Objective To study the pharmacokinetic profile of zidovudine and lamivudine tablets(ZL)in Chinese healthy subjects and to evaluate its bioequivalence and safety.Methods A randomized,open,single-dose,two-sequence,four-cycle and fully replicated crossover bioequivalence trial was conducted in 32 healthy subjects both fasting and postprandial,and two preparations of ZL tablets were administered orally in each cycle,with a washout period of 5 days.The concentrations of zidovudine and lamivudine in plasma were determined using high performance liquid chromatography-tandem mass spectrometry.The pharmacokinetic evaluation index parameters were statistically analyzed using Phoenix WinNonlin version 8.1 data statistical software to evaluate bioequivalence.Results The Cmax of zidovudine under fasting and postprandial conditions between ZL and the reference drugs after a single dose were(3 782.499±1 921.649)vs.(3 543.164±1 946.076)ng·mL-1 and(1 585.827±914.246)vs.(1 667.595±862.945)ng·mL-1,respectively.And the AUC0-t for fasting and postprandial conditions of zidovudine was(3 177.091±819.538)vs.(3 071.375±972.145)h·ng·mL-1 and(2 437.999±478.147)vs.(2 402.725±477.792)h·ng·mL-1,respectively;while the AUC0-∞ were(3 225.674±825.131)vs.(3 093.448±972.340)h·ng·mL-1and(2 464.310±480.790)vs.(2 427.693±477.933)h·ng·mL-1,respectively.The Cmax of a single dose of lamivudine under fasting and postprandial conditions between ZL and the reference drugs were(1 923.329±490.572)vs.(1 830.570±476.947)ng·mL-1 and(1 922.711±589.130)vs.(1 881.857±527.577)ng·mL-1,respectively.The AUC0-t for preprandial and postprandial lamivudine was(7 598.265±1 376.774)vs.(7 283.422±1 356.146)h·ng·mL-1 and(7 554.169±958.379)vs.(7 329.376±924.075)h·ng·mL-1,respectively,whereas the AUC0-∞ were(7 734.038±1 326.907)vs.(7 405.088±1 340.036)h·ng·mL-1 and(7 660.916±958.694)vs.(7 435.102±930.448)h·ng·mL-1,in fasting and fed tests,the 90％confidence intervals(CI)of the geometric mean ratios of the main pharmacokinetic parameters between test and reference preparations were all within the range of 80％-125％,respectively.A total of 37 adverse events occurred during the trial period,including 21 in the fasting group and 16 in the postprandial group,and no serious adverse events occurred.Conclusion The test formulations of zidovudine and lamivudine tablets were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions compared to the reference tablets.

Objective To study the pharmacokinetic profile of zidovudine and lamivudine tablets(ZL)in Chinese healthy subjects and to evaluate its bioequivalence and safety.Methods A randomized,open,single-dose,two-sequence,four-cycle and fully replicated crossover bioequivalence trial was conducted in 32 healthy subjects both fasting and postprandial,and two preparations of ZL tablets were administered orally in each cycle,with a washout period of 5 days.The concentrations of zidovudine and lamivudine in plasma were determined using high performance liquid chromatography-tandem mass spectrometry.The pharmacokinetic evaluation index parameters were statistically analyzed using Phoenix WinNonlin version 8.1 data statistical software to evaluate bioequivalence.Results The Cmax of zidovudine under fasting and postprandial conditions between ZL and the reference drugs after a single dose were(3 782.499±1 921.649)vs.(3 543.164±1 946.076)ng·mL-1 and(1 585.827±914.246)vs.(1 667.595±862.945)ng·mL-1,respectively.And the AUC0-t for fasting and postprandial conditions of zidovudine was(3 177.091±819.538)vs.(3 071.375±972.145)h·ng·mL-1 and(2 437.999±478.147)vs.(2 402.725±477.792)h·ng·mL-1,respectively;while the AUC0-∞ were(3 225.674±825.131)vs.(3 093.448±972.340)h·ng·mL-1and(2 464.310±480.790)vs.(2 427.693±477.933)h·ng·mL-1,respectively.The Cmax of a single dose of lamivudine under fasting and postprandial conditions between ZL and the reference drugs were(1 923.329±490.572)vs.(1 830.570±476.947)ng·mL-1 and(1 922.711±589.130)vs.(1 881.857±527.577)ng·mL-1,respectively.The AUC0-t for preprandial and postprandial lamivudine was(7 598.265±1 376.774)vs.(7 283.422±1 356.146)h·ng·mL-1 and(7 554.169±958.379)vs.(7 329.376±924.075)h·ng·mL-1,respectively,whereas the AUC0-∞ were(7 734.038±1 326.907)vs.(7 405.088±1 340.036)h·ng·mL-1 and(7 660.916±958.694)vs.(7 435.102±930.448)h·ng·mL-1,in fasting and fed tests,the 90％confidence intervals(CI)of the geometric mean ratios of the main pharmacokinetic parameters between test and reference preparations were all within the range of 80％-125％,respectively.A total of 37 adverse events occurred during the trial period,including 21 in the fasting group and 16 in the postprandial group,and no serious adverse events occurred.Conclusion The test formulations of zidovudine and lamivudine tablets were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions compared to the reference tablets.

In 2020,the Pharmaceutical Service Committee of the Chinese Pharmaceutical Association,the Respiratory Disease Branch of the Chinese Medical Association,and the Respiratory Physician Branch of the Chinese Medical Doctor Associ-ation jointly established the"Cough and Wheezing Pharmaceutical Care Clinic(CWPC)program".The specification on CWPC construction provides guidance and reference for improving the quality of cough and wheezing pharmaceutical care services.The Chinese Pharmaceutical Association Specifications on Cough and Wheeze Pharmaceutical Care Clinic construction covered two as-pects,the construction and service of CWPC,respectively.With the analysis of relevant standards,policies and regulations,tech-nical specifications,literature,and other materials,the specification standardized 19 key elements in the organization's construc-tion,service process,quality management,and evaluation improvement.This paper mainly analyzed the construction process and content of the Chinese Pharmaceutical Association Specifications on Cough and Wheeze Pharmaceutical Care Clinic construction,to strengthen the publicity and implementation of the specification,deepen the understanding of the specification content,and pro-mote the implementation of the specification.

In 2020,the Pharmaceutical Service Committee of the Chinese Pharmaceutical Association,the Respiratory Disease Branch of the Chinese Medical Association,and the Respiratory Physician Branch of the Chinese Medical Doctor Associ-ation jointly established the"Cough and Wheezing Pharmaceutical Care Clinic(CWPC)program".The specification on CWPC construction provides guidance and reference for improving the quality of cough and wheezing pharmaceutical care services.The Chinese Pharmaceutical Association Specifications on Cough and Wheeze Pharmaceutical Care Clinic construction covered two as-pects,the construction and service of CWPC,respectively.With the analysis of relevant standards,policies and regulations,tech-nical specifications,literature,and other materials,the specification standardized 19 key elements in the organization's construc-tion,service process,quality management,and evaluation improvement.This paper mainly analyzed the construction process and content of the Chinese Pharmaceutical Association Specifications on Cough and Wheeze Pharmaceutical Care Clinic construction,to strengthen the publicity and implementation of the specification,deepen the understanding of the specification content,and pro-mote the implementation of the specification.

ObjectiveTo study the relationship between qi stagnation constitution and suboptimal health status (SHS) or lifestyle.MethodsFrom 2012 to 2013, we conducted a cross-sectional survey of 24 159 Chinese individuals aged 12–80 years. The qi stagnation constitution was assessed using the Constitution in Chinese Medicine Questionnaire. Health status was evaluated through medical records and the Subhealth Measurement Scale V1.0 (SHMS V1.0). Health-promoting lifestyles were measured using the Health-Promoting Lifestyle Profile II (HPLP-II).ResultsOf the 24 159 participants, 16.1% and 15.2% were classified as “always” and “sometimes” having the qi stagnation constitution, respectively. Those classified as “rarely” having the qi stagnation constitution scored higher on both the HPLP-II and SHMS V1.0. The participants classified as “always” having the qi stagnation constitution showed a significant association with SHS or disease compared to other imbalanced constitutions. Those in the “always” category were approximately 21 times more likely to be classified as having SHS (odds ratio [OR]: 21.17, 95% confidence interval [CI]: 15.74–28.45), whereas those in the “sometimes” category were approximately six times more likely (OR: 5.89, 95% CI: 5.04–6.90). Accordingly, the qi stagnation constitution score was significantly associated with the diagnosis of SHS, with an area under the curve of 0.77 (P .001). A score of 18.75 yielded the highest Youden Index (0.407), with a sensitivity of 60.5% and a specificity of 80.3%. Significant associations were observed between health-promoting lifestyles and qi stagnation constitution severity in an ordinal regression analysis (P .001). Protective factors included stress management (OR: 1.59), self-actualization (OR: 1.57), and exercise (OR: 1.36). In contrast, poorer interpersonal relationships (OR: 0.79), greater health responsibilities (OR: 0.86), and poorer nutrition (OR: 0.91) were associated with increased severity.ConclusionModulating the qi stagnation constitution through lifestyle interventions may help prevent the progression of SHS to disease, which aligns with core preventive principles in traditional Chinese medicine.

[Objective]To summarize the clinical experience of LEI's massage therapy of restraining wood and supporting earth in treating cough variant asthma,infantile anorexia and tic disorder in children.[Methods]Through clinical follow-up study,based on three medical records of cough variant asthma,infantile anorexia and tic disorder treated with LEI's massage therapy of restraining wood and supporting earth,combining with learning from the clinic and author's realization on treatment of children's diseases by restraining wood and supporting earth,this paper analyzed and summarized the clinical experience of applying LEI's massage therapy in treating disorder of liver and spleen diseases in children by restraining wood and supporting earth.[Results]Children have the physiological characteristics of"spleen is often deficient,liver is often surplus".When the spleen is weak,the liver is strong,subjugation and counterrestriction relationship between liver and spleen causes the disorder of liver and spleen in children.The treatment should be based on the principle of restraining wood and supporting earth,added and subtracted herbs according to the characteristics of the disease,such as soothing the liver and strengthening the spleen,clearing the lung and resolving phlegm massage to treat liver depression and spleen deficiency,phlegm fire disturbing the lung type cough variant asthma;soothing the liver and strengthening the spleen,regulating the stomach and aiding in transport to treat liver depression and spleen deficiency,stomach disorders type of infantile anorexia;strengthening the spleen and eliminating phlegm,calming the liver and calming wind to treat tic disorder of liver depression and spleen deficiency,internal wind phlegm disturbance syndrome.[Conclusion]LEI's massage manipulation of restraining wood and supporting earth,which is mainly composed of tonifying the spleen channel and clearing the liver channel,can strengthen the spleen and stomach,soothe the liver Qi,invigorate Qi and blood,dredge the meridians and regulate Qi activity,as a result,children's Zang and Fu organs are harmonized,Qi and blood are abundant,Yin and Yang are balanced,and the disease is cured,which is worthy of clinical promotion and application.

[Objective]To summarize the clinical experience of LEI's massage therapy of restraining wood and supporting earth in treating cough variant asthma,infantile anorexia and tic disorder in children.[Methods]Through clinical follow-up study,based on three medical records of cough variant asthma,infantile anorexia and tic disorder treated with LEI's massage therapy of restraining wood and supporting earth,combining with learning from the clinic and author's realization on treatment of children's diseases by restraining wood and supporting earth,this paper analyzed and summarized the clinical experience of applying LEI's massage therapy in treating disorder of liver and spleen diseases in children by restraining wood and supporting earth.[Results]Children have the physiological characteristics of"spleen is often deficient,liver is often surplus".When the spleen is weak,the liver is strong,subjugation and counterrestriction relationship between liver and spleen causes the disorder of liver and spleen in children.The treatment should be based on the principle of restraining wood and supporting earth,added and subtracted herbs according to the characteristics of the disease,such as soothing the liver and strengthening the spleen,clearing the lung and resolving phlegm massage to treat liver depression and spleen deficiency,phlegm fire disturbing the lung type cough variant asthma;soothing the liver and strengthening the spleen,regulating the stomach and aiding in transport to treat liver depression and spleen deficiency,stomach disorders type of infantile anorexia;strengthening the spleen and eliminating phlegm,calming the liver and calming wind to treat tic disorder of liver depression and spleen deficiency,internal wind phlegm disturbance syndrome.[Conclusion]LEI's massage manipulation of restraining wood and supporting earth,which is mainly composed of tonifying the spleen channel and clearing the liver channel,can strengthen the spleen and stomach,soothe the liver Qi,invigorate Qi and blood,dredge the meridians and regulate Qi activity,as a result,children's Zang and Fu organs are harmonized,Qi and blood are abundant,Yin and Yang are balanced,and the disease is cured,which is worthy of clinical promotion and application.

Objective:To investigate the distribution and drug resistance of common pathogens causing urinary tract infection (UTI) in children in Beijing, so as to provide reference for clinical rational use of antibiotics.Methods:It was a retrospective cohort study. The results of clinical data, urine culture and drug sensitivity in children with urinary infection treated in the Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics from June 2018 to June 2018 were retrospectively analyzed. According to the diagnostic criteria of "Chinese expert consensus on the diagnosis and treatment of UTI (2015 edition) - Complicated urinary tract infection", the children were divided into complex group and simple group according to whether they had complicated factors, and the pathogenic factors of the complex group were analyzed. The χ 2 test was used to compare the distribution of pathogenic bacteria in urine culture and the resistance rate of Escherichia coli to common antibiotics between the two groups. Results:A total of 187 children with UTI were enrolled in this study. The age ranged from 1 month after birth to 17 years old, and the median age was 8 months. There were 88 males (47.1%) and 99 females (52.9%), and the male/female ratio was 1:1.125. Male infants accounted for 79.5% (70/88) of male infants and female infants accounted for 48.5% (48/99) of female infants. There were 45 cases (24.1%) in the simple UTI group and 142 cases (75.9%) in the complicated UTI group. A total of 216 strains of pathogens were isolated, mainly Gram-negative bacteria (151/216, 69.9%), of which Escherichia coli was the most common (86/216, 39.8%). The second was gram-positive bacteria (57/216, 26.4%), among which Enterococcus faecium (37/216, 17.1%) was the most common. The positive rate of Escherichia coli infection in the simple UTI group was significantly higher than that in the complicated UTI group [71.1% (32/45) vs. 31.6% (54/171), χ2=23.234, P<0.001], and the positive rate of Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterococcus faecium and fungal infection in the simple UTI group was significantly lower than those in the complicated UTI group. However, the differences were not statistically significant (all P>0.05). The resistance rate of Escherichia coli to ampicillin was the highest in children with UTI [91.9% (79/86)], and it was sensitive to amikacin, meropenem, imipenem, piperacillin/tazobactam, cefepime, piperacillin, cefazolin, cefoperazone/sulbactam. The drug resistance rates were 5.8% (5/86), 5.8% (5/86), 9.3% (8/86), 10.5% (9/86), 14.0% (12/86), 15.1% (13/86), 18.6% (16/86) and 18.6% (16/86), respectively. The resistance rate of Escherichia coli infection to ceftriaxone in the complicated UTI group was significantly higher than that in the simple UTI group [59.3% (32/54) vs. 24.4% (11/32), χ2=4.977, P=0.026]. Eight fungi (3.7%) were susceptible to fluconazole, voriconazole, itraconazole and amphotericin B. Conclusions:The main pathogens of UTI in children are Gram-negative bacteria, among which Escherichia coli is the most common pathogen, but the proportion of infection has a downward trend in recent years. The resistance rate of ceftazidime and ceftriaxone is relatively low, which can be used as empirical drugs for children with UTI in this region.

Objective:To investigate the distribution and drug resistance of common pathogens causing urinary tract infection (UTI) in children in Beijing, so as to provide reference for clinical rational use of antibiotics.Methods:It was a retrospective cohort study. The results of clinical data, urine culture and drug sensitivity in children with urinary infection treated in the Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics from June 2018 to June 2018 were retrospectively analyzed. According to the diagnostic criteria of "Chinese expert consensus on the diagnosis and treatment of UTI (2015 edition) - Complicated urinary tract infection", the children were divided into complex group and simple group according to whether they had complicated factors, and the pathogenic factors of the complex group were analyzed. The χ 2 test was used to compare the distribution of pathogenic bacteria in urine culture and the resistance rate of Escherichia coli to common antibiotics between the two groups. Results:A total of 187 children with UTI were enrolled in this study. The age ranged from 1 month after birth to 17 years old, and the median age was 8 months. There were 88 males (47.1%) and 99 females (52.9%), and the male/female ratio was 1:1.125. Male infants accounted for 79.5% (70/88) of male infants and female infants accounted for 48.5% (48/99) of female infants. There were 45 cases (24.1%) in the simple UTI group and 142 cases (75.9%) in the complicated UTI group. A total of 216 strains of pathogens were isolated, mainly Gram-negative bacteria (151/216, 69.9%), of which Escherichia coli was the most common (86/216, 39.8%). The second was gram-positive bacteria (57/216, 26.4%), among which Enterococcus faecium (37/216, 17.1%) was the most common. The positive rate of Escherichia coli infection in the simple UTI group was significantly higher than that in the complicated UTI group [71.1% (32/45) vs. 31.6% (54/171), χ2=23.234, P<0.001], and the positive rate of Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterococcus faecium and fungal infection in the simple UTI group was significantly lower than those in the complicated UTI group. However, the differences were not statistically significant (all P>0.05). The resistance rate of Escherichia coli to ampicillin was the highest in children with UTI [91.9% (79/86)], and it was sensitive to amikacin, meropenem, imipenem, piperacillin/tazobactam, cefepime, piperacillin, cefazolin, cefoperazone/sulbactam. The drug resistance rates were 5.8% (5/86), 5.8% (5/86), 9.3% (8/86), 10.5% (9/86), 14.0% (12/86), 15.1% (13/86), 18.6% (16/86) and 18.6% (16/86), respectively. The resistance rate of Escherichia coli infection to ceftriaxone in the complicated UTI group was significantly higher than that in the simple UTI group [59.3% (32/54) vs. 24.4% (11/32), χ2=4.977, P=0.026]. Eight fungi (3.7%) were susceptible to fluconazole, voriconazole, itraconazole and amphotericin B. Conclusions:The main pathogens of UTI in children are Gram-negative bacteria, among which Escherichia coli is the most common pathogen, but the proportion of infection has a downward trend in recent years. The resistance rate of ceftazidime and ceftriaxone is relatively low, which can be used as empirical drugs for children with UTI in this region.

Objective To comprehensively analyze the clinical outcomes of total cavopulmonary connection (TCPC) in the treatment of functional single ventricle combined with heterotaxy syndrome (HS). Methods A retrospective analysis was conducted on the patients with functional single ventricle and HS who underwent TCPC (a HS group) in Guangdong Provincial People's Hospital between 2004 and 2021. The analysis focused on postoperative complications, long-term survival rates, and identifying factors associated with patient survival. Early and late postoperative outcomes were compared with matched non-HS patients (a non-HS group). Results Before propensity score matching, 55 patients were collected in the HS group, including 42 males and 13 females, with a median age of 6.0 (4.2, 11.8) years and a median weight of 17.0 (14.2, 28.8) kg. Among the patients, there were 53 patients of right atrial isomerism and 2 patients of left atrial isomerism. Eight patients underwent TCPC in one stage. TCPC procedures included extracardiac conduit (n=39), intracardiac-extracardiac conduit (n=14), and direct cavopulmonary connection (n=2). Postoperative complications included infections in 27 patients, liver function damage in 19 patients, and acute kidney injury in 11 patients. There were 5 early deaths. The median follow-up time was 94.7 (64.3, 129.8) months. The 1-year, 5-year, and 10-year survival rates were 87.2%, 85.3%, and 74.3%, respectively. After propensity score matching, there were 45 patients in the HS group and 81 patients in the non-HS group. Compared to the non-HS group, those with HS had longer surgical and mechanical ventilation time, higher infection rates (P<0.05), and a 12.9% lower 10-year survival rate. Multivariate Cox regression analysis identified asplenia was a risk factor for mortality (HR=8.98, 95%CI 1.86-43.34, P=0.006). Conclusion Compared to non-HS patients, patients with HS have lower survival rates after TCPC, and asplenia is an independent risk factor for the survival of these patients.