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.     

Study on Tongkuaixiao Babu Plaster(痛块消巴布剂)in Treating Cancer Pain

Objective: To explore the efficacy of Tongkuaixiao Babu plaster (痛块消巴剂, TKXBBP)in treating cancer pain. Methods: In the clinical observation, sixty-five patients with moderate or severe cancer pain were randomly divided into two groups: 32 in the treated group (TKXBBP group) and 33 in the control group (Bucinnazine group). The therapeutic effects in relieving pain, improving quality of life (QOL),and the rate of satisfaction the patients felt of the two groups were compared respectively. Results: TKXBBP was effective in treating cancer pain. There wasn't any statistically significant difference in total effective rate (P＞0.05), but the statistical difference was significant in obvious remission rate (P＜0.05) between the treated and control group, and the effect on serious pain shown in the treated group was better than that of the control group (P＜0.05). The difference in the initiation time of relieving cancer pain was insignificant (P＞0.05), while in the remission period, the treated group showed its treatment was obviously superior to that of the control group (P＜0.05). TKXBBP showed better effect in the improvement of QOL (P＜0.05)and satisfaction rate, with significant difference between the treated and the control groups (P＜0.01). Conclusion: TKXBBP's effect in treating cancer pain was obvious, its application was safe and convenient. It was shown that the external treatment with this kind of Chinese medicine had great advantage in treating cancer pain.     

Clinical study on effect of Astragalus Injection (黄芪注射液) and its immuno-regulation action in treating chronic aplastic anemia

Objective:To observe the clinical effect of Astragalus Injection(黄芪注射液,AI) and its immuno-regulatory action in treating chronic aplastic anemia(CAA).Methods:Sixty patients with CAA were randomly assigned to two groups equally,both were treated with Stanozolol three times a day,2 mg each time through oral intake,but AI was given additionally to the patients in the treated group once a day via intravenous dripping.All were treated for 15 days as one therapeutic course and the whole medication lasted for more than 4 months totally,with follow-up adopted.The clinical effi cacy was estimated and the changes of T-lymphocyte subsets in peripheral blood as well as the serum levels of tumor necrosis factor-α(TNF-α) and interleukin-2(IL-2) were observed.Results:The total effective rate in the treated group was 83.3%(25/30),which was higher than that in the control group 66.7%(20/30),showing significant difference between them(P<0.05).Levels of hemoglobin,WBC,reticular cell and platelet were elevated in both groups after treatment,but the improvement was signif icantly better in the treated group than that in the control group with respect to the former three indexes(P<0.05).The level of CD4 increased and that of CD8 decreased signifi cantly after treatment in the treated group(P<0.05),which showed significant difference as compared with those in the control group(P<0.05).Levels of serum TNF-α and IL-2 lowered after treatment in both groups,but signifi cance only showed in the treated group(P<0.05).The degree of proliferation in bone marrow got raised signifi cantly and the percentage of non-hemopoietic cells reduced signifi cantly in the treated group after treatment,also showing significant difference to those in the control group(P<0.05).Conclusion:AI could promote the recovery of hemopoietic function,which might be through improving T-lymphocyte subsets and reducing the release of negative regulatory factors such as TNF-α and IL-2 to alleviate the inhibition on hemopoietic function.     

Evaluation of the Clinical Efficacy of Qingqiao Capsule (清窍胶囊) in Treating Patients with Secretory Otitis Media

Objective: To ooserve the clinical efficacy of Qingqiao Capsule (清窍胶囊, QQC) in treating patients with secretory otitis media (SOM). Methods: A total of 90 patients were randomly assigned into the treated group (n=45 ) and the control group (n =45). Patients in the treated group were administrated with QQC, 5 capsules each time, 3 times a day for totally 10-14 days, and those in the control group were given per os cefaclor capsules 0.5g each time for adult, 3 times a day, or 20mg/(kg· d) for children, for 10-14 days. The therapeutic efficacy of treatment on the patients was observed and compared after treatment and followed up for 3-6 months. Results: (1) The clinical efficacy in the treated group was superior to that in the control group with significant statistical difference ( P＜0.01 ); (2) Comparison of the efficacies in patients of three different TCM syndrome types (the external pathogenic wind invasion caused auditory orifice stuffiness type, the Gan-Dan damp-heat steaming up auditory orifice type and the Pi-deficiency dysfunction induced dirty dampness blocking ear type) showed no statistically significant difference(P＞0.05); (3) The vanishing rate and time needed of the main symptoms and signs in the treated group were superior to those in the control group on ear muffle, tinnitus, hearing impairment, hydrotypanum, pure tone threshold and abnormal tongue figure, and the difference was statistically significant ( P＜0.05 or P＜0.01), only those of earache,otopiesis and abnornal pulse figure were insignificantly different between the two groups ( P＞0.05). Conclusion: QQC is an effective Chinese composite medicine on patients with SOM, and shows no obvious adverse reaction.     

Clinical observation on the treatment of childhood refractory idiopathic thrombocytopenic purpura with Dihuang Zhixue Capsule (地黄止血胶囊)

Objective： To observe the clinical effect of Dihuang Zhixue Capsule （地黄止血胶囊, DZC, a Chinese preparation for cooling blood and dispelling toxic substances） in the treatment of childhood refractory idiopathic thrombocytopenic purpura （RITP）, with cyclosporin A （CsA） used as the control. Methods： Forty-one children of RITP were randomized into the treated group and the control group. The 21 patients in the treated group were orally given 2 to 3 DZC capsules each time, thrice a day and the 20 in the control group were given 3 mg/kg CsA per day, with 3 months as one therapeutic course. The therapeutic efficacy, platelet count and adverse reaction in the two groups were compared at the end of the course. Results： （1） In the treated group, 1 （4.8%） patient was evaluated as cured, 3 （14.3%） as markedly effective, 5 （23.8%） as effective, 5 （23.8%） as improved, 7 （33.3%） as ineffective, with the total effective rate being 66.7%; while in the control group, the corresponding numbers were 0. 2 （10.0%）, 2 （10.0%）, 3 （15.0%）, 13 （65.0%） and 35.0%, respectively, showing statistical significance in difference between the total effective rates of the two groups （ Х^2=4.11, P=0.0426）. （2） As compared with the baseline, the platelet count increased in both groups after 2 months＇ treatment （P〈0.05）. After 3 months＇ treatment, the platelet count was higher in the treated group than in the control group （P〈0.05）. （3） The improvement of hemorrhage in the treated group after 8 weeks＇ treatment was better than that in the control group （P〈0.05）. （4） No apparent adverse reaction was observed in the treated group, while in the control group, hirsutism was shown in 15 cases; gingival hyperplasia in 10; digestive reaction in 5, liver function impairment in 5, hypertension in 2 and renal impairment in 2. Conclusion： The therapeutic efficacy of DZC is better than that of CsA, and DZC shows good compliance but brings no obvious adver     

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.     

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

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

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

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

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 on Treatment of Senile Rheumatoid Arthritis by Tripterygium Polyglycosides Combined with Small Dose of Methotrexate

Objective: To observe the effect and adverse reaction of tripterygium polyglycosides (TP) combined with small dose of methotrexate (MTX) in treating senile rheumatoid arthritis (RA). Methods: Sixty old patients with RA were equally divided into two groups, the treated group was treated with oral intake of TP (10 mg three times per day) plus MTX (7.5 mg, once per week), and the control group was treated with MTX (15 mg per week) respectively for 3 months. The changes from before to after treatment in resting pain, morning rigidity, bilateral grip strength, local tenderness index, arthroncus index, patient's evaluation, doctor's evaluation, erythrocyte sedimentation rate (ESR), C-reaction protein (CRP) and rheumatoid factor(RF) titre were observed and the clinical therapeutic effect assessed. Results: The total effective rate in the treated group was 86.67% and that in the control group 83.33% , showing insignificant difference between them (P>0.05). But the improvement in local tenderness index, arthroncu     

CLINICAL RESEARCH ON ACUTE HEMOPTYSIS TREATED WITH KEXUE NING

The efficacy of Kexue Ning (stopping hemoptysis) in the treatment of acute hemoptysis, and its comparicon with that of the control group (treated with western medicine) are reported in this pap . The results showed that both the time for cessation of hemoptysis and the cure rate -re better in the therapeutic group than in the control group. In addition, marked improvement in blood rheology after treatment was also found in the therapeutic group, but not in the control group.     

Clinical efficacy and safety of Gubitong Recipe (骨痹通方) in treating osteoarthritis of knee joint

Objective:To observe the therapeutic efficacy and safety of Gubitong Recipe(骨痹通方,GBT) in treating osteoarthritis(OA) of knee joint.Methods:Ninety patients with knee osteoarthritis were equally assigned, according to a randomizing digital table,to the treatment group and the control group.The treatment group was treated with GBT Decoction one dose every day and the control group with glucosamine sulfate 500 mg thrice a day,respectively,for eight successive weeks.Besides,diclofenac sodium could be given as...     

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

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

Multi-centered clinical study on effects of nano-Amomi Paste in treating children’s anorexia

Objective： To assess the effect and safety of nano-Amoni Paste （nmAP） in the treatment of children＇s anorexia （AR）. Methods： One hundred and eighty patients of AR were assigned according to the randomized, double-blinded, double-simulated and parallel controlled principle to three groups, the treated group （TG）, the positive control group （PCG） and the negative control group （NCG）, 60 in each group. The patients in TG were treated by sticking 1.5 ml of nmAP on the acupoint of Shenque （Ren 8） once a day and orally taking placebo liquid 10 ml twice a day; those in PCG and NCG treated with sticking paste of placebo on Ren 8, and oral taking of Shanmai Jianpi Oral Liquid （山麦健脾口服液） and placebo liquid respectively, 10 ml each time twice per day. The course of treatment for all was 10 days, all patients were treated for 2 courses. Results： The total effective rate and the effective rate on cardinal symptom in TG was 85.0% and 95.0% respectively, that in PCG 86.2% and 96.55% and in NCG 45.5% and 65.45%, respectively, showing significant difference between groups （P〈0.05）. Comparison of the clinical manifestation before and after treatment showed significant improvement in volume of food intake, appetite, complexion and reduction of restlessness symptom （P〈0.05） in all three groups, and there was no adverse reaction found in them. Conclusion： nmAP is an effective and safe remedy for treatment of Children＇s anorexia.     

Clinical Study on Treatment of Primary Hepatocellular Carcinoma by Shenqi Mixture(参芪合剂)Combined with Microwave Coagulation

Objective: To observe the short-term efficacy and safety of Shenqi mixture (参芪合剂,SQM) combined with microwave coagulation in treating primary hepatocellular carcinoma (HCC). Methods:Seventy-two patients with primary HCC of stage Ⅱ - Ⅲ, Karnofsky scoring ≥50 scores and predicted survival period ≥3 months were selected and randomly assigned into two groups, the treated group and the control group, 36 in each. Microwave therapy was applied to both groups by double leads, 60 W, 800 sec once a week for two weeks. To the treated group, SQM was given additionally through oral intake of 20 ml, three times a day for 1 month. The changes in tumor size, main symptoms, serum level of alpha-fetoprotein (AFP), immune function and adverse reaction were observed after treatment and the immune parameters of the patients were compared with 30 healthy persons in the normal control group. Results: (1) In the SQM treated group, after treatment 3 patients got completely remitted (CR), 24 partial remitted (PR), 4 unchanged (NC) and 5 progressively deteriorated (PD), the effective rate being 75.00%; while in the control group, 1 got CR, 19 PR, 9 NC and 7 PD, the effective rate being 55.56%. Comparison of the effective rate between the two groups showed significant difference ( P＜0.05). (2) AFP level decreased after treatment in both groups, but the decrement in the treated group was significantly higher than that in the control group (P＜0.01). (3) After treatment, in the treated group, CD3 , CD4 , CD4 /CD8 and NK activity were improved, Karnofsky scores increased and liver function bettered, with these improvements significantly superior to those in the control group (P＜0.01). (4) The improvement in symptoms such as hepatic region pain, fever, weakness, poor appetite and jaundice in the treated group after treatment was also superior to that in the control group ( P＜0.01). (5) The 12-month, 18-month and 24-month survival rates were higher and the recurrence rate was lower in the treated group than those in the control group, showing significant difference (P＜0.05). Conclusion: Combined therapy with SQM and microwave coagulation could not only kill the tumor and residue tumor cells to prevent recurrence, but also enhance the cellular immunity of organism. It is one of the effective therapies for patients with middle-advanced hepatocarcinoma, who have lost the chance of surgical operation. it could improve clinical symptoms, elevate the quality of life, prolong the survival period of patients, but shows no evident adverse reaction.     

Effect of volatile oil of amomum on expressions of platelet activating factor and mastocarcinoma-related peptide in the gastric membrane of chronic gastritis patients with helicobacter-pylori infection

Objective： To observe the effect of volatile oil of amomum （VOA） on the expressions of mastocarcinoma-related peptide （PS2） and platelet activating factor （PAF） in helicobacter pylori- associated gastritis （HPG） and to analyze its potential mechanism. Methods： Eighty patients with HPG were randomly assigned to two groups, 42 patients in the treated group treated with 0.5 mL VOA, thrice per day; and the 38 patients in the control group receiving Western tertiary medicinal treatment. Gastroscopic picture and helicobacter pylori （HP） infection （by quick urease and Warthin- Starry stain） of the gastro-membrane, expressions of PS2 and PAF （by immunohistochemical assay and Western blotting） as well as the contents of aminohexose and phospholipid （by Neuhaus method） in the gastric membrane of all patients were detected before treatment and 4 weeks after treatment. The clinical efficacy in the two groups was compared. Results： The total effective rate in the treated group was 88.1%, which was significantly higher than that in the control group （78.9%, P〈0.05）. After treatment, in the treated group, gastric membranous contents of aminohexose and phospholipid was increased, expression of PS2 elevated but that of PAF lowered, all showing significant difference as compared with those in the control group （P〈0.01）. In the control group, the expressions of PS2 and PAF changed insignificantly. The radical eliminating rate of HP in the treated group and the control group was insignificantly different between them （76.1% vs. 65.8%, P 〉 0.05）. Conclusion： The mechanism of VOA for anti-gastritis might be related with its action in increasing the expression of PS2 and decreasing the expression of PAF, and thus regulating the hydrophobicity of the gastric membrane.     

Effect of Composite Xinyi Aerosol(复方辛夷雾化剂)on Asthma Related Cytokines in Serum and Sputum of Patients with Bronchial Asthma

Objective:To observe the therapeutic effect of composite Xinyi aerosol (复方辛夷雾化剂,XYA) in treating asthma and its influence on asthma related cytokines in serum and sputum of patientswith mild or moderate bronchial asthma. Methods: Sixty patients were divided randomly into the treatedgroup and the control group, 30 in each group. They were treated with XYA and Salbutamol aerosol (SA)respectively by spray inhalation once a day for seven days as one therapeutic course to observe the antiasth-matic effect of the treatment. Changes of lung function and the levels of tumor necrosis factor α (TNF-α),interleukine-2 receptor (IL-2R) and interleukine-8 (IL-8) in serum and sputum were observed before andafter treatment using enzyme linked immunosorbent assay (ELISA). Levels of TNF-α, IL-2R andIL-8 inthe sputum of part of the patients in the treatment group were also observed. Results: In the treated group,6 patients had the asthma clinically controlled after treatment, 12 were markedly alleviated, 9 alleviatedand 3 remained unchanged, while in the control group, the respective numbers were 4, 6, 15 and 5. Thecontrolled-markedly effective rate of XYA was 60.0%, which was significantly better than that of SA (33.3 %, P＜0.05). The one second forced expiratory volume percent (FEV1 %) and peek expiratory flow rate(PEFR) improved significantly and the levels of TNF-α, IL-2R and IL-8 in serum decreased noticeably inboth groups after treatment (P＜0.05 or P＜0.01), but the improvement in the treated group was moresignificant as compared with those in the control group (P＜0.05). The levels of TNF-α, IL-2R and IL-8in sputum considerably lowered also after XYA treatment (P＜0.01). Conclusion: XYA could regulate therelated cytokines in patients with mild or moderate bronchial asthma, and reduce the releasing of inflam-matory factors, which is consistent with the improvement of lung functions, so as to ease the airway in-flammation chiefly exhibited as cell infiltration in bronchi.     

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

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

Study on effect of Yishen Capsule (益肾胶囊) in preventing recurrence of chronic glomerulonephritis

Objective:To observe the effect of Yishen Capsule (益肾胶囊,YSC) on preventing the recurrence of chronic glomerulonephritis (CGN) and to explore its mechanism preliminarily.Methods: CGN patients were assigned to the treated group (61 cases) and the control group (48 cases) and all of them were orally administered with 4 mg of Perindopril twice a day,but 3 capsules of YSC,thrice a day, were given additionally to patients in the treated group.The therapeutic course for both groups was 18 months.The recurrence rate of CGN at the 6th,12th,and 18th month in the two groups was observed and compared,and the changes of 24-h urinary protein quantity and T-lymphocyte subsets before and after treatment were observed as well.Results:(1) Comparison of recurrence rate between the two groups showed insignificant difference at the 6th month,but it did show significant difference at the 12th and the 18th month,which was significantly decreased in the treated group than in the control group (P<0.05,P<0.01);(2) The 24-h urinary protein quantity at the 18th month decreased significantly in both groups (P<0.05,P<0.01),but in the treated group was more significant (P<0.01);(3) T-lymphocyte subsets showed no obvious change in the control group after treatment (P>0.05),while in the treated group,it showed significant increase in CD3,CD4 and CD4/CD8 (P<0.05 or P<0.01) and significant decrease in CD8 (P<0.05),and also the difference after treatment in T-lymphocyte subsets between the two groups was significant (P<0.05 or P<0.01).Conclusion:YSC has marked effects in reducing the recurrence of CGN and in decreasing urinary protein,and its mechanism might be related with its function in regulating the ratio of T-lymphocyte subsets to enhance the immunity of patients.     

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)