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Objective:To systematically evaluate the clinical efficacy and safety of Xixian Tongshuan Capsules/Pills combined with Western medicine in treating cerebral infarction.Methods:All RCTs about Xixian Tongshuan Capsules/Pills combined with Western medicine in treating cerebral infarction were retrieved from CNKI, Wanfang Database, VIP database, PubMed and CBM. The search period was from the database establishment to December 31, 2021. Two researchers independently extracted the basic literature data and evaluated the methodological quality, then used RevMan5.4 software for meta-analysis.Results:Totally 9 articles were included, involving a total of 988 patients, including 505 cases in the observation group and 483 cases in the control group. Meta-analysis showed that the total effective rate of Xixian Tongshuan Capsules/Pills combined with Western medicine in treating cerebral infarction was higher than that of conventional Western medicine [ RR=1.20, 95% CI (1.13, 1.27), P<0.05]. At the same time, the effect of NIHSS score, Barthel score and FIB were better than those of conventional Western medicine [respectively: MD=-3.21, 95% CI (-4.45, -1.97), P<0.05; MD=11.83, 95% CI (10.66, 13.00), P<0.05; MD=-0.95, 95% CI (-1.36, -0.54), P<0.05]. After treatment with Xixian Tongshuan Capsules/Pills combined with Western medicine, the adverse reactions mainly included dizziness, nausea, indigestion, rash, facial blushing, etc. There was no statistically significant difference in safety between the two groups [ RR=1.50, 95% CI (0.75, 3.01), P>0.05]. Conclusions:Under the treatment of conventional Western medicine, the addition of Xixian Tongshuan Capsules/Pills can improve the clinical efficacy of cerebral infarction treatment, effectively improve the symptoms of neurological impairment, improve the ability of daily life, and promote the prognosis and recovery, and without increasing the incidence of adverse reactions. However, large sample and high quality studies are still needed to support the conclusion.
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Objective:To analyze the formula and medication rules based on the Chinese patent medicines database for treating jaundice, so as to provide reference for the treatment of jaundice.Methods:By using descriptive statistics and data mining methods to analyze the current condition of Chinese patent medicines treating jaundice, Chinese medicines that are frequently appeared and the Chinese medicine paris as well as the combination of mediicnes, and then by using complex network clustering and topology parameter analysis to screen the potential formulations and core Chinese medicines.Results:Seventy-nine Chinese patent medicines with the function of heat-clearing and detoxification were obtained, heat-clearing and removing dampness, and removing jaundice. A total of 233 Chinese medicines are involved, and the most frequently used are Artemisiae Scopariae Herba, Glycyrrhizae Radix et Rhizoma, Bupleuri Radix, Gardeniae Fructus, Scutellariae Radix, etc. The Chinese medicine pairs with high association rule support were Scutellariae Radix- Artemisiae Scopariae Herba, Gardeniae Fructus- Artemisiae Scopariae Herba, Glycyrrhizae Radix et Rhizoma- Artemisiae Scopariae Herba, etc. Based on the compatibility network, four clusters with close connection were obtained, including 23 Chinese medicines. According to the degree and closeness index, the core nodes of Artemisiae Scopariae Herba, Bovis Calculus, Carthami Flos, Glycyrrhizae Radix et Rhizoma, Aucklandiae Radix, Cyperi Rhizoma, Rhei Radix et Rhizoma, Bupleuri Radix, Salviae Miltiorrhizae Radix et Rhizoma were obtained. Conclusion:The combination of herbs and formula for treating icterus conforms to the TCM theory and clinical practice, which could provide reference for the treatment of icterus with TCM and related Chinese patent medicine research.
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At present, the registration process of Traditional Chinese Medicine (TCM) in Canada is refering to the requirements of Natural Health Products (NHPs). In terms of registration material, both NHPs and TCM include plants, animals and minerals with medicinal components, but the fundamental difference between them is that TCM is guided by the basic theory of TCM. As for the registration classification of TCM in Canada, first of all, judge whether the product to be applied for is NHPs; Secondly, we should clarify the types and ways of registration, mainly including simple application, traditional application and non-traditional application, and provide application forms, label texts, summary reports, evidence, animal tissue forms, finished product specifications and other materials according to different requirements. At present, the successful registration experience of TCM products in Canada mainly mainly includes applying for superior varieties, selecting appropriate application channels, communicating with local health management units and providing sufficient scientific evidence and good clinical application records. The regulations on the registration of NHPs in Canada have not fully considered the particularity of TCM and the registration of TCM products is still facing some difficulties. In the future, we can learn from the registration process and requirements of the Health Canada, promote the interconnection and mutual recognition of the Pharmacopoeia of the People's Republic of China and the NNHPD monographs in Canada, reduce the obstacles to the local application for registration of TCM, and promote the further improvement of the international standards of TCM.
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By searching for the Canadian Licensed Natural Health Products Database, (LNHPD), this paper analyzed the characteristics and current status of 92 Chinese patent medicines successfully registered and listed in Canada, and found that the enterprises of successfully registered enterprises are mainly located in areas with better development condition of Traditional Chinese Medicine (TCM) such as Beijing, Guangdong and Tianjin; The successfully registered Chinese patent medicines include 64 kinds of single medicine or medicine with single active ingredient (69.6%) and 28 kinds of compound medicine (30.4%), the forms of the dosage are mainly tablets and capsules, which have the characteristics of accuracy in dosage and stable physicochemical properties. There are also granules, solutions, powders and other dosage forms, which can be preserved for a long time and have low requirements on technic and environment. These Chinese patent medicines are mainly used to treat respiratory and circulatory system diseases, some are used to treat urogenital and digestive system diseases, and few are used to treat difficuilt diseases like tumors, diabetes. There are some other health care products. It is suggested to strengthen the connection between domestic standards of TCM registration and international standards, and promote the scientific and technological capacity of relevant enterprises, and encourage enterprises to strengthen international registration of advantageous products, so as to accelerate the speed of international development of TCM in China.
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ObjectiveTo investigate the effect of anti-liver fibrosis Chinese patent drugs on renal hypofunction associated with alcoholic liver disease (ALD). MethodsA retrospective analysis was performed for 592 patients with ALD who were admitted to Beijing Ditan Hospital, Capital Medical University, from August 1, 2008 to March 1, 2016, and according to whether they were treated with Fuzheng Huayu capsules, Anluo Huaxian pills, or Fufang Biejia Ruangan tablets for ≥180 cumulative defined daily doses, they were divided into Chinese medicine group and control group. After propensity score matching at a ratio of 1∶1, two groups were obtained with 187 patients in each group. Related data were recorded, including medical history, drinking amount, routine blood test results, liver and renal function, coagulation, and abdominal imaging findings. The t-test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups; the chi-square test was used for comparison of categorical data between groups; the Kaplan-Meier method was used to compare the cumulative incidence rate of renal hypofunction between two groups. ResultsThere were no significant differences between the two groups in age, drinking amount, proportion of patients with hypertension or diabetes, baseline aspartate aminotransferase, estimated glomerular filtration rate, uric acid, and prothrombin time, and the patients were followed up for 36 months (range 23-54 months). Uric acid (hazard ratio ［HR］=1.003, 95% confidence interval ［CI］: 1001-1.005, P=0.001), prothrombin time (HR=1.103, 95%CI: 1.034-1.177, P=0.003), and red cell volume distribution width (HR=1.024, 95%CI: 1.011-1.038, P＜0.001) were independent risk factors for renal hypofunction in patients with ALD, and anti-liver fibrosis Chinese patent drug was an independent protective factor against renal hypofunction (HR=0.170, 95%CI: 0.053-0552, P=0.003). The Chinese medicine group had a significantly lower incidence rate of renal hypofunction than the control group (166% vs 32.1%, χ2=10.263, P=0.001). The subgroup analysis of the patients in the Chinese medicine group showed that Chinese medicine treatment for ＞24 months had the best effect (HR=0.210, 95%CI: 0.084-0.525, P=0.001). Compared with the control group, the Chinese medicine group had a significantly longer time to the onset of renal hypofunction (36 months vs 24 months, Z=-2.652, P=0.008). ConclusionAnti-liver fibrosis Chinese patent drugs can reduce the incidence rate and delay the onset of renal hypofunction in patients with ALD.
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The consistency of quality on Chinese patent drugs is a hotspot and difficulty in the control of traditional Chinese medicine preparations, and has become one of the bottlenecks restricting its internationalization. Based on the analysis of current studies on quality and problems of Chinese patent drugs, this paper explored relevant methods of quality evaluation on Chinese patent drugs and possible factors affecting the consistency of quality in the pharmaceutical cycle by consulting relevant literatures about quality evaluation methods and consistency control techniques of large-scale Chinese patent drugs. And it put forward the evaluation system on high-quality Chinese patent drugs with "consistency" as the core, so as to promote the overall improvement of the quality of Chinese patent drugs, guide the rational price of Chinese patent drugs of the same species, and provide a new reference model for the quality evaluation of Chinese patent drug.
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Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription DrugsABSTRACT
Qili-Qiangxin capsules have been wildly used for the cardiovascular diseases. Qili-Qiangxin capsules have good effect on the myocardial infarction, dilated cardiomyopathy, congestive heart failure, diastolic heart failure and HFPEF patients. Patients' cardiac function and quality of life can be improved after treatment. In the basic researches, we concluded the mechanisms of Qili-Qiangxin capsules'effect on the heart failure that Qili-Qiangxin capsules could effectively restrain the cardiac remodeling, improve cardiac function.Although the Qili-Qiangxin capsules were wild used in the clinic, its precise molecular mechanisms for cardiovascular diseases remained unknown.
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The common Aconitum herbs in clinical application mainly include Aconiti Radix(Chuanwu), Aconiti Kusnezoffii Radix(Caowu) and Aconiti Lateralis Radix Praeparaia(Fuzi), all of which have toxicity. Therefore, the safety of using Chinese patent drugs including Aconitum herbs has become an hot topic in clinical controversy. Based on the data-mining methods, this study explored the characteristics and causes of adverse drug reactions/events (ADR/ADE) of the Chinese patent drugs including Aconitum, in order to provide pharmacovigilance and rational drug use suggestions for clinical application. The detailed ADR/ADE reports about the Chinese patent drugs including Aconitum herbs were retrieved in the domestic literature databases since 1984 to now. The information extraction and data-mining were conducted based on the platforms of Microsoft office Excel 2016, Clementine 12.0 and Cytoscape 3.3.0. Finally, 78 detailed ADR/ADE reports involving a total of 30 varieties were included. 92.31% ADR/ADE were surely or likely led by the Chinese patent drugs including Aconitum, mostly involving multiple system/organ damages with good prognosis, and even 1 case of death. The incidence of included ADRs/ADEs was associated with various factors such as the patient idiosyncratic, drug toxicity, as well as clinical medication. The patient age was most closely related to ADR/ADEs, and those aged from 60 to 69 were more easily suffered from the ADRs/ADEs of Chinese patent drugs including Aconitum. The probability of ADR/ADEs for the drugs including Chuanwu or Caowu was greater than that of Fuzi, and the using beyond the instructions dose was the most important potential safety hazard in the clinical medication process. For the regular and characteristics of ADR/ADEs led by Chinese patent drugs including Aconitum, special attention shall be paid to the elder patients or with the patients with allergies; strictly control the dosage and course of treatment, strengthen the safety medication education to public, and avoid misuse or abuse to ensure rational drug use.
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Humans , Aconitum , Data Mining , Databases, Bibliographic , Drugs, Chinese Herbal , Nonprescription DrugsABSTRACT
Traditional Chinese medicine (TCM) has showed the many positive treatment for psoriasis with few adverse reactions and low recurrence rate. According to the research literature in recent years, this paper summarizes the treatment of psoriasis from the three aspects of TCM internal treatment, external treatment and combined treatment, in order to provide useful reference for the treatment of psoriasis.
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China has become one of the leading counties in the world to treat hepatic fibrosis with Chinese patent drugs.The therapeutic effect of traditional Chinese medicine (TCM) should be evalvated from the aspects of short-term therapeutic effect,long-term therapeutic effect,and effect of relief of symptoms.This article introduces the results of our exploration of the application of liver stiffness measurement to evaluate therapeutic effect,five-year survival rate to assess]ong-term therapeutic effect,and a TCM syndrome scale to evaluate effect of relief of symptoms,suggesting that the Chinese patent drug Fuzheng Huayu capsules/tablets have a marked clinical effect in the treatment of hepatic fibrosis.It is recommended to use serological diagnostic models,conduct prospective studies with long-term follow-up,and analyze the samples and data accumulated over a long period of time,in order to perfect the methods for evaluating the outcome of hepatic fibrosis.
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OBJECTIVE:To promote the rational use of anti-cold drugs in primary hospital. METHODS:The anti-cold drugs commonly used in outpatient pharmacy of Chinese and western of our hospital were investigated to summarize and analyze the west-ern drugs and Chinese patent drugs. RESULTS:There were totally 33 anti-cold drugs,including 12 kinds of western drugs and 21 kinds of Chinese patent drugs. Mostly anti-cold western drugs were compound preparations,mainly including 5 ingredients:anti-in-flammatory,vasoconstrictor,antitussive,antihistamine and expectorant;the wind-cold common cold and wind-heat common cold should be differentially treated and the role of the characteristics should be grasped. CONCLUSIONS:Physicians and pharmacists should fully understand and grasp the composition,content,indications,the role of the characteristics,adverse reactions and pre-cautions. Different drugs should be given corresponding medication guide based on the clinical symptoms of the patients.
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Objective In order to investigate the situation application of compound Danshen injection (CDI) in the treatment and to provide reference for clinical rational use.Methods Adverse drug reactions (ADR) report literatures through WANFANG DATA, VIP DATA and CNKI from 1989 to 2013 with (CDI) were retrieved the data including patient age, gender, medical history, dosage, medication time and ADR type were got and analyzed.Results One hundred and twenty-one literatures with one hundred and forty-eight ADR report cases wore retrieved. The ADR of (CDI) rate of male was higher than female. The original disease causes were cardiovascular and cerebrovascular diseases. The age, a rather elderly bunch, was not associated with the disease. The frequent onest time of adverse reaction was in 5-20 min after medication, and allergic reaction was the main adverse reaction.Conclusion The ADR of CDI should not be ignored. Patients constitution, gender, medication time and the combined application should be pay more attention to reduce the incidence of ADR and ensure the drug safety.
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Objective To investigate the relationship between that vascular endothelial growth factor (VEGF) expression and microvessel density (MVD) distribution were in the small intestine mucous membrane and that urea and creatinine were eliminated from intestine inrenal failure rat used Shenfushu and atropine treatment.Methods Sprague-Dawely (SD) rats with 5/6 kidney resection were randomly divided into Shenfushu treatment group,Shenfushu + atropine treatment group,pathological control group,and sham operation group for the normal controls.Treatment groups were drenched for eight weeks.Before and after treatment,the concentration of blood urea nitrogen (BUN),serum creatinine (Scr),the fecal urea and fecal creatinine were detected; the expression levels of VEGF and MVD in the small intestinal were detected with small intestinal biopsy immunohistochemical method.The relationship between that expression of VEGF and MVD,and that concentration of BUN,Scr,the fecal urea,and fecal creatinine was analyzed.Results VEGF in the Shenfushu treatment group,Shenfushu + atropine treatment group,and pathological control group was (20.72 ± 1.8) pu,(24.32 ± 1.54) pu,and (28.69 ± 1.82) pu,respectively; MVD was (274.27 ± 10.62)/mm2,(332.71 ± 10.96)/mm2,(436.42 ± 13.70)/mm2,respectively.Expressions of small intestinal VEGF and MVD in two treatment groups were increased significantly than the control group.The concentrations of BUN and Scr were significantly decreased with a negative correlation with the expressions of VEGF and MVD.The concentrations of fecal urea nitrogen and fecal creatinine were significantly increased with a positive correlation with the expressions of VEGF and MVD (P ＜0.05).The concentrations of BUN and serum Cr in the Shenfushu + atropine group were significantly changed more than Shenfushu group (P ＜ 0.05).Conclusions Shenshuaikang and atropine could enhance the expression of VEGF in the small intestinal mucosa,increase microvascular density,promote the elimination of urea nitrogen and creatinine from the intestinal tract to decrease the concentrations of BUN and Scr.Those effects were more obvious with two drugs in combination.
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Objective:To establish a method for detecting synthetic pigments in Chinese patent drugs by solid phase extraction-HPLC(SPE-HPLC). Methods:Purified with SPE and concentrated, the sample was separated on a SHISEIDO C18 column with 0. 02 mol·L-1 ammonium acetate and methanol mixed solution as the mobile phase with gradient elution at the flow rate of 1. 0 ml·min-1 , the detection wavelength of 508nm, column temperature of 30℃,and the injection volume of 10μl. Results: The linear range of the synthetic pigments was 0. 005-0. 200 μg(r=0. 999 9), and the average recovery was 97. 6%(RSD=1. 3%,n=6),97. 0%(RSD=1. 4%,n=6) and 99. 5%(RSD=1. 4%,n=6), respectively. Conclusion:The proposed method is simple, reliable and reproduci-ble, and especially suitable for the detection of synthetic pigments in Chinese patent drugs.
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Objective To analyze the composition principles of Chinese patent drugs containing Lonicerae Japonicae Flos (Jinyinhua) in National Standard for Chinese Patent Drugs (NSCPD) enacted by Ministry of Public Health of China by using Traditional Chinese Medicine Inheritance Support System (TCMISS), and provide reference for its clinical application and development. Methods Based on TCMISS (V2.0), with methods of association rules and improved mutual information method, we analyzed the composition patterns and rules of single drugs and drug combinations. Results Through analyzing on the 201 patent drugs, 21 core drug combinations and 19 diseases that Jinyinhua commonly used were mined, from which influenza, and sore and ulcer were chosen to further analysis, including core drugs and drug combination rules, syndrome etc, disclosing the composition principles of Jinyinhua used in different diseases. Conclusion Patent drugs containing Jinyinhua collected from NSCPD mainly could clear heat and remove toxicity, and the composition principles reflect the compitable characteristics of Jinyinhua in treating different diseases, which are in accordence with clinical application of multiple-efficacy drugs.
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Objective To analyze the composition principles of Chinese patent drugs containing Rehmanniae Radix;To provide reference for clinical application and new drug research and development.Methods Based on the software Traditional Chinese Medicine Inheritance Support System (V2.0), the authors built prescription database containing Rehmanniae Radix in National Standard for Chinese Patent Drugs (NSCPD). Then the authors adopted the statistical module by using data mining methods such as association rules and improved mutual information method, with a purpose to analyze the attending disease, combination rules and the core groups in prescriptions containing Rehmanniae Radix.Results In 357 prescriptions containing Rehmanniae Radix, 17 most commonly used drug combinations were mined. Meanwhile, two diseases, namely, insomnia and vertigo were chosen from the 22 diseases that Rehmanniae Radix was most frequently used to make deeper analysis, showing that Rehmanniae Radix can achieve different therapeutic effects through different compatibility.Conclusion Prescriptions containing Rehmanniae Radixin NSCPD mainly concentrate on clear heat and cool blood, and nourish Yin. The composition principles obtained from the research that Rehmanniae Radix used when curing different diseases can fully play the efficacy of RehmanniaeRadix and provide evidence for clinical scientific formulae.
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[Purpose] For almost ten years of traditional Chinese medicine treatment of infantile herpetic stomatitis, shows that its treatment efficacy and safe-ty, and points out the advantages and disadvantages of traditional Chinese medicine treatment of the disease; in traditional Chinese medicine for infantile herpetic stomatitis targeted multi-channel treatment and flexibility, to open up broader prospects. [Method] To col ect reference infantile herpetic stomati-tis, traditional Chinese medicine treatment of relevant literature reports, the etiology and pathogenesis, dialectical classification and treatment of traditional Chinese medicine, including herbal medicinal broth internal medicine, proprietary Chinese medicine oral treatment, relevant experience and proprietary Chinese medicine atomization, external treatment, acupuncture, massage and so on, carry on the induction, summary. [Results] Chinese medicine treatment for infantile herpetic stomatitis, high total effective rate in clinical effect is better, and with less side effects. [Conclusion] Traditional Chinese medicine in the clinical research of the disease in recent years shows certain advantages, at the same time, carries out multicenter, large sample, prospective clinical study, objective evaluation the clinical curative effect of traditional Chinese medicine treatment of the disease; a clear indication of traditional Chinese medicine treatment of the disease, targeted research and development of convenient and effective inside governance and outside governance drugs wil be the re-search direction of treatment of this disease.
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OBJECTIVE: To analyze the situation and the related problems of Chinese patent drugs including toxicity components used in pediatrics, and to provide the suggestion for the development of Chinese patent drugs for pediatrics. METHODS: 264 Chinese patent drugs which were used in pediatrics were collected from national drug standards, and compared with toxicity drug list. The utilization of toxicity drugs were analyzed statistically. RESULTS: About half of Chinese patent drugs for pediatric included toxicity components. Major problems are complex resource of toxicity components, overdose of toxicity components, single disease and pattern, unscientific determination of amount, etc. CONCLUSION: The in-depth study of Chinese patent drugs requires perfecting national drug standards, to developing more rigorous special approval requirements, to establishing the re-evaluation system and to eliminating unsuitable category of Chinese patent drugs.
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OBJECTIVE: To investigate the utilization of Chinese patent drugs gynaecological patients in our hospital from 2004 to 2006 so as to promote rational drug use.METHOD:The Chinese patent drugs gynaecological patients used in our hospital from 2004 to 2006 were subjected to classification statistic and comprehensive analysis in respect of the consumption sum,DDDs and daily average cost.RESULT: Over the 3 years,the consumption sum of most of the Chinese patent drugs increased year on year,and the proportion of the cost of the Chinese patent drugs in the total increased as well.CONCLUSIONS:The use of Chinese patent drugs gynaecological patients in our hospital is basically rational. However,there are still some points remain to be improved.
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Objective To study the curative effect of ZeGuiLongShuang capsules combined with naftopidil on benign prostatic hyperplasia(BPH).Methods 140 cases with BPH were randomly divided into treatment group and control group.The patients in treatment group were given ZeGuiLongShuang capsules(once 2 tablets,3 times a day) combined with naftopidil(once 25 mg,once a day before sleeping).The patients in control group were given only naftopidil(once 25 mg,once a day before sleeping).Internatianal-prognosic-scoring-system(IPSS),uroflowmetry-max(Qmax),Quality-of-life(QOL),residual urine and weight of prostate before and after treatment were detected.Results IPSS,Qmax,QOL and residual urine changed in two groups.IPSS,Qmax,QOL and residual urine in treatment group were more significant than those in control group(P