Exploration and reflection on evaluation methodology of human use experience for new Chinese drug development / 中国中药杂志

The "triple combination" review system provides an opportunity for the transformation of human use experience into new Chinese drugs. However, there are some methodological and technical limitations in the assessment of human experience. Hence, the efficacy and safety evaluation methods should be established in accordance with the characteristics of Chinese herbs. This study summarized some evidence-based methodology to promote the transformation of human use experience to new Chinese drugs, mainly including the individualized pragmatic randomized controlled trial(RCT), cluster RCT, single-case RCT, single arm RCT with objective performance criteria, and partially nested RCT. As the real world data can be used to support the transformation of human experience, attention should be paid to convenient and efficient collection of data, prudent selection of design types, and adoption of appropriate ana-lysis methods to deal with confounding bias, including multi-factor regression model and propensity score. The newly proposed mixed research method can also be utilized to assess the human use experience, which is suitable for mining the theory of traditional Chinese medicine(TCM) and expert experience from different aspects. Meanwhile, considering the study design requirements and TCM cha-racteristics, this study put forward the common problems and solutions in the development of new Chinese drugs based on human use experience, including how to select the feasible outcome indicators, how to collect prescription data in the case of herb and dosage adjustment, and how to evaluate the comprehensive effectiveness of TCM from the perspective of "combination of disease and syndrome".

Application and significance of mixed methods research in traditional Chinese medicine and narrative medicine / 中国中药杂志

Since narrative medicine was introduced in China, it has been widely used in medical education and clinical practice. The research on narrative medicine in China is especially characterized by its combination with traditional Chinese medicine(TCM). At present, the research on narrative medicine in China is still in the stage of small-scale practicing and theory advocating. Besides, there is also a lack of guidance on experimental design methodology for clinical application, which leads to few high-quality studies in this field. The present study reviewed the current high-quality research on narrative medicine to discuss the value and prospects of mixed methods research in narrative medicine. In addition, the common design, application procedures, and notes of mixed methods research were explained to provide references for the extensive applications of narrative medicine in the medical field, especially TCM clinical practice, education, and scientific research.

Comparison of physical effect between two training methods for individuals with substance use disorder.

BACKGROUND: HIIT has recently been widely used for health promotion in healthy people and patients with chronic diseases. Exercise can help SUD reduce drug cravings, enhance mental health and return to normal life. However, whether HIIT can bring better physical rehabilitation benefits to individuals with SUD than MICT is unclear. The study aimed to compare the effects of HIIT versus MICT on the physical fitness of individuals with SUD. METHODS: One hundred twenty individuals with amphetamine-type stimulant dependence voluntarily participated in this study. They were randomly assigned to the HIIT group and MICT group. Both groups received training three times a week. The intervention lasted from January 2019 to December 2019. Physical fitness was assessed at the baseline, 3 months, 6 months, 9 months and 12 months, including blood pressure (BP), vital capacity(VC), hand grip, push-up, sit-and-reach, one-leg standing with eyes closed and choice reaction time. The craving level was assessed using the Visual Analog Scale at baseline, 6 months and 12 months to see any change along with the improvement in physical fitness. Two-way repeated measures ANOVA was applied to analyse the differences in change by group (HIIT and MICT) and time (baseline, 3 months, 6 months, 9 months and 12 months). RESULTS: The within-group factor displayed significant changes in the HIIT and MICT groups in terms of systolic BP (F (4,336) = 12.799, P < 0.001,η2 = 0.204), diastolic BP (F(4,336) = 9.495, P < 0.001, η2 = 0.16), VC (F(4,336) = 18.121, P < 0.001, η2 = 0.177), hand grip (F(4,336) = 34.815, P < 0.001, η2 = 0.293), sit-and-reach (F(4,336) = 13.871, P < 0.001, η2 = 0.142), push-up (F(4,336) = 28.805, P < 0.001, η2 = 0.255), one-leg standing with eyes closed (F(4,336) = 14.495, P < 0.001, η2 = 0.156) and choice reaction time (F(4,336) = 20.603, P < 0.001, η2 = 0.197). The craving level decreased after 12 months of intervention in both groups (F(2,168) = 11.25, P < 0.001, η2 = 0.118), but no significant differences in physical fitness and craving level were found in between groups and the interactions of group × time. CONCLUSIONS: After 12 months of intervention, physical fitness improved while craving level decreased in the two groups. These findings suggest that both HIIT and MICT have positive effects on individuals with SUD in terms of physical fitness. TRIAL REGISTRATION: ChiCTR1900022158 Chinese Clinical Trial Registry: Registered 27th March, 2019.

A new phloroglucinol compound from Dryopteris fragrans / 中国中药杂志

Two phloroglucinol compounds(1-2) were isolated and purified from 95% ethanol extract of Dryopteris fragrans through various column chromatographies on silica gel, Sephadex LH-20, medium pressure column chromatography, and preparative HPLC. Their structures were elucidated as 2',4',6'-trihydroxy-5'-methyl acetate-3'-methyl-1'-butyrophenone(1) and aspidinol B(2) based on their chemical and physicochemical methods and spectroscopic data. Compound 1 is a new phloroglucinol compound named "dryofraginol".

Electroacupuncture Treatment Conduced Before and After Surgery Is Better in Promoting Reco-very of Gastrointestinal Function in Colorectal Cancer Patients Undergoing Radical Resection / 针刺研究

OBJECTIVE: To investigate the effect of electroacupuncture (EA) at different time-points on postoperative gastrointestinal function in patients undergoing colorectal cancer surgery. METHODS: Eighty patients with colorectal cancer undergoing laparotomy were randomly assigned to intravenous anesthesia, EA A, EA B, and EA C groups (n＝20 cases in each group). All the patients in the four groups received intravenous anesthesia with midazolam, sufentanil, cisatracurium besylate and Propofol, postoperative gastrointestinal decompression and drug analgesia. EA (2－3 mA, 2 Hz) was applied to Zhongwan (CV 12) and Tianshu (ST 25), Neiguan (PC 6), Zusanli (ST 36), Shangjuxu (ST 37), Xiajuxu (ST 39) on the right side for 30 min, once (one day before surgery) in the EA A group, twice (one day and 30 min before surgery) in the EA B group, and 3 times (one day, 30 min before and one day after surgery) in the EA C group. The acupoints used after surgery were PC 6, ST 36, ST 37 and ST 39. The time of postoperative ventilation, defecation, food-intake and water drinking, stomach tube removal and abdominal drainage tube removal, the volumes of stomach tube drainage and abdominal drainage, and postoperative adverse reactions were recorded. RESULTS: The first ventilation time, after surgery in the EA C group was significantly earlier than those in the intravenous anesthesia, EA A and EA B groups (P0.05)．. CONCLUSION: EA treatment combined with intravenous anesthesia conducted before and after surgery is effective in promoting the recovery of gastrointestinal function in patients undergoing colorectal cancer laparotomy, and is obviously better than simple pre-operative EA.

Study on the relationship between partial deletions in the azzospermia factor C region of Y chromosome and male infertility / 中华医学遗传学杂志

<p><b>OBJECTIVE</b>To investigate the relationship between the partial deletions in the azzospermia factor(AZFc) region of Y chromosome and male infertility.</p><p><b>METHODS</b>Multiplex PCR technology was performed to screen the partial deletions in the AZFc region in 158 azoospermia, 160 severe oligozoospermia and 135 oligozoospermia patients and 236 men with normal spermatogenesis.For samples with gr/gr, b2/b3 recombinogenic deletions, author applied RFLP method to identify which DAZ gene doublet deletion was involved.</p><p><b>RESULTS</b>The gr/gr and b2/b3 were two types of common deletions detected. There were significant differences in the b2/b3 deletion in patients with oligozoospermia and severe oligozoospermia compared to the controls (both P< 0.05). However, there was no difference for the gr/gr deletion between the patients and controls.</p><p><b>CONCLUSION</b>The results suggested that the b2/b3 deletion might be a risk factor to spermatogenic impairment and might lead to male infertility.</p>