model rats to different degrees,and may play a myocardial protective effect by anti-inflammation and promotion of angiogenesis. The combined effect suggests that L-Borneolum has the superior effect next to Borneolum,and Borneolum Syntheticum has the inferior effect.


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