稳定性冠心病患者中医证候演变与心血管事件的多因子降维分析

Objective： To analyze the correlation of Chinese medicine syndrome evolvement and cardiovascular events in patients with stable coronary heart disease （CHD）. Methods： This prospective cohort study investigated and collected the clinical information of patients with stable CHD and observed the syndrome type at the baseline and 6-month at follow-up, as well as the cardiovascular events during the 6-month and 12-month follow-up. The patients were divided into the event group and the non-event group. The interaction and the impact of syndrome evolvement on cardiovascular events were examined through multifactor dimensionality reduction （MDR） analysis and the results were verified by Chi-square test. Results： Totally 1,333 of 1,503 stable CHD patients enrolled met the inclusion criteria of MDR analysis. Among them, 959 （71.9%） cases were males and 374 （28.1%） cases were females. Thirty seven cases had cardiovascular events during 6 to 12 months after the study began. The results of the MDR analysis and verification using Chi-square test showed that the development of cardiovascular events was positively correlated with interaction between blood stasis and toxic syndrome at the baseline, blood stasis at the baseline and qi deficiency at the 6-month follow-up, toxic syndrome at the baseline and qi deficiency at the 6-month follow-up, toxic syndrome at the base line and blood stasis at the 6-month follow-up, qi deficiency and blood stasis at the 6-month follow-up （P〈0.05 for all）. Conclusions： Blood stasis, toxic syndrome and qi deficiency are important factors of stable CHD. There are positive correlation between cardiovascular events and syndrome evolution from blood stasis to qi deficiency, from toxic syndrome to qi deficiency and from toxic syndrome to blood stasis, indicating the pathogenesis of toxin consuming qi, toxin leading to blood-stasis in stable CHD patients prone to recurrent cardiovascular events.     

Effect of Shenzhu Guanxin Recipe (参术冠心方)on Patients with Angina Pectoris after Percutaneous Coronary Intervention:A Prospective,Randomized Controlled Trial

Objective:To evaluate the efficacy and safety of a combination therapy using Chinese medicine(CM) Shenzhu Guanxin Recipe(参术冠心方 SGR) and standard Western medicine treatment(SWMT) in patients with angina pectoris after percutaneous coronary intervention(PCI).Methods:Double-blind randomized controlled trial was used in this experimental procedure.One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment(SGR) and control(placebo) groups.Outcome measures including angina pectoris score(APS),CM symptom score,and Seattle Angina Questionnaire(SAQ)score were evaluated in 1,2,3 and 12 months,and the death rate,restenosis and other emergency treatments were observed.The mixed-effects models were employed for the data analysis.Results:In the treatment group,a larger within-treatment effect size(d=1.74) was found,with a 76.7%reduction in APS from pretreatment to12-month follow-up assessment compared with the control group(d=0.83,53.8%symptom reduction);betweentreatment(BT) effect size was d=0.66.CM symptom scores included an 18.3%reduction in the treatment group(d=0.46),and a 16.1%decrease in the control group(d=0.31);d=0.62 for BT effect size.In regard to scores of SAQ,the BT effect size of cognition level of disease was larger in the treatment group(d=0.63),followed by the level of body limitation of activity(d=0.62),condition of angina pectoris attacks(d=0.55),satisfaction level of treatments(d=0.31),and steady state of angina pectoris(d=0.30).Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups,respectively.No significant difference in any cardiovascular event(including death toll,frequency of cardiovascular hospitalization or emergency room visits)was found between the two groups.Conclusion:The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.     

Effect of Yiqi Yangyin Decoction(益气养阴方) on the Quality of Life of Patients with Unstable Angina Pectoris

<正>Objective:To observe the effect of Yiqi Yangyin Decoction(益气养阴方,YQYYD) on the quality of life(QOL) of patients with unstable angina pectoris(UAP).Methods:A total of 108 patients with UAP of qi-yin deficiency syndrome confirmed by coronary angiography were enrolled and assigned to the treated group(treated with YQYYD and conventional therapy of Western medicine) and the control group(treated with conventional therapy of Western medicine),by the use of the PROC PLAN of the SAS 6.12 software,in a prospective, randomized,controlled design.The clinical total effective rate,symptom score,QOL scale[Seattle Angina Questionnaire(SAQ)]and incidence of important clinical events were defined as the observation indices to evaluate the interventional effect of YQYYD on the QOL of patients with UAP of the qi-yin deficiency syndrome. Results:During the study,three cases dropped out in the treated group,one case dropped out in the control group,and 104 cases,including 51 cases in the treatment group and 53 cases in the control group,finished the trial.After four weeks of treatment,the total clinical effective rates in the treated group and the control group were 80.4%and 75.5%respectively,and there was no obvious difference between them(P0.05).However,the symptom score of the treated group(9.31±2.02) was significantly lesser than that of the control group(11.62±3.04,P0.05),and the total score of the QOL scale of the treated group(68.76±5.74) was significantly higher than that of the control group(61.06±3.31,P0.01).Among those in the treated group physical limitation, angina stability,angina frequency,and treatment satisfaction were significantly ameliorated when compared with the control group after treatment(P0.05,P0.01).The incidence of important clinical events in the treated group(3.9%) was lower than that in the control group(5.7%) during the 8-month follow-up period,but the difference was insignificant(P0.05).Conclusion:YQYYD could improve the clinical symptoms of patients with UAP of qi-yin deficiency syndrome and greatly improve their QOL.     

探索中医证型的潜在分子机制：一项关于缺血性脑卒中患者中医证型与生物标志物关系的研究

Objective：To investigate whether Chinese medicine（CM）syndrome is associated with particular molecular mechanism,we explored the correlation between CM syndrome and changes of intercellular adhesion molecule-1（ICAM-1）,matrix metalloproteinase 9（MMP-9）and heat shock protein 70（HSP70）in patients with ischemic stroke,which were reported to play an important role in the inflammatory and apoptosis cascade.Methods：CM syndrome factors of 175 patients with ischemic stroke were assessed using Ischemic Stroke CM Syndrome Factor Diagnostic Scale（ISTSFDS）.The patients were grouped according to the main syndrome factor combinations at different time points based on distribution probability of syndrome factor combinations.Blood levels of ICAM-1,MMP-9 and HSP70 were quantified by enzyme-linked immunosorbent assay.Results：ICAM-1 expression was significantly higher in the internal-wind＋phlegm-dampness＋blood-stasis,phlegmdampness＋blood-stasis,internal-fire＋phlegm-dampness＋blood-stasis group than that in the blood-stasis＋qideficiency group within 72 h from stroke onset（P〈0.05）;HSP70 expression was significantly lower in the phlegm-dampness＋blood-stasis,internal-fire＋phlegm-dampness＋blood-stasis,blood-stasis group than that in the phlegm-dampness＋blood-stasis＋qi-deficiency group on the 7th day from stroke onset（P〈0.05）.Conclusions：Phlegm-dampness and blood-stasis exist through the whole process of ischemic stroke.An increased level of ICAM-1 and a reduced level of HSP70 reflect the pathological state of phlegm-stasis mutual binding.These results suggest that inflammation and apoptosis induced by cerebral vascular injury in the pathological processes of ischemic stroke are more prominent in the excess syndrome state like phlegm-dampness and blood-stasis.     

Effect and Safety of Guanxinning Tablet(冠心宁片) for Stable Angina Pectoris Patients with Xin(Heart)-Blood Stagnation Syndrome:A Randomized,Multicenter,Placebo-Controlled Trial

Objective: To investigate the effect and safety of Guanxinning Tablet(冠心宁片, GXN) for the treatment of stable angina pectoris patients with Xin(Heart)-blood stagnation syndrome(XBSS). Methods: One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN(80 cases) or placebo(80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets(0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test(treadmill protocol), Chinese medicine(CM) syndrome score, electrocardiogram(ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events(AEs) were evaluated during the whole clinical trial. Results: Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28±17.67 s after treatment(P0.05); moreover, the change of exercise duration in the GXN group increased 63.10±96.96 s in subgroup analysis(P0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group(40.58%, 75.36%, 26.92%, 28.21%, respectively, P0.05). Conclusion: GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.     

Effect of Yangxinkang Tablets(养心康片)on Chronic Heart Failure:A Multi-Center Randomized Double-Blind Placebo-Controlled Trial

Objectives:To investigate the safety and efficacy of Yangxinkang Tablets(养心康片) in patients with chronic heart failure(CHF) and syndrome of qi and yin deficiency,blood stasis,and water retention.Methods:In a double-blinded,randomized,placebo-controlled,multicenter clinical trail,228 patients with CHF New York Heart Association(NYHA) class Ⅱ or Ⅲ in stage C were assigned by randomized block method to two groups in a 1:1 ratio to undergo either conventional Western treatment or conventional treatment plus Yangxinkang Tablets for 4 weeks.The outcome measure were effect of cardiac function,Chinese medicine(CM) syndromes,scores of symptoms,signs,and quality of life measured by Minnesota Living with heart failure questionnaire(MLHFQ) before and after the treatment.Results:Totally 112 patients were analyzed in the treatment group and 109 in the control group.They were comparable in NYHA functional class,basic parameters and primary diseases before treatment.Cardiac function and CM syndromes were greatly ameliorated in both groups after treatment.Total effective rates of cardiac function and CM syndrome in the treatment group were significantly higher than those in the control group(P0.05).Total symptom score and sign score in the treatment group decreased significantly after treatment(P0.01),which were significantly lower than those in the control group(P0.05).There were statistically significant differences in post-treatment scores of gasp,cough with phlegm,pulmonary rales and jugular vein engorgement between the two groups(P0.05 or P0.01).Three MLHFQ scores decreased significantly in both groups after treatment(P0.01).Post-treatment total scale score and physical subscale score in the treatment group and the reduction of them showed statistically significant differences(P0.05) as compared with the control group.There was no significant difference between the two groups in emotional subscale score and the reduction after treatment(P0.05).There was no obvious adverse reaction in either group noted during the study.Conclusions:Yangxinkang Tablets were safe and efficacious in improving cardiac function,CM syndromes,symptoms,signs,and quality of life in patients with CHF class Ⅱ orⅢ in stage C on the base of conventional treatment.     

Rosiglitazone could improve clinical outcomes after coronary stent implantation in nondiabetic patients with metabolic syndrome

Background Recent studies have shown that thiazolidinediones （TZDs） could reduce in-stent restenosis and improve clinical outcomes in patients with type 2 diabetes after coronary stent implantation. It remains unclear whether nondiabetic patients with metabolic syndrome after stenting could also benefit from the treatment with TZDs. Methods Three hundred and sixty patients with metabolic syndrome who underwent coronary stent implantation were randomly assigned to a rosiglitazone group （n= 180） or a control group （n= 180）. Patients in the rosiglitazone treatment group were treated with rosiglitazone 1 day before coronary stenting （4 mg once daily） and treatment was continued until the 9 months follow-up; while in the control group, patients were treated with placebo 1 day before the procedure and until the 9 months follow-up. Adverse events were death, myocardial infarction and urgent target vessel revascularization within 9 months after coronary stenting. Results One hundred and fifty two patients in the rosiglitazone group and 145 patients in the control group survived during the follow-up. Baseline characteristics among patients in the two groups were well balanced. There was no significant difference in target vessels or the procedure of stent implantation. Compared with the control group, treatment with rosiglitazone was associated with a lower rate of death, myocardial infarction and urgent target vessel revascularization （7.2% vs 14.5%, P=0.044）. Conclusion Rosiglitazone could reduce the risk of the adverse cardiovascular event and improve clinical outcomes in nondiabetic patients with metabolic syndrome after coronary stent implantation.     

Analysis of 287 patients with aortic dissection: General characteristics,outcomes and risk factors in a single center

The general characteristics,outcomes and risk factors of the patients with aortic dissection(AD) were evaluated in a single medical center.From January 2002 to December 2008,284 patients with AD were treated and followed-up at our institution,including 105 cases of type A AD and 179 cases of type B AD.The patients in each type were divided into three groups according to management:medical treatment group(A or B),open surgery group(A or B),and stent-graft group(A or B).The characteristics and follow-up outcomes were compared between the groups or subgroups.The results showed that there was significant difference in the prognosis for type A AD between medical treatment group and open surgery group,but there was no significant difference in the prognosis for type B AD between medical treatment group and stent-graft group.Independent risk factors of follow-up mortality for patients with type A AD included a history of atherosclerosis(HR,3.807;95% confidence interval [CI],1.489 to 7.611;P=0.003),in-hospital hypotension/shock(HR,4.687;95% CI,1.846 to 11.900;P=0.001),in-hospital myocardial ischemia or infarction(HR,3.734;95% CI,1.613 to 8.643;P=0.002),pleural effusion(HR,2.210;95% CI,1.080 to 4.521;P=0.030),branch vessel involvement(HR,2.747;95% CI,1.202 to 6.278;P=0.016) and surgical treatment(HR,0.177;95% CI,0.063 to 0.502;P=0.001).And there were insignificant independent predictors for mortality of the patients with type B AD.It was concluded that there were significant differences in characteristics and one year mortality between type A AD and type B AD,but after one year,there was no significant difference in the mortality and complications of them.There were several discordant risk factors of AD,such as female gender,age,thrombus,abrupt onset of pain that were considered as the risk factors in some papers.And there was no definite risk factor of mortality in this study in the patients with type B AD.     

Clinical study on treatment of infantile cytomegalovirus hepatitis with integrated Chinese and Western medicine

<正>Objective:To evaluate the efficacy and safety of Chinese medicine(CM) in treating infantile cytomegalovirus hepatitis(ICH).Methods:A total of 100 infant ICH patients were randomly assigned to two groups,60 in the treatment group and 40 in the control group.Ganciclovir was administered to all patients via intravenous dripping at dose of 5 mg/kg every 12 h for 2 weeks,followed by 5 mg/kg once a day for 5 days every week;the whole treatment course lasted 8 weeks.Besides,the patients in the treatment group were treated with CM of Qinggan Lidan Decoction(清肝利胆汤,QLD) during icteric stage,and Yigan Jiangmei Decoction(益肝降酶汤,YJD) in non-icteric hyper-aminotransferase stage by oral medication,while for those in the control group,glucurolactone 50 mg was given three times per day.The efficacy of treatment was evaluated at the ends of 2nd,4th and 8th weeks,respectively.And a follow-up study was carried out for 6-24 months.Results: The total effective rate was 95.0%(57/60) in the treatment group and 77.5%(31/40) in the control group;the overall curative effect in the former was superior to that in the later,showing a significant difference(P=0.021). Cholestasis and liver function were Improved in both groups,and the effect of reducing serum bilirubin level in the treatment group was more rapid and extensive than that in the control group,which could reduce the post-hepatitis cirrhotic risk caused by long-term cholestasis and liver cell damage.Conclusion:The therapeutic efficacy of integrated CM and Western medical drug therapy,by using QLD during icteric stage and YJD in nonicteric hyper-aminotransferase stage,was significantly higher than that of routine Western medical treatment alone;it was an ideal project for the treatment of infantile cytomegalovirus hepatitis.     

A Multicenter,Randomized,Double-blind Clinical Study on Wufuxinnaoqing Soft Capsule(五福心脑清胶囊) in Treatment of Chronic Stable Angina Patients with Blood Stasis Syndrome

Objective:To confirm the efficacy and safety of Wufuxinnaoqing Soft Capsule(五福心脑清胶囊,WSC)in the treatment of chronic stable angina(blood stasis syndrome).Methods:A multicenter,randomized,double-blind,placebo-controlled trial with superiority test was designed.A total of 240 patients with chronic stable angina(blood stasis syndrome)from multiple centers were randomly and equally assigned to the treatment group and the control group.Based on standard treatment of Westem medicine,the treatment group was given WSC,while the control group was given WSC mimetic,both for 12 weeks.Observed indicators included the efficacy in angina,the efficacy in Chinese medicine syndrome,the withdrawal or reduce rate of nitroglycerin and routine safety indices.Results:After 12-week treatment,the significant effective rate and total effective rate of the treatment group were significantly better than those of the control group(23.5%vs.9.2%,64.7%vs.30.8%),respectively,with statistically significant difference(P0.01).After 12-week treatment,the decreased points and the decreased rate of angina symptom score in the treatment group were better than in the control group(5.1±4.2 points vs.2.8±3.5 points,44.9%±37.2%vs.25.4%±30.7%)respectively,with significant difference(P0.01).After 12-week treatment,the significant effective rate and total effective rate of the treatment group were better than the control group(respectively,30.3%vs.15.0%,67.2%vs.45.0%,P0.01).After 8-or 12-week treatment,the decreased points and the decreased rate of Chinese medicine syndrome score in the treatment group were better than the control group(P0.05 or P0.01).After 12-week treatment,nitroglycerin withdrawal rate and the withdrawal or reduce rate in treatment group were better than the control group(P0.01).On safety evaluation,the incidence of adverse events(7.563%vs.7.500%)and the incidence of cardiovascular events(0.840%vs.0.000%)in the treatment group were similar with the control group,and the difference was not statistically significant(P0.05).Conclusion:In treatment of chronic stable angina(blood stasis syndrome),WSC can reduce angina attacks and consumption of nitroglycerin,decrease angina severity degree,effectively relieve the blood stasis syndromes,such as chest pain,chest tightness,palpitations,dark purple tongue and other symptoms.Besides,adverse events and cardiovascular adverse events in the treatment group and the control group showed no difference.All shows that the drug is safe and effective.[This study was registered in Chinese Clinical Trial Registry(ChiCTR),with registration number:ChiCTR-TRC-14005158.]     

癌症疼痛病人伴随阿片类药物导致便秘的中医汤剂标准化治疗：一项多中心前瞻性随机对照试验

Objective： To observe the efficacy and the influence on quality of life （QOL） of syndrome differentiation treatment with Chinese medicine （CM） for opioid-induced constipation as well as the safety and influence on analgesic effect of opioids. Methods： Totally 406 cases enrolled from 53 collaborating medical centers were randomly assigned to a CM group and a control group. The CM group were treated with CM decoction based on syndrome differentiation, and the control group were treated with Phenolphthalein Tablet. Both groups were treated for 14 days. Cleveland constipation score （CCS）, numedcal rating scale （NRS） of pain and Chinese version of European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-C30 V3.0 （EORTC QLQ-C30 V3.0） were used to evaluate the efficacy, pain controlled and QOL status. Results： The comparisons of CCS score reduction and QOL between the two groups after treatment suggested that the improvements of constipation and QOL in the CM group were better than that in the control group （P〈0.05）. The total efficiency of the CM group was better than the control group （93.5% vs. 86.4%, P〈0.05）. There was no significant difference in NRS scores between before and after treatment in both groups. There was no serious drug-related adverse event during the course of study. Conclusion： CM decoction could effectively treat opioid-induced constipation and improve patients＇ QOL at the same time. It is safe and doesnt affect the analgesic effect of opioids when treating constipation.     

Effect of Comprehensive Therapy based on Chinese Medicine Patterns on Self-Efficacy and Effectiveness Satisfaction in Chronic Obstructive Pulmonary Disease Patients

Objective: To evaluate the effect of comprehensive therapy based on Chinese medicine(CM) patterns on self-efficacy and satisfaction with its effectiveness in patients with chronic obstructive pulmonary disease(COPD). Methods: A total of 216 patients were randomly divided into the trial group(n=108) and the control group(n=108) based on the stratified and block randomization design. Patients in the trial group were treated with conventional Western medicine combined with Bufei Jianpi Granules(补肺健脾颗粒), Bufei Yishen Granules(补肺益肾颗粒), and Yiqi Zishen Granules(益气滋肾颗粒) according to the CM patterns respectively, and patients in the control group were treated with conventional Western medicine. The COPD Self-Efficacy Scale(CSES) and the Effectiveness Satisfaction Questionnaire for COPD(ESQ-COPD) were employed in a 6-month treatment and in further 6 month follow-up visit. Results: Among the 216 patients, 191 patients(97 in the trial group and 94 in the control group) fully completed the study. After 12-month treatment and follow-up, the mean scores of the trial group all continued to increase over time, which were significantly higher than those of the control group(P0.05), and the improvement in the following trial group domain: negative affect domain(12.13%), intense emotional arousal domain(12.21%), physical exertion domain(11.72%), weather/environmental domain(13.77%), behavioral risk domain(7.67%) and total score(10.65%). The trial group also exhibited significantly higher mean scores in the ESQ-COPD(P0.05) and the improvement in the following domain: capacity for life and work domain(30.59%), clinical symptoms domain(53.52%), effect of therapy domain(35.95%), convenience of therapy domain(35.54%), and whole effect domain(52.47%). Conclusions: Bufei Jianpi Granules, Bufei Yishen Granules and Yiqi Zishen Granules can improve the self-efficacy and satisfaction of COPD patients.     

Effect of Xuefu Zhuyu Capsule (血府逐瘀胶囊) on the Symptoms and Signs and Health-related Quality of Life in the Unstable Angina Patients with Blood-stasis Syndrome after Percutaneous Coronary Intervention: A Randomized Controlled Trial

Objective: Compared with Shengmai Capsule (生脉胶囊, SM), the study was conducted to evaluate the efficacy and safety of Xuefu Zhuyu Capsule (血府逐瘀胶囊, XFZY) on the symptoms and signs and health-related quality of life (HR-QOL) in the unstable angina (UA) patients with blood-stasis syndrome (BSS) after percutaneous coronary intervention (PCI). Methods: A randomized, double-blinded, doubledummy, and placebo-controlled trial was applied. Ninety patients, diagnosed as UA and BSS after successful PCI, were enrolled and equally randomized into three groups, XFZY group, SM group, and placebo group, and administered with the corresponding medications respectively for four weeks. The clinical symptoms and signs (CSS), electrocardiography (ECG), and BSS scores were recorded and compared among groups during and after the treatment. Short-form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QOL in each group before and after the treatment. Safety indexes (blood routine and liver and kidney function tests) were also examined at the beginning and after the treatment. Results: Eighty-six patients completed the whole study. After the treatment, the total effective rates of the XFZY group in ameliorating CSS and ECG were 76.7% and 60.0%, respectively, which were obviously higher than those in SM (CSS: 53.3%; ECG: 36.7%) and the placebo (CSS: 43.3%; ECG: 30.0%) groups. After one week's treatment, BSS scores slightly decreased in each group, but no significant differences were found among three groups (P0.05). After four weeks' treatment, BSS scores in the XFZY group decreased to a lower level compared with SM (P0.05) and the placebo (P0.01) groups. After the treatment, the efficacy of XFZY group in improving body pain (BP), general health (GH), vitality (VT), society functioning (SF), role emotional (RE), angina stability (AS), angina frequency (AF), and treatment satisfaction (TS) were better than those in the placebo group (P0.05, P0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, and TS were better improved than those in the SM group (P0.05). No obvious adverse reaction was found during and after the treatment except one case in the XFZY group reporting of stomach discomfort. Conclusions: Compared with SM Capsule treatment, a short-term treatment with XFZY Capsule exhibits better efficacy on CSS and BSS scores, and HR-QOL in UA patients with BSS after PCI. However, its long-term efficacy and safety still needs further investigation.     

Whether Fire-Needle Therapy Bene?ts Plaque Psoriasis:A Multicenter,Randomized,and Controlled Trial

Objective: To observe the clinical effectiveness and safety of fire-needle therapy,an external approach of Chinese medicine in treating plaque psoriasis.Methods: This study was a two-parallel-arm randomized controlled trial.A total of 151 participants with plaque psoriasis were randomly assigned to the ?re-needle therapy group(treatment group,76 cases) or the control group(75 cases) at a 1:1 allocation ratio using SAS software.All participants received Oral Huoxue Jiedu Decoction(活血解毒汤,HXJDD) and applied externally vaseline cream twice a day.Participants in the treatment group received ?re-needle therapy once weekly for 4 weeks plus HXJDD and vaseline cream applied the same as the control group.The primary outcome measure was Psoriasis Area and Severity Index(PASI) score,and the secondary outcomes were Dermatology Life Quality Index(DLQL),and Hamilton Anxiety Rating Scale(HAMA),as well as Chinese medicine(CM) syndrome score and photos of target lesions.The indices were evaluated before and after treatment.Results: Sixty-eight patients in each group completed the study.The treatment group has not yet achieved signi?cant improvement in PASI score(P0.05)compared to the control group.However,signi?cant differences were found between the two groups in relieving CM syndrome(P0.05) and improving quality of life(P0.05).Conclusions: Fire-needle appears to be safe and may have bene?t for psoriasis,the short-term treatment and small sample size limit the conclusions of this study.Further rigorous randomized controlled trials with longer treatment are recommended.     

Short-Term Efficacy of Treating Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Based on Cold Pattern Differentiation with Hot Herbs: A Randomized Controlled Trial

Objective: To evaluate the clinical efficacy and safety of Yinchen Zhufu Decoction(茵陈术附汤, YCZFD) in the treatment of acute-on-chronic liver failure caused by hepatitis B virus(HBV-ACLF) with cold pattern in Chinese medicine(CM). Methods: This is a multi-center randomized controlled trial of integrative treatment of CM and Western medicine(WM) for the management of HBV-ACLF patients. A total of 200 HBV-ACLF patients with cold pattern were equally randomly assigned to receive YCZFD and WM(integrative treatment) or WM conventional therapy alone respectively for 4 weeks. The primary end point was the mortality for HBV-ACLF patients. Secondary outcome measures included Model for End-Stage Liver disease(MELD) score, liver biochemical function, coagulation function and complications. Adverse events during treatment were reported. Results: The mortality was decreased 14.28% in the integrative treatment group compared with WM group(χ2=6.156, P=0.013). The integrative treatment was found to significantly improve the MELD score(t=2.353, P=0.020). There were statistically significant differences in aspartate transaminase, total bilirubin, indirect bilirubin, direct bilirubin and prothrombin time between the two groups(P0.05 or P0.01). The complications of ascites(χ2=9.033, P=0.003) and spontaneous bacteria peritonitis(χ2=4.194, P=0.041) were improved significantly in the integrative treatment group. No serious adverse event was reported. Conclusions: The integrative treatment of CM and WM was effective and safe for HBV-ACLF patients with cold pattern in CM. The Chinese therapeutic principle "treating cold pattern with hot herbs" remains valuable to the clinical therapy.(Trial registration No. Chi CTR-TRC-10000766)     

Effect of Huanshuai Recipe Oral Liquid (缓衰口服液) on Renal Dysfunction Progression in Patients with Atherosclerotic Renal Artery Stenosis

Objective:To investigate the effect of Huanshuai Recipe Oral Liquid(缓衰口服液,HSR) on retarding the progression of renal dysfunction in patients with atherosclerotic renal artery stenosis(ARAS).Methods:A total of 52 ARAS patients with the Chinese medicine(CM) syndrome of qi deficiency and blood stasis,phlegm and dampness retention were recruited and randomly assigned into the treatment group(36 cases) and the control group(16 cases).Both groups received a basic treatment(high-quality low-protein diet,blood pressure control,lipid-lowering,correcting the acidosis,etc.).In addition,the treatment group received 20 mL HSR and the control group received placebo,3 times a day for 6 months.Renal function(serum creatinine,blood urea nitrogen and uric acid) and blood lipids(cholesterol,triglycerides and low density lipoprotein) were examined monthly.The estimated glomerular filtration rate(eGFR) and CM syndrome score were compared between groups.Results:After treatment,compared with the control group,the serum creatinine level,uric acid level and CM syndrome score of the treatment group were significantly decreased(P0.05 or P0.01),and the eGFR in the treatment group were significantly increased(P0.05).Conclusion:HSR can effectively improve the renal function and clinical symptoms of ARAS patients.     

脉血康胶囊对PCI术后急性冠脉综合症患者长期预后的改善作用

Objective:To study the changes of adenosine diphosphate(ADP)-induced platelet aggregation rate,and evaluate the effects of Maixuekang Capsule(脉血康胶囊,MKC) on platelet aggregation rate and long-term prognosis of patients with acute coronary syndrome after percutaneous coronary intervention(PCI).Methods:A total of 236 patients with acute coronary syndrome,who received successful PCI,were randomly assigned to a trial group(116 cases) and a control group(120 cases) according to random numbers;treatment allocation occurred when the participants met the inclusion criteria and signed the informed consent forms.In the trial group,the patients were treated with MKC combined with routine medication,and in the control group the patients were treated with routine medication.The therapeutic course for the two groups was 12 months and the follow-up was 12 months.The levels of ADP-induced platelet aggregation rate and serum high-sensitive C-reactive protein(hs-CRP) were determined before PCI,12 h and 30 days after PCI.In the meantime,the incidence of cardio-/cerebrovascular events was recorded during the 12-month follow-up.Results:Compared with before PCI,the levels of ADP-induced platelet aggregation rate and serum hs-CRP were significantly higher at 12 h after PCI(P0.05).They were significantly reduced after 30-day-treatment of MKC,showing statistical differences when compared with those in the control group(P0.05).During the 12-month follow-up,the incidence of cardio-/cerebrovascular events was significantly lower in the trial group than in the control group(6.9%vs.12.5%,P0.01).Conclusions:ADP-induced platelet aggregation function was significantly elevated after PCI.MKC improved the prognosis of patients with acute coronary syndrome,possibly through inhibiting the platelet aggregation,fighting against inflammation,and protecting the vascular endothelial function.     

Effects of Chinese Medicine on Symptoms, Syndrome Evolution, and Lung Inflammation Absorption in COVID-19 Convalescent Patients during 84-Day Follow-Up after Hospital Discharge: A Prospective Cohort and Nested Case-Control Study

Objective:To observe the changes of symptoms,Chinese medicine(CM)syndrome,and lung inflammation absorption during convalescence in patients with coronavirus disease 2019(COVID-19)who had not totally recovered after hospital discharge and whether CM could promote the improvement process.Methods:This study was designed as a prospective cohort and nested case-control study.A total of 96 eligible patients with COVID-19 in convalescence were enrolled from Beijing Youan Hospital and Beijing Huimin Hospital and followed up from the hospital discharged day.Patients were divided into the CM(64 cases)and the control groups(32 cases)based on the treatment with or without CM and followed up at 14,28,56,and 84 days after discharge.In the CM group,patients received the 28-day CM treatment according to two types of CM syndrome.Improvements in clinical symptoms,CM syndrome,and absorption of lung inflammation were observed.Results:All the 96 patients completed the 84-day follow-up from January 21 to March 28,2020.By the 84th day of follow-up,respiratory symptoms were less than 5%.There was no significant difference in the improvement rates of symptoms,including fatigue,sputum,cough,dry throat,thirst,and upset,between the two groups(P>0.05).Totally 82 patients(85.42%)showed complete lung inflammation absorption at the 84-day follow-up.On day 14,the CM group had a significantly higher absorption rate than the control group(P<0.05)and the relative risk of absorption for CM vs.control group was 3.029(95%confidence interval:1.026-8.940).The proportions of CM syndrome types changed with time prolonging:the proportion of the pathogen residue syndrome gradually decreased,and the proportion of both qi and yin deficiency syndrome gradually increased.Conclusions:Patients with COVID-19 in convalescence had symptoms and lung inflammation after hospital discharge and recovered with time prolonging.CM could improve lung inflammation for early recovery.The types of CM syndrome can be transformed with time prolonging.