Comparative efficacy and safety of Chinese patent medicines of iron deficiency anemia during pregnancy:A network meta-analysis

BACKGROUND Iron deficiency anemia(IDA)is a prevalent nutritional disorder during pregnancy.Clinical studies indicate that incorporating Chinese patent medicines(CPMs)with oral iron(OI)in treating IDA in pregnancy can reduce adverse effects and improve clinical outcomes.Nonetheless,the comparative efficacy of different CPMs remains unclear.AIM To assess the safety and effectiveness of different CPMs for treating IDA during pregnancy using network meta-analysis.METHODS We conducted a search for randomized controlled trials(RCTs)that combined CPM and OI for IDA treatment in pregnancy,spanning from 2013 to the present.Data analysis was performed using Rev Man 5.3 and Stata 14.0 on literature that satisfied the quality criteria.RESULTS The analysis included 45 RCTs,encompassing 4422 pregnant patients with IDA.Six CPMs were examined,including Shengxuebao Mixture,Shengxuening Tablets(SXN),Yiqi Weixue CPMs(YQWX),Jianpi Shengxue CPMs(JPSX),Yiqi Buxue Tablets,and Compound Hongyi Buxue Oral Liquid(FFHY).Findings indicated that FFHY+OI significantly improved the clinical effective rate.SXN+OI was most effective in boosting red blood cells counts and hemoglobin levels.YQWX+OI showed superior results in improving serum ferritin,and SXN+OI was most effective in increasing serum iron levels.JPSX+OI was optimal in reducing adverse pregnancy outcomes,while YQBX+OI effectively minimized adverse events.A cluster analysis suggested that SXN+OI could be the potentially optimal therapeutic regimen for IDA in pregnancy.CONCLUSION This study demonstrates that the combination of OI with CPMs offers better outcomes than OI alone.Based on clinical efficacy and other measured outcomes,SXN+OI emerges as the most effective treatment modality for improving the health of pregnant patients with IDA.

Inhibition of hepatitis B virus via selective apoptosis modulation by Chinese patent medicine Liuweiwuling Tablet

BACKGROUND Liuweiwuling Tablet(LWWL)is a Chinese patent medicine approved for the treatment of chronic inflammation caused by hepatitis B virus(HBV)infection.Previous studies have indicated an anti-HBV effect of LWWL,specifically in terms of antigen inhibition,but the underlying mechanism remains unclear.AIM To investigate the potential mechanism of action of LWWL against HBV.METHODS In vitro experiments utilized three HBV-replicating and three non-HBV-replicating cell lines.The in vivo experiment involved a hydrodynamic injectionmediated mouse model with HBV replication.Transcriptomics and metabolomics were used to investigate the underlying mechanisms of action of LWWL.RESULTS In HepG2.1403F cells,LWWL(0.8 mg/mL)exhibited inhibitory effects on HBV DNA,hepatitis B surface antigen and pregenomic RNA(pgRNA)at rates of 51.36%,24.74%and 50.74%,respectively.The inhibition rates of LWWL(0.8mg/mL)on pgRNA/covalently closed circular DNA in HepG2.1403F,HepG2.2.15 and HepG2.A64 cells were 47.78%,39.51%and 46.74%,respectively.Integration of transcriptomics and metabolomics showed that the anti-HBV effect of LWWL was primarily linked to pathways related to apoptosis(PI3K-AKT,CASP8-CASP3 and P53 pathways).Apoptosis flow analysis revealed that the apoptosis rate in the LWWL-treated group was significantly higher than in the control group(CG)among HBV-replicating cell lines,including HepG2.2.15(2.92%±1.01%vs 6.68%±2.04%,P<0.05),HepG2.A64(4.89%±1.28%vs 8.52%±0.50%,P<0.05)and HepG2.1403F(3.76%±1.40%vs 7.57%±1.35%,P<0.05)(CG vs LWWL-treated group).However,there were no significant differences in apoptosis rates between the non-HBV-replicating HepG2 cells(5.04%±0.74%vs 5.51%±1.57%,P>0.05),L02 cells(5.49%±0.80%vs 5.48%±1.01%,P>0.05)and LX2 cells(6.29%±1.54%vs 6.29%±0.88%,P>0.05).TUNEL staining revealed a significantly higher apoptosis rate in the LWWL-treated group than in the CG in the HBVreplicating mouse model,while no noticeable difference in apoptosis rates between the two groups was observed in the non-HBV-replicating mouse model.CONCLUSION Preliminary results suggest that LWWL exerts a potent inhibitory effect on wild-type and drug-resistant HBV,potentially involving selective regulation of apoptosis.These findings offer novel insights into the anti-HBV activities of LWWL and present a novel mechanism for the development of anti-HBV medications.

Clinical research report on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions(2022)

Objective:The paper is to comprehensively summarize and analyze the basic situation and methodological quality of clinical randomized controlled trials(RCTs)of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions published in 2022,to provide evidence and reasonable suggestions for the advancement of clinical research and the formulation of policies and guidelines.Methods:The Evidence Database System of clinical evidence-based evaluation of traditional Chinese medicine was searched,and data from China National Knowledge Infrastructure(CNKI),PubMed,and other databases were supplemented.The search duration was from January 1,2022,to December 31,2022.RCTs of traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were included as the source of clinical evidence,and published information,sample size,intervention,control measures,treatment course,methodological quality,and key link report were analyzed and evaluated.Results:A total of 1,464 RCTs of traditional Chinese patent medicines were included,which comprised 667 types of traditional Chinese patent medicines;“traditional Chinese patent medicines+Western medicine vs.Western medicine”was the most widely used intervention and control setting,involving 417 RCTs(28.48%).A total of 245 RCTs of traditional Chinese classic famous prescriptions were included,comprising 55 types of traditional Chinese classic famous prescriptions.“Decoction+conventional treatment vs.conventional treatment”was the most widely used intervention and control setting,with 87 RCTs(35.51%).Published RCTs on traditional Chinese patent medicines and traditional Chinese classic famous prescriptions were limited by the study design and implementation.Most“allocation concealment”and“blinding of patients and personnel”were rated as medium to high risk.There are insufficient reports on key research links such as experimental registration and ethical approval.Conclusions:The number of RCTs on traditional Chinese patent medicines has decreased in 2022,but there has been a slight improvement in the research quality and impact.There are relatively few studies on traditional Chinese classic famous prescriptions.Measures must be taken to improve clinical trial design,implementation,and reporting.Methodological experts should be invited to provide professional technical guidance on the trial design.In the research implementation process,attention should be paid to quality control,particularly the standardization of the randomized execution.

Effectiveness and safety of seven oral Chinese patent medicines as adjuvant therapy for cancer-related anemia: A systematic review and network meta-analysis of randomized controlled trials

Objective:To evaluate the effectiveness and safety of seven oral Chinese patent medicines(CPMs)as adjuvant therapy for cancer-related anemia(CRA)by network meta-analysis(NMA).Methods:A literature search to obtain randomized controlled trials(RCTs)of seven oral CPMs in the adjuvant treatment of CRA was conducted in multiple databases from the inception to April 2022.The RevMan5.3 and R 4.1.1 software were used for NMA.Results:We ultimately included 29 RCTs with 2140 patients.Traditional meta-analysis showed that Fufang E'jiao syrup(FFEJS),Shengxuebao mixture(SXBM),Shengxuening tablets(SXNT),Jianpi Shengxue granules(JPSXG),and Yixuesheng capsule(YXSC)combined with basic Western treatment(BWT)could improve the hemoglobin(HGB)level.JPSXG combined with BWT could improve the red blood cell(RBC).FFEJS combined with BWT improved the Karnofsky performance status(KPS).NMA showed that FFEJS,JPSXG,SXBM,and SXNT plus BWT improved HGB better than Shengxue tablets(SXT)plus BWT,with top three ranking results being JPSXG plus BWT>SXNT plus BWT>FFEJS plus BWT.FFEJS plus BWT,JPSXG plus BWT,SXBM plus BWT,SXNT plus BWT,and SXT plus BWT improved RBC better than BWT,with top three ranking results being SXNT plus BWT>JPSXG plus BWT>FFEJS plus BWT.In terms of the KPS score,compared with SXT plus BWT,FFEJS,JPSXG,SXBM,SXNT,and Yizhong Shengxue capsule(YZSXC)plus BWT had higher KPS,with top three ranking results being SXBM plus BWT>JPSXG plus BWT>FFEJS plus BWT.Conclusions:Our NMA demonstrated that seven oral CPMs used as adjuvant treatment of CRA had a definite clinical effect.JPSXG not only increases the levels of HGB and RBC to enhance the clinical effect but also improves patients'quality of life.More accurate conclusions need to be verified by more high-quality RCTs.

Efficacy and safety of oral Chinese patent medicine combined with sacubitril/valsartan in the treatment of chronic heart failure:A Metaanalysis

Objective:To systematically evaluate the clinical efficacy of oral Chinese patent medicine combined with sacubitril/valsartan in treating chronic heart failure(CHF).Methods:CNKI,CSPD,CCD,CBM,PubMed,Web of Science,Cochrane Library and EMbase were retrieved to screen out randomized controlled trials Chinese patent medicine and Western medicine in treating CHF.Manual retrieval was also applied as a supplement.The Cochrane Reviewers Handbook 5.1.0 was used to evaluate the bias risk of the included studies and RevMan 5.4 software was used for Meta-analysis.Results:A total of 1301 patients enrolled in the 13 RCTs were included.According to the results of Meta-analysis,a combination of oral Chinese patent medicine and sacubitril/valsartan could further improve total effectiveness rate(RR=1.23,95%CI[1.16,1.30],P<0.001),increase 6 minutes’walk distance(MD=53.04,95%CI[33.43,72.64],P<0.001),improve left ventricular ejection fraction(MD=6.67,95%CI[5.15,8.19],P<0.001)and stroke volume(MD=7.56,95%CI[3.94,11.18],P<0.001),reduce left ventricular end-diastolic dimension(MD=-3.68,95%CI[-4.57,-2.78],P<0.001)and N terminal pro B type natriuretic peptide(MD=-434.08,95%CI[-518.95,-349.22],P<0.001)and no statistically significant difference in drug safety was found between the sacubitril/valsartan-only group and the combined treatment group(RR=0.73,95%CI[0.32,1.65],P=0.45).Conclusion:It’s indicated that a combination of traditional Chinese patent medicine and sacubitril/valsartan had a good clinical efficacy in the treatment of CHF,which had certain guiding significance for clinical practice.

Efficacy and Safety of Traditional Chinese Patent Medicine Qizhi Weitong Granules(气滞胃痛颗粒)in Irritable Bowel Syndrome with Predominant Constipation:A Meta-Analysis and Trial Sequential Analysis of Randomized Controlled Trials

Objective:To systematically review the efficacy and clinical safety of Qizhi Weitong Granules(气滞胃痛颗粒)(QZWT)in the treatment of irritable bowel syndrome with predominant constipation(IBS-C).Methods:Randomized controlled trials(RCTs)of QZWT in patients with IBS-C were retrieved from Pub Med,EMBASE,Cochrane Library,China National Knowledge Infrastructure(CNKI),Wanfang,Chinese Scientific Journals Database(VIP),and Chinese Biological Medical Database(CBM)from inception to December 3,2022.Conventional meta-analysis with random-effects model or fixed-effects model and trial sequential analysis(TSA)were performed by Review Manager 5.4,Stata and TSA software.Results:A total of 4 RCTs and 368 patients with IBS-C were included in this study.The findings of the meta-analysis indicated that the cure and efficacy rate of the experimental group was significantly higher than that of the control group[RR=2.19;(95%CI,1.35–3.55),P<0.01;RR=1.14;(95%CI,1.03–1.27),P<0.05],while the result of Bristol Score was negative.The funnel plot was probably symmetry,and the P value was>0.05 in the Egger test,which confirmed the nonexistence of significant publication bias in this outcome.TSA showed the cumulative z-value crossed the traditional threshold and TSA threshold,while it didn't get to the required information size.Finally,2 studies reported adverse events after QZWT treatment,including 3 cases of diarrhea.No serious adverse events were reported.Conclusion:QZWT was an effective and safe complementary therapy in the treatment of IBS-C with no obvious adverse reactions.TSA analysis confirmed our meta-analysis results.Therefore,QZWT may be a potential candidate for the treatment of IBS-C.However,due to the limited quality of current studies,more long-term,randomized,double-blinded clinical trials are needed in future studies.

Analysis of Adverse Reactions in the Treatment of COVID-19 with Three Chinese Patent Medicines and Three Herbal Formulas

Objective To explore the rules and characteristics of the adverse drug reactions(ADRs)of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19,and to provide a reference for clinical safe medication.Methods The cases and ADR reports of the three Chinese patent medicines and three herbal formulas in PubMed,Web of Science,Springer Link,CNKI,Wanfang and VIP database were retrieved from December 2019 to May 2021.Then we extracted and analyzed the effective information included in the literature.Results and Conclusion According to the pre-developed retrieval plan,a total of 136 documents were obtained,and a total of 6 documents met the inclusion criteria finally.553 patients used three Chinese patent medicines and three herbal formulas,and there were 133 cases of adverse reactions.The adverse reactions of patients taking the three Chinese patent medicines and three herbal formulas can all be explained under the theory of traditional Chinese medicine,and the adverse reactions can be eliminated by adding or subtracting the flavor of the medicine or stopping the medicine.

Ultrasonic Nebulization Extraction Coupled with Gas Chromatography-Mass Spectrometry for Analysis of Volatile Components in Traditional Chinese Patent Medicine

The ultrasonic nebulization extraction（UNE） was developed and applied to the extraction of volatile components from traditional Chinese patent medicine Xiaoyao Pills. Several parameters of ultrasonic nebulization extraction including the sample particle size, solvent volume, extraction time and ultrasonic power were studied and selected. As a result, 2.4 g of sample with particle size of 80 mesh was extracted with 15 mL of n-hexane for 20 min at an ultrasonic power of 35 W. The volatile components were analyzed by gas chromatography-mass spectrometry （GC-MS） under the optimal conditions and 57 compounds were identified. The precision, repeatability and stability of the proposed method were also studied. Compared with ultrasonic-assisted extraction（UAE） and hydrodistillation（HD） extraction, the proposed method is more efficient, faster and easier to be operated at room temperature with smaller sample and energy consumption. It is suggested that the ultrasonic nebulization extraction can be used as a novel alternative method for the extraction of volatile components from traditional Chinese patent medicine.

Partial response to Chinese patent medicine Kangliu pill for adult glioblastoma: A case report and review of the literature

BACKGROUND Glioblastoma is the most common type of brain tumor and is invariably fatal,with a mean survival time of 8-15 mo for recently diagnosed tumors,and a 5-year survival rate of only 7.2%.The standard treatment for newly diagnosed glioblastoma includes surgery followed by concurrent chemoradiotherapy and further adjuvant temozolomide.However,the prognosis remains poor and longterm survival is rare.This report aimed to demonstrate a new therapeutic strategy for the treatment of glioblastoma.CASE SUMMARY A patient was referred to the Department of Neurosurgery with an intracranial space-occupying lesion with a maximum diameter of approximately 5 cm.The tumor was compressing functional areas,and the patient accordingly underwent partial resection and concurrent chemoradiotherapy.The imaging and pathological findings were consistent with a diagnosis of glioblastoma with oligodendroglioma differentiation(World Health Organization IV).The patient was finally diagnosed with glioblastoma.However,the patient discontinued treatment due to intolerable side effects,and was prescribed Kangliu pill(KLP)7.5 g three times/d,which he has continued to date.Significant shrinkage of the tumor(maximum diameter reduced from about 3.5 to about 2 cm)was found after 3 mo of KLP therapy,and the tumor was further reduced to about 1 cm after 3 years.The patient’s symptoms of headache,limb weakness,and left hemiplegia were relieved,with no side effects.CONCLUSION KLP has been a successful intervention for glioblastoma, and the current caseindicates that traditional Chinese medicine may offer effective alternativetherapies for glioblastoma.

Effects of adjuvant Chinese patent medicine therapy on major adverse cardiovascular events in patients with coronary heart disease angina pectoris:a population-based retrospective cohort study

Objective: This study aimed to explore the effects of Chinese patent medicine(CPM) in reducing the incidence of major adverse cardiovascular events(MACE) in patients with coronary heart disease(CHD) angina pectoris and improving clinical effectiveness and provide evidence for its use as clinical adjuvant therapy.Methods: Twenty-eight thousand five hundred and seventeen patients hospitalized with CHD angina pectoris from 6 hospitals were divided into CPM group(n = 11,374) and non-CPM group(n = 17,143) to evaluate the incidence of MACE, including myocardial infarction, percutaneous coronary intervention, and coronary artery bypass grafting.Results: The incidence of MACE in the CPM group was lower than that in the non-CPM group. CPM therapy was an independent protective factor that reduced the overall risk of MACE [adjusted hazard ratio = 0.40, 95% confidence interval(0.33;0.49)]. Patients in the CPM group who received one, two, or three types of CPM could benefit from adjuvant treatment with CPM, and taking more types of CPM was associated with a lower risk of MACE. In addition, the male population was better than the female population at taking CPM, and middle-aged people aged 55 to 64 were more suited to take CPM based on Western medicine.Conclusions: The use of CPM as adjuvant therapy can decrease the occurrence of MACE in patients with CHD angina pectoris,especially in men and middle-aged people, and the drug treatment plan should be optimized accordingly. However, this conclusion needs further verification by prospective cohort studies in the future.

Chinese patent medicine for stable angina pectoris:protocol for a systematic review and network meta-analysis

Stable angina pectoris is a common condition that affects a wide group of patients with coronary artery diseases.A number of Chinese patent drugs based on classic herbal formulations are available for angina management.A network meta-analysis is proposed to assess the relative efficacy and safety of commonly used drugs for stable angina and generate a clinically meaningful ranking for each important outcome.We composed a list of 24 widely-used oral blood-quickening Chinese patent drugs from literature review and expert consultation.Three English and five Chinese electronic databases will be searched up to July 2021 for randomised clinical trials comparing between drugs on the list or with nitrates or placebo for stable angina.Unpublished data or grey literature will be sought through trial registries and correspondence to the report authors.Two reviewers independently screen literature,extract data and assess clinical and methodological features of included studies.The WinBUGS software will be used to perform network meta-analysis and the Stata 13.0 software to generate graphic demonstrations of the results.Primary outcomes are the incidence of cardiovascular events and changes in angina frequency,duration and intensity.We will use the surface under the cumulative ranking curve and the mean value for the numeric presentation of efficacy and safety ranking probabilities of multiple treatments.Heterogeneity and inconsistency will be assessed using appropriate statistical tests,and subgroup analysis and network meta-regression will be resorted when necessary.The quality of evidence for each outcome will be graded with the web-based GRADEpro GDT.

Based on data mining, the study on the medication rule of Chinese patent medicine for constipation

To analyze the medication rule of Chinese patent medicine compound for constipation by data mining,and to provide reference for the treatment of constipation.Methods:The Chinese patent medicines for constipation in the Pharmacopoeia of the People’s Republic of China(2020)and Chinese patent medicine prescription database of yaozhi.com(https://db.yaozh.com/chufang)were collected and sorted.The prescriptions and drug composition were input into Excel2010.ategories,nature,flavour and channel tropism of drugs were analyzed by using ancient and modern medical case cloud platform(V2.3.5).The cluster analysis of high-frequency drugs was carried out by SPSS 22.0,and rules of high-frequency drugs were analyzed by Apriori algorithm provided by SPSS modeler 18.0.Results:Two hundred and thirty-six Chinese patent medicine prescriptions that met the requirements were collected,containing 349 Chinese medicines in total,with a total frequency of 2,277.The drugs with frequency≥25 times were high-frequency drugs,with a total of 24 flavours,and the top 5 were Dahuang(Rhei radix et rhizoma),Huangqin(Scutellariae radix),Gancao(Glycyrrhizae radix et rhizoma),Huanglian(Coptidis rhizoma)and Bohe(Menthae haplocalycis herba).The top 3 frequency of efficacy of high-frequency drugs were“Heat-Clearing(remove heat from the body surface and inside)”drugs,“Purgating(to promote excretion of stools)”drugs and“Reinforcing”(to supplement the body’s lack of“Qi,Blood,Yin and Yang”)drugs.The nature of high-frequency drugs were cold,warm and flat.The top 3 flavour of the high frequency drugs were bitter,spicy and sweet.The top 4 channel tropism of high-frequency drugs were“Spleen”,“Stomach”,“Lung”,“Large intestine”.According to the association rule,11 drug pairs were obtained,and the core drug pairs were Zhizi(Gardeniae fructus)-Rhei radix et rhizoma,Huangbo(Phellodendri chinensis cortex)-Rhei radix et rhizoma.Four new methods were obtained based on cluster analysis.Conclusion:Chinese patent medicine has a certain regularity in the treatment of constipation.This paper can provide some references for the clinical treatment of constipation with Chinese medicine.

Comparative Evaluation of Antitumor Chinese Patent Medicine Injections Based on Evidence-Based Medicine and Markov Model

Objective: The objective of this study was to explore the safety, efficacy, economy, and other aspects of frequently-used antitumor Chinese patent medicine injections through a comprehensive evaluation of evidence-based medical research to provide scientific information and decision-making basis for drug selection, rational drug use, public awareness of safe drug use, and medical insurance. Materials and Methods: The names of five frequently used antitumor Chinese patent medicine injections were used as search terms, including the compound Sophora flavescens injection, Kangai injection, Aidi injection, Kanglaite injection, and Brucea javanica oil emulsion injection. Relevant evidence-based medical research was extracted from the databases. A descriptive evaluation was conducted, and the Markov model was used for the cost-benefit analysis. Finally, the above injections are ranked by comprehensive scores using the multi-criteria decision analysis and Delphi method. Results: The five injections had their own advantages in enhancing the effectiveness of anti-tumor treatments, improving the quality of life for cancer patients, and reducing the incidence of adverse reactions. From the perspective of economy and other attributes, compound S. flavescens was superior to B. javanica oil, Aidi, Kangai, and Kanglaite. After a comprehensive evaluation of the above five injections, the compound S. flavescens injection received the highest score. Conclusions: Compound S. flavescens, Kangai, Aidi, B. javanica oil, and Kanglaite have their own advantages in effectiveness and no significant difference in safety. Compound S. flavescens injection has the highest comprehensive score. Clinical attention should be paid to monitoring the initial stage of medication and special groups.

Appraising the quality of clinical practice guidelines in Chinese patent medicine

Background:Chinese patent medicine(CPM)is a type of traditional Chinese medicine(TCM)that utilizes Chi-nese medicinal materials as its raw ingredients.Following the principles of TCM theory,it undergoes specific processing techniques to create various dosage forms for the prevention and treatment of diseases.The current CPM guidelines,both domestically and internationally,are constrained by limitations in methodological quality and reporting,which do not adequately address the requirements of the majority of clinicians and patients.Objective:To evaluate the methodological rigor and reporting quality of clinical practice guidelines(CPGs)in CPM,with aim to assess their current quality and to provide recommendations for improving guideline develop-ment.Methods:The study utilized the Appraisal of Guidelines for Research and Evaluation II(AGREE II)tool and the Reporting Items for Practice Guidelines in Healthcare for Traditional Chinese Medicine(RIGHT for TCM)checklist to evaluate the methodological rigor and reporting quality of CPM guidelines.After the training session,the four investigators were divided into two groups to evaluate the guidelines of patent Chinese medicine included in this study based on the aforementioned criteria.In case of any discrepancies,a secondary analysis was conducted by all four researchers under the guidance of two clinical experts,ensuring an impartial evaluation outcome.Average score or average reporting rate were calculated for each domain.Results:A total of 32 CPM guidelines that met the inclusion criteria were analyzed.The AGREE II yielded an average score of 67.2%.The domain scores were as follows:scope and purpose(93.3%),stakeholder involve-ment(50.1%),rigor of development(76.8%),clarity of presentation(79.4%),applicability(40.1%),and editorial independence(63.6%).The average reporting rate of the RIGHT for TCM checklist was 70.0%,with the report-ing rates for the seven domains as follows:basic information(94.2%),background(87.9%),evidence(97.5%),recommendation(57.5%),review and quality assurance(11.4%),funding and declaration and management of interests(26.6%),and other information(68.8%).Conclusions:The methodological and reporting quality of CPGs for CPM have been deemed acceptable since 2020.However,there is still room for improvement,particularly in enhancing the reporting quality to provide clinicians and patients with more effective and comprehensive guidance.Additionally,it may be beneficial to develop a comprehensive reporting checklist specifically tailored for CPM guideline development.

Several Considerations in Using Traditional Chinese Patent Medicine for Cerebrallnfarction

Nowadays, a great number of traditional Chinese patent medicine （TCPM） are used more and more widely to treat cerebral infarction in China. When great attention is paid to using TCPM in the real world, several problems can be identified： ignoring the Chinese medicine （CM） therapeutic principle based on syndrome differentiation, a lack of appropriate dosage and usage based on individual patient conditions, and a shortage of evidence from randomized, double-blind, placebo-controlled clinical trials. Furthermore, in terms of evaluation of the TCPM effectiveness, few comprehensive criteria and evaluation methods recognized by the international community exist. This article addresses some opinions regarding the above mentioned problems.

Network Meta-analysis of Four Chinese Patent Medicines Combined with Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blockers in Early Diabetic Nephropathy Treatment

The objective of the study is to systematically evaluate the efficacy of four Chinese patent medicines in combination with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB) in the treatment of early diabetic nephropathy (DN). Retrospectively, previously published randomized controlled trials (RCTs) of four different Chinese patent medicines combined with ACEI or ARB in the treatment of patients with early DN were searched overall from databases. The data were analyzed by R, Generate Mixed Treatment Comparisons and STATA softwares. A total of 78 RCTs were finally included. Network meta-analysis showed that the total effective rate of the Jinshuibao capsule-ACEI/ARB combination group and Huangkui capsule-ACEI/ARB combination groups were better than the others;Jinshuibao capsule-ACEI/ARB combination group reduced the 24-h urinary protein excretion (24-h UTP), urine microalbumin excretion rate (UAER), serum creatinine (Scr), and glycosylated hemoglobin (HbAlc) values. The Huangkui capsule-ACEI/ARB combination demonstrated a better reduction of (blood urea nitrogen [BUN]). Reduced incidences of adverse effects were only observed on treatment with Bailing capsule-ACEI/ARB combination. In early DN, combination of Jinshuibao capsule-ACEI/ARB provided the highest effective rate;moreover, it could reduce the24-h values of UTP, UAER, Scr, and HbAlc;Huangkuai capsule-ACI/ARB combination group showed a good effect on reducing BUN. Bailing capsule-ACEI/ARB combination group had reduced the incidences of adverse reactions.

A Rapid and Effective HPLC Method for Identification of Bovis Calculus in Chinese Patent Medicines

Objective Due to the limited resource and the large demand,many kinds of Bovis Calculus(BC) including artificial Bovis Calculus(ABC),in vivo cultured Bovis Calculus(in vivo CBC),and in vitro cultured Bovis Calculus(in vitro CBC)were used in Chinese patent medicines(CPMs).Previous studies have shown that the chemical constituents of ABC and their properties were different from other BC.The two types of CBC with much higher price than ABC were approximately equivalent with natural Bovis Calculus in quality and clinical effect.The aim of the study is to establish a rapid and effective method for the identification of BC in CPMs.Methods An HPLC method with the higher specificity for analyzing bilirubin was established to distinguish ABC from other three kinds of BC by comparing the change of bilirubin content with the addition of EDTA-2Na as the extraction solvent and stabilizer.Results The bilirubin content in CPMs containing ABC was basically unchanged,while that in CPMs containing other kinds of BC showed significant difference.The proposed method was employed to analyze a variety of CPMs containing Bovis Calculus(CPMBCs) and proven to be universal.Conclusion An effective analytical method is established for the quality control of CPMBCs and further ensures the safety and efficacy of these drugs in clinical practice.

A novel classification method for aid decision of traditional Chinese patent medicines for stroke treatment

Traditional Chinese patent medicines are widely used to treat stroke because it has good efficacy in the clinical environment. However, because of the lack of knowledge on traditional Chinese patent medicines, many Western physicians, who are accountable for the majority of clinical prescriptions for such medicine, are confused with the use of traditional Chinese patent medicines. Therefore, the aid-decision method is critical and necessary to help Western physicians rationally use traditional Chinese patent medicines. In this paper, Manifold Ranking is employed to develop the aid-decision model of traditional Chinese patent medicines for stroke treatment. First, 115 stroke patients from three hospitals are recruited in the cross-sectional survey. Simultaneously, traditional Chinese physicians determine the traditional Chinese patent medicines appropriate for each patient. Second, particular indicators are explored to characterize the population feature of traditional Chinese patent medicines for stroke treatment. Moreover, these particular indicators can be easily obtained by Western physicians and are feasible for widespread clinical application in the future. Third, the aid-decision model of traditional Chinese patent medicines for stroke treatment is constructed based on Manifold Ranking. Experimental results reveal that traditional Chinese patent medicines can be differentiated. Moreover, the proposed model can obtain high accuracy of aid decision.

A Systematic Review of RCTs and quasi-RCTs on Traditional Chinese Patent Medicines for Treatment of Chronic Hepatitis B

Traditional Chinese patent medicines (TCPMs) are widely used for treatment of chronic hepatitis B (CHB) in China. To estimate the overall effectiveness of TCPMs for CHB, we performed a systematic review of clinical reports designed as randomized controlled trials (RCTs). One hundred and thirty-eight available RCTs and quasi-RCTs on 62 TCPMs, involving 16,393 patients, were included. The methodological quality of these trials was generally "poor". Few trials (6.52%) reported the methods of randomization correctly. Another common problem was the lack of allocation concealment, proper blinding, and the reporting of lost cases and dropouts. Forty-two trials (30.43%) on 27 TCPMs reported some anti-viral effect of TCPMs. Others reported beneficial aspects, including improvements of liver function (79.71% of the studies), liver fibrosis (29.99%), and CHB symptoms (92.75%). Forty-one articles (29.71%) reported mild adverse events with TCPMs but these occurred infrequently. In summary, the outcome of the report on currently registered TCPMs may be biased due to poor methodology. The data from these trials, therefore, is too weak to use in forming a recommendation for treatment of CHB. Nevertheless, five drugs (Dan Shen agents, Da Huang Zhe Chong pill/capsule, Shuang Hu Qing Gan granule, Fu Zheng Hua Yu granule and Cao Xian Yi Gan capsule) appear to be more effective than the other TCPMs.

Estimation of bioaccessibility and potential human health risk of mercury in Chinese patent medicines

Mercury（Hg）, mainly in cinnabar species, has been used in medicine for thousands of years in China, and worldwide concern has been raised on its toxicity. In this work, the amount of bioaccessible mercury in 16 Chinese patent medicines（CPMs） was measured by using an in vitro simulated digestion system, consisting of simulated gastric and intestinal fluid, to investigate the bioavailability of mercury in CPMs and evaluate its potential risk to human health. Total mercury and mercury in the gastrointestinal extracts were measured by inductively coupled plasma mass spectrometry（ICP-MS）. The levels of total Hg in 16 CPMs ranged from not detected to 11.89 mg/g, with a mean value of 1.13 mg/g, while the extractable Hg ranged from not detected to 4.37 μg/g, with a mean value of 0.42 μg/g.Mercury bioaccessibility varied significantly in the investigated CPMs, depending on the ingredient. Compared to the CPMs without cinnabar（2.5%–30.9%）, the percentage of mercury in the gastrointestinal supernatants for CPMs with cinnabar was quite a bit lower（0.037%）. By comparing with the Food and Agricultural Organization/World Health Organization Joint Expert Committee on Food Additives（FAO/WHO） safety guideline, the average daily intake dose（ADD） of Hg in the medicines was then calculated to access the risk of mercury to human health from taking CPMs.