炔雌醇环丙孕酮片联合血府逐瘀胶囊(TCM)治疗气滞血瘀型痤疮的临床疗效观察

Clinical Efficacy of Cyproterone Acetate/Ethinylestradiol Combined with Xuefu Zhuyu Capsule (TCM) in Treating Acne Vulgaris with Qi Stagnation and Blood Stasis Pattern

摘要: 目的：探讨炔雌醇环丙孕酮片联合血府逐瘀胶囊(TCM)治疗气滞血瘀型痤疮的临床疗效，分析炔雌醇环丙孕酮片以及血府逐瘀胶囊(TCM)对痤疮的显效性及不良反应。方法：选择我院2024年10月~2025年4月女性痤疮患者106例，治疗前均做过乳腺超声检查、经腹部子宫附件b超检查、肝肾功能检查，均为正常者。采用炔雌醇环丙孕酮片以及血府逐瘀胶囊治疗反复发作型、只口服中药无法起效型痤疮，现将治疗结果和不良反应报告如下。(1) 炔雌醇环丙孕酮片服用方法为从来月经第1天开始，24点前口服一片炔雌醇环丙孕酮片(组份2 mg醋酸环丙孕酮 + 0.035 mg炔雌醇)，连续口服21天后停药，停药7天，该过程为1个周期。停药后月经来潮，来潮当晚继续口服一片连续21天，共4个治疗周期。总有效率xx，服用该药对身体产生不良反应有月经出血淋漓不尽、腹痛、恶心呕吐、情绪不稳等，大多数病例患者可以耐受。(2) 血府逐瘀胶囊服用方法为一次口服1.2 g (每粒0.4 g)，每日2次，2周为1个疗程，根据监测数据显示，服用该药不良反应为恶心、腹胀、皮疹、瘙痒等，根据患者回访调查，并未发现该药显著不良反应。结果：总有效率为94.6%，通过两种药物的联合应用，可以使痤疮的炎性丘疹进一步消散，痘印淡化明显，且随着用药时间的延长，有效率从54%增加至94.6%。结论：炔雌醇环丙片联合血府逐瘀胶囊对于治疗气滞血瘀型痤疮具有有效性，治疗过程相对安全。通过药物警戒数据表明在整个治疗过程中具有统计学显著意义的安全范围。

Abstract: Objective: This clinical investigation systematically evaluates the therapeutic outcomes of cyproterone acetate/ethinylestradiol (CPA/EE) combined with Xuefu Zhuyu capsule (XFZYC, TCM) in managing acne vulgaris associated with qi stagnation and blood stasis pattern. The comparative analysis delineates the clinical effectiveness profiles and safety parameters of both pharmacological interventions, with particular emphasis on their synergistic mechanisms and adverse reaction patterns. Methods: A total of 106 female acne patients admitted to our hospital from October 2024 to April 2025 were enrolled. All patients underwent pre-treatment evaluations, including breast ultrasound, transabdominal pelvic ultrasound, and hepatic/renal function tests, with normal results. Cyproterone acetate and ethinylestradiol tablets combined with Xuefu Zhuyu capsule were administered to treat recurrent acne and cases unresponsive to traditional Chinese herbal medicine (TCM) alone. Treatment outcomes and adverse reactions are reported as follows: (1) Cyproterone acetate and ethinylestradiol tablets: Administration began on the first day of menstruation, with one tablet (containing 2 mg cyproterone acetate + 0.035 mg ethinylestradiol) taken orally before 24:00 daily for 21 consecutive days, followed by a 7-day withdrawal period (one treatment cycle). After menstruation resumed, the regimen was repeated for six cycles. The total effective rate was xx%. Adverse reactions included prolonged menstrual bleeding, abdominal pain, nausea/vomiting, and mood fluctuations, which were tolerable in most cases. (2) Xuefu Zhuyu capsule (TCM): Dosage: 1.2 g (0.4 g per capsule, 3 capsules) orally twice daily for fortnight per treatment course. Adverse reactions included nausea, abdominal distension, rash, and pruritus. Follow-up surveys indicated no significant adverse effects. Result: The integrated therapeutic protocol demonstrated a total clinical efficacy rate of 94.6%. Mechanistic studies revealed that the synergistic pharmacological intervention effectively accelerated the regression of inflammatory papules and significantly improved post-acne pigmentation. Longitudinal therapeutic monitoring documented progressive efficacy enhancement, with response rates demonstrating a statistically significant escalation from 54% to 94.6% throughout the treatment continuum. Conclusion: This therapeutic regimen combining cyproterone acetate/ethinylestradiol tablets with Xuefu Zhuyu capsule (XFZYC) demonstrates clinically validated efficacy in addressing acne vulgaris complicated by qi stagnation-blood stasis pattern, with pharmacovigilance data indicating statistically significant safety margins throughout therapeutic interventions.