Therapeutic Evaluation on Complex Interventions of Integrative Medicine and the Potential Role of Data Mining

It is a common view that the integration of Chinese medicine （CM） and modern Western medicine is an efficient way to facilitate the development of CM. Integrative medicine is a kind of complex interventions. Scientific therapeutic evaluation plays a crucial role in making integrative medicine universally acknowledged. However, the modern method of clinical study, which is based on the concept of evidence-based medicine, mostly focuses on the population characteristics and single interventional factor. As a result, it is difficult for this method to totally adapt to the clinical features of CM and integrative medicine as complex interventions. One possible way to solve this issue is to improve and integrate with the existing method and to utilize the evaluation model on complex interventions from abroad. As an interdisciplinary technique, data mining involves database technology, artificial intelligence, machine learning, statistics, neural network and some other latest technologies, and has been widely used in the field of CM. Therefore, the application of data mining in the therapeutic evaluation of integrative medicine has broad prospects.

A Protocol for Developing a Clinical Practice Guideline for Therapeutic Drug Monitoring of Vancomycin

This study aimed to develop a guideline for therapeutic drug monitoring（TDM） of vancomycin. We adopted the new guideline definition from the Institute of Medicine（IOM）, adhered closely to the six domains of the Appraisal of Guidelines for Research ＆ Evaluation Ⅱ（AGREE Ⅱ）, and made recommendations based on systematic reviews. We established a Guideline Steering Group and a Guideline Development Group, formulated 12 questions in the form of Population, Intervention, Comparison, Outcome（PICO） and completed a literature search. As far as we know, we will develop the first evidenced-based guideline for vancomycin TDM under the framework of the Grade of Recommendations Assessment, Development and Evaluation（GRADE）.

A Clinical Study on the Treat ment of Chronic Pelvic Inflammation of Qi-stagnation with Blood Stasis Syndrome by Penyanqing Capsule (盆炎清胶囊)

Objective： To observe the clinical efficacy of Penyanqing Capsule （盆炎清胶囊, PYQC） in treating pelvic inflammation of Qi-stagnation with blood stasis syndrome. Methods： The randomized, single blinded, parallel positive drug controlled method was adopted, with 82 patients assigned into two groups by envelop method. The 42 patients in the treated group received PYQC 3 times a day, 4 capsules each time taken orally; the 40 patients in the control group were given orally Fuyankang tablets （妇炎康片, FYKT） 3 times a day, 6 tablets each time. The therapeutic course for both groups was 2 months, and 2 courses of treatment were given successively to observe the comprehensive effect, changes of symptoms and signs before and after treatment. The effects of PYQC on hemorrheological character in part of the patients and on the pathogenetic chlamydia and mycoplasma were also observed. Results： The total effective rate in the treated group was 83.3%, which was insignificantly different from that in the control group （77.5%, P〉0.05）. However, PYQC could significantly lower the hemorrheologic indexes in patients and showed definite influence on the pathogenetic chlamydia and mycoplasma. Conclusion： PYQC has good therapeutic effect in treating chronic pelvic inflammation of Qi-stagnation with blood stasis syndrome, and showed definite effect on chlamydia and mycoplasma.

Comparison of Efficacy of Different Treatments for Pulmonary Embolism

An optimal therapy for pulmonary embolism（PE） was explored by comparing three different methods in order to alleviate the sufferings of PE patients and reduce the mortality. Eighty patients with PE diagnosed by computed tomography angiography（CTA） were treated with thrombolysis, anticoagulation only, or surgery/intervention. The clinical efficacy of different treatments were compared and analyzed. Twenty-four out of the 26 patients（92%） in anticoagulation only group showed improvement in CTA and clinical presentations, which was significantly higher than that in the thrombolysis group（87%, n=39, P〈0.05）. However, there was no significant difference in the rate of mortality between thrombolysis group and anticoagulation only group. In the surgery/interventional group（n=15）, the success rate was 47%, and the mortality rate was 14%. Both of them were significantly different from those in thrombolysis and anticoagulation only groups（both P〈0.05）. Log-rank analysis of the data of 5-year follow-up revealed that the survival time in surgery/intervention group was significantly shorter than in the other two groups（P0.05）. It was suggested that it is of importance to choose the appropriate therapeutic regimen for PE patients. Mortality may be reduced and prognosis may be improved with anticoagulation only and thrombolysis therapy.

Evaluation by Survival Analysis on Effect of Traditional Chinese Medicine in Treating Children with Respiratory Syncytial Viral Pneumonia of Phlegm-Heat Blocking Fei Syndrome

Objective:To objectively evaluate the clinical effect of traditional Chinese medicine in treating children s respiratory syncytial viral pneumonia(RSVP) of phlegm-heat blocking Fei(肺) syndrome(PHBFS). Methods:A single-blinded multi-center,blocked,randomized and parallel-controlled method was adopted.The clinical study was carried out on 206 children with RSVP-PHBFS who were assigned to two groups,108 in the test group treated through intravenous dripping of Qingkailing Injection(清开灵注射液) in combination of or...

Application of Response Evaluation Criteria of Traditional Chinese Medicine for Solid Tumor in Advanced Non-Small Cell Lung Cancer

Objective：To evaluate the objectivity and comprehensiveness of Response Evaluation Criteria of Traditional Chinese Medicine for Solid Tumor（Draft,REC-TCM-ST） in application of Chinese medicine therapeutic effect in patients with advanced non-small cell lung cancer（NSCLC）.Methods：A retrospective clinical research was used in 104 NSCLC patients in stages of Ⅲ-Ⅳ,53 cases were in Chinese medicine（CM） group and 51 cases were in Western medicine（WM） group.The therapeutic effect of the two groups was evaluated with both REC-TCM-ST and Response Evaluation Criteria in Solid Tumor（RECIST）.Kaplan-Meier method was used to analyze the survival time.Kappa test method was used to test the consistency of the two kinds of evaluation results.Results：According to REC-TCM-ST,the effective rate on relieving tumor mass in the CM group was significantly lower than that in the WM group（P〈0.05）,but there was no significant difference in tumor-mass stable rate（P〉0.05）;the symptom of weakness in the CM group was improved significantly,indicating better therapeutic effect than that in the WM group（P〈0.01）.Karnofsky score in the CM group was significantly better than that in the WM group（P〈0.01）.In terms of survival conditions,the median survival time and the survival rate of 6 months,1 year and 2 years of the CM group were higher than the WM group.The total effective rate was 9.62%,and the total stable rate was 72.12%for 104 cases according to RECIST;while the total effective rate was 34.62%,and the total stable rate was 84.62%according to REC-TCM-ST,thus there were significant differences between the results of the two criteria（P〈0.01）,and there was also some consistency between them,but not satisfactory.Conclusions：REC-TCM-ST was used to evaluate the therapeutic effect of CM in the treatment of advanced NSCLC,which shows that its evaluation results can better reflect the advantages and disadvantages of CM,and the effectiveness of CM is more objective and comprehensive than RECIST,so REC-TCM-ST is worthy of further improvement and clinical expansion.

Joint Development of Evidence-Based Medical Record by Doctors and Patients through Integrated Chinese and Western Medicine on Digestive System Diseases

Building the clinical therapeutic evaluation system by combing the evaluation given by doctors and patients can form a more comprehensive and objective evaluation system.A literature search on the practice of evidence-based evaluation was conducted in key biomedical databases,i.e.PubMed,Excerpt Medica Database,China Biology Medicine disc and China National Knowledge Infrastructure.However,no relevant study on the subjects of interest was identified.Therefore,drawing on the principles of narrative medicine and expert opinion from systems of Chinese medicine and Western medicine,we propose to develop and pilot-test a novel evidence-based medical record format that captures the perspectives of both patients and doctors in a clinical trial.Further,we seek to evaluate a strategic therapeutic approach that integrates the wisdom of Chinese medicine with the scientific basis of Western medicine in the treatment of digestive system disorders.Evaluation of therapeutic efficacy of remedies under the system of Chinese medicine is an imperative ongoing research.The present study intends to identify a novel approach to assess the synergistic benefits achievable from an integrated therapeutic approach combining Chinese and Western system of medicine to treat digestive system disorders.

Acupuncture is ineffective for chronic low back pain?A critical analysis and rethinking

Acupuncture is a promising treatment for relieving pain and improving lower back function in clinical practice.However,evidence from randomized clinical trials(RCTs)remains controversial.Most RCTs conclude that acupuncture procedures for chronic low back pain(CLBP)had no significant difference in efficacy and belonged to placebo.We carefully reviewed and analyzed the methodology and implementation of sham acupuncture in RCTs.Controversial evidence of acupuncture for CLBP is only a microcosm of the evaluation methodological limitation of acupuncture.Inappropriate selection of sham acupuncture controls,rigorous RCT research models,and incorrect interpretation of results may contribute to negative evidence.Evaluating and disregarding the holistic efficacy of acupuncture with an explanatory RCT model based on evaluation drugs may be unwise.Moreover,sham acupuncture is often proven to be non-inert,unreasonable,and with low fidelity.Pitfalls of the explanatory RCT model and sham acupuncture design should be avoided.Establishing a new evaluation system that is in line with the clinical characteristics of acupuncture and obtaining high-quality evidence are difficult but promising tasks.