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Li Menghan Zhang Bo Meng Zhihong Sha Tao Han Yuhui Zhao Hong Zhang Chunhong 《中医杂志(英文版)》2017,37(2):171-178
Objective
To observe the effect of Tiaoshen Kaiqiao acupuncture in the treatment of ischemic post-stroke depression.Methods
This research was a single-blind, positive-controlled trial done in a single entity. Totally 58 patients with ischemic post-stroke depression were randomly divided into two groups. The acupuncture group was given Tiaoshen Kaiqiao acupuncture therapy and placebo starch tablets treatment, while the control group was treated with fluoxetine tablets and body acupuncture treatment. Evaluated the clinical efficacy of the two groups with Hamilton Depression Scale (HAMD), Anti Depression Drug Side Effects Rating Scale (SERS), Clinical Global Impression Scale (CGI) respectively before treatment, the fourth weekend of treatment, the eighth weekend of treatment, the twelfth weekend of treatment. The adverse reactions in two groups were observed and documented.Results
The HAMD scale scores of the two groups in different treatment period were significantly decreased compared with that before treatment (P < 0.05); the score reduction of HAMD scale between the two groups had no significant differences (P > 0.05). There was significant difference between the SERS scores of two groups (P < 0.05); the control group had more adverse reactions, and the score would be increased with the extension of treatment time. Effect index (EI) of CGI in the acupuncture group is better than that of control group (P < 0.05).Conclusion
The effects of Tiaoshen Kaiqiao acupuncture and fluoxetine in the treatment of ischemic post-stroke depression were similar, but the former had no obvious adverse reaction and side effects. 相似文献3.
背景：单纯收缩期高血压（isolated systolic hypertension,ISH）是老年人的常见病,严重危害老年人的健康。中医及中西医结合治疗模式在改善老年ISH患者生活质量以及保护靶器官等方面具有一定优势,但需要进一步的循证医学研究。目的：观察中医（降压胶囊）及中西医结合（降压胶囊联合尼莫地平）治疗模式对老年ISH患者血压、血管活性物质的影响及其安全性。设计、场所、受试者和干预措施：采用多中心、随机双盲、阳性对照的试验设计。按标准入选中国中医科学院西苑医院、北京延庆县中医院及延庆社区卫生服务中心的老年ISH患者270例,采用随机区组法分为中医组（降压胶囊联合尼莫地平模拟药）、中西医结合组（降压胶囊联合尼莫地平）和西医组（尼莫地平联合降压胶囊模拟药）,每组各90例。疗程为4周。主要结局指标：观察各组治疗后诊室血压和动态血压水平,血管活性物质如内皮素-1（endothelin-1,ET-1）、一氧化氮（nitric oxide,NO）、血栓素B_2（thromboxane B_2,TXB_2）和6-酮-前列腺素1α（6-ketoprostaglandin1α,6-keto-PGF1α）水平的变化,并评价其安全性。结果：治疗结束后,中医组脱落10例（80例完成试验）,中西医结合组脱落14例（76例完成试验）,西医组脱落5例（85例完成试验）。治疗后各组收缩期血压值低于治疗前,差异均有统计学意义（P〈0.05）,中西医结合组收缩期血压明显低于中医组或西医组（P〈0.05）。治疗后各组24 h平均收缩压及昼间平均收缩压明显降低,中西医结合组夜间平均收缩压亦明显降低,与治疗前比较,差异有统计学意义（P〈0.05）;中西医结合组24 h平均收缩压和昼间平均收缩压低于中医组和西医组（P〈0.05）。治疗后各组患者血清NO、血浆6-keto-PGF1α水平均升高,而血浆ET-1和TXB_2水平降低（P〈0.05）,且中西医结合疗法对降低血浆TXB_2含量的作用明显优于中医或西医疗法（P〈0.05）。结论：中医及中西医结合治疗模式应用于老年ISH患者的疗效肯定,安全性高,且中西医结合治疗模式在降压及相关指标改善等方面具有明显协同增效的优势,值得进一步研究。 相似文献
4.
Wang Xianliang Hou Yazhu Mao Jingyuan Zhao Yingqiang Niu Tianfu Yuan Ruyu Wang Yonggang Cui Jinrong Shi Le Jia Xiuli Fan Ruihong Lin Qian Zhang Yan Li Zhijun Shang Hongcai Wang Baohe Wang Hongwu Wang Henghe Zhang Boli 《中医杂志(英文版)》2017,37(6):756-766
Objective
To assess the efficacy and safety in patients with chronic heart failure (CHF) of Western medication plus Traditional Chinese Medicine (TCM) preparations.Methods
This prospective, single-blind, randomized, controlled, and multicenter clinical trial began on September 17, 2008, and was completed on June 25, 2011. A total of 340 inpatients, aged 40–79 years, with exacerbating CHF from 10 hospitals were enrolled and randomly allocated within 24 h of admission. The trial included three intervention periods. During hospitalization, the control group received western medication for CHF and the treatment group received Danhong injection with Shenfu injection or Shenmai injection. After discharge, all patients were treated with Qiliqiangxin capsules and Buyiqiangxin tablets or a placebo for 6 months. After the 6-month intervention, both groups received only continuous western medication. The primary endpoint was all-cause mortality. The efficacy assessments were as follows: B-type natriuretic peptide (BNP), Lee's HF score, the 6-minute walking test (6MWT), left ventricular ejection fraction (LVEF), and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The safety assessments were as follows: blood and urine routine examination, hepatic and renal function, electrolytes in blood and adverse events.Results
Compared with the control group, the treatment group showed a 30.99% reduction in all-cause mortality and an improved survival rate. The treatment group showed greater improvement in 6MWT (P = 0.02) than the control group on discharge, after 12-month follow-up, there was a time-group interaction for MLHFQ (P = 0.03). Incidence rate of adverse events and other relevant safety indexes were not statistically significant between the two groups.Conclusion
Western medication plus TCM treatment can increase 6-minute walking distance (improve exercise tolerance) and quality of life with heart failure patients. 相似文献5.
目的 评价左乙拉西坦治疗成人癫(痌)的临床疗效和安全性.方法 采用随机、双盲、双模拟、阳性药物平行对照试验设计方案,将纳入研究的120例癫(痌)受试者随机分为试验组和对照组,每组各60例.试验组给予左乙拉西坦片+丙戊酸钠缓释模拟片治疗;对照组给予丙戊酸钠缓释片+左乙拉西坦模拟片治疗.两组疗程均为26周,治疗结束后随访3个月.评定两组受试者在治疗后(治疗结束后1～3 d)及随访3个月时的总有效率、癫(痌)每周发作频率、癫(痌)发作持续时间、生活质量(QOLIE-31评分量表)及药物相关的不良反应.结果 治疗前,两组受试者的癫(痌)每周发作频率、癫(痌)发作持续时间和QOLIE-31评分比较差异均无统计学意义.治疗后及随访3个月时,试验组受试者的总有效率为95.0％(57/60)和91.7％(55/60),均分别高于对照组[71.7％(43/60),63.3％(38/60);P＜0.01].治疗后及随访3个月时,两组受试者的癫(痌)每周发作频率、癫(痌)发作持续时间和QOLIE-31评分与同组治疗前相比差异均有统计学意义(P＜0.01),两组间差异也有统计学意义(P＜0.01).治疗后两组受试者的不良反应差异无统计学意义.结论 左乙拉西坦治疗成人癫(痌)的临床疗效优于丙戊酸钠缓释片,不良反应轻微,可作为临床治疗成人癫(痌)的首选药物. 相似文献
6.
Chen Pei Zhang Yong Ling Lili Chen Xing Ren Yi Jiang Lan Wu Shuang Wang Wenting Wang Yuguang Zou Yihuai 《中医杂志(英文版)》2017,37(6):810-818
Objective
To investigate the efficacy and safety of Xinglouchengqi (XLCQ) decoction in treatment of acute ischemic stroke with constipation.Methods
In this prospective, multicenter, assessor-blinded, randomized controlled trial, 360 eligible participants will be randomized to the XLCQ group or the control group. Participants in the XLCQ group will receive XLCQ decoction, while those in the control group will undergo clysis therapy using glycerin enemas or oral administration of lactulose solution. Both groups will undergo a treatment period of (5 ± 2) d and a 1-month follow-up. The primary outcome measure will be the Constipation Scale score. The secondary outcome measures will include scores on the National Institutes of Health Stroke Scale, the Traditional Chinese Medicine (TCM) Stroke Scale, the Diagnostic Scale for TCM Syndromes of Ischemic Stroke and TCM Scale for Syndrome of Phlegm-heat and Fu-organ Excess. Therapeutic mechanism outcomes and safety outcomes will also be assessed. Assessments will be conducted at baseline, at the end of the treatment period, and at the follow-up. Moreover, daily visits will be scheduled to grade the status of constipation during the treatment period.Discussion
The results of this study will provide scientific and objective data with which to assess the efficacy and safety of XLCQ decoction for patients with acute ischemic stroke and constipation. 相似文献7.
OBJECTIVE:To systematically review the benefits of integrated traditional and Western medicine therapies based on the Hamilton depression scale(HAMD) following syndrome differentiation of depression.METHODS:We searched six English and Chinese electronic databases for randomized clinical trials(RCTs) on integrated traditional and Western medicine for treatment of depression.Two authors extracted data and independently assessed the trial quality.RevMan 5 software was used for data analyses with an effect estimate presented as weighted mean difference(WMD) with a 95% confidence interval(CI).RESULTS:Seven RCTs with 576 participants were identified for this review.All trials were eligible for the meta-analysis and were evaluated as unclear or having a risk of bias.Meta-analysis showed,compared with Western medicine alone,integrated traditional and Western medicine based on syndrome differentiation could improve the effect of treatment represented by the HAMD [WMD=-2.39,CI(-2.96,-1.83),Z=8.29,P<0.00001].There were no reported serious adverse effects that were related to integrated traditional and Western medicine based therapies in these trials.CONCLUSIONS:Integrated traditional and Western medicine based therapies for the syndrome differentiation of depression significantly improved the HAMD,illustrating that combining therapies from integrated traditional and Western medicine for treatment of depression is better than Western medicine alone.However,further large,rigorously designed trials are warranted due to the insufficient methodological rigor seen in the trials included in this study. 相似文献
8.
中西医结合分期综合治疗痛风性关节炎的随机对照临床研究 总被引：2，自引：0，他引：2
目的：研究中西医结合分期论治的综合治疗方案防治痛风性关节炎的临床疗效．探索痛风性关节炎更安全、有效、合理的治疗方案。方法：将166例痛风患者随机分成3组：中药组58例、西药组56例和中西药组52例，连续观察12周。急性期中药组予虎杖痛风颗粒、金黄膏。西药组予双氯芬酸钠双释放肠溶胶囊；间歇期中药组予茵连痛风颗粒，西药组予苯溴马隆片或别嘌呤醇片；中西药组予中药组和西药组药物。观察整个治疗期间临床症状积分、血尿酸、显效时间、复发率、愈显率和不良反应发生率等指标。结果：在急性期，3组愈显率和显效时间比较，差异无统计学意义；3组临床症状积分和血尿酸水平降低，但差异无统计学意义。在间歇期，西药组、中西药组血尿酸水平明显降低，而中药组血尿酸水平虽有下降趋势，但差异无统计学意义。中药组复发率为12．07％，西药组为26．79％，中西药组为9．62％；中药组复发时平均症状积分为（10．00±3．61）分，西药组为（12．38±1．85）分，中西药组为（10．75±1．89）分。3组复发率和复发时的症状积分比较，差异有统计学意义。中药组不良反应发生率为3．45％，西药组为21．43％，中西药组为15．38％，3组间不良反应发生率比较，差异有统计学意义。结论：中西医结合分期综合防治方案既能安全、有效地控制痛风性关节炎急性期症状，恢复关节功能．又能有效地控制间歇期血尿酸水平，预防急性发作，减轻不良反应。 相似文献
9.
Objective
To evaluate the influence of clinical pathways in the hospitals using the Traditional Chinese Medicine in treatment of stroke in terms of postoperative complications, length of stay (LOS), costs incurred during hospitalization, compared with standard medical care.Methods
Medline, Embase, China National Knowledge Infrastructure (CNKI) platforms, Wanfang databases and the Cochrane Central Register of Controlled Trials were searched. The search was performed up to August 2014. Each study was assessed independently by two reviewers. The assessment of methodological quality of the included studies was based on the Methodological index for non-randomized studies standard. Meta-analyses were performed using RevMan software, version 5.0.Results
Six studies met the study inclusion criteria and were included in the Meta-analysis for a total sample of 710 patients. The aggregate overall results showed that shorter length of stay in the clinical pathway group was observed during hospital stay was associated with the use of the clinical pathways. No significant differences were found in other effects.Conclusion
Regardless the possible limitations, our findings show that clinical pathways can significantly reduce LOS. Although there is no clear evidence that clinical pathways can reduce hospital costs, but the cost of hospitalization path group for each included study were lower than the control group. 相似文献10.
Zhang Guoliang He Liyun Tang Liuping Yang Tong Zou Xinying Zhu Qingxiong Yan Shiyan Hou Yong Huang Baoju Zhao Jindong Li Yan Huang Jihan 《中医杂志(英文版)》2017,37(3):397-403
Objective
To evaluate the clinical effects of Xiyanping injection intervention in pediatric patients with mild hand foot and mouth disease (HFMD).Methods
A total of 329 patients were stratified and block-randomized for symptomatic treatment of HFMD and assigned to one of the following groups: Western Medicine (group A, n = 103), Xiyanping injection (group B, n = 109), or Xiyanping injection and symptomatic treatment using Western Medicine (group C, n = 117). During the trial, fever, rash, ulcers of the mouth were observed among participants in each group before and after treatment, and conversion rates from mild to severe HFMD were measured.Results
After 3–7 days' treatment, no significant differences in the conversion rates from mild to severe HFMD were observed among the three groups (P > 0.05). There was a significantly low number of patients with the onset time of antifebrile effect, vanished time of hand and foot rashes and cumulative time for the ulcers in the mouth vanished, among the three groups (P < 0.05, P < 0.01). The onset time of antifebrile effect of patients in groups B and C were markedly shorter compared with those in group A (P < 0.05, P < 0.01); there was no statically significant difference observed between groups B and C (P > 0.05). No significant differences were observed in the time for body temperature recovery among the three groups (P > 0.05). There were no significant differences in adverse effects among the three groups (P > 0.05).Conclusion
Xiyanping injection together with use of Western Medicine is most effective for symptomatic treatment of mild HFMD. No severe adverse reactions were observed. 相似文献11.
Objective
To evaluate the safety and effectiveness of traditional Chinese medicinal herbs (TCMHs) as an adjunctive treatment for diabetic foot (DF).Methods
The sources used were PubMed (1966 to August 2015), the Cochrane Library (1988 to August 2015), the Excerpta Medica Database (1974 to August 2015), Wiley (1807 to August 2015), Ovid (1988 to August 2015), ClinicalTrials.gov (1993 to August 2015), the Cochrane Central Register of Controlled Trials (1966 to August 2015), China Science and Technology Journal Database (1994 to August 2015), ChiCTR (2007 to August 2015), SinoMed (1978 to August 2015), the China National Knowledge Infrastructure (1984 to August 2015), Wanfang Data Knowledge Service Platform (1998 to August 2015), and the Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS) (1984 to August 2015). Studies were identified and selected, and the data were extracted by two independent reviewers. The Cochrane Risk of Bias tool was used to assess the quality of studies. Revman 5.2 software was used for data synthesis and analysis.Results
Sixteen studies were included based on the selection criteria. Of these, seven studies had low bias risk and one had high bias risk. In the overall analysis, TCMHs resulted in a significantly higher total effective rate (OR 5.08; 95% CI 3.50 to 7.36; P < 0.000 01), cure rate (OR 2.12; 95% CI 1.63 to 2.77; P < 0.000 01), and shorter time to ulcer healing (SMD ?0.64; 95% CI ?0.89 to ?0.40; P < 0.000 01) when compared with non-TCMHs treated DF. The analysis also revealed that significantly fewer amputations occurred in TCMHs patients (OR 0.36; 95% CI 0.20 to 0.65; P = 0.0007). Sensitivity analysis indicated that the findings of the Meta-analysis were robust to study quality, and the funnel plot of the Egger test showed no publication bias.Conclusion
TCMHs intervention appears to be more effective for DF, with a similar safety profile, when compared with non-TCMHs treatments, although this result requires further verification with more well-designed studies. 相似文献12.
Zhang Shiqiang Wu Tingting Zhang Haisheng Yang Yun Jiang Haiyan Cao Shengcheng Xie Fang Xia Xiaoting Lü Junqiang Zhong Yi 《中医杂志(英文版)》2017,37(2):179-184
Objective
To evaluate the effect of electroacupuncture on chemotherapy-induced peripheral neuropathy (CIPN), quality of life and immune status of patients with malignant tumors.Methods
From Jan, 2013 to May, 2014, 37 patients with malignant tumors were included in this prospective single-blinded study, and randomized to receive either electroacupuncture or acupuncture treatment on basis of chemotherapy. The chemotherapy was continued for 2 courses as previous before the treatments, with 21 days as a course of treatment. Patients received acupuncture and electroacupuncture once per day starting at the day before chemotherapy for consecutive 7 days followed by 14 days off, with 21 days as a course of treatment, and continued for two courses of treatment. Then CIPN, traditional Chinese clinical symptoms, quality of life and immune status were all evaluated for each patient prior treatment and after two courses of treatment.Results
The gender, age, cancer species as well as incidence (83.3% vs 84.2%) and grades of CIPN before treatments were all similar in patients receiving acupuncture or electroacupuncture (all P > 0.05). After treatments, most patients with peripheral neuropathy were cured by two courses of electroacupuncture (84.2% vs 21.1%), whereas the other group of patients had similar incidences of peripheral neuropathy compared with prior-acupuncture (83.3% vs 72.2%). Besides, patients receiving electroacupuncture had lower incidence of peripheral neuropathy than those receiving acupuncture treatment (χ2 = 9.745, P = 0.002). The grades of peripheral neuropathy were significantly different in the two groups post-treatment (χ2 = 13.983, P = 0.007). The total effective rates for traditional Chinese clinical symptoms were 16.7% and 84.2% in acupuncture and electroacupuncture groups, respectively (Z = – 4.239, P < 0.001). The electroacupuncture treatment provided a more satisfactory life for patients compared with acupuncture (Z = – 4.76, P < 0.001). Both electroacupuncture and acupuncture had no effects on immune function.Conclusion
Electroacupuncture could alleviate CIPN, and improve traditional Chinese clinical symptoms and quality of life, but did not affect immune function. 相似文献13.
Jiang Junjie Zhang Yin Xie Yanming Li Yuan Sun Shuailing Zhang Yili Wang Shuo Zhu Yong Qi Wensheng 《中医杂志(英文版)》2017,37(5):621-628
Objective
To observe the curative effect of Jinye Baidu granule in the treatment of fever and swollen and sore throat caused by wind-warmth lung-heat disease (heat in the lung-wei) to further identify the indications.Methods
This randomized, double-blind, parallel, controlled trial will include patients with acute upper respiratory infection and wind-warmth lung-heat disease (heat in the lung-wei). Patients with serious bacterial infection (white blood cell count > 12 × 109, neutrophils > 80%) will be excluded. Patients will be divided into three categories (blocks) according to their condition: fever only, a swollen and sore throat, and combined fever plus a swollen and sore throat. Patients within each of the three blocks will be further divided into a treatment group and a control group via stratified blocked randomization. The treatment group will be treated with Jinye Baidu granule, and the control group will be treated with Fufang Shuanghua granule. The primary outcome measure will be body temperature recovery time for patients with fever, throat symptom score for patients with a swollen and sore throat, and body temperature recovery time and throat symptom score for patients with combined fever plus a swollen and sore throat. Routine blood testing, urine testing, liver function, kidney function and ECG data of all patients will be collected as safety indices before and after enrollment, and adverse events will be recorded during the whole trial course.Conclusion
This study protocol will include stratified block analysis according to patients' symptoms, and identify the accurate clinical indications of Jinye Baidu granule. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment. 相似文献14.
Gao Hui Xia Tian Ma Ruihong Zhao Zhimei Song Xueru Wang Baojuan Liu Lijing Han Kaimei Wang Guoqing Fu Yu Hao Guimin 《中医杂志(英文版)》2017,37(4):530-537
Objective
To evaluate the clinical efficacy and safety of Heyan Kuntai capsule (HYKT) in treating women with infertility caused by diminished ovarian reserve (DOR).Methods
One hundred eight eligible patients from three Chinese hospitals were randomly divided into an HYKT treatment group (n = 55) ora dehydroepiandrosterone (DHEA) treatment group (n = 53). Patients in the HYKT group were treated orally with four 0.5 g HYKT three times a day; patients in the DHEA group were treated with one 25.0 mg DHEA capsule three times a day. All patients were treated for 3 months and followed up over a 3-month period.Results
Of 108 patients, 12 dropped out: six from the HYKT group, and six from the DHEA group. Eleven patients got pregnant during the treatment. Serum anti-Müllerian hormone levels and antral follicle counts increased significantly in both groups after treatment (P < 0.05) especially in the HYKT group (P < 0.05). Serum follicle stimulating hormone (FSH) levels and FSH/luteinizing hormone ratios decreased (P < 0.05) with no significant difference between the two groups. Estradiol levels in the HYKT group and DHEA-sulfate levels in the DHEA group both increased (P < 0.05). The spontaneous pregnancy rates were 12% and 11% in the HYKT and DHEA groups, respectively (not significant). During the follow-up period, 16 patients in the HYKT group underwent in vitro fertilization-embryo transfer (IVF-ET) and the number of retrieved oocytes was (5.1 ± 1.8). In DHEA group, 20 patients underwent IVF-ET and the number of retrieved oocyte was (4.2 ± 1.9) (not significant); clinical pregnancy rates were 38% in the HYKT group and 20% in DHEA group (not significant). No significant adverse reactions were observed.Conclusion
HYKT can improve the ovarian reserve and hormone levels in patients with infertility caused by DOR. Pregnancy rates after HYKT treatment were similar to those of DHEA treatment. HYKT might be an alternative to the treatment of infertility caused by DOR. 相似文献15.
Yu L Lin SM Zhou RQ Tang WJ Huang PX Dong Y Wang J Yu ZH Chen JL Wei L Xing SL Cao HJ Zhao HB 《中西医结合学报》2012,10(7):766-776
背景：阿尔茨海默病（Alzheimer disease,AD）是一种进行性发展的神经退行性疾病,目前对本病的发病机制尚不清楚,也无有效的治疗方法。随着全球人口老龄化程度的提高,AD的患病率不断增加,严重影响老年人的生活质量。目前中医药对AD的研究正逐渐深入。目的：观察中医辨证治疗方案改善轻中度AD患者认知功能的临床疗效,并通过静息态功能性核磁共振技术观察治疗前后AD患者的脑功能变化。设计、场所、受试者和干预措施：在上海徐汇区凌云等5个社区街道与上海市第一福利院等7个福利院,采用国际公认的美国国立神经病、语言交流障碍和卒中研究所-老年性痴呆及相关疾病学会AD诊断标准,纳入轻中度AD患者131例,随机分为中药组66例,西药组65例。中药组每月1次中医辨证对证用药。心气虚证用调心方,肾精虚证用补肾方,2次/d;对夹痰、夹瘀的患者分别加用礞石滚痰丸和血府逐瘀胶囊进行治疗。西药对照组采用盐酸多奈哌齐5mg/d进行治疗,疗程为48周。主要结局指标：治疗前后分别用简易精神状态量表（Mini-Mental State Examination,MMSE）、物体记忆测验（Fuld Object-Memory Evaluation,FOM）、积木测验（Block Design,BD）、数字广度测验（Digit Span,DS）量表进行评定,以评价患者的认知功能;采用静息态功能性核磁共振成像观察患者治疗前后的脑功能变化。结果：中药和西药盐酸多奈哌齐均能够改善轻中度AD患者的认知功能。两药治疗后与治疗前相比MMSE量表总分均有提高（P〈0.05或P〈0.01）。治疗48周,中药组的MMSE有效率为70.91%,恶化率为20.00%;西药组的有效率为55.77%,恶化率为34.62%。两药均能提高患者FOM分母、BD量表分值,中药治疗还能提高FOM分子、DS量表分值（P〈0.05或P〈0.01）。静息态功能性磁共振检查发现,治疗后两组患者后扣带回与脑功能区的连接性均不同程度改善。中药组的作用范围比较局限,主要作用于左侧的顶叶,西药组的作用范围则相对较大,主要作用于双侧的额叶。结论：中医辨证治疗方案能够改善轻中度AD患者的认知功能,且能够提高后扣带回与脑功能区的连接性,改善脑功能,是治疗AD有效的方法。 相似文献
16.
提高中草药随机对照试验的质量Ⅰ:临床试验设计和方法学 总被引：4，自引：11，他引：4
目的:通过对中草药临床随机对照试验的设计及方法学进行质量评价,探讨如何提高中草药临床试验的质量。方法:文献检索2005年7月前发表于Cochrane图书馆的中草药系统评价共11篇,包含167个中草药临床随机对照试验。质量评价方法采用修订版CONSORT声明9项指标以及中草药剂型及质量控制标准指标。结果:所有167个临床试验都含有试验目的、方法、第1结局指标、统计学方法及中药剂型;其中163(97.6%)个临床试验说明了研究对象的纳入标准,只有26(15.6%)个临床试验说明了研究对象的排除标准;只有14(8.4%)个临床试验详细说明了随机序列的产生方法;4(2.4%)个临床试验提及了随机分配隐藏;绝大部分的临床试验(86.8%)属于开放性的,只有13.2%的临床试验采用了盲法设计;只有1个临床试验在试验前进行了样本含量的计算;在中草药剂型方面,45.5%的临床试验使用的是汤剂或中药茶包,只有1个临床试验提及了制剂的质量控制。在167个临床试验中,所有质量评价指标的涉及率只有36.0%。结论:现阶段中草药临床随机对照试验的质量还很低。建议:(1)试验设计者及实施者必须接受正规的临床试验基础知识的培训;(2)推荐采用临床试验设计流程图,逐一解决临床试验过程中的关键问题;(3)在方案正式实施前进行预试验,并根据预试验的结果对临床试验设计方案进行调整;(4)对临床试验设计的最终方案进行注册登记,并预先发表(最好是网上发表)临床试验设计方案;(5)广泛开展国际合作,特别是与对中医药研究感兴趣的国际知名学术研究机构进行合作,以提高中草药临床研究的质量。 相似文献
17.
目的：评价穿心莲内酯滴丸治疗急性上呼吸道感染外感风热证的安全性和有效性。方法：采用随机、阳性药平行对照、多中心临床试验方法。第1阶段纳入202例，随机分为试验组（n=101）和对照组（n=101）；第2阶段纳入276例，随机分为试验组（n=138）和对照组（n=138）。试验组给予穿心莲内酯滴丸，0．15g／次，3次／d；对照组给予穿心莲内酯片，0．15g／次。3次／d。疗程均为3d。观察治疗前后症状、体征变化和有无不良反应，并进行血、粪、尿常规，肝肾功能及心电图检查。结果：第1阶段试验组和对照组治疗后的痊愈率分别为44．55％、42．57％（全分析数据集）和45．00％、43．00％（符合方案数据集），总有效率分别为94．06％、94．06％（全分析数据集）和95．00％、95．00％（符合方案数据集），两组比，较，差异无统计学意义（P〉0．05）。第2阶段试验组和对照组治疗后的痊愈率分别为39．13％、33．82％（全分析数据集）和38．69％、33．58％（符合方案数据集），总有效率分别为96．38％、96．32％（全分析数据集）和96．36％、96．27％（符合方案数据集），两组比较，差异亦无统计学意义（P〉0．05）。在用药过程中，未发现穿心莲内酯滴丸的明显不良反应。结论：穿心莲内酯滴丸是治疗急性上呼吸道感染外感风热证安全有效的药物。 相似文献
18.
Li Huanan Wang Jingui Zhang Wei Zhao Na Hai Xinhua Sun Shiquan Sun Qing Han Yihao Zhang Runchen Ma Fei 《中医杂志(英文版)》2017,37(6):819-826
Objective
To evaluate the effect of the traditional Chinese procedure abdominal Tuina (AT) on chronic fatigue syndrome (CFS).Methods
This randomized, single assessor-blinded clinical trial was carried out from May 2014 to April 2015. Eighty participants in the trial were divided randomly into two groups: experimental group and control. The experimental group (40 cases) was treated by AT and the control group (40 cases) by acupuncture. Each treatment was conducted once a day, 5 d for one course, at an interval of 2 d between each course. The whole treatment course lasted for 4 weeks. To ascertain the effect of AT and acupuncture, Fatigue Scale-14 (FS-14), Self-rating Anxiety Scale (SAS) and Hamilton Rating Scale for Depression (HAMD) scores were used before and after treatment. Patients were followed up for 3 months after treatment.Results
After treatment for 4 weeks, 77 patients (39 cases in the experimental group and 38 cases in the control group) completed the trial. The FS-14, SAS and HAMD scores decreased (P < 0.05) significantly compared with those before treatment in both groups. The FS-14 and HAMD (P < 0.05) scores in the experimental group were much lower than those in the control group. The difference in SAS scores between the two groups was not significant. In the final follow-up, CFS in two cases in the experimental group and three in the control group recurred, but the difference was not significant. The scores for the FS-14, SAS and HAMD in the experimental group were superior to those of the control group, and the difference was significant (P < 0.05). No serious adverse events and few adverse events were observed.Conclusion
AT elicited a more efficacious effect than acupuncture alone on CFS. 相似文献19.
20.
Zhu Qingguang Huang Lingyan Li Jingxian Mao Lijuan Zhang Yunya Min Fang Yu Liu Wu Xie 《中医杂志(英文版)》2017,37(6):774-781