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.     

Clinical Study on Treatment of the Earthquake-caused Post-traumatic Stress Disorder by Cognitive-behavior Therapy and Acupoint Stimulation

Objective: To study the curative effect of acupoint stimulation on the earthquake-caused post-traumatic stress disorder (PTSD). Methods: The 91 PTSD patients in Wenchuan hit by a strong earthquake were randomly divided into a control group of 24 cases treated by the cognitive-behavior therapy, and a treatment group of 67 cases treated by both cognitive-behavior therapy and acupoint stimulation. The scores were evaluated according to Chinese version of the incident effect scale revised (IES-R) and the self-compiled questionnaire for the major post-traumatic psychological condition, and the curative effect was compared between the two groups. Results: The total scores of IES-R, the scores of all factors and the total scores of the questionnaire in the two groups after treatment were much lower than those before treatment (P<0.01). The comparison of reduction in the factor scores between the two groups showed that the curative effect in the treatment group was better that ofin the control group. Conclusion: The acupoint stimulation is effective for the PTSD patients, with better results than that of cognitive-behavior therapy used alone     

A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris by auricular therapy combined with optimized Yinxieling Formula (银屑灵优化方)

Objective:To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula(银屑灵优化方) on psoriasis vulgaris.Methods:A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris was conducted.The patients were randomized to a treatment group(43 cases treated by auricular therapy combined with optimized Yinxieling Formula) and a control group (41 cases treated by optimized Yinxieling Formula alone) according to a random number generated by SPSS 17.0 software.The treatment duration for both groups was 8 weeks.The therapeutic effect was comprehensively measured by the primary outcome measure[Psoriasis Area and Severity Index(PASI) reduction rate]and the secondary outcome measure[PASI,Visual Analogue Scale(VAS),Dermatology Life Quality Index(DLQI), Self-rating Depression Scale(SDS),and Self-rating Anxiety Scale(SAS)].The outcomes of both groups were obtained and compared before and after the intervention.Results:The PASI reduction rate in the treatment group was 74.4%(32/43),which was higher than that in the control group(36.6%,15/41,P<0.01).The PASI scores decreased in both groups after treatment and was lower in the treatment group compared with the control group (P<0.01).With stratified analysis,there were significant differences between the PASI scores in the following subgroups:age 18-30,baseline PASI>10 and stable stage(P<0.05).DLQI decreased in both groups on some categories after treatment,but there were no significant differences between the two groups in SDS,SAS and VAS(P>0.05).No obvious adverse reactions were found in either group.Conclusion:The therapeutic effect of auricular therapy combined with Optimized Yinxieling Formula was superior to Optimized Yinxieling Formula alone with no obvious adverse reaction.     

Effect of Combined Low-frequency Repetitive Transcranial Magnetic Stimulation and Virtual Reality Training on Upper Limb Function in Subacute Stroke:a Double-blind Randomized Controlled Trail

The effect of combined low-frequency repetitive transcranial magnetic stimulation(LF r TMS) and virtual reality(VR) training in patients after stroke was assessed. In a double-blind randomized controlled trial, 112 patients with hemiplegia after stroke were randomly divided into two groups: experimental and control. In experimental group, the patients received LF r TMS and VR training treatment, and those in control group received sham r TMS and VR training treatment. Participants in both groups received therapy of 6 days per week for 4 weeks. The primary endpoint including the upper limb motor function test of Fugl-meyer assessment(U-FMA) and wolf motor function test(WMFT), and the secondary endpoint including modified Barthel index(MBI) and 36-item Short Form Health Survey Questionnaire(SF-36) were assessed before and 4 weeks after treatment. Totally, 108 subjects completed the study(55 in experimental group and 53 in control group respectively). After 4-week treatment, the U-FMA scores [mean difference of 13.2, 95% confidence interval(CI) 3.6 to 22.7, P<0.01], WMFT scores(mean difference of 2.9, 95% CI 2.7 to 12.3, P<0.01), and MBI scores(mean difference 16.1, 95% CI 3.8 to 9.4, P<0.05) were significantly increased in the experimental group as compared with the control group. The results suggested the combined use of LF r TMS with VR training could effectively improve the upper limb function, the living activity, and the quality of life in patients with hemiplegia following subacute stroke, which may provide a better rehabilitation treatment for subacute stroke.     

Xinfeng Capsule(新风胶囊)for the Treatment of Rheumatoid Arthritis Patients with Decreased Pulmonary Function—A Randomized Controlled Clinical Trial

Objective:To determine the effectiveness and safety of Xinfeng Capsules(新风胶囊,XFC) for the treatment of rheumatoid arthritis(RA) patients with decreased pulmonary function.Methods:This was a randomized controlled clinical trial of 80 RA patients.Participants were assigned to the trial group(40 cases) and the control group(40 cases) by block randomization.The trial group was treated with XFC,three pills each time three times daily for 2 months.The control group was treated with tripterygium glycoside(TPT),two pills each time three times daily for 2 months.Both groups were followed up after 2 months.The clinical effects,changes in joint and pulmonary function,and quality of life before and after treatment were observed;safety indices were also evaluated.Results:Pain,swelling,tenderness,and duration of morning stiffness of joints were obviously decreased after treatment in both the trial and the control groups compared with baseline(P0.01).Compared with before treatment,hand grip strength increased significantly after treatment in the trial group(P=0.0000);pulmonary function parameters such as forced expiratory volume in the first second of expiration/forced vital capacity(FEV_1/FVC),50%of the expiratory flow of forced vital capacity(FEF_(50)),carbon monoxide diffusing capacity(DLco) were increased(P0.01 or P0.05);measures of quality of life such as role-physical,body pain,vitality and mental health were also improved after treatment in the trial group(all P0.05).Joint swelling in the trial group decreased compared with the control group(P=0.0043),while hand grip strength was increased after treatment(P=0.0000).The increase in FEF_(50),DLco,and the dimensions of quality of life such as vitality and mental health were all significantly greater in the trial group than the control group(P0.05 or P0.01).Conclusions:XFC not only relieved joint pain in RA patients,but also significantly improved the ventilation and diffusion function of the lungs.Therefore,XFC could improve the whole body function and enhance the quality of life of RA patients.     

Clinical Observation of Shuanghuang Shengbai Granule(双黄升白颗粒) on Prevention and Treatment of Myelosuppression Caused by Chemotherapy in Cancer Patients

Objective: To study the efficacy and safety of Shuanghuang Shengbai Granule(双黄升白颗粒, SSG), a traditional Chinese herbal medicine, on myelosuppression of cancer patients caused by chemotherapy. Methods: A total of 330 patients were randomly assigned to the treatment group(220 cases, analysed 209 cases) and the control group(110 cases, analysed 102 cases) with a 2:1 ratio by envelope method. The patients in the treatment group at the first day of chemotherapy started to take SSG for 14 days, while the patients in the control group took Leucogon Tablets. The changes of the blood routine, clinical symptoms and immune function in both groups were observed for safety and efficacy evaluation. Results: At the 7th day of chemotherapy, the white blood cells(WBCs) level in the treatment group was significantly higher than that in the control group(P0.05). After treatment, the WBCs rate in the normal range accounted for 50.2% in the treatment group, the myelosuppression of WBCs and neutrophil were mainly grade Ⅰ, while 8.1% and 5.7% of patients emerged grade Ⅲ and grade Ⅳ myelosuppression, respectively. The incidence of myelosuppression of the treatment group was significantly lower than that of the control group(P0.05). The total effective rate of Chinese medicine syndrome in the treatment group was significantly higher than that in the control group(84.2% vs. 72.5%, P0.05). The immune cell levels in both groups were maintained in the normal range. Compared with that before treatment, the levels of CD3~+ and CD4~+ cells were significantly increased in the treatment group after treatment(P0.05). The discrepancy of CD3~+ and CD4~+ cell activity before and after treatment in both groups were significantly different(P0.05). No obvious adverse event occurred in both groups. Conclusion: SSG had a protection effect on bone marrow suppression, and alleviated the clinical symptoms together with clinical safety.     

The Therapeutic Effect of Xiaopi-Ⅰ(消痞Ⅰ号) on Functional Dyspepsia

Objective: To observe the therapeutic efficacy of Xiaopi-Ⅰ(消痞Ⅰ号) on functional dyspepsia and its effects on gastric emptying. Methods: A total of 134 patients with functional dyspepsia were randomly assigned to 2 groups. The patients in the Xiaopi-Ⅰ group (66 cases) and the Domperidone group (68 cases) were given Xiaopi-Ⅰ granules and Domperidone 10 mg, 3 times a day, respectively. Another 20 healthy volunteers were chosen as the negative control group. The severity scores of the symptoms, as well as the gastric emptying, were detected before and after 4-week treatment by barium strip-trial meal. Results: During therapy, 6 cases from the Xiaopi-Ⅰ group and 8 cases from the Domperidone group were lost to follow, and 120 cases finally finished the study. Statistical differences were observed from both groups in terms of the symptoms of postprandial fullness early satiety, epigastric pain, and epigastric burning after 4-week treatment (P<0.01). The symptomatic severity scores of the Xiaopi-Ⅰ group before and after the treatment were 7.48±1.64 and 2.16±1.26, respectively (P<0.01). Gastric emptying rates were also improved in the patients with delayed gastric emptying, and the effective rates were 91.3% and 75.8% in the Xiaopi-Ⅰ and Domperidone groups, respectively. No obvious adverse effects were found from both groups. Conclusion: Xiaopi-Ⅰ was an effective and safe agent in the treatment of functional dyspepsia and was worth of further development in clinical.     

Influence of Fuzheng Huayu Tablet (扶正化瘀片) on mental state and social function of patients with post-hepatitis B liver cirrhosis

Objective:To observe the influence of Fuzheng Huayu Tablet(扶正化瘀片,FZHYT)on mental state and social activity of patients with post-hepatitis B liver cirrhosis(LC-HB).Methods:Adopting grouped randomized double-blinded control method,180 LC-HB patients in 3 research centers were distributed to 2 groups,the treated group and the control group,90 in each group.Patients in the treated group were administered with FZHYT;while those in the control group treated with conventional therapy combined with placebo,the course for ail patients were 6 months.Their mental state and social activity were evaluated before treatment,after 3 months’ treatment and at terminal of the 6-month therapeutic course by estimating with Zung self-rating anxiety scale(SAS),self-rating depression scale(SDS)and social deficit screening scale(SDSS). Additionally,the basic demographic materials,liver function,cirrhosis index,hepatic and splenic images,blood coagulation function,etc.in the patients were tested and compared as well.Results:As compared with before treatment,the normal rate of SAS and SDS scores increased and the social deficit rate decreased in the treated group significantly after treatment,showing statistical significance(P<0.05 or P<0.01);while in the control group, change was only shown in the social deficit(P<0.01),inter-group comparisons after treatment showed significant differences in all the three indexes(P<0.05 or P<0.01).Additionally,after treatment,levels of liver function, cirrhosis,blood coagulation function and splenomegaly in the treated group were all improved significantly (P<0.05 or P<0.01),and the improvements were better than those in the control group(P<0.01)in levels of total bilirubin(TBIL),albumin(ALB),typeⅣcollagen(Ⅳ-C),prothrombin time(PT),prothrombin activity(PTA). Conclusion:Most patients of LC-HB have mental disturbance and social activity deficit,which could definitely be improved by intervention with Chinese FZHYT.     

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 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 and Safety of Tongyan Spray (通咽喷雾剂) on Hyoid Motion in Patients with Dysphagia after Ischemic Stroke

Objective: To observe the effects and safety of Tongyan Spray (通咽喷雾剂) on the range and time of hyoid motion in patients with ischemic post-stroke dysphagia. Methods: Seventy-two patients with ischemic post-stroke dysphagia were selected and randomly assigned to a treatment group (36 cases) and a control group (36 cases) by a random number table from January 2013 to October 2014. All patients swallowed 4 kinds of barium meals with different traits respectively, and each patient underwent video fluoroscopy (VF) examination twice. In the treatment group, Tongyan Spray was sprayed to the pharynx on both sides and the middle part once respectively. The spray was applied 30 min before the second examination. Purified water at room temperature was used as placebo in the control group. The changes in the range and time of hyoid motion in both groups were observed before and after treatment. Results: Six patients dropped out in each group, and 60 patients completed the study and were included in the final analysis. Significant improvement was observed in the range of superior hyoid excursion distance and the time of hyoid motion in the treatment group compared with the control group (P<0.05). There were no obvious adverse reactions observed in oral mucosa in both groups during the whole study. Conclusion: Tongyan Spray was an effective and safe medicine for improving swallowing function in patients with ischemic post-stroke dysphagia.     

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.     

Chinese Medicine Improves Postoperative Quality of Life in Endometriosis Patients: A Randomized Controlled Trial

Objective:To investigate the effect of Chinese medicine(CM) and Western medicine(WM) on quality of life(QOL) after conservative surgery for endometriosis.Methods:A total of 320 patients with endometriosis were randomized into two groups by using random block design,CM group(160 cases,activating blood circulation and removing blood stasis treatment based on syndrome differentiation) and WM group(160 cases,gonadotropin-releasing hormone agonist or gestrinone treatment) after conservative surgery.Treatment was given for 3-6 months(according to the revised American Fertility Society scoring system stage),and the World Health Organization QOL-BREF(WHOQOL-BREF) was applied to patients before and after treatment to assess QOL.Results:There were 136 cases in the CM group and 141 cases in the WM group completing therapy.In the CM group,the use of the WHOQOL-BREF showed that the physical,psychological and environmental scores post- treatment were significantly higher than those at pre-treatment(P<0.05),and for 12 items(pain and discomfort, energy and fatigue,sleep and rest,mobility,activities of daily living,work capacity,negative feelings,health and social care:accessibility and quality,participation in and opportunities for recreation/leisure activities,appetite, QOL score,overall health status and QOL),the difference in scores was significant(P<0.05).In the WM group,4 items(pain and discomfort,opportunities for acquiring new information and skills,QOL score,overall health status and QOL) had significantly different scores post-treatment compared with those at pre-treatment(P<0.05).Before treatment,the QOL in the two groups of patients showed no significant difference(P>0.05).After treatment,the scores for physical health in the CM group were significantly higher than those of the WM group(P<0.05) and the scores of 4 items(mobility,activities of daily living,sexual activity,QOL score) in the CM group were significantly higher than those in the WM group(P<0.05).Conclusions:CM and WM treatment could improve the QOL of patients with endometriosis after conservative surgery.CM treatment is more effective than WM.     

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.     

Effectiveness and Safety Evaluation of Qixiong Zhongzi Decoction (芪芎种子汤) in Idiopathic Asthenozoospermia Treatment: A Randomized Controlled Trial

Objective: To evaluate the clinical effectiveness and safety of the Chinese medicine(CM) Qixiong Zhongzi Decoction(芪芎种子汤, QZD) in the treatment of patients with idiopathic asthenozoospermia. Methods: A total number of 66 patients with idiopathic asthenozoospermia were included and randomly divided into treatment and control groups by SAS-generated code from January 2015 to August 2016, 33 patients in each group. Patients in the treatment group were administered with 150 m L of QZD twice a day, whereas those in the control group were given 1 g of levocarnitine oral liquid twice a day. The two groups received the indicated medication for 12 weeks and were then followed up for 4 weeks. The primary outcome was sperm motility, and the secondary therapeutic indices were sperm volume, density, pregnancy probability, and CM syndrome score. The comparison between groups was carried out at 4, 8 and 12 weeks, respectively. The safety was determined before and after treatment. Results:(1) Drop-off: 5 cases(7.58%) were lost after treatment(2 from the treatment group and 3 from the control group).(2) Primary outcomes: after 8-and 12-week treatment, the progressive sperms in the two groups were significantly higher than the baseline(all P0.05); however, the treatment group showed greater improvement compared with the control group at 12-week treatment(22.7%±9.0% vs. 14.1%±8.8%, P0.05). The increasement of non-progressive grade sperms at both groups was observed at 8-and 12-week treatment with statistical difference(all P0.05), however, the treatment group showed remarkable improvement compared with the control group at 12-week treatment(38.7%±14.1% vs. 26.2%±15.4%, P0.05).(3) Secondary outcomes: no significant statistical differences were found in semen volume and density(4, 8, and 12-week treatment) and pregnancy probability of patients' wives(12-week treatment) between two groups(all P0.05), however, the CM syndrome score of the treatment group significantly declined compared with baseline level at each time points(all P0.05).(4) Safety: no obvious side reactions were found during the treatment in both groups. Conclusions: QZD could improve the progressive and non-progressive grade sperm in the treatment of idiopathic asthenozoospermia. It is safe with no obvious side effects.     

Effect of Qingfei Mixture (清肺合剂) on Pediatric Mycoplasma Pneumoniae Pneumonia with Phlegm Heat Obstructing Fei (Lung) Syndrome

Objective: To explore the effect and mechanism of Qingfei Mixture(清肺合剂), a Chinese medicine, in treating mycoplasma pneumonia(MP) in MP patients and rat model. Methods: A total of 46 MP children with phlegm heat obstructing Fei(Lung) syndrome were randomly assigned to two groups by the method of random number table, with 23 children in each group. The control group was treated with intravenous infusion of azithromycin; the treatment group received intravenous infusion of azithromycin and oral administration of Qingfei Mixture. The treatment course was 7 days. Major symptoms and minor symptoms were observed and scored before and after treatments. A rat model of MP was also established. A total of 120 wistar rats were randomly divided into 5 groups: a normal group, infection group, Qingfei Mixture treatment group, azithromycin treatment group, and Qingfei Mixture + azithromycin treatment group. Each group contained 24 rats, from which every 6 were euthanatized 1, 3, 7 and 14 days after infection. MP DNA in pulmonary tissue homogenates was detected using real-time fluorescence quantitative polymerase chain reaction. Pathology was assessed after hematoxylin(HE) staining and lung tissue pathology scores were determined in pulmonary tissue. Transmission electron microscopic detection and electronic image analysis were performed on lung tissue 3 days after infection. Interleukin(IL)-17 was detected in serum using enzymelinked immunosorbent assay(ELISA) 7 days after infection. Results: In the clinical study, both control and the treatment group showed improved results on removing symptoms of phlegm heat syndrome compared to the control group(P0.05). In animal experiments, On the 7th day after MP infection, as detected by electron microscopy, the pulmonary capillary basement membranes of the azithromycin + Qingfei Mixture treatment group were much thinner than those of the azithromycin or Qingfei mixture treatment groups(P0.05). The level of serum IL-17 in the azithromycin + Qingfei Mixture treatment group was lower than that in the azithromycin or Qingfei Mixture groups(P0.01). Conclusion: Both Qingfei Mixture and azithromycin have therapeutic effects on mycoplasma pneumoniae pneumonia, but the combination of both agents had the greatest effect.     

Clinical Study on Yishen Qufeng Shengshi Recipe (益肾祛风胜湿方) for Glomerular Proteinuria Patients: A Randomized Controlled Trial

Objective: To explore the therapeutic effect of Yishen Qufeng Shengshi Recipe(益肾祛风胜湿方,YQSR) in patients with glomerular proteinuria. Methods: A total of 145 patients with glomerular proteinuria were selected and randomly assigned to the treatment group(108 cases) and the control group(37 cases) according to a random number table in a ratio of 3:1. All patients received conventional and symptomatic treatment. In addition, patients in the treatment and control groups were given YQSR(200 m L, twice per day, orally) and losartan(50 mg/d orally), respectively for 6 months. The 24-h urine protein quantity, blood urea nitrogen, and serum creatinine in the two groups were measured at multiple time points before and after treatment. Results: At the end of the study, 5 cases were lost to follow-up in the treatment group and 1 in the control group. Finally, the statistical data included 103 cases in the treatment group and 36 cases in the control group. The total effectiveness after 2, 4, and 6 months was 81.6%(84/103), 87.4%(90/103), and 92.2%(95/103), respectively, in the treatment group and 47.2%(17/36), 55.6%(20/36), and 61.1%(22/36), respectively, in the control group, with significant difference between the two groups(P0.01 at all observation points). In the treatment group, the curative effect after 6 months was better than that after 2 months(P0.05). The 24-h urine protein quantity was significantly lower in the treatment group at 3, 4, 5, and 6 months than that in the control group(P0.05 or P0.01, respectively). Conclusion: YQSR could significantly reduce the amount of glomerular proteinuria in the early stage.     

Clinical Study on Therapeutic Effect of Acupuncture on Behcet''''s Disease

Forty-six cases of Behcet's disease were randomly divided into two groups. The 26 cases in the treatmentgroup were treated by acupuncture and the 20 cases in the control group with the drugs. The level ofL-chain () of IgM and the level of the trace element Zn were determined before and after treatment inthe treatment group. The results showed that the recurrence rate in the treatment group was significantlylower than that in the control group (P<0.01), and the differences in the level of L-chain () of IgM andlevel of Zn in the treatment group before and after treatment were very significant (P<0.01). These twoindexes tended to become normal after treatment.     

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).     

Effect of Weikangfu Granule (胃康复冲剂) on the Physiopathologic Figure of Precancerosis of Gastric Mucosa in Patients of Chronic Gastritis with Pi-Deficiency Syndrome

Objective: To study the physiopathologic basis of Weikangfu Granule ( 胃康复冲剂, WKFG)in treating precancerosis of gastric mucosa in patients of chronic gastritis with Pi-deficiency syndrome (CG-PDS). Methods: One hundred and fifteen patients of CG-PDS who suffered from intestinal metaplasia (IM)and atypical hyperplasia (ATHP) of gastric mucosa, were divided into two groups. The treated group (n =61 ) was treated by WKFG with its ingredients modified according to the syndrome type of patients. The constructural changes were detected by optical microscope, screening electronic microscope, transmission electronic microscope and histochemical staining; the nuclear and mitochondrial ultrastructure of gastric mucosa were analyzed with energy dispersion X-ray analyser and image analysis system. And the changes of cAMP,lipid peroxide (LPO), superoxide dismutase (SOD) before and after treatment in the treated group were measured and compared with those of the health control group consisting of 15 volunteers. Results: The symptomatic and pathological therapeutic effect in the treated group were significantly superior to those in the control group (P＜0.05). The contents of Zn, Cu, cAMP, SOD and 3H-TdR LCT in gastric mucosa of the treated group before treatment were all lower than those of the healthy control group, yet all these indexes markedly increased after treatment, while serum LPO level, which increased before treatment was lowered after treatment. All the changes showed statistical significance (P＜0.05 or P＜0.01). Conclusion: WKFG can reverse IM and ATHP in patients of CG-PDS, and the effect may be realized by way of increasing the level of Zn, Cu, cAMP and SOD in gastric mucosa, promoting cell differentiation, enhancing cellular immunity and reducing oxygen free radicals and lipid peroxidation.