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New drug clinical trials have been considered as a positive way for treating cancer by cancer patients and doctors, and the extended dosing is a special way for patients' withdrawal from antitumor clinical trials to obtain investigational new drugs. However, neither the regulations of expanded dosing nor the detail documents for expanded dosing have been officially published in China. At present, expanded dosing of investigational drugs is still at the exploratory stage in various medical institutions, and a complete management system has not been established to meet patients' urgent needs for drug use. Based on the practical experience of extended dosing in Hunan Cancer Hospital, this paper preliminarily explored the application procedures and ethical review requirements of extended dosing for subjects in antitumor clinical trials. It is necessary to clarify the responsibilities of all patients in the procedure and establish a patient-medical institution-sponsor joint application system. In the process of ethical review, it is recommended that all parties fully consider the risks and benefits of extended dosing for patients, and then the ethics committee makes a comprehensive assessment to decide whether to approve extended dosing.
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Humanos , China , Médicos , Antineoplásicos/uso terapéuticoRESUMEN
Objective@#This pilot human trial demonstrates the ability of the investigational newborn hearing screening device to provide acoustic stimulation to produce evoked potentials, as well as its ability to capture and acquire auditory evoked potentials, especially the auditory brainstem response (ABR) wave V. This pilot study also demonstrates the ease of recognizing and identifying ABR waves in the graphical presentation of the evoked potentials over time. @*Methods@#Fourteen normal-hearing adults or a total of twenty-eight (28) normal-hearing adult ears underwent auditory brainstem response testing using the investigational hearing screening device. A commercially available auditory brainstem response detection device was used to confirm that the acquired ABR waves of the investigational device are normal. The ABR waves displayed by the investigation device were also reviewed by the clinical audiologists to determine their recognizability and identifiability. @*Results@#The pilot trial demonstrates the ability of the investigational newborn hearing screening device in providing acoustic stimulation to produce evoked potentials, and in acquiring and capturing ABR waves, specifically the wave V, among normal-hearing adult ears. The clinical audiologists recognized and identified the ABR wave V among the evoked potentials at 40dB, 60dB, and 80dB acoustic stimulation. About eighty-nine percent (89.2%) of all ears tested had identifiable and recognizable wave V upon acoustic stimulation at 40dB. @*Conclusion@#The investigational hearing screening device: (1) can provide acoustic stimulation to produce evoked potentials, (2) can accurately capture and acquire these evoked potentials, (3) can present these evoked potentials in a voltage per time graphical display which an audiologist and trained HCP can easily read and interpret (diagnostic ABR), and (4) can present wave V auditory brainstem potentials that can be easily identified by an audiologist and trained HCP (screening ABR).
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Recién Nacido , Acústica , Proyectos PilotoRESUMEN
The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.
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In past two decades, understanding of the role of the orexin system in regulating sleep and wakefulness has increased rapidly. Lemborexant, as a dual orexin receptor antagonist, has been approved in some countries for the treatment of insomnia disorders. Existing studies have shown that its safety and tolerability are significantly superior to traditional hypnotic drugs, and it will be new option for treating insomnia disorders. This article reviews the pharmacology, clinical efficacy and safety of lemborexant.
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Objective:To evaluate the clinical value of endoscopic release therapy for fecal impaction in the colorectal diverticulum.Methods:Data of patients with fecal impaction in the colorectal diverticulum who received endoscopy in Shantou Central Hospital from January 2018 to September 2020 were included in this study. Among them, 85 patients treated with endoscopic release therapy were assigned to the observation group (2 patients were excluded from the observation group due to acute appendicitis), and 43 patients receiving no treatment were assigned to the control group. The relief of abdominal symptoms was used as an index to evaluate the clinical value of endoscopic release therapy for fecal impaction in the colorectal diverticulum.Results:In the observation group, 42.2% (35/83) were successfully released at one time. The successful comprehensive measures accounted for 25.0% (12/48) of the first release failure, and the total success rate was 56.6% (47/83). There were no complications related to endoscopy in the observation group. One week after the treatment, patients in the observation group were followed up by telephone. Among the 45 patients who were successfully released, positive symptoms of 30 patients disappeared or significantly improved with the effective rate of 90.9% (30/33). Among the 38 patients who failed to release the fecal impaction, 19 had positive symptoms and 16 improved in varying degrees with the effective rate of 55.2% (16/29). The overall effective rate of the observation group was higher than that of the control group [55.4% (46/83) VS 7.0% (3/43)], showing significant difference( χ2=23.354, P<0.01). The effective rate were significant differences in the successful release group [65.2% (30/46)], unsuccessful release group [29.7% (11/37)] and the control group [7.0% (3/43), χ2=33.792, P<0.01]. By pairwise comparison, the effective rate of the successful release group was the highest, followed by the unsuccessful release group, and that of the control group was the lowest with significant difference ( P<0.017). Conclusion:The endoscopic release therapy for fecal impaction in the colorectal diverticulum is relatively simple, which can relieve and reduce related symptoms, avoid complications, missed diagnosis and misdiagnosis, and show definite curative effects. When colorectal diverticulum with fecal impaction is found in the process of endoscopy, it is of great practical significance to release the incarcerated feces by means of different methods.
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Objective:To analyze whether the sample of elderly subjects in clinical trials of prostate cancer drugs is representative.Methods:From the level of trial design, the age distribution of subjects in clinical trials of prostate cancer drugs for elderly patients from January 2019 to December 2021 was inquired on the platform of drug clinical trial registration and information disclosure.From the actual enrollment level, the prostate cancer drug clinical trials initiated and completed by a hospital from January 2010 to June 2022 were collected.The age information of subjects in all centers was collected for multicenter trials with a summary report, and the age data of subjects in the center was collected for trials without a summary report or single-center trials.The average age of prostate cancer onset and the incidence of prostate cancer in different age groups were compared with the Chinese Cancer Registry System, so as to compare whether the two were consistent.Results:Most of the trials(72.1%、44/61)did not set upper age limit at the protocol design level.Phase Ⅲ and phase Ⅳ trials did not set an upper age limit for enrolled subjects in the protocol.From the actual enrollment level, a total of 19 studies were included in this study, with 1 402 subjects, and the average age of subjects was 67.1±8.6 years old, which was significantly different from the average age of prostate cancer in China and Beijing(all P<0.001). The age group with the largest number of participants was 60-64 years old(34.2%、479/1 402). The population aged ≥75 years was the least(21.5%, 301/1 402), which was different from the high incidence age group of prostate cancer in China in 2017(421.77/100 000). Conclusions:Clinical trials of prostate cancer drugs are designed to cover all age groups of elderly patients, but the actual sample representation of the enrolled elderly subjects is insufficient.Under the premise of protecting the safety of subjects, the trial population who are matched for the average age of prostate cancer onset and the incidence of prostate cancer in age groups, should be gradually increased.
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The objective research conclusions drawn from standardized clinical studies are important evidential basis for the formulation of consensus guidelines for the diagnosis and treatment of various diseases. In order to further improve the level of clinical research work and evidence quality, provide patients with more scientific treatment decision-making opinions, the author investigate the following aspects which should be paid attention to in the clinical study of biliary tract diseases including defining the evaluation system and quality standards evidence-based criteria for clinical studies, setting long-term research goals, strengthening the real-world research,"three elements"of surgical clinical research (surgical quality, pathological analysis and follow-up), and the database construction; emphasizing the significance and implementation of quantitative analysis research, the registration system and standardized clinical research.
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Objective:To investigate the clinical effects of electroacupuncture assisted with facial expression muscle control rehabilitation training in the treatment of patients with severe idiopathic facial paralysis.Methods:A total of 130 patients with severe idiopathic facial paralysis who met inclusion criterion were chosen and randomly divided into 2 groups, 65 patients in each, from January 2017 to December 2019 in our hospital. The control group were treated with facial expression muscle control rehabilitation training and western medicine, and the experiment group with electroacupuncture on the basis of the control group. Both groups were treated for 8 weeks and followed up for 6 months. The facial nerve function was evaluated by H-B scale and facial nerve sunny brook scale the quality of daily life was evaluated by Facial Disability Index Physical Function (FDIP) scale and Facial Disability Index Social Function (FDIS) scale. The latency/M wave amplitude of motor evoked action on orbicularis oculi muscle and orbicularis ORIS muscle were measured by EMG evoked potential instrument. The occurrence of hemifacial spasm during follow-up was recorded. The clinical effective rates were evaluated.Results:The total effective rate of experiment group was 92.31% (60/65), which was significantly higher than that of the control group 76.9% (50/65) ( χ2=6.495, P=0.039). The H-B scale scores of experiment group after treatment were significantly less than that of the control group ( t=3.438, P<0.01). The facial nerve sunny brook scale scores of experiment group after treatment were significantly more than that of the control group ( t=2.674, P=0.032). The FDIP scores of experiment group after treatment were significantly less than that of the control group ( t=3.986, P<0.01). The FDIS scores of experiment group after treatment were significantly more than that of the control group ( t=4.621, P<0.01). The NCV latency of orbicularis oculi muscle [(2.51 ± 0.27) ms vs. (2.82 ± 0.46) ms, t=4.258] and orbicularis oris muscle [(2.97 ± 0.22) ms vs. (3.35 ± 0.40) ms, t=4.783] of observation group were significantly lower than those in the control group ( P<0.01). The M wave amplitudes of orbicularis oculi muscle [(1.83 ± 0.45) mV vs. (1.30 ± 0.39) mV, t=3.827] and orbicularis oris muscle [(2.58 ± 0.60) mV vs. (1.97 ± 0.36) mV, t=4.017] of observation group were significantly higher than those in the control group ( P<0.01). The incidence of facial spasm with follow-up of experiment group for 4.62% (3/65) was significantly lower than that of the control group for 15.38% (10/65) ( χ2=9.271, P=0.033). Conclusion:Electroacupuncture assisted with facial expression muscle control rehabilitation training in the treatment of patients with severe idiopathic facial paralysis can relieve clinical symptoms, improve facial nerve function, improve the quality of daily life and be helpful to reduce the facial spasm risk.
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With the development of antibody manufacturing technology and improvement of new drug research in domestic industry, more innovative monoclonal antibody products submitted investigational new drug (IND) application. At the same time, monoclonal antibody products from abroad which have been approved marketing authorization and/or conducted clinical trials submitted IND applications in China. The National Medical Products Administration (NMPA) issued the "Guideline of Investigational New Drug Application" (No. 16, 2018) which emphasized the chemical, manufacturing, and control (CMC) regulatory, and dossier requirements in IND application, greatly promoted the application quality of innovative biological products. However, compared to the Food and Drug Administration (FDA) and European Medicines Agency (EMA), our particular guidelines are insufficient, such as guideline on virus safety evaluation of biotechnological investigational medicinal products. This review investigated the questions raised by sponsors from 2018 to 2020, including the end of production cell (EOPC) and/or unprocessed bulk (UPB) testing and virus removal or inactivation validation. Meanwhile, sponsors submitted different dossiers due to differences in understanding of stage requirements of guidelines from domestic and abroad. Based on the guidelines of virus safety from NMPA, FDA, and EMA, and the technical considerations, this review puts forward personal suggestions on the adventitious agents testing and virus removal or inactivation validation in manufacturing process, aim to ensure virus safety of innovative monoclonal antibody products in clinical trials.
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Objective@#To observe the effect of Jiawei-Cuyun Decoction on autoimmunity recurrent spontaneous abortion in recurrent spontaneous abortion.@*Methods@#To include eighty patients with autoimmunity recurrent spontaneous abortion from January 2016 to January 2018 in our hospital. The patients were divided into treatment group (36 cases) and control group (44 cases). The control group was treated with aspirin, and the treatment group was treated with Jiawei-Cuyun Decoction. The two groups, who were in the menstrual cycle, both were treated for 5 days until menstruation ends. The course of treatment for pregnancy should be no more than 3 menstrual cycles, and after pregnancy, the treatment should continue until the end of 12 weeks of pregnancy. During three menstrual cycles, the pregnancy serum anticardiolipin (aCL), anti-β2-1 glycoprotein (aβ2GP1) IgG and IgM were detected, and the adverse of drugs and pregnancy outcomes were recorded.@*Results@#For the third menstrual cycle, the overcast rates of serum aCL IgG [94.4% (34/36) vs. 68.2% (30/44); χ2=5.501, P=0.019], IgM [94.4% (34/36) vs. 77.3% (34/44); χ2=4.579, P=0.032], aβ2GP1 IgG [94.4% (34/36) vs. 75.0% (33/44); χ2=4.165, P=0.041], IgM [97.2% (35/36) vs. 79.5% (35/44); χ2=4.156, P=0.042] in the treatment group were significantly higher than those in the control group. After the treatment, the incidence of adverse reactions of the treatment group was 5.6% (2/36), and the control group was 31.8% (14/44), which showed that there was statistically significant difference between two groups (χ2=8.535, P=0.004). Pregnancy success rate of treatment group was 80.6% (29/36), and the control group was 56.8% (25/44), which showed that there was statistically significant difference between two groups (χ2=4.061, P=0.044).@*Conclusions@#Jiawei-Cuyun Decoction can effectively reduce the aCL, aβ2GP1 is IgG and IgM positive expression, reduce adverse drug reactions and improve the successful rate of pregnancy.
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The pathogenesis of atopic dermatitis (AD) has not been fully elucidated,which may be mainly associated with abnormality of immunity,dysfunction of skin barrier and environmental factors.The main symptom of AD is severe pruritus,which can greatly affect the life quality of patients.The management of AD in clinical practice is still a big challenge.Most patients can achieve improvement through avoidance of provocative factors,basic skin care and topical application of anti-inflammatory agents.However,a few patients with generalized lesions are resistant to conventional therapy,and systemic therapy is needed.Biological agents have been widely used in patients with moderate and severe AD.This review summarizes advances in the medications for AD.
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Objective@#To explore the advantages of endoscopy combined with contrast fistulography in the clinical diagnosis and treatment of chronic wound with sinus tract adjacent to body cavity.@*Methods@#Thirty-two patients (14 males and 18 females, aged 17 to 87 years) of chronic wounds with sinus tracts adjacent to body cavity, who underwent endoscopy combined with contrast fistulography (CT or magnetic resonance imaging) for the diagnosis and treatment in the Outpatient Department of Wound Healing Center of our hospital from October 2017 to March 2019, were enrolled in the study. Their diagnosis and treatment results were retrospectively analyzed. The following data were calculated. (1) The incidence rates of sinus wound involving body cavity or fistula. (2) The detection rates of sinus wound involving body cavity detected by routine examination and by endoscopy combined with contrast fistulography. (3) The detection rate of pathological features at deep part of wound by routine examination and by endoscopy combined with contrast fistulography. (4) The proportion of patients who benefited from routine examination and from endoscopy combined with contrast fistulography. Data were processed with paired chi-square test and Fisher′s exact probability test.@*Results@#(1) The incidence rate of sinus wound involving body cavity was 43.75% (14/32); the incidence rate of fistula was 0. (2) The detection rate of sinus wound involving body cavity detected by endoscopy combined with contrast fistulography was 43.75% (14/32), which was obviously higher than that by routine examination [12.50% (4/32), χ2=32.0, P<0.01]. (3) The detection rate of pathological features at deep part of wound by endoscopy combined with contrast fistulography was 37.50% (12/32), which was obviously higher than that by routine examination (0, P<0.01). (4) The proportion of patients who benefited from endoscopy combined with contrast fistulography was 71.43% (20/28), which was obviously higher than that from routine examination [12.50% (4/32), χ2=21.6, P<0.01].@*Conclusions@#Compared with routine examination, endoscopy combined with contrast fistulography is more accurate in detecting chronic wound with sinus tract adjacent to body cavity. The diagnosis and treatment of chronic wound with sinus tract adjacent to the body cavity can benefit from this joint examination.
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Objective@#To investigate the efficacy of Kinesio taping combined with warm needling on knee osteoarthritis (KOA) and its effect on serum levels of immune globulin(Ig)A, IgG, IgM.@*Methods@#Sixty-two KOA patients who met the inclusion criteria were divided into 2 groups by random number table (31 cases in each group). The control group was treated with routine thrapy. Based on the control group, the observation group was treated with Kinesio taping combined with warm needling. After 6 weeks treatment, scores of visual analogue scale (VAS) was used to evaluate knee pain, Japanese orthopaedic association (JOA) scale was used to evaluate knee function, and Lequesne index was used to evaluate disease severity. The score of TCM clinical symptoms was conducted according to the KOA symptom grading quantification table, and the quality of life was evaluated according to the Chinese version of the MOS item short from health survey (SF-36). The Immunoglobulin(Ig)A, IgG and IgM levels were detected by ELISA method.@*Results@#The total effective rate in the observation group was 93.5%, and the control group was 71.0% (28/31). The difference was statistically significant between two groups (χ2=5.415, P=0.020).The total effective rate of clinical symptoms in traditional Chinese medicine in the observation groups as 90.3% (28/31) was higher than the control group as 64.5% (20/31), and the difference was statistically significant (χ2=5.905, P=0.015). After treatment, the serum level of IgA (2.91 ± 0.35 ng/ml vs. 4.50 ± 0.50 ng/ml, t=7.621), IgG (11.17 ± 1.31 pmol/L vs. 15.83 ± 1.94 pmol/L, t=13.523), IgM (3.14 ± 0.44 pmol/L vs. 5.44 ± 0.62 pmol/L, t=8.441) were significantly lower than control group (P<0.01). After 6 weeks’ treatment, tthe scores of VAS, Lequesne index, and clinical symptom of traditional Chinese medicin of the observation group were significant lower than those of the control group (t=7.765 and 9.903 respectively, all Ps<0.01), but the scores of JOA and the SF-36 were significantly higher than those of the control group (t=18.441, P<0.01). After 6 weeks’ treatment, the scores of pain in bed at night, morning stiffness, walking pain, pain from sitting up, maximum walking distance, daily activities, walking up stairs, walking down stairs, bending knee joint score in the observation group were significantly lower than those in the control group (t=8.933, 9.112, 9.225, 8.809, 9.240, 8.910, 7.903, 8.033, 7.031, respectively, all Ps<0.01), but the scores of physical pain, physiological function, physiological function, vitality, social function, emotional function, mental health in the observation group were significantly higher than those in the control group (t=12.450, 13.446, 13.779, 9.003, 13.331, 12.440, 15.309, all Ps<0.01).@*Conclusions@#The kinesio taping combined with warm needling can improve symptoms of traditional Chinese medicine and reduce pain of KOAand increase quality of life with the regulation of IgA, IgG, IgM.
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Objective@#To observe the effect of acupuncture and family exercise on the pain and quality of life in the patients withcervical spondylotic radiculopathy.@*Methods@#A total of 104 patients with cervical spondylotic radiculopathy were randomly divided into 4 groups: the control group was treated with cervical traction therapy, the exercise group were with traction therapy and family exercise, the Acupuncture group were with traction therapy and acupuncture, and the combined group were with traction therapy, family exercise and acupuncture. The short-form of McGill Pain Questionnaire (SF-MPQ), Northwick Park Neck Pain Questionnaire (NPQ) and WHO quality of life (WHOQOL-BREF) were compared between two groups.@*Results@#After treatment, the SF-MPQ were (5.8 ± 1.0, 7.1 ± 1.1, 7.9 ± 2.1 vs. 9.3 ± 1.1, F=44.897) and NPQ (12.9 ± 2.0, 15.5 ± 1.6, 15.9 ± 3.4 vs. 17.8 ± 1.9, F=69.730) in Comb. G, Acu. G, Exe. G were significantly lower than those in the Ctrl G. (P<0.01). The scores of physiology, psychology, society and environment of WHOQOL in the Comb. G, Acu. G and Exe. G after treatment were significantly higher than that in the Ctrl G. (F=154.216, 190.314, 65.227, 344.897, all Ps<0.001).@*Conclusions@#Four groups’ interventions are effective for cervical spondylotic radiculopathy. The combined interventions have more positive impact on pain management and quality of life in patients.
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Objective@#To investigate the effects of comfrey cream combined with narrow-band UVB (NB-UVB) on skin barrier function and immune function in the patients with psoriasis vulgaris.@*Methods@#A total of 100 patients with psoriasis vulgaris admitted from March 2016 to June 2017 were enrolled in the study. They were randomly divided into observation group (Purple Cream + NB-UVB) and control group (NB- UVB), 50 cases in each group. Psoriasis lesion area and severity index (PASI) and degree of pruritus were evaluated before treatment, after 2 weeks and 4 weeks of treatment. The skin barrier function and immune related indicators were compared between the two groups before and after the treatment.@*Results@#After treatment, the PASI score and pruritus score of the observation group and the control group showed a decreasing trend, and the observation group decreased more significantly. The interaction between the two groups at different time points, and between groups and at different time points were statistically significant (t values were 3.462, 2.833, P<0.05). After treatment, the water content of the stratum corneum (54.34% ± 5.04% vs. 49.03% ± 5.26%, t=5.154) and the sebum content (143.03 ± 11.60 μg/cm2 vs. 130.79 ± 14.54 μg/cm2, t=4.653) in the observation group were higher than those in the control group, and the transepidermal water loss (TEWL) [15.87 ± 4.22 g/(h•m2) vs. 19.87 ± 3.06 g/(h•m2), t=5.426] in the observation group was lower than that in the control group (P<0.05). The CD4+ (42.06% ± 4.68% vs. 33.01% ± 3.07%, t=11.433), CD4+/CD8+ (20.89 ± 3.44 vs. 26.03 ± 3.44, t=8.209) in observation group and control group were increased after treament, while CD8+(1.89% ± 0.29% vs. 1.43% ± 0.27%, t=7.471) was decreased, the observation group was superior to the control group (P<0.05).@*Conclusions@#Treatment of vulgaris vulgaris with comfrey cream combined with NB-UVB can improve symptoms and improve skin barrier function and immune function.
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Objective@#To evaluate the effects of the classical prescriptions Dahuang-Huanglian-Xiexin decoction combined with conventional western medicine on the lipid metabolism disorder and changes of intestinal microflora in patients with type 2 diabetes mellitus (T2DM).@*Methods@#A total of 120 patients who met the inclusion criteria were divided into the two group according to the treatment order, with 60 patients in each group. Both groups were given conventional hypoglycemic therapy, the control group was given bifidobacteria lactobacillus triple viable tablets, and the treatment group was given Dahuang-Huanglian-Xiexin decoction on the basis of the control group. Both groups were treated with 14 days for one course and 4 courses in total. The number of gram-positive coccus (G+c), gram-negative coccus (G-c), gram-positive bacillus (G+b) and gram-negative bacillus (G-b) in each 500 bacteria were observed under oil microscope, and the cocci/bacillus ratio were calculated. The TC and TG were detected by oxidase method, and HDL and LDL were detected by automatic biochemical analyzer. The FPG, 2 hPG and HbA1c were detected by automatic biochemical analyzer. TCM symptom scores were calculated.@*Results@#After treatment, the abdominal distension, congestion discomfort, and constipation score were significantly lower than the control group (t values were 3.685, 3.551 and 3.708, respectively, all Ps<0.05); Serum TG, TC and LDL-c levels were significantly lower than the control group (t values were 3.602, 3.581 and 3.421, respectively, all Ps<0.05); HDL-c level was significantly higher than that of the control group (t=3.358, P=0.046); Serum FPG, 2 hPG and HbA1c levels were significantly lower than the control group (t values were 3.502, 3.271 and 3.708, respectively, all Ps<0.05). After treatment, the G-c (271.47/500 ± 22.63/500 vs. 266.81/500 ± 22.36/500, t=3.792), G+b (81.26/500 ± 6.52/500 vs. 73.19/500 ± 6.94/500, t=3.511), G-b (183.76/500 ± 16.19/500 vs. 164.37/500 ± 15.83/500, t=3.306) levels in the treatment group significantly higher than those in the control group (P<0.05). After treatment, both c/b levels was (0.65 ± 0.13 vs. 0.87 ± 0.21, t=3.325) decreased significantly (P<0.05).@*Conclusions@#Dahuang-Huanglian-Xiexin decoction combined with conventional western medicine can improve the clinical symptoms of T2DM patients, reduce blood glucose and lipid levels, and inhibit the body mass and improve insulin resistance by adjusting the structure of intestinal flora, increasing probiotics and reducing pathogenic bacteria.
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Objective To evaluate the effect of Yiqi-Jiedu decoction combined with mesalazine sustained release granules for the patients with ulcerative colitis (UC).Methods A total of 93 UC patients who met the inclusion criteria were divided into control group (46 cases) and study group (47 cases) according to the random number table method.The control group was treated with mesalazine sustained release granules orally.The treatment group added Yiqi-Jiedu decoction on the basis of the control group.Both groups were treated for 2 months.The level of plasma thromboxane B2 (TXB2),6-keto-prostaglandin F1α (6-Keto-PGF1α) and serum CRP,IL-1 and TNF-α were measured by ELISA,and the clinical effect was evaluated.Results The total effective rate was 95.7％ (45/47) in the treatment group and 78.3％ (36/46) in the control group.There was significant difference between the two groups (x2=6.323,P=0.012).After treatment,the plasma TXB2 level in the treatment group was significantly lower than that in the control group (601.14 ± 13.31 pg/ml vs.780.33 ± 16.54 pg/ml;t=57.619,P＜0.01),and the plasma 6-Keto-PGFlα level was significantly higher than that in the control group (84.04 ± 1 1.39 pg/ml vs.69.48 ± 10.21 pg/ml;t=6.487,P＜0.01).After treatment,the level of CRP,IL-1 and TNF-α in the treatment group was significantly lower than those in the control group (t=15.457,7.006 and 17.434,respectively,all Ps＜0.01).Conclusions The Yiqi-diedu decoction combined with mesalazine sustained release granules can reduce the level of serum inflammatory cytokines in UC patients,reduce the level of plasma TXB2,and increase the level of plasma 6-Keto-PGF 1 α,so as to improve the clinical effectiveness.
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Objective To evaluate the effect and safety of acupuncture combined with Mingmu-Dihuang pill in patients with dry eyes.Methods A total of 100 patients with dry eye were enrolled in line with the inclusion criteria and divided into experimental group and control group by random figure table.The experimental group was treated with acupuncture combined with Mingmu-Dihuang pill,and the control group was treated with artificial tears.After 2 months of treatment,the Schirmer test (schirmerI,SIT),tear film break up time (BUT),fluorescent staining (FL) and clinical symptom score were observed and compared,and the clinical efficacy and safety were evaluated.Results The total effective rate of the experimental group was 89.0％ (89/100) and the control group was 67.0％ (67/100),and the difference was significant (x2=14.121,P＜0.001).After treatment,the levels of BUT (7.89 ± 1.65 s vs.5.01 ± 1.72 s,t=8.543),SIT (7.45 ± 1.68 mm vs.5.01 ± 1.72 mm,t=5.991) in the experimental group were significantly higher than those of the control group,and the difference is significant (P＜0.01).The FL score and dry eye score in the experimental group were significantly lower than those of the control group (t were 11.551,12.342,P＜0.01).Conclusions Acupuncture combined with Mingmu-Dihuang pill has better clinical effect and good safety for the treatment of dry eye patients.
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Objective To investigate the efficacy of Kinesio taping combined with warm needling on knee osteoarthritis (KOA) and its effect on serum levels of immune globulin(Ig)A, IgG, IgM. Methods Sixty-two KOA patients who met the inclusion criteria were divided into 2 groups by random number table (31 cases in each group). The control group was treated with routine thrapy. Based on the control group, the observation group was treated with Kinesio taping combined with warm needling. After 6 weeks treatment, scores of visual analogue scale (VAS) was used to evaluate knee pain, Japanese orthopaedic association (JOA) scale was used to evaluate knee function, and Lequesne index was used to evaluate disease severity. The score of TCM clinical symptoms was conducted according to the KOA symptom grading quantification table, and the quality of life was evaluated according to the Chinese version of the MOS item short from health survey (SF-36). The Immunoglobulin(Ig)A, IgG and IgM levels were detected by ELISA method. Results The total effective rate in the observation group was 93.5%, and the control group was 71.0% (28/31). The difference was statistically significant between two groups (χ2=5.415, P=0.020).The total effective rate of clinical symptoms in traditional Chinese medicine in the observation groups as 90.3% (28/31) was higher than the control group as 64.5% (20/31), and the difference was statistically significant (χ2=5.905, P=0.015). After treatment, the serum level of IgA (2.91 ± 0.35 ng/ml vs. 4.50 ± 0.50 ng/ml, t=7.621), IgG (11.17 ± 1.31 pmol/L vs. 15.83 ± 1.94 pmol/L, t=13.523), IgM (3.14 ±0.44 pmol/L vs. 5.44 ±0.62 pmol/L, t=8.441) were significantly lower than control group (P<0.01). After 6 weeks’ treatment, tthe scores of VAS, Lequesne index, and clinical symptom of traditional Chinese medicin of the observation group were significant lower than those of the control group (t=7.765 and 9.903 respectively, all Ps<0.01), but the scores of JOA and the SF-36 were significantly higher than those of the control group (t=18.441, P<0.01). After 6 weeks’ treatment, the scores of pain in bed at night, morning stiffness, walking pain, pain from sitting up, maximum walking distance, daily activities, walking up stairs, walking down stairs, bending knee joint score in the observation group were significantly lower than those in the control group (t=8.933, 9.112, 9.225, 8.809, 9.240, 8.910, 7.903, 8.033, 7.031, respectively, all Ps<0.01), but the scores of physical pain, physiological function, physiological function, vitality, social function, emotional function, mental health in the observation group were significantly higher than those in the control group (t=12.450, 13.446, 13.779, 9.003, 13.331, 12.440, 15.309, all Ps<0.01). Conclusions The kinesio taping combined with warm needling can improve symptoms of traditional Chinese medicine and reduce pain of KOAand increase quality of life with the regulation of IgA, IgG, IgM.