Comparing the effects of Calendula officinalis and clotrimazole on vaginal Candidiasis: A randomized controlled trial

This triple-blind trial examined the effects of Calendula officinalis vaginal cream on the treatment of vaginal Candidiasis (primary outcome) and sexual function (secondary outcome). Married women aged 18–45 years with vaginal Candidiasis (n = 150) were recruited from April to October 2014 and randomized into Calendula and clotrimazole groups, using 5-g vaginal cream every night for seven nights. Clinical and laboratory assessments were conducted at 10–15 and 30–35 days after intervention and the female sexual function index was assessed at 30–35 days. Six women were lost to follow-up. The frequency of testing negative for Candidiasis in the Calendula group was significantly lower at the first (49% vs. 74%; odds ratio (OR) 0.32; 95% confidence interval (CI) 0.16–0.67) but higher at the second (77% vs. 34%; OR 3.1; 95% CI 1.5–6.2) follow-up compared to the clotrimazole group. The frequency of most signs and symptoms were almost equal in the two groups at the first follow-up, but were significantly lower in the Calendula group at the second follow-up. Sexual function had almost equal significant improvement in both groups. Calendula vaginal cream appears to have been effective in the treatment of vaginal Candidiasis and to have a delayed but greater long-term effect compared to clotrimazole.     

口腔溃疡膜有效成分提取方法的考察及含量测定

目的 考察不同溶剂对口腔溃疡膜中有效成分地塞米松磷酸钠和克霉唑的提取率,优化有效成分含量测定方法。方法 采用不同提取溶剂(甲醇、水、70%甲醇)对口腔溃疡膜中的有效成分进行提取,用HPLC法进行含量测定,得到最佳提取方法。结果 纯水对口腔溃疡膜中地塞米松磷酸钠和克霉唑有最好的提取效果。地塞米松磷酸钠在0.482~16.328 μg/ml范围内呈良好的线性关系(r=0.999 9),平均回收率为（103.97±1.02）%;克霉唑在5.014 5~200.580 0 μg/ml范围内呈良好的线性关系（r=0.999 8）,平均回收率为（104.23±0.63）%。结论 本研究建立的纯水提取方法操作简单,提取效率高,含量测定方法操作简便,准确性、重复性好。     

克霉唑治疗轻中度外阴阴道假丝酵母菌病的疗效及对患者依从性的影响

目的 对比分析两种剂型克霉唑在轻中度外阴阴道假丝酵母菌病(VVC)治疗中的临床价值。方法 以随机数字表法,将2019年5月—2020年8月收治的98例轻中度VVC患者予以分组,观察组49例,给予克霉唑乳膏治疗,对照组49例,给予克霉唑阴道片治疗,对两组治疗效果、症状缓解时间、不良反应发生情况及患者依从性予以观察。结果 观察组治疗总有效率为97.96%与对照组93.88%比较差异无统计学意义(χ²=0.2606,P=0.581);观察组外阴肿胀缓解时间比对照组短(2.63±0.51vs2.97±0.65 d,t=2.881,P=0.005),差异有统计学意义;观察组外阴瘙痒缓解时间比对照组短(2.35±0.47vs2.71±0.59 d,t=3.341,P=0.001);观察组阴道分泌物异常缓解时间比对照组短(2.92±0.63vs3.28±0.67 d,t=2.740,P=0.007);观察组不良反应发生率为8.16%,与对照组4.08%比较差异无统计学意义(χ²=0.178,P=0.625),;观察组用药依从率为100.00%稍高于对照组9...     

双唑泰阴道泡腾片微生物限度检查方法学验证

目的建立双唑泰阴道泡腾片微生物限度检查的验证方法。方法根据2005年版《中国药典（二部）》附录ⅪJ微生物限度检查法,对双唑泰阴道泡腾片的微生物限度检查进行方法学验证。结果平皿法可检查该制剂的霉菌、酵母菌数,薄膜过滤法可检查该制剂的细菌、控制菌数。结论薄膜过滤法能有效去除双唑泰阴道泡腾片中的杀菌成分,使污染的微生物得以生长,故能较好地对细菌和控制菌进行检测。     

复方替硝唑栓剂体内外抗阴道毛滴虫研究

目的观察复方替硝唑栓剂的体内外抗阴道毛滴虫作用。方法将临床确诊的滴虫性阴道炎患者100例随机分为两纽，试验纽用复方替硝唑栓治疗，对照组用双唑泰栓治疗，每晚睡前放入阴道1粒。6d为1个疗程，共治疗2个疗程；选用临床分离的阴道毛滴虫9株。观察复方替硝唑栓的体外抗阴道毛滴虫作用。结果临床治愈率复方替硝唑栓为100％，双唑泰栓为78．7％，两者有显著性差异（P〈0．05）；复方替硝唑栓体外抗阴道毛滴虫的抑虫50％浓度（MIC50）、抑虫90％浓度（MIC50）厦最低杀虫浓度（MBC）范围均低于双唑泰栓。结论复方替硝唑检体内外抗阴道毛滴虫作用显著．比双唑泰栓疗效更佳。     

复方奥硝唑栓的制备及质量控制

目的研究复方奥硝唑栓制备工艺及质量控制。方法用高效液相色谱法,20RBA×Eclipse×C8柱（150mm×4.6 mm,5μm）,以甲醇-水-三乙胺（70∶30∶0.3）（含庚烷磺酸钠10 mol·L·mL^-1^-1,用磷酸调pH至4.0）为流动相,检测波长为260 nm,流速为1 mL·min^-1,分别测定奥硝唑、克霉唑的含量。结果奥硝唑在40-240μg·mL^-1,克霉唑在32-192μg·mL^-1线性关系良好,r值分别为0.9998和0.9996,平均回收率分别为99.10%和98.35%。结论复方奥硝唑栓配方合理,制备工艺简单,质控方法可靠,稳定性良好。     

Clinical comparison of the efficacy and tolerability of once daily Canesten with twice daily Nizoral (clotrimazole 1% cream vs. ketoconazole 2% cream) during a 28-day topical treatment of interdigital tinea pedis

The effects of two topical cream formulations containing clotrimazole 1% and ketoconazole 2%, respectively, were clinically compared in a double-blind, randomized manner for a 28-day therapy of interdigital tinea pedis in 106 treated patients. Ketoconazole was to be used twice daily whereas clotrimazole was administered only once daily. The primary response criterion defined as the number of patients with cure or improvement after 28 treatment days was comparable with 62.0% vs. 64.0% (clotrimazole vs. ketoconazole) for the full analysis set of 100 (50 vs. 50) patients. The mycological response revealed a negative culture and microscopy in 53.1% vs. 52.1% of the patients after 14, in 76.0% vs. 79.2% after 28, and in 83.7% vs. 76.9% after 56 days of observation, indicating a possibly better long-term efficacy of clotrimazole. The development of the overall score of tinea-related signs and symptoms did not show relevant differences between the two drugs and continuously decreased from 11+/-5 in both groups at baseline to 2+/-2 vs. 2+/-1 at day 56. As to the remission and improvement rates of single symptoms, better results were obtained under clotrimazole than under ketoconazole particularly for pruritus (97.8 vs. 89.6%) and burning/stinging (97.5 vs. 89.4%) which both are perceived as most bothersome by the patients. Furthermore, both substances appeared as comparably safe and well tolerable (8 vs. 7 adverse events with only 1 vs. 3 drug related). In conclusion, a successful therapy of tinea pedis can be achieved with both clotrimazole and ketoconazole within 28 days of treatment and once-daily clotrimazole is equally effective as twice-daily ketoconazole with favourable influences on the most irritating symptoms of the disease. Mycological and reliable clinical cure cannot be observed during two weeks after start of treatment.     

孚康栓联合双唑泰泡腾片治疗念珠菌性外阴阴道炎的疗效观察

目的 :探讨孚康栓联合双唑泰泡腾片治疗初发性念珠菌性外阴阴道炎在第一疗程的疗效及应用价值。方法 :对 86例念珠菌性外阴阴道炎患者随机分为两组各 4 3例 ,治疗组 (孚康栓 +双唑泰泡腾片 )及对照组 (孚康栓 )放入阴道深处。结果 :治疗组的近期疗效及远期治愈率均高于对照组 (P <0 0 5 )。结论 :孚康栓 +双唑泰泡腾片治疗念珠菌性外阴阴道炎治愈率高 ,复发率低 ,副作用小 ,价格低廉 ,易于患者接受     

A clinical multicenter study comparing efficacy and tolerability of topical combination therapy with clotrimazole (Canesten, two formats) with oral single dose fluconazole (Diflucan) in vulvovaginal mycoses

Two topical formats containing clotrimazole [500 mg single dose vaginal tablet (VT) or 10% single dose vaginal cream (VC) for intravaginal use] combined with additional clotrimazole cream for topical application to the vulval area (Canesten 1 Combi, Bayer AG, Leverkusen, Germany) were compared with oral fluconazole 150 mg single dose treatment of vulvovaginal mycosis (VVM) in a single-blind clinical study. The objective of the study was to demonstrate the equivalent efficacy of the clotrimazole combination therapies (VT + 1% cream and VC + 2% cream), and fluconazole 150 mg oral capsule (Diflucan 1, Pfizer Gmbh, Karlsruhe, Germany) in terms of overall response defined as clinical cure and mycological resolution. Overall, combination therapies containing either clotrimazole 500 mg VTs or clotrimazole 10% VC were as effective as a single dose fluconazole 150 mg oral tablet in treating VVM with rates for overall response being 66%, 61% and 60%, respectively, after 14 days. There were no significant differences in the time to onset of symptom relief in the clotrimazole 500 mg tablet group and clotrimazole 10% VC compared with fluconazole 150 mg oral capsules. Only 50% of 88 patients across treatment groups with mycological recurrence also experienced return of symptoms over the entire 8 week follow-up period. All treatments administered were safe and well-tolerated and the number of patients experiencing adverse events was low.     

Direct Formation of Nanospheres from Amphiphilic β-Cyclodextrin Inclusion Complexes

Purpose. The aim of this work was to develop and characterize a highly loaded nanoparticulate system based on amphiphilic -cyclodextrins (CDs) to facilitate the parenteral administration of poorly soluble antifungal model drugs bifonazole and clotrimazole. Methods. Inclusion complexes were characterized with spectroscopic techniques. Particle size distribution of nanospheres were determined by photon correlation spectroscopy (PCS). Nanospheres were assessed for hemolytic activity. Entrapped and released drug quantities were determined and minimum inhibitory concentration (MIC) values of drugs, amphiphilic -CDs, and drug loaded nanospheres were evaluated. Results. 1:1 inclusion complexes of model drugs with amphiphilic -CDs gave nanospheres <300 nm (polydispersity index < 0.15) by nanoprecipitation technique without using surfactants. By direct preparation from preformed inclusion complexes, loading was increased 2- to 8-fold depending on CD type and loading technique. Conventionally loaded CD nanospheres displayed immediate release whereas preloaded and highly loaded nanospheres liberated model drugs over a period of 1 h reducing the initial burst effect. MIC values of bifonazole and clotrimazole were lowered significantly when associated to amphiphilic -CD nanospheres. Conclusion. Amphiphilic -CDs form nonsurfactant, highly loaded nanospheres with lower hemolytic activity than that of natural CDs directly from inclusion complexes. They enhanced solubility and subsequently therapeutic efficacy of the model drugs.