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OBJECTIVE@#To compare the effect of acupuncture based on syndrome differentiation and estazolam in the treatment of chronic insomnia and its influence on cognitive function.@*METHODS@#A total of 90 patients with chronic insomnia were randomly divided into an acupuncture group and a medication group, 45 cases in each group. The acupuncture group was treated with acupuncture at Sishencong (EX-HN 1) and bilateral Shenmen (HT 7), Sanyinjiao (SP 6) combined with compatibility of acupoints based on syndrome differentiation, once a day for 6 d and then rest for 1 d, for a total of 4 weeks. The medication group was treated with oral estazolam tablets before bedtime, 1 tablet each time, for a total of 4 weeks. Before and after treatment, the scores of Pittsburgh sleep quality index (PSQI), mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA) and auditory verbal memory test (AVMT) of the two groups were compared, and the effects were evaluated.@*RESULTS@#After treatment, the PSQI sub-item scores and total scores of the two groups were lower than those before treatment ( P<0.05 ), and above scores in the acupuncture group were lower than those in the medication group ( P<0.05 ); the scores of MMSE, MoCA and AVMT in the two groups were higher than those before treatment ( P<0.05 ), and the scores in the acupuncture group were higher than those in the medication group ( P<0.05 ). The total effective rate of the acupuncture group was 80.0% (36/45), which was higher than 53.3% (24/45) in the medication group (P<0.05).@*CONCLUSION@#Syndrome differentiation acupuncture can improve the sleep quality and cognitive function of patients with chronic insomnia, and the curative effect is better than that of estazolam.
Subject(s)
Humans , Sleep Initiation and Maintenance Disorders/therapy , Estazolam , Acupuncture Therapy , Cognition , Acupuncture Points , SyndromeABSTRACT
Objective:To investigate the efficacy and safety of internet-based cognitive behavioral therapy for insomnia(iCBT-I) combined with estazolam for patients with chronic insomnia.Methods:Patients with chronic insomnia were randomly assigned to treatment group which were intervened with iCBFI combined with estazolam( n=46) and control group which were intervened with estazolam ( n=43) for 8 weeks according to random number table.Pittsburgh sleep quality index (PSQI) and state-trait anxiety inventory (STAI) were used to measure the anxious state, anxious trait and sleep quality at three time points: before intervention(T1), after one month(T2) and two months(T3). Treatment emergent symptom scale (TESS), blood routine, urine routine, liver and renal function and electrocardiogram were used to measure the safety.The dosage of estazolam was compared between the two groups after two months.χ 2 test and repeated measurement analysis of variance were performed by SPSS 19.0. Results:The PSQI scores of control group and treatment group were (10.41±2.48) vs (9.98±2.96) at T2 and (9.97±2.13) vs (7.82±1.57) at T3.The state anxiety scores of control group and treatment group were (57.27±2.74) vs (56.27±2.89) at T2 and (45.67±2.62) vs (42.67±2.97) at T3.The data of T2 and T3 were statistically significant compared with those before intervention(all P<0.05). Compared with the control group, the treatment group was better on treatment efficiency(86.96% vs 69.77%) at T3( P<0.05). PSQI score, subjective sleep quality, sleep efficiency, sleep disorders, sleep drugs, daytime dysfunction, drug maintenance and adverse reaction were significantly different between the two groups at T3 ( P<0.05). Conclusions:Internet-based cognitive behavioral therapy combined estazolam for insomnia can improve sleep quality, anxious state and trait for chronic insomnia patients.Good safety was improved, as well as reducing the need of drug.So it's worthy of clinic application.
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Objective To investigate the maximum allowable deviation of ion abundance ratios of characteristic fragment ions in common drugs （poisons） in blood by gas chromatography-mass spectrometry （GC-MS） method. Methods Four common drugs （poisons） （dichlorvos, phorate, diazepam and estazolam） were detected by GC-MS full scan mode after liquid-liquid extraction in two laboratories and under three chromatographic conditions. The deviations of ion abundance ratios of the four common drugs （poisons） in marked blood samples with concentrations of 0.5, 1.0, 2.0, 5.0 and 10.0 μg/mL were analyzed. At the same time, the false negative rates of ion abundance ratios were analyzed when the mass concentration was limit of detection （LOD）, 2LOD, limit of quantitation （LOQ） and 2LOQ, and the false positive rates of ion abundance ratios were analyzed with blank blood samples. Results Under the two laboratories, four common drugs （poisons） and three kinds of chromatography conditions, the differences in deviations of the ion abundance ratios of marked blood samples were not statistically significant （P>0.05）. More than 95% of the absolute deviations of the ion abundance ratios of the marked blood samples were within the range of ±10%, and more than 95% of the relative deviations were within the range of ±25%. In cases of low concentration （concentration less than 2LOQ） or low signal to noise ratio （3-15）, the false negative rate was less than 5% and the false positive rate was 0% when the relative deviation was greater than 50%. Conclusion The absolute deviations of ion abundance ratios of four common drugs （poisons） in marked blood samples are advised to have a determination range within ±10%, and the determination range of relative deviations within ±25%.
Subject(s)
Humans , Gas Chromatography-Mass Spectrometry , Ions/chemistry , Limit of Detection , Liquid-Liquid Extraction , Poisons/bloodABSTRACT
OBJECTIVE: To observe the clinical effect of "Yinqi Guiyuan" needling in the treatment of primary insomnia. METHODS: A total of 79 primary insomnia outpatients were randomly divided into treatment group (n=40) and control group (n=39). The patients in the control group were given oral Estazolam tablets once a day, for successive 4 weeks. For patients of the treatment group, Zhongwan (CV12), Xiawan (CV10), Qihai (CV6), Guanyuan (CV4), Baihui (GV20), etc., were punctured with filiform needles for 30 min. The treatment was conducted three times per week for 4 successive weeks. The sleep quality (sleeping quality, falling asleep time, sleep duration, sleep efficiency, sleep disorders, hypnotic and daytime dysfunction, 0 to 21 points) was evaluated by using Pittsburgh Sleep Quality Index (PSQI). The severity of insomnia (self-perception, sleep satisfaction, daytime function damage, sensibility change, and concern for sleep problems, 0 to 28 points) was assessed using insomnia severity index (ISI) score. The therapeutic effect was evaluated according to the PSQI score reduction rate = (pre-treatment PSQI score-post-treatment PSQI score)/pre-treatment PSQI score ×100%. RESULTS: After treatment, the total score of PSQI, ISI and the score of each item were all significantly reduced in the two groups relevant to their own pre-treatment (P0.05). CONCLUSION: "Yinqi Guiyuan" needling and Estazolam are comparable in treatment primary insomnia, and the former is superior to the latter in avoiding hypnotic drug use and in improving daytime function.
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OBJECTIVE@#To observe the differences in the sleep quality and the effects on insomnia severity between 's three-promotion needling method and the oral administration of estazolam.@*METHODS@#A total of 70 patients of subacute insomnia were randomized into a three-promotion needling group and a medication group, 35 cases in each one. In the three-promotion needling group, the mild promotion technique with the filiform needle, the warm promotion technique with the fire needle and the strong promotion technique with the three-edged needle were adopted in combination. The acupuncture with the filiform needle was used at Baihui (GV 20), Sishencong (EX-HN1), Shenting (GV 24), Shenmen (HT 7), etc, The treatment was given 3 times a week, once every 2 days. The pricking technique with fire needle was applied to Ganshu (BL 18), Xinshu (BL 15), Feishu (BL 13), Pishu (BL 20), Shenshu (BL 23) and Geshu (BL 17), once every 3 days, twice a week. The bleeding technique with the three-edged needle was used at the ear apex, once every 2 days, 3 times a week. In the medication group, the estazolam tablets were taken orally before sleep, 1mg once every 2 days. The treatment was given consecutively for 4 weeks in the two groups. Separately, before treatment, in 2-week treatment and in 4-week treatment as well as in 1-month follow-up after treatment, the Pittsburgh sleep quality index (PSQI) and the insomnia severity index (ISI) scores were recorded in the patients of the two groups. The clinical effects were evaluated in the two groups.@*RESULTS@#In 2 weeks and 4 weeks of treatment, as well as in the follow-up, PSQI scores and ISI scores were all reduced obviously as compared with those before treatment in the two groups (all <0.05). In the three-promotion needling group, the PSQI score at each time point was reduced much more obviously as compared with the medication group (all <0.05). In the follow-up, the ISI score in the three-promotion needling group was lower than the medication group (<0.05). The total effective rates were 97.2% (34/35) and 91.4% (32/35) at the end of treatment and in the follow-up respectively in the three-promotion needling group, higher than 85.7% (30/35) and 71.4% (25/35) in the medication group (both <0.05).@*CONCLUSION@#'s three-promotion needling method much more effectively improves the sleep quality and reduces insomnia severity in the patients of subacute insomnia. This therapy presents the satisfactory short-term and long-term effects.
Subject(s)
Humans , Acupuncture Points , Acupuncture Therapy , Estazolam , Sleep Initiation and Maintenance Disorders , Therapeutics , Treatment OutcomeABSTRACT
Objective To investigate the maximum allowable deviation of retention time (RT) or relative retention time (RRT) between the common poisons (drugs) and standard solvent by gas chromatography-mass spectrometry (GC-MS).Methods After pretreatment with liquid-liquid extraction, four common poisons (drugs) —dichlorvos, phorate, diazepam and estazolam—were detected by full scan mode GC-MS.RT and RRT were analyzed according to combined uncertainty and expanded uncertainty. Results The expanded uncertainty of RT and RRT were 6.0× lO-4-14.1×l0-3 and 2.5 ×l0-6-5.9× lO-5 (k=3), respectively.The RT of poisons (drugs) was relatively stable in blood samples with different mass concentrations.Among dichlorvos, phorate, diazepam and estazolam, the absolute deviation and relative deviation of RT were≤0.03 min and≤0.4％, respectively, and those of RRT were≤0.003 min and≤0.3％, respectively.Conclusion The maximum allowable deviations of RT and RRT for common poisons (drugs) in blood samples are recommended to be±0.05 min and±0.5％.
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<p><b>OBJECTIVE</b>To compare the clinical efficacy differences between "governor vessel method of acupuncture" combined with estazolam and estazolam alone for insomnia.</p><p><b>METHODS</b>Seventy patients of insomnia were randomly divided into an observation group and a control group, 35 cases in each one. The patients in the control group were treated with oral administration of estazolam, 2 mg each time; the estazolam was taken 30 min before sleeping. The patients in the observation group were treated with "governor vessel method of acupuncture" combined with estazolam; the positive reaction points along governor vessel and Baihui (GV 20) were selected as the main points. The acupuncture was given for 30 min per treatment, once every two days. Both groups were treated for four weeks. Pittsburgh sleep quality index (PSQI) and polysomnography (PSG) were observed before and after treatment. Clinical efficacy was assessed between the two groups and adverse reactions were recorded.</p><p><b>RESULTS</b>The total effective rate was 94.3% (33/35) in the observation group, which had no significant difference with 82.9% (29/35) in the control group (>0.05). The cured and markedly effective rate was 71.4% (25/35) in the observation group, which was superior to 42.9% (15/35) in the control group (<0.05). Each item score and total score of PSQI were decreased obviously after treatment in the observation group (all <0.05), while the score of sleep latency, sleep duration and sleep efficiency as well as total score of PSQI were decreased obviously after treatment in the control group (all <0.05). The scores of sleep duration, sleep disturbance and day dysfunction due to sleepiness as well as total score of PSQI in the observation group were lower than that in the control group (all <0.05). After treatment, the PSG-related parameters of total sleeping duration, sleeping latency, sleeping arousal and sleeping efficiency were improved significantly in the observation group (all <0.05); the total sleeping duration, sleeping arousal and sleeping efficiency were also improved in the control group (all <0.05). The total sleeping duration, sleeping latency, sleeping arousal and sleeping efficiency in the observation group were superior to those in the control group (all <0.05). 4 adverse reactions in the observation group and 3 adverse reactions in the control group were observed.</p><p><b>CONCLUSION</b>"Governor vessel method of acupuncture" combined with estazolam could significantly improve insomnia, which are superior to estazolam alone.</p>
Subject(s)
Humans , Acupuncture Therapy , Combined Modality Therapy , Estazolam , Therapeutic Uses , Sleep , Sleep Initiation and Maintenance Disorders , Therapeutics , Treatment OutcomeABSTRACT
<p><b>OBJECTIVE</b>To compare the effect differences between auricular intradermal needling combined with erjian (HX) bloodletting and oral administration of western medicine, and to explore the efficacy of neuroendocrine level in patients with perimenopausal insomnia.</p><p><b>METHODS</b>Ninety patients were randomized into an observation group and a control group, 45 cases in each one. In the observation group, auricular intradermal needling combined with erjian (HX) bloodletting were adopted alternately in the two ears. The auricular points were shen (CO), xin (CO), gan (CO), shenmen (TF), jiaogan (AH), neifenmi (CO) and erjian (HX). The treatment was required once 3 days on the auricular points of one side alternatively. Oral administration of estazolam (1mg each day) was applied in the control group for 2 courses, 4 weeks as 1 course, once a day. The scores of Pittsburgh sleep quality index (PSQI), the levels of serum estrogen (E), 5-hydroxy tryptamine (5-HT) and norepinephrine (NE) were valuated in the two groups before and after treatment.</p><p><b>RESULTS</b>After treatment, the total scores of PSQI reduced in the two groups (both <0.05), and the improvements of sleeping quality, sleeping time, sleeping difficulty, daytime dysfunction and the total PSQI score in the observation group were superior to those in the control group (all <0.05). There was no significant difference in serum E before and after treatment in the two groups，and between the two groups after treatment (all >0.05). After treatment, 5-HT contents increased and NE levels decreased in the two groups (all <0.05), with better results in the observation group (both <0.05). The total effective rate was 95.6% (43/45) in the observation group, which was higher than 82.2% (37/45) in the control group (<0.05).</p><p><b>CONCLUSION</b>Auricular intradermal needling combined with erjian (HX) bloodletting can improve the sleep quality of patients with perimenopausal insomnia, and adjust the neurotransmitter level, which achieves better effect than western medication.</p>
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OBJECTIVE:To observe the effectiveness and safety of Jin's three-needle combined with Jiawei wumei pill in the treatment of menopausal insomnia.METHODS:One hundred and sixty-five patients with perimenopausal insomnia were selected from our hospital during Jan.2015-Mar.2016,and then divided into group A (n=41),group B (n=41),group C (n=41) and group D (n=42) according to random number table.Group A was given Estazolam tablet 1 mg,qd;group B was given Jin's three-needle 30 min/time,qd;group C was given Jiawei wumei pill,one pill,after breakfast and supper warm taking;group D was given Jin's three-needle combined with Jiawei wumei pill with same usage as group C.Four groups were treated for 4 weeks.PSQI score,modified Kupperman score,life quality score,serum levels of E2 and FSH were observed in 4 groups before and after treatment,and the occurrence of ADR was recorded.RESULTS:Before treatment,there was no statistical significance in above score (P＞0.05).After treatment,PSQI score and modified Kupperman score of 4 groups were decreased significantly,compared to before treatment;the group B,C,D were significantly lower than the group A;the group D was significantly lower the group B,C,with statistical significance (P＜0.05).The life quality score of 4 groups were increased significantly,and the group B,C,D were significantly higher than the group A;the group D was significantly higher than the group B,C,with statistical signifi cance (P＜0.05).E2 level of group B,C,D were significantly increased,while FSH level was decreased significantly,the improvement of group D was significantly better than group B,C;the improvement of group D was significantly better than that of group B,C,with statistical significance (P＜0.05).The incidence of ADR in group A was significantly higher than group B,C,D,with statistical significance (P＜0.01),and there was no statistical significance in the incidence of ADR among group B,C,D,with statistical significance (P＞0.05).CONCLUSIONS:Jin's three needle combined with Jiawei wumei pill is effective in the treatment of perimenopausal insomnia with good safety.
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Objective:To prepare the self-microemulsifying drug delivery system (SMEDDS) and relevant tablets of atorvastatin calcium and ezetimibe(Ato-Eze),and investigate the in vitro release of Ato-Eze SMEDDS tablets. Methods:The solubility and excip-ient compatibility of Ato and Eze in different excipients were investigated. The pseudo-ternary phase diagram composed of different oil phase,emulsifier and co-emulsifier was used to obtain the self-emulsifying area. The morphology,particle size distribution and zeta po-tential of microemulsion were determined by a dilution method. The optimal formula of Ato-Eze SMEDDS was prepared into tablets. The drug release profiles of the commercial formula,Ato-Eze SMEDDS and Ato-Eze SMEDDS tablets were compared. Results:The op-timal formula was as follows:propylene glycol monocaprylate as the oil phase,Solutol HS 15 as the surfactant and polyethylene glycol 600 as the co-surfactant with the best ratio of 5 :3.75:1.25. Ato-Eze SMEDDS was a clear and transparent microemulsion solution with homogeneous small spheres as seen under a transmission electron microscope. The particle size and zeta potential of Ato-Eze SMEDDS was(44.2 ± 19.5) nm and( -24.1 ± 1.3) mV,respectively. The in vitro release profile indicated that the accumulated re-lease of Ato-Eze SNEDDS and the tablets reached up to nearly 100% in 45 min. Conclusion: Ato-Eze SMEDDS tablets can signifi-cantly improve the in vitro dissolution rates of the two drugs,and the preparation process is simple and feasible.
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Objective To observe the clinical effects of Chuanxiongqingnaokeli for treatment of insomnia.Methods Eighty-two cases of insomnia patients were randomly divided into treatment group (n =42)and control group (n=40) who were treated in the First Affiliated Hospital of Henan University of Traditional Chinese Medicine from January 2012 to July 2013.The treatment group was administrated Chuanxiongqingnaokeli combined with estazolam tablets while control group was administrated estazolam tablets alone.The indicators including sleep time,easy to waking,sleep time,Pittsburgh sleep quality index and hangover on next day were observed before and after treatment.Results The Pittsburgh sleep quality index of both groups were significantly lower after treatment (treatment group:14.92± 2.89 vs.3.35 ± 1.72,t =2.421,P＜0.05;control group:15.20±3.02 vs.5.81±2.31 score,t=2.537,P＜0.05).And the treatment effect of treatment group was better than control group(t =4.478,P＜0.05).Easy to waking time of the treatment group was (1.49± 1.42) times,sleeping time was (5.78± 1.23) h,hangover on next day was 0,all these data were better than that of control group(2.54±1.56) times,(4.09±1.52) h,37.5％;P＜0.05).The total effective rate of treatment group was 90.5％ (38/42),significantly higher than that of control group (72.5％ (29/40);x2 =61.42,P ＜0.05).Conclusion The chuanxiongqingnaokeli has the significant effects for patients with insomnia.It has more improved in easy to waking and maintaining sleep time significantly which accompanied with advantage of relieving hangover on next day induced by sedative hypnotics at the same time.
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OBJECTIVE: To establish an HPLC-DAD method for the detection of midazolam, phenobarbital, estazolam, oxazepam, nitrazepam, alprazolam, clonazepam and diazepam illegally adulterated into traditional Chinese medicines and health foods. METHODS: An Alltima C18 column (4.6 mm × 250 mm, 5 μm) was used for the separation with 10 mmol · L-1 ammonium dihydro-gen phosphate (adjusted pH to 2.7 with H3PO4) - acetonitrile (65:35) or 10 mmol · L-1 ammonium dihydrogen phosphate (adjusted pH to 2.7 with H3PO4) - methanol (40:60) as the mobile phase at the flow rate of 0.5 mL · min-1. The detection wavelength was 220 nm. RESULTS: The method showed good linearity and sensitivity for the 8 compounds with all correlation coefficients (r) greater than 0.9997 and all LODs between 4.3 - 13.0 ng · mL-1; the spiked recoveries of low, middle and high levels ranged from 98.08% to 102.1%; the precisions were satisfactory with all RSDs lower than 1.58%; the stability within 12 h was acceptable with the RSDs of peak areas and retention times no more than 1.05% and 0.54%. In the test of 19 samples of different dosage forms, nitrazepam was found in two health foods. CONCLUSION: This method is fast, sensitive and propagable for the detection of 8 sedative hypnotics illegally adulterated into traditional Chinese medicines and health foods. Copyright 2012 by the Chinese Pharmaceutical Association.
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OBJECTIVE:To establish HPLC method for simultaneous determination of estazolam and diazepam in serum METHODS:The mobile phase consisted of methanol-water-triethylamine-acetic acid(55∶45∶0 5∶0 35)and the ?max was 254nm Phenytoin was adopted as the internal standard The drugs were extracted by diethyl ether under the alkaline condition RESULTS:The calibrating curves of estazolam and diazepam were linear in the ranges of 0 52～38 62?g/ml and 0 50～40 16?g/ml respectively CONCLUSION:The method was appropriate for determination of estazolam and diazepam qualitatively and quantitatively in intoxication accident