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Objective: To evaluate the safety and efficacy of Compound Huangdai Tablets (Realgar-Indigo Naturalis formula, RIF) combined with all-trans retinoic acid (ATRA) to treat acute promyelocytic leukemia (APL). Methods: This study was registered in PROSPERO (CRD42018108118). The relevant literatures on RIF treatment of APL were systematically searched in the following databases: China National Knowledge Infrastructure, Wanfang, VIP Medical Information System, Chinese Biomedical Database, EMBASE, Cochrane Library, and PubMed. The quality of the included studies was evaluated and Review Manager 5.3 software and Stata 13.0 software were used to perform the Meta-analysis. In addition, this study used the method of network pharmacology to conduct a preliminary exploration of the mechanism of RIF on APL. Results: The study included 12 studies involving 775 APL patients. The Meta-analysis showed that there was no significant difference (P 0.05) between the RIF group and the arsenic trioxide (ATO) group for primary outcomes, secondary outcomes apart from liver dysfunction. The incidence of liver dysfunction (P = 0.006) in the RIF group were significantly lower than those in the ATO group. In addition, the cost of maintenance therapy in the RIF group was significantly lower (P 0.05) than the ATO group. Besides, the active ingredients in RIF mainly act on targets proteins such as ACHE, NCOA2, RXRA, and then play a role in the treatment of APL through regulating multiple molecular mechanisms, such as TP53 regulates transcription of cell cycle genes, nuclear receptor transcription pathway. Conclusion: There was no significant difference in efficacy of oral RIF combined with ATRA compared with intravenous ATO combined with ATRA for the treatment of APL. The oral RIF exposed patients to less risk, offered more convenience and had lower prices. RIF can treat APL by multi-target and multi-pathway interventions that inducing apoptosis of APL cells and inhibiting the proliferation of APL cells, and so on. Therefore, oral RIF in the treatment of APL is worthy of further research and development.
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Objective:To evaluate the efficacy of remimazolam combined with low-dose propofol for sedation during induction of anesthesia.Methods:A total of 228 patients of both sexes, aged 18-64 yr, with body mass index of 19-35 kg/m 2, of American Society of Anesthesiologists physical status Ⅰ-Ⅲ, undergoing elective laparoscopic cholecystectomy, were divided into 2 groups ( n=114 each) by a random number table method: remimazolam combined with low-dose propofol group (group R) and propofol group (group P). Anesthesia was induced with intravenous injection of sufentanil 0.3 μg/kg, remimazolam 0.3 mg/kg, propofol 0.5 mg/kg and micuronium 0.2 mg/kg in group R, and sufentanil 0.3 μg/kg, propofol 2 mg/kg and micuronium 0.2 mg/kg in group P. Endotracheal intubation was performed when bispectral index value ≤ 50.Before induction (T 0), immediately before intubation (T 1), at 1 min (T 2) and 3 min (T 3) after intubation, mean arterial pressure (MAP) and heart rate (HR) were recorded.The anesthesia induction time and the incidence of hypotension and bradycardia were recorded in the two groups. Results:There was no significant difference in MAP and HR at T 0 between the two groups ( P>0.05). Compared with the value at T 0, MAP in two groups and HR were significantly decreased at T 1-3 in group P ( P<0.01). Compared with group P, the anesthesia induction time was significantly prolonged, and hypotension and bradycardia was decreased in group R ( P<0.05). Conclusion:The combination of remimazolam and low-dose propofol exerts better efficacy for sedation during induction of anesthesia than propofol alone.
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OBJECTIVE：To systematically evaluate efficacy and safety of Shengxuening tablets in the treatment of cancer-related anemia （CRA），and to provide evidence-based reference for clinical drug use. METHODS ：Retrieved from the Cochrane Library ，PubMed，Embase，CJFD，CSJD，Wanfang database and CBM ，RCTs about Shengxuening tablets alone or combined with routine therapy （trial group ）versus routine therapy or blank control （control group ）in the treatment of CRA were collected from inception to July 2019. After literature screening and data extraction ，quality evaluation of included literatures with system evaluation bias risk evaluation tool provided by Cochrane intervention measure system evaluation manual 3.0.2， Meta-analysis of the included literatures was carried out by using Rev Man 5.3 software. RESULTS ：A total of 9 RCTs involving 681 patients were included. Results of Meta-analysis showed that red blood cell count [MD ＝0.62，95％CI（0.30，0.93），P＝0.000 1]， hematocrit level [MD ＝6.12，95％CI（4.97，7.27），P＜0.000 01]，hemoglobin level [MD ＝7.47，95％CI（5.29，9.66），P＜0.000 01]， white blood cell count [MD ＝0.31，95％CI（0.12，0.50），P＝0.001]，platelet count [MD ＝3.06，95％CI（0.84，5.28），P＝0.007]， KPS score [MD ＝5.15，95％CI（2.79，7.51），P＜0.000 1]，quality of life score [MD ＝28.27，95％CI（19.27，37.28），P＜0.000 01] after treatment in trial group were significantly higher than control group ，while the incidence of ADR [RR ＝0.14，95％CI（0.03， 0.76），P＝0.02] in trial group was significantly lower than control group. CONCLUSIONS ：Shengxuening tablets have good efficacy and safety in the treatment of CRA.
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Objective To establish a mouse model of 5-fluorouracil ( 5-FU )-induced intestinal mucositis. Methods Different doses of 5-FU were intraperitonealy injected into mice for once or 5 consecutive days. The body weight and diarrhea score of the mice were recorded every day, and peripheral blood and the morphological changes of small intestine were examined at 24 h or 72 h after the last 5-FU administration. Results Compared with the control group, after administered 5-FU, the dosage groups showed various degrees of body weight loss and diarrhea, and the white blood cell and platelet counts in peripheral blood decreased significantly (P＜0. 05 or P＜0. 01). The small intestine showed evident pathological changes after the single dose 400 mg/kg and the continuous injection of 50 mg/kg, 100 mg/kg. The mortality rate was 100% in the 100 mg/kg group. Conclusions A mouse model of intestinal mucositis can be successfully established by a single injection of 5-FU or for consecutive 5 days, in a dose-dependent manner. The optimal dose for single injection is 400 mg/kg, and that of the continual injection for 5 consecutive days is 50 mg/kg.
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Objective To investigate the incidence and risk factors of chronic post-surgical pain (CPSP) and its effects on the quality of life in a large sample prospective study.Methods A total of 1098 patients of either sex,aged 18-70 yr,of American Society of Anesthesiologists physical status Ⅰ or Ⅱ,undergoing elective surgery,were enrolled in the study.Data regarding patient age,gender,body mass index,educational level,marital status,living situations,occupation,pre-surgical pain in the site of surgery,complications,type of surgery,surgery time and anesthesia method were recorded.The highest numeric rating scale scores within 3 days after surgery were also recorded.The patients were followed up at 3,6 and 12 months after surgery to record the development of CPSP.The patients were divided into CPSP group and non-CPSP group according to whether or not CPSP developed.Multivariable logistic regression analysis was performed to identify the risk factors for CPSP,and the quality of life was scored.Results A total of 981 patients completed the 1 year follow-up after surgery,the incidence of CPSP was 35.7％,and the constituent ratio of the distribution of the course was as follows:3 months ≤ postsurgical course ＜ 6 months was 33.1％;6 months ≤ postsurgical course ＜ 12 months was 16.8％;postsurgical course ≥ 12 months was 50.1％.Female,no diabetes mellitus and pre-surgical pain in the site of surgery were the independent risk factors for CPSP (P＜ 0.05).Compared with non-CPSP group,the physiological function score,professional function score,body pain score,vitality score,social function score,mental health score and general health score were significantly decreased (P＜0.01),and no significant change was found in the emotional function score in CPSP group (P＞0.05).Conclusion The probability of development of CPSP is high and the course is long,and the quality of life score is decreased;female,no diabetes mellitus and pre-surgical pain in the site of surgery are the independent risk factors for CPSP.
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Objective To observe the imaging features of ultra-wide field short wave fundus autofluorescence (SW-FAF) in eyes with multiple evanescent white dot syndrome (MEWDS),and analysis the correspondence to conventional images.Methods It was a retrospective case series study.Thirteen patients (14 eyes) diagnosed with MEWDS were enrolled.There were 12 females and 1 male,aged from 22 to 57 years,mean age was 34.5 years.All the eyes underwent fundus color photography,optical coherence tomography (OCT) and ultra-wide field autofluorescence (FAF).Simultaneous fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) were performed in 6 eyes.The characteristic changes of SW-FAF in studied eyes were observed and compared with the images of FFA and ICGA.All the eyes were followed up every 1 to 2 weeks,with an average of 16.7 weeks.The characteristic images of SW-FAF and corresponding OCT were studied during follow up.Results MEWDS presented with numerous multiple hyper-autofluorescent spots,sized from 50-500 μm,with a vague boundary in ultra-wide field SW-FAF.These spots located mainly at the peripapillary area and the posterior pole with a confluent pattern.The lesions extended to the mid-peripheral retina as well and became more scattered.The distribution of the hyper-autofluorescent lesions in SW-FAF corresponded roughly to that of the greyish-white spots seen in color photograph and the hyper-fluorescent spots detected by FFA.It was consistent with the distribution of hypo-fluorescent spots in late-phase ICGA as well.But the number of the spot showed in FAF is much more than that in FFA,and slightly less than that in ICGA.The OCT scans through the hyper-autofluorescent lesions in SW-FAF showed impairment of outer retina.After the recovery,the hyper-autofluorescent spots disappeared with the outer retina structure repaired completely.Conclusions MEWDS presented with numerous multiple hyper-autofluorescent spots which located mainly at the peripapillary area in ultra-wide field SW-FAF.The distribution of the hyper-autofluorescent lesions in SW-FAF corresponded roughly to color photograph,FFA and ICGA in late-phase.The OCT scans through the hyper-autofluorescent lesions in SW-FAF showed impairment of outer retina.
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Objective To comparative analyze the anorectal function before and after anus-preserving laparoscopic rectal resection in ultra low rectal cancer.Methods Radical excision of ultra low rectal cancer was performed with ultrasonic scalpel on 43 patients based on the concept of TME and ultra low colorectal/ anal anastomosis was perfomed by applying the manual anastomosis with two operations out of anus.The time of guid being controlled in the rectus,rectual rest pressure (RRP),anal rest pressure (ARP) and anal maximal contraction pressure (AMCP) were tested before operation.The function of their rectus and anus was tested,including the number of bowel movement in one day of 1,3,6 months after operation,the time of guid being controlled in the rectus,RRP,ARP and AMCP after 3,6 months of operation et al.Results All the operations were finished successfully,four cases were converted to open surgery,but there was no serious damage.All cases were followed up for 6 to 36 months with average of 20 months.After 3 months of operation,the retention time of liquid in rectus,the defecate feel function,the anus control function,RRP and ARP was statistically significant (P ＜ 0.05) compared to them before operation,there was no statistical significance (including AMCP) (P ＞ 0.05) after 6 months of operation.The results of tests in annus and rectus were near normal level after 6 month of operation.Conclusion The manual anastomosis with two operations out of anus in the laparoscopic anal sphincter preserving resection of ultra low rectal cancer is safe,economical,effective,minimally invasive and shorter hospital stay,it is worth to be widely used.
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Objective To explore the values of manual anastomosis with two operations out of anus in laparoscopic anal sphincter preserving resection of ultra low rectal cancer. Methods Radical excision of ultra low rectal cancer was performed with ultrasonic scalpel in 12 patients based on the concept of total mesorectal excision (TME) and ultra low coloreclal/anal anastomosis was performed applying manual anastomosis with two operations out of anus. Results All the operations were finished successfully, without conversions to open for surgery. One case had anastomotic leakage, and there were no bleeding and infection of abdominal cavity, anastomotic stenosis and other complications. The operating time was 185-310 (218 ±10) min, the blood loss was 160-450 (232 ±8) ml,the length of hospital stay was 9-14 (11 ±3) d. All patients were followed up 6-36(18 ± 2) months, local recurrence was not found but 1 case had liver metastasis.Conclusions The manual anastomosis with two operations out of anus in laparoscopic anal sphincter preserving resection of ultra low rectal cancer is safe,economical,effective,minimally invasive, and has the benefits of less bleeding during the operation and shorter hospital stay. It should be widely used.
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This article discusses the characteristics of cmmunity herbal monographs for traditional herbal medicinal products and its establishment procedure. It also reviews the new development of cmmunity traditional herbal monographs. The purpose is to clarify the relationship between cmmunity herbal monographs and simplified registration for traditional herbal medicinal product in European Union and provide reference to the registration of taditional Chinese mdicinal products in Europe.
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Humans , Drug Approval , European Union , Phytotherapy , Plants, MedicinalABSTRACT
<p><b>OBJECTIVE</b>To investigate the objectivity and authenticity of the difference of the Cold and Hot nature between Mahuang decoction and Maxingshigan decoction based on the cold/hot plate differentiating assay.</p><p><b>METHOD</b>The measuring time and dosage of Mahuang decoction and Maxingshigan decoction were investigated before the compliance experiment. Meanwhile, the activities of adenosine triphosphatase were detected in order to probe into the mechanism of their action.</p><p><b>RESULT</b>It was found that the drug dose should be 10 times amount to human dose (0.80 g x kg(-1) of Mahuang decoction and 2.26 g x kg(-1) of Maxing Shigan decoction) and the measuring time should be from 30 min to 60 min after administering. Compared with the control group, the remaining ratio of the mice treated with Mahuang decoction on the hot pad significantly decreased (P < 0.01). Compared with Mahuang decoction, the remaining ratio of the mice treated with Maxingshigan decoction on the hot pad significantly increased (P < 0.05). Compared with the control group, the Na(+) -K(+) -ATPase activity of liver tissue of the mice treated by Mahuang decoction significantly increased (P < 0.05), while the activity of Na(+) -K(+) -ATPase and Mg(2+) -Ca(2+) -ATPase of liver tissue of the mice treated by Maxingshigan decoction reduced significantly (P < 0.05).</p><p><b>CONCLUSION</b>This study showed that the differences of Cold and Hot nature of Mahuang decoction and Maxingshigan decoction were objectively existent from animal ethology, which was consistent with the traditional theroy of Chinese medicine. And the changes of ATPase activity of liver tissue might be the mechanism of drug action.</p>
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Animals , Male , Mice , Cold Temperature , Drugs, Chinese Herbal , Pharmacology , Ephedra sinica , Hot Temperature , Liver , Medicine, Chinese Traditional , Sodium-Potassium-Exchanging ATPase , Metabolism , ThermosensingABSTRACT
Objective:To study the protective effect of Huangqi Injection on cardiotoxicity induced by doxorubicin (DOX) and its mechanism. Methods: The molders of Dox-induced myocardial mitochondria damage of rat in vitro and Dox-induced cardiotoxicity in mice were used. The protective effect of Huangqi Injection on cardiotoxicity induced by doxorubicin was determined by biochemical method.Results: Doxorubicin can increse malondialdehyde level, induce mitochondrin swelling and decrease glutathione (GSH) content of myocardial mitochondria of rat in vitro, while all these damages caused by doxorubicin were reduced significantly by Huangqi Injection. Cardiotoxicity of doxorubicin in mice as measured by increases of myocardial malondialdehyde level and serum creatine phosphokinase activity, decreases of superoxide dimutase was significantly alleviated by Huangqi Injection. Conclusions: Huangqi Injection can protect heart against Dox-induced cardiotoxicity, which provides experimental evidence for Huangqi Injection as an anti-tumor adjuvant drug in clinical application.