針刺平行隨機對照試驗通常沒有準確報告試驗組和對照組的干預方法.為促進標準化,國際上有經驗的針刺醫師和研究者組成的小組制定了一些原則,即針刺臨床對照試驗中干預措施報告的標準(縮寫為STRICTA).在征求意見過程中,一些期刊編輯協助對此標準進行了修改,使之與隨機對照試驗報告的標準(CON-SORT)格式一致,作為該指南對針剌研究報告的延伸.參與此事的雜志編輯已確定要發表該標準,建議其作者群按照此標準準備論文,并將邀請更多雜志采用該標準.目的是使針剌對照試驗的干預措施充分報告,從而有利于對這些研究的嚴格評價、分析及這些措施的推廣.
Objective To study the role of hydrogen sulfide （H2S） in prophase of acute peritoneal cavity infection. Methods NaHS was taken as a donor of H2S. Seventy-two Sprague-Dawley rats were divided into 4 groups randomly：control group， cecal ligation and puncture （CLP） and treated with natural saline group，CLP and treated with NAHS group， and CLP and treated with DL-propargylglycine （PAG， an inhibitor of H2S formation） group. Selected 6 rats at 2h， 6h， and 12h after treatment in each group. The contents of TNF-αand H2S in serum and the content of MPO in intestinal tissue were measured， respectively. The histopathological change of ileum tissues were observed at 6 h after treatment in each group. Results The H2S could alleviate CLP-induced inflammation obviously， decrease the content of TNF-α in serum when inflammation，and attenuate the infiltration of neutrophilic granulocyte in small intestine. Conclusion The H2S has anti-inflammation effect in prophase of acute peritoneal cavity infection.
Objective To compare the clinical and hemodynamic results of patients undergoing transcatheter aortic valve replacement (TAVR) with different vascular approaches. Methods We retrospectively analyzed the baseline status, procedure status, procedure-related clinical complications defined by Valve Academic Research Consortium-2 consensus document, and postoperative hemodynamic results of patients with severe aortic stenosis who underwent TAVR between April 2012 and January 2019 in West China Hospital of Sichuan University. Results A total of 436 patients were enrolled, including 58 patients undergoing surgical cutdown and 378 patients undergoing percutaneous puncture. The prevalence of tumor in the surgical cutdown group was higher than that in the percutaneous puncture group (8.62% vs. 2.65%, P=0.037), while the other baseline characteristics, including age, male proportion, body mass index, and Society of Thoracic Surgeons scores, were similar between the two groups (P>0.05); the proportion of patients with aortic regurgitation equal to or greater than a moderate degree in the surgical cutdown group was lower than that in the percutaneous puncture group (22.41% vs. 35.98%, P=0.043), and there was no statistically significant difference in other preoperative cardiac ultrasound-related indicators (P>0.05). The procedure success rate was high in both groups (96.55% vs. 98.68%, P=0.236). Immediately after operation, the incidences of new-onset left bundle branch block (43.10% vs. 24.87%, P=0.004), severe bleeding (12.07% vs. 4.23%, P=0.030), and mild bleeding (20.69% vs. 3.44%, P<0.001) were higher in the surgical cutdown group than those in the percutaneous puncture group, and the postoperative hemodynamics indicated that there was no statistically significant difference in maximum blood flow velocity between the two groups [(2.37±0.52) vs. (2.50±1.67) m/s, P=0.274]. At the 1 year follow-up, the cardiac death rate (5.17% vs. 3.17%, P=0.696) and all-causes mortality rate (8.62% vs. 8.47%, P=1.000) between the two groups were not statistically different.Conclusions Compared with percutaneous puncture, surgical cutdown is associated with a higher incidence of bleeding events, while the incidence of other clinical complications such as vascular complications and the postoperative hemodynamic outcomes were similar.
Objective To evaluate the reporting quality of randomized controlled trials (RCTs) on acupuncture for acute ischemic stroke. Methods Six databases including The Cochrane Central Register of Controlled Trials (CENTRAL, Issue 4, 2005), MEDLINE (1966 to December 2005), EMbase (1984 to December 2005), China National Knowledge Infrastructure (CNKI, 1994 to December 2005), China Biomedicine Database disc (CBMdisc, 1980 to December 2005), VIP (a full text issues database of China, 1989 to December 2005) were searched systematically. Handsearch for further references was conducted. Language was limited to Chinese and English. We identified 74 RCTs that used acupuncture as an intervention and assessed the quality of these reports against the Consolidated Standards for Reporting of Trials (CONSORT) statement and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).Results In regard to the items in the CONSORT statement, 54 (73%) RCTs described baseline demographic and clinical characteristics in each group. Twenty-six (35%) mentioned the method of generating the random sequence, with 4 (5%) using a computer allocation. Only 6 (8%) RCTs had adequate allocation concealment, with 5 RCTs using sealed opaque envelopes and 1 RCT using centralized computer allocation. Only 8 (11%) RCTs used blinding, including 5 described as double-blind. Four (5%) RCTs reported the sample size calculation and 5 (7%) RCTs reported that an intention-to-treat (ITT) analysis. In regard to the items in STRICTA , only 4 (5%) RCTs reported the numbers of needles inserted. In 35 (47%) RCTs the needle type was reported, but only 26 (35%) mentioned the depths of insertion. Only 1 (1%) RCT mentioned the length of clinical experience and 6 (8%) RCTs reported the background of the acupuncture practitioners, but none stated the duration of their training.Conclusion The reporting quality of RCTs of acupuncture for acute ischemic stroke was low. The CONSORT statement and STRICTA should be used to standardize the reporting of RCTs of acupuncture.
Objective To assess the efficacy and safety of acupuncture versus western medicine in the treatment of depression neurosis. Methods Randomized controlled trials (RCTs) involving acupuncture versus western medicine in the treatment of depression neurosis were identified from CBM (1978 to 2009),VIP (1989 to 2009),WANFANG Database (1998 to 2009), CNKI (1979 to 2009), PubMed (1966 to 2009), EMbase (1980 to 2009), and The Cochrane Library (Issue 4,2008). We also hand searched relevant journals from Tianjin University of Traditional Chinese Medicine. Data were extracted and evaluated by two reviewers independently with a specially designed extraction form. The Cochrane Collaboration’s RevMan 5.0.2 software was used for data analyses. Results A total of 9 trials involving 903 patients were included. Meta-analyses showed that the total effective rate in the acupuncture group was similar when compared with Dailixin (RR= 1.01, 95%CI 0.82 to 1.23) on 20 d, fluoxetine (RR= 1.06, 95%CI 0.82 to 1.37) at week 8, but showing difference between acupuncture and fluoxetine (RR= 1.15, 95CI 1.07 to 1.22) at week 12. As for the HAMD score, no significant difference was noted between acupuncture and Dailixin (WMD= 0.45, 95%CI – 2.47 to 3.37) at 20 d, or amitriptyline at week 6, or fluoxetine on 30 d, and weeks 4, 8, 12; there was a difference between acupuncture and amitriptyline observed at week 1 (WMD= – 2.67, 95%CI – 4.38 to – 0.96) and week 2 (WMD= – 2.18, 95%CI – 3.28 to – 1.08). In terms of the SDS scores, significant difference was found between acupuncture and fluoxetine (WMD= – 4.26, 95%CI – 6.67 to – 1.85) at week 6, but no difference at week 4 and 12. Four trials reported adverse events. One trial found that no adverse events existed in acupuncture according with TESS score, contrasting with thirst, constipation, vision vague, shimmy, fast heart rate, and some change in liver function and cardiogram in amitriptyline group.Two trials reported very low score in acupuncture showing difference when compared with the drugs. And one trial described that four people had stomach and intestinal tract disorders. While no adverse reactions happened in the acupuncture group. Conclusion Acupuncture is not inferior to western medicine, and it is worth noting that acupuncture is associated with few adverse reactions. Further large-scale trials are required to define the role of acupuncture in the treatment of depression neurosis.
Objective To investigate the combined effects of digastric muscle low frequency modulated medium frequency electro-acupuncture therapy and voice training for dysphagia in patients who underwent aortic arch surgery. Methods Forty-two consecutive patients with dysphagia after aortic arch surgery between October 2014 and November 2017 were divided into two groups including an observation group and a control group. There were 21 patients in each group. There were 17 males and 4 females at age of 51.0±6.5 years in the observation group, while 18 males and 3 females at age of 49.8±7.3 years in the control group. The patients in the observation group underwent electroacupuncture therapy and voice training (20 min per day for each therapy, 2 weeks), while the patients in the control group only received safe swallowing education and rehabilitation guidance (2 weeks). The test results, such as fibrolaryngoscope and functional oral intake scale (FOIS) score, and the data of computer phonatory detection, before and after the intervention were compared. Results The fibrolaryngoscope of vocal cords significantly decreased and the FOIS score significantly increased after digastric muscle low frequency modulated medium frequency electro-acupuncture therapy and voice training in the observation group(6.30 vs. 4.60, P<0.05). Bucking was obviously reduced. The indicators of hoarse degree, such as median pitch, fundamental frequency, jitter (0.60%±0.96%vs. 1.99%±1.86%, P=0.033), shimmer (2.47%±4.26% vs. 5.89%±3.66%, P=0.043), maximum phonation time (15.31±9.10 s vs. 3.72±8.83 s, P=0.006), maximum and loud phonation time (9.30±5.73 s vs. 2.32±2.99 s, P=0.039), mean noise-to-harmonics ratio (23.99±10.17 vs .9.98±9.37, P=0.006) and mean harmonics-to-noise ratio (0.03±0.02 vs. 0.17±0.23, P=0.019) improved after the treatment in both groups. But the improvement in the observation group was significantly better than that in the control group. Conclusion The combination of digastric muscle low frequency modulated medium frequency electro-acupuncture therapy and voice training on dysphagia in patients who underwent aortic arch surgery can significantly improve the swallowing function of patients. Meanwhile, it also helps the recovery of phonic function and improves the ability of feeding and communication in these patients.
World Federation of Acupuncture-Moxibustion Societies (WFAS) standard Norms for Formulation and Evaluation of the Clinical Practice Guidelines of Acupuncture and Moxibustion (Hereinafter referred to as Norms) is the first methodological specification for the development of guidelines of acupuncture and moxibustion (Acup-Mox) issued by an international academic organization. The Norms stipulates the principles, procedures, review process and requirements of the development of WFAS guidelines of Acup-Mox. It also proposes the development method, evaluation method, and reporting standards of WFAS guidelines of Acup-Mox. This article introduces the development process of the Norms and provides an interpretation of the methodological supplementary requirements for key links such as "formulation of clinical questions", "evidence retrieval, evaluation and synthesis", and "consensus decision-making", as well as the "framework and contents of recommendation" to provide relevant references for users in learning and using the Guidelines.
ObjectiveTo select the key questions of the reporting quality of acupuncture therapy network meta-analysis. MethodsA question pool about reporting quality of acupuncture therapy network meta-analysis was conducted by preliminary literature research and qualitative systematic review. A correspondence questionnaire was designed and the selection of key questions was carried out through two rounds of expert consultation using the Delphi method. ResultsA total of 21 key questions were selected for the network meta-analysis report standard of acupuncture, including whether to report details of acupuncture interventions (e.g., needle type, acupoints used, number of needles inserted, depth of needle insertion, retention time, needling techniques, and treatment duration), diagnostic criteria for diseases or traditional Chinese medicine syndromes, and qualifications of acupuncture practitioners. Of these, the only three key questions answered by the preferred reporting items for systematic reviews and network meta-analysis (PRISMA-NMA) were summary, protocol and registration, and source of funding, while the remaining 19 were specific to acupuncture-related report standards. ConclusionThe conducted key question on reporting guideline of acupuncture network meta-analysis can improve the standardization and rigor of relevant research and better utilize its academic and clinical value.
Objective To summarize the recent minimally invasive approach for cervical spondylotic radiculopathy (CSR). Methods The recent l iterature at home and abroad concerning minimally invasive approach for CSR was reviewed and summarized. Results There were two techniques of minimally invasive approach for CSR at peresent: percutaneous puncture techniques and endoscopic techniques. The degenerate intervertebral disc was resected or nucleolysis by percutaneouspuncture technique if CSR was caused by mild or moderate intervertebral disc herniations. The cervical microendoscopicdiscectomy and foraminotomy was an effective minimally invasive approach which could provide a clear view. The endoscopy techniques were suitable to treat CSR caused by foraminal osteophytes, lateral disc herniations, local l igamentum flavum thickening and spondylotic foraminal stenosis. Conclusion The minimally invasive procedure has the advantages of simple handl ing, minimally invasive and low incidence of compl ications. But the scope of indications is relatively narrow at present.
Objective To evaluate the evidence-based prevention and treatment of post-dural puncture headache (PDPH) for parturient women. Methods We searched The Cochrane Library (Issue 3, 2006), Medline (Jan. 1980 to Oct. 2006) and CBM-disc (Jan. 1980 to Oct. 2006) to identify current best evidence on the prevention and treatment of PDPH for parturient women. The quality of available evidence was critically appraised.Results We identified 2 Cochrane systematic reviews, 2 meta-analyses and 9 randomized controlled trials. Evidence indicated that posture, fluid, and pharmacological managements had no significant effect on PDPH except epidural blood patch. The selection of appropriate spinal needle and the technique of needle insertion may reduce the incidence of PDPH, whereas the effect of intrathecal saline infusion and catheter insertion need further clinical validation. Conclusions Epidural blood patch has definite therapeutic effect on PDPH. Appropriate spinal needle and insertion technique may effectively prevent PDPH for parturient women.