Effect of Jianpi Shengxue Tablet on Iron Metabolism and Nutritional Status in Patients with Renal Anemia:A Prospective,Randomized,Open,Parallel Controlled and Multicenter Clinical Study

Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups.Patients in the control group were treated with polysaccharide-iron complex,and those in the experimental group were administered Jianpi Shengxue tablet.After 8 weeks of continuous treatment,the therapeutic outcomes regarding anemia were compared between the two groups.Results After treatment,the red blood cell(RBC)count,hematocrit(HCT),reticulocyte percentage(RET),ferritin(SF),serum iron(SI),transferrin saturation(TSAT),and serum albumin(ALB)all increased(P<0.01),and the clinical symptom score and total iron binding capacity decreased(P<0.01)in the experimental group.Moreover,the improvements in RBC,HCT,RET,SF,SI,TAST,ALB,and clinical symptoms(fatigue,anorexia,dull skin complexion,numbness of hands and feet)in the experimental group were significantly greater than those in the control group(P<0.05).The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group(P<0.01).Conclusion The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia,leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.

Botulinum toxin type A for treating chronic low back pain:A double blinded randomized control study

BACKGROUND Low back pain(LBP)is a prevalent issue that orthopedic surgeons frequently address in the outpatient setting.LBP can arise from various causes,with stiffness in the paraspinal muscles being a notable contributor.The administration of Botulinum toxin type A(BoNT-A)has been found to alleviate back pain by relaxing these stiff muscles.While BoNT-A is approved for use in numerous conditions,a limited number of randomized clinical trials(RCTs)validate its efficacy specifically for treating LBP.AIM To study the safety and the efficacy of BoNT-A in minimizing pain and improving functional outcomes in patients of chronic LBP(CLBP).METHODS In this RCT,adults aged 18-60 years with mechanical LBP persisting for at least six months were enrolled.Participants were allocated to either the Drug group,receiving 200 Ipsen Units(2 mL)of BoNT-A,or the Control group,which received a 2 mL placebo.Over a 2-month follow-up period,both groups were assessed using the Visual Analog Scale(VAS)for pain intensity and the Oswestry Disability Index(ODI)for disability at the start and conclusion of the study.A decrease in pain by 50%was deemed clinically significant.RESULTS The study followed 40 patients for two months,with 20 in each group.A clinically significant reduction in pain was observed in 36 participants.There was a statistically significant decrease in both VAS and ODI scores in the groups at the end of two months.Nonetheless,when comparing the mean score changes,only the reduction in ODI scores(15 in the placebo group vs 16.5 in the drug group,clinically insignificant)was statistically significant(P=0.012),whereas the change in mean VAS scores was not significant(P=0.45).CONCLUSION The study concludes that BoNT-A does not offer a short-term advantage over placebo in reducing pain or improving LBP scores in CLBP patients.

Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial

BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.

Effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸)in the treatment of premenstrual syndrome(liver depression,spleen deficiency,and blood-heat syndrome):a multi-center,randomized,placebo-controlled trial

OBJECTIVE:To investigate the effectiveness and safety of Jiawei Xiaoyao pill(加味逍遥丸,JXP)in the treatment of symptoms associated with premenstrual syndrome(PMS).METHODS:A total of 144 regularly menstruating women with PMS were recruited at 8 sites in China from August 2017 to December 2018,and randomized to receive either a JXP or a matching placebo(12 g/d,6 g twice a day)for 3 menstrual cycles.The primary indicator was the reduced Daily Record of Severity of Problems(DRSP)scores in the luteal phase after 3 months of treatment.The safety outcomes included clinical adverse events(AEs),adverse reactions(ARs),changes in vital signs,and laboratory tests.RESULTS:JXP surpassed the placebo in reducing DRSP scores(psychological/somatic dysfunction)in the luteal phase over 3 menstrual cycles of treatment(PFAS=0.002,PPPS=0.001).Additionally,there were no significant differences in the incidence of AEs,severe AEs,withdrawal due to AEs and ARs between the two groups(all P>0.05),and no clinically significant adverse medical events related to the test drug observed.CONCLUSIONS:JXP was superior to the placebo in relieving the symptoms associated with PMS,which signified that JXP may be effective,safe,and welltolerated as an alternative therapy.

Double-blinded,randomized clinical trial of Gegen Qinlian decoction pinpoints Faecalibacterium as key gut bacteria in alleviating hyperglycemia

Background:Accumulating evidence suggests that metabolic disorders,including type 2 diabetes mellitus(T2DM),can be treated with traditional Chinese medicine formulas,such as the Gegen Qinlian decoction(GQD).This study elucidates the mechanisms by which gut microbes mediate the anti-diabetic effects of GQD.Methods:We conducted a double-blind randomized clinical trial involving 120 untreated participants with T2DM.During the 12-week intervention,anthropometric measurements and diabetic traits were recorded every 4 weeks.Fecal microbiota and serum metabolites were measured before and after the intervention using 16S rDNA sequencing,liquid chromatography-mass spectrometry,and Bio-Plex panels.Results:Anti-diabetic effects were observed in the GQD group in the human trial.Specifically,glycated hemoglobin,fasting plasma glucose,and two-hour postprandial blood glucose levels were significantly lower in the GQD group than in the placebo group.Additionally,Faecalibacterium was significantly enriched in the GQD group,and the short-chain fatty acid levels were higher and the serum inflammation-associated marker levels were lower in the GQD group compared to the placebo group.Moreover,Faecalibacterium abundance negatively correlated with the levels of serum hemoglobin,fasting plasma glucose,and pro-inflammatory cytokines.Finally,the diabetes-alleviating effect of Faecalibacterium was confirmed by oral administration of Faecalibacterium prausnitzi(DSMZ 17677)in T2DMmousemodel.Conclusions:GQD improved type 2 diabetes primarily by modulating the abundance of Faecalibacterium in the gut microbiota,alleviating metabolic disorders and the inflammatory state.

Effect and Safety of Kangfuyan Capsules(抗妇炎胶囊)for Relieving Chronic Pelvic Pain:A Multicenter,Randomized,Controlled,Double-Blind,Parallel-Group Clinical Trial

Objective To evaluate the effect and safety of Kangfuyan Capsules(抗妇炎胶囊)for treating pelvic inflammatory disease(PID)in patients with chronic pelvic pain(CPP)in a multicenter,randomized,controlled,double-blind,parallel-group clinical trial.Methods Totally,240 PID patients with CPP were randomized into 2 groups using a computer generated random number at a 1:1 ratio from 10 hospitals in China between September 2014 and November 2015.Patients received either oral Kangfuyan Capsules or Gongyanping Capsules(宫炎平胶囊,control);the regimen for both groups comprised 4 capsules(3 times daily)for 12 weeks,with follow-up visit 4 weeks after treatment.The visual analogue scale(VAS)scores,clinical responses,remarkable cure rates for each symptom,and quality of life scores were assessed at baseline,and after 1,2,and 3 months.Adverse events were also recorded.Results The VAS scores were significantly lower(P<0.05),whereas the clinical responses,remarkable cure rates for lower abdominal pain,uterine tenderness,adnexal mass,and adnexal tenderness,and Health-related quality of life(EQ-5D)scores were higher in the Kangfuyan group than in the control group at 3 months(P<0.05).Common treatment-related adverse events included high hepatic enzyme levels,reduced hemoglobin levels,and elevated platelet counts,although all the adverse events were either mild or moderate in severity.Conclusion Compared with Gongyanping therapy,Kangfuyan therapy yielded markedly better analgesia effects for CPP caused by PID,with obvious long-term efficacy and good safety.(Registration No.ChiCTR190022732)

Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis:a multi-center parallel-group double-blind randomized controlled trial

OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.

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-to moderate 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 (Aβ 42) were detected with enzyme linked immunosorbent assay kits. The scale assessments were conducted at baseline, the 3rd and 6th months of treatment, respectively. Biochemistry tests were conducted at baseline and the 6th 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 P<0.01). Both treatments remarkably reduced the serum levels of AchE and Aβ 42 (both P<0.05). The CM-SS total effective rate of HYF was significantly higher than donepezil [75.00%(21/28) vs. 54.17%(13/24), P<0.05]. No severe adverse events were observed in both groups. Conclusion: HYF is effective and safe for improving the cognitive function in mild to-moderate AD patients.[Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-IOR-17011746)].

Effectiveness of Jinying capsule on pelvic inflammatory disease in patients with symptom pattern of damp and heat accumulation: a double-blinded, multicenter, randomized, placebo-controlled clinical trial

OBJECTIVE: To evaluate the therapeutic effectiveness and safety of Jinying capsule on pelvic inflammatory disease(PID) in patients with symptoms identified as the pattern of damp and heat accumulation in terms of Traditional Chinese Medicine(TCM).METHODS: We conducted a double-blinded, multicenter, randomized, placebo-controlled clinical trial which included 155 patients diagnosed with PID and identified as symptom pattern of damp and heat accumulation. They were randomly divided into experimental group(n = 78) and control group(n = 77) according to a random number table. The treatment lasted for a period of 28 d. The experimental group was given Jinying capsules and oral levofloxacin plus oral metronidazole for first 7 d.They continued with Jinying capsules and levofloxacin placebo and metronidazole placebo for another 7 d. For the remaining 14 d, they continued with Jinying capsules only. Whereas, the control group was treated with oral levofloxacin and metronidazole and Jinying capsule placebo for the first 14 d in the same way as the experimental group and then continued with Jinying capsule placebo only for the remaining 14 d. The clinical efficacy was assessed using McCormack scale, TCM symptom pattern scores, physicochemical indexes including white blood cell and erythrocyte sedimentation rate, C-reaction protein, smear of vaginal discharge,and pelvic ultrasound.RESULTS: Comparing McCormack scale between both groups after treatment, the difference in curative effect between both groups was significant (P = 0.0269). The cure rate of the experimental group and control group is 76.32% and 59.46% respectively at week 4. Comparing TCM symptom pattern scores between both groups before and after treatment, the differences in total effective rate were both significant(P < 0.05). The curative effect rate of experimental group is 2.63% and 13.70% of the control group at week 1(P = 0.0131), and73.33% of the experimental group and 56.94% of the control group at week 4(P = 0.0369). No significant differences were found between the two groups on the Physicochemical indexes(all P >0.05). No adverse events or reactions occurred in the experimental groups.CONCLUSION: Jinying capsule can reduce the dosage of antibiotics needed for PID treatment, and improve the symptoms in PID patients.

Parallel Subgroup Design of a Randomized Controlled Clinical Trial——Comparing the Approaches of Chinese Medicine and Western Medicine

A new method for the comparison of the treatment efficacy for specific diseases or conditions between Chinese medicine and Western medicine, which serve the same medical aim but are based on substantially different theoretical systems, was identified. Abiding by the principle of parallel subgroup design of a randomized controlled trial （PSD-RCT）, participants were recruited following identical inclusion and exclusion criteria and were randomly allocated into two groups to receive treatment using the respective approaches of Chinese medicine and Western medicine. The Chinese medicine group was divided into subgroups according to the theory of Chinese medicine and the Western medicine group was also divided into subgroups according to the theory of Western medicine. The treatment for each subgroup was well defined in the protocol, including major formulae and principles for individualized modifications. The primary outcome measure was ascertained to be directly related to the patients＇ status but independent from both theories of Chinese medicine and Western medicine, while the secondary outcomes were represented by the patient-reported outcomes and some laboratory tests commonly accepted by Chinese medicine and Western medicine. Then, taking functional dyspepsia as an example, the authors explain the framework of the PSD-RCT for efficacy comparisons between Chinese medicine and Western medicine, and recommend that the PSD-RCT can be used to compare treatment efficacy for a specific disease or condition between Chinese medicine and Western medicine, and the comparison among subgroups can provide valuable clues for further studies.

Efficacy of Huadananshen mistura on insomnia: a randomized, double-blind, placebo-controlled, and multi-center clinical trial

OBJECTIVE: To evaluate the effect of Huadananshen mistura in clinical treatment of Chinese patients with insomnia. METHODS: In this randomized, double-blind, placebo-controlled, multi-center study, 244 patients with insomnia were randomly assigned to a placebo group, a low-dose (10 mL/day), or a high-dose (20 mL/day) mistura group. Efficacy was assessed by using the sleep dysfunction rating scale (SDRS) and Clinical Global Impression-Improvement (CGI-I) scores. Safety and tolerability assessments included emergent adverse events, laboratory tests, and electrocardiograms. RESULTS: Total SDRS scores decreased in all three groups, and there were significant differences between the placebo group and the lowand high-dose mistura groups (P=0.000). CGI-I ratings in the lowand high-dose mistura groups were sig-nificantly better than that of the placebo group (P= 0.000). Incidences of rebound insomnia were similar in all three groups (placebo group: 6.94% , low-dose mistura group: 12.99% , and high-dose mistura group: 10.96% ; P=0.475). The efficacy of Huadananshen mistura in the lowor high-dose group was significantly better than that of the placebo group (P=0.000), but with no significant difference found between the lowand high-dose mistura groups (P=0.887). The rates of adverse events were similar in the three groups (placebo 2.44% , low-dose mistura 0%, and high-dose mistura 5%; P=0.088). CONCLUSION: Huadananshen mistura is an effective and generally well-tolerated hypnotic medicine for the treatment of Chinese patients with insomnia.

Efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder:a randomized,double-blind,controlled trial

OBJECTIVE: To evaluate the clinical efficacy of Zhenjingdingzhi decoction in treating insomnia with Qi-deficiency of heart and gallbladder.METHODS: We conducted a double-blind,randomized,controlled trial involving 100 patients with insomnia of Qi-deficiency of heart and gallbladder.Patients were randomly divided into the treatment group(n = 50) and the control group(n = 50) according to a random number table. The treatment group was given Zhenjingdingzhi decoction,while the control group was treated with Suanzaoren decoction. the pharmacological treatment lasted for 8weeks. The clinical efficacy was assessed by using Spiegel scale,Pittsburgh sleep quality index(PSQI)and Traditional Chinese Medicine(TCM) syndrome scores.RESULTS: Comparing Spiegel scores between the two groups at 4 and 8 weeks,the differences in curative effect between the two groups were both significant(both P < 0.05). The total effective rate was46% in the treatment group and 27.7% in the control group at 4 weeks,and 80% and 53.2% at 8weeks,respectively; After 8 weeks,PSQI scores showed that the total effective rates differed significantly between the two groups(P < 0.01): 84% in the treatment group and 59.6% in the control group; In improving sleep quality and sleep duration,the curative effect of the treatment group was better than that of the control group(P < 0.05).TCM syndrome,especially insomnia and palpitation,was improved better in the treatment group after 8 weeks as compared to that in the control group(P < 0.05). The total effective rate of the two groups was 84% and 66%,respectively.CONCLUSION: Zhenjingdingzhi decoction is effective and safe for the treatment of insomnia with Qi-deficiency of heart and gallbladder,especially for improving sleep quality and sleep duration.

Safety and efficacy of Tongkuaixiao ointment in reliving cancer-induced pain: a multicenter double-blind placebo-controlled randomized trial

OBJECTIVE: To evaluate the safety and efficacy of Tongkuaixiao ointment(TKXO) in treating moderate-to-severe cancer induced somatalgia.METHODS: Totally 130 patients with moderateto-severe cancer induced somatalgia were randomly divided into a TKXO group and a control group.The patients were treated with either TKXO applied externally or placebo, with opioid analgesics orally at the same time. Observation parameters were included numerical rating scale(NRS) scores,analgesic efficacy, initiation effective time, persistent analgesic time, equivalent morphine dose,National Comprehensive Cancer Network(NCCN)grade in Impact of Pain Measurement Scores, and safety and satisfaction extent investigation.RESULTS: NRS scores and NCCN grade in Impact of Pain Measurement Scores decreased significantly after 5-days' treatment in the two groups(P <0.0001). Compared to the control group, initiation effective time was significantly shorter(P < 0.05)and persistent analgesic time was significantly longer(P < 0.01), equivalent oral morphine doses of the first day and the whole treatment course were significantly decreased in the TKXO treatment group(P < 0.01 or P < 0.05). No obvious adverse effects were found in the TKXO group.CONCLUSION: TKXO combined with opioid analgesics possesses the advantages of high efficacy,fast action, long persistent action, safety and convenience in use, and it can reduce the dose of opioid.

Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels： a double-blind placebo-controlled randomized clinical trial

Background： Lipid-lowering effect ofRhus coriaria L. （Rhus） has been investigated in multiple animal stud- ies with promising results. Nonetheless, its clinical efficacy has not been adequately examined. Objective： The aim of this study was to evaluate the lipid-lowering effects of Rhus among patients with hyperlipidemia. Design, setting, participants and interventions： The study was designed as a two-arm, double-blind placebo-controlled randomized clinical trial, using a parallel design. Eighty patients with primary hyper- lipidemia were randomly assigned to receive Rhus capsules or placebo for 6 weeks. Main outcome measures： The serum lipid levels, apolipoprotein-A1 （Apo-A1） and apolipoprotein-B （Apo-B） were measured. Results： Mean serum high-density lipoprotein cholesterol （HDL-C） and Apo-Al levels were significantly increased in the Rhus group, compared with the placebo group, after 6 weeks of intervention （P= 0.001）. The analysis of covariance test including age, gender, body mass index （BMI）, and smoking as co-variables revealed that the increase in HDL-C and Apo-A1 levels remained significant, and increases in HDL-C were dependent on the increase in Apo-A1 levels. No significant difference was observed between Rhus and placebo groups in terms of mean reductions in total cholesterol, low-density lipopro- tein cholesterol and triglyceride levels; however, more significant improvement was observed among obese patients （BMI≥ 30 kg/m^2）. Conclusion： The study showed significant increases in HDL-C and Apo-Al levels in response to Rhus sup- plementation in patients with hyperlipidemia. Trial registration： ClinicalTrials.gov ID： NCT02295293.

眼针对缺血性中风急性期神经功能的随机平行对照研究

目的观察眼针作为独立施加因素治疗缺血性中风急性期神经功能的临床疗效。方法使用随机平行对照方法,将120例处于缺血性中风急性期患者随机分为试验组和对照组。对照组予常规西医基础治疗,试验组在对照组的基础上,予眼针治疗。每日1次,每周5 d,休息2 d。总疗程均2周。以Fugl-Meyer运动功能量表(FMA)评分、美国国立卫生院卒中量表(NHISS)评分、改良Barthel指数及汉密尔顿评分量表(HAMD)评分对两组治疗前后神经功能、肢体运动、日常生活能力及焦虑抑郁情况进行评定。结果两组治疗后FMA评分、Barthel指数、NHISS评分、HAMD评分均较治疗前提高(均P<0.05),试验组治疗后FMA评分、Barthel指数、HAMD评分均优于对照组(均P<0.05),试验组与对照组NHISS评分差异无统计学意义(P>0.05)。结论眼针作为独立施加因素可以改善缺血性中风急性期患者的神经功能,疗效优于常规西医治疗,值得应用及推广。

基于概率Hough线段检测算法的天花板影像边界提取

对天花板影像进行线段检测,传统的概率Hough线段检测有两个问题:随机选取边界点导致效率低下;检测结果中含有平行且邻近的多条线段。论文提出了分块处理和线宽控制两种方法,验证了这两种方法可消除噪点对线段检测效率的影响,避免了天花板影像过检测现象的发生。实验表明新方法能快速提取到可靠、完整的天花板的边缘线段,提高了线段检测的效率和质量。

乌灵胶囊治疗女性更年期焦虑抑郁状态的随机、阳性药平行对照临床试验

背景:更年期焦虑抑郁的发病率逐年上升。精神类药物对本病虽有不错的干预效果,但患者的依从性较差,因此,有必要寻找一种切实有效而又容易被患者接受的药物。目的:评价乌灵胶囊对女性更年期综合征伴抑郁、焦虑状态患者的临床疗效。设计、场所、对象和干预措施:收集就诊于复旦大学华山医院中西医结合妇科、上海中医药大学龙华医院中医妇科以及复旦大学妇产科医院中医科门诊的更年期征合征伴焦虚抑郁的病例共96例。采用随机、阳性药平行对照的方法,64例为治疗组,口服乌灵胶囊;32例为对照组,口服更年安片。主要结局指标:两组在治疗前及治疗后第3周、第6周分别以 Kupperman 评分表、抑郁自评量表(Self-ratingDepression Scale,SDS)及焦虑自评量表(Self-rating Anxiety Scale,SAS)进行评估。结果:治疗组和对照组的临床总有效率分别为89.66%(52/58)、76.67%(23/30),Ridit 检验显示治疗组总有效率更高,差异有统计学意义(P<0.05)。两组治疗后 Kupperman 评分均低于治疗前(P<0.01);两组治疗后的 SAS 和 SDS 的评分也显著改善(P<0.01),经协方差分析,治疗组在用药第3周和第6周时 SAS评分的改善程度优于对照组(P<0.05,P<0.01),治疗组用药第6周时 SDS 评分改善程度优于对照组(P<0.05)。结论:乌灵胶囊和更年安片均适合于女性更年期综合征伴焦虑、抑郁状态的治疗。乌灵胶囊在某些时相对SAS 和 SDS 评分的改善程度优于更年安片,在缓解抑郁和焦虑状态方面,乌灵胶囊疗效更好一些。

头孢美唑钠治疗呼吸系统急性细菌性感染疗效观察

目的:评价国产注射用头孢美唑钠治疗中、重度呼吸系统细菌性感染的临床疗效和安全性。方法:采用双盲、随机、平行对照试验设计,以进口头孢美唑钠为对照药物。两组均为每次静脉滴注给药2.0g,q12h,疗程均为5～12天。结果:本次试验共入选病例数为48例,两组各为24例。可纳入临床疗效分析的病例数为46例,试验组24例,对照组22例。治疗结束时试验组和对照组临床有效率分别为75.0%和81.82%,两组细菌清除率分别为88.89%,81.25%,不良反应发生率分别为8.33%、16.67%。以上结果经统计学处理均无显著性差异。结论:国产头孢美唑钠注射剂治疗细菌性呼吸系统感染临床疗效确切,安全性好。

焦虑障碍伴糖调节受损帕罗西汀联合团体心理治疗的随机双盲对照研究

目的:比较帕罗西汀联合团体心理治疗与单用帕罗西汀治疗焦虑障碍伴糖调节受损患者的疗效。方法:本研究为随机双盲对照研究。选取52例符合国际疾病和相关健康问题统计分类第十版(ICD-10)焦虑障碍(包括惊恐障碍、广泛性焦虑障碍)诊断标准,同时伴有糖调节受损的患者,随机分为两组,每组26例,一组给予帕罗西汀联合团体心理治疗(团体+药物组),另一组单用帕罗西汀治疗(药物组),疗程6个月。采用Zung焦虑自评量表(SAS)评定焦虑症状及改善情况,检测空腹血糖(FPG)、葡萄糖耐量试验(OGTT)后2 h血糖(2hPG)和糖化血红蛋白(HbA1C)、空腹胰岛素(FINS)并计算胰岛素抵抗指数(HOMA-IR)来评价糖代谢和胰岛素抵抗水平,采用药物副反应量表(TESS)评定安全性。结果:治疗6个月后,两组的FPG、2hPG、HbA1C、FINS、HOMA-IR及SAS评分均低于治疗前(均P<0.05);团体+药物组较药物组的2hPG、FINS、HOMA-IR、SAS评分降低更明显[(7.5±1.1)vs.(8.3±1.4),(8.3±1.3)vs.(9.9±1.6),(1.9±0.3)vs.(2.3±0.4),(41.2±4.5)vs.(45.3±5.7);均P<0.05]。治疗后两组间FPG、HbA1C下降差异无统计学意义(P>0.05)。两组TESS评分差异无统计学意义(P>0.05)。结论:本研究提示,帕罗西汀联合团体心理治疗较单用帕罗西汀能更有效地降低焦虑障碍伴糖调节受损患者的餐后血糖水平,改善焦虑症状,提高胰岛素敏感性。

急性湿疹辨证施治和氯雷他定随机平行对照研究

目的:通过随机对照研究,观察中医辨证治疗急性湿疹(含慢性湿疹急性发作)4种主症的临床疗效。方法:选择100例急性湿疹患者,随机分为治疗组50例和对照组50例。治疗组按辨证给予固定方剂内服,对照组给予氯雷他定。观察主要症状、体征疗效、起效时间、治疗前后缓解程度及同证型疗效。结果:改善瘙痒症状;对红斑及水疱的起效时间;缩短瘙痒、丘疹病程方面,中药组优于西药组(P<0.05)。中药对脾虚湿盛证主症瘙痒与红斑的治疗效果优于西药(P<0.05)。结论:中医辨证治疗对缓解急性湿疹皮肤主症有明显疗效。