Objective To assess the clinical efficacy of stroke unit (SU) of integrated traditional Chinese medicine and western medicine in the treatment of acute cerebral stroke. Methods Randomized or quasi-randomized controlled trials (RCTs or q-RCTs) were identified from CBM (1978-2009), CNKI (1994-2009), VIP (1989-2009), PubMed (1966-2009), MEDLINE (1978-2009), Scifinder (1998-2009), and The Cochrane Library (Issue 6, 2009), and relevant journals from Liaoning University of Traditional Chinese Medicine were also hand searched. Data were extracted and evaluated by two reviewers independently with a designed extraction form. RevMan5.0.23 software was used for data analyses. Results A total of 12 RCTs and q-RCTs involving 2 316 patients were included. Meta-analyses showed that, stroke unit of integrated traditional Chinese medicine and western medicine was superior to general medicine treatment (Plt;0.05) in case fatality rate one month after stroke (RR= 0.34, 95%CI 0.22 to 0.54), discharge NIHSS score (WMD= –1.01, 95%CI –1.52 to –0.51) and discharge OHS score (WMD= –0.48, 95%CI –0.78 to –0.18); and it was superior to SU of western medicine (Plt;0.05) in NIHSS score one week after stroke (WMD= –2.38, 95%CI –4.08 to –0.68), NIHSS score one month after stroke (WMD= –1.52, 95%CI –2.32 to –0.73) NIHSS score three months after stroke (WMD= –1.77, 95%CI –2.59 to –0.95), difference value of NIHSS score of hospital admission and discharge (WMD= –1.94, 95%CI –2.54 to –1.34), OHS score one month after stroke (WMD= –0.56, 95%CI –0.95 to –0.17) and OHS score three months after stroke (WMD= –1.05, 95%CI –1.44 to –0.66). Conclusion The current limited evidence shows that there is a significant difference between stroke unit of integrated traditional Chinese medicine and western medicine and general medicine treatment. Although there is no significant difference compared with SU of western medicine, it is superior in improving the functional impairment of nerve as well as disability of injury. More large-scale RCTs with high quality are required to verify the effect of stroke unit of integrated traditional Chinese medicine and western medicine in the treatment of acute cerebral stroke.
The research background, way of thinking, research contents and methods of a united research project - "The Clinical Research on the Treatment of SARS with Integrated Traditional and Western Medicine" were reviewed. The latest research achievements on the treatment of SARS with integrated traditional and western medicine and the difficult points in the research were discussed. Furthermore, some tentative ideas were put forward to further the research. The conclusion was drawn that the principles of evidence-based medicine and the research scheme of multi-centered, prospective and randomized controlled trials, as well as the standard statistical and analyzing methods are the best way to assess the effectiveness and safety of treating SARS with integrated traditional and western medicine.
【摘要】 目的 评价生长抑素联合中药在治疗重症急性胰腺炎中的有效性。 方法 应用国际Cochrane协作网系统评价方法对生长抑素联合中药治疗重症急性胰腺炎的随机对照试验（RCT）进行系统评价。计算机检索MEDLINE（Ovid）、PubMed数据库、中文科技期全文数据库（VIP）、万方数据库、中国期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）。检索时间均为建库至2009年9月。文献检索语种为英语和中文。 结果 共纳入8个RCT，436例患者，所有纳入试验在治疗末均未进行随访。Meta分析结果显示，生长抑素联合中药治疗组（治疗组）的病死率（13/188，6.9%）明显低于单纯生长抑素治疗组（对照组）（24/174，13.7%），差异有统计学意义[Peto OR=0.46，95%CI（0.22，0.94），Plt;0.05]。治疗组平均住院日低于对照组[WMD=-7.01，95%CI（-7.89，-6.13），Plt;0.000 01]。治疗组腹痛缓解时间明显低于对照组，其差异有统计学意义[WMD=-0.77，95%CI（-0.82，-0.72），Plt;0.000 01]。治疗组与对照组治疗第7天APACHE Ⅱ评分均下降，治疗组下降幅度大于对照组，两组比较差异有统计学意义（Plt;0.05）。治疗组并发症发生率（26/91，28.6%）与对照组（35/88，39.8%）相比，其差异无统计学意义[Peto OR=0.61，95%CI（0.32，1.13），P=0.12]。 结论 生长抑素联合中药治疗在改善重症急性胰腺炎的病死率、平均住院时间、腹痛缓解时间、APACHE Ⅱ评分下降幅度优于单纯生长抑素治疗。
目的：对中药配合肝动脉栓塞化疗（Transcatheter Arterial Chemoembolization,TACE）辅助治疗原发性肝癌随机对照试验(Randomized controlled trial,RCT)文献进行评价。方法：对国内外公开发表的有关中药配合TACE辅助治疗原发性肝癌的随机对照试验进行检索，检索数据库包括Cochrane图书馆临床对照试验库，MEDLINE、CBM、CNKI和VIP电子数据库。手工检索中文相关期刊以及附加检索相关会议论文集。质量评价采用Jadad评分量表、CONSORT标准和其他自拟评价指标进行分析。结果：共纳入103篇RCTs，其中Jadad评分得5分有1篇文献，3分1篇，2分10篇，71篇1分，其余20篇均为0分，有3篇文献报告了分配隐藏。按CONSORT标准，仅1篇(0.97%)RCT描述了如何产生随机顺序，没有RCT报道如何执行随机，其中1篇为半随机，有1篇(0.97%)RCT采用安慰剂对照，有54篇(52.43%)报道了终点指标，分别各有2篇(1.94%)报道了双盲和单盲，14篇(1359%)进行了具体统计量计算，54篇(52.43%)提供了随访记录，7篇(6.80%)报道了阴性结果，16篇(15.53%)报道不良事件，仅有1篇(0.97%)进行样本含量计算与意向性分析(ITT),有2篇(1.94%)进行分层分析，属于多中心的仅有1篇(0.97%)，均未进行伦理审批和知情同意。描述了中医证型的有3篇(2.91%)。结论:目前中药配合TACE辅助治疗原发性肝癌临床研究的方法学和报告质量尚低，且多数RCT可能存在选择性偏倚和测量性偏倚，期待更多高质量的随机双盲对照试验为临床应用提供可靠的依据。
To compare the effectiveness of dressing by a combination of traditional Chinese medicine (TCM)-Western medicine (WM) after TCM bath and by the silver sulfadiazine cream (SD-Ag) in treating residual deep burn wound. Methods A total of 128 cases of residual deep burn wound between July 2003 and December 2009 were randomly divided into the TCM-WM treatment group (70 cases) and the WM control group (58 cases). In the treatment group, there were 45 males and 25 females with an average age of 38.6 years (range, 18-60 years), including 34 cases of flame burns, 28 cases of molten steel burns, and 8 cases of chemical burns with an average burn area of 57.6% total body surface area (TBSA) and an average residual wound of 7.4% TBSA. In the control group, there were 50 males and 8 females with an average of 37.9 years (range, 20-59 years), including 26 cases of flame burns, 12 cases of hot water burns, 16 cases of molten steel burns, and 4 cases of chemical burns with an average burn area of 56.5% TBSA and an average residual wound of 6.9%TBSA. There was no significant difference in general data between 2 groups (P gt; 0.05), so the cl inical data of 2 groups had comparabil ity. In the treatment group, the patients had a bath with TCM, and then the wounds were treated with dressing change of combined TCM-WM. In the control group, the wounds were treated with SD-Ag after cleaning the wounds with chlorhexidine solution. The pain, wound heal ing time, and the rate of scar formation were observed in 2 groups after treatment. Results According to wound pain classification after medication, the results were excellent in 23 cases, good in 30 cases, fair in 17 cases in the treatment group; were excellent in 17 cases, good in 20 cases, fair in 13 cases, poor in 5 cases, and fairly poor in 3 cases in the control group. The wound heal ing time of the treatment group (13.45 ± 4.74) days was significantly shorter than that of the control group [(23.87 ± 14.45) days, P lt; 0.05)]. After 2 weeks of treatment, scar occurred in 15 patients (21.4%) of the treatment group and 35 patients (60.3%) of the control group, showing significant difference (P lt; 0.05). Conclusion Based on TCM bath, a combination of TCM-WM for the residual burn wounds is obviously superior to SD-Ag. It has the advantages of rapid heal ing, l ight pain, no obvious scar, and short hospital ization time.
Objective To analyze the effectiveness of conservative medical treatments for ectopic pregnancy (EP): methotrexate (MTX) + mifepristone + Ectopic Pregnancy II decoction (EP-II) vs. methotrexate + mifepristone. Methods A total of 95 patients with EP in Shenzhen Shajing Affiliated Hospital of Guangzhou Medical University from January 2009 to January 2011 were randomly divided into two groups: 45 patients in the experimental group were treated with MTX, mifepristone and EP II decoction, while the other 50 patients in the control group were treated with MTX and mifepristone. The effectiveness of the two groups was analyzed with SPSS 13.0 software. Results There were significant differences in the time of serum β-HCG return to normal (16.13±8.13 ds vs. 22.05±7.15 ds, Plt;0.05), time of EP mass absorption (30.46±7.56 ds vs. 39.99±18.26 ds, Plt;0.05) and tubal patency rate (80% vs. 75%, Plt;0.05) between the two groups. But there were no significant differences in effective rate (95.56%, 43/45 vs. 94%, 47/50, χ2=0.0809, Pgt;0.05) and side effects. Conclusion The combination of methotrexate, mifepristone and EP II decoction for ectopic pregnancy is more effective than mifepristone and methotrexate in coordinately killing the embryo, shortening the time of serum β-HCG return to normal and the time of EP mass absorption, and improving the function of oviducts.
Objective To explore the condition and quality of domestic clinical therapeutic studies on integrated traditional Chinese and western medicine for posthepatitic cirrhosis in recent 30 years. Methods Jadad scale was used to score 121 literatures selected from January 1980 to January 2010 in periodicals of domestic authoritative resources databases, such as CNKI, VIP, WanFang Data, and CBM. Systematic reviews were conducted to 39 randomized controlled trials (RCTs) literatures of treating posthepatitic cirrhosis with integrated traditional Chinese medicine and western medicine scored two or more points. Results In 30 years, the main problems existing in domestic posthepatitic cirrhosis clinical research of integrated traditional Chinese and western medicine were as follows: the design of clinical RCTs was not strict enough; there was deficiency in the use of blind method; the standardized and uniformed research standard were insufficiency; the sample content was low without specific estimation methods; there was lack of analyses in compliance with cases falling off or without follow-up; and the report of adverse reaction and the quality of life research was neglected. Conclusion Posthepatitic cirrhosis therapy of integrated traditional Chinese and western medical is of “personalized” and “diversified” characteristics. Its therapeutic effects are significantly better than those of pure western medicine and worthy to be popularized in the clinic. However, the quality and level of its clinical scientific research methods still need further improvement.
Objective To explore the quality of the reporting of randomized controlled trials (RCTs) published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004. Methods A manual search was performed and the 22 checklists of CONSORT statement and other self-established criteria were applied. Results Six volumes and 72 issues were checked. There were 1 874 clinical trials of which 1288 (68.73%) RCTs were identified in 2 765 articles. Randomization methods were described in 630 (48.92%) RCTs which showed there was more significant difference than the RCTs published in 1998 (Plt;0.001).In the 1288 RCTs, placebo control was reported only in 21 trials (1.63%) and endpoint measurements were reported in 114 trials (8.85%). Seven trials (0.55%) mentioned the estimation of sample size. None mentioned randomization concealment. Blinding was reported in 54 trials (4.2%) and P value was reported in 9 trials (0.70%).Flow chart was not mentioned in any trials. Compliance was reported in 2 trials (0.16%), and only one trial (0.08%) reported negative results. Ancillary analysis was used in 33 trials (2.57%). 10 trials are multi-centre RCTs. None of the trials reported the approval of ethics committee. Informed consent was reported in 3 trials (0.24%). Acknowledgements were mentioned in 3 trials (0.24%). Syndrome types defined by traditional Chinese medicine (TCM) were reported in 163 trials (12.66%). The criteria of intervention quality control was mentioned in 2 trials (0.15%). Double dummy was used in 8 trials (0.63%) and outcome measurement of TCM was reported in 258 trials (20.04%). All Items reported in RCTs were of low quality. Conclusions The quality of reporting of RCTs published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004 has been improved, but it does not meet the CONSORT statement.