Wendan Decoction(温胆汤) for Treatment of Schizophrenia: A Systematic Review of Randomized Controlled Trials

Objective: To assess the beneficial and adverse effects of Wendan Decoction(温胆汤, WDD) for the treatment of schizophrenia. Methods: Five electronic databases were searched until May 2014, including the Chinese National Knowledge Infrastructure, the Chinese Biomedical Literature Database, the Chinese Scientist Journal Database, Pub Med, and the Cochrane Central Register of Controlled Trials in the Cochrane Library. The randomized controlled trials(RCTs) testing WDD against placebo, antipsychotic drugs, or WDD combined with antipsychotic drugs against antipsychotic drugs alone were included. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. Results: Thirteen RCTs(involving 1,174 patients) were included and the methodological quality was evaluated as generally low. The pooled results showed that WDD combined with antipsychotic drugs were more effective in clinical comprehensive effect, Positive and Negative Syndrome Scale(PANSS) scores and Brief Psychiatric Rating Scale scores compared with antipsychotic drugs alone. However, WDD had less effectiveness compared with antipsychotics in clinical comprehensive effect; and WDD was not different from antipsychotic drugs for PANSS scores. The side effects were significantly reduced in the intervention group compared with the control group. Conclusions: WDD appears to be effective on improving symptoms in patients with schizophrenia. However, due to poor methodological quality in the majority of the included trials, the potential benefit from WDD needs to be confirmed in rigorous trials and the design and reporting of trials should follow the international standards.     

Safety and efficacy of Qingre Buyi Decoction (清热补益煎剂) in the treatment of acute radiation proctitis: A prospective, randomized and controlled trial

Objective:To investigate the efficiency,safety,and possible mechanisms of Qingre Buyi Decoction(清热补益煎剂,QBD)in the treatment of acute radiation proctitis(ARP).Methods:This study was a single center,prospective,single blind,randomized,and placebo-controlled clinical trial.A total of 60 patients with ARP was equally and randomly distributed into the control group(conventional treatment)and the combination group(conventional treatment plus QBD).The changes of main Chinese medicine clinical symptoms and signs...     

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)     

Systems Pharmacology Uncovers Multiple Mechanisms of Erxian Decoction (二仙汤) for Treatment of Premature Ovarian Failure

Objective: To predict the chemical compositions and drug targets and to systematically dissect the pharmacological mechanism of Erxian Decoction(二仙汤,EXD) as a treatment for premature ovarian failure(POF) using a systems pharmacology approach. Methods: The compounds present in EXD were obtained from three databases. The active ingredient was identified by analyzing the values of oral bioavailability(OB), drug-likeness(DL), and Lipinski's rule(LR). The active ingredients were further searched in research articles, drug targets in the Drug Bank database, and the C-T and T-P networks, as well as by pathway analysis using the Cytoscape platform. Results: A total of 728 compounds were identified in EXD. Of these, 59 were identified as active compounds that conformed to the criteria with OB 30% and DL 0.18. By further searches in the literature, 126 related targets were identified that could interact with the active compounds. Additionally, it was found that the beneficial effects of EXD in POF are probably exerted via regulation of the immune system, modulation of estrogen levels, and anti-oxidative activities, and that it may act in a synergistic or cooperative manner with other therapeutic agents. Conclusions: The systems pharmacology approach is a comprehensive system that was used to elucidate the pharmacological mechanism of EXD as a treatment for POF. The results of this study will also facilitate the application of traditional medicine in modern treatment strategies.     

A One-year Evaluation of Radiographic Progression in Patients with Rheumatoid Arthritis Treated by Qingre Huoxue Decoction(清热活血方)

<正>Objective:To investigate the effects of Qingre Huoxue Decoction(清热活血方,clearing heat and promoting blood flow;QRHXD),on the radiographic progression in patients with rheumatoid arthritis(RA) by X-ray imaging.Methods:Eighty-six patients with active RA diagnosed as damp-heat and blood stasis syndrome were randomized into a QRHXD group and a QRHXD plus methotrexate(MTX) group,with 43 cases in each group.After one-year of treatment,21 cases in each group(42 in total) were evaluated.Radiographs of hands were obtained at the baseline and after 12 months of treatment.Images were evaluated by investigators blinded to chronology and clinical data,and assessed according to the Sharp/Van der Heijde methods.Results:High intrareader agreements were reached(mean intraobserver intraclass coefficients:0.95).No significant change in any imaging parameters of joint destruction was observed at 12 months in either group;and the differences between the two groups were not significant(P0.05).The mean of the changing score in the QRHXD group was 3.5±4.1,and 2.4±3.5 in the QRHXD+MTX group,while the baseline radiographic score of patients in the QRHXD group was relatively higher(18.9±19.1 vs.14.0±14.0).The mean rates of the changing scores of the two groups were similar(0.24±0.28 vs.0.25±0.44,P=0.40).The severity of progression in the two groups was also similar(P=0.46),7 cases without radiographic progression in the QRHXD group and 8 in the QRHXD+MTX group,3 cases with obvious radiographic progression in the QRHXD group and 1 in the QRHXD+MTX group. Conclusion:Radiographic progression of RA patients in both groups is similar,indicating that the QRHXD Decoction has a potential role in preventing bone destruction.     

Songling Xuemaikang Capsule(松龄血脉康胶嚢)for Primary Hypertension: A Systematic Review of Randomized Controlled Trials

Objective:To evaluate the effectiveness and safety of Songling Xuemaikang Capsule(松龄血脉康胶囊,SXC) for the treatment of primary hypertension.Methods:An extensive search including Cochrane Library,PubMed,Cochrane Central Register of Controlled Trials(CENTRAL),Chinese Biomedical Literature Database(CBM),Chinese National Knowledge Infrastructure(CNKI),Chinese Scientific Journal Database(VIP),KoreaMed,Japanese database,and online clinical trial registry websites was performed up to February 2013.Randomized controlled trials(RCTs) regarding SXC for the treatment of primary hypertension were searched without no language restrictions.The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0,and RevMan 5.0 provided by the Cochrane Collaboration.Result:A total of 17 RCTs involving1,778 patients were included.Meta-analysis showed that there was no significant difference between SXC and antihypertensive agents on systolic blood pressure[mean difference(MD):-0.10[-4.83,4.63];P=0.97]and diastolic blood pressure(MD:1.00[-1.16,3.16];P=0.36),but SXC combined with antihypertensive drugs was more effective in lowering systolic blood pressure(MD:-6.17[-7.86,-4.49];P0.00001) and diastolic blood pressure(MD:-7.24[-8.62,-5.85];P0.00001) compared with the antihypertensive drugs alone.Conclusions:SXC used alone or combined with antihypertensive drugs appear to be an effective treatment for lowering elevated blood pressure and improving symptoms in patients with primary hypertension.However,the conclusion cannot be drawn definitely due to the poor quality of the included studies.There is still an urgent need for well-designed,long-term studies to address the benefits of SXC for treating primary hypertension.     

Efficacy of Getong Tongluo Capsule(葛酮通络胶嚢)for Convalescent-Phase of Ischemic Stroke and Primary Hypertension:A Multicenter,Randomized,Double-Blind,Controlled Trial

Objective:To evaluate whether the efficacy of Getong Tongluo Capsule(葛酮通络胶囊,GTC,consisted of total flavone of Radix Puerariae)on improving patients'quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba(EGB)for patients with convalescent-phase ischemic stroke and primary hypertension.Methods:This randomized,positive-drug-and placebo-controlled,double-blind trial was conducted from September 2015 to October 2017.Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions,twice a day for 12 weeks:(1)GTC 250 mg plus EGB-matching placebo 40 mg(237 cases,GTC group),(2)EGB 40 mg plus GTC-matching placebo 250 mg(120 cases,EGB group)or(3)GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg(120 cases,placebo group).Moreover,all patients were orally administered aspirin enteric-coated tablets 100 mg,once a day fo r 12 weeks.The primary outcome was the Barthel Index(Bl).The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale(NIHSS)scores.The incidence and severity of adverse events(AEs)were calculated and assessed.Results:The Bl relative independence rates,the clinical recovery rates of NIHSS,and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment(P<0.05),and no statistical significance was found between the GTC and EGB groups(P>0.05).The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12,18 and 24 weeks after treatment(P<0.01).There were no statistically significant differences in the incidences of AEs,adverse drug reactions,or serious AEs among the 3 groups(P>0.05).Conclusion:GTC exhibited significant efficacy in improving patients'quality of life as well as neurological function and controlling hypertension.     

Sodium Tanshinone ⅡA Sulfonate Injection as Adjuvant Treatment for Unstable Angina Pectoris: A Meta-Analysis of 17 Randomized Controlled Trials

Objective: To systematically evaluate the effectiveness and safety of Sodium Tanshinone ⅡA Sulfonate Injection(STS) as one adjuvant therapy for treating unstable angina pectoris(UAP). Methods: Randomized controlled trials(RCTs) of UAP treated by STS were searched in the China National Knowledge Infrastructure Database(CNKI), VIP Database for Chinese Technical Periodicals(VIP), Wanfang Database, the Chinese Biomedical Literature Database(CBM), Web of Science, the Cochrane Library, Embase, and Pub Med, which from inception to January, 2016. The Cochrane Risk Assessment Tool was used to evaluate the methodological quality of the RCTs. The Review Manager 5.3 software was used to conduct the metaanalysis. Results: The results showed that 17 RCTs involving 1,372 patients were included. The meta-analysis indicated that the combined use of STS and Western medicine(WM) in the treatment of UAP can obviously improve the total effective rate [risk ratio(RR)=1.31, 95% confidence interval(CI)(1.24,1.39), P0.0001], and the total effective rate of electrocardiogram [RR=1.43, 95% CI(1.30,1.56), P0.0001], decrease the level of CRP [mean difference(MD)=–3.06, 95%CI(–3.85, –2.27), P0.00001], fibrinogen [MD=–1.03, 95% CI(–1.16, –0.89), P0.00001], and whole blood high shear viscosity [MD=–0.70, 95% CI(–0.92, –0.49), P0.00001]. Additionally, the occurrence of adverse drug reaction of the experimental group was significantly higher than that of the control group [RR=3.57, 95% CI(1.28, 9.94), P0.05]. Conclusions: Compared with WM, the combined use of STS was more effective.     

Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder(加味丁桂散)in Patients with Chronic Nonbacterial Prostatitis:A Randomized,Double-Blind,Placebo-Controlled Clinical Trial

Objective:To evaluate the effectiveness and safety of Chinese herbal external umbilicus treatment with Modified Dinggui Powder(加味丁桂散,MDGP)in patients with chronic nonbacterial prostatitis(CNP).Methods:A randomized,double-blind,placebo-controlled clinical trial was conducted among 72 patients with CNP.Participants were randomly allocated to a treatment group and a placebo group using computer software in a 1:1 ratio,and received either MDGP external umbilicus treatment(MDGP group,36 cases)or placebo(control group,36 cases)at acupoints Shenque(CV 8),twice a week for 4 weeks.In addtion,patients all received herbal medicine treatment twice a day for 4 weeks.The primary outcome was the US National Institutes of Health Chronic Prostatitis Symptom Scores Index(NIH-CPSI)with a questionnaire at weeks 2 and 4.The secondary outcomes including prostatic fluid examination(white blood cells and lecithin bodies),the clinical efficacy evaluation,and the adverse events were also assessed during the entire trial.Results:The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2(P=0.001)and week 4(P=0.004),respectively.NIH-CPSI scores of symptom severity,total scores and leukocytes number in the prostatic fluid in the MDGP group were significantly improved(P<0.05).There was no statistical difference in the urinary symptoms,quality of life,lecithin and other scores between two groups(P>0.05).The clinical effective rate was 73.53%(25/34)in the MDGP group,which was significally higher than the placebo control group with 48.39%(25/31,P<0.05).Patients were blinded successfully,and no serious adverse effects were found during the trial.Conclusion:A 4-week course of umbilicus treatment with modified Dinggui Powder seems to relieve pain and symptom severity effectively and increase the amount of leukocytes number in patients with CNP(Trial registration No.ChiCTRI 800014687).     

Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial

Objective:To verify the efficacy and safety of Quxie Capsule(祛邪胶囊) in patients with metastatic colorectal cancer(mC RC).Methods:The present study was a randomized,double-blind,placebo-controlled trial.Sixty patients with mC RC were randomized into two groups at a 1:1 ratio by sealed envelope.The treatment group received conventional therapy combined with Quxie Capsule for 3 months.The control group was treated with conventional therapy combined with placebo for 3 months.Main outcome measures were overall survival(OS) and progression-free survival(PFS).Subgroup analysis was performed according to age,right or left-sided disease,and second-line therapy to determine the differences in PFS and OS between the two groups.Patients were followed up every 3 months until Dec 31 st 2016.Results:The median OS was 23 months in the treatment group [95% confidence interval(CI):15–not calculated] vs.14 months in the control group(95% CI:11–22,P=0.060).The OS of the treatment group tended to be longer than that of the control group(P0.05).In the subgroups of patients 65 years old,left-sided colon,and 2 nd-line therapy,the treatment group showed a significant survival benefit compared with the control group(P=0.006,0.038,0.013,respectively).There were no significant differences between the two groups in PFS(P0.05).Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.Conclusions:Quxie Capsule showed good safety and efficacy,and could prolong the OS of patients with mC RC.     

A microarray analysis of angiogenesis modulation effect of Xuefu Zhuyu Decoction (血府逐瘀汤) on endothelial cells

Objective:To study the angiogenesis modulation mechanism of Xuefu Zhuyu Decoction(血府逐瘀汤) on the endothelial cell line ECV304.Methods:ECV304 cells were treated with 2.5%Xuefu Zhuyu Decoctioncontaining serum(XFZYD-CS) for 24 h,48 h or 72 h.Thiazolyl blue tetrazolium bromide(MTT),fluorescence activating cell sorter(FACS),migration,adhesion and in vitro tube formation assays were conducted to confirm an angiogenesis effect of XFZYD at 3 time points.An analysis of angiogenesis regulator profiles was performed at 3 times with real-time polymerase chain reaction(RT-PCR) superarray.Results:At 48 h,XFZYD-CS induced ECV304 significantly improved cell viability,number in S phase,migration,adhesion and tube formation.At 24 h and 72 h, only cell migration was elevated.Microarray results showed that the expression of 27 angiogenesis-related genes was changed.Conclusion:XFZYD-CS treatment induced angiogenesis on ECV304 cells with significant cellcular changes occurring at 48 h and genetic changes as early as 24 h.     

Qiangzhi Decoction(羌跖汤) Protects Mice from Influenza A Pneumonia through Inhibition of Inflammatory Cytokine Storm

Objective:To investigate the preventive effects of Qiangzhi Decoction(羌跖汤,QZD) on influenza A pneumonia through inhibition of inflammatory cytokine storm in vivo and in vitro.Methods:One hundred ICR mice were randomly divided into the virus control,the Tamiflu control and the QZD high-,medium-,and low-dose groups.Mice were infected intranasally with influenza virus(H1N1) at 10 median lethal dose(LD_(50)).QZD and Tamiflu were administered intragastrically twice daily from day 0 to day 7 after infection.The virus control group was treated with distilled water alone under the same condition.The number of surviving mice was recorded daily for 14 days after viral infection.The histological damage and viral replication and the expression of inflammatory cytokines were monitored.Additionally,the suppression capacity on the secretion of regulated on activation normal T cells expressed and secreted(RANTES) and tumor necrosis factor- α(TNF- α) in epithelial and macrophage cell-lines were evaluated.Results:Compared with the virus control group,the survival rate of the QZD groups significantly improved in a dose-dependent manner(P0.05),the viral titers in lung tissue was inhibited(P0.05),and the production of inflammatory cytokines interferon-γ(IFN- γ),interleukin-6(IL-6),TNF- α,and intercellular adhesion molecule-1(ICAM-1) were suppressed(P0.05).Meanwhile,the secretion of RANTETS and TNF-α by epithelial and macrophage cell-lines was inhibited with the treatment of QZD respectively in vitro(P0.05).Conclusions:The preventive effects of QZD on influenza virus infection might be due to its unique cytokine inhibition mechanism.QZD may have significant therapeutic potential in combination with antiviral drugs.     

Effects of Kaixin Jieyu Decoction (开心解郁汤) on Behavior and Glial Fibrillary Acidic Protein Expression in Cerebral Hippocampus of A Rat Vascular Depression Model

Objective:To explore the effects and anti-depression mechanisms of Kaixin Jieyu Decoction(开心解郁汤,KJD).Methods:The rat vascular depression(VD) model was established by ligation of bilateral common carotid arteries(LBCCA) combined with chronic unpredictable mild stress(CUMS).Forty Wistar rats were randomly divided into sham,VD model,VD + high-dose KJD[15.4 g/(kg·d) of crude drug],VD + medium-dose KJD[7.7 g/(kg·d) of crude drug],and VD + fluoxetine[2.4 mg/(kg·d)]groups(r=8 in each group),and the treatments lasted for 21 days.Changes of behavior and hippocampus pathology were observed.The level of glial fibrillary acidic protein(GFAP)protein and mRNA in hippocampus was detected respectively by immunohistochemistry and real-time polymerase chain reaction.Results:Compared with the sham group,rats in model group showed a variety of behavioral obstacles,including a significant reduction in sucrose consumption percentage,horizontal and vertical activity scores in open-field tests(P0.05 or P0.01),pathological damage like neuronal degeneration,necrosis,and a significant decrease of GFAP protein and mRNA in hippocampus(P0.01);compared with the model group,rats in the high-dose KJD group,medium-dose KJD group and fluoxetine group obtained notable higher behavioral scores,and pathological injury lessened in hippocampus with a increased expression of GFAP protein and mRNA(P0.05 or P0.01);compared with the medium-dose KJD group and fluoxetine group,GFAP mRNA in highdose KJD group expressed higer(P0.05).Conclusion:LBCCA combined with CUMS may cause depression-like behavioral changes resulting in the VD model of rats whose depression state can be ameliorated by KJD,and the mechanism of cerebral protection is related possibly with promoting expression of GFAP in hippocampus.     

Changes of Pharmacokinetics of 6,7-Dimethoxycoumarin in A Rat Model of Alpha-Naphthylisothiocyanate-Induced Experimental Hepatic Injury after Yinchenhao Decoction(茵陈蒿汤) Treatment

<正>Objective:To study the changes of pharmacokinetics of 6,7-dimethoxycoumarin in a rat model of alpha-naphthylisothiocyanate(ANIT)-induced experimental hepatic injury after oral administration of Yinchenhao Decoction(茵陈蒿汤,YCHD) using an ultra pressure liquid chromatography(UPLC) method.Methods:Rats were divided into a normal group and a model group,after modeled by 4%ANIT(75 mg/kg) for 48 h,they were orally administrated with YCHD extract at the dose of 0.324 g/kg,and then blood was collected from their orbital sinus after different intervals.Changes in liver function were monitored by the levels of liver enzymes [alanine aminotransferase(ALT),aspartate aminotransferase(AST)]and bilirubins[total bilirubin(TBIL),direct bilirubin(DBIL)],the concentration of 6,7-dimethoxycoumarin in plasma were measured by UPLC,and the pharmaceutical parameters were calculated with DAS2.1.1 software.Results:The concentration-time curve of both normal and modeled rats after oral administration of YCHD was obtained.Their time to maximum plasma concentration(t_(max)) were both 0.25 h,the maximum concentration(C_(max)) were 4.533μg/mL and 6.885μg/mL, and their area under concentration-time curve(AUC)_(0→24h) were 16.272 and 32.981,respectively.There was a 51.88%and 100.46%increase in C_(max) and AUC_(0-t)(P0.05),but there showed a 45.52%and 92.93%reduction in clearance of drug and volum of distribution(P0.05),respectively.Conclusions:Hepatic injury could significantly influence the pharmacokinetics of 6,7-dimethoxycoumarin after oral administration of YCHD,the absorption and distribution process was accelerated in liver injured rats,but the metabolism and elimination process was slowed.And this may lead to a significant accumulation of 6,7-dimethoxycoumarin in the body.     

Clinical Efficacy and Safety of Bathing with Chinese Medicine Taohong Siwu Decoction (桃红四物汤) for Treatment of Diffuse Cutaneous Systemic Sclerosis: A Randomized Placebo-Controlled Trial

Objective:To examine the efficacy and safety of bathing therapy with Taohong Siwu Decoction(桃红四物汤,TSD) in the treatment of early-stage,mild-moderate diffuse cutaneous systemic sclerosis(dc SSc).Methods:This randomized,placebo-controlled trial enrolled 148 men and women(18–60 years) with dc SSc(disease duration 12 months) and baseline modified Rodnan skin score(MRSS) 10.Patients were randomized into a TSD group(71 cases bathing with TSD plus oral prednisone) or control group(71 cases bathing with placebo plus oral prednisone).Bathing(40 ℃,30 min) of the upper and lower limbs was carried out once daily for 12 consecutive weeks.The primary outcome measure was MRSS;secondary outcomes were Raynaud's phenomenon(RP) score,quality of life(QOL),physician visual analogue scale(VAS),patient VAS,percent predicted diffusing capacity for carbon monoxide(DLCO),percent predicted forced vital capacity(FVC),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP) level and overall treatment effect.Results:The final analysis included 135 patients(control group,68 cases;TSD group,67 cases).Primary and secondary outcome measures after 2 weeks of treatment showed no improvement(versus baseline) in both groups,with no differences between groups.At 12 weeks,QOL,physician VAS,patient VAS,ESR and CRP were improved in both groups,but MRSS and RP score were improved only in the TSD group(all P0.05).MRSS,RP score,QOL,physician VAS,patient VAS,ESR and CRP differed significantly between groups(all P0.05).Meanwhile,the overall treatment effect was significantly higher in the TSD group than in the control group(P0.05).Adverse events in the two groups were similar(P0.05).Conclusions:Bathing with TSD plus oral prednisone achieves better outcomes than oral prednisone alone in patients with dcS Sc and is not associated with serious adverse events.     

Dalitong Granule(达立通颗粒)Combined with Electroacupuncture in the Treatment of Functional Dyspepsia:A Randomized Controlled Trial

Objective:To explore clinical short and long-term effect of combining Dalitong Granule(达立通颗料,DG) and electroacupuncture group(EA) in the treatment of functional dyspepsia.Methods:Totally 640 patients with confirmed functional dyspepsia were randomly divided into 4 groups using a randomized digital table:the DG group,the EA group,the combined group and the control group,160 cases in each group.The DG group was treated with 6 g DG 3 times daily;the EA group was treated with puncture of points Zusanli(ST36),Zhongwan(CV12),Neiguan(PC6),Taichong(LR3) and Gongsun(SP4) twice daily;the combined group with above-mentioned DG and EA;and the control group with 5 mg mosapride 3 times,20 mg pantoprazole and25 mg amitriptylines twice daily.The treatment course was 4 weeks for all groups.The symptom score,quality of life score by Short Form 36 Health Survey Questionnaires(SF-36),plasma motilin by radioimmunoassay,electrogastrographic frequencies by electrogastrogram(EGG) and gastric emptying by B-sonography were examined,and adverse reactions were observed before,at the end of treatment and 60 weeks post-treatment.Results:In the DG group 1 case dropped out for not taking medicine strictly and 1 case was lost to follow-up,while 1 case in the EA group and 2 cases in the combined therapy group were lost to follow-up.Compared with pre-treatment,quality of life score,plasma motilin,electrogastrographic frequencies and gastric emptying were all increased significantly,while symptom score was decreased significantly at the end of treatment in each group(P0.01);in the combined group quality of life score,plasma motilin,electrogastrographic frequencies and gastric emptying were all significantly higher than those in the other groups,while symptom score was significantly lower than in the other groups(P0.05).Compared with at the end of treatment,these indices changed insignificantly in the combined group and the EA group 60 weeks post-treatment(P0.05),but the 4increased indices were all decreased significantly,and symptom score was increased significantly in the DG and the control groups(P0.05).The short and long-term total effective rates in the combined group were all significantly higher than those in the other treatment groups(P0.05 or P0.01).No serious adverse reaction occurred in the four groups.Conclusion:Combined treatment of DG and EA could increase both plasma motilin and electrogastrographic frequencies,promote gastric emptying,alleviate the symptom of dyspepsia so as to increase quality of life,with better safety and long-term effect.     

Effect of Modified Xijiao Dihuang Decoction(加味犀角地黄汤)on Intestinal Flora and Th17/Treg in Rats with Radiation Enteritis

Objective: To observe the effect of Modified Xijiao Dihuang Decoction(加味犀角地黄汤,MXDD)on rats with radiation enteritis,and explore its action mechanism.Methods: Th...     

Efficacy of Ursodeoxycholic Acid Combined with Tongdan Decoction(通胆汤) on Immunological Indices and Histopathological Changes in Primary Biliary Cirrhosis Patients

<正>Objective:To observe the efficacy of ursodeoxycholic acid(UDCA) combined with Tongdan Decoction(通胆汤) on immunological indices and histopathological changes in patients with primary biliary cirrhosis(PBC) ofⅡorⅢhistological stage.Methods:Sixty PBC patients were assigned randomly and equally to the control group treated with UDCA alone and the treatment group treated with UDCA combined with Tongdan Decoction.The immunological indices and histopathological changes were detected before and after 24-week treatment,and the follow-up lasted for 1-3 years.Results:After 24-week treatment,CD4~+CD28~- in the peripheral blood was lowered and CD4~+CD25~+ was increased in both groups,and better effect was shown in the treatment group(P0.01).The levels of IgM,IgG,and IgA decreased markedly after 96-week treatment in the treatment group(P0.05,P0.01),while in the control group,only the latter two showed significant decrease after 148 week(all P0.05).At the end of the 3-year follow-up,the medians of histopathological inflammation grading and fibrosis staging declined to a lower rank,and the effect on inflammation was superior in the treatment group to the control group shown by non-parameters Wilcoxon paired symbols test(Z = 2.761, P=0.006).Conclusion:Combined therapy of Tongdan Decoction and UDCA showed a better therapeutic effect than UDCA monotherapy on PBC,especially in improving immunological indices and histopathological hepatic changes.     

Effects of Qianlie''''an(前列安)Suppository in Patients with Chronic prostatitis Syndrome:A Randomized Open-Labelled Prospective and Controlled Trial

Objective:To evaluate the clinical efficacy of Qianllie’an(前列安,QLA)suppository via a-nal route administration in treating chronic prostatitis syndrome.Methods:A randomized open-labelledprospective controlled trial was carried out.The total of 120 patients with chronic prostatitis syndromewere randomly divided into 2 groups:60 patients in the treated group who were treated with QLA supposi-tory combined with ofloxacin,and the other 60 patients in the control group who were given ofloxacin a-lone.The efficacy was evaluated by WBC Count in the expressed prostatic secretion(EPS)and the ChronicProstatitis Symptom Index(CPSI)made by the National Institute of Health(NIH).The clinical effectsWere also observed in a 4-week follow-up.Results:All but six cases completed the trial and the follow-up.It showed that in the treated group recovery rate was 17.2％,markedly effective rate 34.5％,effectiverate 32.8％,total markedly effective rate 51.7％,and total effective rate 84.5％,all of which were supe-rior to th