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.]     

Summary of 32 patients with cardiac syndrome X treated by TCM therapy of regulating qi relieving chest stuffiness and promoting blood circulation

Objective： To evaluate the clinical effect of Liqi Kuanxiong Huoxue method （宽胸活血,LKH, traditional Chinese medicine, TCM therapeutic method for regulating qi, relieving chest stuffiness and promoting blood circulation） in treating patients with cardiac syndrome X （CSX）. Methods： The prospective, non-randomized controlled study was conducted on 51 selected patients with CSX, who were non-randomly assigned to 2 groups, the treated group treated with LKH in addition to the conventional treatment （32 patients）, and the control group treated with conventional treatment （19 patients） like nitrate, diltiazem hydrochloride, etc. The treatment course was 14 days. The changes of such symptoms as angina pectoris, TCM syndrome and indexes of treadmill exercise test before and after treatment were observed. Results： After treatment, such symptoms as chest pain and stuffy feeling and palpitation in the treated group were improved more than those in the control group （P〈0.05）; the total effective rate on angina pectoris and TCM syndrome in the treated group was better than that in the control group （P〈0.05）. The treadmill exercise test showed that the maximal metabolic equivalent （Max MET）, the time of angina onset and ST segment depression by 0.1 mV were obviously improved after treatment in both groups, but the improvement in the treated group was better than that in the control group respectively （P〈0.05）. Conclusion： The LKH method could reduce the frequency of angina attacks and improve the clinical condition of patients with CSX.     

Effect of Compound Zhuye Shigao Granule (复方竹叶石膏颗粒) on Acute Radiation-Induced Esophagitis in Cancer Patients: A Randomized Controlled Trial

Objective: To observe the efficacy and safety of the Chinese medicine(CM) Compound Zhuye Shigao Granule(复方竹叶石膏颗粒, CZSG) on acute radiation-induced esophagitis(ARIE) in cancer patients. Methods: In a blinded, randomized, Kangfuxin Solution(康复新液, KFX)-controlled, single-centre clinical trial, 120 patients with lung, esophagus or mediastinal cancer were prospectively enrolled and assigned to the treatment group(60 cases) and control group(60 cases) by the random number table method. All patients received concurrent or sequential radiotherapy(2 Gy per day, 5 times per week, for 4 weeks) and were treated for 4 weeks since the radiation therapy. Patients in the treatment group were given 12 mg CZSG orally, thrice daily, while patients in the control group were given 10 m L KFX orally, thrice daily. The major indicators were observed, including the incidence and grade of esophagitis, time of occurrence and duration. Minor indicators were changes of CM symptoms, weight and Karnofsky Performance Status(KPS) Scale during 4 weeks from the beginning, recorded once a week. Blood routine examination and hepatorenal function were detected at the 2nd and 4th weeks. Results: The incidence and grade of ARIE were significantly decreased in the treatment group compared with the control group(P0.05). CZSG appeared to significantly delay the time of ARIE occurrence and reduce the duration compared with KFX(P0.05). The scores of CM symptoms, KPS and weight were improved significantly in the treatment group compared with the control group(P0.05). There were no blood routine and hepatorenal function abnormal or obvious side-effects in both groups. Hemoglobin was improved and neutrophil and interleukin 6 were decreased in both groups after 4-week treatment compared with before treatment(P0.05), and there was no significant difference between the two groups(P0.05). Conclusions: CZSG can decrease the incidence and grade of ARIE, delay the time of occurrence, reduce duration and alleviate the damage of ARIE. It is safe and effective in the prevention and cure of ARIE.     

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.     

Study on Effect of Zhixinkang Capsule （脂欣康胶囊）in Treating Unstable Effort Angina and Hyperlipidemia and Its Function in Vascular Endothelium Protection

Objective:To observe the clinical effect and protection of vascular endothelium of Zhixin-kang Capsule (ZXKC) in middle-aged and old people with unstable effort angina and hyperlipidemia. Methods: Sixty-five patients with unstable effort angina were randomly divided into ZXKC group (34 cases) and control group (31 cases). Conventional western medical therapy was given to both groups, with ZXKC group receiving additional ZXKC treatment. Data of 20 healthy persons were taken as normal group. Forty-eight patients with hyperlipidemia were divided into ZXKC group treated with ZXKC (31 cases) and control group treated with Yixintong (17 cases). The changes of clinical symptoms and laboratory indexes in all the patients were observed before and after treatment. Results: In patients with unstable effort angina, the efficacy of treatment of ZXKC, the withdrawal rate of nitroglycerin, the relieving of symptoms, the improvement of the electrocardiogram, the counts of circulating endothelial cells, the content of p     

Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable angina (SERIES Trial): A Protocol of Multicenter, Randomized, Double-Blind, Placebo Parallel Controlled Clinical Triallimited

Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules (参术冠心方颗粒, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES (ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic (ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events (MACE) in stable anginal patients. Methods: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR (10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. Discussion: This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events. (Trial registration No. ChiCTR-TRC-14004504)     

The serum levels of MMP-9, slCAM-1, CRP and WBC increased in patients with acute coronary syndrome

Objective：To evaluate the association of the peripheral levels of the defined inflammatory markers with different types of acute coronary syndrome （ACS） and stable angina, and the role inflammation played in the pathogenesis of ACS. Methods ：For understanding the variation of serum concentrations of matrix metalloproteinase-9 （MMP-9）, soluble intercellular adhesion molecule-1 （sICAM-1） ,C-reactive protein （CRP）, and white blood cell count （WBC） and their association with ACS, 90 patients with coronary heart disease （CHD） and 30 healthy volunteers were recruited. The enrolled people were assigned into four equal groups, including acute myocardial infarction （AMI） group, unstable angina pectoris（UAP） group, stable angina pectoris（SAP） group and healthy control group. The serum levels of MMP-9 and sICAM-1 were measured with ELISA kits, CRP were measured with im munoturbidimetric assay, and WBC number were assessed all before any treatment was administrated. Results： （1）The serum levels of MMP-9 ,sICAM-1 ,CRP and WBC in the patients with ACS were significantly higher than those in the control group （P 〈 0.01 ）. （2）Compared with control group, patients with SAP only had higher serum level of sICAM-1 （P 〈 0.01 ）. While the levels of MMP-9, CRP, and WBC had no significant difference between them （P 〉 0.05 all）. （3）Significant positive correlation between the serum levels of MMP-9 and sICAM-1 and CRP and WBC all were observed in the patients with ACS （P 〈 0.05）. Conclusion： The elevation of serum concentrations of inflammatory markers including MMP-9, slCAM-1, CRP and WBC were associated with initiation and progression of ACS, and they may help predicting cardiovascular events.     

Clinical and Experimental Study on Effect of Garlicin in Treating Angina Pectorls

Objective: To observe the effect and mechanism of Garlicin in treating coronary heart disease (CHD) with angina pectoris. Methods: Clinical study: 55 patients were selected and randomized into the Garlicin group and the nitroglycerin group. To Garlicin group, 60 mg of Garlicin was given by adding in 5% glucose solution for intravenous dripping once per day, the therapeutic course     

曲美他嗪治疗老年顽固性心绞痛临床疗效观察

目的 观察在强化治疗基础上加用曲美他嗪治疗老年顽固性心绞痛的疗效.方法 将65例老年顽固性心绞痛患者随机分为强化治疗组和联合治疗组,联合治疗组在强化治疗的基础上加用曲美他嗪20 mg,每日3次,疗程为4周.观察患者心绞痛发作次数、持续时间、心电图ST-T改变和硝酸酯类药物的用量.结果 联合治疗组患者总有效率为88.57%,与强化治疗组相比差异有统计学意义(P＜0.05),两组间心绞痛发作次数与持续时间、硝酸酯类药物用量、心电图改善差异均有统计学意义(P＜0.05).结论 治疗老年顽固性心绞痛,在强化治疗基础上加用曲美他嗪疗效安全可靠. Abstract： Objective To evaluate the effect of trimetazidine on elderly patients with refractory angina pectoris on the basis of intensive treatment. Methods Sixty - five patients with refractory angina pectoris were randomized into intensive treatment group and TMZ treatment group. In TMZ treatment group,TMZ(20 mg, 3 times per day) were given in addition to intensive treatment. The cycles of treatments in both groups were 4 weeks. The frequency and duration of angina attack, the ST - T segment change of electrocardiogram and the dosage of drugs belonging to ester nifrate were observed in patients with refractory angina pectoris. Results The total effective rate was 88.57% in TMZ group,and there was significant difference between the two groups ( P ＜ 0. 05 ). With regard to the frequency and duration of angina attack,the dosage of drugs belonging to ester nitrate, the maximal ST - T segment depression, there were also significant differences between the two groups ( P ＜0. 05). Conclusions Combinating therapy of TMZ with intensive drugs have good curative effect for refractory angina pectoris, and is safe and reliable.     

Effect of Shugan Jianpi Granule(舒肝健脾颗粒) on Gut Mucosal Serotonin-positive Cells in Patients with Irritable Bowel Syndrome of Stagnated Gan-qi Attacking Pi Syndrome Type

Objective:To evaluate the effect of Shugan Jianpi Granule (舒肝健脾颗粒,SJG) on the number of gut mucosal serotonin-positive cells (5-HT+C) in patients with irritable bowel syndrome (IBS) of stagnated Gan-qi attacking Pi (SGAP) syndrome type.Methods:Twenty-four patients were randomized equally into three groups.All were treated with the basic conventional treatment by cognition-behavior therapy with assistance of lactein 3 tablets thrice a day.Additionally,24 g of SJG was given three times a day to group A,and the same dosage of SJG and Smecta 15 g thrice a day was given to group B,while no additional treatment was given to the control group.The number of 5-HT+C was measured respectively before and two weeks after treatment by immunohistochemical method.Results:The number of 5-HT+C decreased after treatment in all the three groups (P＜0.05),but the decrement was more significant in the two test groups than in the control group (P＜0.05 and P＜0.01,respectively),while comparison of 5-HI+C between the two test groups showed insignificant difference (P＞0.05).Conclusion:SJG can reduce the number of 5-HT+C in IBS patients of SGAP syndrome type,and its effect is enhanced when used in combination with Smecta.     

Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial):A Protocol of Multicenter,Randomized,Double-Blind,Placebo Parallel Controlled Clinical Trial

Background: Many patients with chronic angina experience anginal episodes despite successful recanalization, antianginal and antiischemic medications. Empirical observations suggested that Shenzhu Guanxin Recipe Granules(参术冠心方颗粒, SGR), a Chinese herbal compound, exerted potential impacts on increased treadmill exercise performance and angina relieve. However, there has been no systematic study to clarify the impact of SGR on exercise tolerance in patients with stable angina. The SERIES(ShEnzhu guanxin Recipe for Improving Exercise tolerance in patients with Stable angina) trial is designed to determine the effects of SGR on exercise duration, electrocardiographic(ECG) evidence of myocardial ischemia, and incidence of major adverse cardiac events(MACE) in stable anginal patients. Methods: A total of 184 eligible patients with stable angina will be randomly assigned to receive placebo or SGR(10 g/day for 12 weeks) in a 1:1 ratio. The primary outcome will be the change from baseline in total exercise tolerance duration, time to onset of angina and ECG ischemia during exercise treadmill testing performed over a 12-week study period. The secondary outcome will include ECG measures, the occurrence and composite of MACE and the Seattle Angina Questionnaire score. Moreover, the coronary microcirculation will be evaluated to explore the possible effects in response to treatment of SGR. After the procedure, all participants will be followed up by interview at 3 and 6 months, enquiring about any cardiac events, hospitalizations, cardiac functional level and medication usage. Additionally, the occurrence of adverse events will be evaluated at each follow-up. Discussion: This study may provide novel evidence on the efficacy of SGR in improving exercise tolerance and potentially reducing clinical adverse events.     

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.     

Effect of Shenshao Tablet (参芍片) on the quality of life for coronary heart disease patients with stable angina pectoris

Objective： To observe the effect of Chinese medicine Shenshao Tablet （参芍片, SST） on the quality of life in coronary heart disease （CHD） patients with stable angina pectoris （SAP）. Methods： Sixty-six patients with SAP confirmed by coronary angiography were enrolled and assigned to two groups by means of PROC PLAN using a SAS 6.12 software in a double-blinded, randomized, placebo-controlled design. Patients in the treated group were treated with SST, and the others in the control group were given placebo. The weekly angina frequency, quality of life scale [Seattle Angina Questionnaire （SAQ）] and incidence of important clinical events were observed to evaluate the intervention effect of SST on the quality of life for CHD patients with SAP. Results： During the study, one case dropped out in the treated group and two cases in the control group, respectively, and 63 cases including 32 cases in the treated group, and 31 cases in the control group completed the trial. After four weeks of treatment, the weekly angina frequency of the treated group （5.32± 2.46 times per week） was significantly less than that of the control group （7.32± 3.20 times per week, P 〈 0.05）. The total score of the quality of life in the treated group （71.30± 5.44） was obviously higher than that in the control group （63.50± 4.60, P 〈 0.01）, and the angina stability, angina frequency, and treatment satisfaction were significantly superior to those in the control group （P〈 0.01）. The incidence of important clinical events of the treated group （3.1%） was lower than that of the control group （6.5%） during the six-month follow-up period, but the difference was insignificant （P 〉 0.05）. Conclusion： SST could lower the angina frequency and greatly improve the quality of life in CHD patients with SAP.     

Influence of Shengmai Capsule (生脉胶囊) on recovery of living capacity in patients after myocardial infarction

ABSTRACT Objective： To observe the effect of long-term application of Shengmai Capsule （生脉胶囊, SMC） on recovery of patients after myocardial infarction. Methods： A total of 120 myocardial infarction patients were assigned into two groups. Changes of angina pectoris, electrocardiogram （ECG）, living capacity and heart function in patients were observed after 6-month treatment. Results： The total effective rate in alleviating angina pectods was 90.0% and that in improving ECG figure was 93.3% in the treatment group, both were significantly higher than those in the control group, 73.4% and 70.0% respectively （P〈0.05）. The Karnofsky Performance Status scores of heart function were increased and the Activity of Daily Living scores in living capacity decreased in both groups, but the improvements were better in the treatment group （P〈0.01 and P〈0.05）. The parameters of cardiac function, including cardiac output, stroke volume, cardiac index and ejection fraction, were increased in both groups, but the increments in the treatment group were more significant （P〈0.01 or P〈0.05）. Conclusion： Long-term application of SMC could effectively prevent and treat angina pectoris, improve the living capacity and accelerate the recovery of heart function in patients after myocardial infarction.     

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.     

Clinical observation on treatment of hyperplasia of mammary gland by Lirukang Granule (利乳康颗粒)

Objective:To explore the effi cacy and mechanism of Lirukang Granule(利乳康颗粒,LRKG) in treating hyperplasia of mammary gland(HMG).Methods:One hundred patients with HMG were randomly assigned to two groups,50 in each group.The patients in the treated group were orally administered with LRKG thrice a day,one package each time,and those in the control group were given orally Rukuaixiao Tablet(乳块消,RKX) thrice a day,4 tablets each time.The therapeutic course for both groups was 4 months.The clinical eff icacy,pain alleviating rate,as well as changes of local sign and symptom scores were observed before and after treatment.The changes of serum estradiol(E2),progesterone(P),testosterone(T),follicle stimulating hormone(FSH),luteinizing hormone(LH) and prolactin(PRL) in some randomly selected patients(24 patients in the treated group and 24 in the control group) before and after treatment were measured with radioimmunoassay.Results:The total clinical effi cacy in the treated group was superior to that in the control group,signifi cant difference was shown between the two groups(P<0.01).The cure-effective rate and total effective rate in the treated group were 70.0%and 88.0% respectively,signif icantly higher than those in the control group(38.0% and 64.0%) respectively(P<0.01),and the pain alleviating rate in the treated group was also significantly higher in the former than that in the latter(88.0% vs 64.0%,P<0.05).Moreover,the treated group showed obvious superiority in improving the patients' symptom and sign scores(P<0.01),and abnormalities of gonadal hormone as compared with the respective items in the control group(P<0.01).Conclusion:LRKG has good effi cacy in the treatment of HMG,and its mechanism may be related to the regulation on endocrine and immune function.     

Prognostic efficacy of troponin T measurement in angina pectoris.

This study was designed to evaluate the efficacy of the newly developed Troponin T (TNT) enzyme immunoassay for predicting the prognosis of patients with angina pectoris. TNT, creatine kinase (CK) and MB isoenzyme of creatine kinase (CK-MB) were monitored in 134 patients with angina pectoris. There was no abnormality with any of these tests in 40 patients with stable angina pectoris and 30 patients with unstable angina pectoris of Class I and 2 according to Braunwald's criteria. None of them developed acute myocardial infarction or other cardiac events. Elevation of TNT concentration with normal level of CK and CK-MB was found in 34 of the 64 cases of unstable angina pectoris of Class 3. Among the 34 patients, 11 had acute myocardial infarction within 10 days during hospitalization. In contrast, only one of the patients with unstable angina pectoris of Class 3 with normal value of TNT developed acute myocardial infarction. As the incidence of angina pectoris is quite high clinically but only a small numb     

Clinical Observation on the Effect of Zengse Pill (增色丸) in Treating Patients with Vitiligo of Qi-stagnancy and Blood-stasis Syndrome Type

Objective:To observe the clinical efficacy of Zengse Pill(增色丸,ZSP)on patients with vitiligo of qi-stagnancy and blood-stasis syndrome type(V-QB),and to preliminarily explore its mechanism of action.Methods:Sixty-five V-QB patients,with their diagnosis confirmed by clinical examination,were randomized by digital table method into two groups,with 31 patients in the control group and 34 in the treatment group.Cobamamide(2 tablets)was administered orally to all patients,and Psoralea tincture(a self-formulated preparation)was applied externally thrice a day.In addition,for patients in the treatment group,ZSP was given orally,at 5 pills per dose,3 times every day.The therapeutic course for both groups was 3 months.Patients were re-examined every half-month,and changes in the skin lesions were observed and recorded.The levels of lymphocyte subsets,serum immune globulin,and complement C3 and C4 in patients were determined before and after the therapeutic course and compared with the corresponding indexes determined in 21 healthy subjects.Results:The total effective rate in the treatment group was 82.4%,which was markedly higher than that in the control group(54.8%),showing a significant difference(P<0.05).After treatment,CD_4~ percentage,CD_4~ /CD_8~ ratio,and blood levels of C3 and C4 increased,while CD_8~ percentage decreased in the treatment group(P<0.05 or P<0.01).All these indexes remained unchanged in the control group,and the respective comparisons between groups showed significant differences(P<0.01).Conclusion:ZSP has a definite clinical effect on the treatment of V-QB but with no evident adverse reactions,and it can increase the CD_4~ percentage,CD_4~ /CD_8~ ratio,and the levels of serum C3 and C4,thus regulating the immunity of the organism,which might be one of its mechanisms of action.     

Effect of Kuanxiong Aerosol(宽胸气雾剂)on Patients with Angina Pectoris:A Non-inferiority Multi-center Randomized Controlled Trial

Objective: To evaluate the effect and safety of Kuanxiong Aerosol(宽胸气雾剂, KA) on patients with angina pectoris. Methods: Block randomization was performed to randomly allocate 750 patients into KA(376 cases) and control groups(374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA(0.6 m L per spray). The control group received 1 sublingual nitroglycerin tablet(NT, 0.5 mg/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment(1, 2, 3, 4, 5, and 5 min). Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society(CCS) classes of angina. Results: The 5-min remission rates in the KA and control groups were not significantly different(94.41% vs. 90.64%, P0.05). The angina CCS class significantly influenced the rate of remission (95% confidence interval = 0.483–0.740, P0.01). In the CCS subgroup analysis, the 3-and 5-min remission rates for KA and NT were similar in the CCSⅠ and Ⅳ subgroups(P0.05), while they were significantly better for KA in the CCSⅡ and Ⅲ subgroups(P0.05 or P0.01). Furthermore, the incidence of adverse reactions was significantly lower in the KA group than in the control group for the CCSⅡ and Ⅲ subgroups(9.29% vs. 26.22%, 10.13% vs. 20.88%, P0.05 or P0.01). Conclusions: KA is not inferior to NT in the remission of angina. Furthermore, in CCSⅡ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions.