Background:To systematically evaluate the efficacy and safety of activating blood and resolving stasis in patients with IgA nephropathy.Methods:From inception to May 2022,databases including PubMed,Embase,the Cochrane...Background:To systematically evaluate the efficacy and safety of activating blood and resolving stasis in patients with IgA nephropathy.Methods:From inception to May 2022,databases including PubMed,Embase,the Cochrane Library,Web of Science,WanFang database,Chinese Biomedical Database,VIP,and China National Knowledge Infrastructure were searched for randomized controlled trials about enhancing blood circulation and removing stasis for IgA nephropathy.For the articles that satisfied the requirements,quality assessment and meta-analysis were done.Results:Seventeen randomized controlled trials with a total of 1653 patients were included.Meta-analysis showed that activating blood and resolving stasis could increase therapeutic effectiveness(risk ratio(RR)=-0.47,95%confidence interval(CI)(-0.37,-0.2),P=0.0006)and decrease levels of serum creatinine(RR=-0.47,95%CI(-0.37,-0.2),P=0.0006),urea nitrogen(RR=0.85,95%CI(1.44,0.26),P=0.005),24-hour urinary protein quantification(RR=1.6,95%CI(2.44,0.95).P=0.00001),and urine red blood cell count(RR=1.7,95%CI(2.57,0.82),P=0.0001).There was no significant difference between the two groups in terms of security(RR=0.6,95%CI(0.36,1.01),P=0.05).Conclusion:Western medicine combined activating blood and resolving stasis is more efficient than Western medicine therapy alone in treating IgA nephropathy,but it still needs to be supported by additional large-scale,multi-center randomized controlled clinical trials due to the poor quality of the included trials.展开更多
Objective:To explore the clinical effect differences of moxibustion with different doses on primary dysmenorrhea with cold congelation and blood stasis type.Methods:A total of 60 patients of primary dysmenorrhea were ...Objective:To explore the clinical effect differences of moxibustion with different doses on primary dysmenorrhea with cold congelation and blood stasis type.Methods:A total of 60 patients of primary dysmenorrhea were randomized into an intensified dose group and a conventional dose group.All of the patients were treated with moxibustion.In the intensified dose group,the treatment was given three times daily(once every morning,afternoon and at bedtime successively) and during the trial,1 case was dropped out and 29 cases were included in the statistical analysis finally.In the conventional dose group,the treatment was given once daily and 1 case was dropped out during trial and 29 cases were included in the statistical analysis.The score of visual analogue scale(VAS) at the worst painful time point,the score of dysmenorrhea symptoms and recurrence rate were observed and compared before and after treatment in the patients between the two groups.The clinical therapeutic effects were observed in the two groups too.Results:VAS difference value(D-value) and dysmenorrhea symptoms D-valuebefore and after treatment in the intensified dose group were higher than those in the conventional dose group respectively(both P<0.05).The recurrence rate was 14.29% in the intensified dose group,lower than 42.31% in the conventional dose group,with the statistical significance(P<0.05).The total clinical effective rate was 96.55%in the intensified dose group,higher than 89.66% in the conventional dose group,with the statistical significance(P<0.05).Conclusion:Compared with the conventional dose moxibustion,moxibustion with intensified dose achieves satisfactory therapeutic effect on primary dysmenorrhea of cold congelation and blood stasis type.This therapy is low in recurrent rate and convenient in manipulation,thus it deserves to be promoted in clinical application.展开更多
Objective:To assess the effect and safety of Hydroxysafflor Yellow A for Injection(HSYAI)in treating patients with acute ischemic stroke(AIS)and blood stasis syndrome(BSS).Methods:A multicenter,randomized,double-blind...Objective:To assess the effect and safety of Hydroxysafflor Yellow A for Injection(HSYAI)in treating patients with acute ischemic stroke(AIS)and blood stasis syndrome(BSS).Methods:A multicenter,randomized,double-blind,multiple-dose,active-controlled phaseⅡtrial was conducted at 9 centers in China from July 2013 to September 2015.Patients with moderate or severe AIS and BSS were randomly assigned to low-,medium-,high-dose HSYAI groups(25,50 and 70 mg/d HSYAI by intravenous infusion,respectively),and a control group(Dengzhan Xixin Injection(灯盏细辛注射液,DZXXI)30 mL/d by intravenous infusion),for 14 consecutive days.The primary outcome was the Modified Rankin Scale(mRS)score 1 at days 90 after treatment.The secondary outcomes included the National Institute of Health Stroke Scale(NIHSS)score 1,Barthel Index(BI)score 95,and BSS score reduced 30%from baseline at days 14,30,60,and 90 after treatment.The safety outcomes included any adverse events during 90 days after treatment.Results:Of the 266 patients included in the effectiveness analysis,66,67,65 and 68 cases were in the low-,medium-,and high-dose HSYAI and control groups,respectively.The proportions of patients in the medium-and high-dose HSYAI groups with mRS score 1 at days 90 after treatment were significantly larger than the control group(P<0.05).The incidences of favorable outcomes of NIHSS and BI at days 90 after treatment as well as satisfactory improvement of BSS at days 30 and 60 after treatment in the medium-and high-dose HSYAI groups were all significantly higher than the control group(P<0.05).No significant difference was reported among the 4 groups in any specific adverse events(P>0.05).Conclusions:HSYAI was safe and well-tolerated at all doses for treating AIS patients with BSS.The medium(50 mg/d)or high dose(75 mg/d)might be the optimal dose for a phaseⅢtrial.展开更多
OBJECTIVE:To evaluate the clinical efficacy of Traditional Chinese Medicine prescriptions for resolving phlegm in the treatment of angina pectoris of phlegmstasis coronary heart disease by a network Meta-analysis.METH...OBJECTIVE:To evaluate the clinical efficacy of Traditional Chinese Medicine prescriptions for resolving phlegm in the treatment of angina pectoris of phlegmstasis coronary heart disease by a network Meta-analysis.METHODS:Randomized controlled trials(RCTs)on clinical efficacy of CHD angina pectoris with interaction of phlegm and blood stasis were searched in PubMed,Springer,the Cochrane Library and Chinese-language databases China National Knowledge Infrastructure,China Science and Technology Journal Database,and Wanfang Data from their inception to December 2021.Literature was screened and literature bias risk was assessed by RevMan5.4 software.The overall response rate,the duration of angina attack,the levels of serum lipids such as total cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C),and high density lipoprotein cholesterol(HDL-C),and expression of hypersensitive C-reactive protein(hs-CRP)were selected as outcome indicators for network Meta-analysis and mapped using Stata15.1 software.RESULTS:Totally,26 RCTs were included,involving 2098 participants.There were 6 TCM formulas with the effects of dispelling phlegm and removing blood stasis.Taking conventional Western Medicine as the common intervention measures,the results showed that the overall response improvement rate from high to low was displayed as modified Xiaoxianxiong decoction(小陷胸汤,MXD),Danlou tablet(丹蒌片,DT),modified Gualou Xiebai Banxia decoction(瓜蒌薤白半夏汤,MGXBD),modified Wendan decoction(温胆汤,MWD),modified Zhishi Xiebai Guizhi decoction(枳实薤白桂枝汤,MZXGD),and modified Erchen decoction(二陈汤,MED).The sequence of angina attack duration improvement from high to low was MZXGD,MGXBD,DT,MWD,MXD.The sequence of TC improvement from high to low was MZXGD,MED,DT,and MGXBD.Sequence of improving TG from high to low was MED,MZXGD,MGXBD,and DT.For LDL-C improvement,the effect from good to poor was MZXGD,MGXBD,DT,and MED.With regard to HDL-C improvement,the effect was ranked as MED,MZXGD,MGXBD,and DT from good to poor.hs-CRP expression from high to low was MZXGD,MXD,MED,MWD,and MGXBD.CONCLUSION:TCM formula with the effects of dispelling phlegm and removing blood stasis combined with conventional Western Medicine has obvious advantages in treating CHD angina pectoris with interaction of phlegm and blood stasis.MZXGD has great potential in increasing the overall response rate,reducing Duration of angina attack improving blood lipids,and reducing inflammatory factors.However,due to the limitations of extant studies,the conclusions of this study need to be confirmed by numerous reasonably-designed RCTs.展开更多
Objective: To observe the efficacy and safety of Guihuang Formula(GHF) in treating patients with type Ⅲ prostatitis and Chinese medicine syndrome of dampness-heat and blood stasis. Methods: Sixty-six type Ⅲ prostati...Objective: To observe the efficacy and safety of Guihuang Formula(GHF) in treating patients with type Ⅲ prostatitis and Chinese medicine syndrome of dampness-heat and blood stasis. Methods: Sixty-six type Ⅲ prostatitis patients with dampness-heat and blood stasis syndrome were randomly divided into the treatment group(GHF) and the control group(tamsulosin) using a random number table, with 33 cases each group. The treatment group received GHF twice a day, and the control group received tamsulosin 0.2 mg once daily before bedtime. Patients in both groups received treatment for 6 weeks and was followed up for 2 weeks. The outcomes included the National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) score, Chinese Medicine Symptoms Score(CMSS), expressed prostatic secretions(EPS) and adverse events(AEs). Results: After treatment, the NIH-CPSI total score and domain scores of pain discomfort, urination and quality of life decreased significantly from the baseline in both groups(P<0.05). The CMSS score decreased in both groups(P<0.05). The white blood cell(WBC) count decreased and lecithin body count increased in both groups(P<0.05). GHF showed a more obvious advantage in reducing the pain discomfort and quality of life domain scores of NIH-CPSI, reducing the CMSS score, increasing the improvement rate of the WBC and lecithin body counts, compared with the control group(P<0.05). There were no significant differences in decreasing urination domain score of NIH-CPSI between two groups(P>0.05). In addition, no serious AEs were observed. Conclusion: GHF is effective in treating type Ⅲ prostatitis patients with dampness-heat and blood stasis syndrome without serious AEs.(Registration No. ChiCTR1900026966)展开更多
OBJECTIVE:To evaluate the efficacy and safety of flesh-moistening paste for treating psoriasis vulgaris in patients with blood stasis pattern in terms of Traditional Chinese Medicine(TCM).METHODS:Eudipleural rashes on...OBJECTIVE:To evaluate the efficacy and safety of flesh-moistening paste for treating psoriasis vulgaris in patients with blood stasis pattern in terms of Traditional Chinese Medicine(TCM).METHODS:Eudipleural rashes on both the left and right side of the same patients with psoriasis vulgaris,diagnosed via TCM as blood stasis pattern,were selected as the targeted skin lesions.A randomized,double-blind,parallel-controlled,multicenter controlled trial was conducted.The targeted skin lesions were categorized into either the treatment or control group.The treatment group used the flesh-moistening paste;the control group used a placebo.Both the paste and the placebo were topically applied twice daily for eight weeks.The patients were examined biweekly to evaluate the effects.The two groups were compared in terms of the psoriasis area and severity index(PASI)of the targeted skin lesions,which is scored according to erythema,desquamation,infiltration,area,pruritus,and improvement of skin barrier function.Adverse events were recorded during the study period.SPSS 21.0 was used to analyze the data.RESULTS:Fifty-six patients were enrolled between February 2016 and October 2017.Two were complicated by cardio-cerebrovascular disease and were excluded;thus,54 outpatients were finally enrolled in the study.Four dropped out during the study period:three failed to complete their follow-up visits for unknown reasons,and one exited due to an adverse event.The final trial comprised 50 of the 56 originally selected patients,with a 92.6%completion rate.After 8 weeks of treatment,the targeted skin lesion scores differed significantly(P<0.05).The PASI scores of the targeted skin lesions differed significantly beginning at week 6(P<0.05).The treatment group presented better results than those of the control group.Only one patient had an adverse reaction associated with the treatment.Improvements in skin barrier function differed significantly(P<0.05).CONCLUSION:The flesh-moistening paste demonstrated a reliable curative effect and safety for treating psoriasis vulgaris in patients with blood stasis patterns.The topical paste improved the barrier function of the skin lesions.展开更多
Objective To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule(养阴益气活血颗粒,YYHG)in the treatment of ischemic stroke(IS)patients with qi-yin deficiency and blood stasis syndrome(QYDBSS),and to explor...Objective To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule(养阴益气活血颗粒,YYHG)in the treatment of ischemic stroke(IS)patients with qi-yin deficiency and blood stasis syndrome(QYDBSS),and to explore its effective dosage.Methods The total of 288 patients were randomly assigned to the YYHG high-dose,YYHG low-dose,positive control(administered Xiaoshuantong Granule,XSTG,消栓通颗粒),or placebo control(administered inert granule)groups(72 cases per group)by software-drived competitive block randomization.The trial was conducted for a 28-day period,with a 180-day follow-up period.The primary outcome was the comprehensive curative evaluation,and secondary outcomes were the National Institute of Health Stroke Scale(NIHSS)score,Barthel activities of daily living(ADL)index score,the quality of life index(QLI)score,and the Chinese medicine syndrome(CMS)score.All analyses were done on an intention-to-treat basis.The clinical safety was also assessed.Results The total of 288 participants were recruited between June 1,2008 and September 30,2009,and 287 patients received intervention;the treatment groups were well balanced at baseline.The comprehensive cure rates of YYHG high-dose,low-dose,positive and placebo control groups were 63.38%,31.94%,36.11%and 6.14%,respectively;there was a statistical difference between the two groups(P<0.01),while the high-dose YYHG treatment group was significantly higher than the other 3 groups(P<0.01).The improvement of NIHSS,ADL,QLI and CMS scores of the YYHG high-dose and low-dose groups was significantly better than that of the positive control group and the placebo control group(P<0.05).In terms of improving the classification of the NIHSS scale and the assessment of the ADL scale,the YYHG high-dose group was significantly better than the other three groups(P<0.05),and the YYHG low-dose group was better than the placebo control group(P<0.01).At the same time,except for the QLI score,the high-dose group was better than the low-dose group(P<0.05).In terms of safety,adverse reactions after YYHG treatment were generally mild(3.78%),and no serious adverse reactions have been reported.Conclusion YYHG is safe and effective in the treatment of IS patients with QYDBSS.展开更多
文摘Background:To systematically evaluate the efficacy and safety of activating blood and resolving stasis in patients with IgA nephropathy.Methods:From inception to May 2022,databases including PubMed,Embase,the Cochrane Library,Web of Science,WanFang database,Chinese Biomedical Database,VIP,and China National Knowledge Infrastructure were searched for randomized controlled trials about enhancing blood circulation and removing stasis for IgA nephropathy.For the articles that satisfied the requirements,quality assessment and meta-analysis were done.Results:Seventeen randomized controlled trials with a total of 1653 patients were included.Meta-analysis showed that activating blood and resolving stasis could increase therapeutic effectiveness(risk ratio(RR)=-0.47,95%confidence interval(CI)(-0.37,-0.2),P=0.0006)and decrease levels of serum creatinine(RR=-0.47,95%CI(-0.37,-0.2),P=0.0006),urea nitrogen(RR=0.85,95%CI(1.44,0.26),P=0.005),24-hour urinary protein quantification(RR=1.6,95%CI(2.44,0.95).P=0.00001),and urine red blood cell count(RR=1.7,95%CI(2.57,0.82),P=0.0001).There was no significant difference between the two groups in terms of security(RR=0.6,95%CI(0.36,1.01),P=0.05).Conclusion:Western medicine combined activating blood and resolving stasis is more efficient than Western medicine therapy alone in treating IgA nephropathy,but it still needs to be supported by additional large-scale,multi-center randomized controlled clinical trials due to the poor quality of the included trials.
文摘Objective:To explore the clinical effect differences of moxibustion with different doses on primary dysmenorrhea with cold congelation and blood stasis type.Methods:A total of 60 patients of primary dysmenorrhea were randomized into an intensified dose group and a conventional dose group.All of the patients were treated with moxibustion.In the intensified dose group,the treatment was given three times daily(once every morning,afternoon and at bedtime successively) and during the trial,1 case was dropped out and 29 cases were included in the statistical analysis finally.In the conventional dose group,the treatment was given once daily and 1 case was dropped out during trial and 29 cases were included in the statistical analysis.The score of visual analogue scale(VAS) at the worst painful time point,the score of dysmenorrhea symptoms and recurrence rate were observed and compared before and after treatment in the patients between the two groups.The clinical therapeutic effects were observed in the two groups too.Results:VAS difference value(D-value) and dysmenorrhea symptoms D-valuebefore and after treatment in the intensified dose group were higher than those in the conventional dose group respectively(both P<0.05).The recurrence rate was 14.29% in the intensified dose group,lower than 42.31% in the conventional dose group,with the statistical significance(P<0.05).The total clinical effective rate was 96.55%in the intensified dose group,higher than 89.66% in the conventional dose group,with the statistical significance(P<0.05).Conclusion:Compared with the conventional dose moxibustion,moxibustion with intensified dose achieves satisfactory therapeutic effect on primary dysmenorrhea of cold congelation and blood stasis type.This therapy is low in recurrent rate and convenient in manipulation,thus it deserves to be promoted in clinical application.
文摘Objective:To assess the effect and safety of Hydroxysafflor Yellow A for Injection(HSYAI)in treating patients with acute ischemic stroke(AIS)and blood stasis syndrome(BSS).Methods:A multicenter,randomized,double-blind,multiple-dose,active-controlled phaseⅡtrial was conducted at 9 centers in China from July 2013 to September 2015.Patients with moderate or severe AIS and BSS were randomly assigned to low-,medium-,high-dose HSYAI groups(25,50 and 70 mg/d HSYAI by intravenous infusion,respectively),and a control group(Dengzhan Xixin Injection(灯盏细辛注射液,DZXXI)30 mL/d by intravenous infusion),for 14 consecutive days.The primary outcome was the Modified Rankin Scale(mRS)score 1 at days 90 after treatment.The secondary outcomes included the National Institute of Health Stroke Scale(NIHSS)score 1,Barthel Index(BI)score 95,and BSS score reduced 30%from baseline at days 14,30,60,and 90 after treatment.The safety outcomes included any adverse events during 90 days after treatment.Results:Of the 266 patients included in the effectiveness analysis,66,67,65 and 68 cases were in the low-,medium-,and high-dose HSYAI and control groups,respectively.The proportions of patients in the medium-and high-dose HSYAI groups with mRS score 1 at days 90 after treatment were significantly larger than the control group(P<0.05).The incidences of favorable outcomes of NIHSS and BI at days 90 after treatment as well as satisfactory improvement of BSS at days 30 and 60 after treatment in the medium-and high-dose HSYAI groups were all significantly higher than the control group(P<0.05).No significant difference was reported among the 4 groups in any specific adverse events(P>0.05).Conclusions:HSYAI was safe and well-tolerated at all doses for treating AIS patients with BSS.The medium(50 mg/d)or high dose(75 mg/d)might be the optimal dose for a phaseⅢtrial.
基金the Fundamental Research Funds for the Central Public Welfare Research Institutes:Theoretical Study of Combination of Facial Color and Pulses Mode in Traditional Chinese Medicine(No.KJ-202013)Objective Study of“Wei Qi”in Pulse Based on Color Doppler Flow Imaging(CDFI)Technology(No.YZ-202124)。
文摘OBJECTIVE:To evaluate the clinical efficacy of Traditional Chinese Medicine prescriptions for resolving phlegm in the treatment of angina pectoris of phlegmstasis coronary heart disease by a network Meta-analysis.METHODS:Randomized controlled trials(RCTs)on clinical efficacy of CHD angina pectoris with interaction of phlegm and blood stasis were searched in PubMed,Springer,the Cochrane Library and Chinese-language databases China National Knowledge Infrastructure,China Science and Technology Journal Database,and Wanfang Data from their inception to December 2021.Literature was screened and literature bias risk was assessed by RevMan5.4 software.The overall response rate,the duration of angina attack,the levels of serum lipids such as total cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C),and high density lipoprotein cholesterol(HDL-C),and expression of hypersensitive C-reactive protein(hs-CRP)were selected as outcome indicators for network Meta-analysis and mapped using Stata15.1 software.RESULTS:Totally,26 RCTs were included,involving 2098 participants.There were 6 TCM formulas with the effects of dispelling phlegm and removing blood stasis.Taking conventional Western Medicine as the common intervention measures,the results showed that the overall response improvement rate from high to low was displayed as modified Xiaoxianxiong decoction(小陷胸汤,MXD),Danlou tablet(丹蒌片,DT),modified Gualou Xiebai Banxia decoction(瓜蒌薤白半夏汤,MGXBD),modified Wendan decoction(温胆汤,MWD),modified Zhishi Xiebai Guizhi decoction(枳实薤白桂枝汤,MZXGD),and modified Erchen decoction(二陈汤,MED).The sequence of angina attack duration improvement from high to low was MZXGD,MGXBD,DT,MWD,MXD.The sequence of TC improvement from high to low was MZXGD,MED,DT,and MGXBD.Sequence of improving TG from high to low was MED,MZXGD,MGXBD,and DT.For LDL-C improvement,the effect from good to poor was MZXGD,MGXBD,DT,and MED.With regard to HDL-C improvement,the effect was ranked as MED,MZXGD,MGXBD,and DT from good to poor.hs-CRP expression from high to low was MZXGD,MXD,MED,MWD,and MGXBD.CONCLUSION:TCM formula with the effects of dispelling phlegm and removing blood stasis combined with conventional Western Medicine has obvious advantages in treating CHD angina pectoris with interaction of phlegm and blood stasis.MZXGD has great potential in increasing the overall response rate,reducing Duration of angina attack improving blood lipids,and reducing inflammatory factors.However,due to the limitations of extant studies,the conclusions of this study need to be confirmed by numerous reasonably-designed RCTs.
基金Supported by the National Natural Science Foundation of China (No.82104880)Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences (No.CI2021A02208)the Nursery Project of Xiyuan Hospital of China Academy of Chinese Medical Sciences (No.2019XYMP-23)。
文摘Objective: To observe the efficacy and safety of Guihuang Formula(GHF) in treating patients with type Ⅲ prostatitis and Chinese medicine syndrome of dampness-heat and blood stasis. Methods: Sixty-six type Ⅲ prostatitis patients with dampness-heat and blood stasis syndrome were randomly divided into the treatment group(GHF) and the control group(tamsulosin) using a random number table, with 33 cases each group. The treatment group received GHF twice a day, and the control group received tamsulosin 0.2 mg once daily before bedtime. Patients in both groups received treatment for 6 weeks and was followed up for 2 weeks. The outcomes included the National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) score, Chinese Medicine Symptoms Score(CMSS), expressed prostatic secretions(EPS) and adverse events(AEs). Results: After treatment, the NIH-CPSI total score and domain scores of pain discomfort, urination and quality of life decreased significantly from the baseline in both groups(P<0.05). The CMSS score decreased in both groups(P<0.05). The white blood cell(WBC) count decreased and lecithin body count increased in both groups(P<0.05). GHF showed a more obvious advantage in reducing the pain discomfort and quality of life domain scores of NIH-CPSI, reducing the CMSS score, increasing the improvement rate of the WBC and lecithin body counts, compared with the control group(P<0.05). There were no significant differences in decreasing urination domain score of NIH-CPSI between two groups(P>0.05). In addition, no serious AEs were observed. Conclusion: GHF is effective in treating type Ⅲ prostatitis patients with dampness-heat and blood stasis syndrome without serious AEs.(Registration No. ChiCTR1900026966)
基金Supported by the Clinical Characteristics Application of Beijing Municipal Science and Technology Commission(No.Z161100000516108)a Randomized Controlled Clinical Study on the Indications of TCM External Treatment for Psoriasis with"Analogic Drug Selection"the Project of Ten Diseases and Ten Drugs funded by the Beijing Municipal Science and Technology Commission(No.Z161100001816024)Research and Development of Traditional Chinese Medicine Preparation for Treatment of Sunburn By Hao Qin Huaban Granule+1 种基金the project supported by the National Natural Science Foundation of China(No.81673975 Study on the Mechanism of Hui Yang Sheng Ji Gao Promoting Ulcer Angiogenesis in Type 2 Diabetes Mellitus and 81774309 Study on the Immune Regulation Mechanism of PI3K/Akt/m TOR Signaling Pathway Mediated by tlrs-4 in Light Sensitive Skin Diseases by Clearing Heat,Cooling Blood and Detoxification)the Beijing Key Laboratory of Clinic and Basic Research with TCM on Psoriasis(No.BZ0375)。
文摘OBJECTIVE:To evaluate the efficacy and safety of flesh-moistening paste for treating psoriasis vulgaris in patients with blood stasis pattern in terms of Traditional Chinese Medicine(TCM).METHODS:Eudipleural rashes on both the left and right side of the same patients with psoriasis vulgaris,diagnosed via TCM as blood stasis pattern,were selected as the targeted skin lesions.A randomized,double-blind,parallel-controlled,multicenter controlled trial was conducted.The targeted skin lesions were categorized into either the treatment or control group.The treatment group used the flesh-moistening paste;the control group used a placebo.Both the paste and the placebo were topically applied twice daily for eight weeks.The patients were examined biweekly to evaluate the effects.The two groups were compared in terms of the psoriasis area and severity index(PASI)of the targeted skin lesions,which is scored according to erythema,desquamation,infiltration,area,pruritus,and improvement of skin barrier function.Adverse events were recorded during the study period.SPSS 21.0 was used to analyze the data.RESULTS:Fifty-six patients were enrolled between February 2016 and October 2017.Two were complicated by cardio-cerebrovascular disease and were excluded;thus,54 outpatients were finally enrolled in the study.Four dropped out during the study period:three failed to complete their follow-up visits for unknown reasons,and one exited due to an adverse event.The final trial comprised 50 of the 56 originally selected patients,with a 92.6%completion rate.After 8 weeks of treatment,the targeted skin lesion scores differed significantly(P<0.05).The PASI scores of the targeted skin lesions differed significantly beginning at week 6(P<0.05).The treatment group presented better results than those of the control group.Only one patient had an adverse reaction associated with the treatment.Improvements in skin barrier function differed significantly(P<0.05).CONCLUSION:The flesh-moistening paste demonstrated a reliable curative effect and safety for treating psoriasis vulgaris in patients with blood stasis patterns.The topical paste improved the barrier function of the skin lesions.
基金Supported by the National Natural Science Foundation of China(No.81630105,No.81374053,No.81173647)Zhejiang Provincial Natural Science Foundation of China(No.LZ17H270001)Zhejiang Provincial Program for the Cultivation of High-Level Innovative Health Talents(No.2018R1002)。
文摘Objective To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule(养阴益气活血颗粒,YYHG)in the treatment of ischemic stroke(IS)patients with qi-yin deficiency and blood stasis syndrome(QYDBSS),and to explore its effective dosage.Methods The total of 288 patients were randomly assigned to the YYHG high-dose,YYHG low-dose,positive control(administered Xiaoshuantong Granule,XSTG,消栓通颗粒),or placebo control(administered inert granule)groups(72 cases per group)by software-drived competitive block randomization.The trial was conducted for a 28-day period,with a 180-day follow-up period.The primary outcome was the comprehensive curative evaluation,and secondary outcomes were the National Institute of Health Stroke Scale(NIHSS)score,Barthel activities of daily living(ADL)index score,the quality of life index(QLI)score,and the Chinese medicine syndrome(CMS)score.All analyses were done on an intention-to-treat basis.The clinical safety was also assessed.Results The total of 288 participants were recruited between June 1,2008 and September 30,2009,and 287 patients received intervention;the treatment groups were well balanced at baseline.The comprehensive cure rates of YYHG high-dose,low-dose,positive and placebo control groups were 63.38%,31.94%,36.11%and 6.14%,respectively;there was a statistical difference between the two groups(P<0.01),while the high-dose YYHG treatment group was significantly higher than the other 3 groups(P<0.01).The improvement of NIHSS,ADL,QLI and CMS scores of the YYHG high-dose and low-dose groups was significantly better than that of the positive control group and the placebo control group(P<0.05).In terms of improving the classification of the NIHSS scale and the assessment of the ADL scale,the YYHG high-dose group was significantly better than the other three groups(P<0.05),and the YYHG low-dose group was better than the placebo control group(P<0.01).At the same time,except for the QLI score,the high-dose group was better than the low-dose group(P<0.05).In terms of safety,adverse reactions after YYHG treatment were generally mild(3.78%),and no serious adverse reactions have been reported.Conclusion YYHG is safe and effective in the treatment of IS patients with QYDBSS.