Efficacy of Qizi Yusi Pill on Pregnancy Outcomes in Women of Advanced Reproductive Age: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial / 中国结合医学杂志

OBJECTIVE@#To evalvate efficacy of Qizi Yusi Pills (QYP), a Chinese medicine compound preparation, on in vitro fertilization-embryo transfer (IVF-ET) in women of advanced reproductive age.@*METHODS@#This multicenter, randomized, double-blind, placebo-controlled trial was conducted from June 2018 to October 2019. A total of 124 patients were randomly allocated to either the QYP group or the placebo group using a stratified block randomization design, with 62 patients in each group. All patients completed controlled ovarian stimulation using a standard gonadotropin-releasing hormone agonist (GnRH-a) long protocol. As the QYP group, QYP was administered while the control group received placebo. QYP and placebo were administered for a total of 24 to 30 days from the day of GnRH-a pituitary downregulation to transvaginal oocyte retrieval. Both medications were taken orally at doses of 10 g three times each day. The primary outcome was cumulative pregnancy rate, and the secondary outcomes were periodic medication, follicular status, serum hormone and endometrial receptivity. Follow-up continued until 4 weeks after delivery. Maternal and neonatal complications, such as gestational diabetes, were also observed.@*RESULTS@#Overall, 119 patients completed the study, 60 in the QYP group and 59 in the placebo group. Per protocol (PP) analysis revealed that 6-month cumulative pregnancy rate in the QYP group was significantly higher than that in the placebo group [43.33% (26/60) vs. 25.42% (15/59), P=0.040). Additionally, more oocytes were retrieved from the QYP group than those from the placebo group (8.95 ± 3.12 vs. 7.85 ± 1.91, P=0.022). Moreover, the endometrial thickness of HCG day in the QYP group was significantly higher than that in the placebo group (11.78 ± 2.27 mm vs. 10.68 ± 2.07 mm, P=0.012). Maternal and neonatal complications between the two groups were not significantly different (P>0.05). Intention-to-treat analysis was in line with PP results.@*CONCLUSIONS@#QYP can enhance ovarian reserve capacity and ovarian response, and possibly promote endometrial receptivity. QYP effectively improves cumulative pregnancy rates in older patients (⩾35 years) undergoing IVF-ET. (Registration No. ChiCTR1800014427).

Multi-center randomized double-blind controlled study on children's anorexia (spleen-stomach disharmony) treated with Child Compound Endothelium Corneum / 中国中药杂志

Child Compound Endothelium Corneum(CCEC)has the effects in invigorating the spleen and appetizing the appetite, and dissolving the accumulation of food. The recent studies have proved that it could improve gastrointestinal motility, restore physiological gastrointestinal peristalsis, increase gastrointestinal digestive motility, and enhance appetite. This trial aimed to evaluate its clinical efficacy and safety in the treatment of children's anorexia(spleen-stomach disharmony). A total of 240 children with anorexia in line with the inclusion and exclusion criteria were selected and randomly divided into experimental group and control group, with 120 in each group. Patients in the experimental group took CCEC and Erpixing Granules simulant. Patients in the control group took Erpi-xing Granules and CCEC simulant. After 21 days of treatment, there was no statistical difference in the recovery rate of anorexia, reduced food intake, eating time, weight change, traditional Chinese medicine syndrome effect, single symptom effect, and trace element Zn recovery rate between the two groups. Based on the non-inferiority test, the experimental group was not inferior to the control group in efficacy. How-ever, the effect of CCEC in reducing appetite in children with anorexia was better than that of control drugs(P<0.05). There was no statistical difference in the incidence of adverse events and adverse reactions between the two groups during the trial. This experiment confirmed the efficacy and safety of CCEC in the treatment of children's anorexia(spleen-stomach disharmony), with a safety and re-liability in clinical application. In addition, it was a better choice for children with anorexia who were mainly manifested by reduced appetite. Meanwhile, compared with granule, chewable tablets were more convenient to take in clinic. Therefore, the efficacy and safety of CCEC for the treatment of children's anorexia(spleen-stomach disharmony) were not inferior to those of Erpixing Granules, with a safety and reliability in clnic. However, due to the small sample size of this trial, the efficacy results only show a trend. It is suggested to further carry out a large-sample-size clinical study to define the clinical advantages of CCEC.

Enhancement of an In Vivo Anti-Inflammatory Activity of Oleanolic Acid through Glycosylation Occurring Naturally in Stauntonia hexaphylla.

Stauntonia hexaphylla (Lardizabalaceae) has been used as a traditional herbal medicine in Korea and China for its anti-inflammatory and analgesic properties. As part of a bioprospecting program aimed at the discovery of new bioactive compounds from Korean medicinal plants, a phytochemical study of S. hexaphylla leaves was carried out leading to isolation of two oleanane-type triterpene saponins, 3-O-[ß-d-glucopyranosyl (1→2)-α-l-arabinopyranosyl] oleanolic acid-28-O-[ß-d-glucopyranosyl (1→6)-ß-d-glucopyranosyl] ester (1) and 3-O-α-l-arabinopyranosyl oleanolic acid-28-O-[ß-d-glucopyranosyl (1→6)-ß-d-glucopyranosyl] ester (2). Their structures were established unambiguously by spectroscopic methods such as one- and two-dimensional nuclear magnetic resonance and infrared spectroscopies, high-resolution electrospray ionization mass spectrometry and chemical reactions. Their anti-inflammatory activities were examined for the first time with an animal model for the macrophage-mediated inflammatory response as well as a cell-based assay using an established macrophage cell line (RAW 264.7) in vitro. Together, it was concluded that the saponin constituents, when they were orally administered, exerted much more potent activities in vivo than their sapogenin core even though both the saponins and the sapogenin molecule inhibited the RAW 264.7 cell activation comparably well in vitro. These results imply that saponins from S. hexaphylla leaves have a definite advantage in the development of oral medications for the control of inflammatory responses.

Epidemiological analysis of liver injury related to bone diseases / 中国中药杂志

A total of 1 392 reports on liver injury associated adverse drug reaction(LI-ADR) related to bone diseases were retrospectively analyzed based on national ADR monitoring system [18.75% of the patients used traditional Chinese medicine(TCM) alone and 68.68% used Western medicine alone]. This kind of cases accounted for 2.5% of all drug-related liver injury adverse reactions, ranking top ten of all drug categories. The number of reported cases and the proportion of serious cases showed an increasing trend from 2012 to 2016. The average age of the patients was(54.2±15.8) years old, and there was little difference in overall gender(male-female 1.04∶1). However, the number of female patients with rheumatoid arthritis was significantly higher than that of male patients(male-female 1∶2.6), while the number of male patients with gout was significantly higher than that of female patients(male-female 7.16∶1). The overall prognosis was good, with the recovery and improvement rate of 85.27%. The time from medication to liver injury varied due to different medicines. The median time to liver injury was 27 days in TCM alone group, later than 11 days in Western me-dicine alone group(P<0.05). Drugs for bone diseases have been one of the important categories for clinical drug-induced liver injury, and the number of reported cases on liver injury caused by drugs for bone diseases is increasing, so we should pay close attention to the safe and rational use of them. The LI-ADRs of male and female were different due to their different diseases, and the latency of adverse reactions in TCM group was generally longer than that in Western medicine group. In clinical medication, liver function should be monitored according to different diseases and characteristics of drugs to prevent the risk of liver injury.

Effect of acupuncture at proximal and distal acupoints combined with neuromuscular electrical stimulation on children with cerebral palsy salivation / 中国针灸

<p><b>OBJECTIVE</b>To explore the effect of acupuncture at the proximal and distal acupoints combined with neuromuscular electrical stimulation (NMES) for the children with cerebral palsy salivation on the basis of oral function training.</p><p><b>METHODS</b>A total of 124 children were randomized into an observation group and a control group, 62 cases in each one. Oral function training (30 min a time) and NMES (20 min a time) were used in the two groups. Acupuncture was applied after NMES in the observation group. The main acupoints were Baihui (GV 20), Sishencong (EX-HN 1), Speech AreaⅠ, Dicang (ST 4), Jiache (ST 6), Hegu (LI 4), Zusanli (ST 36), etc. Scalp acupuncture was for 1 h, and body acupuncture was for 30 min. Pricking blood was used at Jinjin (EX-HN 12) and Yuye (EX-HN 13) for the patients of Ⅴ in teacher salivation grading (TDS). All the treatment was given for 3 courses, 30 days as a course, 5 times a week, once a day. TDS, safety, dysphagia and Gesell development scale were assessed before and after treatment.</p><p><b>RESULTS</b>After treatment, the total effective rate of TDS in the observation group was 83.9% (52/62), which was better than 58.1% (36/62) in the control group (<0.05). The total effective rate of dysphasia in the observation group was 88.7% (55/62), which was better than 69.4% (43/62) in the control group (<0.05). The lip and tongue movement, chewing and swallowing after treatment in the observation group were superior to those in the control group (all <0.05). After treatment, the Gesell development scale of adaptability, language behavior and personal social development quotient were better compared with those before treatment in the observation group (all <0.05); the language behavior improved after treatment in the control group (<0.05). The adaptability, language behavior and personal social development quotient after treatment in the observation group were superior to those in the control group (<0.05，<0.01). The adverse reactions in the observation group were less than those in the control group.</p><p><b>CONCLUSION</b>Acupuncture at the proximal and distal acupoints combined with NMES are better than simple NMES for children with cerebral palsy salivation. The methods could not only improve children's behavior cognitive ability, but also improve the sensation and motor coordination of the lip, tongue, pharynx, etc. As a result, the salivation and swallowing function improve.</p>

Dynamic monitoring of the cytotoxic effects of protoberberine alkaloids from Rhizoma Coptidis on HepG2 cells using the xCELLigence system / 中国天然药物

AIM@#To investigate the cytotoxic effects of the six protoberberine alkaloids (PAs) from Rhizoma Coptidis on HepG2 cells.@*METHOD@#A systematic screening was conducted to investigate the dynamic response of HepG2 cells to the PAs using the impedance-based xCELLigence system. Cisplatin was selected as the positive control. The real time, concentration-response curves and the 50% inhibitory concentrations (IC50) were acquired to evaluate the anticancer activity of the PAs.@*RESULTS@#All of the six PAs inhibited cell growth and induce death in HepG2 cells in a time- and concentration-dependent manner. The IC50 values of cisplatin, berberine, columbamine, coptisine, epiberberine, jatrorrhizine, and palmatine were 5.13, 42.33, 226.54, 36.90, 302.72, 383.54, and 456.96 μg·mL(-1), respectively. The results obtained using the xCELLigence system corresponded well with those of the conventional methods.@*CONCLUSION@#The xCELLigence system is a reliable and efficient tool for real-time screening of the cytotoxic effect of compounds in cell-based in vitro assays. Coptisine and berberine, with methylenedioxy group at C2 and C3 on the phenyl ring showed stronger effect.than the other four PAs. However, compared with cisplatin, the six PAs didn't show obvious cytotoxic effect on HepG2 cells. These results provided some useful data for the evaluation of the anticancer compounds, and the clinical application of traditional Chinese medicine.

Research on correlation between lung and large intestine based on meridian and acupoint palpation in patients with bronchial asthma / 中国针灸

<p><b>OBJECTIVE</b>To explore correlation between lung and large intestine and the two meridians under pathological condition in the view of meridian theory.</p><p><b>METHODS</b>Ninety-six cases of bronchial asthma were applied palpation at the running course of 12 regular meridians under the elbow and knees and back-shu points. And abnormal reactions were recorded, the affected meridians and back-shu points were discovered.</p><p><b>RESULTS</b>The abnormal reactions most frequently appeared on the Lung Meridian, followed by the Large Intestine Meridian, the Spleen Meridian, the Liver Meridian, the Stomach Meridian and the Triple Energizer Meridian. And the unusual reaction of the back-shu points most frequently appeared on Feishu (BL 13), and Dachangshu (BL 25) and Pishu (BL 21) followed as the next two.</p><p><b>CONCLUSION</b>The existence of correlation between the Lung Meridian and the Large Intestine Meridians under pathological condition can be proved through meridian and acupoint palpation on bronchial asthma patients.</p>

A novel method for testing sterility of injections based on biothermodynamics / 药学学报

This study aims at trying to establish a novel method of sterility test for injections based on biothermodynamics, in order to overcome the deficiencies of routine sterility tests such as long detecting cycle, low sensitivity and prone to misjudgments. A biothermodynamics method was adopted to rapidly detect the microorganism contamination of injections by monitoring the heat metabolism during the growth of microbe. The growth rate equal to or greater than zero and the heat power difference of P(i) and P(0) with three folds higher than the noise of baseline were chosen as indexes to study the heat change rule of microbe. In this way, the effectiveness of the new method to detect strains required by conventional sterility test or in injection samples was also investigated. Results showed that the Gram-positive bacteria, Gram-negative bacteria and fungi demanded by sterility testing methodology could be detected by biothermodynamics method within 10 hours, with the sensitivity lower than 100 CFU x mL(-1). Meanwhile, this method was successfully applied to the sterility test of Compound Yinchen injection (FFYC), Shuanghuanglian powder injection (SHL) and Compound Triamcinolone injection (TAND) which were sterilized with different degrees. Therefore, the biothermodynamics method, with advantages of fast detection and high sensitivity, could be a complementary solution for conventional sterility tests.

Impacts on the life quality of patients with bronchial asthma treated with acupuncture in terms of the lung and large intestine theory / 中国针灸

<p><b>OBJECTIVE</b>To observe the improvement of the quality of life (QOL) of patients with bronchial asthma treated with acupuncture based on the interior-exterior relationship of the lung and large intestine, in terms of meridian-collateral theory and through the lung and large intestine meridians.</p><p><b>METHODS</b>According to the random number table, 52 cases of bronchial asthma at chronic persistent stage of the middle degree in accordance with the inclusive criteria were divided into a lung meridian acupoint group (group A), a large intestine meridian acupoint group (group B), a lung and large intestine meridian acupoint group (group C) and a control group at the ratio of 1:1:1 = 1, 13 cases in each one. In the control group, according to the requirement, Ventolin aerosol was used, one spray/time, < or = 4 times/day. The treatment of 12 weeks was required. In the first 3 groups, on the basis of the treatment as the control group, acupuncture was supplemented. In group A, Chize (LU 5), Kongzui (LU 6), Lieque (LU 7), etc. were selected. In group B, Quchi (LI 11), Hegu (LI 4), Tianshu (ST 25), etc. were selected. In group C, Chize (LU 5), Kongzui (LU 6), Lieque (LU 7), Quchi (LI 11), Hegu (LI4), etc. were selected. Acupuncture was given once every two days, 3 times a week. Totally, 12 treatments made one session and 3 sessions (12 weeks) were required. The Asthma Quality of Life Questionnaire (AQLQ) was adopted to assess the total score and four subscales, named activity limitation, environment stimulation, emotion and symptom, and determine the efficacy.</p><p><b>RESULTS</b>In comparison before and after treatment in the same group, AQLQ total score, emotion score and symptom score were all increased significantly in group A and group C separately (P < 0.05, P < 0.01). The environment stimulation score was increased in group C (P < 0.05). In group B, AQLQ total score and the activity score were increased remarkably (both P < 0.05). In comparison among groups: compared with the control group, AQLQ total score and symptom score in group A and group C were improved obviously (P < 0.05, P < 0.01); the emotion score was increased obviously in group B and group C (both P < 0.01) and the environment stimulation score was increased obviously in group C (P < 0.05). Compared with group B, the symptom score was improved much obviously in group C (P < 0.05).</p><p><b>CONCLUSION</b>Acupuncture improves the quality of life much more obviously for the patients with bronchial asthma in terms of the lung and large intestine theory.</p>

Assessment of external methods of traditional Chinese medicine in patients with chronic ulcer of the lower extremities: study protocol of a multicenter, randomized, parallel-group, prospective trial / 中西医结合学报

Chronic ulcer of the lower extremities amounts for a grave and serious problem for public health. Western medicine focuses on controlling infection, improving blood circulation, surgical debridement, skin grafting, etc, but there are bottlenecks in the treatment. Traditional Chinese medicine (TCM) has a long history and a legacy of sound clinical efficacy in this area. TCM has developed a unique, effective external theory, and a large number of topical prescriptions and external technology. Through this research, a safe and effective treatment protocol of TCM for chronic ulcer of the lower extremities can be formed. To this end, during China's "Eleventh Five-Year" Plan, special research committees and projects on TCM external treatments and external technologies were established. This study on ulcer of the lower extremities constitutes one of the major research topics.