Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies / 中国结合医学杂志

Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently, a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12, 2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs, which will further develop the scientific integrity and quality of clinical studies.

Problems to pay attention to in taking patient-reported outcomes as clinical outcomes assessment / 中国中西医结合杂志

Patient-reported outcomes (PROs) provide clinical researchers with a good means to assess patient-based outcomes. Yet there are still some problems to pay attention to while using PROs as an effectiveness assessment index, including the selection of an appropriate scale of PRO, quality control in PRO data collection, and the interpretations and application ranges of the PRO results.

Principles of ethics review on traditional medicine and the practice of institute review board in China / 中国结合医学杂志

As one of the significant parts of medical science research in China, the research on Chinese medicine (CM) reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture. Therefore, in the practice of ethics review on CM research protocols, besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study, we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values. In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics, and then attempted to summarize the key points for the bioethics review to CM researches in China, so as to serve as reference for the bioethics review to traditional and alternative medicine researches.

Synthetic evaluation of the clinical effect of the Shengmai capsule for treatment of chronic congestive heart failure using analytic hierarchy process / 南方医科大学学报

<p><b>OBJECTIVE</b>To explore the approaches and techniques for synthetic evaluation of the clinical therapeutic effect of new Chinese herbal medicine in clinical trials.</p><p><b>METHODS</b>In a double-blind, randomized, and placebo-controlled clinical trail, analytic hierarchy process (AHP) was applied to evaluate the clinical therapeutic effect of Shengmai capsule in the treatment of chronic congestive heart failure.</p><p><b>RESULTS</b>Shengmai capsule produced positive therapeutic effect on chronic congestive heart failure.</p><p><b>CONCLUSION</b>A feasible method is established for evaluating and grading the clinical therapeutic effect of Chinese herbal medicine.</p>

A prospective comparative study of three treatment options in patients with malignant gastric outlet obstruction / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To evaluate outcomes after different treatment options including endoscopic stent placement, surgical bypass, and percutaneous gastrostomy for malignant gastric outlet obstruction (GOO).</p><p><b>METHODS</b>Thirty-nine patients with GOO secondary to unresectable primary or metastatic cancer were treated with endoscopic stent placement (group 1, n=13), surgical bypass (group 2, n=21), or percutaneous gastrostomy (group 3, n=5). QLQ-STO22 form was used to assess quality of life (QOL) at baseline, 1 month, and 3 months following intervention.</p><p><b>RESULTS</b>Overall median survival time was 68 days. Median survival time in group 1 and group 2 was 85 and 72 days respectively, longer than that in group 3 (48 days, P<0.05). Fourteen patients (7 cases in group 1 and 7 cases in group 2) completed all three QOL surveys. All the patients in group 1 had significant improvement in dysphagia, dietary restrictions, dry mouth, and reflux (P<0.05). In group 2, dysphagia and dietary restrictions were significantly improved (P<0.05), while there were no significant improvements in dry mouth, reflux and pain (all P>0.05).</p><p><b>CONCLUSION</b>Although the prognosis of malignant GOO is poor, endoscopic stent placement and surgical bypass may improve QOL of patients and therefore are reasonable alternatives for palliation.</p>

Comparison of pragmatic clinical trials and explanatory clinical trials / 中国中西医结合杂志

Clinical trials are often designed as either pragmatic or explanatory. The pragmatic clinical trials are generally used for measuring the effectiveness of a treatment in common clinical practice, while the explanatory trial for measuring the efficacy of a treatment under ideal conditions. Since the methods concerning pragmatic clinical trials are less introduced in China, its archetypal features, advantages and limitations were introduced in this paper. And a current study of pragmatic clinical trials on using acpuncture for treatment of low back pain carried out in German was taken as an example to illustrate the practical methods concretely. The key steps of the design were presented in detail, and reasonable suggestions about the problems often encountered in the trial, as well as how to balance the internal and external validity, outcome measurement, etc., were offered.

Development of a Medication Compliance Scale in Patients with Chronic Diseases / 中国慢性病预防与控制

Objective To develop a reliable scale for evaluating medication compliance among patients with chronic diseases in China.Methods An initial item pool was generated by literature review,based on the definition of compliance generally accepted in China.The items were then subjected to item selections by using item answer distribution and other four methods,which resulted in a primary scale with 16 items.The reliability and validity of this scale was examined.Results Common factors extracted by factor analysis were well explained,there being a close correspondence between the scale construction and the theoretical construction. Convergent validity with the patients' self-ratings on medication compliance ranged from 0.55 to 0.59,and the correlation coefficient with the score of Morisky questionnaire was 0.58.The Cronbach ?,0 and ? coefficients were 0.717,0.751,0.893 respectively,and test-retest reliability was 0.95.Conclusion The newly developed scale appears reliable and may be a useful tool for measuring drug compliance among patients with chronic diseases,but there are still areas where further improvements may be needed.

Pharmacokinetics of ginsenosides Rg1 and Re in Shenmai injection / 药学学报

<p><b>AIM</b>To study the pharmacokinetics of ginsenosides Rg1 and Re after iv infusion of Shenmai injection in human.</p><p><b>METHODS</b>Ginsenosides Rg1 and Re in plasma were determined by LC/MS/MS and the pharmacokinetic parameters were calculated.</p><p><b>RESULTS</b>The linear regressive curves were obtained in the range of 1.023-1023 microg x L(-1) for Rg1 and 1.05-1050 microg x L(-1) for Re. Recoveries using the method of Rg1 and Re were 99%-105% and 99%-104%, respectively. The within-day and between-day RSDs were less than 15%. After iv infusion of Shenmai injection to volunteers, the concentration-time curves of Rg1 and Re fitted to the two-compartment model, T1/2alpha were 0.28 h and 0.10 h, T1/2beta were 2.1 h and 1.2 h, respectively.</p><p><b>CONCLUSION</b>The method is specific, simple, sensitive and suitable for the measurement of plasma Rg1 and Re concentrations. The distribution and elimination of Rg1 and Re were rapid after iv infusion of Shenmai injection in volunteers, the pharmacokinetic characteristics were fitted with the two-compartment model.</p>

Preliminary study on outcome assessment system of treatment of stroke / 中国中西医结合杂志

<p><b>OBJECTIVE</b>In order to scientifically reflect the real efficacy of TCM treatment and to preliminarily establish a definitely valid and reliable assessment system of stroke treatment, with multi-dimensional outcome assessment indexes, including efficacy evaluation system of conventional western medicine, syndrome evaluation criteria in TCM and quality of life assessment system.</p><p><b>METHODS</b>An integrative approach of cross-sectional survey and prospective follow-up was adopted. Two hundred and forty-five case-episodes of stroke patients were assessed by determining such parameters as nerve functional deficit scale, grading of total status of living ability, activity of daily living (ADL), TCM stroke criteria of diagnosing-treatment, TCM syndrome related symptoms/signs, Health Survey Questionnaire (Short form 36, SF-36), and index of quality of life (QOL), and their construction and relation were analyzed by such methods as multivariate relation, partial relation, linear regression, factor analysis, Cronbach's alpha coefficients, and the responsiveness estimation.</p><p><b>RESULTS</b>The multi-dimensional assessment system of stroke treatment, containing 57 indexes with clarified constructions and classification, was created, and its validity and reliability confirmed after assessement. Various degrees of relationship were found between different TCM Syndromes and different domains of QOL.</p><p><b>CONCLUSION</b>The assessment system of stroke treatment preliminarily created has satisfied reliability and validity. It could be expected to reflect the real efficacy of TCM treatment more inclusive and accurate. TCM Syndrome indexes are considered to be the factor related to both domains of mental and physical health, particularly with the former, therefore, to improve the TCM Syndrome would imply improvement of the mental health, physical health and QOL of the patients.</p>

Method performance verification of the clinical chemiluminescence immunoassay / 中华检验医学杂志

Objective To establish a method performance verification project and experimental method for the clinical chemiluminescence immunoassay.Methods Referring to CLSI evaluation protocols and pertinent literature,and by combining our actual works,we designed a verification procedure and experimental method.By Using these above,the precision,accuracy,analytical sensitivity,analytical measurement range,clinical reportable range and biotic interval of AFP on the Bayer Centaur 240 chemiluminescence immunoassay system were verificated.Results would be compared with the declaration of the manufacturer or desirable specifications derived from biologic variation.Results The results showed that the between-day inaccuracy on AFP levels at 77.4 ng/ml and 168.0 ng/ml was 5.70% and 4.84% respectively,these were consistent with manufacturer's inaccuracy claimed.The relative bias between the results measured for calibrator at four levels and target value was less 5.0%,and the relative bias between the results measured for EQA control sample at five levels and target value was-3.4% to 11.9%.Lower limit of detection was 1.04 ng/ml,lower slightly manufacturer's analytical sensitivity claimed.Biologic limit of detection was 2.65 ng/ml-3.53 ng/ml,functional sensitivity was 3.53 ng/ml.Analytical measurement range was 3.53-912.00 ng/ml,within manufacturer's liner range claimed.Clinical reportable range was 3.53-182 400.00 ng/ml.Reference interval was 0.6-7.7 ng/ml,within manufacturer' s claimed.Conclusions The main performances of the detection system are accorded with the declaration of the manufacturer.The performance verification procedure and experimental method of our research ars simple and practical,which has important significations for building medical laboratory and laboratory accreditation, improving quality of the chemiluminescence immunoassay.