1.Clinical Comprehensive Evaluation of Zhichuanling Oral Liquid in Treatment of Asthma and Considerations for Cultivating High-value Patents
Shuo YANG ; Haiyan LI ; Yanming XIE ; Lianxin WANG ; Jingming CHENGFENG ; Xin CUI ; Lixun LI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):208-216
ObjectiveThis study conducted a "6 + 1" clinical comprehensive evaluation of the existing research on Zhichuanling oral liquid (ZOL) in the treatment of asthma,so as to clarify the clinical advantages and precise clinical positioning of ZOL in the treatment of asthma, lay a foundation for further research and academic promotion of ZOL, and provide new directions for patent cultivation. MethodAn evaluation method featuring a qualitative and quantitative combination was used, which considered the dimensions of safety,effectiveness,economy,innovation,suitability,accessibility, and traditional Chinese medicine (TCM) characteristics. According to Expert Meeting Law, relevant weights were obtained through voting. CSC_v2.0 software was used to calculate each dimension and convert it into the corresponding grade score. ResultBased on the existing materials,① ZOL instruction indicates the adverse reactions,taboo, and notes. Multiple data of clinical research before and after marketing and spontaneous reporting system shows that ZOL has controllable risk and good safety. Safety is rated as B grade. ② Multiple data of clinical research before marketing, systematic evaluation of clinical effectiveness, and Meta-analysis shows that ZOL has good effectiveness and clinical significance. Effectiveness is rated as a B grade. ③ Analysis of the cost-effectiveness of ZOL combined with conventional treatment shows that the economy of the drug is good and rated as a B grade. ④ ZOL has better innovation, which is rated as an A grade. ⑤ ZOL can basically meet the clinical drug needs based on the result of the questionnaire survey and has good suitability, which is rated as a B grade. ⑥ ZOL has better accessibility, and accessibility is rated as A grade. ⑦ ZOL involves a rich theory of TCM but insufficient experience of human usage. It is thus rated as a C grade in terms of TCM characteristics. Based on the results of "6 + 1" dimension,the clinical comprehensive evaluation of ZOL in the treatment of asthma (cold syndrome and heat syndrome)is rated as B category. ConclusionZOL has good clinical value and outstanding innovation and accessibility in the treatment of asthma (cold syndrome and heat syndrome). It is recommended that ZOL be transformed into the relevant policy results of basic clinical drug management procedurally. At the same time,it is recommended to actively cultivate patents with TCM characteristics.
2.Preparation of curcumin nanocrystalline injection and evaluation of its in vivo and in vitro properties
Rongrong WANG ; Wenjun SUN ; Jiangwei LIU ; Aiping ZHENG ; Hui ZHANG ; Lixun LYU
Journal of China Pharmaceutical University 2022;53(1):54-59
In this study, the formulation and preparation process of curcumin nanocrystalline injection were optimized to improve curcumin dissolution rate and bioavailability in vivo.Media grinding method was used to prepare curcumin nanocrystals, and the particle size was used as the evaluation index.The Box-Behnken experimental design was used to optimize its formulation and preparation process, and to characterize its physical and chemical properties.In addition, the dissolution of nanocrystal with different particle sizes was investigated by the paddle method, and the pharmacokinetics in rats were studied.The experimental results showed that the optimal formula and process were obtained through Box-Behnken experimental design, and that uniform curcumin nanocrystals with an average particle size of 223.1 nm were obtained.The results of X-ray diffraction and differential scanning calorimetry analysis showed that the crystal form was stable during the preparation of nanocrystals. In vitro dissolution experiments with different particle sizes showed that the dissolution rate and the degree of dissolution would increase if the particle size was smaller.Pharmacokinetic studies in rats showed that cmax and AUC0-∞ of curcumin nanocrystal injection were 4.9 and 4.1 times that of curcumin raw materials, respectively.In summary, the curcumin nanocrystal injection developed in this research have a stable preparation process and can significantly improve the dissolution rate and bioavailability of the drug, which provides some ideas for the research on curcumin preparation.
3.Efficacy analysis of thoracic closed drainage assisted by thin drainage tube after esophagectomy
Lixun CHAI ; Qiang LI ; Gengpu YANG ; Yuxuan WANG ; Zhijie SHANG ; Hai WANG
Cancer Research and Clinic 2018;30(11):749-752
Objective To investigate the clinical effect of thick drainage tube thoracic closed drainage assisted by thin drainage tube after esophagectomy. Methods A total of 112 patients who received esophagectomy in the Department of Thoracic Surgery of Shanxi Dayi Hospital from January 2014 to December 2017 were retrospectively analyzed. The patients were divided into the test group (60 patients) and the control group (52 patients). The test group used thick tube in thoracic close drainage assisted by thin drainage tube, and the control group took general thoracic closed drainage. The operation time, the bleeding of operation, the number of lymph node dissection, the number of post-operative complications, the hospitalization time after operation, postoperative fever time, the frequency of post-operative puncture in both groups were observed. The post-operative pain was evaluated by using visual analogue score (VAS). Results There were no statistical differences in the time of operation [(4.3±1.3) h vs. (4.5±0.9) h], bleeding of operation [(137±21) ml vs. (141±21) ml], the number of lymph node dissection [(18.5±5.2) vs. (17.2±2.4)] and the number of post-operative complications (11 cases vs. 7 cases) between the test group and the control group (all P>0.05). There were statistical differences in the hospitalization time after surgery [(14.9±2.4) d vs. (20.5 ±3.2) d], post-operative fever days [(5.8 ±1.4) d vs. (7.4 ±1.4) d] and the frequency of post-operative puncture (7 vs. 13) between the test group and the control group (all P< 0.05). And there were statistical differences in the VAS scores for post-operative resting and coughing from 48 h to 72 h (all P< 0.05). Conclusion The thin drainage tube is more effective in assisting thoracic closed drainage after esophagectomy. It can reduce post-operative pain and shorten the length of hospitalization, which is worthy of further promotion.
4.Determination of EC50 of Dexmedetomidine Hydrochloride Causing Disappearance of Explicit Memory by Process Dissociation Procedure
Rui GUO ; Wanwen HE ; Lixun WANG ; Hui LI ; Youli CHEN ; Jianbin LI
Herald of Medicine 2016;35(4):341-344
Objective To determine the EC50 of dexmedetomidine hydrochloride ( DEX) which causes disappearance of explicit memory by process dissociation procedure (PDP). Methods Forty patients those who had senior middle school or higher educational background undergoing lower extremity surgery with grade ASA Ⅰ or Ⅱ, without hearing impairment, dysphasia,nervous system disorders,and having no drugs in the treatment of the central nervous system were included.PDP was applied to establish study table and record, and calculate performance of explicit memory and implicit memory. Memory performance was statistically compared with 0, 0 memory was considered to be statistically significant and disappearance, respectively.Sequential method was used for determination.According to explicit memory disappearance or not,target concentration of the next patient was adjusted (increase or decrease).DEX target concentration of the first patient was set to 4 ng?mL-1,and the ratio of target concentration between the adjacent patients was 1.2.If the explicit memory of the former patient disappeared,the target concentration of the next patient was decreased by 1 concentration gradient;if the explicit memory of the former patient did not disappear,the target concentration of the next patient was increased by 1 concentration gradient, and so forth. All the 40 patients were determined.The median effective dose (D1) and 95% confidence interval (CI) of DEX were calculated. Results The ED50 of DEX causing explicit memory disappearance was 5.23 ng?mL-1,and the 95% CI was 4.07-6.39 ng?mL-1. Conclusion In clinical,target concentration of dexmedetomidine hydrochloride 5.23 ng?mL-1 levels for sedation,can cause half of patients’ explicit memory disappear,so as to avoid intraoperative awareness.
5.The effect of continuous thoracic paravertebral block analgesia guided by sonography on pulmonary func-tion after thoracotomy
Ganghua YANG ; Jingli LIN ; Qitao HE ; Tao WANG ; Lixun WANG
The Journal of Clinical Anesthesiology 2016;(2):118-121
Objective To investigate the effect of continuous thoracic paravertebral block anal-gesia guided by sonography on pulmonary function after thoracotomy.Methods Sixty patients,male 29 cases,female 31 cases,aged 18-60 years,BMI 1 6-28 kg/m2 ,ASA grade Ⅰ or Ⅱ,who had under-went thoracotomy were divided randomly into 2 groups,30 cases each:group G with general anesthe-sia and postoperative patient controlled intravenous analgesia (PCIA),whereas group GP with general anesthesia combined with continuous thoracic paravertebral block (CTPVB)and postoperative continuous CTPVB.CTPVB were performed before induction as the patient was conscious so that the effect of CTPVB could be tested by blocking range.Both resting and coughing visual analogue scales (VAS)were recorded at the points of 30 minutes after extubation (T1 ),2 hours after operation (T2 ),6 hours after operation (T3 ),24 hours after operation (T4 )and 48 hours after operation (T5 ). Forced vital capacity (FVC),forced expiratory volume in the first second (FEV1 )and maximal mid expiratory flow (MMF)were measured by spirometer and the three maximal values were recorded at time points of entry of operating room (T0 ),T4 and T5 .Blood gas analysis was employed at corre-sponding time points by a blood gas analyzer and oxygen inhalation was ceased 30 minutes before drawing blood from radial artery.PaCO 2 ,PaO 2 and alveolararterial oxygen difference (PA-a O 2 )were recorded.Adverse effects were observed.Results Compared with group G,VAS when resting and coughing in group GP at T1-T5 decreased significantly (P <0.05).Compared with T0 ,FVC,FEV1 , MMF and PaO 2 at T4 ,T5 in both groups decreased significantly (P <0.05),PA-a O 2 increased signifi-cantly (P <0.05 ).Compared with group G,PaO 2 in group GP at T4 ,T5 increased and PA-a O 2 in group GP at T4 ,T5 decreased significantly (P <0.05).Conclusion CTPVB guided by sonography had excellent effect.It can not only improve pulmonary function after thoracotomy significantly but also promote intrapulmonary oxygenation.
6.Photopic laryngoscope can reduce half effective concentration of Propofol for inhibiting intubation response
Wanwen HE ; Aiting LIN ; Rui GUO ; Lixun WANG ; Youli CHEN
China Journal of Endoscopy 2016;22(3):7-10
Objective To compare the EC50 of Propofol for inhibiting intubation response. Methods 80 cases un-derwent tracheal intubation general anesthesia, all patients were randomly divided into two groups. The general situ-ation between the two groups showed no significant difference. Except for Propofol, other anesthesia drugs infusion method and dosage were the same. Sequential determination the EC50 of Propofol which for inhibiting intubation re-sponse of each groups by up-and-down. Propofol target concentration of the first patient was set to 4 μg/ml, and ad-justed according to intubation stress response disappeared or not, concentration of two adjacent patients with ratio of 1.2. Results A group inhibited the cardiovascular responses of Propofol EC50 and 95%CI was 5.19 μg/ml (95%CI:4.88 ~ 5.50 μg/ml). B group inhibited the cardiovascular responses of Propofol EC50 and 95 %CI was 4.15μg/ml (95%CI:3.80~4.40μg/ml). The EC50 and 95% confidence interval of the B group were significantly lower than those of the A group ( P< 0.05). The MAP and HR at T2 were higher than that of T1 in each group ( P< 0.05), and the MAP and HR of observe group were lower than that of control group ( P< 0.05). The MAP and HR at T3 were lower than that of T1 in control group ( P< 0.05), but there were no significant deference in observe group ( P> 0.05).Conclusion The EC50 and 95% confidence interval of Propofol for inhibiting intubation response under photopic laryngoscopes was significant lower than those of under direct laryngoscopes, the circulation during period of induc-tion and intubation was more stable.
7.Single operation video intubationscope assisted by mouthpiece in orotracheal intubation
Zengting LU ; Zehua TU ; Haoxiang HU ; Qianlin YE ; Kangcong ZHANG ; Lixun WANG
China Journal of Endoscopy 2016;22(6):9-12
Objective To evaluate the effect of single operation video intubationscope assisted by disposable mouthpiece in orotracheal intubation. Methods 100 patients undergoing general anesthesia were randomly divided into two groups with 50 cases in each: mouthpiece group (group M): single operation video intubationscope assisted by disposable mouthpiece in orotracheal intubation was performed; control group (group C): Video intubationscope oral intubation assisted by helper were applied. The BP, MAP, HR and SpO2 in the two groups were recorded during intubation. The success rate of intubation, duration of glottis exposure, duration of intubation and complications were recorded. Results Oral-tracheal intubation with video intubationscope were successfully completed for all 100 pa-tients, SpO2 during intubation in two groups was maintained above 95.0%, there was no significant hemodynamic changes in two groups. There were no significant difference in the one-time success rate of intubation, duration of glottis exposure and duration of intubation between group M and group C [92.0%vs 88.0%, (13.0 ±7.0) vs (14.0 ±8.0), (20.0 ± 10.0) vs (21.0 ± 11.0), > 0.05]. No significant complications were reported. Conclusion Compared with video intubationscope oral intubation assisted by helper, single operation video intubationscope assisted by dis-posable mouthpiece in orotracheal intubation also is feasible and effective without needing assistant, it is a simple and convenient technology worthy of application.
8.Effects of different sedation depth of propofol on cerebral oxygen metabolism of the elder patients during anesthesia
Rui GUO ; Wanwen HE ; Lixun WANG ; Hui LI ; Youli CHEN ; Jianbin LI
The Journal of Practical Medicine 2015;31(15):2551-2553
Objective To evaluate the effect of propofol with different sedation depth on CERO 2 of elder patientsduring anesthesia. Method 60 case patients under cholecystotomywith laparoscope, ASA IorⅡgrading, 65-75 year old , 45-75 kg , were randomly divided into 3 groups ( n = 20 ) and were divided into group A (3 μg/mL), group B (4 μg/mL), group, C (5 μg/mL), according to TCI of propofol. TCI in different groups were modified after gereral anesthesia. Bloodgas was analyzed by blood samples taken from radial artery and Sjv ball, Da-jvO2 and CERO2 were calculated. Results The Da-jvO2 and CERO2 of group B and C were significantly lower thanthose of group A at T2,3, while CjvO2 were significantly higher thangroup A (P < 0.05). The Da-jvO2 and CERO2 of group B and C werenot significantly different (P > 0.05); NI value of group A in T1-3 was significantly higher thangroup B (P < 0.05), while. NI value of group B in T1-3 was significantly higher thangroup C (P < 0.05). Conclusion Propofol TCI 4 μg/mL, can improve cerebral oxygen metabolism of elder patients and decrease CERO2.
9.Investigation of Feedback Regulation of Close-loop Muscle Relaxant Injection System on Accuracy of Cisatracurium Besilate Usage
Rui GUO ; Jianbin LI ; Lixun WANG ; Wanwen HE ; Hui LI ; Youli CHEN
Herald of Medicine 2015;34(12):1599-1602
Objective To investigate feedback regulation of close-loop muscle relaxant injection system on accuracy of cisatracurium besilate usage. Methods Two hundred patients undergoing laparoscopic cholecystectomy surgery, aged 20 to 40 years old, at ASA Ⅰ or Ⅱ, were randomly divided into two groups:control group and treatment group (n=100 each group).In the control group, the patients received injection of cisatracurium besilate with closed-loop muscle relaxant injection system at 1.5-2.0 μg·kg-1 ·min-1 , until 30 min before the end of surgery;if the muscle relaxant level could not meet the requirement of the operation, extra 0.05 mg·kg-1 was added.The treatment group was adopted closed-loop muscle relaxant monitoring under negative feedback regulation of infusion cisatracurium, and the close-loop control parameters were set to: drug was added when TOF was 8%, and injection speed was 2. 5 μg · kg-1 · min-1 , maintaining speed was 0. 33 μg · kg-1 · min-1 , the stimulus current for monitoring muscle relaxant was 60 mA , and the pulse width was 200μs.The Cooper score, cisatracurium dosage, and muscle recovery index, TOFr75 and TOFr90 of the two groups were compared. Prediction probability ( Pk ) of NI on awakening period of eye opening and directional force recovery of the two groups were detected, and regression equation was established to predict ED50 and ED95 related NI . Results Cooper score was significantly higher in the treatment group than in the control group ( P<0. 01 ) . Muscle recovery index, TOFr75 , TOFr90 , and cisatracurium dosage per unit time and body mass were significantly lower in the treatment group than in the control group(P<0.01). Pk of NI on awakening period of eye opening and directional force recovery of the two groups were higher than 0.5; and Pk of the treatment group were significantly higher than those of the control group ( P<0.01) . Regression equation predicted that ED95 was significantly lower in the treatment group than in the control group ( P<0.01) , while the ED50 between the two groups has no significant difference ( P>0.05) . Conclusion The accuracy of closed loop muscle relaxant injection system is higher than that of the traditional method, it provides better muscle relaxation effect for tracheal intubation, reduces recovery time, increases the Pk of NI on patient awakening.
10.Effects of Sub-target Concentrations of Propofol on Explicit Memory and Hemodynamics During Intraoperative Awakening
Rui GUO ; Lirong ZENG ; Wanwen HE ; Lixun WANG ; Dashang LING ; Ruiyu LI
Herald of Medicine 2014;(7):895-899
Objective To compare the effects of five different target-controlled concentrations of propofol combined with finite concentration of remifentanil on intraoperative awareness,so as to determine the safer and more effective concentration of propofol which could decrease explicit memory and reduce the incidence of intraoperative awareness. Methods One hundred and fifty patients ( ASAⅠ-Ⅱ) were randomly divided into five groups. There was no significant difference between each group in general condition. Before awaking,the target controlled concentration of remifentanil was adjusted to 2. 4 μg·L-1 in all five groups. Groups R1,R2,R3,R4 and R5 also received 0. 9%normal saline,0. 5 mg·L-1,1. 0 mg·L-1,1. 5 mg·L-1 and 2. 0 mg·L-1 of target controlled infusion ( TCI) of propofol, respectively. Narcotrend index ( NI), mean arterial pressure (MAP),heart rate (HR) and t [the time from t1(the time of awareness beginning) to the end of awareness] at t0(the time of adjusting propofol),t1,t2(the period of awareness),t3(wake period end 5 min) were recorded. Elimination of explicit memory after surgery was followed up. Results There were no significant differences in t and NI between groups R1,R2 and R3(P>0. 05). NI of groups R4 and R5 was significantly lower than that in groups R1,R2 and R3(P<0. 05),but t of groups R4 and R5 was longer than that in the other groups (P<0. 05). The MAP,HR and explicit memory of groups R3,R4 and R5 were lower than those in groups R1 and R2 (P<0. 05),but there were no significant differences between groups R3,R4 and R5 (P>0. 05). Conclusion Target controlled infusion of remifentanil 2. 4μg·L-1 combined with TCI propofol 1. 0 mg·L-1 does not affect the wakening controllability. The circulation was steadier and explicit memory could be eliminated during intraoperative awakening.

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