Double-Blind Comparison of Indapamide with a Placebo in Hypertensive Patients Treated by Practicing Physicians

The antihypertensive effect of indapamide (2.5 mg/day) was compared to that obtained with a placebo in a controlled trial carried out by 11 physicians in their private practice. Thirty-one patients with uncomplicated essential hypertension were included. After a run-in period of 3 weeks without any treatment, either indapamide (n=16) or a placebo (n=15) were administered for 8 weeks in double-blind fashion. Blood pressure decreased in both groups. In patients treated with indapamide, systolic pressure was significantly lower than in those given the placebo at 3 out of the 4 follow-up visits; diastolic pressure, however, was significantly lower only at the end of the trial. Both the active drug and the placebo were well tolerated. No significant change in body weight, plasma potassium and uric acid occurred during the study in either group of patients. It appears therefore that indapamide, at a dose which apparently has no major diuretic effect, may be useful for practitioners in managing patients with mild to moderate hypertension.     

Therapeutic efficacy of the Qing Dai in patients with intractable ulcerative colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that may become intractable when treated with conventional medications such as aminosalicylates, corticosteroids, and azathioprine. The herbal medicine Qing Dai has traditionally been used in Chinese medicine to treat UC patients, but there is a lack of published data on the efficacy of Qing Dai in UC treatment. We report several cases of patients with intractable UC who take Qing Dai in a retrospective observational study. Furthermore, we explore the mechanisms of action of Qing Dai. Nine patients with active UC who received conventional medications but wished to receive Qing Dai as an alternative medication were included in our analysis. The UC severity level was determined based on the clinical activity index (CAI). Additionally, 5 of the 9 patients were endoscopically evaluated according to the Matts grading system. Each patient received 2 g/d of Qing Dai orally and continued taking other medications for UC as prescribed. Electron spin resonance was applied to explore the mechanisms of action of Qing Dai. After 4 mo of treatment with Qing Dai, the CAI score decreased from 8.3 ± 2.4 to 2.4 ± 3.4 (mean ± SD; P < 0.001). Similarly, the endoscopic Matts grade decreased from 3.4 ± 0.5 to 2.2 ± 0.8 (P = 0.02). Six of 7 patients who were on prednisolone upon enrollment in the study were able to discontinue this corticosteroid. Electron spin resonance revealed that Qing Dai possesses strong hydroxyl radical scavenging activity. Qing Dai showed significant clinical and endoscopic efficacy in patients who failed to respond to conventional medications. Scavenging of hydroxyl radicals appears to be a potential mechanism through which Qing Dai acts, but the significance of the scavenging ability of Qing Dai with respect to the anti-inflammatory effect in UC patients warrants further investigation.     

拉米夫定联合贞芪扶正胶囊治疗慢性乙型肝炎疗效观察

目的观察拉米夫定（LAM）联合贞芪扶正胶囊治疗慢性乙型肝炎患者的疗效和安全性。方法收集我院2010年1月～2012年12月诊治的HBeAg阳性CHB患者67例,随机分为两组。治疗组35例联合应用LAM和贞芪扶正胶囊治疗,对照组32例单用LAM。结果在治疗12 w,治疗组患者血TBIL、ALT、AST分别为（21.3±10.3）μmol/L、（32±24）U/L、（30±26）U/L,明显优于对照组[分别为（29.8±13.6）μmol/L、（53±95）U/L、（57±68）U/L,P〈0.05];在治疗48 w,治疗组患者TBIL、ALT、AST复常率分别为94.3%、97.1%和91.4%,而对照组则分别为93.7%、93.7%和87.5%,两组差异无统计学意义（P〉0.05）;联合组HBV DNA阴转率和HBeAg/抗HBe血清转换率分别为91.4%和37.1%,与对照组71.9%和12.5%比较,差异有统计学意义（P〈0.05）;联合组HBeAg阴转率为45.7%,也高于对照组的15.6%（P〈0.01）。结论 LAM联合贞芪扶正胶囊治疗慢性乙型肝炎患者疗效肯定,在肝功能恢复速度、HBV DNA和HBeAg阴转率及HBeAg/抗-HBe血清转换率方面优于单用拉米夫定治疗。     

Efficacy of nano-modified Runji ointment in the treatment of mild and moderate psoriasis with blood dryness syndrome: a study protocol for a double-blind randomized controlled trial

Introduction:Psoriasis is a common, recurrent, immune skin disease, which seriously affects patients’ quality of life. In clinical practice, modified Runji ointment can effectively treat mild-to-moderate psoriasis with blood dryness syndrome, but there is a lack of high-quality evidence-based medical evidence. This trial aims to evaluate the efficacy and safety of nano-modified Runji ointment in the treatment of mild-to-moderate psoriasis with blood dryness syndrome.Methods/design:This study will be a randomized double-blind placebo-controlled trial. A total of 80 patients will be recruited and randomly divided into an intervention group (nano-modified Runji ointment group) and a placebo group at a ratio of 1:1. All included patients will receive 8 weeks of nano-modified Runji ointment or placebo ointment respectively, twice a day. The primary outcome will be the change in psoriasis area and disease severity index score at week 8 compared to baseline. The secondary outcomes will be rash area score, pruritus score, Dermatology Life Quality Index score, traditional Chinese medicine symptom score and adverse events.Discussion:This study may provide high-quality evidence for the efficacy of nano-modified Runji ointment in the treatment of mild to moderate psoriasis with blood dryness syndrome. The results of this study will be published in peer-reviewed journals.Trial registration:ChiCTR, ChiCTR2000034292. Registered July 1, 2020, https://www.chictr.org.cn/edit.aspx?pid=55884&htm=4     

奥曲肽联合隔下逐瘀汤治疗肝硬化上消化道出血患者临床疗效和血流动力学的变化

目的 观察活血软坚、化瘀通络法治疗肝脾血瘀型肝硬化并发上消化道出血患者的临床疗效及治疗前后患者血流动力学的变化。方法 选取我院消化内科2012年1月~2015年1月收住入院的肝硬化并发上消化道出血患者76例,随机分为试验组38例和对照组38例。给予对照组垂体后叶素和奥曲肽静脉滴注,试验组在对照组基础上给予中药“隔下逐瘀汤”加减治疗,治疗14 d。使用Olympus 240/260电子胃镜检查,使用西门子X150彩色多普勒超声显像仪测定门静脉和脾静脉内径（D）和血流流速（V）。观察中医症状积分变化。结果 试验组平均止血时间为（35.82±12.47） h,对照组平均止血时间为（49.16±11.58） h,经统计学分析,t=10.254,P=0.000<0.05,差异有统计学意义;治疗后,试验组中医证候积分为（10.25±7.54）,对照组中医证候积分为（13.47±6.73）,两组经统计学分析,t=4.538,P=0.000<0.005,差异有统计学意义;试验组门静脉血流量为（580.34±176.38） ml/min,对照组为（650.25±142.47） ml/min,差异有统计学意义（P<0.05）;试验组脾静脉血流量为（213.36±90.74） ml/min,对照组为（286.74±101.25） ml/min,差异有统计学意义（P<0.05）;治疗后试验组门静脉内径、脾静脉内径改善方面明显优于对照组,差异有统计学意义（P<0.05）。结论 活血软坚、化瘀通络法联合止血药治疗肝硬化上消化道出血患者临床疗效满意,对患者脾静脉和门静脉血流动力学改善明显,治疗方法简便可行,患者依从性高。     

健脾利水方治疗失代偿期肝硬化55例疗效和安全性研究

目的 研究健脾利水方联合螺内酯、氢氯噻嗪和复方甘草酸苷片治疗肝硬化腹水患者的临床效果。方法 2012年10月~2014年12月在我院住院治疗的失代偿期肝硬化患者110例被随机分为对照组55例,给予螺内酯、氢氯噻嗪、复方甘草酸苷片治疗,另外55例观察组患者接受除了上面提到的常规治疗药物外,另外加用自拟健脾利水方（茯苓、泽泻、白术、丹参、茵陈、甘草、太子参、蒲公英）治疗,两组均治疗28天。在治疗结束时,比较两组患者血生化指标、凝血指标、脾脏厚度和门静脉内径。结果 治疗组患者治疗后血ALT、PT和TBIL分别为61.6±9.8 IU/L,12.3±6.7 s和21.1±4.7μmol/L,对照组患者治疗后血ALT、PT和TBIL分别为100.7±10.7 IU/L,16.8±3.4 s和28.7±6.3μmol/L,与治疗前比较,均明显降低,同时ALB明显升高,治疗组与对照组分别为39.6±8.7 g/L和32.9±4.1 g/L,观察组患者上述四项指标变化更明显,明显要好于对照组,差异有统计学意义（P＜0.05）;经过28天治疗,治疗组和观察组患者脾脏厚度58.7±7.3 mm和58.8±7.7 mm,但观察组患者门静脉内径降至12.8±4.3mm,明显小于对照组患者的14.1±5.5 mm,差异有统计学意义（P＜0.05）;观察组总有效率为92.7%,对照组为72.7%,差异有统计学意义（P＜0.05）。结论 采用健脾利水方联合螺内酯、氢氯噻嗪和复方甘草酸苷片治疗失代偿期肝硬化患者临床效果显著,联合治疗组疗效好于单一的常规西药治疗,并且没有出现明显的不良反应。     

补肾健脾活血法治疗慢性乙型肝炎患者临床研究

目的观察补肾健脾活血法治疗慢性乙型肝炎的临床疗效。方法采用补肾健脾活血法治疗50例慢性乙型肝炎患者,疗程6个月。结果治疗后,患者血清HA、LN、PCIII和IV-C均有下降（P〈0.01）,脾脏厚度和门静脉直径也缩小（P〈0.05）;肝功能指标均有明显的改善（P〈0.01）。结论补肾健脾活血方对慢性乙型肝炎有较好的疗效。     

基于方证辨证之茵陈四逆汤治疗慢性乙型肝炎阴黄患者临床观察*

目的 评价茵陈四逆汤治疗慢性乙型肝炎（CHB）阴黄患者的临床疗效。方法 采用随机数字表法将60例CHB患者分为两组,给予30例对照组患者降酶、退黄、抗病毒治疗,观察组在对照组治疗的基础上加用茵陈四逆汤治疗。结果 在治疗8 w末,观察组临床总有效率为96.7%,显著高于对照组的86.7%（P<0.05）;观察组血清丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）和总胆红素（TBIL）水平分别为【（24.0±9.3） U/L、（21.4±8.3） U/L和（26.9±7.8） μmol/L】,显著低于对照组【分别为（39.5±8.8） U/L、（33.3±8.5） U/L和（60.6±5.0）μmol/L,P<0.05】。结论 在综合治疗的基础上加用茵陈四逆汤治疗CHB阴黄证患者具有显著的临床疗效。     

云南白药治疗溃疡性结肠炎的meta分析

[目的]系统评价云南白药治疗溃疡性结肠炎（UC）的有效性。[方法]计算机检索PubMed（1966-2013）、CBM（1978-2013）、CNKI（1979-2013）、WangfangData（1990-2013）、VIP（1989-2013）等数据库,收集采用云南白药治疗溃疡性结肠炎的随机对照试验（RCT）,并追溯纳入研究的参考文献,由2位评价者按照纳入与排除标准独立筛选文献、提取资料和评价质量后,采用RevMan5．1软件进行Meta分析。[结果]共纳入20个RCT,1463例患者。Meta分析结果显示：云南白药组在治疗溃疡性结肠炎的总有效率[0R=4．05,95％CI（2．98,5．50）,P〈0．01]、治愈率[0R=3．24,95％CI（2．57,4．09）,P〈O．01]均高于对照组,不良反应发生率则低于对照组[OR=O．27,95％CI（0．12,0．58）,P〈0．01]。漏斗图分析显示存在发表性偏倚。[结论]现有证据显示,云南白药组治疗溃疡性结肠炎的疗效优于对照组,但尚需更多高质量的前瞻性多中心随机对照研究为临床提供更可靠的证据。     

TACE联合中药治疗原发性肝癌患者初步临床研究*

目的 探讨中药联合肝动脉化疗栓塞术（TACE）治疗肝细胞癌（HCC）患者的疗效。 方法 按照入院顺序抽签随机将80例中晚期HCC患者分为试验组和对照组,对照组患者接受TACE治疗,试验组患者在此基础上给予中药健脾益肝方口服,观察治疗8周后两组肝功能指标和甲胎蛋白（AFP）]变化及近期疗效情况。 结果 40例试验组患者总有效率为90.00%,明显高于对照组的72.50%（P＜0.05）;试验组患者治疗后血清ALT、AST、AFP水平分别为（53.55±8.26） U/L、（59.06±8.66） U/L和（216.02±10.27） ng/ml,明显低于对照组的（73.08±9.97） U/L、（71.17±8.85） U/L和（292.85±11.22） ng/ml （P＜0.05）;试验组患者消化道反应和肝损害发生率分别为45.00%和12.50%,明显低于对照组的80.00%和45.00% （P＜0.05）。 结论 在TACE基础上加用中药健脾益肝方治疗能够显著提高治疗HCC患者的近期疗效,能改善肝功能,减轻毒副反应。     

Clinical efficacy and safety of traditional Chinese medicine Xiao Yao San in insomnia combined with anxiety

Background:Patients with long-term insomnia generally experience anxiety and depression. Traditional sleeping pills and anti-anxiety drugs have certain limitations. Xiao Yao San (XYS), a complementary and alternative therapy, has been widely used to treat insomnia combined with anxiety. This study aims to evaluate the efficacy and safety of XYS in the treatment of insomnia combined with anxiety.Methods:Related literature was retrieved from 8 electronic databases from the establishment time to March 2021. The subjects were diagnosed with insomnia combined with anxiety. We assessed the methodological quality of randomized controlled trials (RCTs) according to the Cochrane Handbook. Data analysis was conducted using RevMan 5.3 software.Results:The analysis includes 9 RCTs involving 681 patients. Meta-analysis supported that as an auxiliary drug for Western medicine (WM), XYS could enhance the clinical efficacy of insomnia calculated according to the traditional Chinese medicine (TCM) syndrome score scale (risk ratio [RR]: 1.26; 95% confidence interval [CI]: 1.13–1.43; P = .0002) and reduced the scores of Hamilton Anxiety Scale (mean difference [MD]: −5.19; 95% CI: −7.78 to −2.60; P < .001), Pittsburgh Sleep Quality Index (MD: −3.35; 95% CI: −4.86 to −1.84; P < .001), Self-rating Anxiety Scale (MD: −9.38; 95% CI: −10.20 to −8.75; P < .001), TCM syndrome score scale for insomnia (MD: −4.45; 95% CI: −6.65 to −2.24; P < .001), and TCM syndrome score scale for anxiety (MD: −5.54; 95% CI: −9.48 to −1.6; P = .006). The summary analysis also shows that the separate use of XYS was advantageous in reducing the scores of the Hamilton Anxiety Scale (MD: −3.70; 95% CI: −6.31 to −1.09; P = .005), Pittsburgh Sleep Quality Index (MD: −1.82; 95% CI: −2.39 to −1.24; P < .001), and Self-rating Anxiety Scale (MD: −10.79; 95% CI: −14.09 to −7.49; P < .001). The incidence of adverse events with XYS as an ancillary drug or used separately was lower than that in the WM.Conclusion:Our systematic evaluation and meta-analysis showed that XYS combined with WM or XYS alone was beneficial for improving sleep quality and relieving anxiety. Due to the low methodological quality, small sample size, and significant heterogeneity of RCTs, more rigorous and scientific clinical trials are required to further evaluate the efficacy and safety of XYS.PROSPERO registration number:CRD42020190613.     

恩替卡韦联合自拟中药治疗慢性乙型肝炎患者疗效初步评价

目的 研究自拟中药联合恩替卡韦治疗慢性乙型肝炎患者的疗效以及不良反应发生情况。方法 2015年1月~2016年12月我科收治的69例慢性乙型肝炎患者,34例接受自拟中药（党参20 g,醋柴胡10 g,郁金10 g,鳖甲30 g,丹参20 g,龙葵10 g,白花蛇舌草15 g,绞股蓝15 g,三七10 g,片姜黄10 g,赤芍15 g,炙甘草6 g,水煎 400 ml,每日1剂,分早晚温服）联合恩替卡韦治疗,35例只接受恩替卡韦治疗。应用SPSS 19.0统计软件完成数据分析处理。结果 在治疗前和治疗24 w末,观察组与对照组血清ALB水平差别未见统计学意义（P> 0.05）,但治疗后观察组血清TBIL水平为（20.1± 4.7） μmol/L,显著低于对照组的（28.7± 4.8）μmol/L （P<0.05）;观察组血清ALT水平为（40.9± 6.8） U/L,显著低于对照组的（50.2± 6.7） U/L（P<0.05）;观察组血清AST水平为（39.6± 8.4） U/L,显著低于对照组的（52.5± 8.1） U/L （P<0.05）;治疗后,观察组和对照组血清透明质酸（HA）、层连蛋白（LN）、4型胶原（IV-C）和3型前胶原（PC-Ⅲ）水平均有所下降,其中观察组血清HA水平由[（256.3± 9.3）μg/L下降至（98.3± 9.1） μg/L,对照组血清HA水平由[（255.3± 9.8） μg/L下降至（140.3± 9.6） μg/L,观察组血清LN水平由[（241.3± 7.8） μg/L下降至（110.3± 7.7） μg/L,对照组血清LN水平由[（240.4± 7.8） μg/L下降至（170.5± 7.9） μg/L,观察组血清IV-C水平由[（98.4± 6.8） μg/L降至（53.6± 6.7） μg/L,对照组血清IV-C水平由[（98.00± 6.5） μg/L下降至（70.9± 6.6） μg/L,观察组血清PC-Ⅲ水平由[（193.6± 13.2） μg/L下降至（98.3± 9.9） μg/L,对照组血清PC-Ⅲ水平由[（193.5± 13.4） μg/L下降至（120.3± 9.7） μg/L,显示出治疗后观察组肝纤四项指标均显著低于对照组（P<0.05）。另外,治疗后观察组与对照组血清HBeAg转阴率和HBV DNA转阴率均未见统计学差异,而消化道症状,如腹泻、腹痛以及呕吐的发生率在观察组和对照组分别为2.9%和8.6%,差别也无统计学意义（P>0.05）。结论 自拟中药联合恩替卡韦联合治疗慢性乙型肝炎患者,两者结合一方面可以迅速抑制HBV复制,在另一方面可以发挥祖国医学治本的优势,扶正而固本,增强了疗效。     

自拟中药治疗非酒精性脂肪性肝病患者血清炎症反应指标水平的变化*

目的 探讨应用自拟中药辅助治疗非酒精性脂肪性肝病（NAFLD）患者对血清肝损伤、炎症反应和糖脂代谢指标的影响。方法 2015年1月~2017年1月诊治的NAFLD患者100例,采用office软件提供的数字表随机将患者分为观察组50例和对照组50例,给予对照组饮食和运动指导,观察组在常规指导的基础上加上自拟中药辅助治疗8 w。常规检测血生化指标,包括空腹血糖（FBG）和空腹胰岛素（FINS）,计算胰岛素抵抗指数（HOMA-IR）,采用ELISA法检测血清总抗氧化能力（T-AOC）、超氧化物歧化酶（SOD）、丙二醛（MDA）和一氧化氮（NO）水平。结果 在治疗结束时,观察组血清ALT、AST和GGT水平分别为（65.1±7.8） U/L、（69.4±8.5） U/L和（95.4±12.3） U/L,显著低于对照组[分别为（94.1±12.3） U/L、（99.3±8.6） U/L和（141.9±15.7） U/L,P<0.05];观察组血清T-AOC、SOD、NO和MDA水平分别为（38.1±5.1） U/ml、（89.1±12.1） μg/ml、（20.1±1.8） mg/L和（8.4±1.1） ng/ml,与对照组的（25.1±3.2） U/ml、（62.1±6.9） μg/ml、（13.1±1.2） mg/L和（12.0±1.2） ng/ml比,差异显著（P<0.05）; 观察组FBG、HOMA-IR、TC和TG分别为（6.1±1.2） mmol/L、（5.8±0.9）、（2.2±0.1） mmol/L和（0.4±0.1）mmol/L,均显著低于对照组【分别为（6.8±2.3） mmol/L、（6.4±1.9）、（2.7±0.3） mmol/L和（0.7±0.3） mmol/L,P<0.05]。结论 应用自拟中药治疗非酒精性脂肪性肝病患者,短期内能降低血清肝酶活性,调节糖脂代谢,其远期作用还有待观察。     

拉米夫定联合中草药治疗慢性乙型肝炎疗效观察

目的 探究拉米夫定联合中药治疗慢性乙型肝炎（CHB）患者的临床疗效和安全性。方法 将72例慢性乙型肝炎患者随机分为对照组和观察组,各36例。给予观察组患者拉米夫定联合中草药：茵陈32 g、赤芍16 g、贝母14 g、射干13 g、黄芩30 g、藿香12 g、薄荷10 g、木通14 g、丹参16 g、石宫蒲17 g、连翘12 g、白豆蔻12 g、滑石43 g,煎服,1剂/d;对照组仅接受拉米夫定治疗。两组患者均连续用药90天。使用全自动生化仪检测肝功能指标,采用RT-PCR法检测血清HBV DNA载量,采用ELIAS法检测血清乙型肝炎病毒标志物。结果 在治疗90 d时,观察组患者血ALT、AST和TBIL水平分别为（34.46±10.35） U/L、（28.32±8.76） U/L和（12.27±3.78） μmol/L,显著低于对照组的[（127.25±40.22） U/L、（92.48±28.61） U/L和（30.82±10.46）μmol /L,P<0.05];观察组和对照组患者血清HBV DNA阴转率分别为56.25%和23.33%（P<0.05）。结论 拉米夫定联合中草药治疗慢性乙型肝炎患者近期疗效显著,且安全性高。     

国产奥司他韦治疗流行性感冒的随机对照临床研究

目的 评价国产奥司他韦治疗流行性感冒(流感)的有效性与安全性.方法 采用随机单盲对照试验,国产组采用国产奥司他韦治疗,进口组采用进口奥司他韦治疗,用法均为75 mg/次,每日2次口服,疗程5 d.对两组治疗前、后的各项指标进行评价,以此判断疗效.两组基线和不良反应比较采用卡方检验,疗效差异性比较采用配对t检验.结果 共入选209例患者,其中国产组98例,进口组111例.两组在体温动态变化方面比较,差异无统计学意义(t=0.061,P>0.05).进口组症状评分在24～48 h内下降速度快于国产组,但至72 h时接近同一水平,两组比较差异无统计学意义(t=0.875,P>0.05).两组在不良反应方面比较,差异无统计学意义(X2=0.197,P>0.05).结论 国产奥司他韦治疗流感与进口奥司他韦同样安全、有效.     

自拟中药方剂联合水飞蓟宾治疗非酒精性脂肪性肝病患者临床疗效研究

目的 观察自拟中药方剂联合水飞蓟宾治疗非酒精性脂肪性肝病（NAFLD）患者的临床效果。方法 2012年5月~2016年4月我院诊治的NAFLD患者98例,采用随机数字表法分为对照组49例和观察组49例,分别给予水飞蓟宾或水飞蓟宾联合自拟中药方剂治疗,观察3 m。使用流式细胞仪检测外周血调节性T细胞百分比。结果 在治疗3 m末,观察组有效率为98.0%,显著高于对照组的81.6%（P<0.01）;观察组血清ALT、AST和GGT水平分别为38.10±13.92 U/L、42.84±21.9 4U/L和36.07±15.13 U/L,明显低于对照组（59.10±14.23 U/L、63.99±22.51U/L和48.59±13.27 U/L,P<0.01）;观察组TG和TC水平分别为1.28±0.32 mmol/L和4.14±0.64 mmol/L,明显低于对照组（1.83±0.57 mmol/L和5.34±0.51 mmol/L （P<0.05）,但两组调节性T细胞百分比无统计学差异（P>0.05）。结论 自拟中药方剂联合水飞蓟宾治疗NAFLD患者能促进肝功能的改善,降低血脂水平。