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 Longbishu Capsule (癃闭舒胶囊) plus Doxazosin on Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Objective:To investigate the effect of Longbishu Capsule(癃闭舒胶囊,LBS),doxazosin,and combination therapy on benign prostatic hyperplasia(BPH).Methods:A randomized,double-blind,multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing(108 cases),Heilongjiang(90 cases),Sichuan(90 cases),Shanghai(72 cases),China.They were randomly assigned with central randomization method to group A(LBS placebo plus doxazosin),group B(LBS plus doxazosin)or group C(LBS plus doxazosin placebo),120 cases for each group.The international prostate symptom score,maximum urinary flow rate,postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments.Results:At baseline,there was no significant difference in the measured variables among the three groups.After 12-month treatment,the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline(P0.01).Although postvoid residual urine volume was not significantly different from the baseline in group A(P0.05),it significantly decreased in group B and C(P0.05).The incidence of adverse events were similar among the three groups.Conclusions:The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH.The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well.     

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)     

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

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

Effect of chinese herbal medicine for calming Gan (肝) and suppressing hyperactive yang on arterial elasticity function and circadian rhythm of blood pressure in patients with essential hypertension

Objective:To observe the effect of Chinese herbal medicine for calming Gan(肝) and suppressing hyperactive yang(平肝潜阳,CGSHY) on arterial elasticity function and the circadian rhythm of blood pressure in patients with essential hypertension(EH).Methods:Adopting a parallel,randomized design,sixty-four patients with EH of stagesⅠandⅡwere randomly divided into two groups according to a random number table,with 32 in each group.The patients in the treatment group were treated with CGSHY and those in the control group were treated with Enalapril.All patients were given 24-h ambulatory blood pressure monitoring(ABPM) before and after a 12-week treatment.Trough/peak(T/P) ratios of systolic and diastolic blood pressure(SBP & DBP) of each group were calculated.The circadian rhythm of their blood pressure was observed at the same time. The changes in elasticity of the carotid artery in the patients,including stiffness parameter(β),pressure-strain elastic modulus(Ep),arterial compliance(AC),augmentation index(Al),and pulse wave velocity(PVWβ) were determined by the echo-tracking technique before and after a 12-week treatment.In the meantime,their levels of nitric oxide(NO) and endothelin-1(ET-1) were measured respectively.Results:After treatment,all parameters in the 24-h ABPM and the elasticity of the carotid artery(β,Ep,AC and PVWβ) were markedly improved,the level of NO was increased,and ET-1 was decreased in both groups as compared with values before treatment (P<0.05 or P<0.01).Further,the improvements in the ratio of T/P of SBP & DBP and in the level of NO and ET-1 in the treatment group were more significant than those in the control group(P<0.05).There were no significant differences in all parameters in the ABPM monitoring and the elasticity of the carotid artery,the recovery of blood pressure circadian rhythm,and the therapeutic effect of antihypertension in EH patients between the two groups (P>0.05).Conclusions:Chinese herbal medicine for CGSHY may lower the blood pressure smoothly and recover the circadian rhythm of blood pressure in EH patients.They may also improve the carotid elasticity of EH patients similar to that of Enalapril.The mechanism of action of Chinese herbs on EH might be related to the regulation of vascular endothelium function.     

Clinical Assessment on Treatment of Hyperlipidemia with Pushen Capsule (蒲参胶囊)

Objective: To explore the therapeutic effect of Pushen capsule (PSC, 蒲参胶囊) in treating primary hyperlipidemia. Methods: Two hundred and forty patients with primary hyperlipidemia were randomly divided into two groups, the 120 patients in the treated group treated with PSC (4 capsules, tid) and the 120 patients in the control group treated with Zhibituo tablet (脂必妥, 3 tablets, tid), and they were administered at the same time with Zhibituo placebo. The therapeutic course for both groups was 4 weeks. The therapeutic effect and the effects on blood lipids and viscosity were observed. Results: The effective rate in thetreated group was 76. 3%, which was significantly higher than that in the control group (48. 7% , P< 0. 01). PSC showed a significant lowering effect on TC, TG and LDL-C and raising effect on HDL-C, and the effect in lowering TG was significantly better than that of Zhibituo (P<0.01). PSC also showed a certain effect in decreasing whole blood viscosity of both high-sheared and low-shear     

A Multicentral Randomized Control Study on Clinical Acupuncture Treatment of Bell's Palsy

To confirm the clinical therapeutic effects of acupuncture and moxibustion on Bell's palsy.Methods:480 cases from 4 hospitals were enrolled for this study,among whom 439 cases completed thewhole course of the study.The patients were randomly divided into the following 3 groups,a controlgroup(treated with prednisone,vitamin Bl,vitamin B_(12)and dibazol),an acu-moxibustion group(treatedwith filiform needle plus moxibustion),and a basic treatment plus acu-moxibustion group(treated withoral medicine like those in the control group plus acupuncture,and with moxibustion like in theacu-moxibustion group).The whole treatment course lasted 4 weeks.The therapeutic effects wereevaluated according to the symptoms and signs,House-Brackmann grading scale and facial disabilityindexes(FDI).Results:All the 4 centers(hospitals)completed this study well,with no statisticallysignificant difference found among the 4 centers in therapeutic effects.The patients with differentconditions were well distributed in the 3 groups,thus the basic general,data were comparable(P>0.05).The therapeutic effects of the two treatment groups were better than the control group(respectivelyP<0.05 and P<0.01),and it was the best in the acu-moxibustion group(P<0.01).Conclusion:Acupuncture and moxibustion may exert definite therapeutic effects on Bell's palsy,better than that ofthe basic treatment group or the basic treatment plus acu-moxibustion group.     

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

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

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.     

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

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

Effect and Safety of Guanxinning Tablet(冠心宁片) for Stable Angina Pectoris Patients with Xin(Heart)-Blood Stagnation Syndrome:A Randomized,Multicenter,Placebo-Controlled Trial

Objective: To investigate the effect and safety of Guanxinning Tablet(冠心宁片, GXN) for the treatment of stable angina pectoris patients with Xin(Heart)-blood stagnation syndrome(XBSS). Methods: One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN(80 cases) or placebo(80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets(0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test(treadmill protocol), Chinese medicine(CM) syndrome score, electrocardiogram(ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events(AEs) were evaluated during the whole clinical trial. Results: Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28±17.67 s after treatment(P0.05); moreover, the change of exercise duration in the GXN group increased 63.10±96.96 s in subgroup analysis(P0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group(40.58%, 75.36%, 26.92%, 28.21%, respectively, P0.05). Conclusion: GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.     

Bromelain and Cardiovascular Risk Factors in Diabetes: An Exploratory Randomized, Placebo Controlled, Double Blind Clinical Trial

Objective: To assess whether the dietary supplement(bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease(CVD) risk factors in patients with diabetes. Methods: This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain(1,050 mg/day) on plasma fibrinogen. This randomized controlled trial(RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years(standard deviation(SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg(3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken(2×350 mg) after breakfast and another(350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks. Results: The change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L(standard deviation(SD) 0.86g/L) compared with the mean reduction of 0.36 g/L(SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups(mean difference=0.23g/L(SD 0.22 g/L), P=0.291). Similarly, the difference in mean change in other CVD risk factors(blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study. Conclusion: This RCT failed to show a beneficial effect in reducing fibrinogen or influencing other selected CVD risk factors but suggests other avenues for subsequent research on bromelain.     

Influence of Valsartan on myocardial apoptosis in spontaneously hypertensive rats

Objective To explore the pathogenic changes of myocardial apoptosis in heart hypertrophy d uring hypertension and evaluate the anti-apoptosis effect of Valsartan.Methods Thirty spontaneously hypertensive rats (SHRs) were divided into two groups: 15 t reated with Valsartan (20 mg·kg(-1)·d(-1)) (SHR+Valsartan group), t he others with placebo (SHR+placebo group), with 15 normal Wistar rats as contro l.Systolic blood pressure was measured by the tail-cuff method.The observat ion period was from 8 to 16 weeks of age.Cardiac apoptosis was evaluated by a Terminal Deoxynucleotidyl Transferase-Mediated dUTP-biotin Nick End Labeling ( TUNEL) assay.Results Mean blood pressure values were 127±2 mm Hg in controls, 163±6 mm Hg in th e SHR+Valsartan group and 193±7 mm Hg in the SHR+placebo group at 16 weeks of age, whereas the blood pressure in 8-week-old SHR and Wistar rats were 175±3 mm Hg and 125±5 mm Hg, respectively.The ratio of the heart weight over b ody weight declined in Wistar (3. 07±0. 03 mg/g) and SHR+Valsartan groups (3. 22±0. 19 mg/g) compared with the SHR+placebo group (4. 02±0. 31 mg/g) (P &lt;0. 05).The density of TUNEL-positive cells in Wistar and SHR±Valsartan grou ps was 23. 3±3. 3 nuclei/HPF and 35. 0±1. 3 nuclei/HPF, both of which were sig nificantly less than that of the SHR+placebo group （116. 7±11. 3 nuclei/HPF） . Conclusions In response to chronic pressure overload, cardiomyocyte-specific apoptosis cont ributes to the transition from compensatory hypertrophy to decompensation. Apo ptosis may be effectively inhibited by Valsartan in the early stage of hypertension.     

Efficacy of Aidi Injection (艾迪注射液) on Overexpression of P-Glycoprotein Induced by Vinorelbine and Cisplatin Regimen in Patients with Non-Small Cell Lung Cancer

Objective:To investigate the efficacy of Aidi Injection(艾迪注射液) on overexpression of P-glycoprotein(P-gp) induced by vinorelbine and cisplatin(NP) regimen in patients with non-small cell lung cancer(NSCLC), and study the difference between intravenous administration and targeting intratumor administration of Aidi Injection with thoracoscope. Methods:Totally 150 patients with NSCLC were randomly assigned to the control group, the intravenous group and the intratumor group by the random envelope method, 50 cases in each group. The patients were treated with NP regimen(2 cycles), NP regimen(2 cycles) plus Aidi intravenous injection, or NP regimen(2 cycles) plus Aidi intratumor injection with thoracoscope, respectively for 6 weeks. The clinical efficacy was observed based on Response Evaluation Criteria in Solid Tumors(RECIST) rules, the expression of P-gp in the tumor tissue was tested before, 3 and 6 weeks after treatment, the safety was evaluated by monitoring the toxicity in the process of treatment, and the progressionfree survival(PFS) was measured. Results:Fifteen cases dropped out because of the irreconcilable conditions which had no relationship with the treatment, 4 in the control group, 5 in the intravenous group, and 6 in the intratumor group, respectively. Compared with the control group, the response rates(complete remission + partial response) and the disease control rates(complete remission + partial response + stable disease) were significantly higher, the P-gp expressions were significantly decreased after 3 and 6 weeks of treatment, and the Kaplan-Meier survival curves of PFS were significantly longer in the intravenous and intratumor groups(P0.05 or P0.01), and the intratumor group showed better effects than the intravenous group(P0.05 or P0.01). Compared with the control group, the occurrences of rash, nausea and leukocytopenia were significantly decreased in the intravenous and intratumor groups(P0.05), but without significant difference between the intravenous and intratumor groups(P0.05). Conclusion:Aidi Injection not only improves the efficacy of NP regime, but also has the function of reducing adverse events and preventing against overexpression of P-gp induced by chemotherapy of NP regimen.     

Changes in Plasma Angiotensin Ⅱ and Circadian Rhythm of Blood Pressure in Hypertensive Patients with Sleep Apnea Syndrome Before and After Treatment

Objective To explore the changes in plasma angiotensin II (Ang II) and circadian rhythm of blood pressure among hypertensive patients with sleep apnea syndrome (SAS) before and after continuous positive airway pressure (CPAP) or surgical treatment.Methods A total of 180 essential hypertension patients were enrolled in our study.The determination of plasma Ang II concentration,ambulatory blood pressure (ABP),and polysomnography (PSG) monitoring were performed before and 3 months after CPAP or surgical treatment.Results Patients were classified into three groups by their apnea-hypopnea index (AHI):essential hypertension group (EH group,n=72;AHI<5),essential hypertension with mild SAS group (EH+mild SAS group,n=60,5≤AHI<20),and essential hypertension with moderate and severe SAS group (EH+moderate-severe SAS group,n=48,AHI≥20).The concentrations of plasma AngⅡ in the above three groups were 13.42±3.27,16.17±3.82,and 18.73±4.05 ng/mL respectively before treatment,and AngⅡ concentration in EH patients combined with SAS was significantly higher than that in EH group (all P<0.05).After treatment the values in the latter two groups significantly decreased to 14.67±2.56 and 15.03±3.41 ng/mL respectively (P<0.05).The incidence of non-dipper blood pressure curve in EH patients was 31.9%,and those in hypertensive patients with mild SAS and moderate-severe SAS were 51.7% and 58.3%,respectively before treatment.The incidence of non-dipper blood pressure curve in the EH patients with mild SAS was significantly higher than that of patients with EH alone (P<0.05).After CPAP treatment or surgery,the incidence of non-dipper blood pressure curve in the two SAS groups was significantly decreased to 38.3% and 39.6%,respectively (P<0.05).Conclusions Ang II might play a role in blood pressure variability in patients with obstructive SAS.CPAP or surgical treatment can improve blood pressure disorder and decrease plasma Ang II level in patients with obstructive SAS.     

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

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

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)     

Selenium supplement in the prevention of pregnancy induced hypertension.

The effect of selenium (Se) supplement on pregnancy was studied in 52 pregnant women with high risk factors of pregnancy induced hypertension (PIH). They were given natural Se dietetic liquid (100 μg / d) for 6-8 weeks during late pregnancy, and 48 controls were given placebo. They received similar routine prenatal care. The results revealed that Se supplement on the pregnant women prevented and decreased the incidence of PIH and gestational edema, and elevated the mother's blood Se level by 0.1008± 0.091 ppm in the treated group while decreased by 0.0402±0.046 ppm in the control group (P<0.01). The umbilical blood Se level was 0.2756± 0.100 ppm in the treated group and 0.1544 ± 0.051 ppm in the control (P<0.01). The differences of the neonatal birth weight and the amount of postpartum hemorrhage between the two groups were not significant.     

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)     

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.