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1.
Acta Pharmaceutica Sinica ; (12): 314-318, 2021.
Article in Chinese | WPRIM | ID: wpr-872609

ABSTRACT

Under the guidance of Chinese Pharmacopoeia (2020 edition), the functionality-related characteristics of hydroxypropyl methylcellulose (HPMC) type 2208 from imported A manufacturer, domestic S manufacturer, domestic T manufacturer and different batches of the same manufacturer were characterized. The principal component analysis was used to comprehensively evaluate the functionality-related characteristics. The results were as follows: hydroxypropyl methylcellulose had no significant difference in viscosity and molecular weight distribution between different manufacturers, and there were significant differences in the cumulative particle size distribution of the sample reaches 50% (d50) and 90% (d90), bulk density, tap density and Carr's index. The HPMC from A manufacturer have the biggest inter-batch difference of particle size and their inter-batch difference of polydispersion coefficientis smaller than S manufacturer. Domestic manufactures have the largest inter-batch difference in other functionality-related characteristics. The three principal components were extracted by principal component analysis, and the variance contribution rate reached 89.44%, indicating that the extracted principal components can explain all the data well. By constructing a comprehensive evaluation model, the comprehensive score ranking of all HPMC samples is obtained: S manufacturer > A manufacturer > T manufacturer.

2.
Article in Chinese | WPRIM | ID: wpr-911238

ABSTRACT

Objective:To evaluate the effect of remimazolam combined with remifentanil used for painless gastroscopy.Methods:A total of 150 patients of American Society of Anesthesiologists physical status Ⅰ or Ⅱ, aged 18-64 yr, with body mass index of 18-30 kg/m 2, scheduled for elective painless gastroscopy, were divided into 3 groups ( n=50 each) using a random number table method: propofol combined with remifentanil group (group P), remimazolam 0.3 mg/kg combined with remifentanil group (group R1) and remimazolam 12 mg combined with remifentanil group (group R2). Drugs were administrated according to body weight, and calculation was carried out according to ideal body weight.Remifentanil 0.25 μg/kg was injected intravenously, propofol 1.5 mg/kg was then injected intravenously in group P, remimazolam 0.3 mg/kg was injected intravenously in group R1, and remimazolam 12 mg was injected intravenously in group R2.When Modified Observer′s Assessment/Alertness and Sedation (MOAA/S) score was≤3, gastroscopy was performed.It was defined as sedation failure when MOAA/S score was still ≥4 at 3 min after administration of propofol or remimazolam.When intraoperative body movement occurred, 1/4 of the initial dose of propofol was injected intravenously in group P, 1/4 of the initial dose of remimazolam was injected intravenously in group R1, and remimazolam 2.5 mg was injected intravenously in group R2 to maintain MOAA/S score ≤3.It was defined as sedation failure when sufficient sedation was not maintained after the additional drugs were given more than 3 times within 15 min.The success of sedation, time for gastroscopy, emergence time and discharge time were recorded.The occurrence of intraoperative body movement, bradyeardia, hypotension, respiratory depression, hiccup, coughing and injection pain was recorded. Results:Compared with group P, no significant change was found in the success rate of sedation ( P>0.05), and the incidence of intraoperative body movement, bradyeardia, hypotension, respiratory depression, hiccup, coughing and injection pain was decreased in group R1, and the success rate of sedation was significantly decreased, the incidence of intraoperative body movement, bradyeardia, hypotension, respiratory depression, coughing and injection pain was decreased, and the incidence of hiccup was increased in group R2 ( P<0.05). Compared with group R2, the success rate of sedation was significantly increased, and the incidence of intraoperative body movement, coughing and hiccup was decreased in group R1 ( P<0.05). Conclusion:Remimazolam 0.3 mg/kg combined with remifentanil can be safely and effectively used for painless gastroscopy.

3.
Chinese Journal of School Health ; (12): 1544-1547, 2021.
Article in Chinese | WPRIM | ID: wpr-904603

ABSTRACT

Objective@#To explore the performances of HbA1c when identifying elevated blood glucose among pre pubertal children, and to provide scientific basis for early screening biomarkers of abnormal blood glucose in children.@*Methods@#A total of 1 208 prepubertal children aged 7 to 10 years old in Xiamen were sampled with the cluster sampling method. Fasting venous blood was drawn to measure the level of HbA1c and FPG. According to American Diabetes Association (ADA) criteria, participants were divided into normal group, HbA1c abnormal group, FPG abnormal group and combined abnormal group. Partial correlation analysis was used to analyze the correlation between HbA1c and FPG. The cutoffs of HbA1c were calculated when FPG was 5.6 mmol/L. Receiver operating curve (ROC) was used to judge the performances of HbA1c while screening abnormal blood glucose.@*Results@#With HbA1c, FPG and the combined indicators as the screening criteria, the prevalence of high blood glucose were 2.2%, 4.0%, and 5.8%, respectively. The partial correlation coefficient of FPG and HbA1c was 0.15( P <0.01), and the correlation coefficient in girls( r =0.22) and non overweight group( r =0.16) were higher. The cutoff of HbA1c was 5.15% if FPG was 5.6 mmol/L. Taking the combined indicator as the reference standard, the AUC of FPG was 0.84 (95% CI =0.79-0.90) and the AUC of HbA1c was 0.69 (95% CI =0.63-0.74).@*Conclusion@#There is a low correlation between HbA1c and FPG in pre pubertal children. The performance of HbA1c is different from FPG when used as the indicator to screen children with abnormal blood glucose. It is recommended to use the combined indicator of HbA1c and FPG to screen abnormal blood glucose in prepubertal children.

4.
Article in Chinese | WPRIM | ID: wpr-887938

ABSTRACT

Magnoliae Officinalis Cortex, a common Chinese medicinal in clinic, should undergo "sweating" process in producing area according to Chinese Pharmacopoeia, which affects its genuineness and quality. In light of the concept and research mode of quality marker(Q-marker) for decoction pieces, the active components of Magnoliae Officinalis Cortex pieces which altered significantly before and after "sweating" were identified in this study. The main pharmacodynamic material basis was clarified by pharmacodynamic, pharmacokinetic and drug property research, followed by the prediction of Q-markers of Magnoliae Officinalis Cortex before and after "sweating", for better improving its quality standard.


Subject(s)
Drugs, Chinese Herbal , Magnolia
5.
Article in English | WPRIM | ID: wpr-880686

ABSTRACT

OBJECTIVES@#To determine the association between glycosylated hemoglobin (HbA1c) and ambulatory blood pressure or heart rate in hypertensive patients.@*METHODS@#A total of 585 patients, who performed ambulatory blood pressure monitoring (ABPM) from September 2018 to April 2019 in Xiangya Hospital, Central South University, were enrolled and assigned into 2 groups (470 in a hypertensive group and 115 in a normal group). HbA1c levels were compared. According to the HbA1c level, the hypertensive group was divided into 2 subgroups: A high HbA1c group (HbA1c≥6.1%, @*RESULTS@#The hypertensive group had higher HbA1c level than the normal group [(6.1±1.3)% vs (5.1±1.7)%, @*CONCLUSIONS@#In hypertensive patients, HbA1c is positively correlated with ambulate blood pressure, blood pressure load, and heart rate, and it has no correlation with blood pressure variability, heart rate variability, or morning blood pressure.


Subject(s)
Blood Pressure , Blood Pressure Monitoring, Ambulatory , Glycated Hemoglobin A/analysis , Heart Rate , Humans , Hypertension
6.
Neuroscience Bulletin ; (6): 1397-1411, 2021.
Article in English | WPRIM | ID: wpr-922649

ABSTRACT

Exposure to chronic hypoxia is considered to be a risk factor for deficits in brain function in adults, but the underlying mechanisms remain largely unknown. Since active myelinogenesis persists in the adult central nervous system, here we aimed to investigate the impact of chronic hypoxia on myelination and the related functional consequences in adult mice. Using a transgenic approach to label newly-generated myelin sheaths (NG2-CreER


Subject(s)
Animals , Clemastine , Hypoxia/complications , Mice , Mice, Inbred C57BL , Mice, Transgenic , Myelin Sheath , Oligodendroglia
7.
Article in Chinese | WPRIM | ID: wpr-921941

ABSTRACT

OBJECTIVE@#To study the clinical efficacy and complications of Endobutton titanium plate and clavicle hook plate in the treatment of acromioclavicular dislocation.@*METHODS@#Total 48 patients with Rockwood Ⅲ to Ⅴ acromioclavicular joint dislocation from March 2015 to May 2019 were retrospectively divided into two groups according to different surgical methods. Among the patients, 23 patients were treated with Endobutton loop titanium plate fixation (observation group), including 15 males and 8 females, ranging in age from 23 to 59 years old, with an average of(36.2±8.1) years old;Rockwood type Ⅲ in 6 cases, type Ⅳ in 11 cases and type Ⅴ in 6 cases. Twenty-five patients were treated with clavicular hook plate(control group), including 17 males and 8 females, ranging in age from 22 to 54 years old, with an average of (34.7±6.4) years old; Rockwood type Ⅲ in 6 cases, type Ⅳ in 14 cases and type Ⅴ in 5 cases. The operation time, intraoperative bleeding, hospitalization time, visual analogue scale (VAS) of pain, Constant-Murley score of shoulder function and postoperative complications were compared between the two groups.@*RESULTS@#All the patients were followed up, and the duration ranged from 24 to 51 months, with a mean of (30.5±6.5) months. The amountof bleeding and hospitalization time in the observation group were (71.9±4.0) ml and(8.2±1.6) d respectively;and those in the control group were (97.6±13.4) ml and (12.8±1.2) d respectively. There was significant difference between the two groups (@*CONCLUSION@#Compared with clavicular hook plate internal fixation in the treatment of acromioclavicular joint dislocation, Endobutton loop titanium plate internal fixation technology has the advantages of less surgical bleeding, shorter hospitalization time, less postoperative pain, good recovery of shoulder joint function and less complications.


Subject(s)
Acromioclavicular Joint/surgery , Adult , Bone Plates , Case-Control Studies , Female , Humans , Joint Dislocations/surgery , Male , Middle Aged , Retrospective Studies , Treatment Outcome , Young Adult
8.
Article in Chinese | WPRIM | ID: wpr-869301

ABSTRACT

The infectious disease outpatient service as a frontier is an important fulcrum of public health service. Its standardized construction is an important support for ensuring medical safety, reducing nosocomial infections, and controlling the epidemic of infectious diseases. The sub-specialty outpatient service of infection diseases includes fever outpatient service, intestinal outpatient service, tuberculosis outpatient service, AIDS outpatient service, liver disease outpatient service, etc. According to the characteristics of each subspecialty outpatient service and combining with clinical practice, we elaborated the setting norms of subspecialty outpatient service for common infectious diseases from the perspective of planning and design, building layout, equipment and facilities configuration, staffing, daily management and demonstration.

9.
Article in Chinese | WPRIM | ID: wpr-865955

ABSTRACT

In recent years, the detection rate and incidence of thyroid cancer are increasing, and there is a gap in the number and quality of thyroid surgeons. In order to meet the short-term clinical needs, young surgeons who are interested in thyroid cause and have the foundation of general surgery for 3 to 5 years can be selected to carry out 0.5-1 year thyroid surgery specialist training, while from the long-term demand, it is recommended to carry out thyroid surgery specialist training (2-3 years). Here, this paper puts forward some specific views and suggestions on the goal, content and assessment system of short-term and long-term thyroid surgery specialist training.

10.
Article in Chinese | WPRIM | ID: wpr-817643

ABSTRACT

@#【Objective】To prepare rapamycin(RAPA)sustained-release film and to evaluate its dissolution.【Methods】RAPA sustained- release film was created by using polymer polyactioglyconic acid (PLGA),copolymer of polyactic acid(PLA)and polyglycolic acid(PGA). Drug content of the sustained-release film was determined using specificity test,recovery,relative standard deviation(RSD)and stability test. Then,the dissolution of the sustained- release film was analyzed.【Results】The concentration of RAPA had a linear relationship with peak area,which ranged between 0.408 μg/mL and 40.8 μg/mL through the standard curve. The specificity test of the drug content determination indicated the excipient of the film and the solution with 0.3% sodium dodecyl sulfate(SDS)did not affect in determining the RAPA content. The recovery and RSD were excellent through drug content determination in blank films,which had three different levels of RAPA concentrations. The mean RAPA content of the sustained-release films was(112.6±10.1)μg(RSD 8.99%)through the drug content determination of the films,and the stability of RAPA with 0.3% SDS was good within 15 days. In addition,dissolution test of the sustained- release film indicated that the amount of drug release reached a high level and sustained up to 15 days.【Conclusion】 The RAPA sustained-release film with certain behavioral characteristic parameters had a stable drug content and favorable sustained-release property,and it may have certain application potential in anti-proliferation after glaucoma filtering surgery.

11.
Article in Chinese | WPRIM | ID: wpr-792980

ABSTRACT

OBJECTIVE@#To study the correlation and clinical value of the arc height of upper and lower endplates, the height of intervertebral space and osteophyte of posterior edge of intervertebral space in patients with cervical spondylosis.@*METHODS@#A total of 108 patients with cervical spondylosis who underwent cervical spondylosis surgery from September 2017 to September 2018 were included in the study. Including 48 males with an average age of 52 years (30 to 72) and 60 females with an average age of 54 years (37 to 79). Among them, C of 6 cases, C of 15 cases, C of 32 cases, C of 42 cases, C of 13 cases. X-ray films of cervical spine were taken before and after operation. The images were accessed by PACS (Picture Archiving and Communication Systems) system. The lower and upper endplate arc heights (L, L), intervertebral space height (L), and posterior osteophyte width (L) were measured. Spearman was used to analyze the correlation between them.@*RESULTS@#L was negatively correlated with L (r=-0.34, 0.05), L and L (>0.05).@*CONCLUSION@#The arc height of the lower endplate is negatively correlated with the width of osteophyte in the posterior margin of the intervertebral space. The cervical degeneration degree can be determined by measuring the arc height of the lower endplate, which has guiding significance for the early prevention and treatment of cervical spondylosis.

12.
Journal of Medical Postgraduates ; (12): 1163-1166, 2018.
Article in Chinese | WPRIM | ID: wpr-818002

ABSTRACT

ObjectiveThe genotypes and drug-resistance mutation of hepatitis B virus (HBV) are closely related to the progression of chronic hepatitis B (CHB) and effects of medication. This study was to identify the genotypes and drug-resistance mutation genes of HBV in West Guangxi and provide some laboratory evidence for anti-HBV treatment.MethodsWe collected serum samples from 869 CHB patients with HBV DNA >1.0×103 IU/mL, all from West Guangxi, between January 2016 and March 2018. We detected the genotypes and drug-resistance mutation genes in the patients by PCR and reverse dot blot (PCR-RDB).ResultsA total of 7 genotypes were identified in the patients, including genotypes B in 304 cases (34.98%), C in 268 (30.84%), D in 147 (16.92%), B+C in 28 (3.22%), B+D in 22 (2.53%), C+D in 1 (0.12%) and B+C+D in 1 (0.12%). Drug-resistance mutation was observed in 63 cases (7.25%), including 31 cases with genotype C (49.21%) and 19 with genotype B (30.16%). Fourteen gene mutation patterns were found in all, including rt204I, rt181V, rt236T, rt180M+rt204V, and rt180M+rt204V+rt204I, among which, rt180M+rt204V exhibited the highest mutation frequency (17.46%). There was a statistically significant difference between the mutation rates of genotypes B and C (19% vs 31%, P < 0.05).ConclusionCHB patients in West Guangxi have a wide variety of genotypes of HBV, mainly including genotypes B and C, with a high rate and complicated patterns of drug-resistance mutation, which has provided some reference for anti-HBV treatment in West Guangxi.

13.
Journal of Medical Postgraduates ; (12): 267-272, 2018.
Article in Chinese | WPRIM | ID: wpr-700816

ABSTRACT

Objective There is still a lack of effective treatment for hepatitis B. The article aimed to investigate the inhibito-ry and antiviral effects of hepatitis B virus(HBV)S gene expression by anti-gene locked nucleic acid(LNA)in vivo in transgenic mice. Methods The HBV transgenic mice were divided into 5 groups by random number,6 in each group. They were blank group, irrelevant sequence group,lamivudine group,antisense locked nucleic acid group,and anti-gene locked nucleic acid group respective-ly. The lamivudine group was treated by oral gastric lavage,with 2mg/kg dose 2 times per day for continuous 7d,and the rest groups were injected with 500 mL by tail vein injection at 1,3,5 d after ad-ministration. HBV DNA was tested by real-time quantitative polymer-ase chain reaction(qPCR);HBsAg was tested by ELISA;mRNA of HBV S gene was detected by reverse transcription PCR(RT-PCR);the positive rate of HBsAg in liver cells was detected by immunohisto-chemistry. Results After the treatment of anti-gene locked nucleic acid on 3rd,5th,7thday,the inhibition rate of HBV DNA were 37.18%,50.27%,61.46%,and HBsAg were 30.17%,44%,57.76%. The inhibitory effect on 7thday was more obvious than those of the blank group,the unrelated sequence group,the lamivudine group and the antisense lock nucleic acid group,and the difference was statistically significant(P<0.05).The expression of mRNA S gene HBV(0.33)and liver cells HBsAg positive rate(31%)was signif-icantly reduced compared with control group(P<0.05).No abnormal change was found in the function of liver and kidney tests and tis-sue HE staining. Conclusion Anti-gene lock nucleic acid targeting to S gene has strong inhibitory effects on HBV replication and expression in transgenic mice,which provides theoretical and experimental knowledge for HBV gene therapy.

14.
Article in Chinese | WPRIM | ID: wpr-698755

ABSTRACT

BACKGROUND: Currently, there are few studies about prostaglandin E1 in the paracrine and migration of bone marrow mesenchymal stem cells. OBJECTIVE: To explore the effects of prostaglandin E1 in the paracrine and migration of bone marrow mesenchymal stem cells. METHODS: Bone marrow mesenchymal stem cells isolated from Sprague Dawley rats were cultured in vitro. Passage 3 cells were co-cultured with prostaglandin E1 at concentrations of 10 μg/L, and then culture supernatant was collected at 3, 6, 9, 12, 24, 48, and 72 hours after co-culture. The level of vascular endothelial growth factor was detected by enzyme-linked immunosorbent assay. Effects of prostaglandin E1 on the migration of bone marrow mesenchymal stem cells were detected by Transwell assay and cell scratch assay. RESULTS AND CONCLUSION: After treatment with prostaglandin E1 for 3 hours, bone marrow mesenchymal stem cells began to secrete vascular endothelial growth factors, and the secretion level was peaked at 24 hours and then gradually decreased. Results from the Transwell assay and cell scratch assay showed that the migration ability of bone marrow mesenchymal stem cells was significantly promoted by prostaglandin E1 (P < 0.05). Overall findings reveal that prostaglandin E1 promotes the secretion of vascular endothelial growth factor from bone marrow mesenchymal stem cells and enhances cell migration.

15.
Article in Chinese | WPRIM | ID: wpr-838263

ABSTRACT

Objective To investigate the effect of syntenin-1 on the assembly of hepatitis C virus (HCV) particles. Methods The content of syntenin-1 in human primary hepatocytes was detected by Western blotting analysis. Human hepatocellular carcinoma cell line Huh7.5.1 was transfected with lentiviral plasmids to construct syntenin-1 overexpressed cell line and green fluorescent protein (GFP) overexpressed cell line. After transferring HCV RNA into Huh7.5.1 cells, syntenin-1 overexpressed cells and GFP overexpressed cells by electroporation, the effects of syntenin-1 overexpression on HCV in the cells were investigated in terms of RNA replication, viral protein contents and secretion of infectious virus particles by luciferase analysis, Western blotting and virus titer, respectively. The density of viral particles was assessed by isopycnic ultracentrifugation to analyze the distributions of HCV RNA and infective titer. Results The contents of syntenin-1 in three human primary hepatocytes were higher than that in the Huh7.5.1 cells (P0.01). Syntenin-1 overexpression had no effect on HCV RNA replication in host cells; the infectivity of HCV derived from syntenin-1 overexpressed cells was not significantly different compared with the Huh7.5.1 cells or GFP overexpressed cells. In syntenin-1 overexpressed cell culture supernatants, some infectious HCV particles mainly concentrated in the region of concentration of 1.08-1.16 g/mL gradually transferred to the low-density region of 1.01-1.02 g/mL. Conclusion Syntenin-1 overexpression alters the distribution of density components of infectious HCV particles.

16.
Article in Chinese | WPRIM | ID: wpr-690279

ABSTRACT

Objective To explore the efficacy and prognostic factors of cetuximab therapy for KRAS or all RAS wild-type(WT)metastatic colorectal cancer(mCRC).Methods We screened mCRC patients receiving at least two cycles of cetuximb and chemotherapy from those with KRAS WT(before November 2013)or all-RAS-WT(after November 2013)in the Department of Medical Oncology,Peking Union Medical College Hospital from November 2007 to December 2016. The relationship between the clinicopathological characteristics and the efficacy was retrospectively analyzed.Results A total of 60 patients were included. For the 34 patients receiving cetuximab as first-line treatment,the objective response rate(ORR)was 55.9%,and the progression-free survival and overall survival(OS)was 10 and 24 months,respectively. All-RAS-WT mCRC had significantly lower risk of progression than those with KRAS-only-WT(P=0.012),and left-sided colorectal cancer had higher ORR than right-sided colon cancer(62.1% vs. 0,P=0.033)during the first-line treatment. The median OS of the eight patients continuing cetuximab beyond first-line progression was 35.0(95%CI:23.6-46.4)months.Conclusions The efficacy of cetuximab for left-sided colorectal cancer was better than for right-sided colon cancer,and patients with all-RAS-WT have lower risk of progression than those with KRAS-only-WT. Patients benefiting from first-line cetuximab and continuing cetuximab beyond progression survive longer.

17.
Article in Chinese | WPRIM | ID: wpr-701506

ABSTRACT

Objective To study virulence factors and drug resistance mechanism of linezolid-intermediate Enterococcus faecalis(E.faecalis) isolated from patients with bloodstream infection.Methods Two linezolid-intermediate E.faecalis strains,namely A and B,were isolated from two patients with bloodstream infection,the treatment of two patients was analyzed.The minimum inhibitory concentration (MIC) of linezolid and vancomycin were determined.The virulence genes (esp,asa1,gelE,ace,agg,efaA,cylA,and hyl) and linezolid resistance genes (domain V region of the 23SrRNA,cfr,cfr[B],optrA) were amplified by polymerase chain reaction (PCR).PCR products of domain V region of 23SrRNA gene were sequenced and analyzed.Results Symptoms of two patients who isolated two linezolid-intermediate E.faecalis strains were controlled after accepted linezolid therapy.Strains A and B were both susceptible to vancomycin(MICs were 1μg/mL and 4μg/mL respectively),teicoplain,ampicillin,and nitrofurantoin,while intermediate to linezolid(MIC were both 4μg/mL).Two strains both contained multiple virulence factors,strain A were negative for cylA and hyl,strain B were negative for hyl and esp,but positive for other virulence genes.There was G2621T mutation in domain V region of 23SrRNA in strain A,and no variation was found in strain B.Drug resistance genes of cfr,cfr(B),and optrA were all negative in both strain A and B.Conclusion In the present study,two linezolid-intermediate E.faecalis strains isolated from patients with bloodstream infection were susceptible to vancomycin and ampicillin,although the treatment of linezolid in two patients is effective,the utilization of linezolid therapy in clinical practice still needs to be cautious.The mutation of target site is a significant resistance mechanism,it is necessary for us to pay more attention to these clinical strains which are non-susceptible to such antimicrobial agents,and the treatment strategy needs further study.

18.
China Pharmacy ; (12): 3892-3895, 2017.
Article in Chinese | WPRIM | ID: wpr-661988

ABSTRACT

OBJECTIVE:To provide suggestions for standardizing and protecting the off-label drug use. METHODS:Accord-ing to the field interviews with pharmacists and lawyers,the present situation of off-label drug use in judicial practice at home and abroad,and relevant countermeasures were put forward. RESULTS & CONCLUSIONS:At present,there was no mechanism for off-label drug use in the laws and regulations in China;there was only"special circumstances"statement in sporadic terms,while lacking explanation. In judicial practice of medical disputes,judges had different identifications in various references,such as the le-gality of routine and guidelines,teaching medical materials,clinical pathways,and internal regulations of medical institutions pre-pared by authoritative departments. Meanwhile,the judicial environment of hearing cases by identification made the off-label drug use had impartial adjudication. Legislation in 6 countries,including America,allows reasonable off-label drug use;FDA required off-label drug use must be for the benefit of patients rather than clinical trials,and it also should protect the patient's right to know. China should establish the authority specification of off-label drug use,providing scientific identification procedures,protect the patient 's informed consent by law. Medical institutions should develop relevant management system and processes to regulate medical prac-tices and ensure off-label drug use in line with the interests of doctors and patients.

19.
China Pharmacy ; (12): 3892-3895, 2017.
Article in Chinese | WPRIM | ID: wpr-659172

ABSTRACT

OBJECTIVE:To provide suggestions for standardizing and protecting the off-label drug use. METHODS:Accord-ing to the field interviews with pharmacists and lawyers,the present situation of off-label drug use in judicial practice at home and abroad,and relevant countermeasures were put forward. RESULTS & CONCLUSIONS:At present,there was no mechanism for off-label drug use in the laws and regulations in China;there was only"special circumstances"statement in sporadic terms,while lacking explanation. In judicial practice of medical disputes,judges had different identifications in various references,such as the le-gality of routine and guidelines,teaching medical materials,clinical pathways,and internal regulations of medical institutions pre-pared by authoritative departments. Meanwhile,the judicial environment of hearing cases by identification made the off-label drug use had impartial adjudication. Legislation in 6 countries,including America,allows reasonable off-label drug use;FDA required off-label drug use must be for the benefit of patients rather than clinical trials,and it also should protect the patient's right to know. China should establish the authority specification of off-label drug use,providing scientific identification procedures,protect the patient 's informed consent by law. Medical institutions should develop relevant management system and processes to regulate medical prac-tices and ensure off-label drug use in line with the interests of doctors and patients.

20.
Article in English | WPRIM | ID: wpr-301049

ABSTRACT

<p><b>OBJECTIVE</b>To study the efficacy and safety of Shuanghuang Shengbai Granule (, SSG), a traditional Chinese herbal medicine, on myelosuppression of cancer patients caused by chemotherapy.</p><p><b>METHODS</b>A total of 330 patients were randomly assigned to the treatment group (220 cases, analysed 209 cases) and the control group (110 cases, analysed 102 cases) with a 2:1 ratio by envelope method. The patients in the treatment group at the first day of chemotherapy started to take SSG for 14 days, while the patients in the control group took Leucogon Tablets. The changes of the blood routine, clinical symptoms and immune function in both groups were observed for safety and efficacy evaluation.</p><p><b>RESULTS</b>At the 7th day of chemotherapy, the white blood cells (WBCs) level in the treatment group was significantly higher than that in the control group (P<0.05). After treatment, the WBCs rate in the normal range accounted for 50.2% in the treatment group, the myelosuppression of WBCs and neutrophil were mainly grade I, while 8.1% and 5.7% of patients emerged grade III and grade IV myelosuppression, respectively. The incidence of myelosuppression of the treatment group was significantly lower than that of the control group (P<0.05). The total effective rate of Chinese medicine syndrome in the treatment group was significantly higher than that in the control group (84.2% vs. 72.5%, P<0.05). The immune cell levels in both groups were maintained in the normal range. Compared with that before treatment, the levels of CD3and CD4cells were significantly increased in the treatment group after treatment (P<0.05). The discrepancy of CD3and CD4cell activity before and after treatment in both groups were significantly different (P<0.05). No obvious adverse event occurred in both groups.</p><p><b>CONCLUSION</b>SSG had a protection effect on bone marrow suppression, and alleviated the clinical symptoms together with clinical safety.</p>


Subject(s)
Antineoplastic Agents, Phytogenic , Therapeutic Uses , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Drugs, Chinese Herbal , Therapeutic Uses , Female , Granulocyte Precursor Cells , Humans , Immune Tolerance , Male , Medicine, Chinese Traditional , Middle Aged , Neoplasms , Drug Therapy , Pancytopenia , Treatment Outcome
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