Effect of Wuziyanzong Pill on sperm quality and calcium ion content in oligoasthenospermia rats

OBJECTIVE:To study the effect of Wuziyanzong treatment on the sperm quality and content of calcium ions(Ca 2+) in oligoasthenospermia rats.METHODS:A model of oligoasthenospermia was induced in 50 Sprague Dawley rats by treatment with tripterygium glycosides at 30 mg/kg per day for 8 weeks.They were divided randomly into a model group,a positive group(Huangjingzanyu capsule,3.01 g/kg),and low,medium and high dose Wuziyanzong treatment groups(2.30,4.60,9.20 g/kg crude drug respectively) with 10 in each group.Another 10 rats were used as a control group.The rats in the control and model groups were administered distilled water,while the rats in the remaining groups were administered Wuziyanzong for 30 d.The epididymides were removed,spermatozoa recovered and the sperm density and viability were measured.The spermatozoa were purified and the contents of Ca 2+ in the cytoplasm and mitochondria were detected by flow cytometry and atomic absorption spectrometry,respectively.RESULTS:After 8 weeks of treatment with tripterygium glycosides,the sperm density,sperm activity and the Ca 2 + content of spermatozoa in the model rats were all significantly decreased compared with the control group(all P<0.05).After 30 d treatment,the sperm density and activity improved and the Ca 2 + content of sperm were increased significantly in the medium and high dose Wuziyanzong treatment groups in comparison with the model group(all P<0.05).CONCLUSION:The Wuziyanzong treatment increased sperm density,improved sperm viability and enhanced the content of Ca 2+ in the sperm cytoplasm and mitochondria in this rat model of oligoasthenospermia.     

The Effect of Chinese Tea on Occurrence of Esophageal Tumor Induced by N-Nitrosomethylbenzylamine in Rats

Five groups of rats (40 rats per group) were given five different varieties of Chinese tea (1 g/50 ml) and another two groups of rats (a positive control and a negative control) were given tap water as drinking water. Except for the negative control group, all the animals were intubated with A'-nitrosomethyibenzylamine (NMBzA, 5 mg/kg body wt/week). Half of the animals in each group were sacrificed after 6 weeks and the remaining animals at the end of 12 weeks. The incidences of esophageal mucosa lesions (16-59%) at the end of6 weeks were significantly lower in the tea-treated rats than in the positive control group (100%). The incidences of esophageal tumor at the end of 12 weeks (42-67%) were also significantly lower in the tea-treated groups than in the positive control group (90%). The same phenomenon was found with respect to the size and number of tumors in each tumor-bearing animal. The relative anticarcinogenic effects of the five varieties of Chinese tea were different. The Fujian oolong tea and jasmine tea exhibited the strongest effects. The results suggest that Chinese tea can effectively inhibit the carcinogenesis Caused by an N-nitroso compound. 1990 Academic Press.Inc.     

Clinical observation on treatment of depression by electro-acupuncture combined with Paroxetine

Objective:To observe the clinical efficacy and adverse reactions of Paroxetine combined with electro-acupuncture (EA) in treating depression.Methods:Forty-two patients with depression were randomly assigned to the observation group (22 patients) treated with EA combined with Paroxetine,and the control group (20 patients) treated with Paroxetine alone,and the therapeutic course for both groups was 6 weeks.The therapeutic efficacy and adverse reactions were evaluated with scores by Hamilton depression scale (HAMD) and treatment emergent symptoms scale (TESS), respectively.Results:HAMD scores determined at the end of the 1st,2nd,4th,and 6th week of the treatment course were significantly lower in the observation group than those in the control group (P<0.05).The significant improvement rate evaluated at the end of the 6-week treatment was remarkably higher in the observation group than that in the control group (72.7% vs 40.0%).No significant difference of TESS scores was found between the two groups.Conclusion:EA combined with Paroxetine has better clinical efficacy than that of Paroxetine alone,with milder adverse reaction and quicker initiation of effect.     

Effect of Xiaoaiping injection on advanced hepatocellular carcinoma in patients

OBJECTIVE: To investigate the effect of Xiaoaiping Injection (XAP) on advanced hepatocellular carcinoma (HCC) in patients. METHODS: Sixty-eight patients with advanced HCC were assigned to a control group of 36 and a treatment group of 32.The control group was treated with best supportive treatment (BST) and the treatment group was given XAP plus BST. XAP was administered daily by iv and the treatment course was lasted for 30 days for both groups.The immediate therapeutic efficacy, Karnofsky performance status (KPS) scores, and the changes in immunity indicators (CD3+, CD4+ and CD8+ T cells) were measured and compared before and after treatment. The progression-free survival (PFS) rate and overall survival (OS) rate in the 2 groups were analyzed. RESULTS: The immediate therapeutic efficacy and KPS of the treatment group were better than those in the control group (P<0.05). Patients in the treat-ment group had higher percentages of CD3 and CD4 T-lymphocytes in peripheral blood than those in the control group (P<0.05). The median survival time was 27.0 weeks in the treatment group and 24.5 weeks in the control group. The 6-months cumulative survival rates in the treatment and control groups were 33.3% and 25.0% , respectively, with no significant difference (P>0.05). The PFS was 18 weeks in the treatment group and 15 weeks in control group (P<0.05). CONCLUSION: XAP enhances the quality of life (QOL) of patients with advanced HCC, improves their immunity and extends their PFS.     

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.     

Effectiveness of Bushen Huoxue Granule (补肾活血颗粒) on 5-Serotonin and Norepinephrine in the Brain of Parkinson's Disease Patients with Depressive State

Objective：To observe the clinical curative effect of Chinese medicine Bushen Huoxue Granule（补肾活血颗粒,BHG） on Parkinson＇s disease（PD） patients with depressive state.Methods：Sixty-two PD patients with depressive state were randomly assigned to two groups by using a random number table,31 in each group.Madopar was given to all as the conventional treatment.The fluoxetine hydrochloride dispersible tablet was given to the patients in the control group and BHG was given to those in the treatment group.The therapeutic course for all was 12 weeks.Before and after treatment,Hamilton depression rating scale（HAMD） was applied to judge the curative effect,and the changes of cerebral neurotransmitters levels in the brain of patients were detected by encephalofluctuograph technique.Results：The scores of HAMD in the two groups were decreased markedly after 12-week treatment.It was lower in the treatment group than that in the control group with significant difference（P〈0.01）.The contents of norepinephrine（NE） and 5-serotonin（5-HT） in the PD patients were obviously lower than normal value.There was no significant difference between the two groups before treatment（P〉0.05）.The contents of NE and 5-HT were all increased in the two groups after treatment（P〈0.05）,with significant differences between the two groups（P〈0.01）.Conclusion：BHG could increase the contents of NE and 5-HT in PD patients＇ brain to improve the depressive state of PD patients.     

Effects of simvastatin on early oxidative stress and endothelial function in apolipoprotein E-deficient mice

Objective:To investigate the mechanisms that Simvastatin,a 3-ydroxy-3-methylglutaryl coenzyme A(HMG-CoA)reductase inhibitor,plays an important role in primary prevention of atherosclerosis independently of its lipid-lowering effect in Apolipoprotein E-deficient mice in the early stage of atherosclerosis.Methods:Twenty-four 6-week old male apoE-deficient mice were randomly divided into two groups:control group(normal saline)and treatment group[simvastatin(5 mg/(kg·d))].Simvastatin was administered to treatment group mice by gavage and the same volume of normal saline was administered to control group mice by the same method for 2 or 4 weeks.Total cholesterol(TC),super-oxide dismutase(SOD),malondialdehyde(MDA)and serum nitric oxide(NO)were measured by biochemical analysis.Results:There was no significant difference in serum TC between control and treatment groups.Compared with the control's,the effects of simvastatin were more signiticant in decreasing serum MDA level(P＜0.01 vs control's at 2-week;P＜0.006 vs control's at 4-week),increasing serum SOD level(P＜0.03 vs control's at 2-week;P＜0.003 vs control's at 4-week)and NO level (P＜0.01 control's at 2-week;P＜0.001 vs control's at 4-week)either at 2 or 4 weeks.Conclusion:Simvastatin attenuates oxidative stress and protects endothelial function by the mechanisms of decreasing serum MDA level,increasing serum SOD level and NO level,which were inconsistent with its cholesterol-lowering effect.It may play an important role in primary(if not all)prevention of atherosclerosis and might be independent of lipid-regulation mechanism.     

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).     

Clinical curative effect of electroacupuncture combined with Zhizhukuanzhong Capsules for treating gastroesophageal reflux disease

OBJECTIVE:To study the clinical curative effect,safety and mechanism of action of electroacupuncture combined with Zhizhukuanzhong capsules(ZZKZC) in treating gastroesophageal reflux disease(GERD).METHODS:A total of 480 patients with confirmed GERD were randomly divided into four groups:the electroacupuncture group,the ZZKZC group,the combined therapy group,and the control group,with 120 cases in each group.Each case in the electroacupuncture group was treated with electroacupuncture on Zusanli(ST36),Zhongwan(CV12),Neiguan(PC6),Taichong(LR3)and Gongsun(SP 4)once daily for 6 weeks.Each case in the ZZKZC group was treated with oral administration of 1.29 g ZZKZC three times daily.The combined therapy group had electroacupuncture and ZZKZC.The control group was given oral administration of 5 mg mosapride three times and 20 mg pantoprazole twice daily.The 24-hour intraesophageal total number of reflux episodes with pH <4(or bilirubin absorbance ≥ 0.14),the number of long-term(≥5 min) reflux episodes,the percentage of upright time,the percentage of supine time,the percentage of total time of pH <4(or bilirubin absorbance ≥0.14),endoscopic grading score,symptom score,quality of life score,and adverse reactions were observed before treatment,at the end of treatment and 54 weeks after treatment in the four groups.RESULTS:The 24-hour intraesophageal pH and bile reflux,endoscopic grading score and symptom score were all significantly decreased at the end of treatment in every group,while the scores of 8 dimensions of quality of life were all increased compared with those before treatment(P<0.01).All of these indices were better in the combined therapy group than those in the other groups(P<0.05).These indices did not significantly deteriorate in the combined therapy group and electroacupuncture group 54 weeks after treatment compared with the end of treatment(P>0.05);however,these indices all significantly deteriorated in the ZZKZC and control groups(P>0.05).The short and long-term total efficacy rates in the combined therapy group showed significant superiority to those in the other groups(P<0.05 or P<0.01).No serious adverse reactions were found in the four groups.CONCLUSION:Electroacupuncture and ZZKZC play an important role in inhibiting intraesophageal acid and bile reflux,decreasing the endoscopic grading score,and alleviating the symptoms of gastroesophageal reflux to improve the quality of life.However,the effect of combined treatment is more effective,with better security and long-term efficacy,and therefore,this combination treatment is appropriate for clinicaluse.     

Efficacy of Chinese Medicine Acupoint Application Combined with Montelukast on Children with Perennial Allergic Rhinitis: A Randomized Controlled Trial

Objective: To evaluate the efficacy of Chinese medicine acupoint application(CMAA) combined with Western medicine for perennial allergic rhinitis(PAR) in children. Methods: In this prospective, parallel, randomized, placebo-controlled and single-blind trial from August to September, 2017, 180 children with PAR were randomly assigned to an integrative group(CMAA and Montelukast), CMAA group(CMAA and placebo tablet), or Montelukast group(placebo CMAA and Montelukast). Participants were applied with CMAA for 6 sessions over 2 weeks, and/or Montelukast Chewable Tablet orally once daily for 12 weeks. The changes in severity of symptoms were measured by Visual Analog Scale(VAS) and rhinitis control assessment test(RCAT) at 0, 2, 4 and 12 weeks of treatment. Blood samples were collected for serum interleukin-4, interferon gamma γ and T helper type 1(Th1)/Th2 flow cytometric analysis at the time points of 0, 4 and 12 weeks. Results: Eight cases dropped out from the trial, 3 in the integrative group, 2 in the CMAA group and 3 in the Montelukast group. The VAS scores decreased significantly while the RCAT scores increased significantly in all three groups at 4 and 12 weeks compared with baseline(P0.01 or P0.05). The VAS scores were significantly lower while the RCAT scores were significantly higher in the integrative and CMAA groups than the Montelukast group at 2 and 4 weeks(P0.01 or P0.05). At 2, 4 and 12 weeks, the scores of nasal congestion, sneezing, sleep problem, and rhinitis symptom control in the integrative and CMAA groups increased significantly compared with baseline(P0.01 or P0.05). The least percentages of Th2 and the most alleviated Th2 shift(highest Th1/Th2) were observed in the integrative group at 12 weeks compared with the other two groups(P0.05). Conclusion: The combination of CMAA with Montelukast might be more effective and appropriate than either option alone for children with PAR.(Registered at Chinese Clinical Trial Register, registration No. Chi CTR-IOR-17012434)     

Comparative study on the efficacy of tiotropium bromide inhalation and oral doxofylline treatment of moderate to severe stable chronic obstructive pulmonary disease

This study compared the efficacy and safety of tiotropium bromide inhalation powder (spiriva) and doxofylline oral tablet (doxofylline) in the treatment of chronic obstructive pulmonary disease (COPD). A multi-center, randomized, double-blind, double-dummy, parallel-controlled study involved 127 eligible stable moderate to severe COPD patients treated with inhaled tiotropium dry powder (18 μg/day) or oral doxofylline tablets (0.2 g/time, 2 times a day) for 12 and 24 weeks. Before and after treatment for 12 weeks and 24 weeks, respectively, pulmonary function, 6-min walking distance and dyspnea index were recorded. The results showed that in both tiotropium group and doxofylline groups, after 12-week treatment, FEV1, FEV1/FVC% and 6-min walk distance were sig-nificantly higher than those before the medication, while dyspnea index decreased as compared with that before treatment. After 24-week treatment, a slight improvement in the measures was observed as compared with that of 12-weeks treatment, but the difference was not statistically significant. With both 12-week and 24-week treatment, the effect of tiotropium was slightly better than that of doxofylline tablets, with the difference being statistically insignificant. The major adverse events in the tiotropium group and doxofylline group were observed in 9 cases (9.9%) and 12 cases (12.9%), respectively, and no statistically significant difference was found between them. We are led to conclude that both tiotropium at 18 μg a day and doxofylline tablets at 0.2 g/day (two times a day) are effective and safe for the treatment of COPD.     

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 Xuesaitong Soft Capsule(血塞通软胶囊)on Hemorrheology and in Auxiliarily Treating Patients with Acute Cerebral Infarction

Objective: To observe the therapeutic effect of Xuesaitong soft capsule(血塞通软胶囊,XST)and its effect on platelet counts, coagulation factor 1 (CF1) as well as hemorrheologic indexes in treating patients with acute cerebral infarction (ACI). Methods: Two hundred and four patients with ACI were assigned into two groups, the control group ( n = 96) and the treated group ( n = 108). They were all treated with conventional Western medicines, including mannitol, troxerutin, citicoline, piracetam and aspirin, while to the treated group, XST was given additionally through oral intake, twice a day, 2 capsules each time for 8successive weeks. The clinical efficacy was evaluated according to the nerve function deficits scoring and the changes of platelet count. CF1 and hemorrhe.ological indexes were measured before and after treatment. Results: The total effective rate was 87.0% in the treated group, and 87.5% in the control group, respectively, showing insignificant difference between them. But the markedly effective rate in the treated group (66.7%) was significantly higher than that in the control group (27.1%, P＜0.01). The count of platelet was not changed significantly in both groups after treatment, while CF1 inthem evidently lowered at the end of the 4th and 8th weeks of treatment, but showed insignificant difference between the two groups. The hematocrit, whole blood viscosity and plasma viscosity in both groups were all improved significantly after treatment, but also showed insignificant difference in comparison of the two groups. Conclusion: XST has good efficacy in auxiliary treatment of patients with ACI, though its mechanism remains to be further explored.     

Clinical Observation on the Treatment of Atrial Fibrillation with Amiodarone Combined with Shenmai Injection (参麦注射液)

Objective: To observe the therapeutic efficacy and safety of amiodarone combined with Shenmai Injection (参麦注射液) on atrial fibrillation. Methods: A total of 351 patients with atrial fibrillation caused by cardiovascular diseases and idiopathic atrial fibrillation were assigned to amiodarone group (control group, 128 cases) and amiodarone combined with Shenmai Injection group (treatment group, 223 cases). The patients in the control group received intravenous injection of 150 mg amiodarone in 10 min, followed by intravenous drip infusion at 1 mg /min and 6 h later at 0.5 mg /min until 48 h or cardioversion. The patients in the treatment group received the same treatment of amiodarone, while in addition, they received an injection of Shenmai Injection of 100 mL simultaneously. Blood pressure, ventricular rate, and cardioversion were observed. Results: The total efficiency rate was 98% (control group) and 99% (treatment group) (P0.05). The mean ventricular rate decreased 23% and 31% in the control group and the treatment group, respectively (P0.05). The mean cardioversion time of the two groups was 570±211 min and 351±123 min, respectively (P0.05). Only mild side effects were observed in both groups. Conclusion: Compared with amiodarone, amiodarone combined with Shenmai Injection takes effect more quickly with low side effects on the treatment of atrial fibrillation.     

通络方对糖尿病大鼠C型钠尿肽及钠尿肽B型受体表达的调节作用

Objective: To investigate the expression of C-type natriuretic peptides (CNP) and natriuretic peptide receptor-B (NPR-B) receptor in diabetic rats renal cortex, and the regulation by Tongluo Recipe (通络方, TLR). Methods: Sixty male SD rats were divided into 3 groups: the normal control group, diabetic model group and diabetic TLR group. Each group was further divided into two subgroups of ten in each, according to 4-week or 12-week observation period. Streptozotocin (STZ)-induced diabetic rats were treated with TLR (110 g?kg-1?d-1) for 4 and 12 weeks, respectively. (1) The essential information was collected for comparing renal mass, serum creatinine and 24 h urine albumen on each group was calculated. (2) CNP mRNA and NPR-B mRNA were detected by realtime-polymerase chain reaction (PCR) on rats renal cortex. (3) Concentration of CNP on renal cortex or serum were analyzed by enzyme-linked immunosorbent assay (ELISA). (4) Pathological evaluation and NPR-B immunostaining for renal tissue were also performed. Results: (1) CNP and NPR-B mRNA levels were detected in each treated or untreated group, with slight elevated in untreated diabetes rats administrated with STZ after 4-week and CNP mRNA level remarkable elevated at 39.21 times higher than normal control group after 12 weeks, but NPR-B mRNA level showed a remarkably down-regulation at 98.07% after 12 weeks. CNP mRNA of TLR-treated group was also elevated after 12-week treatment, but less than untreated group. (2) Concentrations of CNP in renal cortex were obviously increased in treated or untreated diabetes rats, within these groups the treatment of TLR was found more significantly on prompting CNP concentration. Comparing to normal group, serum concentrations of CNP were also increased in treated or untreated diabetic groups, but there was no difference between these diabetic groups. (3) Renal lesions like glomerular volume increased are observed mostly in the relative early stage after 4 weeks. Although TLR treated group had no significant difference in their glomerular volume, the degrees of injury of glomerulus were ameliorated, as well as the NPR-B immunostaining enhanced in glomerulus. Weakly positive immunostaining of NPR-B are observed in glomerulus of normal control, and negative in glomerulus of untreated diabetes rats administrated with STZ after 12 weeks, whereas TLR-treatment groups showed a little enhancement. Conclusion: CNP and NPR-B showed different characteristic on renal cortex at different pathological period in diabetes rats, and TLR regulated their expression.     

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)     

Short and long-term efficacy of combining Fuzhengliqi mixture with acupuncture in treatment of functional constipation

OBJECTIVE: To explore the short and long-term efficacy of combining Fuzhengliqi mixture (FLM) with acupuncture in treating functional constipation (FC). METHODS: The 560 patients with confirmed diagnosis of FC were randomly assigned to four groups: FLM group, acupuncture group, combined therapy group, and control group. There were 140 cases in each group. The FLM group was administered FLM 60 mL twice a day, while the acupuncture group was treated with acupuncture at acupoints Tianshu (ST 25), Shangjuxu (ST 37), Zusanli (ST 36), Dachangshu (BL 25), and Zhigou (TE 6) twice a day, the combined therapy group with FLM and acupuncture, and the control group was administered mosapride (5 mg thrice a day) and Macrogol 4000 (10 g twice a day). The treatment lasted 6 weeks. The defecation interval, stool property, constipation symptoms, and accompanying symptomswere recorded, graded, and scored.The gastrointestinal transit time (GITT) and motilin (MTL) level in serum and life quality score were detected at three time points (pre-treatment, at the end of treatment, and 60 weeks post-treatment). Moreover, the adverse reactions were also observed. RESULTS: In the FLM group 2 cases were eliminated for not taking medication strictly according to the research plan and 1 case was lost to follow-up, while 2 cases in the acupuncture group and 2 cases in the combined therapy group were lost to follow-up. Compared with those detected pre-treat- ment, the defecation interval, stool property, consti- pation symptom grade, accompanying symptom grade, and GITT were all decreased markedly at the end of treatment in every group, while the MTL levels in serum and life quality score were increased markedly (P<0.01), the above-mentioned detecting indices were better in the combined therapy group than those in other groups (P<0.05). Compared with the end of treatment, above-mentioned detecting indices all recurred significantly in the FLM group and control group 60 weeks post-treatment (P>0.05), but these indices recurred insignificantly in the acupuncture and combined therapy groups (P>0.05). The short and long-term total effective rates in the combined therapy group were significantly different from those in other groups (P<0.05 or P<0.01). No serious adverse reactions were found in four groups. CONCLUSION: Both FLM and acupuncture can significantly shorten the defecation interval and GITT, increase MTL levels in serum, decrease the scores of stool property, constipation symptoms, and accompanying symptoms in patients with FC to increase their life quality. The combined therapy is much better in long-term efficacy and the safety is also good, worth spreading in clinical practice.     

Effect of Formaldehyde on Spermatogenesis and Testicular Morphology in Adult Rats

Objective To study the effects of formaldehyde （FA） on spermatogenesis and testicular morphology in adult rats. Methods The rats were divided at random into two experimental groups and one control group, each comprising 10 individuals. Rats in two experimental groups were respectively exposed to FA at concentrations of 0.5mg.m^-3 and 10mg.m^-3 （12h per day） for 2 weeks. After the treatment, the testicular weight and morphology, as well as the quantity and quality of sperm were evaluated. Results compared with the control, the testicular weight, sperm count, the percentage of motile sperm significantly decreased （p〈0.05）, while the percent of abnormal sperm significantly increased （p〈0.05） in rats of 10mg.m^-3 FA exposure group. Microscopy with HE staining showed that seminiferous tubules atrophy, spermatogenic cells decreased, seminiferous epithelial cells disintegrated and shed in rats of 10mg.m^-3 FA exposure group. Conclusion FA has a harmful effect on the spermatogenesis; it induces tubular atrophy and sperm abnormality at a dose-dependent manner.     

Role of Removing Stasis and Reducing Heat Formula in Clearance of Proximal Ureteral Calculi after Ureteroscopic Ho:YAG Laser Lithotripsy: A Prospective Randomized Study

Objective To prospectively evaluate the efficacy of Removing Stasis and Reducing Heat Formula in accelerating calculus clearance and improving lower urinary tract symptoms of patients with proximal ureteral calculi after ureteroscopic Ho:YAG laser lithotripsy. Methods A total of 138 patients with proximal ureteral calculi underwent ureteroscopic Ho:YAG laser lithotripsy by a single endocrinologist. Stone size varied from 10 to 15 mm. After operation, the patients were randomly divided into three groups: the control group(group A), tamsulosin group(group B), and Removing Stasis and Reducing Heat Formula group(group C). The treatment lasted for 4 weeks or until stone clearance. The primary and secondary outcomes of the three groups at follow-up were assessed. Results Of the 131 patients available for follow-up, 44 cases were in the group A, 45 in the group B, and 42 in the group C, respectively. The stone free rate at 2 weeks in the groups B and C were significantly higher than that in the group A(95.56%, 97.62% vs. 79.55%; all P<0.05). The ureteral colic rate and mean time of fragment expulsion were significantly reduced in the groups B(4.44% and 7.86±4.99 days) and C(2.43% and 6.76±4.37 days) compared with the group A(22.73% and 11.54±9.89 days, all P<0.05). On the day of double-J ureteric stent removal, the group C differed significantly from the group A in the total International Prostate Symptom Score, irritative subscore, obstructive subscore, and quality of life score(all P<0.05). Conclusion Removing Stasis and Reducing Heat Formula in the medical expulsive therapy might be an effective modality for patients with calculus in the proximal uretera after ureteroscopic Ho:YAG laser lithotripsy.     

Expression of Peptidylarginine Deiminase 4 and Protein Tyrosine Phosphatase Nonreceptor Type 22 in the Synovium of Collagen-Induced Arthritis Rats

Objective To study the expression level of peptidylarginine deiminase 4（PADI4） and protein tyrosine phosphatase nonreceptor type 22（PTPN22） in the synovium of rat model of collagen-induced arthritis, and to explore their possible therapeutic role in rheumatoid arthritis. Methods Thirty-two female Wistar rats weighing 100±20 g were randomly assigned into 3-week collagen-induced arthritis（CIA） model group（n=8）, 4-week CIA model group（n=8）, 6-week CIA model group（n=8）, and the control group（n=8）. The body weight changes of each group were recorded. The expression levels of PADI4 and PTPN22 were detected and compared by the methods of immunohistochemical staining and Western blot. Results Arthritis of rat began to form 14 days after sensitization and the joint swelling reached peak at 28 days. The weights of the rats slowly grew both in CIA model groups and the control group. Immunohistochemical staining results showed that the positive expression of PADI4 and PTPN22 was mainly located in cartilage peripheral mononuclear cells, the cytoplasm of infiltrated cells, and bone marrow cavity. There were significant differences in the optical density of PADI4 and PTPN22 among CIA model groups and the control group（PADI4, 0.2898±0.012, 0.2982±0.022, 0.2974±0.031, 0.2530±0.013 in 3-week CIA model, 4-week CIA model, 6-week CIA model and control groups; PTPN22, 0.2723±0.004, 0.2781±0.010, 0.2767±0.008, 0.2422±0.019; all P 〈0.05）. The expression bands of PADI4 were observed in Western blot 3 weeks after initial immunization, the thickest in the 4th week, and decreased in the 6th week. The expression bands of PTPN2 were observed at all the time points, with no obvious time-dependent trend. Conclusions PADI4 and PTPN22 are obviously correlated with CIA in rat model. PADI4 is expressed at early stage of the disease, while the expression of PTPN22 sustains throughout the course.