Objective To observe the efficacy and safety of Morinda officinalis oligosaccharides in the continuation treatment of mild and moderate depression.Methods An open,single-arm,multi-center design was adopted in our study.Adult patients with mild and moderate depression who had received acute treatment of Morinda officinalis oligosaccharides were enrolled and continue to receive Morinda officinalis oligosaccharides capsules for 24 weeks,the dose remained unchanged during continuation treatment.The remission rate,recurrence rate,recurrence time,and the change from baseline to endpoint of Hamilton Depression Scale(HAMD),Hamilton Anxiety Scale(HAMA),Clinical Global Impression-Severity(CGI-S)and Arizona Sexual Experience Scale(ASEX)were evaluated.The incidence of treatment-related adverse events was reported.Results The scores of HAMD-17 at baseline and after treatment were 6.60±1.87 and 5.85±4.18,scores of HAMA were 6.36±3.02 and 4.93±3.09,scores of CGI-S were 1.49±0.56 and 1.29±0.81,scores of ASEX were 15.92±4.72 and 15.57±5.26,with significant difference(P＜0.05).After continuation treatment,the remission rate was 54.59％(202 cases/370 cases),and the recurrence rate was 6.49％(24 cases/370 cases),the recurrence time was(64.67±42.47)days.The incidence of treatment-related adverse events was 15.35％(64 cases/417 cases).Conclusion Morinda officinalis oligosaccharides capsules can be effectively used for the continuation treatment of mild and moderate depression,and are well tolerated and safe.

Research on polymer impurities has always been important in the quality control of cephalosporins. Research on polymers in cephalosporins that lack active amino groups on the C-7 side chain has not been reported. Therefore, our study used cefazolin sodium, which is widely used in the clinic, as an example. The polymer in cefazolin sodium and its product "cefazolin sodium pentahydrate for injection" was analyzed by column switching liquid chromatography-high resolution mass spectrometry. Two polymer impurity peaks were detected and the possible structures of these polymers were suggested. Through two-dimensional liquid chromatography, the chromatographic peaks following Sephadex gel chromatography and high-performance gel chromatography were compared to those obtained by reverse high-performance liquid chromatography (HPLC) for cefazolin sodium as reported in the Chinese Pharmacopoeia. The HPLC method proves more suitable for polymer detection than Sephadex gel chromatography and high-performance gel chromatography. The method of polymer detection for cefazolin sodium was established using the method of related substances HPLC as described in the Chinese Pharmacopoeia.

Objective:To investigate the effect of body weight-supported treadmill training on neuropathic pain and expression of glutamate decarboxylase-65/67 (GAD-65/67) in spinal dorsal horn of rats with spinal cord injury (SCI). Methods:A total of 24 Sprague-Dawley rats were randomly divided into sham group, SCI-sedentary (SCI-Sed) group and SCI-Exercise (SCI-Ex) group, with eight rats in each group. Allen's method was used to make T₁₀ incomplete SCI model. Seven days after SCI, SCI-Ex group was given body weight-supported treadmill training. Before SCI, and seven days, 14 days, 21 days, 28 days and 35 days after SCI, the von Frey filaments and thermal stimulation pain tester were used to evaluate the mechanical and thermal pain thresholds. Then, Western blotting and immunohistochemical analysis were performed on the spinal cord of all rats to detect the expression of GAD-65 and GAD-67. Results:The mechanical and thermal pain thresholds were higher in SCI-Ex group than in SCI-Sed group 21 days, 28 days and 35 days after SCI (P < 0.01). Compared with the sham group, the expression of GAD-65 and GAD-67 decreased in SCI and SCI-Ex groups (P < 0.05), and increased in SCI-Ex group compared with that of SCI-Sed group (P < 0.05). Conclusion:Body weight-supported treadmill training could increase the synthesis of GAD-65/67 in the distal spinal cord dorsal horn of incomplete SCI rats, and improve the pain thresholds of hind limbs in rats with SCI.

To establish a method for the determination of polymer impurities in ceftazidime raw materials and preparations, a ceftazidime degradation solution containing polymer impurities was prepared by forced polymerization. Polymer impurities in the degradation solution were separated and identified by high performance gel chromatography and the column switching-LC-MSⁿ method. A new RP-HPLC method for ceftazidime polymer was established and validated with a Phenomenex Gemini-C18 column using a mobile phase gradient elution of 0.02 mol·L^-1 phosphate buffer, methanol and acetonitrile. The results showed that when using this high performance gel chromatography method some small molecular weight impurities were co-eluted with the polymers, resulting in a poor specificity and poor quantitative accuracy. But when using the RP-HPLC method, four polymer impurities were detected in the 25-45 min time range with good specificity, sensitivity and robustness, including two ceftazidime dimers, trimers, and derivatives. Therefore, the described RP-HPLC method is suitable for the quality control of polymer impurities in ceftazidime, and ceftazidime degradation solution can be used as suitable solution for analysis of ceftazidime polymers.

OBJECTIVES: To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients. METHODS: A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed. RESULTS: An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048). CONCLUSIONS Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).
Administration, Inhalation ; Adult ; China ; Coronavirus Infections ; diagnosis ; drug therapy ; mortality ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Follow-Up Studies ; Humans ; Integrative Medicine ; Interferon-alpha ; administration & dosage ; Lopinavir ; administration & dosage ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral ; diagnosis ; drug therapy ; mortality ; Risk Assessment ; Severe Acute Respiratory Syndrome ; diagnosis ; drug therapy ; mortality ; Severity of Illness Index ; Survival Rate

To establish a method for the determination of polymer impurities in cefixime raw materials and preparations, a cefixime degradation solution containing polymer impurities was prepared by forced polymerization. Polymer impurities in the degradation solution were separated and identified by high performance gel chromatography and the column switching-LC-MSⁿ method. A new RP-HPLC method for cefixime polymer was established and validated with a Phenomenex Gemini-C18 column using a mobile phase gradient elution of 0.5% formic acid-water solution and 0.5% formic acid-acetonitrile solution. The results showed that when using this high performance gel chromatography method some small molecular weight impurities were co-eluted with the polymers, resulting in a poor specificity and poor quantitative accuracy. But when using the RP-HPLC method, three polymer impurities were detected with good specificity, sensitivity and robustness, including two cefixime dimers, and dehydrate dimer. Therefore, the described RP-HPLC method is suitable for the quality control of polymer impurities in cefixime, and cefixime degradation solution can be used as suitable solution for analysis of cefixime polymers.

Objective To understand the characteristics of sexual network of 321 HIV positive MSM and HIV infection status among sexual partners in Zhejiang Province. Methods A cross-sectional study selected HIV positive MSM diagnosed between September, 2015 and September, 2016 were conducted in Hangzhou, Ningbo, Wenzhou in Zhejiang Province using self-administrated questionnaire. Information related to socio-demographic characteristics, risky behavior, size of sexual network were collected. Results A total of 321 HIV positive MSM were recruited in this study. 71.76％ aged 20 to 40 years old and 51.71％ were native. The rate of self-reported sexual behavior with stable homosexual partners, casual homosexual partners, spouse and other heterosexual partners at investigation were 37.78％, 45.00％, 36.56％ and 66.67％. The rate of never using condom with stable homosexual partners, casual homosexual partners, spouse were 27.91％, 16.36％ and 44.00％. HIV positive rate among stable homosexual partners, casual homosexual partners, spouse and other heterosexual partners were 28.26％ , 3.77％, 11.43％ and 0.00％. Conclusion The size of sexual network was large, especially in casual sexual network. Unsafe sexual behavior, like consistent condom use was low and multiple sexual partners . HIV infection was high among stable homosexual partners and spouse.

OBJECTIVE Paeoniflorin (PF) and albiflorin (AF) are the major active components of total peony glucosides(TPG)from Paeonia lactiflora Pal,which have many biological activities such as anti-inflammatory, antioxidation and anti-hypertension effects. The drug-drug pharmacokinetic interaction among PF,AF and TPG,the pharmacokinetic comparisons of AF between hypoxia and normoxia,the transport of AF cross the blood-brain barrier cell model and the transport of AF/PF/TPG cross Caco-2 cell model were investigated.METHODS A highly sensitive and rapid UPLC-MS method with multiple-reaction monitoring(MRM)scanning via electrospray ionization(ESI)source operating both in the positive and negative ionization mode was successfully developed and validated for simultaneous quantitation of PF and AF in rat plasma after an oral administration of PF,AF and TPG. RESULTS The validated and developed UPLC-MS/MS method was successfully applied to simultaneously determine the AF and PF concentration in rat plasma and investigate pharmacokinetic interactions after a single intragastrical ad-ministration of PF,AF,co-administration of PF with AF and TPG,respectively.The elimination of both PF co-administered with AF and PF in TPG were slower than those for PF alone and the distribution in the tissues was wider.The combination of PF with AF or TPG could significantly increase the values of the AUC, MRT and t1/2of the drug PF, and reduce the values of CL of PF. From a comparison of the main pharmacokinetic parameters among AF alone, AF combined with PF and AF in TPG, the values of the MRT and t1/2of AF in TPG were greater than that of AF alone,and there were statistically signifi-cant differences in these parameters(P<0.05,P<0.01).It was also noticed that AUC and Cmaxof PF in hypoxia rats were significantly decreased compared with that of normaxia rats, suggesting that there was a decreased exposure of PF in rats under hypoxia. The multiple active components in TPG may lead to DDIs between some P-gp substrates. CONCLUSION The clinical performance of total peony glucosides would be better than that of single constitute. The outcomes of the study are expected to serve as a basis for development of clinical guidelines on total peony glucosides usage.

Objective To explore developmental states on the preterm and term neonatal brain white matter based on the co-variation of metrics derived from diffusion tensor imaging(DTI).Methods This work enrolled 66 neonates,consisting of 33 preterm(21 males and 12 females;gestational age:30.143-36.286 weeks)and 33 full-term neonates(22 males and 11 females;gestational age:37.000 -41.429 weeks).DTI derived metrics included axial diffusivity(AD),radial diffusivity(RD),and fractional anisotropy(FA).Spearman's rank correlation between metrics and postmenstrual age was analyzed in the preterm and term neonates.Developmental states were evaluated according to the method proposed by Dubois:fiber organization was associated with increased AD, decreased RD and increased FA;pre-myelination was related to decreased AD,decreased RD and unchanged/increased FA;myelination was revealed by unchanged AD,decreased RD and increased FA.Mann-Whitney U test was used to compare DTI metrics between the preterm and term neonates.Results According to the method proposed by Dubois,posterior limb of internal capsule and corpus callosum underwent myelination in the preterm-neonate period.Cerebral peduncle started myelination in the term-neonate period.Superior corona radiate,inferior fronto-occipital fasciculus and external capsule underwent pre-myelination on preterm and term neonates.FA values were higher in term neonates than those in preterm neonates in all the selected regions(P＜0.05).AD and RD values were lower in term neonates than those in preterm neonates in the selected regions except for cerebral peduncle(P＜0.05).Conclusion Changes in DTI metrics and the method of Dubois can be used to quantitatively evaluate developmental states of the neonatal brain white matter.The changes coincided with DTI variations associated with pre-myelination and myelination.White matter development is delayed in preterm neonates compared with term neonates.

To understand the status of human hookworm (Ancylostoma duodenale or Necator americanus) infection in Jiangxi Province.A stratified cluster random sampling was conducted based on the geographical location and economic condition in 2014. Kato-Katz’s thick smear method was used for stool examinations, and filter paper cultivation was conducted for distinguishing the species of hookworms.A total of 21 615 persons were involved in the investigation, and there were 1 095 persons infected with hookworm with the prevalence of 5.07% (standardized rate of 4.05%). The infection rate of hookworm in Nanfeng County was the highest (13.96%). Most of the infected people had low worm burden (95.43%). The infection rate of hookworm of the female was higher than that of the male (χ² = 28.03, P < 0.05). The prevalence increased with the age, while the infection rate of hookworm in people at ages of 75 years and higher was the highest (14.79%). Housewife was the highest risk occupation with the infection rate of 7.55%. The differences of infection rates among different educational level groups were significant (χ² = 135.88, P < 0.05). The prevalence rates of hookworm in different landforms were significantly different (χ² = 34.37, P < 0.05). The priority species was N. americanus (80.41%) in Jiangxi Province.The infection rate of hookworm decreases obviously in Jiangxi Province. The high risk groups of hookworm infection are the people with low educational level, female and elder age-group.