To systemically evaluate the effect of Qishen Yiqi Dripping Pills combined with Western medicine on adverse cardiovascular events and quality of life after percutaneous coronary intervention(PCI). A total of 7 Chinese and English databases including CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were searched by computer to collect the randomized controlled trials(RCTs) on Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients with coronary heart disease after PCI with the retrieval time from the database establishment to April 1, 2020. Two researchers independently conducted li-terature screening, data extraction and bias risk assessment. Then, Meta-analysis was performed by using RevMan 5.3 software. A total of 31 RCTs were included, involving 3 537 patients. The results of Meta-analysis showed that in terms of major adverse cardiovascular events(MACE) after PCI, the combination of Qishen Yiqi Dripping Pills could significantly reduce the recurrence of angina pectoris, incidence of arrhythmia, heart failure and re-revascularization, and the effect was better than that of Western medicine treatment alone. However, there was no significant difference between the two groups in the improvement of non-fatal myocardial infarction, cardiac death, stent restenosis, stroke and other adverse cardiovascular events. In terms of improving left ventricular ejection fraction(LVEF), 6 min walking test(6 MWT), high-sensitivity C-reactive protein(hs-CRP) and Seattle angina pectoris scale(SAQ), the combination of Qishen Yiqi Dripping Pills and Western medicine treatment had obvious advantages over Western medicine treatment alone in increasing LVEF, 6 MWT and SAQ, and reducing the level of hs-CRP, with statistically significant differences. There were few adverse reactions in both groups, and there was no significant difference between the two groups. The main manifestations were gastrointestinal reactions, rash, gingiva and other small bleeding, and no serious adverse reactions occurred. The above reactions could disappear after drug withdrawal or symptomatic treatment. The application of Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients after PCI could reduce the occurrence of MACE, improve the clinical efficacy, quality of life and prognosis in a safe and reliable manner. However, due to the quantity and quality limitations of included studies, more standardized, rigo-rous and high-quality clinical studies are still needed to further verify the above conclusions.
Drugs, Chinese Herbal/adverse effects* ; Humans ; Medicine ; Percutaneous Coronary Intervention/adverse effects* ; Quality of Life ; Stroke Volume ; Ventricular Function, Left

Traditional Chinese Medicine (TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
Clinical Protocols ; Clinical Trials as Topic ; Humans ; Medicine, Chinese Traditional ; Research Design

BACKGROUND: Syndrome is one of the most important concepts in Chinese medicine (CM) theory. However, it was not well accounted in most of randomized controlled trials (RCTs). OBJECTIVES: To determine whether CM syndrome differentiation affects the treatment results, functional constipation (FC) was selected as a target disease, and MaZiRenWan (, MZRW), a classic CM formula commonly used for constipation with excessive heat syndrome, was selected for study. METHODS: It is an 18-week prospective double-blinded, doubledummy RCT, including 2-week run-in, 8-week treatment and 8-week post treatment follow-up. A total of 120 FC patients diagnosed as excessive heat syndrome will be recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and the Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine. Patients will be randomly allocated into fixed MZRW (f_MZRW) granule group, modified MZRW (m_MZRW) granule group or bisacodyl group. For m_MZRW group, no more than two herbal granules can be added according to the syndrome differentiation for individual participants. The primary end point is the mean of complete spontaneous bowel movements (CSBMs) per week during the treatment period. Secondary end points include mean of CSBMs per week during follow-up, stool form, global symptom improvement, constipation and constipation-related symptoms assessment, CM syndrome change, and reported adverse events. DISCUSSION This trial is designed to evaluate the effectiveness of these three interventions for FC patients with the CM syndrome of excessive heat, and to determine the change of CM syndrome and the progress of disease during the treatment course. The results are important to explore whether syndrome differentiation is important for the therapeutic effect of a formula on a disease. [Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-TRC-13003742); protocol version: MZRW/NSFC-81173363 (2015.05.04)].
Constipation ; diagnosis ; drug therapy ; Double-Blind Method ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Outcome Assessment (Health Care) ; Prospective Studies ; Randomized Controlled Trials as Topic

Global Health ; Humans ; Pulmonary Disease, Chronic Obstructive ; prevention & control ; therapy

Objective: To summarize the clinical effects of Shuxuening Injection on diseases and evaluate the quality of evidence to provide reference for the clinical application of Shuxuening Injection. Methods: Journal articles and conference papers were retrieved from the databases CNKI, Wanfang, VIP, CBM, EMbase, Pubmed and Cochrane with thematic word"Shuxuening"in Chinese and English, then all forms of clinical studies were screened and the disease types and frequency were analyzed, the dominant disease types of Shuxuening Injection were identified. Futhermore, RCT was extracted, and the literature quality was graded using the cochrane manual recommendation method, and its effectiveness and safety were evaluated. Results: All clinical research results show that Shuxuening Injection to treat disease with as many as 74 kinds of varieties, mainly circulation system disease and neural system disease, followed by endocrine disease, respiratory disease, scattered remaining research in ten other system diseases. These researches appeared with the highest frequency of the three diseases were cerebral infarction and its aftermath, angina pectoris and coronary heart disease, diabetes mellitus and its complication. A total of 337 RCT articles were included, all of which were of poor quality. In general, the efficiency of Shuxuening Injection treatment group was significantly higher than that of the control group, with a total efficiency of 84.48％. There were 21.96％ references to adverse reactions, but all of them were minor adverse reactions, such as pruritus, which generally got better by itself or after treatment. Conclusion:Shuxuening Injection has a wide range of clinical application and remarkable effect, especially for the ischemic diseases of cardiovascular and cerebrovascular diseases with good efficacy, less adverse reactions and safety. However, the quality of evidence is generally poor, which needs further study.

Objective: To investigate the effects of the compound preparation Jinghuosu on oligospermia and asthenospermia. METHODS: This multi-centered clinical study included 120 cases of mild to moderate idiopathic oligospermia or asthenospermia, all treated with oral Jinghuosu once a bag, bid, for 3 successive months. Before and at 1, 2 and 3 months after treatment, we detected sperm concentration, total sperm motility, progressive sperm motility and normal sperm morphology of each ejaculate, and recorded whether the patients had any adverse reactions. RESULTS: After 3 months of treatment, all the patients showed obvious improvement in semen parameters, most significantly in sperm concentration, total sperm motility, and the percentages of progressive motile sperm and morphologically normal sperm (P <0.05). No significant adverse reactions were observed during the 3 months of medication. CONCLUSIONS Jinghuosu has a significant efficacy and no obvious adverse effect in the treatment of mild to moderate oligospermia and asthenospermia.
Asthenozoospermia ; drug therapy ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Male ; Oligospermia ; drug therapy ; Semen ; drug effects ; physiology ; Sperm Count ; Sperm Motility

ABSTRACT:Objective To compare and analyze tip malposition of 2 central venous catheteri-zations in cancer patients.Methods Totally 1656 cancer patients received 1799 cases of peripheral-ly inserted central catheter(PICC)/conventional central venous catheter(CVC)were consecutively assessed by means of routine post-catheterization chest X-ray.The catheter with its tip strike and terminal position were confirmed individually.All tip malpositions were calculated.And the catheters with tip malpositions were readjusted and reevaluated.Results The failure rate in PICC group (2.68%)was significantly higher than that in CVC group(0.34%,P <0.01).Eighty three catheters(4.84%)were found tip malpositioned,in which 38 catheters(6.42%)were from PICC group and 45 ones(4.01%)from CVC group (P <0.01).The achievement ratio of readjustment for tip malposition in PICC group (71.1%)was much higher than that in CVC group (26.7%,P<0.01).Conclusion Compared with CVCs in cancer patients,the prevalence of tip malposition from PICCs was higher although the tip malpositions in PICCs were more likely to be corrected with readjustment.These findings suggest that tip position of PICC /CVC should be confirmed post-catheterization with chest x-ray.

ABSTRACT:Objective To compare and analyze tip malposition of 2 central venous catheteri-zations in cancer patients.Methods Totally 1656 cancer patients received 1799 cases of peripheral-ly inserted central catheter(PICC)/conventional central venous catheter(CVC)were consecutively assessed by means of routine post-catheterization chest X-ray.The catheter with its tip strike and terminal position were confirmed individually.All tip malpositions were calculated.And the catheters with tip malpositions were readjusted and reevaluated.Results The failure rate in PICC group (2.68%)was significantly higher than that in CVC group(0.34%,P <0.01).Eighty three catheters(4.84%)were found tip malpositioned,in which 38 catheters(6.42%)were from PICC group and 45 ones(4.01%)from CVC group (P <0.01).The achievement ratio of readjustment for tip malposition in PICC group (71.1%)was much higher than that in CVC group (26.7%,P<0.01).Conclusion Compared with CVCs in cancer patients,the prevalence of tip malposition from PICCs was higher although the tip malpositions in PICCs were more likely to be corrected with readjustment.These findings suggest that tip position of PICC /CVC should be confirmed post-catheterization with chest x-ray.

The aim of this study was to analyze the FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) allelic ratios (AR), number of ITD, ITD length and positions of ITD insertions in de novo acute myeloid leukemia (AML) patients with FLT3-ITD positive, and the relationship between mutant level and therapeutic efficacy. Genomic DNA was amplified by PCR, capillary electrophoresis was used to detect the ITD characteristics in 31 de novo AML patients, and DNA sequences analysis of FLT3-ITD(+) were performed in 13 patients. The results showed that the ratios of mutant to wild type FLT3 allele ranged from 0.01 to 2.8; 28 patients (90.32%) had a single ITD, the remaining 3 patients had more than one ITD; the ITD length ranged from 3 to 144 bp in all FLT3-ITD(+) patients. 13 sequence-analyzed patients, 4 patients were of pure duplications, and 2 patients had foreign bases inserted, and the other 7 patients were partial duplications. The ITD occurred in the regions from p.E573 to p.P606 of the FLT3 protein, with the majority clustered in a stretch between p.F590 and p.R595. The complete remission (CR) rate in AR < 0.5 patients (43.75%) were more prevalent as compared with AR ≥ 0.5 patients (16.67%) (p > 0.05). It is concluded that the ITD length and AR are vary widely. Some of the insertions are foreign bases, and all of the 13 sequences-analyzed ITD were concentrated on the juxtamembrane domain. The CR rate in patients of AR < 0.5 had no statistical significance compared with patients of AR ≥ 0.5.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Alleles ; Base Sequence ; DNA, Neoplasm ; genetics ; Female ; Humans ; Leukemia, Myeloid, Acute ; genetics ; Male ; Middle Aged ; Mutation ; Sequence Analysis, DNA ; Tandem Repeat Sequences ; Young Adult ; fms-Like Tyrosine Kinase 3 ; genetics

Objective To evaluate the accuracy of Hadeco ES-1000spm hand-held doppler during the anterolateral thigh(ALT)flap harvest.Methods Twenty-five patients(26 sides)with ALT flaps for head and neck reconstruction between May 2005 and May 2010 received preoperative Doppler examination for the location of the cutaneous perforators of ALT flaps.The Doppler signals and body mass index(BMI)were recorded preoperatively according to ABC system.The locations of Doppler signals and of the actual cutaueous perforators at surgery were plotted and compared.The diameter of perforators was measured.Results One to three cutaneous perforators of the ALT flap were consistently found at specific locations.They were named perforators A,B,C from proximal to distal.Perforators A,B and C were present in 15(58%),24(92%)and 20(77%)cases and the diameter(>0.5 mm)of A,B and C were 11/15,22(92%)and 8(40%)respectively.The Doppler signal was within 0.5 cm of the actual perforator location in 85% flaps.The accuracy of Doppler decreased with increase of BMI.Conclusions Preoperative assessment by hand-held Doppler is useful in predicting the perforator vessels'locations and diameter although it's accuracy is limited.