Huangqi Guizhi Wuwu Decoction for treating diabetic peripheral neuropathy：a meta-analysis of 16 randomized controlled trials

OBJECTIVE：This meta-analysis was performed to systematically assess the efficacy and safety of the Chinese herbal medicine Huangqi Guizhi Wuwu Decoction（HGWWD） for treating diabetic peripheral neuropathy.DATA SOURCES：Six electronic databases,including the Cochrane Library,MEDLINE database,Chinese Biomedical Database,Chinese National Knowledge Infrastructure Database,Chinese Science and Technique Journals Database,and the Wanfang Database,were search ed on the internet for randomized controlled trials published up until 1 December 2015.The search terms included ＂Chinese herbal medicine＂,＂diabetic peripheral neuropathy＂ and ＂randomized controlled trials＂ in Chinese and in English.DATA SELECTION：We included randomized controlled trials using HGWWD/modified HGWWD for the treatment group,without restriction for the control group.We assessed literature quality in accordance with the Cochrane Review Handbook.A random or a fixed effects model was used to analyze outcomes using Rev Man 5.2 software.OUTCOME MEASURES：The primary outcomes were changes in symptoms and nerve conduction velocities.The secondary outcomeswere fasting blood glucose and hemorheological indexes.RESULTS：Sixteen randomized controlled trials,with a total of 1,173 patients,were included.Meta-analysis revealed that the efficacy of HGWWD for diabetic peripheral neuropathy was significantly superior compared with the control treatment（i.e.,control group）（risk ratio = 0.36,95% confidence interval（CI）：0.29–0.46,Z =8.33,P 〈 0.00001） Compared with the control group,there was an increase in median motor nerve conduction velocity（mean difference（MD） = 3.46,95%CI：1.88–5.04,Z = 4.30,P 〈 0.01） and median sensory nerve conduction velocity（MD = 3.30,95%CI：2.04–4.56,Z = 5.14,P 〈 0.01）.There was also an increase in peroneal motor nerve conduction velocity（MD = 3.22,95%CI：2.45–3.98,Z = 8.21,P 〈 0.01） and peroneal sensory nerve conduction velocity（MD = 3.05,95%CI：2.01–4.09,Z = 5.75,P 〈 0.01） in the treatment groups.No significant difference in fasting blood glucose was found between the treatment groups and the control groups（MD =-0.12,95%CI：-0.42–0.19,Z = 0.76,P = 0.45）.Plasma viscosity was significantly decreased after treatment（MD =-0.11,95%CI：-0.21 to-0.02,Z = 2.30,P = 0.02）.No significant difference in fibrinogen was detectable（MD =-0.53,95%CI：-1.28–0.22,Z = 1.38,P = 0.17）.Four trials reported that treatment groups experienced no adverse reactions.Adverse events were not mentioned in the other 12 trials.No trial reported the incidence of complications,quality of life outcomes,or health economics.CONCLUSION：HGWWD treatment improves diabetic neurologic symptoms and ameliorates nerve conduction velocities.Our study suggests that HGWWD may have significant therapeutic efficacy for the treatment of diabetic peripheral neuropathy.However,the methodological quality of the randomized controlled trials was generally low.Larger and better-designed randomized controlled trials are required to more reliably assess the clinical effectiveness of HGWWD.

Acupuncture for cerebral palsy: a meta-analysis of randomized controlled trials

OBJECTIVE： To evaluate the efficacy and safety of acupuncture therapy for children with cerebral palsy. DATA SOURCES： We conducted electronic searches of PUBMED（1950/2017）, EMBASE（1974/2017）, Science Direct（1986/2017）, Academic Source Premier（1887/2017）, the Cochrane Library（Issue 4, April 2017）, Science Citation Index Expanded（1900/2017）, China National Knowledge Infrastructure（1915/2017）, China Biological Medicine（1990/2017-04）, Wan Fang（1980/2017）, VIP（1989/2017）, and Chinese Science Citation Database（1989/2017）. DATA SELECTION： We included randomized controlled trials that aimed to compare the effect of acupuncture plus rehabilitation training versus rehabilitation training alone. Data about functional motor abilities, daily activity/social participation, effective rate, intellectual development, and adverse effects were included. We used Revman 5.2 software for statistical analysis. OUTCOME MEASURES： The primary outcomes included functional motor abilities, daily activity, and effective rate. The secondary outcomes included intellectual development and adverse effects.RESULTS： Twenty-one studies with a total of 1718 participants met the inclusion criteria. The effect size of gross motor function（SMD = 0.64, 95% CI： 0.52 to 0.76, P 〈 0.00001; I^2 = 0%, P = 0.69; in 13 studies with 1144 patients） and the total effective rate（RR = 1.28, 95% CI： 1.20 to 1.37, P 〈 0.00001; I^2 = 18%, P = 0.27; in 12 studies with 1106 patients） suggested that acupuncture plus rehabilitation produced a significant improvement in gross motor function and a high total effective rate. The pooled fine motor function（SMD = 3.48, 95% CI： 2.62 to 4.34, P 〈 0.00001; I^2 = 64%, P = 0.10; in 2 studies with 193 patients）, modified Ashworth scale scores（SMD = –0.31, 95% CI： –0.52 to –0.11, P = 0.003; I^2 = 74%, P = 0.004; in 5 studies with 363 patients） and activities of daily living（SMD = 1.45, 95% CI： 1.20 to 1.71, P 〈 0.00001; I^2 = 78%, P = 0.004; in 4 studies with 313 patients） also indicated improvements in children with cerebral palsy. Publication bias was not observed. Only mild adverse events related to acupuncture were reported. CONCLUSION： Acupuncture plus rehabilitation training improved gross motor function, reduced muscle spasms, and enhanced daily life activities in children with cerebral palsy. However, this conclusion should be interpreted with caution due to the small number of randomized controlled trials available and the small sample sizes. More high-quality and large-scale studies are needed.

Safety and efficacy of intraperitoneal perfusion with tumor vesicle-encapsulated methotrexate for the treatment of cancerous ascites - an open, randomized and controlled clinical trial

Background:Cancerous ascites is a common and severe complication that occurs in patients with late-stage malignant tumors.The prognosis of cancerous ascites is poor,clinical treatment is difficult and therapeutic outcome is disappointing.In the present study,tumor cell-derived vesicles were used as drug delivery vehicles that encapsulated a chemotherapeutic agent and were perfused into a patients’abdominal cavity to effectively kill the cancer cells in cancerous ascites.Pre-clinical data has demonstrated that tumor vesicles that carry low-dose chemotherapeutics can efficiently eliminate metastatic tumor cells in the abdominal cavity with minimal toxic or adverse effects.When combined,tumor cell-derived vesicles can sensitize tumor cells,which facilitates the entry of chemotherapeutics into tumor cells,thereby enhancing killing of tumor cells and limiting the risk of drug resistance.In this study,we designed a clinical trial to evaluate the safety and efficacy of intraperitoneal perfusion with tumor vesicle-encapsulated methotrexate for the treatment of cancerous ascites.Methods:Sixty patients with cancerous ascites were enrolled in this open,randomized and controlled clinical trial.Participants were randomly assigned a visit number and,according to their visiting order for which a random numerical table was used,were assigned to the trial group or the control group in a 1:1 ratio.The change in ascetic volume was used as the study outcome and adverse events were monitored during the entire length of the study.Conclusion:In this clinical trial,randomization and electronic case report forms were implemented.The trial indicated that tumor vesicle-encapsulated methotrexate was proposed to be a safe and effective method for treating malignant ascites.Our study may provide at the first time evidence for the clinical application of tumor vesicles in tumor therapy.

Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill (冠心苏合丸) for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial

Objective To assess the clinical effectiveness of acupoint application(AP)of Guan Xin Su He Pill(冠心苏合丸,GXSHP)for patients with chronic stable angina pectoris(CSAP).Methods This study was carried out in 3 local hospitals in Chengdu,China.After baseline evaluation,eligible patients were randomly assigned to the placebo application for acupoints(PAA)group or the herbal application for acupoints(HAA)group.Patients in the HAA group underwent AP with herbal powder,which was mainly GXSHP,and patients in the PAA group underwent AP with sham drugs.For each treatment session,unilateral acupoints including Neiguan(PC 6),Danzhong(RN 17),Xinshu(BL 15)and Jueyinshu(BL 14),were stimulated for both groups.AP was performed 3 times a week with a 2-day interval for 4 weeks.The primary outcome was the frequency of angina pectoris attacks per week,while the secondary outcomes included angina pain intensity measured by the Visual Analogue Scale(VAS),dose of rescue oral drugs(nitroglycerin),scores on the Seattle Angina Questionnaire(SAQ),Self-Rating Anxiety Scale scores(SAS)and Self-Rating Depression Scale scores(SDS).Clinical outcomes were measured at week 0,4 and 8.The safety of AP of GXSHP treatment for CSAP were assessed.Results A total of 121 patients were enrolled.Baseline characteristics were comparable across the 2 groups.After treatment,the angina attack numbers in the HAA group were significantly reduced from 11.00 to 4.81(P<0.05).While,for PAA group,the angina frequency was not significantly improved(baseline 10.55;post-treatment 11.05).The HAA group had significantly fewer angina attacks than the PAA group(P<0.05).Pain intensity measured by VAS in HAA group was significantly reduced from 4.06 to 3.02(P<0.05).While,for PAA group,the VAS was significantly increased(baseline 3.62;post-treatment 3.96;P<0.05).Clinical outcomes showed better improvement after treatment in the HAA group than in the PAA group in terms of oral administration of rescue drugs,SAS,SDS and SAQ scores(P<0.05).The adverse events were also reported.Conclusion AP of GXSHP is a safe and effective treatment for CSAP patients(Registration No.NCT02029118).

Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial

Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.

Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study

AIM To assess the efficacy and safety of a Chinese herbal medicine(CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia(FD). METHODS We performed a randomized, double-blind, placebocontrolled trial with patients from three centers. Two hundred and sixteen subjects diagnosed with FD according to ROME Ⅲ criteria and confirmed by upper gastrointestinal endoscopy and spleen-deficiency and Qi-stagnation syndrome were selected to receive Xiangsha Liujunzi granules or placebo for 4 wk in a 2:1 ratio by blocked randomization. The subjects also received follow-up after the 4-wk intervention. Herbal or placebo granules were dissolved in 300 m L of water. Participants in both groups were administered 130 m L(45 ℃) three times a day. Participants were evaluated prior to and following 4 wk of the intervention in terms of changes in the postprandial discomfort severity scale(PDSS) score, clinical global impression(CGI) scale score, hospital anxiety and depression scale(HADS) score, traditional Chinese medicine symptoms score(SS), scores of various domains of the 36-item short form health survey(SF-36), gastric emptying(GE) and any observed adverse effects. RESULTS Compared with the placebo group, patients in the CHM group showed significant improvements in the scores of PDSS, HADS, SS, SF-36 and CGI scale(P < 0.05 or P < 0.01). They also showed the amelioration in the GE rates of the proximal stomach and distal stomach(P < 0.05 or P < 0.01).CONCLUSION Xiangsha Liujunzi granules offered significant symptomatic improvement in patients with FD.

Pain reduction and adverse effects of intravenous metoclopramide for acute migraine attack: A systematic review and meta-analysis of randomized-controlled trials

BACKGROUND Metoclopramide may be used to treat people suffering from acute migraine.However,no comprehensive investigation on this issue has been recorded.This review will provide more solid evidence for the use of metoclopramide in treating acute migraine.AIM To compare the efficacy of intravenous metoclopramide with other therapies in migraine attack treatment in an emergency department(ED).METHODS We included randomized controlled trials of participants older than 18 years with acute migraine headaches,which included at least one arm that received intravenous(IV)metoclopramide at the ED.A literature search of PubMed,Web of Science,Cochrane Collaboration,and Reference Citation Analysis on December 31,2021 retrieved other drugs or placebo-controlled studies without language limitation.The risk of bias was assessed using the Cochrane risk of bias tool.The primary endpoint was pain reduction at 60 min or closest to 1 h after treatment,as measured by the pain scale.Secondary endpoints included adverse effects or reactions resulting from metoclopramide or comparisons.RESULTS Fourteen trials with a total of 1661 individuals were eligible for review.The risk of bias ranged from low to intermediate.IV metoclopramide administration was not associated with higher pain reduction at 1 h(Standard mean difference[SMD]=-0.03,95%confidence interval[CI]:-0.33-0.28,P=0.87).However,metoclopramide was associated with better pain reduction than placebo(SMD=1.04,95%CI:0.50-1.58,P=0.0002).In addition,side effects were not significantly different between IV metoclopramide and other drugs or placebo(odds ratio[OR]=0.76,95%CI:0.48-1.19,P=0.09 and OR=0.92,95%CI:0.31-2.74,P=0.54,respectively).CONCLUSION Metoclopramide is more effective than placebo in treating migraine in the ED.Despite the observed tendency of decreased side effects,its effectiveness compared to other regimens is poorly understood.More research on this area is needed to treat migraine in acute care settings effectively.

益肾固疏方干预老年性骨质疏松症患者骨代谢标志物的变化及临床疗效

背景:随着疾病治疗模式的改变及近年来对老年性骨质疏松症研究的深入,越来越多的研究证实中医药在防治老年性骨质疏松症方面的效果显著。目的:探讨益肾固疏方对肾虚血瘀型老年性骨质疏松症患者骨代谢标志物的影响。方法:选择2020年7月至2022年3月广西中医药大学附属瑞康医院收治的肾虚血瘀型老年性骨质疏松症患者102例,其中男32例,女70例,年龄71-93岁。采用随机数字表法将102例患者分为试验组及对照组,每组51例,对照组给予碳酸钙D3颗粒+阿仑磷酸钠片治疗,治疗组给予碳酸钙D3颗粒+阿仑磷酸钠片+益肾固疏方治疗,连续治疗3个月。治疗前及治疗3个月后,检测两组患者L_(1-4)椎体与左侧股骨颈骨密度,评估目测类比评分,检测血清骨钙素、骨桥素、Ⅰ型胶原交联C-末端肽及抗酒石酸酸性磷酸酶水平,评估中医证候积分与治疗有效率。结果与结论:①两组治疗3个月后的L1-4椎体与左侧股骨颈骨密度均高于治疗前(P<0.05),试验组治疗3个月后的L1-4椎体与左侧股骨颈骨密度均高于对照组(P<0.05);②两组治疗3个月后的目测类比评分均低于治疗前(P<0.05),试验组治疗3个月后的目测类比评分低于对照组(P<0.05);③两组治疗3个月后的血清骨钙素、骨桥素、Ⅰ型胶原交联C-末端肽及抗酒石酸酸性磷酸酶水平均较治疗前明显改善(P<0.05),试验组治疗3个月后的血清骨钙素、骨桥素水平高于对照组(P<0.05),Ⅰ型胶原交联C-末端肽及抗酒石酸酸性磷酸酶水平低于对照组(P<0.05);④两组治疗3个月后的中医证候总评分均低于治疗前,试验组治疗3个月后的中医证候总评分低于对照组;治疗3个月后,两组均未发生明显不良反应,试验组于对照组治疗总有效率分别为88.2%,70.6%,组间比较差异有显著性意义(P<0.05);⑤结果显示,益肾固疏方联合抗骨质疏松药物可通过调节骨代谢、提高骨密度、减轻患者病痛来显著改善肾虚血瘀型老年性骨质疏松症患者的临床症状,阻止疾病的进一步发展。

芪胶升白胶囊防治恶性肿瘤放化疗后骨髓抑制临床疗效Meta分析

目的系统评价芪胶升白胶囊防治恶性肿瘤放射治疗和化学治疗(简称放化疗)后骨髓抑制的临床疗效,为临床用药提供参考。方法采用计算机检索中国知网(CNKI)、万方(WanFang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Web of Science、The Cochrane Library等数据库中关于芪胶升白胶囊防治恶性肿瘤放化疗后骨髓抑制的随机对照试验(RCT),检索时限为自建库起至2023年4月22日。采用改良的Jadad量表对纳入文献进行质量评价,采用RevMan 5.4软件进行Meta分析。结果共纳入25项RCT,涉及患者2754例,其中试验组1466例,对照组1288例。Meta分析结果显示,予芪胶升白胶囊的试验组患者的总体骨髓抑制率[OR=0.27,95%CI(0.21,0.35),P<0.00001],Ⅲ-Ⅳ级骨髓抑制率[OR=0.23,95%CI(0.16,0.34),P<0.00001],白细胞[MD=1.18,95%CI(0.98,1.38),P<0.00001],血小板[MD=14.06,95%CI(12.95,15.16),P<0.00001],血红蛋白[MD=0.98,95%CI(0.87,1.09),P<0.00001],卡氏评分体系(KPS)评分改善率[OR=2.65,95%CI(1.90,3.70),P<0.00001],KPS评分[MD=6.13,95%CI(4.48,7.79),P<0.00001]的改善效果均显著优于对照组。结论芪胶升白胶囊可有效降低恶性肿瘤患者放化疗后的总体骨髓抑制率、Ⅲ-Ⅳ级骨髓抑制率,升高KPS评分、白细胞、血红蛋白、血小板,改善骨髓抑制情况。

陆氏健脾和胃针刺法治疗代谢综合征的随机对照研究

目的:观察陆氏健脾和胃针刺法治疗代谢综合征(MetS)的临床疗效。方法:选取2020年3月至2022年3月于上海市第七人民医院就诊的MetS患者90例作为研究对象,按照随机数字表法分为观察组和对照组,每组45例。对照组采用健康宣教及常规药物治疗,观察组在此基础上加用陆氏健脾和胃针刺法。比较2组患者治疗前后体质量、腰围、体质量指数(BMI)、血脂、血糖、血压的变化。结果:意向性治疗(ITT)分析结果显示,2组患者各时间点体质量、腰围及BMI均较治疗前显著降低(P<0.05),且观察组各时间点体质量、腰围及BMI显著低于对照组(P<0.05);2组患者治疗后血清总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)均较治疗前下降(P<0.05),高密度脂蛋白胆固醇(HDL-C)明显上升(P<0.05),治疗后观察组TC、TG、HDL-C变化幅度较对照组更显著(P<0.05);2组患者治疗后空腹血糖(FBG)、糖化血红蛋白(HbA1c)及胰岛素抵抗指数(HOMA-IR)均比治疗前降低(P<0.05),治疗后观察组FPG、HbA1c及HOMA-IR值均比对照组降低明显(P<0.05)。2组患者治疗前后血压指标无明显变化(P>0.05),针刺期待值与临床疗效无明显相关性(P>0.05)。结论:陆氏健脾和胃法针刺法能有效降低MetS患者的体质量、腰围、BMI,改善血脂、血糖水平,并且具有良好的远期疗效。

基于网状Meta分析对8个经典名方治疗不稳定型心绞痛的临床疗效评价

目的:运用网状Meta分析方法系统评价8种经典名方联合西医常规治疗不稳定型心绞痛(UAP)的临床疗效,并分别进一步比较不同经典名方治疗实证和虚证(包括虚实夹杂)2大证型的疗效。方法:检索并筛选中文科技期刊数据库(CCD)、中国生物医学文献数据库(CBM)、中国国家知识基础设施数据库(CNKI)与中国学术期刊数据库(CSPD)等数据库中关于8个经典名方(血府逐瘀汤、补阳还五汤、四妙勇安汤、丹参饮、炙甘草汤、枳实薤白桂枝汤、瓜蒌薤白半夏汤、化痰祛瘀通脉汤)联合西医常规治疗UAP的随机对照试验(RCT),检索时限从各数据库建库至2022年1月14日,采用Stata 16.0软件进行网状Meta分析。结果:共纳入60个RCT,总计5088例UAP患者,涉及9种干预措施。其中,UAP属实证的有41个RCT,UAP患者共3432例,涉及5种干预措施;虚证或虚实夹杂共13个,共1130例患者,涉及4种干预措施。网状Meta分析结果提示,枳实薤白桂枝汤+西医常规治疗总有效率最优,UAP属实证者,四妙勇安汤+西医常规治疗最佳;虚证或虚实夹杂者,补阳还五汤+西医常规治疗最佳;心电图改善方面,四妙勇安汤疗效最佳;枳实薤白桂枝汤+西医常规在降低超敏C反应蛋白(hs-CRP)改善炎症反应方面更优。结论:与西医常规治疗UAP比较,枳实薤白桂枝汤联合西药常规治疗疗效较显著。但仍需要纳入更多高质量的RCT证实。

补中益气汤加减治疗女性压力性尿失禁的有效性及安全性Meta分析

目的系统评价补中益气汤加减治疗女性压力性尿失禁(Stress urinary incontinence,SUI)的有效性及安全性。方法检索中国知网(CNKI),万方(Wanfang),维普资讯中文科技期刊(VIP),中国生物医学(CBM),PubMed,Cochrane Library,EMbase数据库建库至2023年3月1日期间补中益气汤加减治疗女性SUI的随机对照试验,筛选文献,并提取资料后,使用RevMan 5.4软件对纳入研究内容进行Meta分析。结果最终有28篇文献符合纳入标准,经统计共3506例患者,Meta分析结果显示,补中益气汤加减联合西医传统治疗在提高临床有效率(RR=1.27,95%CI[1.22,1.32],P<0.00001)、I-QOL评分(MD=-1.24,95%CI[-1.67,-0.81],P<0.00001),降低1 h尿垫试验漏尿量(MD=-1.75,95%CI[-2.73,-0.77],P=0.0004)、ICI-Q-SF评分(MD=-1.24,95%CI[-1.67,-0.81],P<0.00001)、24 h尿失禁次数(MD=-1.16,95%CI[-2.06,-0.26],P=0.01)方面均优于单纯西医传统治疗;有8篇文献提及不良反应,主要为胃肠不适。结论补中益气汤加减治疗女性SUI有效性显著安全性高,但确切疗效仍有待临床开展大规模、多中心、高质量RCT研究进一步证实。

多烯磷脂酰胆碱注射液治疗酒精性肝病的系统评价与Meta分析

目的系统评价多烯磷脂酰胆碱注射液治疗酒精性肝病(ALD)的有效性和安全性。方法计算机检索PubMed、Embase、the Cochrane Library、ClinicalTrial.gov、中国知网、SinoMed、维普和万方数据库,搜集有关多烯磷脂酰胆碱注射液治疗ALD的随机对照临床试验(RCT),检索时限均为建库至2022年12月31日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,使用Stata 17.0软件进行随机效应模型的Meta分析。结果最终纳入10个RCT,包含809例患者。Meta分析结果显示,多烯磷脂酰胆碱注射液组的有效率高于对照组[RR=1.12,95%CI(1.04,1.20),P=0.0038];与对照组相比,多烯磷脂酰胆碱注射液可以降低丙氨酸氨基转移酶(ALT)水平[MD=-18.92 U/L,95%CI(-27.75,-10.09),P<0.001]、天门冬氨酸氨基转移酶(AST)水平[MD=-31.19 U/L,95%CI(-46.27,-16.11),P=0.0001]、总胆红素(TBiL)水平[MD=-7.31μmol/L,95%CI(-10.75,-3.88),P<0.001]和γ-谷氨酰转肽酶(GGT)水平[MD=-48.93 U/L,95%CI(-54.64,-43.21),P<0.001]。仅1项研究报告了轻度的不良反应,6项研究均报告患者未出现明显不良反应。结论当前证据显示,多烯磷脂酰胆碱注射液治疗ALD可以提高有效率,改善肝功能指标(ALT、AST、TBiL、GGT)的水平,不良反应较少。受纳入研究数量和质量的限制,上述结论尚需开展更多高质量研究予以验证。

豨莶通栓制剂联合西医常规疗法治疗急性缺血性脑卒中Meta分析

目的对豨莶通栓胶囊/丸治疗缺血性脑卒中的疗效进行系统评价。方法计算机检索中国知识资源总库(CNKI)、中国生物医学文献服务系统(SinoMed)、中文科技期刊数据库(VIP)、中国学术期刊数据库(Wanfang Data)、PubMed、Medline、Embase、Cochrane Library、Web of Science建库至2023年2月28日豨莶通栓制剂联合西医常规疗法治疗急性缺血性脑卒中相关文献,对可量化分析的研究作Meta分析,对有效率和其他疗效指标进行合并。结果共纳入7篇文献用于Meta分析。结果显示,西医常规疗法治疗急性缺血性脑卒中加用豨莶通栓胶囊/丸剂有效率(RR=0.34,95%CI[0.23,0.51],P<0.01)、美国国立卫生研究院卒中量表(NIHSS)评分(MD=-2.90,95%CI[-3.74,-2.06],P<0.01)、日常生活活动能力量表(BI)评分(MD=-10.08,95%CI[-13.47,-6.68],P<0.01)、纤维蛋白原(MD=-1.18,95%CI[-1.59,-0.77],P<0.01)差异有统计学意义,白细胞介素-6(MD=-15.4,95%CI[-33.3,2.49],P=0.09)差异无统计学意义。不同剂型和用药疗程对有效率和NIHSS评分的影响差异无统计学意义。结论联合使用豨莶通栓胶囊/丸可更好地改善急性缺血性脑卒中患者的NIHSS和BI评分,辅助患者的神经功能恢复,还可通过减少纤维蛋白原含量改善血液的高凝状态风险,且安全性良好。

近十年电针治疗失眠的临床研究综述

目的:评述近十年电针治疗失眠的临床研究现状。方法:检索国家知识基础设施数据库(CNKI)、中国生物医学文献数据库(CBM)、中国学术期刊数据库(CSPD)及中文科技期刊数据库(CCD)、PubMed、Cochrane Library、Embase关于电针治疗失眠的随机对照试验。检索年限从2012年1月1日至2021年12月31日。提取文献诊断标准、治疗方法、腧穴选择与归经、电针参数、治疗时间与疗程、疗效观察指标等。结果:共纳入文献55篇。研究发现电针治疗失眠干预手段主要分为单纯使用电针、电针配合其他外治法、电针配合口服药3类。诊断标准及疗效评价指标的使用缺乏统一标准,治疗方法差异较大,实验设计不够完善。选取穴位以足太阳膀胱经、督脉、足少阳胆经、足阳明胃经所属经穴较多,多位于头部、四肢末端及背部。结论:目前电针治疗失眠的临床研究总体质量偏低,在诊断标准、治疗方法、疗效评价指标及试验设计方面都不甚完善,影响临床研究结果的可重复性及临床结论可信度。

脾胃培源方加减联合针刺治疗慢性萎缩性胃炎伴肠化生效果的多中心临床随机对照试验

背景慢性萎缩性胃炎(CAG)伴肠化生(IM)是胃癌的独立危险因素,长期的炎症与氧化应激反应刺激患者的身心状态。现代医疗模式下质子泵抑制剂和胃黏膜保护剂满足不了患者的高抗药性,寻求有效的中医新疗法、多手段治疗CAG伴IM已迫在眉睫。目的评价中药复方脾胃培源方加减联合针刺治疗CAG伴IM临床疗效及其安全性。方法选取2022年1月—2023年9月就诊于安徽中医药大学第二附属医院脾胃科、治未病中心和北京中医药大学第三附属医院经胃镜及病理组织检查确诊结果为CAG伴IM患者202例,采用随机数字表法分为对照组67例,治疗组A 68例,治疗组B 67例,均参与6周治疗。(1)对照组:铝镁加混悬液联合叶酸片(3次/d);(2)治疗组A:予脾胃培源方分证型加减(2次/d);(3)治疗组B:脾胃培源方(用法同组A)联合针刺(1次/d),以足三里、梁丘、公孙、内关、中脘为主穴,据证型选用配穴。治疗前及治疗6周后记录OLGA、OLGIM分期,胃黏膜病理疗效,胃黏膜病理评分,临床症状评分,患者报告结局(PRO)量表评分,药物相关不良事件(AE)和药物不良反应(ADR)情况。结果完成6周疗程的患者共192例(对照组:62例,治疗组A:66例,治疗组B:64例)患者。对照组有效率为48.39%(30/62),治疗组A有效率为69.70%(46/66),治疗组B有效率为71.88%(46/64);三组有效率比较,差异有统计学意义(χ^(2)=9.144,P=0.01)。三组治疗后胃黏膜病理评分、临床症状评分、PRO量表评分均较同组治疗前降低(P<0.05)。胃黏膜病理评分:治疗组A和治疗组B慢性炎症、萎缩、IM评分均低于对照组,活动性炎症、发育不良评分均高于对照组(P<0.05)。临床症状评分:治疗组A和治疗组B胃脘胀满、胃脘痛评分均低于对照组(P<0.05)。PRO量表评分:治疗组A和治疗组B反酸、消化不良、排便、心理状态、全身症状及总分均低于对照组(P<0.05)。三组AE、ADR发生率比较,差异均无统计学意义(P>0.05)。结论脾胃培源方联合针刺治疗CAG伴IM的总体临床疗效优于铝镁加混悬液联合叶酸片,比传统抗酸剂与胃黏膜保护剂效果更佳。

康复新液在消化内镜术后患者中应用效果和安全性的Meta分析

目的系统评价康复新液联合常规治疗在消化内镜术后患者中的应用效果与安全性。方法计算机检索PubMed、Embase、Cochrane Library、CNKI、WanFang Data、VIP数据库,搜集关于消化内镜术后应用康复新液的随机对照试验(RCT),检索时限均从建库至2023年12月31日,由2名研究者独立筛选文献、提取数据并评价纳入研究的偏倚风险后,使用RevMan 5.3和Stata 14软件进行Meta分析。结果共纳入14个RCT,包括1359例患者。Meta分析结果显示,与常规治疗组相比,康复新液联用组可以提高术后溃疡完全愈合率[RR=1.32,95%CI(1.07,1.61),P=0.009]、术后临床症状缓解率[RR=1.20,95%CI(1.13,1.27),P<0.001],但2组的不良反应发生率差异无统计学意义(P>0.05)。亚组分析显示,康复新液联用组术后2周的溃疡完全愈合率高于常规治疗组[RR=1.56,95%CI(1.28,1.92),P<0.001],但2组术后4周的溃疡完全愈合率差异无统计学意义(P>0.05);康复新液口服给药组[RR=1.19,95%CI(1.11,1.27),P<0.001]或经内镜外用喷洒给药组[RR=1.23,95%CI(1.09,1.39),P<0.001]的临床症状缓解率均高于常规治疗组。结论消化内镜术后常规用药基础上联合康复新液治疗可进一步提高患者的临床疗效,尤其是促进术后2周内溃疡完全愈合、缓解术后临床症状方面效果较好,但能否降低药品不良反应发生率的证据不足。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

音乐疗法对抑郁情绪的影响

目的探讨音乐疗法对抑郁症患者情绪的影响。方法选取2018年9月至2019年9月在河北医科大学第一医院精神卫生中心住院的102例抑郁症患者作为研究对象,采用随机数字表法随机分为对照组和研究组,每组51例。研究组采用音乐疗法联合抗抑郁(SSRIs)药物治疗,对照组单独SSRIs药物治疗,采用HAMD量表对患者抑郁情绪的严重程度进行评估。获取患者基本人口学资料:性别、年龄、性格、合并症、发作次数、职业、文化程度、婚姻状况、家庭经济状况等。在基线、治疗第1周、治疗第2周、治疗第4周采用HAMD量表评估患者抑郁情绪的严重程度。结果不同时间点HAMD差异有统计学意义(F时间=1033.961,P时间<0.001),组别与时间点间存在交互作用(F=4.405,P=0.014)。进一步分析单独的效应,第3和第4时间点研究组的HAMD的减分率均高于对照组(P<0.05)。不同特征患者HAMD比较,结果显示治疗后研究组HAMD评分明显低于对照组,男性HAMD高于女性,年龄36~59、≥60岁HAMD高于18~35岁患者,内向性格患者HAMD高于中性性格,在职人员高于非在职人员,差异均有统计学意义(P<0.05)。组别和入组HAMD为治疗后HAMD的独立影响因素,研究组HAMD低于对照组(P=0.001),入组HAMD越高,治疗后HAMD越高(P<0.001),其余因素对治疗后HAMD均无影响(P>0.05)。结论音乐疗法在辅助改善抑郁症患者的抑郁情绪有积极影响,联合药物治疗能够快速缓解患者的抑郁情绪。

德曲妥珠单抗治疗乳腺癌有效性和安全性的Meta分析

目的 系统评价德曲妥珠单抗(T-Dxd)治疗乳腺癌的有效性和安全性。方法 计算机检索PubMed、Cochrane Library、Embase、Web of Science、SinoMed、CNKI、WanFang Data、VIP数据库,搜集T-Dxd(试验组)对比化疗药物或其他抗肿瘤药物(对照组)的随机对照试验(RCT),检索时限均从建库至2024年2月15日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3.1软件进行Meta分析。结果 共纳入3个RCT,包括1 689例患者。Meta分析结果显示,试验组患者的无进展生存期(PFS)[HR=0.37,95%CI(0.27,0.51),P <0.001]、总生存期(OS)[HR=0.63,95%CI(0.53,0.75),P <0.001]以及客观缓解率(ORR)[RR=2.52,95%CI(2.21,2.88),P <0.001]均显著长于或高于对照组。试验组药物相关间质性肺病[RR=10.82,95%CI(4.83,24.23),P <0.001]及射血分数降低[RR=5.05,95%CI(1.91,13.33),P=0.001]的发生率均显著高于对照组。进一步依据激素受体表达(阳性和阴性)、脑转移发生情况(发生和未发生)的不同进行亚组分析,结果显示,试验组患者的PFS均显著长于对照组(P <0.001)。敏感性分析结果显示,以PFS、OS、ORR为指标时,所得结果均较稳健。结论 当前证据表明,与化疗药物或其他抗肿瘤药物相比,T-Dxd治疗乳腺癌可延长的PFS和OS、提高ORR,但可能会增加间质性肺病及射血分数降低的发生风险。受纳入研究数量和质量的限制,上述结论尚需开展更多高质量的研究予以验证。

胰高血糖素样肽1受体激动剂治疗合并超重或肥胖的2型糖尿病的疗效和安全性的Meta分析

目的系统评价胰高血糖素样肽1受体激动剂(GLP-1RA)治疗合并超重或肥胖2型糖尿病(T2DM)患者的有效性与安全性。方法计算机检索PubMed、Embase、Cochrane Library、Ovid、ClinicalTrial.gov、SinoMed、CNKI、WanFang Data和VIP数据库,搜集有关GLP-1RA治疗T2DM合并超重或肥胖患者的随机对照试验(RCT),检索时限均从2005年1月1日至2023年11月1日。由2位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用R软件进行Meta分析,并采用GRADE系统进行证据质量评价。结果共纳入71个RCT,包括29476例患者。Meta分析结果显示,相比于其他降糖药,GLP-1RA在改善糖化血红蛋白[WMD=-0.55,95%CI(-0.65,-0.45),P<0.001]、减重[WMD=-2.61,95%CI(-3.25,-1.97),P<0.001]方面均具有优势;GLP-1RA对空腹血糖的改善效果呈时间依赖性[16周以内:WMD=0.25,95%CI(-0.17,0.66),P=0.250;16~52周:WMD=-0.06,95%CI(-0.32,0.20),P=0.650;>52~104周:WMD=-1.67,95%CI(-1.91,-1.43),P<0.001];安全性方面,GLP-1RA的总体不良反应发生率较高[RR=1.11,95%CI(1.07,1.15),P<0.001];但低血糖发生率低于胰岛素[RR=0.58,95%CI(0.48,0.71),P<0.001],而与口服降糖药的差异无统计学意义[RR=0.83,95%CI(0.58,1.19),P=0.310]。GRADE系统评价显示,仅低血糖发生率的证据等级为中等,其余结局指标的证据水平均为低级。结论当前证据显示,对于T2DM合并肥胖或超重患者,GLP-1RA尤其是司美格鲁肽相比于安慰剂、胰岛素或口服降糖药,能更有效兼顾降糖和减重,虽总体不良反应较多,但可减少低血糖发生。