Treatment of Uncomplicated Recurrent Urinary Tract Infection with Chinese Medicine Formula: A Randomized Controlled Trial

Objective: To evaluate Chinese medicine(CM) formula Bazheng Powder(八正散) as an alternative therapeutic option for female patients with recurrent urinary tract infection(RUTI). Methods: A randomized double-blinded trial was performed. Eligible female patients with RUTI were recruited from one hospital and two community health centers. By using a blocked randomization scheme, participants were randomized to receive a CM formula(10 herbs) and antibiotics placebo for 4 weeks, or antibiotics for 1 week followed by 3 weeks of placebo and CM formula placebo. Clinical cure rate and microbiological cure and recurrence after treatment were evaluated. Results: A total 122 eligible patients were enrolled, with 61 cases in each group. The clinical cure rate by the intent-to-treatment approach was 90.2% for the CM group and 82.0% for the antibiotics group(P0.05). Bacteria were cleared from 88.5%(54/61) of patients in the CM group and 82.0%(50/61) in the antibiotics group. The recurrence rate in recovered patients at the 6-month follow-up was 9.1%(5/61) and 14.0(7/61) in the CM and antibiotics groups, respectively(P0.05). Conclusion: CM formula Bazheng Powder is a good alternative option for RUTI treatment.(Registration No. NCT01745328)     

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

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

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

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

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.     

Efficacy of acupuncture and moxibustion in treating Bell’s palsy: a multicenter randomized controlled trial in China

Background Bell‘s palsy involves acute facial paralysis due to inflammation of the facial nerve. Acupuncture and moxibustion (acu-moxi) is beneficial in treating facial palsy. In order to verify the efficacy of acu-moxi on Bell‘s palsy, a randomized single-blind, multicenter clinical trial was performed.Methods A total of 480 patients from four clinical centers were involved in this trial, of whom 439 completed the trial and 41 did not. All patients were randomly assigned to either the control group or to one of two treatment groups. The control group was treated with prednisone, vitamin B1, vitamin B12,and dibazole; the treatment groups were treated either with acu-moxi alone or in combination with prednisone, Vitamin B1, vitamin B12, and dibazole. Symptoms and signs, the House-Brackmann scale, and facial disability index (FDI) scores were assessed and determined both pre- and post-treatment to evaluate the effectiveness of the treatment methods. Results The characteristics of the control and two treatment groups were comparable without statistically significant differences before treatment. There were significant differences between the control and treatment groups after treatment (X^2=15.265, P=0.018). According to evaluations based on the House-Brackmann scale and FDI scores, the effectiveness of treatment in the two treatment groups was better than in the control group and was most effective in patients receiving acumoxi treatment alone (Z=-2.827, P=0. 005).Conclusion The efficacy of acu-moxi treatment for Bell‘s palsy is verified scientifically.     

Neurotransmitter-precursor-supplement intervention for detoxified heroin addicts

This study examined the effects of combined administration of tyrosine, lecithin, L-glutamine and L-5-hydroxytryptophan (5-HTP) on heroin withdrawal syndromes and mental symptoms in detoxified heroin addicts. In the cluster-randomized placebo-controlled trial, 83 detoxified heroin addicts were recruited from a detoxification treatment center in Wuhan, China. Patients in the intervention group (n=41) were given the combined treatment with tyrosine, lecithin, L-glutamine and 5-HTP and those in the control group (n=42) were administered the placebo. The sleep status and the withdrawal symptoms were observed daily throughout the study, and the mood states were monitored pre- and post-intervention. The results showed that the insomnia and withdrawal scores were significantly improved over time in participants in the intervention group as compared with those in the control group. A greater reduction in tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia and total mood disturbance, and a greater increase in their vigor-activity symptoms were found at day 6 in the intervention group than in the control group (all P<0.05). It was concluded that the neurotransmitter-precursor-supplement intervention is effective in alleviating the withdrawal and mood symptoms and it may become a supplementary method for patients’ recovery from heroin addiction.     

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)     

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.     

Effect of Xuefu Zhuyu Capsule (血府逐瘀胶囊) on the Symptoms and Signs and Health-related Quality of Life in the Unstable Angina Patients with Blood-stasis Syndrome after Percutaneous Coronary Intervention: A Randomized Controlled Trial

Objective: Compared with Shengmai Capsule (生脉胶囊, SM), the study was conducted to evaluate the efficacy and safety of Xuefu Zhuyu Capsule (血府逐瘀胶囊, XFZY) on the symptoms and signs and health-related quality of life (HR-QOL) in the unstable angina (UA) patients with blood-stasis syndrome (BSS) after percutaneous coronary intervention (PCI). Methods: A randomized, double-blinded, doubledummy, and placebo-controlled trial was applied. Ninety patients, diagnosed as UA and BSS after successful PCI, were enrolled and equally randomized into three groups, XFZY group, SM group, and placebo group, and administered with the corresponding medications respectively for four weeks. The clinical symptoms and signs (CSS), electrocardiography (ECG), and BSS scores were recorded and compared among groups during and after the treatment. Short-form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QOL in each group before and after the treatment. Safety indexes (blood routine and liver and kidney function tests) were also examined at the beginning and after the treatment. Results: Eighty-six patients completed the whole study. After the treatment, the total effective rates of the XFZY group in ameliorating CSS and ECG were 76.7% and 60.0%, respectively, which were obviously higher than those in SM (CSS: 53.3%; ECG: 36.7%) and the placebo (CSS: 43.3%; ECG: 30.0%) groups. After one week's treatment, BSS scores slightly decreased in each group, but no significant differences were found among three groups (P0.05). After four weeks' treatment, BSS scores in the XFZY group decreased to a lower level compared with SM (P0.05) and the placebo (P0.01) groups. After the treatment, the efficacy of XFZY group in improving body pain (BP), general health (GH), vitality (VT), society functioning (SF), role emotional (RE), angina stability (AS), angina frequency (AF), and treatment satisfaction (TS) were better than those in the placebo group (P0.05, P0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, and TS were better improved than those in the SM group (P0.05). No obvious adverse reaction was found during and after the treatment except one case in the XFZY group reporting of stomach discomfort. Conclusions: Compared with SM Capsule treatment, a short-term treatment with XFZY Capsule exhibits better efficacy on CSS and BSS scores, and HR-QOL in UA patients with BSS after PCI. However, its long-term efficacy and safety still needs further investigation.     

No Additional Cholesterol-Lowering Effect Observed in the Combined Treatment of Red Yeast Rice and Lactobacillus Casei in Hyperlipidemic Patients:A Double-Blind Randomized Controlled Clinical Trial

Objective:To observe the effect of combining red yeast rice and Lactobacillus casei(L.casei)in lowering cholesterol in patients with primary hyperlipidemia,the later has also been shown to remove cholesterol in in vitro studies.Methods:A double-blind clinical trial was conducted to evaluate the cholesterol-lowering effect of the combination of red yeast rice and L.casei.Sixty patients with primary hyperlipidemia were recruited and randomized equal y to either the treatment group(red yeast rice+L.casei)or the control group(red yeast rice+placebo).One red yeast rice capsule and two L.casei capsules were taken twice a day.The treatment lasted for 8 weeks,with an extended follow-up period of 4 weeks.The primary endpoint was a difference of serum low-density lipoprotein cholesterol(LDL-C)level at week 8.Results:At week 8,the LDL-C serum level in both groups was lower than that at baseline,with a decrease of 33.85±26.66 mg/dL in the treatment group and 38.11±30.90 mg/dL in the control group;however,there was no statistical difference between the two groups(P0.05).The total cholesterol was also lower than the baseline in both groups,yet without a statistical difference between the two groups.The only statistical y significant difference between the two groups was the average diastolic pressure at week 12,which dropped by 2.67 mm Hg in the treatment group and increased by 4.43 mm Hg in the placebo group(P0.05).The antihypertensive activity may be associated with L.casei.Red yeast rice can significantly reduce LDL-C,total cholesterol and triglyceride.Conclusion:The combination of red yeast rice and L.casei did not have an additional effect on lipid profiles.     

Effect and Safety of Huannao Yicong Formula(还脑益聪方) in Patients with Mild-to-Moderate Alzheimer's Disease: A Randomized,Double-Blinded,Donepezil-Controlled Trial

Objective: To assess the effect and safety of Huannao Yicong Formula(还脑益聪方, HYF) in the treatment of patients with mild-to-moderate Alzheimer's disease(AD). Methods: Sixty patients with mild-tomoderate AD were evenly randomized into HYF group and donepezil group with the random number method. Patients in the HYF group took 5 g of HYF granules twice daily and 5 mg placebo of donepezil once daily. Patients in the donepezil group took 5 mg donepezil once daily and 5 g placebo of HYF granules twice daily. The intervention lasted for 6 months. Clinical researchers, participants and statisticians were blinded to the treatment assignment throughout the study. The primary outcomes were scores of Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog) and Chinese Medicine Symptom Scale(CM-SS). The secondary outcomes were scores of Montreal Cognitive Assessment(MoCA) test and Mini-Mental State Exam(MMSE). The serum levels of acetylcholinesterase(AchE) and amyloid-β protein 42(Aβ42) were detected with enzymelinked immunosorbent assay kits. The scale assessments were conducted at baseline, the 3 rd and 6 th months of treatment, respectively. Biochemistry tests were conducted at baseline and the 6 th month of treatment. Results: A total of 52 patients completed the trial, 28 in HYF group and 24 in donepezil group. Compared with the baseline, HYF and donepezil significantly decreased the total scores of ADAS-Cog and CM-SS, and significantly increased the scores of MoCA and MMSE after 6-month treatment(all P0.01). Both treatments remarkably reduced the serum levels of AchE and Aβ42(both P0.05). The CM-SS total effective rate of HYF was significantly higher than donepezil [75.00%(21/28) vs. 54.17%(13/24), P0.05]. No severe adverse events were observed in both groups. Conclusion: HYF is effective and safe for improving the cognitive function in mildto-moderate AD patients. [Trial registration: Chinese Clinical Trial Registry(Reg No. ChiCTR-IOR-17011746)]     

Effect of Yiqi Yangyin Decoction(益气养阴方) on the Quality of Life of Patients with Unstable Angina Pectoris

<正>Objective:To observe the effect of Yiqi Yangyin Decoction(益气养阴方,YQYYD) on the quality of life(QOL) of patients with unstable angina pectoris(UAP).Methods:A total of 108 patients with UAP of qi-yin deficiency syndrome confirmed by coronary angiography were enrolled and assigned to the treated group(treated with YQYYD and conventional therapy of Western medicine) and the control group(treated with conventional therapy of Western medicine),by the use of the PROC PLAN of the SAS 6.12 software,in a prospective, randomized,controlled design.The clinical total effective rate,symptom score,QOL scale[Seattle Angina Questionnaire(SAQ)]and incidence of important clinical events were defined as the observation indices to evaluate the interventional effect of YQYYD on the QOL of patients with UAP of the qi-yin deficiency syndrome. Results:During the study,three cases dropped out in the treated group,one case dropped out in the control group,and 104 cases,including 51 cases in the treatment group and 53 cases in the control group,finished the trial.After four weeks of treatment,the total clinical effective rates in the treated group and the control group were 80.4%and 75.5%respectively,and there was no obvious difference between them(P0.05).However,the symptom score of the treated group(9.31±2.02) was significantly lesser than that of the control group(11.62±3.04,P0.05),and the total score of the QOL scale of the treated group(68.76±5.74) was significantly higher than that of the control group(61.06±3.31,P0.01).Among those in the treated group physical limitation, angina stability,angina frequency,and treatment satisfaction were significantly ameliorated when compared with the control group after treatment(P0.05,P0.01).The incidence of important clinical events in the treated group(3.9%) was lower than that in the control group(5.7%) during the 8-month follow-up period,but the difference was insignificant(P0.05).Conclusion:YQYYD could improve the clinical symptoms of patients with UAP of qi-yin deficiency syndrome and greatly improve their QOL.     

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

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

Short-term Effect of Combined Therapy with Jinlong Capsule(金龙胶囊)and Transcatheter Arterial Chemoembolization on Patients with Primary Hepatic Carcinoma and Its Influence on Serum Osteopontin Expression

<正>Objective:To observe the clinical combination effect of Jinlong Capsule(金龙胶囊,JLC) and transcatheter arterial chemoembolization(TACE) on the patients with primary hepatic carcinoma(PHC) and JLC's influence on serum osteopontin(OPN) expression and elucidate the correlation between the serum OPN level and curative effect of JLC and TACE.Methods:A total of 98 patients with PHC were observed in a randomized controlled trial(RCT).They were assigned to the Chinese medicine(CM) group(53 patients who were treated with TACE and JLC) and the intervention group(45 patients who were treated with TACE only).The serum OPN levels were measured before and after treatment by quantitative sandwich enzyme-linked immunosorbent assay(ELISA).Forty healthy people were assigned to the control group.The clinical efficacy was observed and Karnofsky score(KPS) was graded.Results:The clinical efficacy of the CM group(60.38%) was better than that of the intervention group(40.00%),and the KPS(84.35±12.19) was higher than the intervention group(69.86±11.58)(P0.05).The serum OPN levels before and after treatment in the patients with PHC were significantly elevated compared with those in the control group(P0.01).After treatment,the OPN levels in CM group(117.69±78.50) were significantly lower compared with those in intervention group(151.09±83.90,P0.05).The OPN levels of responders were remarkably lowered than the non-responders after treatment,and the level of OPN in the CM group was lower than the intervention group(P0.05).Conclusions:The short-term clinical efficacy and the quality of life of patients with PHC can be improved by combining JLC with TACE.The serum OPN levels in PHC patients can reflect the curative effect of treatment and the prognosis of the disease.     

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

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

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.     

Effect of Ligustrazine Injection on Levels of Interleukin-4 and Interferon-γ in Patients with Bronchial Asthma

Objective:To explore the effect of ligustrazine injection (LI) on serum levels of interleukin-4 (IL-4) and interferon-γ (IFN-γ) in patients with bronchial asthma and determine the mechanism of action of LI in preventing and treating asthma.Methods:Sixty-eight patients with mild or moderate bronchial asthma were assigned to two groups equally according to their sequence number,odd or even.The conventional treatment was administered to both groups,and LI was given to the treatment group by ultrasonic spray inhalation twice a day but not to the control group.The therapeutic course for all was 2 weeks.Further,30 healthy subjects who had no history of smoking were enrolled as the normal control group.The clinical condition scores,frequency of attacks and dosage of Terbutaline inhaled were scored and recorded on the first day of hospitalization (before treatment) and after treatment.At the same time,the indexes of lung function,including forced expiratory volume in one second (FEV1),forced expiratory volume in one second to forced vital capacity ratio (FEV1%) and the peak expiratory flow (PEF) were determined before treatment.The levels of IL-4 and IFN-γ in peripheral blood were detected by ELISA before and after treatment,and compared with that of the healthy control group.]Results:After treatment,the clinical condition scores were found to be lower,indexes of lung function were elevated,but serum level of IL-4 and ratio of IL-4/IFN-γ were reduced in both groups,showing significant differences as compared to those before treatment (P＜0.05).However,the changes in all the indexes were more significant in the treatment group than in the control group,also showing statistical significance (P＜0.05).No significant difference was revealed when IFN-γ levels were compared before and after treatment in both groups,though a lowering trend could be seen,significant difference could not be found in the comparison of IFN- γ levels between groups after treatment (P＞0.05).Conclusion:LI shows good clinical effect in treating bronchial asthma,and its mechanism might be related to the suppression of the synthesis of IL-4,thus leading to the inhibition of TH2 cell subset preponderant response and immune equilibrium regulation.     

Effect of Shenzhu Guanxin Recipe (参术冠心方)on Patients with Angina Pectoris after Percutaneous Coronary Intervention:A Prospective,Randomized Controlled Trial

Objective:To evaluate the efficacy and safety of a combination therapy using Chinese medicine(CM) Shenzhu Guanxin Recipe(参术冠心方 SGR) and standard Western medicine treatment(SWMT) in patients with angina pectoris after percutaneous coronary intervention(PCI).Methods:Double-blind randomized controlled trial was used in this experimental procedure.One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment(SGR) and control(placebo) groups.Outcome measures including angina pectoris score(APS),CM symptom score,and Seattle Angina Questionnaire(SAQ)score were evaluated in 1,2,3 and 12 months,and the death rate,restenosis and other emergency treatments were observed.The mixed-effects models were employed for the data analysis.Results:In the treatment group,a larger within-treatment effect size(d=1.74) was found,with a 76.7%reduction in APS from pretreatment to12-month follow-up assessment compared with the control group(d=0.83,53.8%symptom reduction);betweentreatment(BT) effect size was d=0.66.CM symptom scores included an 18.3%reduction in the treatment group(d=0.46),and a 16.1%decrease in the control group(d=0.31);d=0.62 for BT effect size.In regard to scores of SAQ,the BT effect size of cognition level of disease was larger in the treatment group(d=0.63),followed by the level of body limitation of activity(d=0.62),condition of angina pectoris attacks(d=0.55),satisfaction level of treatments(d=0.31),and steady state of angina pectoris(d=0.30).Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups,respectively.No significant difference in any cardiovascular event(including death toll,frequency of cardiovascular hospitalization or emergency room visits)was found between the two groups.Conclusion:The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.