Enlightenment of COVID-19 Treated by Botanical Drugs on the Development of Drugs for Rare Diseases in China

Objective To study the feasibility of developing botanical drugs to treat intractable diseases and play an important role in dealing with major public health crises.Methods From January 1990 to May 2021,a bibliographic search was carried out on the use of botanical drugs,rare disease drugs,related registration management policies and regulations in PubMed and CNKI.The following keywords were searched in the database:Rare disease policies and regulations,orphan drugs,botanical drugs for intractable diseases,botanical drugs for the treatment of new coronary pneumonia,traditional Chinese medicine,and emergency guidelines for major public health crisis.Other data were obtained from“Chinese Pharmacopoeia”and relevant Chinese government websites for sorting and analysis.Results and Conclusion Based on 39 Chinese corresponding policies and regulations,challenges and opportunities of developing and researching drugs for treating rare diseases were found out after the analysis and comparison.Based on the study of national policies on drugs for rare diseases,the priority review and approval procedures in the drug registration,as well as China’s emergency guidelines and policies for major public health events,some problems in the use of drugs for rare diseases are found out.Therefore,it is recommended to actively adopt the property rights protection system,explore the folk prescriptions of traditional Chinese medicine and the potential of hospital preparations,and the registration review strategy of giving priority to the use of botanical drugs for rare diseases.Thus,the international status of botanical drugs for rare disease and the influence of responding to major public health events can be enhanced.

Stereotactic multi-target limbic leucotomy for treating intractable psychiatric disease in 30 patients Three-year follow-up of memory, intelligence, and psychiatric symptoms

BACKGROUND： The biochemical hypothesis of dopamine hyperfunction in the brain can explain the pathological mechanisms of schizophrenia. Surgery is performed based on limbic system circuit theory correspondence to above-mentioned hypothesis. Stereotactic surgery for the treatment of mental disorders is related to stereotactic surgery that influences the Papez circuit. OBJECTIVE： To observe the effects of stereotactic multi-target limbic leucotomy on the improvements in memory, intelligence and psychiatric symptoms in the treatment of intractable psychiatric disease. DESIGN： Self-control case analysis and follow-up of therapeutic effects. SETTING： Department of Neurosurgery, First Hospital, Hebei Medical University. PARTICIPANTS： Thirty patients with intractable psychiatric disease, who received stereotactic surgery in the Department of Neurosurgery, First Hospital, Hebei Medical University between July 2002 and August 2005, were included in this study. The patients, 21 males and 9 females, all met the diagnostic criteria of intractable psychiatric disease, determined by the national psychosurgery cooperation team in 1998. Informed consents for surgery and clinical follow-up exams were obtained from patients and/or patients＇ relatives （guardians）. METHODS： In 30 patients with intractable psychiatric disease, limbic leucotomy was performed by stereotactic technique. Multi-target radiofrequency hyperthermia was performed in the intracranial amygdaloid nucleus, anterior limb of internal capsule, callosal gyrus, among other regions. The therapeutic effects of patients were evaluated by Brief Psychiatric Rating Scale （BPRS） before surgery, and 6 months, 1, and 3 years after surgery. The Wechsler Adult Intelligence Scale （WAIS） and Clinical Memory Scale （CMS） were used to assess memory and intelligence before and after surgery. MAIN OUTCOME MEASURES： Memory, intelligence, and psychiatric symptoms of patients before and after operation. RESULTS： Thirty patients were included in the final analysis. （1） Memory and intelligence changes of patients： CMS and WAIS showed there were no significant differences in the changes of brain functions before and after operation （P 〉 0.05）. （2） Improved degree of symptoms： 5 patients were cured, 8 patients significantly improved, 8 patients improved, 3 patients had no changes, and 6 patients had recurrent symptoms. CONCLUSION： Stereotactic multi-target limbic leucotomy can improve the symptoms of patients with intractable psychiatric disease. Follow-up results showed that memory and intelligence were not noticeably improved after surgery.

Modified Titration Intratympanic Gentamicin Injection for Unilateral Intractable Ménière's Disease

This study looked into the efficacy of a modified titration protocol of intratympanic gentamicin injection（ITG） in the patients with unilateral intractable Ménière＇s disease（MD）. Modified titration protocol of ITG at a low dose（20 mg/m L） was administered to 10 patients with definite unilateral intractable MD. After initial first two fixed ITGs on weekly basis,the patients might or might not be given any more injections,depending on the appearance of unilateral vestibular loss（UVL）. ITG was terminated if the patients satisfied the criteria of UVL. All patients were followed-up for at least two years. The effects of ITG on the vertigo attack,functional level scores and postural balance were evaluated. Of the 10 cases,8 showed the sign of UVL after receiving initial two ITGs and were not given any more intratympanic injections,and the other 2 patients were administered three ITGs. A two-year follow-up revealed that complete and substantial vertigo control was achieved in 9 cases,and limited vertigo control in 1 patient. Hearing level was lowered in 2 patients. The posture stability and functional level scores were improved. Our study showed that the modified titration protocol of ITG at a low dose could effectively control vertigo in patients with unilateral intractable MD.

Study on Effect of Small Dosage Tripterygium Glycosides in Auxiliary Treatment of Intractable Still's Disease

Intractable Still’s disease, namely the intractable systemic juvenile idiopathic arthritis (JIA) is a clinical difficulty of pediatrics, and so far there still lacks any special treatment. In virtue of the markedly anti-inflammatory and immunosuppres-sive effects of tripterygium glycosides (TG, product of Huangshi Pharmaceutical Factory, 10 mg/

Fifty-Four Infantile Intractable Diarrhea Patients Treated with Integrated Traditional Chinese and Western Medicine

Objective: To explore the treatment on infantile intractable diarrhea with integrated traditional Chinese and western medicine. Methods: Paired control method was used to study 54 cases of infantile intractable diarrhea patients, who were randomly divided into the treated group and the control group (western medicine treated group). The treated group was further subdivided into two syndrome-types: Spleen deficiency diarrhea type and Spleen-Kidney Yang deficiency diarrhea type, and modified Shenling Baizhu powder (参苓白术散) and Sijunzi decoction (四君子汤) with modified Sishen pill (四神丸) were used for them respectively, while the control group was given only the conventional western drugs. At the same time, immunoglobulin (IG) and T lymphocyte transformation rate (TLTR) were observed. Results: Before treatment, IgG, IgA and TLTR of all the patients in both groups were lowered; after treatment, all of them improved, and the improvement of the treated group was more significant than that of control group (P<0.01). In the treated group, the cure rate and total effective rate were significantly higher than that of control group (P<0.01). Conclusion: Using integrated traditional Chinese and western method, the immune function of the patients were enhanced, and the function of Spleen-Stomach was recuperated, therefore satisfactory results were reached.