Shenqi Fuzheng Injection(参芪扶正注射液) for Advanced Gastric Cancer:A Systematic Review of Randomized Controlled Trials

Objective:To evaluate the effectiveness of Shenqi Fuzheng Injection(参芪扶正注射液,SFI)combined with chemotherapy for advanced gastric cancer.Methods:Randomized controlled trials(RCTs) from10 databases were searched for this meta-analysis till December 31,2012 without language restriction.Grey literature and potential unpublished literature was also searched.The key search terms were "chemotherapy","Shenqi Fuzheng Injection" and "advanced gastric cancer".Criteria were built to select these clinical trials,in which SFI combined with chemotherapy was compared with chemotherapy alone for advanced gastric cancer.The methodological quality of each RCT was assessed using the Cochrane risk of bias tool.RevMan 5.1software was applied for data analyses.Results:Thirteen RCTs involving 860 patients met the selection criteria(all articles were from Chinese databases).The meta-analysis showed positive results for the use of SFI combined with chemotherapy according to quality of life in terms of the scores when compared with chemotherapy alone.Positive results were also obtained for the combination treatment,in terms of complete remission and partial remission efficacy rate,body weight and decreased adverse events including nausea and vomiting at grade 3-4,oral mucositis at grade 1-2,leucopenia at grade 3-4,and myelo-suppression at grade 1-2.Conclusions:This systematic review found encouraging albeit limited evidence for SFI combined with chemotherapy.However,to obtain stronger evidence without the drawbacks of trial design and the quality of studies,we recommend comparative effectiveness researches to test the effectiveness of combination treatment.     

Preliminary Results of Combination Therapy with Chinese Herbs and Vinorelbine in Elderly Advanced Non-Small Cell Lung Cancer

Objective To observe the efficacy and toxicity of combination therapy with Xiaoji decoction （XJY）, Huachansu （HCS） and Vinorelbine （NVB） in elderly patients with advanced non-small cell lung cancer （NSCLC）. Methods 29 elderly patients with ⅢB/Ⅳ NSCLC were treated with XJY 30ml/m^2, p.o., twice a day for 21 days; HCS 20ml/m^2, i.v., once a day for 10 days; and NVB 30ml/m^2, i.v., on dayl and dayS. The drugs were repeated every 21 days until 6 cycles, tumor progression, unacceptable toxicity or withdrawal of consent. Results 29 enrolled patients received median 3.2 cycles of therapy. The overall response rate and stabilization rate of tumors were 13.8% and 89.7%, respectively. The median survival time （MST） was 7.0 months and time-to-progression （TTP） was 5.0 months. The one year overall survival rate was 27.6%. Major toxicities include leucocytopenia, anemia and fatigue. Conclusion This combination regimen showed preliminary therapeutic efficacy and mild toxicity in elderly patients with advanced NSCLC and suitable for further clinical trial.     

Effect of Astragalus Injection Combined with Chemotherapy on Qual ity of Life in Patients with Advanced Non-small Cell Lung Cancer

Effect of Astragalus Injection Combined with Chemotherapy on Qual ity of Life in Patients with Advanced Non-small Cell Lung Cancer@邹雨荷$Jiangmen Central Hospital!Guangdong (529071) @刘雪梅$Jiangmen Central Hospital!Guangdong (529071)     

Modified Liujunzi Decoction (六君子汤) Alleviates Chemotherapy Induced Anorexia in Advanced Non-Small Cell Lung Cancer: A Propensity Score Matched Case-Control Study

Objective: To evaluate the effect of Chinese herbal medicine formula, modified Liujunzi Decoction(六君子汤, MLJZT), for anorexia, utilized as adjunct therapy during chemotherapy treatment for patients with advanced non-small cell lung cancer(NSCLC). Methods: The study adopted a propensity score-matched design based on a prospective database. From February 2016 to September 2017, patients with advanced NSCLC that received both cisplatin-based chemotherapy and MLJZT(IM group) were 1:1 propensity score-matched to patients that received the cisplatin-based chemotherapy alone(control group). Changes in anorexia and weight, as well as side effects were evaluated per week within 4-cycle chemotherapy. Results: Overall, 156 patients with advanced NSCLC that had received chemotherapy from our database were identified and 53 pairs were matched successfully. In total, 48.6%(50/53) of patients in the IM group had anorexia-improvement compared to 28.3%(15/53) of patients in the control group, and a total of 39.6%(21/53) of patients in the control group had a worsening of anorexia compared to only 7.8%(8/53) of patients in the IM group(P0.01). The weight reduced significantly over time in the control group(–2.36±2.53 kg) as compared to the IM group(–0.62±3.89 kg, P0.01). CHM didn't reduce the efficacy of chemotherapy in shrinking tumor size, and didn't increase the incidence of side effects such as hematological and hepatorenal toxicity. Conclusion: MLJZT is effective and safe for alleviating anorexia in patients with NSCLC. These findings warrant the conduct of a randomized controlled trial.     

Clinical Study on Kangquan Recipe (康泉方) for Benign Prostatic Hyperplasia Patients: A Randomized Controlled Trial

Objective：To observe the effectiveness and safety of Kangquan Recipe（康泉方,KQR） for benign prostatic hyperplasia（BPH） patients.Methods：One hundred and six BPH patients were randomly assigned to the treatment group（53 cases） and the control group（53 cases） according to a random number table.The treatment group was given KQR orally;the control group was given cemilton orally.After 24-week treatment,the clinical effect and safety were evaluated using the International Prostatic Symptom Score（l-PSS）,quality of life（QOL）,maximum flow rate（Qmax）,average flow rate（Qave）,residual urine volume（RUV）,total prostatic volume（TPV）,etc.Results：After treatment,the score of l-PSS was decreased from 16.9 ±5.6 to 12.5 ±4.6in the treatment group,significantly lower compared with the control group;the levels of Qmax and Qave were from 10.9 ±3.5 to 15.6 ±4.5 and 5.4 ±2.1 to 7.3 ±2.5（mL/s） in the treatment group,significantly higher compared with the control group;the levels of RUV and TPV were from 70.8 ±28.2 to 35.2 ±21.8 and37.2 ± 16.9 to 30.1 ± 10.8（mL） in the treatment group,significantly lower compared with the control group（all P〈0.05）.The incidence rate of adverse reaction was similar between the two groups（P〉0.05）.Conclusion：KQR is effective and safe for the treatment of BPH.     

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.     

Effect of Kuanxiong Aerosol(宽胸气雾剂)on Patients with Angina Pectoris:A Non-inferiority Multi-center Randomized Controlled Trial

Objective: To evaluate the effect and safety of Kuanxiong Aerosol(宽胸气雾剂, KA) on patients with angina pectoris. Methods: Block randomization was performed to randomly allocate 750 patients into KA(376 cases) and control groups(374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA(0.6 m L per spray). The control group received 1 sublingual nitroglycerin tablet(NT, 0.5 mg/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment(1, 2, 3, 4, 5, and 5 min). Logistic regression analysis was performed to observe the factors influencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society(CCS) classes of angina. Results: The 5-min remission rates in the KA and control groups were not significantly different(94.41% vs. 90.64%, P0.05). The angina CCS class significantly influenced the rate of remission (95% confidence interval = 0.483–0.740, P0.01). In the CCS subgroup analysis, the 3-and 5-min remission rates for KA and NT were similar in the CCSⅠ and Ⅳ subgroups(P0.05), while they were significantly better for KA in the CCSⅡ and Ⅲ subgroups(P0.05 or P0.01). Furthermore, the incidence of adverse reactions was significantly lower in the KA group than in the control group for the CCSⅡ and Ⅲ subgroups(9.29% vs. 26.22%, 10.13% vs. 20.88%, P0.05 or P0.01). Conclusions: KA is not inferior to NT in the remission of angina. Furthermore, in CCSⅡ and Ⅲ patients, KA is superior to NT, with a lower incidence of adverse reactions.     

Shenyi Capsule (参一胶囊) plus Chemotherapy versus Chemotherapy for Non-Small Cell Lung Cancer: A Systematic Review of Overlapping Meta-Analyses

Objective:To assist decision-makers interpret and choose among conflicting meta-analyses,as well as to offer treatment recommendations based on current best evidence by performing a systematic review of overlapping meta-analyses regarding Shenyi Capsule(参一胶囊,SC) plus chemotherapy versus chemotherapy of non-small cell lung cancer(NSCLC).Methods:A literature search was conducted to select systematic reviews comparing SC plus chemotherapy with chemotherapy for NSCLC.Meta-analyses only composed of randomized controlled trials(RCTs) met the inclusion criteria.Two authors individually estimated the quality of meta-analysis and extracted data.The Jadad decision algorithm was applied to guarantee which meta-analysis provided the best original evidence.Results:A total of 5 meta-analyses were included.All the studies composed of RCTs or quasi-RCTs and were regarded as level-Ⅱ evidence.The scores of the Assessment of Multiple Systematic Reviews ranged from 3 to 6(median 4).A high-quality meta-analysis with more RCTs was chosen,which suggested that SC plus chemotherapy could increase incidence of short-term efficacy,improve the quality of life and survival rate in comparison to chemotherapy.However,there was no statistically significant difference between SC plus chemotherapy and chemotherapy regarding chemotherapy-induced side effect,such as liver and kidney function obstacle,leukopenia,hemoglobin decrement and gastrointestinal adverse reaction.Conclusions:Based on the best available evidence,treatment effect of SC plus chemotherapy was better than chemotherapy and did not increase side effects.Therefore,SC plus chemotherapy may be superior to chemotherapy for treating NSCLC.However,due to some limitations,SC plus chemotherapy should be cautiously considered,and further high-quality meta-analyses are needed.     

Improvement of Quality of Life with Shenfu Injection (参附注射液) in Non Small Cell Lung Cancer Patients Treated with Gemcitabine plus Cisplatin Regimen

~~Improvement of Quality of Life with Shenfu Injection (参附注射液) in Non Small Cell Lung Cancer Patients Treated with Gemcitabine plus Cisplatin Regimen@吴万垠$Department of Cancer,Guangdong Provincial Traditional Chinese Medicine Hospital!Guangzhou(510370) @龙顺钦$Department of Cancer,Guangdong Provincial Traditional Chinese Medicine Hospital!Guangzhou(510370) @张海波$Department of Cancer,Guangdong Provincial Traditional Chinese Medicine Hospital!Guangzhou(510370) @柴小…     

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

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

Clinical Study on Yishen Qufeng Shengshi Recipe (益肾祛风胜湿方) for Glomerular Proteinuria Patients: A Randomized Controlled Trial

Objective: To explore the therapeutic effect of Yishen Qufeng Shengshi Recipe(益肾祛风胜湿方,YQSR) in patients with glomerular proteinuria. Methods: A total of 145 patients with glomerular proteinuria were selected and randomly assigned to the treatment group(108 cases) and the control group(37 cases) according to a random number table in a ratio of 3:1. All patients received conventional and symptomatic treatment. In addition, patients in the treatment and control groups were given YQSR(200 m L, twice per day, orally) and losartan(50 mg/d orally), respectively for 6 months. The 24-h urine protein quantity, blood urea nitrogen, and serum creatinine in the two groups were measured at multiple time points before and after treatment. Results: At the end of the study, 5 cases were lost to follow-up in the treatment group and 1 in the control group. Finally, the statistical data included 103 cases in the treatment group and 36 cases in the control group. The total effectiveness after 2, 4, and 6 months was 81.6%(84/103), 87.4%(90/103), and 92.2%(95/103), respectively, in the treatment group and 47.2%(17/36), 55.6%(20/36), and 61.1%(22/36), respectively, in the control group, with significant difference between the two groups(P0.01 at all observation points). In the treatment group, the curative effect after 6 months was better than that after 2 months(P0.05). The 24-h urine protein quantity was significantly lower in the treatment group at 3, 4, 5, and 6 months than that in the control group(P0.05 or P0.01, respectively). Conclusion: YQSR could significantly reduce the amount of glomerular proteinuria in the early stage.     

Efficacy and Safety of Qiaoshao Formula(翘芍方) on Patients with Lifelong Premature Ejaculation of Gan(Liver) Depression and Shen(Kidney) Deficiency Syndrome:A Randomized Controlled Trial

Objective: To observe the efficacy and safety of Qiaoshao Formula(翘芍方, QSF) on patients with lifelong premature ejaculation(LPE) of Gan(Liver) depression and Shen(Kidney) deficiency syndrome. Methods: A total of 60 LPE patients were randomly divided into treatment(QSF) and control(dapoxetine) groups. The treatment group received QSF twice a day and the control group received dapoxetine 1 to 2 h prior to planned sexual intercourse for 4 weeks. The outcomes included intra-vaginal ejaculation latency time(IELT), premature ejaculation diagnostic tool(PEDT), clinical global impression of change(CGIC), scores of Chinese medicine symptoms(CMSS), sex life satisfaction(SLS) and adverse events(AEs). Results: In the treatment group, the median IELT was 3 min vs. 1.5 min before and after treatment(P0.05). PEDT in the treatment group was reduced to 11.76±1.68 from 15.83±2.30 after treatment(P0.05). Besides, patient's SLS was improved from 1.30±0.05 to 6.30±0.04(P0.05), and spouse's SLS was increased from 1.30±0.08 to 6.10±0.06(P0.05); CMSS was decrease from 14.86±3.02 to 9.62±2.87(P0.05). In addition, no significant AE was observed in both groups. Conclusion: QSF may be effective and safe on LPE patients with Gan depression and Shen deficiency syndrome.     

Treatment of Patients with Erectile Dysfunction by Shugan Yiyang Capsule(疏肝益阳胶囊):A Multi-Centered Randomized Controlled Trial

Objective: To evaluate the efficacy and safety of Shugan Yiyang Capsule (SGYY, 疏肝益阳ficiency Syndrome type with or without blood stasis. Methods: A multi-centered, randomized, double-blinded, placebo-controlled trial in 304 patients was conducted by dividing them into 3 groups, who received re101), 1.0g taken three times a day for 4 weeks. Besides, 205 patients were arranged in an open-label studyand treated with SGYY 1.0 g taken three times a day for 4 weeks. The total effective rate, total remarkablyeffective rate, erection recovery rate tested by penis hardness test ring, time taken for improving erection among groups, as well as therapeutic effect between psychogenic ED group and mild arteriogenic ED group were compared. Adverse reactions related to SGYY were recorded. And a 3-month follow-up study was conducted on 105 cured patients. Results: The trial was completed in 500 patients. The total effective rate and total remarkably effective rate in the SGYY treated double-blinded group were 88.0% and 64.0% respectively, and those in the open-label group 90.5% and 65.0%, respectively, all significantly higher th an thosein the placebo (21.0%, 6.0%) and SYBS groups (60.0%, 29.0%), P＜0.01. At the same time, the e rection recovery rate and improving time in SGYY group were significantly better than those in other groups ( P＜0.01). No adverse reactions related to SGYY were found. The successful rate of potency to have intercourse within 3 months was over 80% (100 patients out of the 105 cured patients). Conclusion: SGYY was an effective and safe treatment for patients with psychogenic and mild arteriogenic ED of Gan stagnation and Shen deficiency Syndrome type with or without blood stasis, especially for psychogenic ED patients.     

Effect of Wuye Decoction (五叶汤) on Lymphocyte Phenotype in Patients with Non-small Cell Lung Cancer

Theimmunefunctionoflymphocytesplaysavitalroleintheoccurrenceandde velopingprocessoftumor,whichconsti tutesanimportantpartoforganism sim munedefensefunction.Thelymphocytephenotype(CDantigen),animportantmarkerthatreflectesthefunctionoflym phocyte,changesalongsidewiththeprogno sisofdisease.Whilekillingtumorcells,chemotherapycouldalsocauseloweringofimmunityatthesametime.Thesupplemen tarytherapeuticactionoftraditionalChinesemedicine(TCM)ontumorhasbeenrecog nizedbyall(1).Theincidenceoflungcancerr…     

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 Compound Zhuye Shigao Granule (复方竹叶石膏颗粒) on Acute Radiation-Induced Esophagitis in Cancer Patients: A Randomized Controlled Trial

Objective: To observe the efficacy and safety of the Chinese medicine(CM) Compound Zhuye Shigao Granule(复方竹叶石膏颗粒, CZSG) on acute radiation-induced esophagitis(ARIE) in cancer patients. Methods: In a blinded, randomized, Kangfuxin Solution(康复新液, KFX)-controlled, single-centre clinical trial, 120 patients with lung, esophagus or mediastinal cancer were prospectively enrolled and assigned to the treatment group(60 cases) and control group(60 cases) by the random number table method. All patients received concurrent or sequential radiotherapy(2 Gy per day, 5 times per week, for 4 weeks) and were treated for 4 weeks since the radiation therapy. Patients in the treatment group were given 12 mg CZSG orally, thrice daily, while patients in the control group were given 10 m L KFX orally, thrice daily. The major indicators were observed, including the incidence and grade of esophagitis, time of occurrence and duration. Minor indicators were changes of CM symptoms, weight and Karnofsky Performance Status(KPS) Scale during 4 weeks from the beginning, recorded once a week. Blood routine examination and hepatorenal function were detected at the 2nd and 4th weeks. Results: The incidence and grade of ARIE were significantly decreased in the treatment group compared with the control group(P0.05). CZSG appeared to significantly delay the time of ARIE occurrence and reduce the duration compared with KFX(P0.05). The scores of CM symptoms, KPS and weight were improved significantly in the treatment group compared with the control group(P0.05). There were no blood routine and hepatorenal function abnormal or obvious side-effects in both groups. Hemoglobin was improved and neutrophil and interleukin 6 were decreased in both groups after 4-week treatment compared with before treatment(P0.05), and there was no significant difference between the two groups(P0.05). Conclusions: CZSG can decrease the incidence and grade of ARIE, delay the time of occurrence, reduce duration and alleviate the damage of ARIE. It is safe and effective in the prevention and cure of ARIE.     

Effect of Feitai Capsule(肺泰胶囊) on Quality of Life and Progression-Free Survival of Patients with Unresectable Non-Small Cell Lung Cancer

<正>Objective:To examine the effect of a Chinese medicinal herbal formula(Feitai Capsule,肺泰胶囊) on the quality of life(QOL) and progression-free survival(PFS) of patients with unresectable non-small cell lung cancer(NSCLC).Methods:Sixty-two patients were randomly divided into the treatment group(31 cases) and the control group(31 cases).For the treatment group,4 capsules(1.2 g/capsule) of Feitai Capsule were administered 3 times a day after meals for 3 weeks;then no drug was administered for 1 week.This schedule was continued for at least 3 more cycles(12 weeks totally).If there were no obvious toxic reactions,the treatment was extended.The patients were evaluated at least once every 8 weeks until progressive disease(PD). For the control group,the regular follow-up and evaluation were performed at least once every 8 weeks until PD.Clinical symptoms,objective response,physical constitution and energy,QOL,and PFS were evaluated regularly.Analysis of variance(ANOVA),a non-parametric test,and analysis of covariance were used to compare clinical features,amelioration of clinical symptoms,physical constitution and energy,and QOL.Kaplan-Meier analysis was used to compare the two-group PFS.Results:Sixty patients finished the final evaluation, with 30 patients in each group.Baseline characters between groups were not significantly different(P0.05). The control group had a 36.7%improvement in clinical symptoms,while the treatment group had a 73.3% improvement.This difference was statistically significant(Z=-2.632,P=0.008).The control group had a 26.7% improvement in the Karnofsky performance status(KPS),while the treatment group had a 53.4%improvement. This was also significantly different(Z=-2.182,P=0.029).A comparative analysis indicated a positive correlation (r=0.917,P0.001).Compared with the control group,QOL in the treatment group was significantly improved, except in the social/family condition and doctor-patient relationship indicators.The PFS of the treatment group and control group were 6.23 months and 4.67 months,respectively(P=0.048).Conclusion:Feitai Capsule,a Chinese medicinal herbal treatment could improve the QOL and extend the PFS of the unresectable NSCLC patients.     

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.     

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.