BACKGROUND The generalized tonic-clonic seizure(GTCS)is the most usual variety of epileptic seizure.It is mainly characterized by strong body muscle rigidity,loss of consciousness,a disorder of plant neurofunction,and...BACKGROUND The generalized tonic-clonic seizure(GTCS)is the most usual variety of epileptic seizure.It is mainly characterized by strong body muscle rigidity,loss of consciousness,a disorder of plant neurofunction,and significant damage to cognitive function.The effect of antiepileptic drugs on cognition should also be considered.At present,there is no effective treatment for patients with epilepsy,but traditional Chinese medicine has shown a significant effect on chronic disease with fewer harmful side effects and should,therefore,be considered for the therapy means of epilepsy with cognitive dysfunction.AIM To investigate the clinical efficacy of Baijin pills for treating GTCS patients with cognitive impairment.METHODS This prospective study enrolled patients diagnosed with GTCS between January 2020 and December 2023 and separate them into two groups(experimental and control)using random number table method.The control group was treated with sodium valproate,and the experimental group was Baijin pills and sodium valproate for three months.The frequency and duration of each seizure,the Montreal Cognitive Assessment Scale(MoCA),and the Quality of Life Rating Scale(QOLIE-31)were recorded before and after treatment.RESULTS There were 85 patients included(42 in the control group and 43 in the experimental group).After treatment,the seizure frequency in the experimental group was significantly reduced(P<0.05),and seizure duration was shortened(P<0.01).The total MoCA score in the experimental group significantly increased compared to before treatment(P<0.01),and the sub-item scores,except naming and abstract generalization ability,significantly increased(P<0.05),whereas the total MoCA score in the control group significantly decreased after treatment(P<0.05).The QOLIE-31 score of the experimental group increased significantly after treatment compared to before treatment(P<0.01).CONCLUSION Baijin pills have a good clinical effect on epilepsy with cognitive dysfunction.展开更多
for about 20%of all clinically confirmed pregnancy.It is the main cause of early abortion.Vaginal bleeding is the main clinical manifestation,which seriously affects the mental health and quality of life of pregnant w...for about 20%of all clinically confirmed pregnancy.It is the main cause of early abortion.Vaginal bleeding is the main clinical manifestation,which seriously affects the mental health and quality of life of pregnant women.Currently,there is effective treatment for this condition.A recent meta-analysis showed that Shoutai Pill(ST Pill),a traditional Chinese medicine(TCM)formula,can effectively decrease the rate of threatened abortion.However,high heterogeneity was found among the studies included in the meta-analysis,this conclusion on the efficacy of TCM is not definitive.Although several have been conducted,some of them do not describe randomization and blinding methods.To address these problems,this article proposes an improved clinical treatment scheme based on ST Pill,which is to be tested through a well-designed randomized controlled trial,for the treatment of threatened abortion.Methods:This is a double-blinded,randomized,placebo-controlled trial to be conducted in a public Three-A hospital in China's Mainland.A total of 200 people will be enrolled.Using computer-generated random numbers,the participants will be randomly divided into two groups at a ratio of 1:1(treatment group(treated with ST Pill group)and placebo group).Both groups will receive medication to the end of the 20th gestational week or 1 week after vaginal bleeding stops,depending on which is longer.Participants in the treatment group will be treated with ST Pill(20 pills/time,once a day),and those in the placebo group will receive a placebo drug which is similar in appearance and smell with ST Pill.The main observation index is the live birth rate.Discussion:Although the efficacy of ST Pill in threatened abortion is well-known,no study has tested its efficacy through a double-blinded,randomized trials.Therefore,there is an urgent need for a standardized randomized double-blinded controlled trial to evaluate the clinical efficacy of ST Pill.ST Pill is likely to be a convenient and effective TCM pill for the prevention of threatened abortion.展开更多
Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-...Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-blind,placebo-controlled trial encompassing a three-menstrual cycle intervention followed by a three-menstrual cycle follow-up period.A total of 164 eligible females with endometriosis-associated dysmenorrhea were randomly divided into HHRY pills and placebo groups in a 1:1 ratio.The primary outcome included dysmenorrhea symptoms assessed using Visual Analog Scale(VAS)scores and quality of life,whereas the secondary outcome measures included the maximum VAS for non-menstrual pelvic pain,duration of pain episodes(in days),frequency and quantity of the consumption of ibuprofen sustained-release capsules(or other non-steroidal anti-inflammatory drugs),and days off work/study for staff/student due to dysmenorrhea,ovarian cyst,and/or pelvic nodule size.The safety was monitored throughout the treatment period.All the analyses were based on the intention-to-treat principle.For continuous outcomes,simple or multiple linear regressions were used to estimate the differences between the HHRY pills and placebo groups,with categorical data expressed as the number and percentage of occurrences.Differences were compared using the chi-square test or Fisher's exact test.The predefined analysis was adjusted for concomitant treatment,a variable considered to be associated with outcomes but unaffected by treatment allocation.Estimates of treatment effects were reported with 95%confidence intervals.Two-tailed P values≤.05 were considered statistically significant.Conclusion:Positive results from this trial,upon completion would provide robust evidence for the efficacy and safety of HHRY pills in treating dysmenorrhea in patients with endometriosis.展开更多
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 ...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.展开更多
Background: Compromised circulatory and bone/lipid metabolic dysfunction are two major contributors to non-traumatic osteonecrosis of the femoral head (ONFH). Qing’e pill plus Salvia has significant anti-inflammatory...Background: Compromised circulatory and bone/lipid metabolic dysfunction are two major contributors to non-traumatic osteonecrosis of the femoral head (ONFH). Qing’e pill plus Salvia has significant anti-inflammatory and anti-atherosclerotic action, and it could also regulate bone formation and remodeling by suppressing osteoclasts. Case Report: We describe a case of a 62-year- old man with ONFH of idiopathic type in earlier stage that could not be adequately controlled with oral non-steroidal analgesics and restoring bone loss agents for past 3 years. After six months treatment with Qing’e pill plus Salvia, the plasma low-density lipoprotein (LDL), high-density lipoprotein (HDL), apolipoprotein A1 (apo A1), apolipoprotein B (apo B), total cholesterol (TC), triglycerides (TG), and blood viscosity were measured on an empty stomach. The Harris scores were maintained during a six months follow-up after discontinuation of Qing’e pill plus Salvia. Discussion: Our case has shown that plasma levels of inflammatory and atherosclerotic relaxed factors and the Harris scores may be controlled with herbal medication in ONFH of idiopathic type in earlier stage that could not be adequately controlled with oral non-steroidal analgesics and restoring bone loss agents.展开更多
Functional dyspepsia(FD) is a common and frequently occurring disease in clinic. With the infuence of environmental factors, social factors and dietary factors, the incidence rate of FD in the general population is ye...Functional dyspepsia(FD) is a common and frequently occurring disease in clinic. With the infuence of environmental factors, social factors and dietary factors, the incidence rate of FD in the general population is yearly increasing. Traditional Chinese medicine has a long history and far-reaching infuence in the treatment of FD. It can prevent and treat FD in the form of multiple-components, targets and channels,with obvious effect and prominent advantages. This article starts with the common syndrome types of FD, and discusses the research progress of single Chinese medicine, effective ingredients and the mechanism of traditional Chinese medicines in treating FD, in order to provide a theoretical basis for the treatment of FD with traditional Chinese medicines.展开更多
Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western ...Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western societies.To ensure the safety and quality of the herbal medicines that are a major part of the TCM tradition,they must be held to modern pharmaceutical standards.Erzhi pill(EZP)is a Chinese Pharmacopeia-listed herbal preparation that is used in the long-term clinical management of postmenopausal symptoms,osteoporosis and menstrual disorders.Until now,whether the drug release mechanism of EZP is in line with its intended TCM usage has not been studied.Methods:The release of specnuezhenide from three EZPs(self-made,Leiyunshang and Renhe)in simulated gastric fluid(SGF),acetate buffer(p H 4.5 buffer)and simulated intestinal fluid(SIF)was investigated in a dissolution test.The water uptake capacity and erosion extent of the three EZPs were investigated using swelling and erosion studies.The drug release mechanism was further assessed through statistical model fitting,using DDSolver software.Results:The release of specnuezhenide from all three EZPs in SGF was less than 50%within a 4 h period.However,over 70%of the specnuezhenide was released from each EZP in both p H 4.5 buffer and SIF in the same time.Analysis of the swelling and erosion behaviors and the drug release mechanism of the three EZPs confirmed that the release rate from EZP followed a sustained release profile,which was an interactive combination of swelling and erosion.Conclusion:This study showed that the release pattern from the pills was in line with the intended TCM use of EZP.TCM had not only theoretically considered sustained release from the pills,but also formulated them to achieve this release pattern.When establishing quality control standards for pills,the theoretical TCM usage and the actual release patterns need to be considered.展开更多
基金Supported by Jiangsu Province Phase 6"333 Project",No.BRA202201.
文摘BACKGROUND The generalized tonic-clonic seizure(GTCS)is the most usual variety of epileptic seizure.It is mainly characterized by strong body muscle rigidity,loss of consciousness,a disorder of plant neurofunction,and significant damage to cognitive function.The effect of antiepileptic drugs on cognition should also be considered.At present,there is no effective treatment for patients with epilepsy,but traditional Chinese medicine has shown a significant effect on chronic disease with fewer harmful side effects and should,therefore,be considered for the therapy means of epilepsy with cognitive dysfunction.AIM To investigate the clinical efficacy of Baijin pills for treating GTCS patients with cognitive impairment.METHODS This prospective study enrolled patients diagnosed with GTCS between January 2020 and December 2023 and separate them into two groups(experimental and control)using random number table method.The control group was treated with sodium valproate,and the experimental group was Baijin pills and sodium valproate for three months.The frequency and duration of each seizure,the Montreal Cognitive Assessment Scale(MoCA),and the Quality of Life Rating Scale(QOLIE-31)were recorded before and after treatment.RESULTS There were 85 patients included(42 in the control group and 43 in the experimental group).After treatment,the seizure frequency in the experimental group was significantly reduced(P<0.05),and seizure duration was shortened(P<0.01).The total MoCA score in the experimental group significantly increased compared to before treatment(P<0.01),and the sub-item scores,except naming and abstract generalization ability,significantly increased(P<0.05),whereas the total MoCA score in the control group significantly decreased after treatment(P<0.05).The QOLIE-31 score of the experimental group increased significantly after treatment compared to before treatment(P<0.01).CONCLUSION Baijin pills have a good clinical effect on epilepsy with cognitive dysfunction.
文摘for about 20%of all clinically confirmed pregnancy.It is the main cause of early abortion.Vaginal bleeding is the main clinical manifestation,which seriously affects the mental health and quality of life of pregnant women.Currently,there is effective treatment for this condition.A recent meta-analysis showed that Shoutai Pill(ST Pill),a traditional Chinese medicine(TCM)formula,can effectively decrease the rate of threatened abortion.However,high heterogeneity was found among the studies included in the meta-analysis,this conclusion on the efficacy of TCM is not definitive.Although several have been conducted,some of them do not describe randomization and blinding methods.To address these problems,this article proposes an improved clinical treatment scheme based on ST Pill,which is to be tested through a well-designed randomized controlled trial,for the treatment of threatened abortion.Methods:This is a double-blinded,randomized,placebo-controlled trial to be conducted in a public Three-A hospital in China's Mainland.A total of 200 people will be enrolled.Using computer-generated random numbers,the participants will be randomly divided into two groups at a ratio of 1:1(treatment group(treated with ST Pill group)and placebo group).Both groups will receive medication to the end of the 20th gestational week or 1 week after vaginal bleeding stops,depending on which is longer.Participants in the treatment group will be treated with ST Pill(20 pills/time,once a day),and those in the placebo group will receive a placebo drug which is similar in appearance and smell with ST Pill.The main observation index is the live birth rate.Discussion:Although the efficacy of ST Pill in threatened abortion is well-known,no study has tested its efficacy through a double-blinded,randomized trials.Therefore,there is an urgent need for a standardized randomized double-blinded controlled trial to evaluate the clinical efficacy of ST Pill.ST Pill is likely to be a convenient and effective TCM pill for the prevention of threatened abortion.
基金supported by the National Natural Science Foundation of China(81830115).
文摘Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-blind,placebo-controlled trial encompassing a three-menstrual cycle intervention followed by a three-menstrual cycle follow-up period.A total of 164 eligible females with endometriosis-associated dysmenorrhea were randomly divided into HHRY pills and placebo groups in a 1:1 ratio.The primary outcome included dysmenorrhea symptoms assessed using Visual Analog Scale(VAS)scores and quality of life,whereas the secondary outcome measures included the maximum VAS for non-menstrual pelvic pain,duration of pain episodes(in days),frequency and quantity of the consumption of ibuprofen sustained-release capsules(or other non-steroidal anti-inflammatory drugs),and days off work/study for staff/student due to dysmenorrhea,ovarian cyst,and/or pelvic nodule size.The safety was monitored throughout the treatment period.All the analyses were based on the intention-to-treat principle.For continuous outcomes,simple or multiple linear regressions were used to estimate the differences between the HHRY pills and placebo groups,with categorical data expressed as the number and percentage of occurrences.Differences were compared using the chi-square test or Fisher's exact test.The predefined analysis was adjusted for concomitant treatment,a variable considered to be associated with outcomes but unaffected by treatment allocation.Estimates of treatment effects were reported with 95%confidence intervals.Two-tailed P values≤.05 were considered statistically significant.Conclusion:Positive results from this trial,upon completion would provide robust evidence for the efficacy and safety of HHRY pills in treating dysmenorrhea in patients with endometriosis.
基金the Foundation for Beijing Science and Technology Development of TCM,No.JJ2016-10the National Traditional Chinese Medicine Innovative Talents Training Project from Beijing Municipal Science and Technology Commission,No.Z171100001717006.
文摘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.
文摘Background: Compromised circulatory and bone/lipid metabolic dysfunction are two major contributors to non-traumatic osteonecrosis of the femoral head (ONFH). Qing’e pill plus Salvia has significant anti-inflammatory and anti-atherosclerotic action, and it could also regulate bone formation and remodeling by suppressing osteoclasts. Case Report: We describe a case of a 62-year- old man with ONFH of idiopathic type in earlier stage that could not be adequately controlled with oral non-steroidal analgesics and restoring bone loss agents for past 3 years. After six months treatment with Qing’e pill plus Salvia, the plasma low-density lipoprotein (LDL), high-density lipoprotein (HDL), apolipoprotein A1 (apo A1), apolipoprotein B (apo B), total cholesterol (TC), triglycerides (TG), and blood viscosity were measured on an empty stomach. The Harris scores were maintained during a six months follow-up after discontinuation of Qing’e pill plus Salvia. Discussion: Our case has shown that plasma levels of inflammatory and atherosclerotic relaxed factors and the Harris scores may be controlled with herbal medication in ONFH of idiopathic type in earlier stage that could not be adequately controlled with oral non-steroidal analgesics and restoring bone loss agents.
文摘Functional dyspepsia(FD) is a common and frequently occurring disease in clinic. With the infuence of environmental factors, social factors and dietary factors, the incidence rate of FD in the general population is yearly increasing. Traditional Chinese medicine has a long history and far-reaching infuence in the treatment of FD. It can prevent and treat FD in the form of multiple-components, targets and channels,with obvious effect and prominent advantages. This article starts with the common syndrome types of FD, and discusses the research progress of single Chinese medicine, effective ingredients and the mechanism of traditional Chinese medicines in treating FD, in order to provide a theoretical basis for the treatment of FD with traditional Chinese medicines.
基金supported by Mitacs,Canada(Mitacs Accelerate:IT13686)and JRC Pharmaceuticals Inc,Canada。
文摘Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western societies.To ensure the safety and quality of the herbal medicines that are a major part of the TCM tradition,they must be held to modern pharmaceutical standards.Erzhi pill(EZP)is a Chinese Pharmacopeia-listed herbal preparation that is used in the long-term clinical management of postmenopausal symptoms,osteoporosis and menstrual disorders.Until now,whether the drug release mechanism of EZP is in line with its intended TCM usage has not been studied.Methods:The release of specnuezhenide from three EZPs(self-made,Leiyunshang and Renhe)in simulated gastric fluid(SGF),acetate buffer(p H 4.5 buffer)and simulated intestinal fluid(SIF)was investigated in a dissolution test.The water uptake capacity and erosion extent of the three EZPs were investigated using swelling and erosion studies.The drug release mechanism was further assessed through statistical model fitting,using DDSolver software.Results:The release of specnuezhenide from all three EZPs in SGF was less than 50%within a 4 h period.However,over 70%of the specnuezhenide was released from each EZP in both p H 4.5 buffer and SIF in the same time.Analysis of the swelling and erosion behaviors and the drug release mechanism of the three EZPs confirmed that the release rate from EZP followed a sustained release profile,which was an interactive combination of swelling and erosion.Conclusion:This study showed that the release pattern from the pills was in line with the intended TCM use of EZP.TCM had not only theoretically considered sustained release from the pills,but also formulated them to achieve this release pattern.When establishing quality control standards for pills,the theoretical TCM usage and the actual release patterns need to be considered.
文摘目的研究中药复方颈椎康复丸治疗蛋白聚糖诱导小鼠骨关节炎的影响,为扩大该药的适应证及临床应用提供参考。方法采用Balb/c小鼠进行实验,将小鼠随机分为正常组,模型组,颈椎康复丸高、低剂量(6、3 g·kg^(-1)·d^(-1))组。全部小鼠(正常组除外)腹腔注射0.2 mL DDA佐剂(含100μg蛋白聚糖)造模;正常组给予0.2 mL生理盐水。首次免疫后,每隔2周进行关节炎评估和体重监测直到第14周。应用HE染色和番红固绿染色观察关节组织病理形态。应用ELISA法测定小鼠血清炎症因子IL-1β、IL-6、TNF-α和IL-17A。结果颈椎康复丸对小鼠骨关节炎有明显的抑制作用,能降低关节炎性评分和肿胀度。镜下观察,颈椎康复丸能保护小鼠关节组织,减少炎性浸润。颈椎康复丸能降低小鼠血清中炎症因子IL-1β、IL-6、TNF-α和IL-17A水平。结论颈椎康复丸对蛋白聚糖诱导的小鼠骨关节炎有改善作用。