Formulation of technical guidelines in line with characteristics and principles of traditional Chinese medicine changes to improve quality of such preparations--interpretation of Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines / 中国中药杂志

In leading the high-quality development of Chinese medicine preparations, it is an important link to formulate the scientific, reasonable, and feasible guidelines for the change of Chinese medicines in accordance with the change characteristics and principles of the Chinese medicines is an important work to promote the Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines was formed by a broad consensus based on the characteristics and research results of the pharmaceutical changes in Traditional Chinese Medicines(TCM)with the principles of science and risk management. This guideline has clarified the basic principles and requirements for the evaluation of changes in TCM, specified the research and verification work of common change scenarios, defined the boundaries of changes in TCM, and proposed to encourage the use of new technologies, new methods, and new excipients that meet product characteristics. It will definitely promote the quality improvement and the secondary development of TCM. In this article, the revision background and main content of the guideline were introduced, and the main features of the Guideline were analyzed, in order to provide references for the industry.

Design of Chinese materia medica compound preparation based on clinical value and inheritance and innovation / 中草药

Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form in clinic of traditional Chinese medicine, the main categories and direction of research and registration of new CMM products, and an important carrier for traditional Chinese medicine inheritance and innovation. Due to the characteristics of complicated chemical constituents, weak research foundation, unclear effective components and multi-target effects, coupled with the limitations of research methods and evaluation of CMM compound preparation, how to scientifically carry out the design of CMM compound preparation has become a difficult question to answer. In this paper, from the basic attributes and requirements of drugs, combined with the discussion of research and development path, rule, strategy of new CMM compound preparation, it is proposed that the design of CMM compound preparation should be based on clinical value and inheritance and innovation, in the principle of the safety and effectivity of preparations, respecting traditional medicine experience, quality by design, whole quality evaluation, and quality uniformity and stability, etc. The pretreatment, dosage, process, dosage form, formulation design, equipment selection and industrial production in the CMM compound preparation design are also discussed.

Quality design, quality improvement and evaluation requirement by stages on new traditional chinese medicine compound preparation / 中草药

Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form and method of clinical medicine of CMM, the main categories and direction of the research and registration of new CMM products, the important part of “inheritance and development” of CMM culture, and mainly reflects the characteristics of CMM. According to the evaluation practice for many years, the research path and the knowledge of the research rules for new drugs of CMM compound were discussed, and the requirements for pharmaceutical research works of new CMM compound preparation. The pharmaceutical research on new CMM compound preparation is a process of quality design and quality improvement. The evaluation requirements of different stages for new CMM compound preparation were elaborated. It is the conclusion that the discussion of R&D path, R&D law, and R&D strategy on new CMM compound preparation will improve the technical evaluation standard system with the characteristics of CMM, increase the ability of R&D for CMM new products, promote the innovation of CMM, and accelerate the new CMM products to go on market.

Common questions and suggestions of evaluation for NDA of TCM / 中国中药杂志

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.

Ultrasound-guided aspiration and ethanol sclerotherapy (EST) for treatment of cyst recurrence in patients after previous endometriosis surgery: analysis of influencing factors using a decision tree.

STUDY OBJECTIVE: To evaluate the efficiency of transvaginal aspiration accompanied by ethanol sclerotherapy for treating cyst recurrence in patients who have previously undergone surgery to treat endometriosis and to analyze various factors that influence success rates using a data mining system. DESIGN: Retrospective cohort study (Canadian Task Force classification II-3). SETTING: Teaching hospital affiliated with Chang Gung University, Taoyuan, Taiwan. PATIENTS: One hundred ninety-six patients with endometrioma recurrence. INTERVENTION: A total of 274 transvaginal aspirations followed by sclerotherapy with 95% ethanol. Treatment times varied from immediate removal (0-10 minutes) to in situ retention. Patients were followed up at 3, 6, and 12 months to detect complications, determine the size and persistence of cysts, obtain the pelvic pain score, and assess for pregnancy or the need for repeat surgical intervention. A decision tree was used to determine factors from the collected data that most influenced the success of treatment. MEASUREMENTS AND MAIN RESULTS: Cyst size was consistently reduced until 6 months after ethanol sclerotherapy. The mean (SD) cyst reduction rate was 37.2% (42.2%), and the pain score reduction rate was 20.5% (71.5%). The antral follicle count was simultaneously increased by 36.4%. Sixty-three patients (23%) required repeated surgery during the observation period and were treated with either repeat aspiration (13.5%) or major laparoscopic or open laparotomic interventions (8.4%). Eighteen of 101 infertile patients (17.8%) achieved pregnancy. The total recovery rate (pregnancy or no persistence of symptoms or cyst) was significantly higher in patients in the groups that received longer treatment (7-10 minutes and retention) than in the groups with shorter treatment (0-6 minute) (47.0% vs 28.7%; p < .005). The highest recovery rate was observed in patients with longer treatment time, smaller cysts (≤5.05 cm), lower CA 125 level (≤62.03 IU/mL), and fewer cysts (≤3 cm) (35 of 49 [71.4%]). In patients with larger cysts and cysts with clear contents, better success can be achieved with longer treatment. The use of postoperative ovarian suppression, traditional Chinese medicine, or no therapy for 6 months before the study was not significant among groups. CONCLUSION: Ultrasound-guided sclerotherapy with 95% ethanol retention is an effective alternative therapy for recurrent ovarian endometrioma, in particular in selected patient groups.

New treatments for autosomal dominant polycystic kidney disease.

Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited kidney disease and results from mutations in PKD1 or PKD2. Cyst initiation and expansion arise from a combination of abnormal cell proliferation, fluid secretion and extracellular matrix defects and results in kidney enlargement and interstitial fibrosis. Since its first description over 200 years ago, ADPKD has been considered an untreatable condition and its management is limited to blood pressure reduction and symptomatic treatment of disease complications. Results of the recently reported TEMPO 3/4 trial thus represent a paradigm shift in demonstrating for the first time that cystic disease and loss of renal function can be slowed in humans. In this paper, we review the major therapeutic strategies currently being explored in ADPKD including a range of novel approaches in preclinical models. It is anticipated that the clinical management of ADPKD will undergo a revolution in the next decade with the translation of new treatments into routine clinical use.

Korean red ginseng improves blood pressure stability in patients with intradialytic hypotension.

Introduction. Intradialytic hypotension (IDH) is a common complication during hemodialysis which may increase mortality risks. Low dose of Korean red ginseng (KRG) has been reported to increase blood pressure. Whether KRG can improve hemodynamic stability during hemodialysis has not been examined. Methods. The 8-week study consisted of two phases: observation phase and active treatment phase. According to prehemodialysis blood pressure (BP), 38 patients with IDH were divided into group A (BP ≥ 140/90 mmHg, n = 18) and group B (BP < 140/90 mmHg, n = 20). Patients were instructed to chew 3.5 gm KRG slices at each hemodialysis session during the 4-week treatment phase. Blood pressure changes, number of sessions disturbed by symptomatic IDH, plasma levels of vasoconstrictors, blood biochemistry, and adverse effects were recorded. Results. KRG significantly reduced the degree of blood pressure drop during hemodialysis (P < 0.05) and the frequency of symptomatic IDH (P < 0.05). More activation of vasoconstrictors (endothelin-1 and angiotensin II) during hemodialysis was found. The postdialytic levels of endothelin-1 and angiotensin II increased significantly (P < 0.01). Conclusion. Chewing KRG renders IDH patients better resistance to acute BP reduction during hemodialysis via activation of vasoconstrictors. Our results suggest that KRG could be an adjuvant treatment for IDH.