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.     

Clinical Study on Electro-acupuncture Treatment for 30 Cases ofMental Depression

To observe the clinical therapeutic effects of electro-acupuncture therapy for mental depression, 30 cases were treated by electro-acupuncture on Baihui (GV20), Yintang (EX-HN3) and the differential points.Maprotiline was used in the control group of 31 cases. After the treatment, the scores in HAMD for both groups were found to be obviously decreased as compared with those before the treatment (P＜0.01),without significant between-group differences (P＞0.05). The total effective rate in the treatment group was 96.7%, and that of the control group was 90.3%, showing no significant between-group differences (P＞0.05). After the treatment, the two groups all showed obvious decrease in the TCM symptomatic integrals (P＜0.01), with significant between-group differences (P＜0.05), the integral of the treatment group showing obvious superiority to that of the control group. And the decrease of the Asberg scores testing the side effect of antidepressants of the treatment group was obviously superior to that of the control group. After the treatment, the cortisol (CORT) content and the endothelin-1 (ET-1) content of the two groups were all obviously decreased (P＜0.01), and basically turned to normal, without significant between-group differences (P＞0.05). Conclusion: Electro-acupuncture therapy can produce the same clinical therapeutic effect as that produced by the tetracyclic drug maprotiline, giving less side effect and better symptomatic improvement.     

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 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.     

Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome:A Multi-center,Randomized,Double-Blind,Double-Dummy and Positive Control Trial

Objective: To evaluate the efficacy and safety of Tongxiening Granules(痛泻宁颗粒, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea(IBS-D). Methods: A randomized, double-blind, double-dummy, and positive paral el control ed clinical trial was conducted from October 2014 to March 2016. Total y 342 patients from 13 clinical centers were enrolled and randomly assigned(at the ratio of 1:1) to a treatment group(171 cases) and a control group(171 cases) by a random coding table. The patients in the treatment group were administered oral y with TXNG(5 g per time) combined with pinaverium bromide Tablet simulator(50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator(5 g per time) combined with pinaverium bromide Tablets(50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score(IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief(AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire(IBS-QOL), Hamilton Anxiety Scale(HAMA), Hamilton Depression Scale(HAMD), and the recurrence rate at fol ow-ups. Safety indices including the adverse events(AEs) and related laboratory tests were evaluated. Results: Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set(FAS) and per protocol set(PPS, P0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group(147/171, 86.0%) was higher than the control group(143/171, 83.6%) by FAS(P0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups(P0.05). The recurrence rate at 8-week fol ow-up was 12.35%(10/18) in treatment group and 15.79%(12/76) in control group, respectivery(P0.05). A total of 21 AEs occurred in 15 cases, of which 11 occurred in 8 cases in the treatment group and 10 AEs in 7 cases in the control group. The incidence of AEs had no statistical significance between the two goups(P0.05). Conclusion: Tongxiening Granules could relieve the symptoms of patients with IBS-D and the treatment effect was comparable to pinaverium bromide.(No. ChiCTR-IPR-15006415)     

Efficacy of Modified Qufeng Runmian Powder (加减祛风润面散) on Acne Vulgaris with Syndromes of Dampness and Blood Stasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of a Chinese medicine(CM) Modified Qufeng Runmian Powder(加减祛风润面散, MQFRMP) for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis. Methods: In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo, with 110 cases in each group. MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks, respectively. The primary index of efficacy was the effective rate according to the acne severity score(ASS). The secondary indices of efficacy included the changes in the dermatology life quality index(DLQI) score, VISIA scores(spots, pores, brown spots, porphyrins and red areas) and skin assessment(skin p H, sebum amount and hydration) according to a SOFT skin multianalyzer. Results:(1) Follow-up: a total of 204 patients completed the follow-up, with 103 in the treatment group and 101 in the control group.(2) Effective rate: the total effective rate of the treatment group was significantly higher than the control group [83.5%(86/103) vs. 31.7%(32/101), P0.01)] with 95% confidence interval of 39.3%–66.4%.(3) DLQI: DLQI scores were significantly decreased the treatment and control groups(both P0.01), but the treatment group was more obvious than the placebo group(P0.01).(4) VISIA scores: the scores of spots, brown spots and red areas in the treatment group decreased compared with baseline(P0.05). In the control group, the scores of brown spots and pores decreased compared with baseline(P0.05). The improvement was more obvious in the treatment group than in the control group for all items(P0.05).(5) Skin assessment : the p H and sebum score in the both groups decreased drastically compared with the baseline(all P0.01), however, the improvement was more obvious in the treatment group than in the control group(P0.01). The hydration amount in the two groups showed no statistically significant difference compared with the baseline(both P0.05).(6) Safety: two cases of mild drug allergy were observed in the treatment group. Conclusion: MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis.(No. ChiCTR1900020479).     

Clinical Observation on 930 Child Epilepsy Cases Treated with Anti-epilepsy Capsules

1090 cases of child epilepsy were divided randomly into two groups:the treatment group(930 cases treatedwith anti-epilepsy capsules)and the control group(160 cases treated with luminal).The results showed thatin the treatment group,534 cases were markedly effective,241 effective,96 improved,46 ineffective,and 13aggravated,with a total effective rate of 83.33%;while in the control group,64 cases were markedlyeffective,19 effective,38 improved,29 ineffective,and 10 aggravated,with a total effective rate of 51.88%.The treatment group showed an obviously higher total effective rate than that in the control group(P<0.01).After treatment,cases in the two groups all had lower frequency of epilepsy attacks and shorter duration ofeach attack as compared with that before treatment(P<0.01),but the situation was obviously better in thetreatment group.The anti-epilepsy capsules had very good effect on various types of epilepsy,especially onautonomic epilepsy and on epilepsies due to wind,phlegm,or terror as differentiated in TCM.Aftertreatment,the recovery rate shown by EEG examination was 54.3% in the treatment group,while 38.4% inthe control group,the former being obviously higher than the latter(P<0.01).     

Thirty Cases of Obsession Treated by Point-Stimulation and with Small Dose of Chlorimipramine

Objective: To investigate the clinical therapeutic effects of point-stimulation for obsession. Methods: Sixty cases of obsession were divided into two groups: a control group of 30 cases treated with chlorimipramine (Ch1), and a treatment group of 30 cases treated by point-stimulation (PS) plus chlorimipramine (PS Chl). The therapeutic effects and side-effect were evaluated according to the criteria set in Yale-Brown Obsession Scale (Y-BOCS), Hamilton's depression scale (HAMD), brief psychiatric rating scale (BPRS) and treatment emergent symptom scale (TESS). Results: The cure rate and markedly effective rate were respectively 26.7% and 56.6% in the control group, and 43.3% and 50% in the treatment group, suggesting that the therapeutic effect in the treatment group was better than that in the control group. The incidence of adverse side-effects was 73.33% in the control group and 46.67% in the treatment group, with a significant difference between the two groups (P<0.05). Conclusion: Point-stimulation plus small dose of chlorimipramine was superior to the simple chlorimipramine treatment, indicating that the combined method was more effective and safe for obsession with less side effects.     

Efficacy of Modified Wuzhuyu Decoction Granule(加减吴茱萸汤颗粒剂)for Migraine Patients with Cold and Stasis Obstructing Meridian Syndrome:A Randomized,Double-Blind,Placebo-Controlled Trial

Objective: To study the efficacy of modified Wuzhuyu Decoction Granule(加减吴茱萸汤颗粒, MWDG) in the treatment of migraine patients with cold and stasis obstructing meridian syndrome. Methods: This study was a randomized, double-blind, placebo-controlled trial. A total of 78 migraine patients with cold and stasis obstructing meridian syndrome were recruited and randomly assigned by a ratio of 2:1 into a treatment group(51 cases) and a placebo group(27 cases). Patients in the treatment group were treated with MWDG while placebo granules were applied in the control group. The treatment course lasted for 12 weeks with a follow-up of 4 weeks. The primary outcome measures included frequency and days of migraine attacks and the secondary outcome measures were analgesics consumption and visual analogue scale(VAS) scores. All outcome assessments were conducted respectively at baseline, the 4 th, 8 th and 12 th week, and the end of follow-up. Results: In the treatment group, significant decrease in frequency of migraine attacks were observed since the 4 th week and that of analgesics consumption since the 8 th week(both P0.05). While, in the placebo group, significant decrease in frequency of migraine attacks were observed since the 8 th week and that of analgesics consumption since the 12 th week(both P0.05). No significant decrease in days of migraine attacks and VAS scores of migraine pain were observed in both groups. Between the two groups, there were significant differences in VAS scores and intensity of pain appeared in the 8 th week(P0.05). However, no significant differences were found in days and frequency of migraine attacks and analgesics consumption(P0.05). Conclusions: MWDG was probably effective in the treatment of migraine especially for alleviating pain intensity. Furthermore, MWDG could reduce the frequency of migraine attacks and analgesics consumption sooner than the placebo.     

Therapeutic Effect of Chang'an Ⅰ Recipe(肠安Ⅰ号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of Chinese medicine(CM) decoction Chang'an Ⅰ Recipe(肠安Ⅰ号方) in the treatment of irritable bowel syndrome with diarrhea(IBS-D). Method: A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Based on the order of inclusion, the IBS-D patients were randomly assigned to the treatment group or the placebo control group, administrated with Chang'an Ⅰ Recipe or placebo, 150 m L/bag, 3 times daily, for 8 weeks. The primary indices of efficacy included the effective rates of IBS symptom severity score(IBS-SSS) and the differences in adequate relief(AR) responder; the secondary indexes of efficacy included the changes in scores of the IBS Quality of Life(IBS-QOL) and Hospital Anxiety and Depression(HAD) scales. The safety indices included adverse events and related laboratory tests. Results: A total of 216 patients were included, with 109 in the treatment group and 107 in the control group, and finally 206 were included in the full analysis set(FAS), 191 were included in the per protocol set(PPS). In FAS, the total effective rate was 67.6% and 40.2% for the treatment and control groups, respectively, with 95% confidence interval(CI) for difference in the effective rates between the two groups of 14.4%–40.2%; while in PPS, the total effective rate was 71.3% and 41.2% for the treatment and control groups, respectively(95% CI 16.6%–43.4%). The consistent conclusions of FAS and PPS showed a better efficacy in the treatment group. Both FAS and PPS showed higher AR responder in the treatment group(FAS: 59.6% vs. 35.5%; PPS: 62.8% vs. 38.1%). As for IBS-QOL, the total score and scores in various dimensions of IBS-QOL were not significantly different between the two groups(P0.05). Both anxiety and depression scales of HAD were not significantly different between the two groups(P0.05). No adverse events or laboratory abnormalities were found to be obviously related to the tested drugs or clinically significant. Conclusion: Chang'an Ⅰ Recipe was more effective than placebo in the treatment of IBS-D, with no obvious adverse reactions.(No.ChiC TR-TRC-09000328)     

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     

Effect of Tanreqing Injection(痰热清注射液)on Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Chinese Medicine Syndrome of Retention of Phlegm and Heat in Fei(肺)

<正>Objective:To explore the effect of Tanreqing Injection(痰热清注射液,TRQI) on the treatment of acute exacerbation of chronic obstructive pulmonary disease(AECOPD) with Chinese medicine syndrome of retention of phlegm and heat in Fei(痰热阻肺证,RPHF).Methods:In a prospective randomized controlled clinical trial,90 patients with AECOPD of RPHF syndrome were randomly assigned to 3 groups,TRQI and controls A and B,each with 30 cases.The TRQI group was administered with the intravenous injections of 20 mL TRQI once a day and conventional Western medicine treatment.Control group A was administered with the intravenous injection of 15 mg ambroxol hydrochloride twice a day and conventional Western medicine treatment,and control group B was administered with conventional Western medicine treatment only.The treatments were administered for 10 days.Chinese medical symptoms and signs were scored,and plasma concentrations of interleukin(IL)-8 and neutrophil elastase(NE) were recorded.Results:(1) The Chinese medical symptoms (cough,sputum amount,expectoration,dyspnea and fever) and signs(tongue and pulse) improved significantly in the TRQI group(P0.05 or P0.01),and improvements in cough,sputum amount and expectoration were better in the TRQI group than control group B(P0.05);there was no significant difference between the TRQI group and control group A(P0.05).The sign of tongue was also improved significantly in the TRQI group (P0.05).(2) The overall effects in the TRQI group and control group A were significantly better than in control group B(P0.05),with no significant differences between the TRQI group and control group A(P0.05).There was no significant difference in the total effective rate among the three groups(P0.05).(3) After treatment, the plasma concentrations of IL-8 and NE decreased in the TRQI group and control group A(P0.05),and the concentration of IL-8 in control group B decreased(P0.05).The difference in IL-8 was greater in the TRQI group than in control group A and B before and after treatment,and the change in NE was greater in control group A than in the TRQI group and control group B,but there was no statistical significance among the three groups with regards to the change in IL-8 or NE(P0.05).Conclusion:TRQI could improved the Chinese medical signs and symptoms in the patients with AECOPD,possibly because of the decreasing plasma levels of IL-8 and NE which could improve response to airway inflammation and mucus hypersecretion.     

Effect of Xin''''anning Nasal Drop ( 心安宁滴鼻剂 ) in Treating Coronary Heart Disease with Unstable Angina Pectoris

Objective: To observe the clinical efficacy of Xin'anning Nasal Drop (XAND, 心安宁滴鼻剂 )in treating coronary heart disease with unstable angina pectoris (CHD-UAP). Methods: Sixty patients with CHD-UAP were assigned, according to the randomizing number table, to two groups, the control group treated with conventional Western medicine, and the treated group treated with conventional Western medicine plus XAND. The clinical efficacy and the changes of S-T segment in resting EKG and total ischemia burden (TIB) in 24-h dynamic EKG were observed. Results: The clinical efficacy, including the effect of angina alleviation, its initiation, and the effect of TCM syndrome score reduction, were significantly superior in the treated group to those in the control group ( P＜0.05 or P＜0.01 ). The degree and extent of myocardial ischemia were significantly improved in both groups ( P＜0.01 ), but the improvement in the treated group was better than that in the control group ( P＜0.05). Moreover, it was worth mentioning that the immediate effect in the treated group was better than that in the control group, and the reduction of TIB, the improvement in heart rate and myocardial oxygen consumption (immediately after the first administration or by the end of the therapeutic course), and systolic blood pressure after treatment in the former were all superior to those in the latter, showing significant difference ( P＜0.05 or P＜0. 01 ). Conclusion: XAND has a quick effect in alleviating angina in patients with CHD-UAP, and it is worthy of further studies and spreading in clinical practice.     

Clinical study of western medicine combined with Chinese medicine based on syndrome differentiation in the patients with polarized hypertension

<正>Objective:To investigate the effects and safety of Western medicine combined with Chinese medicine(CM) based on syndrome differentiation in the treatment of elderly polarized hypertension(PHPT),or isolated systolic hypertension with low diastolic blood pressure(DBP).Methods:A total of 125 elderly patients with PHPT were randomly assigned to two groups:59 in the control group treated by Western medicine and 66 in the intervention group treated by Western medicine combined with CM treatment.Based on syndrome differentiation,the patients in the intervention group were further divided into subgroups of yang-qi deficiency and yin-qi deficiency.All subjects were treated with Western medicine of Amlodipine Besylate Tablets and Irbesartan Tablets(or Irbesartan and Hydrochlorothiazide Tablets),to decrease their systolic blood pressure (SBP) slowly to 125-135 mm Hg in 2-6 weeks.In the intervention group,Shiyiwei Shenqi Capsule(十一味参芪胶囊) was given additionally to the subgroup of yang-qi deficiency at the dosage of 3-5 capsules,thrice a day, while Dengzhan Shengmai Capsule(灯盏生脉胶囊) was given additionally to the subgroup of yin-qi deficiency at the dosage of 2 capsules,2-3 times per day.For all subjects,SBP,pulse pressure(PP),and DBP were measured before treatment and at the terminal of a 6-week treatment.For subjects in the intervention group, left ventricular ejection fraction(LVEF) was also recorded.Results:After a 6-week treatment,the SBP in the two groups and the PP in the intervention group decreased significantly compared to those before treatment (P0.05),while the PP in the control group showed no significant difference between prior and post-treatment (P0.05).After treatment,the DBP in the control group decreased(P0.05),while the DBP and LVEF in the intervention group showed an increase tendency although it had no statistical significance(P0.05).When subjects in the intervention group were classified further by the course of disease,the DBP and LVEF of subjects whose course of disease were less than 2 years,increased significantly after treatment(P0.05). Conclusion:Western medicine combined with CM treatment based on syndrome differentiation was safer and more effective than Western medicine alone in the treatment of elderly PHPT,because it not only reduced SBP but also improved DBP,which might lower the incidence of the cardiovascular and cerebrovascular events.     

Therapeutic Effect of Chang'an Ⅰ Recipe (肠安Ⅰ 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of Chinese medicine (CM) decoction Chang''an Ⅰ Recipe (肠安Ⅰ 号方) in the treatment of irritable bowel syndrome with diarrhea (IBS-D). Method: A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Based on the order of inclusion, the IBS-D patients were randomly assigned to the treatment group or the placebo control group, administrated with Chang''an Ⅰ Recipe or placebo, 150 mL/bag, 3 times daily, for 8 weeks. The primary indices of efficacy included the effective rates of IBS symptom severity score (IBS-SSS) and the differences in adequate relief(AR) responder; the secondary indexes of efficacy included the changes in scores of the IBS Quality of Life (IBS-QOL) and Hospital Anxiety and Depression (HAD) scales. The safety indices included adverse events and related laboratory tests. Results: A total of 216 patients were included, with 109 in the treatment group and 107 in the control group, and finally 206 were included in the full analysis set (FAS), 191 were included in the per protocol set (PPS). In FAS, the total effective rate was 67.6% and 40.2% for the treatment and control groups, respectively, with 95% confidence interval (CI) for difference in the effective rates between the two groups of 14.4%–40.2%; while in PPS, the total effective rate was 71.3% and 41.2% for the treatment and control groups, respectively (95% CI 16.6%–43.4%). The consistent conclusions of FAS and PPS showed a better efficacy in the treatment group. Both FAS and PPS showed higher AR responder in the treatment group (FAS: 59.6% vs. 35.5%; PPS: 62.8% vs. 38.1%). As for IBS-QOL, the total score and scores in various dimensions of IBS-QOL were not significantly different between the two groups (P>0.05). Both anxiety and depression scales of HAD were not significantly different between the two groups (P>0.05). No adverse events or laboratory abnormalities were found to be obviously related to the tested drugs or clinically significant. Conclusion: Chang''an Ⅰ Recipe was more effective than placebo in the treatment of IBS-D, with no obvious adverse reactions. (No.ChiCTR-TRC-09000328)     

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.     

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.     

STUDY ON ACUPUNCTURE AND MOXIBUSTION THERAPY FOR FEMALE URETHRAL SYNDROME

Among 180 patients with female urethral syndrome, 128 were treated by acupuncture and moxibustion and 52 by western medicine as controls. The short-term effective rate in the acupuncture and moxibustion group was 90.6% and the long-term effective rate, 80.4%; whereas the short-term effective rate of the control group was 26.9% (P< 0.01). The maximal uroflow rate increased by an average of 4.6 ml/ s, after acupuncture and moxibustion treatment (P< 0.001) and the mean uroflow rate increased by an average of 3.1 ml/ s (P< 0.001); on the contrary, no changes were found in the control group (P> 0.05). Sixty-nine cases from the acupuncture and moxibustion group and 39 from the control group were subjected before and after treatment to determinations of the maximal bladder pressure, maximal abdominal pressure, bladder-neck pressure, and maximal urethral closure pressure during urination. All these indexes were decreased remarkably in the acupuncture and moxibustion group, while no changes were observed in the control group.     

Thirty Cases of the Blood-Stasis Type Prolapse of Lumbar Intervertebral Disc Treated by Acupuncture at the Xi （cleft） Point plus Herbal Intervention Injection

Objective:To observe the clinical therapeuric effects and explore the mechanism of acupuncture at the xi (cleft)points combined witll herbal intervention injection for treatment of prolapse of the lumbar intervertebral disc with TCM symptoms and signs of blood stasis.Methods:The 60 CaSeS in this series were randomly divided into a treatment group and a control group,30 cases in each group.The patients in the treatment group were treated by acupuncture at Jiaji L4-S1,Waiqiu(GB 36),Weizhong(BL 40)and Xiaxi (GB 43)plus intervention injection of Gegensu Zhusheye(葛根素注射液 Puerarin Injectio).The patients of the control group were given the routine acupuncture combined with injection of Gegensu Zhusheye (葛根素注射液 Puerarin Injectio)into the Ashi points.The changes in interleukin-6(IL-6) and hempdynamics were observed before and after treatment in both the two groups.Resuits:The total therapeutic effect in the treatment group was obviously better(P＜0.05)and the treatment course was obviously shorter than that of the control group(P＜0.01).After the treatment,the total score,the visual analog scale(VAS)pain-evaluating score,and the score in straight-leg raising test were obviously improved in both the two groups,in which the improvement in the treatment group shown by the score in straight-leg raising test and the total score superior to that of the control group(P＜0.05).The IL-6 level,red blood cell ratio,K value of blood sedimentation equation.and whole blood high shearing specific viscosity were improved in both the two groups.but the treatment group showed better improvement than that of the control group in the red blood cell ratio,K value of blood sedimentation,and IL-6 level(P＜0.05 or P＜0.01).Conclusions:The treatment group was superior to the control group in improvement of the symptoms and signs,the daily life ability,and in pain alleviation.The mechanism is possibly related witb the improvement in the IL-6 level and hemodynamic indexes.which may promote the subsidence of inflammation of the nerve roots.     

AN OBSERVATION ON COMBINED USE OF CHEMOTHERAPY AND TRADITIONAL CHINESE MEDICINE TO RELIEVE CANCER PAIN

We have treated 50 patients with stage Ⅲ, Ⅵmalignant tumors confirmed by pathology. The patients were divided into two groups. One group was treated by combination of chemotherapy and traditional Chinese medicine (treatment group); the other only by chemotherapy (control group). The effect of cancer treatment was evaluated according to the criteria of WHO. The results showed that the effective rate was 80% in treatment group and 52% in control group. The pain relieving rate was 68% in treatment group and 40% in control group (P< 0.01). This fact demonstrates that the application of traditional Chinese medicine can invigorate blood circulation, eliminate blood stasis, soften hardness and dissolve the mass, nourish blood and increase vigor. This kind of application can not only enhance the effect of cancer treatment but also increase the cancer pain relieving rate.