Preparation and <i>in Vitro</i>Drug Release Evaluation of Once-Daily Metformin Hydrochloride Sustained-Release Tablets

The objective of this study was to develop once-daily metformin hydrochloride sustained-release tablets (MHSRT) and evaluate their in vitro release behavior. MHSRT were prepared by the film coating method. The in vitro drug release rate of MHSRT and the commercial tablets Fortamet? made in the United States of America in water was fitted with zero order kinetic equation, and Ritger-Peppas kinetic equation in 0.1 M HCl and pH 6.8-phosphate buffer, respectively. The similarity factor f2 values of MHSRT in three different dissolution medium were 82, 80 and 74, respectively in comparison with imported Fortamet?, which were all greater than 50. The results of storage-stability showed that MHSRT were stable for at least 6 months under stress condition (40℃ ± 2℃, RH 75% ± 5%). Therefore, in this study, MHSRT were successfully prepared using optimized formulation technologies that meet mass produce. The in vitro release behavior of MHSRT was almost similar to that of imported Fortamet?.

Pharmacokinetics of nifedipine sustained-release tablets in healthy Chinese volunteers

Aim To establish a LC-MS method for determining the concentration of nifedipine in human plasma and to evaluate the pharmacokinetic characteristics of nifedipine sustained-release tablets. Methods A XB-C18 （5 μm, 4.6 mm ×150 mm） column and a mobile phase of methanol： 0.01 mol·L^-1ammonium acetate （60：40, V/V） were used to separate nifedipine, the detections was accuracy under atmosperic pressure electronic spray ionization （AP-ESI） mode and ion mass spectrum （m/z） of 314.9 [M＋H]^＋ for nifedipine, and 320.8 [M＋H]^＋ for lorazepam （Internal Standard, IS）. Results The linear range of nifedipine was 0.3 - 80 ng·mL^-1 （ r = 0.9997）, and the limit of quantitation （LOQ） was 0.3 ng·mL^-1. The nifedipine pharmacokinetic parameters after a single dose of 20 mg nifedipine sustained-release tablets test （T） or reference （R） were as the followings, t1/2 （6.73 ± 2.00） h and （7.04 ± 2.18） h, Tmax （4.28 ± 0.70） h and （4.48 ± 0.70） h, Cmax（39.66 ± 10.58） ng·mL^-1 and （40.19 ± 10.97） ng·mL^-1, AUC0-36 （391.63 ± 108.55） ng·mL^-1·h and （387.57 ± 121.51） ng·mL^-1·h, and AUC0-∞ （408.28 ± 121.16） ng·mL^-1·h and （406.15 ± 133.13） ng·mL^-1·h. The relative bioavailability of nifedipine sustained-release tablets （test） was （103.02 ± 13.93） %. Conclusion LC-MS method for the determination of concentrations of nifedipine in human plasma was sensitive and accurate, and could be used in nifedipine bioavailability and pharmacokinetic studies.

Pharmacokinetic Study on Lovastatin Sustained-release Tablet and Sustained-release Capsule in Begal Dogs

This study pharmacokinetically examined the lovastatin sustained-release tablet and sustained-release capsule in Beagle dogs. An reversed-phase HPLC method was established for the determination of lovastatin in Beagle dog plasma. Pharmacokinetic findings were compared among three preparation(lovastatin sustained-release tablet,T p; sustained-release capsule,T J and conventional capsule). Our results showed that the pharmacokinetic parameters in 6 dogs after single-dose oral administration of three perparations were calculated. T max, C max and MRT revealed significant difference (P<0.05). Relative bioavailability was 111.5±16.9 % (T P) and 110.4%±9.6 % (T J). The pharmacokinetic parameters in the 6 dogs after multiple-dose oral administration of three perparations, T max, C max MRT and DF had significant difference (P<0.05); C av , C min and AUC 0-24 h displayed no significant difference (P>0.05). It is concluded that the lovastatin sustained-release tablet and sustained-release capsule are able to maintain a sustained-release for 24 h.

Preparation and evaluation of sustained-release azithromycin tablets in vitro and in vivo

The objective of this study was to prepare azithromycin(AZI)sustained-release products in order to allow for a high dose to be administered,reduce gastrointestinal side-effects and increase the compliance of patients.AZI sustained-release tablets with different release performance(F-I:T_(100%)=3 h and F-II:T_(100%)=8 h in pH 6.0 phosphate buffer)were successfully prepared by wet granulation.The in vitro release rate and drug release mechanism were studied.The release rate of F-Iwas affected by dissolutionmedia with different pH,but not for F-II.HixsoneCrowellmodel was the best regression fitting model for F-I and F-II.Additionally,F-I and F-II both belonged to non-Fick diffusion.Oral pharmacokinetics of the two tablets and one AZI dispersible tablet as reference were studied in six healthy beagle dogs after oral administration.Compared with the reference,the C_(max) of F-I and F-II were decreased,and the T_(max) were prolonged,in that case which meet the requirement of sustained-release tablets.The relative bioavailability of F-I and F-II were 79.12%and 64.09%.T-test ofAUC_(0-144),and AUC_(0-∞) for F-I and F-II indicated there was no significant difference between F-I and F-II.These mean that the extended release rate did not induce different pharmacokinetics in vivo.

Clinical observation of Baitou Weng Decoction combined with mesalazine sustained-release tablets in treating heat-toxic and smoldering ulcerative colitis

Objective:To observe the clinical efficacy of Baitou Weng Decoction combined with mesalazine sustained-release tablets in the treatment of ulcerative colitis with febrile heat and its effect on immune function and serum inflammatory factors.Methods: A total of 84 patients with ulcerative colitis were randomly divided into control group and treatment group, with 42 cases in each group. The control group was given mesalazine sustained-release tablets orally, while the treatment group was given Baitou Weng Decoction and mesalazine sustained-release tablets orally. The treatment period was 30 days and the patients were followed up for 3 months. After treatment, the clinical efficacy, quality of life, immune function and serum inflammatory factors of the two groups were observed.Results: The effective rate of treatment group (90.47%) was higher than that of control group (73.81%) (P<0.05);compared with before treatment, the scores of inflammatory bowel disease quality of life questionnaire scale in both groups were significantly improved (P<0.05), and the difference between the two groups was significant (P<0.05);after treatment, the plasma CD4+/CD8+ ratio and NK+ levels in both groups were significantly higher than those before treatment (P<0.05), and the treatment group was changed. The serum levels of tumor necrosis factor-α, interleukin-17 and interleukin-23 were significantly decreased in both groups after treatment (P<0.05), and the improvement was more significant in the treatment group (P<0.05). No significant adverse reactions were observed in the treatment group.Conclusions: Modified Baitou Weng Decoction combined with mesalazine in the treatment of heat-toxic and incandescent ulcerative colitis can significantly improve the clinical efficacy, improve the quality of life of patients, effectively regulate the expression level of serum inflammatory factors in ulcerative colitis patients, promote the recovery of patients' immune function, and have high drug safety.

Clinical observation on treatment of cancer pain with TCM oriented drugs combined with oxycodone sustained-release tablets and nimesulide sustained-release tablets

Objective： To study the effect of the transdermal preparation of traditional Chinese medicine in treating cancer pain. Methods： From October 2016 to January 2018, 126 patients with cancer pain were enrolled and divided into 4 groups, 39 patients in group A （directed TCM permeation）, 26 patients in group B （oxycodone sustained-release tablets）, 32 patients in group C （Chinese medicine directed drug penetration ＋ oxycodone sustained-release tablets）, and 29 patients group D （Chinese medicine directed drug penetration ＋ oxycodone sustained-release tablets ＋ nimesulide sustained release tablets）, according to KPS scores. Results： Transdermal preparations of traditional Chinese medicine can significantly alleviate cancer pain. For the treatment of moderate to severe cancer pain, the Chinese medicine transdermal preparation can reduce the dosage of oxycodone sustained-release tablets. At the same time, the patient＇s KPS and NRS scores were significantly reduced. Moreover, the transdermal preparation of traditional Chinese medicine has a better therapeutic effect on visceral pain. Conclusion： The traditional Chinese medicine tra_nsdermal preparation combined with western medicine for the treatment of cancer pain may be a new method for the treatment of cancer pain.

Compound Metformin/Glipizide Bilayer Extended Release Tablets: Development and in Vitro Release

Aim In this study, compound metformin/glipizide bilayer extended release tablets were formulated with hydroxypropyl methylcellulose （HPMC） by wet granulation technique in order to tackle the problems associated with the muhidrug therapy of non-insulin dependent diabetes mellitus. Me^ls High-dose metformin is difficult to formulate into a tablet dosage form due to its poor compressibility and compactibility. In this study, the way to overcome the difficulty was to utilize stearic alcohol to prepare the tablet formulation. The influences of viscosity, amount of HPMC, and weight of fillers were investigated. The optimal formulation had acceptable physicochemical properties and released metformin and glipizide over 10 h. Results The data of metformin obtained from in vitro release fitted Higuchi kinetics best, while the release of glipizide in vitro was found to follow zero kinetics. Conclusion Compound metformin/glipizide bilayer extended release tablets have been successfully developed.

Continuous melt granulation to develop high drug loaded sustained release tablet of Metformin HCl

The present work explores the application of melt granulation technology to develop a high drug loaded sustained release matrix tablet of Metformin HCl using hydroxypropylcellulose(HPC) as a hydrophilic binder and stearic acid as an extrusion aid for producing cohesive granules. This novel approach allowed the use of a minimum number of excipients to reduce the tablet size, and to enhance compressibility of the drug. This also offered a cost effective method owing to the elimination of a ‘drying step’ prevalent in wet granulation method.Moreover, this research also focuses on resolving the processability issues associated with the use of HPC Nisso-H at high drug loading. The thermal lubricants were screened for this purpose and evaluated for their impact on extrudability, granule and tablet characteristics. Stearic acid was selected as the thermal lubricant, which not only contributed to the inhibition of burst release, but also improved the flow property of the granules.The developed matrix tablet(75% drug loading) resulted in 670 mg of weight for 500 mg dose strength and showed sustained drug release over 10 h. When compared, with conventional granulation techniques, it was observed that, under identical compression force, the tablet prepared by MG exhibited superior compactibility along with tablet hardness and optimal drug release profile. FTIR suggested nonexistence of chemical interaction between the drug and the other excipients while XRD and DSC analysis revealed the crystalline state of the drug.Furthermore, the results obtained from Raman spectroscopy proved the uniform distribution of the Metformin HCl and polymer in the final dosage form. This technology leads to the manufacture of sustained release matrix formulation with reduced tablet size of a high dose,highly water soluble drug otherwise difficult to process using standard batch-granulation.

细化生活方式联合屈螺酮炔雌醇片(Ⅱ)、二甲双胍治疗多囊卵巢综合征合并高胆固醇血症不孕症患者的临床效果及对Betatrophin水平的影响

目的探讨细化生活方式联合屈螺酮炔雌醇片(Ⅱ)、二甲双胍治疗多囊卵巢综合征(PCOS)合并高胆固醇血症不孕症患者的临床效果及对Betatrophin水平的影响。方法选择2021年1月至8月在河北省承德市中心医院生殖医学科确诊的30例PCOS合并高胆固醇血症不孕症患者,根据不同治疗方案分为A组和B组,各15例。A组给予平衡膳食、运动管理联合屈螺酮炔雌醇片(Ⅱ)和二甲双胍治疗,B组给予屈螺酮炔雌醇片(Ⅱ)和二甲双胍治疗。比较两组的体重指数、总胆固醇、性激素及血清Betatrophin水平、排卵和妊娠情况。结果治疗后A组体重指数、总胆固醇、黄体生成素、雄烯二酮、Betatrophin水平低于B组(P<0.05);两组排卵、临床妊娠率比较,差异无统计学意义(P>0.05)。结论细化生活方式联合屈螺酮炔雌醇片(Ⅱ)、二甲双胍治疗PCOS合并高胆固醇血症不孕症患者,可有效改善脂代谢紊乱,降低黄体生成素、雄烯二酮、血清Betatrophin水平。

Development of Prolonged Release Microspheres of Metformin Hydrochloride Using Ion Exchange Resins

Aim To prepare the prolonged-released microspheres of mefformin hydrochloride. Methods Ion-exchange resin-drug mefformin hydrochloride complexes were prepared as core materials, and followed by coating using ethylcellulose （EC） by the emulsion solvent diffusion technique. The release rate of mefformin from the microcapsules was highly dependent on the encapsulating formulation, thus being used as an index for formulation screening. Orthogonal experiments were performed to optimize the coating formulation. Results The final chosen formulation for coating of mefformin microcapsules were as follows： （ 1 ） the ratio of EC （20cps） to EC （45cps） was 50：50; （2） the ratio of plasticizer to coating materials was 20% ;and （3） the ratio of resin-mefformin complexes to coating materials was 5 ： 1. Conclusion The prolonged release microspheres of mefformin hydrochloride were successfully prepared.

二甲双胍恩格列净片治疗2型糖尿病合并HFpEF的临床效果

目的:探讨二甲双胍恩格列净片治疗2型糖尿病(T2DM)合并射血分数保留性心力衰竭(HFpEF)患者的临床效果和安全性。方法:选取2021年10月—2022年9月保定市第一中心医院80例T2DM合并HFpEF患者,通过随机数字表法将其分为观察组(n=40)和对照组(n=40)。对照组给予常规药物治疗,观察组在对照组的用药基础上联合二甲双胍恩格列净片治疗。两组均接受为期6个月的连续治疗。对比两组血糖指标、心功能指标及不良反应发生情况。结果:治疗后,两组空腹血糖(FBG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1c)均较治疗前下降,且观察组均低于对照组(P<0.05)。治疗后,两组左室射血分数(LVEF)、左室舒张末径(LVEDD)、左室收缩末径(LVESD)、脑钠肽(BNP)均优于治疗前,且观察组均优于对照组(P<0.05)。观察组不良反应发生率(5.0%)低于对照组(22.5%),差异有统计学意义(P<0.05)。结论:二甲双胍恩格列净片治疗2型糖尿病合并HFpEF临床效果显著,能够使患者的血糖水平下降并提高心功能相关指标,同时安全性较高。

二甲双胍联合来曲唑片对PCOS患者的影响

目的:观察二甲双胍联合来曲唑片对多囊卵巢综合征(polycystic ovary syndrome,PCOS)患者的影响。方法:选取2022年1月—2023年12月苏州大学附属第一医院收治的100例PCOS患者作为研究对象。根据随机数表法将其分为来曲唑组与联合组,各50例。来曲唑组给予来曲唑片,联合组在来曲唑组基础上给予盐酸二甲双胍片。比较两组治疗后临床疗效,治疗前后相关指标、性激素指标。结果:治疗后,联合组治疗总有效率高于来曲唑组,差异有统计学意义(P<0.05)。治疗后,两组子宫内膜厚度增加,两侧卵巢体积缩小,联合组子宫内膜厚度高于来曲唑组,两侧卵巢体积小于来曲唑组,差异有统计学意义(P<0.05)。治疗后,两组睾酮(testosterone,T)、抗米勒管激素(anti-Müllerian hormone,AMH)、硫酸脱氢表雄酮(dehydroepiandrosterone sulfate,DHEA-S)水平均降低,联合组T、AMH、DHEA-S水平均低于来曲唑组,差异有统计学意义(P<0.05)。结论:二甲双胍联合来曲唑片治疗能够降低PCOS患者的血清T、AMH、DHEA-S水平,改善卵巢体积及子宫内膜厚度,提高治疗效果。

二甲双胍联合炔雌醇环丙孕酮片治疗青春期月经失调及多囊卵巢综合征的效果及对TC水平的影响

目的探究二甲双胍与炔雌醇环丙孕酮片综合疗法在优化青春期月经失调及多囊卵巢综合征患者总胆固醇(Total Cholesterol,TC)水平方面产生的积极作用。方法选取2021年7月—2023年6月山东省滕州市妇幼保健院青春期保健科收治的72例青春期月经失调及多囊卵巢综合征患者为研究对象,以奇偶数法分为两组,其中的奇数编号患者纳入对照组(n=36,实施炔雌醇环丙孕酮片单一疗法),偶数编号患者纳入观察组(n=36,实施二甲双胍片与炔雌醇环丙孕酮片综合疗法),比较两组的治疗情况。结果治疗后,观察组胰岛素、血脂以及性激素相关指标优于对照组,差异有统计学意义(P均<0.05)。观察组的不良反应总发生率为5.56%,低于对照组的22.22%,差异有统计学意义(χ^(2)=4.181,P<0.05)。结论青春期月经失调及多囊卵巢综合征患者接受二甲双胍与炔雌醇环丙孕酮片综合疗法的治疗后,可大幅度优化机体的TC水平,异常的胰岛素及性激素水平得以明显恢复,且治疗后不良反应少,安全性佳,临床效果显著。

炔雌醇环丙孕酮片联合二甲双胍治疗多囊卵巢综合征伴胰岛素抵抗的疗效研究

目的 分析炔雌醇环丙孕酮片联合二甲双胍治疗多囊卵巢综合征伴胰岛素抵抗的疗效。方法 84例多囊卵巢综合征伴胰岛素抵抗患者,根据随机数字表法分为对照组与观察组,每组42例。对照组患者给予炔雌醇环丙孕酮片治疗,观察组患者在对照组基础上增加二甲双胍治疗。比较两组患者治疗前后性激素指标(雌二醇、黄体生成素、促卵泡生成素)以及胰岛素抵抗指数,临床疗效,不良反应发生情况。结果 治疗前,两组雌二醇、黄体生成素、促卵泡生成素、胰岛素抵抗指数比较,差异无统计学意义(P>0.05)。治疗后,观察组雌二醇(51.56±3.21)pg/ml、黄体生成素(8.19±0.43)mIU/ml、促卵泡生成素(4.56±0.24)mIU/ml以及胰岛素抵抗指数(1.56±0.12)显著低于对照组的(71.72±4.51)pg/ml、(10.21±1.43)mIU/ml、(6.67±0.57)mIU/ml、(2.67±0.34),差异有统计学意义(P<0.05)。观察组治疗总有效率95.2%高于对照组的76.2%,差异有统计学意义(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论 炔雌醇环丙孕酮片联合二甲双胍对于多囊卵巢综合征伴胰岛素抵抗的治疗效果确切,可改善性激素水平,缓解胰岛素抵抗,且安全性高,值得推广。

2型糖尿病患者采用达格列净片联合盐酸二甲双胍缓释片治疗的临床效果

目的探索2型糖尿病行达格列净片+盐酸二甲双胍缓释片治疗的优势。方法选取大田县中医院于2021年1月—2023年12月收治的139例2型糖尿病患者为研究对象,按照随机抽签方式将患者分为两组,对照组69例,给予盐酸二甲双胍缓释片治疗,观察组70例,开展达格列净片+盐酸二甲双胍缓释片治疗,比较两组临床治疗效果、血糖指标、血脂指标、体质指数、同型半胱氨酸、胰岛功能和不良反应。结果观察组总有效率(97.14%)高于对照组(88.41%),差异有统计学意义(χ^(2)=3.973,P<0.05)。治疗前两组血糖、血脂指标、体质指数、同型半胱氨酸对比,差异无统计学意义(P均>0.05);治疗后观察组血糖、血脂指标、体质指数、同型半胱氨酸低于对照组,差异有统计学意义(P均<0.05)。治疗前两组胰岛功能对比,差异无统计学意义(P>0.05);治疗后观察组胰岛功能优于对照组,差异有统计学意义(P<0.05)。观察组不良反应发生率低于对照组,差异有统计学意义(P<0.05)。结论达格列净片+盐酸二甲双胍缓释片可以有效改善患者血糖指标,保证血糖稳定,同时改善患者胰岛功能,降低对机体产生的副作用,安全性良好。

二甲双胍联合阿卡波糖治疗2型糖尿病的临床效果分析

目的:探讨二甲双胍联合阿卡波糖治疗2型糖尿病的临床效果。方法:选取2022年1月—2023年3月山东菏泽定陶区人民医院收治的68例2型糖尿病患者作为研究对象,采用随机数字表法分成观察组和对照组,各34例。对照组应用阿卡波糖治疗,观察组在对照组基础上采用二甲双胍治疗。比较两组血糖水平、胰岛功能、临床疗效及不良反应发生情况。结果:治疗前,两组糖化血红蛋白(HbA_(1c))、空腹血糖(FPG)、餐后2 h血糖(2 hPBG)水平比较,差异无统计学意义(P>0.05);治疗后,两组HbA_(1c)、FPG、2 hPBG水平低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05)。治疗前,两组胰岛β细胞功能指数、胰岛素抵抗指数比较,差异无统计学意义(P>0.05);治疗后,两组胰岛β细胞功能指数高于治疗前,且观察组高于对照组;两组胰岛素抵抗指数低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05)。观察组治疗总有效率高于对照组,差异有统计学意义(P=0.016)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:二甲双胍联合阿卡波糖治疗2型糖尿病的临床效果较好,能够降低患者血糖水平,提高胰岛功能,且安全性较高。

屈螺酮炔雌醇片联合二甲双胍治疗多囊卵巢综合征的临床效果

目的探讨屈螺酮炔雌醇片联合二甲双胍治疗多囊卵巢综合征的临床效果。方法选取2020年3月至2022年10月吉林国文医院妇科治疗的150例多囊卵巢综合征患者作为研究对象,按照随机数字表法分为对照组(75例)和观察组(75例)。对照组采用屈螺酮炔雌醇片治疗,观察组在对照组基础上联合二甲双胍治疗。比较两组性激素水平、临床指标及排卵率、妊娠率。结果治疗后,观察组睾酮、雌二醇、黄体生成素水平低于对照组,促卵泡激素水平高于对照组(P<0.05);观察组子宫内膜厚度、卵巢体积、体重指数小于对照组(P<0.05);观察组排卵率、妊娠率高于对照组(P<0.05)。结论屈螺酮炔雌醇片联合二甲双胍治疗多囊卵巢综合征可有效缓解临床症状,改善内分泌紊乱,提高排卵率及妊娠率,临床疗效较好,值得推广应用。

吡格列酮二甲双胍片联合达格列净片治疗2型糖尿病的疗效及对糖脂代谢、血清CRP、MMP-9水平的影响

目的:分析吡格列酮二甲双胍片联合达格列净片治疗2型糖尿病(Diabetes mellitus type 2,T2DM)的疗效及对糖脂代谢、血清C反应蛋白(C-reactive Protein,CRP)、基质金属蛋白酶-9(Matrix metalloproteinas-9,MMP-9)水平的影响.方法:以治疗方案的不同将我院2018年1月至2022年1月接收的102例T2DM患者分为参照组(吡格列酮二甲双胍片治疗)和联合组(吡格列酮二甲双胍片+达格列净片治疗),两组各51例.观察治疗3 m后疗效、治疗期间不良反应.于治疗前及治疗后以高效液相法测定糖化血红蛋白(Glycosylated hemoglobin,HbAlc);以放射免疫分析法测定空腹胰岛素(Fasting insulin,FIns);用血糖仪检测餐后2 h血糖(2 h postprandial blood glucose,2hPG)、空腹血糖(Fasting blood-glucose,FPG);同时采用全自动生化分化仪以终点法检测甘油三酯(Triglyceride,TG)、高密度脂蛋白胆固醇(High density lipoprotein cholesterol,HDL-C)、总胆固醇(Total cholesterol,TC)、低密度脂蛋白胆固醇(Low density lipoprotein cholesterol,LDL-C)水平.结果:联合组总有效率高于参照组(P<0.05);与治疗前相比,治疗后两组2hPG、FPG、HbAlc、FIns水平均降低(P<0.05),其中联合组更为显著(P<0.05);与治疗前相比,治疗后两组TG、TC、LDL-C水平均降低,HDL-C升高(P<0.05),其中联合组变化更为显著(P<0.05);与治疗前相比,治疗后两组CRP、MMP-9、CysC、Hcy水平均降低(P<0.05),其中联合组更为显著(P<0.05);联合组不良反应总发生率与参照组相比无明显差异(P>0.05).结论:吡格列酮二甲双胍片联合达格列净片治疗T2DM疗效显著,能改善糖脂代谢,减轻炎症,降低并发症发生率,且较安全可靠.

达格列净片联合二甲双胍片治疗2型糖尿病的临床效果

目的探讨2型糖尿病(T2DM)患者采用达格列净片联合二甲双胍片治疗的临床效果。方法选取2022年5月至2023年7月我院收治的60例T2DM患者,采用随机数字表法分成观察组和对照组各30例。对照组采用二甲双胍片治疗,观察组采用达格列净片联合二甲双胍片治疗,对两组临床疗效、血糖水平、体质量指数(BMI)、不良反应发生率进行比较。结果观察组治疗总有效率为93.33%,高于对照组的66.67%,差异有统计学意义(P<0.05);治疗后,两组空腹血糖值(FPG)、餐后2 h血糖(2hPG)、糖化血红蛋白(HbAlc)水平均下降,且观察组较对照组更低,差异有统计学意义(P<0.05);治疗后,两组BMI降低,且观察组较对照组更低,差异有统计学意义(P<0.05);观察组不良反应发生率为6.67%,稍低于对照组的13.33%,差异无统计学意义(P>0.05)。结论达格列净片联合二甲双胍片应用于T2DM患者治疗中,能够提高临床疗效,改善血糖水平,降低BMI,安全性较高。

二甲双胍片联合屈螺酮炔雌醇片(Ⅱ)治疗多囊卵巢综合征的临床获益评估

目的探讨多囊卵巢综合征(polycystic ovary syndrome,PCOS)患者能否在二甲双胍片联合屈螺酮炔雌醇片(Ⅱ)治疗中获益。方法选取2021年1月至2022年12月广州市妇女儿童医疗中心确诊的84例PCOS患者。根据治疗方案及稳态模型评估的胰岛素抵抗(homeostasis model assessment of insulin resistance,HOMA-IR)指数将患者分为单药正常组[屈螺酮炔雌醇片(Ⅱ),HOMA-IR指数<2.69,29例]、单药异常组[屈螺酮炔雌醇片(Ⅱ),HOMA-IR指数≥2.69,15例]、联合用药正常组[屈螺酮炔雌醇片(Ⅱ)+二甲双胍,HOMA-IR指数<2.69,11例]和联合用药异常组[屈螺酮炔雌醇片(Ⅱ)+二甲双胍,HOMA-IR指数≥2.69,29例],比较各组患者的黄体生成素(luteinizing hormone,LH)、睾酮(testosterone,T)、性激素结合球蛋白(sex hormone binding globulin,SHBG)、HOMA-IR指数和疗效。结果治疗前,单药异常组患者的HOMA-IR指数显著高于单药正常组(P<0.05),联合用药异常组患者的HOMA-IR指数显著高于联合用药正常组(P<0.05);治疗后,四组患者的LH、T均显著低于本组治疗前,SHBG显著高于本组治疗前(P<0.05),除单药正常组外,其余三组患者的HOMA-IR指数均显著低于本组治疗前(P<0.05);治疗后,单药异常组患者的HOMA-IR指数显著高于单药正常组(P<0.05);联合用药正常组和联合用药异常组患者的LH、T、HOMA-IR指数和SHBG比较差异均无统计学意义(P>0.05)。单药正常组和联合用药正常组患者的总有效率比较差异无统计学意义(χ^(2)=3.398,P=0.183);联合用药异常组患者的总有效率显著高于单药异常组(χ^(2)=6.360,P=0.042)。结论二甲双胍片联合屈螺酮炔雌醇片(Ⅱ)可改善PCOS患者的胰岛素抵抗,对PCOS合并胰岛素抵抗的患者采用联合方案将获益更多。